The Protection Of Women From Domestic Violence Act, 2005
ACT NO. 43 OF 2005
[13th September, 2005.]
An Act to provide for more effective protection of the rights of women guaranteed under the Constitution who are victims of violence of any kind occurring within the family and formatters connected therewith or incidental thereto.
BE it enacted by Parliament in the Fifty-sixth Year of the Republic of India as follows:—
TABLE OF CONTENTS
CHAPTER I
PRELIMINARY
1. Short title, extent and commencement—(1) This Act may be called the Protection of Women from Domestic Violence Act, 2005.
(2) It extends to the whole of India
(3) It shall come into force on such date2 as the Central Government may, by notification in the Official Gazette, appoint.
2. Definitions—In this Act, unless the context otherwise requires,—
(a) “aggrieved person” means any woman who is, or has been, in a domestic relationship with the respondent and who alleges to have been subjected to any act of domestic violence by the respondent;
(b) “child” means any person below the age of eighteen years and includes any adopted, step or foster child;
(c) “compensation order” means an order granted in terms of section 22;
(d) “custody order” means an order granted in terms of section 21;
(e) “domestic incident report” means a report made in the prescribed form on receipt of a complaint of domestic violence from an aggrieved person;
(f) “domestic relationship” means a relationship between two persons who live or have, at any point of time, lived together in a shared household, when they are related by consanguinity, marriage, or through a relationship in the nature of marriage, adoption or are family members living together as a joint family;
(g) “domestic violence” has the same meaning as assigned to it in section 3;
(h) “dowry” shall have the same meaning as assigned to it in section 2 of the Dowry Prohibition Act, 1961 (28 of 1961);
(i) “Magistrate” means the Judicial Magistrate of the first class, or as the case may be, the Metropolitan Magistrate, exercising jurisdiction under the Code of Criminal Procedure, 1973(2 of 1974) in the area where the aggrieved person resides temporarily or otherwise or the respondent resides or the domestic violence is alleged to have taken place;
(j) “medical facility” means such facility as may be notified by the State Government to be a medical facility for the purposes of this Act;
(k) “monetary relief” means the compensation which the Magistrate may order the respondent to pay to the aggrieved person, at any stage during the hearing of an application seeking any relief under this Act, to meet the expenses incurred and the losses suffered by the aggrieved person as a result of the domestic violence;
(l) “notification” means a notification published in the Official Gazette and the expression “notified” shall be construed accordingly;
(m) “prescribed” means prescribed by rules made under this Act;
(n) “Protection Officer” means an officer appointed by the State Government under sub-section (1) of section 8;
(o) “protection order” means an order made in terms of section 18;
(p) “residence order” means an order granted in terms of sub-section (1) of section 19;
(q) “respondent” means any adult male person who is, or has been, in a domestic relationship with the aggrieved person and against whom the aggrieved person has sought any relief under this Act: Provided that an aggrieved wife or female living in a relationship in the nature of a marriage may also file a complaint against a relative of the husband or the male partner;
(r) “service provider” means an entity registered under sub-section (1) of section 10;
(s) “shared household” means a household where the person aggrieved lives or at any stage has lived in a domestic relationship either singly or along with the respondent and includes such a house hold whether owned or tenanted either jointly by the aggrieved person and the respondent, or owned or tenanted by either of them in respect of which either the aggrieved person or the respondent or both jointly or singly have any right, title, interest or equity and includes such a household which may belong to the joint family of which the respondent is a member, irrespective of whether the respondent or the aggrieved person has any right, title or interest in the shared household;
(t) “shelter home” means any shelter home as may be notified by the State Government to be as helter home for the purposes of this Act.
CHAPTER II
DOMESTIC VIOLENCE
3. Definition of domestic violence—For the purposes of this Act, any act, omission or commission or conduct of the respondent shall constitute domestic violence in case it—
(a) harms or injures or endangers the health, safety, life, limb or well-being, whether mental or physical, of the aggrieved person or tends to do so and includes causing physical abuse, sexual abuse, verbal and emotional abuse and economic abuse; or
(b) harasses, harms, injures or endangers the aggrieved person with a view to coerce her or any other person related to her to meet any unlawful demand for any dowry or other property or valuable security; or
(c) has the effect of threatening the aggrieved person or any person related to her by any conduct mentioned in clause (a) or clause (b); or (d) otherwise injures or causes harm, whether physical or mental, to the aggrieved person.
Explanation I—For the purposes of this section,—
(i) “physical abuse” means any act or conduct which is of such a nature as to cause bodily pain, harm, or danger to life, limb, or health or impair the health or development of the aggrieved person and includes assault, criminal intimidation and criminal force;
(ii) “sexual abuse” includes any conduct of a sexual nature that abuses, humiliates, degrades or otherwise violates the dignity of woman;
(iii) “verbal and emotional abuse” includes—
(a) insults, ridicule, humiliation, name calling and insults or ridicule specially with regard to not having a child or a male child; and
(b) repeated threats to cause physical pain to any person in whom the aggrieved person is interested;
(iv) “economic abuse” includes—
(a) deprivation of all or any economic or financial resources to which the aggrieved person is entitled under any law or custom whether payable under an order of a court or otherwise or which the aggrieved person requires out of necessity including, but not limited 5 to, house hold necessities for the aggrieved person and her children, if any, stridhan, property, jointly or separately owned by the aggrieved person, payment of rental related to the shared house hold and maintenance;
(b) disposal of household effects, any alienation of assets whether movable or immovable, valuables, shares, securities, bonds and the like or other property in which the aggrieved person has an interest or is entitled to use by virtue of the domestic relationship or which may be reasonably required by the aggrieved person or her children or her stridhan or any other property jointly or separately held by the aggrieved person; and
(c) prohibition or restriction to continued access to resources or facilities which the aggrieved person is entitled to use or enjoy by virtue of the domestic relationship including access to the shared household.
Explanation II—For the purpose of determining whether any act, omission, commission or conduct of the respondent constitutes “domestic violence” under this section, the overall facts and circumstances of the case shall be taken into consideration.
CHAPTER III
POWERS AND DUTIES OF PROTECTION OFFICERS, SERVICE PROVIDERS, ETC
4. Information to Protection Officer and exclusion of liability of informant—
(1) Any person who has reason to believe that an act of domestic violence has been, or is being, or is likely to be committed, may give information about it to the concerned Protection Officer.
(2) No liability, civil or criminal, shall be incurred by any person for giving in good faith of information for the purpose of sub-section (1).
5. Duties of police officers, service providers and Magistrate—A police officer, Protection Officer, service provider or Magistrate who has received a complaint of domestic violence or is otherwise present at the place of an incident of domestic violence or when the incident of domestic violence is reported to him, shall inform the aggrieved person—
(a) of her right to make an application for obtaining a relief by way of a protection order, an order for monetary relief, a custody order, a residence order, a compensation order or more than one such order under this Act;
(b) of the availability of services of service providers;
(c) of the availability of services of the Protection Officers;
(d) of her right to free legal services under the Legal Services Authorities Act, 1987 (39 of 1987);
(e) of her right to file a complaint under section 498A of the Indian Penal Code (45 of 1860),wherever relevant:
Provided that nothing in this Act shall be construed in any manner as to relieve a police officer from his duty to proceed in accordance with law upon receipt of information as to the commission of a cognizable offence.
6. Duties of shelter homes—If an aggrieved person or on her behalf a Protection Officer or a service provider requests the person in charge of a shelter home to provide shelter to her, such person in charge of the shelter home shall provide shelter to the aggrieved person in the shelter home.
7. Duties of medical facilities—If an aggrieved person or, on her behalf a Protection Officer or a service provider requests the person in charge of a medical facility to provide any medical aid to her, such person in charge of the medical facility shall provide medical aid to the aggrieved person in the medical facility.
8. Appointment of Protection Officers—(1) The State Government shall, by notification, appoint such number of Protection Officers in each district as it may consider necessary and shall also notify the area or areas within which a Protection Officer shall exercise the powers and perform the duties conferred on him by or under this Act.
(2) The Protection Officers shall as far as possible be women and shall possess such qualifications and experience as may be prescribed.
(3) The terms and conditions of service of the Protection Officer and the other officers subordinate to him shall be such as may be prescribed.
9. Duties and functions of Protection Officers—(1) It shall be the duty of the Protection Officer—
(a) to assist the Magistrate in the discharge of his functions under this Act;
(b) to make a domestic incident report to the Magistrate, in such form and in such manner as may be prescribed, upon receipt of a complaint of domestic violence and forward copies thereof to the police officer in charge of the police station within the local limits of whose jurisdiction domestic violence is alleged to have been committed and to the service providers in that area;
(c) to make an application in such form and in such manner as may be prescribed to the Magistrate, if the aggrieved person so desires, claiming relief for issuance of a protection order;
(d) to ensure that the aggrieved person is provided legal aid under the Legal Services Authorities Act, 1987 (39 of 1987) and make available free of cost the prescribed form in which a complaint is to be made;
(e) to maintain a list of all service providers providing legal aid or counselling, shelter homes and medical facilities in a local area within the jurisdiction of the Magistrate;
(f) to make available a safe shelter home, if the aggrieved person so requires and forward a copy of his report of having lodged the aggrieved person in a shelter home to the police station and the Magistrate having jurisdiction in the area where the shelter home is situated;
(g) to get the aggrieved person medically examined, if she has sustained bodily injuries and forward a copy of the medical report to the police station and the Magistrate having jurisdiction in the area where the domestic violence is alleged to have been taken place;
(h) to ensure that the order for monetary relief under section 20 is complied with and executed, in accordance with the procedure prescribed under the Code of Criminal Procedure, 1973 (2 of 1974);
(i) to perform such other duties as may be prescribed.
(2) The Protection Officer shall be under the control and supervision of the Magistrate, and shall perform the duties imposed on him by the Magistrate and the Government by, or under, this Act.
10. Service providers—(1) Subject to such rules as may be made in this behalf, any voluntary association registered under the Societies Registration Act, 1860 (21 of 1860) or a company registered under the Companies Act, 1956 (1 of 1956) or any other law for the time being in force with the objective of protecting the rights and interests of women by any lawful means including providing of legal aid, medical, financial or other assistance shall register itself with the State Government as a service provider for the purposes of this Act.
(2) A service provider registered under sub-section (1) shall have the power to—
(a) record the domestic incident report in the prescribed form if the aggrieved person so desires and forward a copy thereof to the Magistrate and the Protection Officer having jurisdiction in the area where the domestic violence took place;
(b) get the aggrieved person medically examined and forward a copy of the medical repot to the Protection Officer and the police station within the local limits of which the domestic violence took place;
(c) ensure that the aggrieved person is provided shelter in a shelter home, if she so requires and forward a report of the lodging of the aggrieved person in the shelter home to the police station within the local limits of which the domestic violence took place.
(3) No suit, prosecution or other legal proceeding shall lie against any service provider or any member of the service provider who is, or who is deemed to be, acting or purporting to act under this Act, for anything which is in good faith done or intended to be done in the exercise of powers or discharge of functions under this Act towards the prevention of the commission of domestic violence.
11. Duties of Government—The Central Government and every State Government, shall take all measures to ensure that—
(a) the provisions of this Act are given wide publicity through public media including the television, radio and the print media at regular intervals;
(b) the Central Government and State Government officers including the police officers and the members of the judicial services are given periodic sensitization and awareness training on the issues addressed by this Act;
(c) effective co-ordination between the services provided by concerned Ministries and Departments dealing with law, home affairs including law and order, health and human resources to address issues of domestic violence is established and periodical review of the same is conducted;
(d) protocols for the various Ministries concerned with the delivery of services to women under this Act including the courts are prepared and put in place.
CHAPTER IV
PROCEDURE FOR OBTAININGORDERS OF RELIEFS
12. Application to Magistrate—(1) An aggrieved person or a Protection Officer or any other person on behalf of the aggrieved person may present an application to the Magistrate seeking one or more reliefs under this Act:
Provided that before passing any order on such application, the Magistrate shall take into consideration any domestic incident report received by him from the Protection Officer or the service provider.
(2) The relief sought for under sub-section (1) may include a relief for issuance of an order for payment of compensation or damages without prejudice to the right of such person to institute a suit for compensation or damages for the injuries caused by the acts of domestic violence committed by the respondent:
Provided that where a decree for any amount as compensation or damages has been passed by any court in favour of the aggrieved person, the amount, if any, paid or payable in pursuance of the order made by the Magistrate under this Act shall be set off against the amount payable under such decree and the decree shall, notwithstanding anything contained in the Code of Civil Procedure, 1908 (5 of 1908), or any other law for the time being in force, be executable for the balance amount, if any, left after such set off.
(3) Every application under sub-section (1) shall be in such form and contain such particulars as may be prescribed or as nearly as possible thereto.
(4) The Magistrate shall fix the first date of hearing, which shall not ordinarily be beyond three days from the date of receipt of the application by the court.
(5) The Magistrate shall Endeavour to dispose of every application made under sub-section (1) within a period of sixty days from the date of its first hearing.
13. Service of notice—(1) A notice of the date of hearing fixed under section 12 shall be given by the Magistrate to the Protection Officer, who shall get it served by such means as may be prescribed on the respondent, and on any other person, as directed by the Magistrate within a maximum period of two days or such further reasonable time as may be allowed by the Magistrate from the date of its receipt.
(2) A declaration of service of notice made by the Protection Officer in such form as may be prescribed shall be the proof that such notice was served upon the respondent and on any other person as directed by the Magistrate unless the contrary is proved.
14. Counselling—(1) The Magistrate may, at any stage of the proceedings under this Act, direct the respondent or the aggrieved person, either singly or jointly, to undergo counselling with any member of a service provider who possess such qualifications and experience in counselling as may be prescribed.
(2) Where the Magistrate has issued any direction under sub-section (1), he shall fix the next date of hearing of the case within a period not exceeding two months.
15. Assistance of welfare expert—In any proceeding under this Act, the Magistrate may secure the services of such person, preferably a woman, whether related to the aggrieved person or not, including a person engaged in promoting family welfare as he thinks fit, for the purpose of assisting him in discharging his functions.
16. Proceedings to be held in camera—If the Magistrate considers that the circumstances of the case so warrant, and if either party to the proceedings so desires, he may conduct the proceedings under this Act in camera.
17. Right to reside in a shared household—(1) Notwithstanding anything contained in any other law for the time being in force, every woman in a domestic relationship shall have the right to reside in the shared household, whether or not she has any right, title or beneficial interest in the same.
(2) The aggrieved person shall not be evicted or excluded from the shared household or any part of it by the respondent save in accordance with the procedure established by law.
18. Protection orders—The Magistrate may, after giving the aggrieved person and the respondent an opportunity of being heard and on being prima facie satisfied that domestic violence has taken place or is likely to take place, pass a protection order in favour of the aggrieved person and prohibit the respondent from—
(a) committing any act of domestic violence;
(b) aiding or abetting in the commission of acts of domestic violence;
(c) entering the place of employment of the aggrieved person or, if the person aggrieved is a child, its school or any other place frequented by the aggrieved person;
(d) attempting to communicate in any form, whatsoever, with the aggrieved person, including personal, oral or written or electronic or telephonic contact;
(e) alienating any assets, operating bank lockers or bank accounts used or held or enjoyed by both the parties, jointly by the aggrieved person and the respondent or singly by the respondent, including her stridhan or any other property held either jointly by the parties or separately by them without the leave of the Magistrate;
(f) causing violence to the dependants, other relatives or any person who give the aggrieved person assistance from domestic violence;
(g) committing any other act as specified in the protection order.
19. Residence orders—(1) While disposing of an application under sub-section (1) of section12, the Magistrate may, on being satisfied that domestic violence has taken place, pass a residence order—
(a) restraining the respondent from dispossessing or in any other manner disturbing the possession of the aggrieved person from the shared household, whether or not the respondent has a legal or equitable interest in the shared household;
(b) directing the respondent to remove himself from the shared household;
(c) restraining the respondent or any of his relatives from entering any portion of the shared household in which the aggrieved person resides;
(d) restraining the respondent from alienating or disposing off the shared household or encumbering the same;
(e) restraining the respondent from renouncing his rights in the shared household except with the leave of the Magistrate; or
(f) directing the respondent to secure same level of alternate accommodation for the aggrieved person as enjoyed by her in the shared household or to pay rent for the same, if the circumstances so require:
Provided that no order under clause (b) shall be passed against any person who is a woman.
(2) The Magistrate may impose any additional conditions or pass any other direction which he may deem reasonably necessary to protect or to provide for the safety of the aggrieved person or any child of such aggrieved person.
(3) The Magistrate may require from the respondent to execute a bond, with or without sureties, for preventing the commission of domestic violence.
(4) An order under sub-section (3) shall be deemed to be an order under Chapter VIII of the Code of Criminal Procedure, 1973 (2 of 1974) and shall be dealt with accordingly.
(5) While passing an order under sub-section (1), sub-section (2) or sub-section (3), the court may also pass an order directing the officer in charge of the nearest police station to give protection to the aggrieved person or to assist her or the person making an application on her behalf in the implementation of the order.
(6) While making an order under sub-section (1), the Magistrate may impose on the respondent obligations relating to the discharge of rent and other payments, having regard to the financial needs and resources of the parties.
(7) The Magistrate may direct the officer in-charge of the police station in whose jurisdiction the Magistrate has been approached to assist in the implementation of the protection order.
(8) The Magistrate may direct the respondent to return to the possession of the aggrieved person her stridhan or any other property or valuable security to which she is entitled to.
20. Monetary reliefs—(1) While disposing of an application under sub-section (1) of section 12,the Magistrate may direct the respondent to pay monetary relief to meet the expenses incurred and losses suffered by the aggrieved person and any child of the aggrieved person as a result of the domestic violence and such relief may include, but not limited to,—
(a) the loss of earnings;
(b) the medical expenses;
(c) the loss caused due to the destruction, damage or removal of any property from the control of the aggrieved person; and
(d) the maintenance for the aggrieved person as well as her children, if any, including an order under or in addition to an order of maintenance under section 125 of the Code of Criminal Procedure, 1973 (2 of 1974) or any other law for the time being in force.
(2) The monetary relief granted under this section shall be adequate, fair and reasonable and consistent with the standard of living to which the aggrieved person is accustomed.
(3) The Magistrate shall have the power to order an appropriate lump sum payment or monthly payments of maintenance, as the nature and circumstances of the case may require.
(4) The Magistrate shall send a copy of the order for monetary relief made under sub-section (1) to the parties to the application and to the in charge of the police station within the local limits of whose jurisdiction the respondent resides.
(5) The respondent shall pay the monetary relief granted to the aggrieved person within the period specified in the order under sub-section (1).
(6) Upon the failure on the part of the respondent to make payment in terms of the order under sub-section (1), the Magistrate may direct the employer or a debtor of the respondent, to directly pay to the aggrieved person or to deposit with the court a portion of the wages or salaries or debt due to or accrued to the credit of the respondent, which amount may be adjusted towards the monetary relief payable by the respondent.
21. Custody orders—Notwithstanding anything contained in any other law for the time being in force, the Magistrate may, at any stage of hearing of the application for protection order or for any other relief under this Act grant temporary custody of any child or children to the aggrieved person or the person making an application on her behalf and specify, if necessary, the arrangements for visit of such child or children by the respondent:
Provided that if the Magistrate is of the opinion that any visit of the respondent may be harmful to the interests of the child or children, the Magistrate shall refuse to allow such visit.
22. Compensation orders—In addition to other reliefs as may be granted under this Act, the Magistrate may on an application being made by the aggrieved person, pass an order directing the respondent to pay compensation and damages for the injuries, including mental torture and emotional distress, caused by the acts of domestic violence committed by that respondent.
23. Power to grant interim and ex parte orders—(1) In any proceeding before him under this Act, the Magistrate may pass such interim order as he deems just and proper.
(2) If the Magistrate is satisfied that an application prima facie discloses that the respondent is committing, or has committed an act of domestic violence or that there is a likelihood that the respondent may commit an act of domestic violence, he may grant an ex parte order on the basis of the affidavit in such form, as may be prescribed, of the aggrieved person under section18, section 19, section 20, section 21 or, as the case may be, section 22 against the respondent.
24. Court to give copies of order free of cost—The Magistrate shall, in all cases where he has passed any order under this Act, order that a copy of such order, shall be given free of cost, to the parties to the application, the police officer in-charge of the police station in the jurisdiction of which the Magistrate has been approached, and any service provider located within the local limits of the jurisdiction of the court and if any service provider has registered a domestic incident report, to that service provider.
25. Duration and alteration of orders—(1) A protection order made under section 18 shall be in force till the aggrieved person applies for discharge.
(2) If the Magistrate, on receipt of an application from the aggrieved person or the respondent, is satisfied that there is a change in the circumstances requiring alteration, modification or revocation of any order made under this Act, he may, for reasons to be recorded in writing pass such order, as he may deem appropriate.
26. Relief in other suits and legal proceedings—(1) Any relief available under sections 18, 19,20, 21 and 22 may also be sought in any legal proceeding, before a civil court, family court or a criminal court, affecting the aggrieved person and the respondent whether such proceeding was initiated before or after the commencement of this Act.
(2) Any relief referred to in sub-section (1) may be sought for in addition to and along with any other relief that the aggrieved person may seek in such suit or legal proceeding before a civil or criminal court.
(3) In case any relief has been obtained by the aggrieved person in any proceedings other than a proceeding under this Act, she shall be bound to inform the Magistrate of the grant of such relief.
27. Jurisdiction—(1) The court of Judicial Magistrate of the first class or the Metropolitan Magistrate, as the case may be, within the local limits of which—
(a) the person aggrieved permanently or temporarily resides or carries on business or is employed; or
(b) the respondent resides or carries on business or is employed; or
(c) the cause of action has arisen, shall be the competent court to grant a protection order and other orders under this Act and to try offences under this Act. (2) Any order made under this Act shall be enforceable throughout India.
28. Procedure—(1) Save as otherwise provided in this Act, all proceedings under sections 12,18, 19, 20, 21, 22 and 23 and offences under section 31 shall be governed by the provisions of the Code of Criminal Procedure, 1973 (2 of 1974).
(2) Nothing in sub-section (1) shall prevent the court from laying down its own procedure for disposal of an application under section 12 or under sub-section (2) of section 23.
29. Appeal—There shall lie an appeal to the Court of Session within thirty days from the date on which the order made by the Magistrate is served on the aggrieved person or the respondent, as the case may be, whichever is later.
CHAPTER V
MISCELLANEOUS
30. Protection Officers and members of service providers to be public servants—The Protection Officers and members of service providers, while acting or purporting to act in pursuance of any of the provisions of this Act or any rules or orders made thereunder shall be deemed to be public servants within the meaning of section 21 of the Indian Penal Code (45 of 1860).
31. Penalty for breach of protection order by respondent—(1) A breach of protection order, or of an interim protection order, by the respondent shall be an offence under this Act and shall be punishable with imprisonment of either description for a term which may extend to one year, or with fine which may extend to twenty thousand rupees, or with both.
(2) The offence under sub-section (1) shall as far as practicable be tried by the Magistrate who had passed the order, the breach of which has been alleged to have been caused by the accused.
(3) While framing charges under sub-section (1), the Magistrate may also frame charges under section 498A of the Indian Penal Code (45 of 1860) or any other provision of that Code or the Dowry Prohibition Act, 1961 (28 of 1961), as the case may be, if the facts disclose the commission of an offence under those provisions.
32. Cognizance and proof—(1) Notwithstanding anything contained in the Code of Criminal Procedure, 1973 (2 of 1974), the offence under sub-section (1) of section 31 shall be cognizable and non-bailable. (2) Upon the sole testimony of the aggrieved person, the court may conclude that an offence under sub-section (1) of section 31 has been committed by the accused.
33. Penalty for not discharging duty by Protection Officer—If any Protection Officer fails or refuses to discharge his duties as directed by the Magistrate in the protection order without any sufficient cause, he shall be punished with imprisonment of either description for a term which may extend to one year, or with fine which may extend to twenty thousand rupees, or with both.
34. Cognizance of offence committed by Protection Officer—No prosecution or other legal proceeding shall lie against the Protection Officer unless a complaint is filed with the previous sanction of the State Government or an officer authorised by it in this behalf.
35. Protection of action taken in good faith—No suit, prosecution or other legal proceeding shall lie against the Protection Officer for any damage caused or likely to be caused by anything which is in good faith done or intended to be done under this Act or any rule or order made thereunder. 36. Act not in derogation of any other law.—The provisions of this Act shall be in addition to, and not in derogation of the provisions of any other law, for the time being in force.
37. Power of Central Government to make rules—(1) The Central Government may, by notification, make rules for carrying out the provisions of this Act.
(2) In particular, and without prejudice to the generality of the foregoing power, such rules may provide for all or any of the following matters, namely:—
(a) the qualifications and experience which a Protection Officer shall possess under sub-section (2) of section 8;
(b) the terms and conditions of service of the Protection Officers and the other officers subordinate to him, under sub-section (3) of section 8;
(c) the form and manner in which a domestic incident report may be made under clause (b) of sub-section (1) of section 9;
(d) the form and the manner in which an application for protection order may be made to the Magistrate under clause (c) of sub-section (1) of section 9;
(e) the form in which a complaint is to be filed under clause (d) of sub-section (1) of section 9;
(f) the other duties to be performed by the Protection Officer under clause (i) of sub-section (1) of section 9;
(g) the rules regulating registration of service providers under sub-section (1) of section 10;
(h) the form in which an application under sub-section (1) of section 12 seeking reliefs under this Act may be made and the particulars which such application shall contain under sub-section (3) of that section;
(i) the means of serving notices under sub-section (1) of section 13;
(j) the form of declaration of service of notice to be made by the Protection Officer under sub-section (2) of section 13;
(k) the qualifications and experience in counselling which a member of the service provider shall possess under sub-section (1) of section 14;
(l) the form in which an affidavit may be filed by the aggrieved person under sub-section (2) of section 23;
(m) any other matter which has to be, or may be, prescribed.
(3) Every rule made under this Act shall be laid, as soon as may be after it is made, before each House of Parliament, while it is in session, for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rule or both Houses agree that the rule should not be made, the rule shall thereafter have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule.
The Motor Vehicles Act, 1988
ACT NO. 59 OF 1988
[14th October, 1988.]
An Act to consolidate and amend the law relating to motor vehicles. BE it enacted by Parliament in the Thirty-ninth Year of the Republic of India as follows:—
TABLE OF CONTENTS
CHAPTER I
PRELIMINARY
1. Short title, extent and commencement.— (1) This Act may be called the Motor Vehicles Act, 1988.
(2) It extends to the whole of India.
(3) It shall come into force on such date1 as the Central Government may, by notification in the Official Gazette, appoint; and different dates may be appointed for different State and any reference in this Act to the commencement of this Act shall, in relation to a State, be construed as a reference to the coming into force of this Act in that State.
2. Definitions—In this Act, unless the context otherwise requires,—
(1) “area”, in relation to any provision of this Act, means such area as the State Government may, having regard to the requirements of that provision, specify by notification in the Official Gazette;
(2) “articulated vehicle” means a motor vehicle to which a semitrailer is attached;
(3) “axle weight” means in relation to an axle of a vehicle the total weight transmitted by the several wheels attached to that axle to the surface on which the vehicle rests;
(4) “certificate of registration” means the certificate issued by a competent authority to the effect that a motor vehicle has been duly registered in accordance with the provisions of Chapter IV;
(5) “conductor”, in relation to a stage carriage, means a person engaged in collecting fares from passengers, regulating their entrance into, or exit from, the stage carriage and performing such other functions as may be prescribed;
(6) “conductor’s licence” means the licence issued by a competent authority under Chapter III authorising the person specified therein to act as a conductor;
(7) “contract carriage” means a motor vehicle which carries a passenger or passenger or passengers for hire or reward and is engaged under a contract, whether expressed or implied, for the use of such vehicle as a whole for the carriage of passengers mentioned therein and entered into by a person with a holder of a permit in relation to such vehicle or any person authorised by him in this behalf on a fixed or an agreed rate or sum—
(a) on a time basis, whether or not with reference to any route or distance; or
(b) from one point to another, and in either case, without stopping to pick up or set down passengers not included in the contract anywhere during the journey, and includes—
(i) a maxicab; and
(ii) a motor cab notwithstanding that separate fares are charged for its passengers;
(8) “dealer” includes a person who is engaged—
2 * * * * *
(b) in building bodies for attachment to chassis; or
(c) in the repair of motor vehicles; or
(d) in the business of hypothecation, leasing or hire-purchase of motor vehicle;
(9) “driver” includes, in relation to a motor vehicle which is drawn by another motor vehicle, the person who acts as a steersman of the drawn vehicle;
(10) “driving licence” means the licence issued by a competent authority under Chapter II authorising the person specified therein to drive, otherwise than as a learner, a motor vehicle or a motor vehicle of any specified class or description;
(11) “educational institution bus” means an omnibus, which is owned by a college, school or other educational institution and used solely for the purpose of transporting students or staff of the educational institution in connection with any of its activities;
(12) “fares” includes sums payable for a season ticket or in respect of the hire of a contract carriage;
(13) “goods” includes live-stock, and anything (other than equipment ordinarily used with the vehicle) carried by a vehicle except living persons, but does not include luggage or personal effects carried in a motor car or in a trailer attached to a motor car or the personal luggage of passengers travelling in the vehicle;
(14) “goods carriage” means any motor vehicle constructed or adapted for use solely for the carriage of goods, or any motor vehicle not so constructed or adapted when used for the carriage of goods;
(15) “gross vehicle weight” means in respect of any vehicle the total weight of the vehicle and load certified and registered by the registering authority as permissible for that vehicle;
(16) “heavy goods vehicle” means any goods carriage the gross vehicle weight of which, or a tractor or a road-roller the unladen weight of either of which, exceeds 12,000 kilograms;
(17) “heavy passenger motor vehicle” means any public service vehicle or private service vehicle or educational institution bus or omnibus the gross vehicle weight of any of which, or a motor car the unladen weight of which, exceeds 12,000 kilograms;
(18) “invalid carriage” means a motor vehicle specially designed and constructed, and not merely, adapted, for the use of a person suffering from some physical defect or disability, and used solely by or for such a person;
(19) “learner’s licence” means the licence issued by a competent authority under Chapter II authorising the person specified therein to drive as a learner, a motor vehicle or a motor vehicle of any specified class or description;
(20) “licensing authority” means an authority empowered to issue licences under Chapter II or, as the case may be, Chapter III;
(21) “light motor vehicle” means a transport vehicle or omnibus the gross vehicle weight of either of which or a motor car or tractor or road-roller the unladen weight of any of which, does not exceed 1 [7500] kilograms; 2
[(21A) “manufacturer” means a person who is engaged in the manufacture of motor vehicles;]
(22) “maxicab” means any motor vehicle constructed or adapted to carry more than six passengers, but not more than twelve passengers, excluding the driver, for hire or reward;
(23) “medium goods vehicle” means any goods carriage other than a light motor vehicle or a heavy goods vehicle;
(24) “medium passenger motor vehicle” means any public service vehicle or private service vehicle, or educational institution bus other than a motor cycle, invalid carriage, light motor vehicle or heavy passenger motor vehicle;
(25) “motorcab” means any motor vehicle constructed or adapted to carry not more than six passengers excluding the driver for hire or reward;
(26) “motor car” means any motor vehicle other than a transport vehicle, omnibus, road-roller, tractor, motor cycle or invalid carriage;
(27) “motor cycle” means a two-wheeled motor vehicle, inclusive of any detachable side-car having an extra wheel, attached to the motor vehicle;
(28) “motor vehicle” or “vehicle” means any mechanically propelled vehicle adapted for use upon roads whether the power of propulsion is transmitted thereto from an external or internal source and includes a chassis to which a body has not been attached and a trailer; but does not include a vehicle running upon fixed rails or a vehicle of a special type adapted for use only in a factory or in any other enclosed premises or a vehicle having less than four wheels fitted with engine capacity of not exceeding1 [twenty-five cubic centimetres];
(29) “omnibus” means any motor vehicle constructed or adapted to carry more than six persons excluding the driver;
(30) “owner” means a person in whose name a motor vehicle stands registered, and where such person is a minor, the guardian of such minor, and in relation to a motor vehicle which is the subject of a hire-purchase, agreement, or an agreement of lease or an agreement of hypothecation, the person in possession of the vehicle under that agreement;
(31) “permit” means a permit issued by a State or Regional Transport Authority or an authority prescribed in this behalf under this Act authorising the use of a motor vehicle as a transport vehicle;
(32) “prescribed” means prescribed by rules made under this Act;
(33) “private service vehicle” means a motor vehicle constructed or adapted to carry more than six persons excluding the driver and ordinarily used by or on behalf of the owner of such vehicle for the purpose of carrying persons for, or in connection with, his trade or business otherwise than for hire or reward but does not include a motor vehicle used for public purposes;
(34) “public place” means a road, street, way or other place, whether a thoroughfare or not, to which the public have a right of access, and includes any place or stand at which passengers are picked up or set down by a stage carriage;
(35) “public service vehicle” means any motor vehicle used or adapted to be used for the carriage of passengers for hire or reward, and includes a maxicab, a motorcab, contract carriage, and stage carriage;
(36) “registered axle weight” means in respect of the axle of any vehicle, the axle weight certified and registered by the registering authority as permissible for that axle;
(37) “registering authority” means an authority empowered to register motor vehicles under Chapter IV;
(38) “route” means a line of travel which specifies the highway which may be traversed by a motor vehicle between one terminus and another;
[(39) “semi-trailer” means a vehicle not mechanically propelled (other than a trailer), which is intended to be connected to a motor vehicle and which is so constructed that a portion of it issuperimposed on, and a part of whose weight is borne by, thatmotor vehicle;]
(40) “stage carriage” means a motor vehicle constructed or adapted to carry more than six passengers excluding the driver for hire or reward at separate fares paid by or for individual passengers, either for the whole journey or for stages of the journey;
(41) “State Government” in relation to a Union territory means the Administrator thereof appointed under article 239 of the Constitution;
(42) “State transport undertaking” means any undertaking providing road transport service, where such undertaking is carried on by,—
(i) the Central Government or a State Government;
(ii) any Road Transport Corporation established under section 3 of the Road Transport Corporations Act, 1950 (64 of 1950);
(iii) any municipality or any corporation or company owned or controlled by the Central Government or one or more State Governments, or by the Central Government and one or more State Governments;
[(iv) Zilla Parishad or any other similar local authority.]
Explanation.—For the purposes of this clause, “road transport service” means a service of motor vehicles carrying passengers or goods or both by road for hire or reward;
(43) “tourist vehicle” means a contract carriage constructed or adapted and equipped and maintained in accordance with such specifications as may be prescribed in this behalf;
(44) “tractor” means a motor vehicle which is not itself constructed to carry any load (other than equipment used for the purpose of propulsion); but excludes a road-roller;
(45) “traffic signs” includes all signals, warning sign posts, direction posts, markings on the road or other devices for the information, guidance or direction of drivers of motor vehicles;
(46) “trailer” means any vehicle, other than a semi-trailer and a side-car, drawn or intended to be drawn by a motor vehicle;
(47) “transport vehicle” means a public service vehicle, a goods carriage, an educational institution bus or a private service vehicle;
(48) “unladen weight” means the weight of a vehicle or trailer including all equipment ordinarily used with the vehicle or trailer when working, but excluding the weight of a driver or attendant; and where alternative parts or bodies are used the unladen weight of the vehicle means the weight of the vehicle with the heaviest such alternative part or body;
(49) “weight” means the total weight transmitted for the time being by the wheels of a vehicle to the surface on which the vehicle rests.
[2A. e-cart and e-rickshaw.—(1) Save as otherwise provided in the proviso to sub-section (1) of section 7 and sub-section (10) of section 9, the provisions of this Act shall apply to e-cart and e-rickshaw.
(2) For the purposes of this section, “e-cart or e-rickshaw” means a special purpose battery powered vehicle of power not exceeding 4000 watts, having three wheels for carrying goods or passengers, as the case may be, for hire or reward, manufactured, constructed or adapted, equipped and maintained in accordance with such specifications, as may be prescribed in this behalf.]
CHAPTER II
LICENSING OF DRIVERS OF MOTOR VEHICLES
3. Necessity for driving licence.—(1) No person shall drive a motor vehicle in any public place unless he holds an effective driving licence issued to him authorising him to drive the vehicle; and no person shall so drive a transport vehicle [other than 3 [a motor cab or motor cycle] hired for his own use or rented under any scheme made under sub-section (2) of section 75] unless his driving licence specifically entitles him so to do.
(2) The conditions subject to which sub-section (1) shall not apply to a person receiving instructions in driving a motor vehicle shall be such as may be prescribed by the Central Government.
4. Age limit in connection with driving of motor vehicles.—(1) No person under the age of eighteen years shall drive a motor vehicle in any public place:
Provided that 1 [a motor cycle with engine capacity not exceeding 50cc] out gear may be driven in a public place by a person after attaining the age of sixteen years.
(2) Subject to the provisions of section 18, no person under the age of twenty years shall drive a transport vehicle in any public place.
(3) No learner’s licence or driving licence shall be issued to any person to drive a vehicle of the class to which he has made an application unless he is eligible to drive that class of vehicle under this section.
5. Responsibility of owners of motor vehicles for contravention of sections 3 and 4.—No owner or person in charge of a motor vehicle shall cause or permit any person who does not satisfy the provisions of section 3 or section 4 to drive the vehicle.
6. Restrictions on the holding of driving licences.—(1) No person shall, while he holds any driving licence for the time being in force, hold any other driving licence except a learner’s licence or a driving licence issued in accordance with the provisions of section 18 or a document authorising, in accordance with the rules made under section 139, the person specified therein to drive a motor vehicle.
(2) No holder of a driving licence or a learner’s licence shall permit it to be used by any other person.
(3) Nothing in this section shall prevent a licensing authority having the jurisdiction referred to in sub-section (1) of section 9 from adding to the classes of vehicles which the driving licence authorises the holder to drive.
7. Restrictions on the granting of learner’s licences for certain vehicles.—2 [(1) No person shall be granted a learner’s licence to drive a transport vehicle unless he has held a driving licence to drive a light motor vehicle for at least one year:]
[Provided that nothing contained in this sub-section shall apply to an e-cart or e-rickshaw.] (2) No person under the age of eighteen years shall be granted a learner’s licence to drive a motor cycle without gear except with the consent in writing of the person having the care of the person desiring the learner’s licence.
8. Grant of learner’s licence.—(1) Any person who is not disqualified under section 4 for driving a motor vehicle and who is not for the time being disqualified for holding or obtaining a driving licence may, subject to the provisions of section 7, apply to the licensing authority having jurisdiction in the area—
(i) in which he ordinarily resides or carries on business, or
(ii) in which the school or establishment referred to in section 12 from where he intends to receive instruction in driving a motor vehicle is situate, for the issue to him of a learner’s licence.
(2) Every application under sub-section (1) shall be in such form and shall be accompanied by such documents and with such fee as may be prescribed by the Central Government.
(3) Every application under sub-section (1) shall be accompanied by a medical certificate in such form as may be prescribed by the Central Government and signed by such registered medical practitioner, as the State Government or any person authorised in this behalf by the State Government may, by notification in the Official Gazette, appoint for this purpose:
[Provided that no such medical certificate is required for licence to drive a vehicle other than a transport vehicle.]
(4) If, from the application or from the medical certificate referred to in sub-section (3), it appears that the applicant is suffering from any disease or disability which is likely to cause the driving by him of a motor vehicle of the class which he would be authorised by the learner’s licence applied for to drive to be a source of danger to the public or to the passengers, the licensing authority shall refuse to issue the learner’s licence:
Provided that a learner’s licence limited to driving an invalid carriage may be issued to the applicant, if the licensing authority is satisfied that he is fit to drive such a carriage.
(5) No learner’s licence shall be issued to any applicant unless he passes to the satisfaction of the licensing authority such test as may be prescribed by the Central Government.
(6) When an application has been duly made to the appropriate licensing authority and the applicant has satisfied such authority of his physical fitness under sub-section (3) and has passed to the satisfaction of the licensing authority the test referred to in sub-section (5), the licensing authority shall, subject to the provisions of section 7, issue the applicant a learner’s licence unless the applicant is disqualified under section 4 for driving a motor vehicle or is for the time being disqualified for holding or obtaining a licence to drive a motor vehicle:
Provided that a licensing authority may issue a learner’s licence to drive a motor cycle or a light motor vehicle notwithstanding that it is not the appropriate licensing authority, if such authority is satisfied that there is good reason for the applicant’s inability to apply to the appropriate licensing authority.
(7) Where the Central Government is satisfied that it is necessary or expedient so to do, it may, by rules made in this behalf, exempt generally, either absolutely or subject to such conditions as may be specified in the rules, any class of persons from the provisions of sub-section (3), or sub-section (5), or both.
(8) Any learner’s licence for driving a motor cycle in force immediately before the commencement of this Act shall, after such commencement, be deemed to be effective for driving a motor cycle with or without gear.
9. Grant of driving licence—(1) Any person who is not for the time being disqualified for holding or obtaining a driving licence may apply to the licensing authority having jurisdiction in the area—
(i) in which he ordinarily resides or carries on business, or
(ii) in which the school or establishment referred to in section 12 from where he is receiving or has received instruction in driving a motor vehicle is situated, for the issue to him of a driving licence.
(2) Every application under sub-section (1) shall be in such form and shall be accompanied by such fee and such documents as may be prescribed by the Central Government.
[(3) If the applicant passes such test as may be prescribed by the Central Government, he shall be issued the driving licence: Provided that no such test shall be necessary where the applicant produces proof to show that—
(a) (i) the applicant has previously held a driving licenceto drive such class of vehicle and that the period between thedata of expiry of that licence and the date of the applicationdoes not exceed five years, or
(ii) the applicant holds or has previously held a driving licence to drive such class of vehicle issued under section 18, or
(iii) the applicant holds a driving licence to drive such class of vehicle issued by a competent authority of any country outside India, subject to the condition that the applicant complies with the provisions of sub-section (3) of section 8,
(b)the applicant is not suffering from any disabilitywhich is likely to cause the driving by him to be a source ofdanger to the public; and the licensing authority may, for that purpose, require the applicant to produce a medical certificate in the same form and in the same manner as is referred to in sub-section
(3) of section 8:
Provided further that where the application is for a driving licence to drive a motor vehicle (not being a transportvehicle), the licensing authority may exempt the applicant from the test of competence to drive a vehicle prescribed under this sub-section, if the applicant possesses a driving certificate issued by any institution recognised in this behalf bythe State Government.]
(4) Where the application is for a licence to drive a transport vehicle, no such authorisation shall be granted to any applicant unless he possesses such minimum educational qualification as may be prescribed by the Central Government and a driving certificate issued by a school or establishment referred to in section 12.
[(5) Where the applicant does not pass the test; he may be permitted to re-appear for the test after a period of seven days: Provided that where the applicant does not pass the test even after three appearances, he shall not be qualified to re-appear for such test before the expiry of a period of sixty days from the date of last such test.]
(6) The test of competence to drive shall be carried out in a vehicle of the type to which the application refers: Provided that a person who passed a test in driving a motor cycle with gear shall be deemed also to have passed a test in driving a motor cycle without gear.
(7) When any application has been duly made to the appropriate licensing authority and the applicant has satisfied such authority of his competence to drive, the licensing authority shall issue the applicant a driving licence unless the applicant is for the time being disqualified for holding or obtaining a driving licence:
Provided that a licensing authority may issue a driving licence to drive a motor cycle or a light motor vehicle notwithstanding that it is not the appropriate licensing authority, if the licensing authority is satisfied that there is good and sufficient reason for the applicant’s inability to apply to the appropriate licensing authority:
Provided further that the licensing authority shall not issue a new driving licence to the applicant, if he had previously held a driving licence, unless it is satisfied that there is good and sufficient reason for his inability to obtain a duplicate copy of his former licence.
(8) If the licensing authority is satisfied, after giving the applicant an opportunity of being heard, that he—
(a) is a habitual criminal or a habitual drunkard; or
(b) is a habitual addict to any narcotic drug or psychotropic substance within the meaning of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985); or
(c) is a person whose licence to drive any motor vehicle has, at any time earlier, been revoked, it may, for reasons to be recorded tin writing, make an order refusing to issue a driving licence to such person and any person aggrieved by 586 an order made by a licensing authority under this sub-section may, within thirty days of the receipt of the order, appeal to the prescribed authority.
(9) Any driving licence for driving a motor cycle in force immediately before the commencement of this Act shall, after such commencement, be deemed to be effective for driving a motor cycle with or without gear.
[(10) Notwithstanding anything contained in this section, the driving licence to drive e-cart or e-rickshaw shall be issued in such manner and subject to such conditions, as may be prescribed.]
10. Form and contents of licences to drive.—(1) Every learner’s licence and driving licence, except a driving licence issued under section 18, shall be in such form and shall contain such information as may be prescribed by the Central Government.
(2) A learner’s licence or, as the case may be, driving licence shall also be expressed as entitling the holder to drive a motor vehicle of one or more of the following classes, namely:—
(a) motor cycle without gear;
(b) motor cycle with gear;
(c) invalid carriage;
(d) light motor vehicle;
[(e) transport vehicle;]
(i) road-roller;
(j) motor vehicle of a specified description.
11. Additions to driving licence.—(1) Any person holding a driving licence to drive any class or description of motor vehicles, who is not for the time being disqualified for holding or obtaining a driving licence to drive any other class or description of motor vehicles, may apply to the licensing authority having jurisdiction in the area in which he resides or carries on his business in such form and accompanied by such documents and with such fees as may be prescribed by the Central Government for the addition of such other class or description of motor vehicles to the licence.
(2) Subject to such rules as may be prescribed by the Central Government, the provisions of section 9 shall apply to an application under this section as if the said application were for the grant of a licence under that section to drive the class or description of motor vehicles which the applicant desires to be added to his licence.
12. Licensing and regulation of schools or establishments for imparting instruction in driving of motor vehicles.—(1) The Central Government may make rules for the purpose of licensing and regulating, by the State Governments, schools or establishments (by whatever name called) for imparting instruction in driving of motor vehicles and matters connected therewith.
(2) In particular, and without prejudice to the generality of the foregoing power, such rules may provide for all or any of the following matters, namely:—
(a) licensing of such schools or establishments including grant, renewal and revocation of such licences;
(b) supervision of such schools or establishments;
(c) the form of application and the form of licence and the particulars to be contained therein;
(d) fee to be paid with the application for such licences;
(e) conditions subject to which such licences may be granted;
(f) appeals against the orders of refusal to grant or renew such licences and appeals against the orders revoking such licences;
(g) conditions subject to which a person may establish and maintain any such school or establishment for imparting instruction in driving of motor vehicles;
(h) nature, syllabus and duration of course or courses for efficient instruction in driving any motor vehicle;
(i) apparatus and equipments (including motor vehicles fitted with dual control) required for the purpose of imparting such instruction;
(j) suitability of the premises at which such schools or establishments may be established or maintained and facilities to be provided therein;
(k) qualifications, both educational and professional (including experience), which a person imparting instruction in driving a motor vehicle shall possess;
(l) inspection of such schools and establishments (including the services rendered by them and the apparatus, equipments and motor vehicles maintained by them for imparting such instruction);
(m) maintenance of records by such schools or establishments;
(n) financial stability of such schools or establishments;
(o) the driving certificates, if any, to be issued by such schools or establishments and the form in which such driving certificates shall be issued and the requirements to be complied with for the purposes of issuing such certificates;
(p) such other matters as may be necessary to carry out the purposes of this section.
(3) Where the Central Government is satisfied that it is necessary or expedient so to do, it may, by rules made in this behalf, exempt generally, either absolutely or subject to such conditions as may be specified in the rules, any class of schools or establishments imparting instruction in driving of motor vehicles or matters connected therewith from the provisions of this section.
(4) A school or establishment imparting instruction in driving of motor vehicles or matters connected therewith immediately before the commencement of this Act whether under a licence or not, may continue to impart such instruction without a licence issued under this Act for a period of one month from such commencement, and if it has made an application for such licence under this Act within the said period of one month and such application is in the prescribed form, contains the prescribed particulars and is accompanied by the prescribed fee, till the disposal of such application by the licensing authority.
13. Extent of effectiveness of licences, to drive motor vehicles.—A learner’s licence or a driving licence issued under this Act shall be effective throughout India.
14. Currency of licences to drive motor vehicles.—(1) A learner’s licence issued under this Act shall, subject to the other provisions of this Act, be effective for a period of six months from the date of issue of the licence.
(2) A driving licence issued or renewed under this Act shall,—
(a) in the case of a licence to drive a transport vehicle, be effective for a period of three years:
1 ***
[Provided that in the case of licence to drive a transport vehicle carrying goods of dangerous or hazardous nature be effective for a period of one year and renewal thereof shall be subject to the condition that the driver undergoes one day refresher course of the prescribed syllabus; and;]
(b) in the case of any other licence,—
(i) if the person obtaining the licence, either originally or on renewal thereof, has not attained the age of 3 [fifty years] on the date of issue or, as the case may be, renewal thereof,—
(A) be effective for a period of twenty years from the date of such issue or renewal;or
(B) until the date on which such person attains the age of 3 [fifty years], whichever is earlier;
[(ii) if the person referred to in sub-clause (i), has attained the age of fifty years on the date of issue or as the case may be. renewal thereof, be effective, on payment of such fee as may be prescribed, for a period of five years from the date of such issue or renewal:] Provided that every driving licence shall, notwithstanding its expiry under this sub-section, continue to be effective for a period of thirty days from such expiry.
15. Renewal of driving licences.—(1) Any licensing authority may, on application made to it, renew a driving licence issued under the provisions of this Act with effect from the date of its expiry:
Provided that in any case where the application for the renewal of a licence is made more than thirty days after the date of its expiry, the driving licence shall be renewed with effect from the date of its renewal:
Provided further that where the application is for the renewal of a licence to drive a transport vehicle or where in any other case the applicant has attained the age of forty years, the same shall be accompanied by a medical certificate in the same form and in the same manner as is referred to in sub-section (3) of section 8, and the provisions of sub-section (4) of section 8 shall, so far as may be, apply in relation to every such case as they apply in relation to a learner’s licence.
(2) An application for the renewal of a driving licence shall be made in such form and accompanied by such documents as may be prescribed by the Central Government.
(3) Where an application for the renewal of a driving licence is made previous to, or not more than thirty days after the date of its expiry, the fee payable for such renewal shall be such as may be prescribed by the Central Government in this behalf.
(4) Where an application for the renewal of a driving licence is made more than thirty days after the date of its expiry, the fee payable for such renewal shall be such amount as may be prescribed by the Central Government:
Provided that the fee referred to in sub-section (3) may be accepted by the licensing authority in respect of an application for the renewal of a driving licence made under this sub-section if it is satisfied that the applicant was prevented by good and sufficient cause from applying within the time specified in sub-section (3):
Provided further that if the application is made more than five years after the driving licence has ceased to be effective, the licensing authority may refuse to renew the driving licence, unless the applicant undergoes and passes to its satisfaction the test of competence to drive referred to in sub-section (3) of section 9.
(5) Where the application for renewal has been rejected, the fee paid shall be refunded to such extent and in such manner as may be prescribed by the Central Government.
(6) Where the authority renewing the driving licence is not the authority which issued the driving licence it shall intimate the fact of renewal to the authority which issued the driving licence.
16. Revocation of driving licence on grounds of disease or disability.—Notwithstanding anything contained in the foregoing sections, any licensing authority may at any time revoke a driving licence or may require, as a condition of continuing to hold such driving licence, the holder thereof to produce a medical certificate in the same form and in the same manner as is referred to in sub-section (3) of section 8, if the licensing authority has reasonable grounds to belive that the holder of the driving licence is, by virtue of any disease or disability, unfit to drive a motor vehicle and where the authority revoking a driving licence is not the authority which issued the same, it shall intimate the fact of revocation to the authority which issued that licence.
17. Orders refusing or revoking driving licences and appeals therefrom—(1) Where a licensing authority refuses to issue any learner’s licence or to issue or renew, or revokes, any driving licence, or refuses to add a class or description of motor vehicle to any driving licence, it shall do so by an order communicated to the applicant or the holder, as the case may be, giving the reasons in writing for such refusal or revocation.
(2) Any person aggrieved by an order made under sub-section (1) may, within thirty days of the service on him of the order, appeal to the prescribed authority which shall decide the appeal after giving such person and the authority which made the order an opportunity of being heard and the decision of the appellate authority shall be binding on the authority which made the order.
18. Driving licences to drive motor vehicles, belonging to the Central Government.—(1) Such authority as may be prescribed by the Central Government may issue driving licence valid throughout India to persons who have completed their eighteenth year to drive motor vehicles which are the property or for the time being under the exclusive control of the Central Government and are used for Government purposes relating to the defence of the country and unconnected with any commercial enterprise.
(2) A driving licence issued under this section shall specify the class or description of vehicle which the holder is entitled to drive and the period for which he is so entitled.
(3) A driving licence issued under this section shall not entitle the holder to drive any motor vehicle except a motor vehicle referred to in sub-section (1).
(4) The authority issuing any driving licence under this section shall, at the request of any State Government, furnish such information respecting any person to whom a driving licence is issued as that Government may at any time require.
19. Power of licensing authority to disqualify from holding a driving licence or revoke such licence.—(1) If a licensing authority is satisfied, after giving the holder of a driving licence an opportunity of being heard, that he—
(a) is a habitual criminal or a habitual drunkard; or
(b) is a habitual addict to any narcotic drug or psychotropic substance within the meaning of the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985); or
(c) is using or has used a motor vehicle in the commission of a cognizable offence; or
(d) has by his previous conduct as driver of a motor vehicle shown that his driving is likely to be attended with danger to the public; or
(e) has obtained any driving licence or a licence to drive a particular class or description of motor vehicle by fraud or misrepresentation; or
(f) has committed any such act which is likely to cause nuisance or danger to the public, as may be prescribed by the Central Government, having regard to the objects of this Act; or
(g) has failed to submit to, or has not passed, the tests referred to in the proviso to sub-section (3) of section 22; or
(h) being a person under the age of eighteen years who has been granted a learner’s licence or a driving licence with the consent in writing of the person having the care of the holder of the licence and has ceased to be in such care, it may, for reasons to be recorded in writing, make an order—
(i) disqualifying that person for a specified period for holding or obtaining any driving licence to drive all or any classes or descriptions of vehicles specified in the licence; or
(ii) revoke any such licence.
(2) Where an order under sub-section (1) is made, the holder of a driving licence shall forthwith surrender his driving licence to the licensing authority making the order, if the driving licence has not already been surrendered, and the licensing authority shall,—
(a) if the driving licence is a driving licence issued under this Act, keep it until the disqualification has expired or has been removed; or
(b) if it is not a driving licence issued under this Act, endorse the disqualification upon it and send it to the licensing authority by which it was issued; or
(c) in the case of revocation of any licence, endorse the revocation upon it and if it is not the authority which issued the same, intimate the fact of revocation to the authority which issued that licence:
Provided that where the driving licence of a person authorises him to drive more than one class or description of motor vehicles and the order, made under sub-section (1), disqualifies him from driving any specified class or description of motor vehicles, the licensing authority shall endorse the disqualification upon the driving licence and return the same to the holder.
(3) Any person aggrieved by an order made by a licensing authority under sub-section (1) may, within thirty days of the receipt of the order, appeal to the prescribed authority, and such appellate authority shall give notice to the licensing authority and hear either party if so required by that party and may pass such order as it thinks fit and an order passed by any such appellate authority shall be final.
20. Power of Court to disqualify.—(1) Where a person is convicted of an offence under this Act or of an offence in the commission of which a motor vehicle was used, the Court by which such person is convicted may, subject to the provisions of this Act, in addition to imposing any other punishment authorised by law, declare the persons so convicted to be disqualified, for such period as the Court may specify, from holding any driving licence to drive all classes or description of vehicles, or any particular class or description of such vehicles, as are specified in such licence: Provided that in respect of an offence punishable under section 183 no such order shall be made for the first or second offence.
(2) Where a person is convicted of an offence under clause (c) of sub-section (1) of section 132, section 134 or section 185, the Court convicting any person of any such offence shall order the disqualification under sub-section (1), and if the offence is relatable to clause (c) of sub-section(1) of section 132 or section 134, such disqualification shall be for a period of not less than one month, and if the offence is relatable to section 185, such disqualification shall be for a period of not less than six months.
(3) A Court shall, unless for special reasons to be recorded in writing it thinks fit to order otherwise, order the disqualification of a person—
(a) who having been convicted of an offence punishable under section 184 is again convicted of an offence punishable under that section,
(b) who is convicted of an offence punishable under section 189, or
(c) who is convicted of an offence punishable under section 192:
Provided that the period of disqualification shall not exceed, in the case referred to in clause (a), five years, or, in the case referred to in clause (b), two years or, in the case referred to in clause (c), one year.
(4) A Court ordering the disqualification of a person convicted of an offence punishable under section 184 may direct that such person shall, whether he has previously passed the test of competence to drive as referred to in sub-section (3) of section 9 or not, remain disqualified until he has subsequent to the making of the order of disqualification passed that test to the satisfaction of the licensing authority.
(5) The Court to which an appeal would ordinarily lie from any conviction of an offence of the nature specified in sub-section (1) may set aside or vary any order of disqualification made under that sub-section notwithstanding that no appeal would lie against the conviction as a result of which such order of disqualification was made.
21. Suspension of driving licence in certain cases.—(1) Where, in relation to a person who had been previously convicted of an offence punishable under section 184, a case is registered by a police officer on the allegation that such person has, by such dangerous driving as is referred to in the said section 184, of any class or description of motor vehicle caused the death of, or grievous hurt to, one or more persons, the driving licence held by such person shall in relation to such class or description of motor vehicle become suspended—
(a) for a period of six months from the date on which the case is registered, or
(b) if such person is discharged or acquitted before the expiry of the period aforesaid, until such discharge or acquittal, as the case may be.
(2) Where by virtue of the provisions of sub-section (1), the driving licence held by a person becomes suspended, the police officer, by whom the case referred to in sub-section (1) is registered, shall bring such suspension to the notice of the Court competent to take cognizance of such offence, and thereupon, such Court shall take possession of the driving licence, endorse the suspension thereon and intimate the fact of such endorsement to the licensing authority by which the licence was granted or last renewed.
(3) Where the person referred to in sub-section (1) is acquitted or discharged, the Court shall cancel the endorsement on such driving licence with regard to the suspension thereof.
(4) If a driving licence in relation to a particular class or description of motor vehicles is suspended under sub-section (1), the person holding such licence shall be debarred from holding or obtaining any licence to drive such particular class or description of motor vehicles so long as the suspension of the driving licence remains in force.
22. Suspension or cancellation of driving licence on conviction.—(1) Without prejudice to the provisions of sub-section (3) of section 20 where a person, referred to in sub-section (1) of section 21 is convicted of an offence of causing, by such dangerous driving as is referred to in section 184 of any class or description of motor vehicle the death of, or grievous hurt to, one or more persons, the Court by which such person is convicted may cancel, or suspend for such period as it may think fit, the driving licence held by such person in so far as it relates to that class or description of motor vehicle.
(2) Without prejudice to the provisions of sub-section (2) of section 20, if a person, having been previously convicted of an offence punishable under section 185 is again convicted of an offence punishable under that section, the Court, making such subsequent conviction, shall, by order, cancel the driving licence held by such person.
(3) If a driving licence is cancelled or suspended under this section, the Court shall take the driving licence in its custody, endorse the cancellation or, as the case may be, suspension, thereon and send the driving licence so endorsed to the authority by which the licence was issued or last renewed and such authority shall, on receipt of the licence, keep the licence in its safe custody, and in the case of a suspended licence, return the licence to the holder thereof after the expiry of the period of suspension on an application made by him for such return:
Provided that no such licence shall be returned unless the holder thereof has, after the expiry of the period of suspension, undergone and passed, to the satisfaction of the licensing authority by which the licence was issued or last renewed, a fresh test of competence to drive referred to in sub-section (3) of section 9 and produced a medical certificate in the same form and in the same manner as is referred to in sub-section (3) of section 8.
(4) If a licence to drive a particular class or description of motor vehicles is cancelled or suspended under this section, the person holding such a licence shall be debarred from holding, or obtaining, any licence to drive such particular class or description of motor vehicles so long as the cancellation or suspension of the driving licence remains in force.
23. Effect of disqualification order.—(1) A person in respect of whom any disqualification order is made under section 19 or section 20 shall be debarred to the extent and for the period specified in such order from holding or obtaining a driving licence and the driving licence, if any, held by such person at the date of the order shall cease to be effective to such extent and during such period.
(2) The operation of a disqualification order made under section 20 shall not be suspended or postponed while an appeal is pending against such order or against the conviction as a result of which such order is made, unless the appellate court so directs.
(3) Any person in respect of whom any disqualification order has been made may at any time after the expiry of six months from the date of the order apply to the Court or other authority by which the order was made, to remove the disqualification; and the Court or authority, as the case may be, may, having regard to all the circumstances, either cancel or vary the disqualification order: Provided that where the Court or other authority refuses to cancel or vary any disqualification order under this section, a second application thereunder shall not be entertained before the expiry of a period of three months from the date of such refusal.
24. Endorsement—(1) The Court or authority making an order of disqualification shall endorse or cause to be endorsed upon the driving licence if any, held by the person disqualified, particulars of the order of disqualification and of any conviction of an offence in respect of which an order of disqualification is made; and particulars of any cancellation or variation of an order of disqualification made under sub-section (3) of section 23 shall be similarly so endorsed.
(2) A Court by which any person is convicted of an offence under this Act as may be prescribed by the Central Government, having regard to the objects of this Act, shall, whether or not a disqualification order is made in respect of such conviction, endorse or cause to be endorsed particulars of such conviction on any driving licence held by the person convicted.
(3) Any person accused of an offence prescribed under sub-section (2) shall when attending the Court bring with him his driving licence if it is in his possession.
(4) Where any person is convicted of any offence under this Act and sentenced to imprisonment for a period exceeding three months the Court awarding the sentence shall endorse the fact of such sentence upon the driving licence of the person concerned and the prosecuting authority shall intimate the fact of such endorsement to the authority by which the driving licence was granted or last renewed.
(5) When the driving licence is endorsed or caused to be endorsed by any Court, such Court shall send the particulars of the endorsement to the licensing authority by which the driving licence was granted or last renewed.
(6) Where on an appeal against any conviction or order of a Court, which has been endorsed on a driving licence, the appellate court varies or sets aside the conviction or order, the appellate court shall inform the licensing authority by which the driving licence was granted or last renewed and such authority shall amend or cause to be amended the endorsement.
25. Transfer of endorsement and issue of driving licence free from endorsement.—(1) An endorsement on any driving licence shall be transferred to any new or duplicate driving licence obtained by the holder thereof until the holder becomes entitled under the provisions of this section to have a driving licence issued to him free from endorsement.
(2) Where a driving licence is required to be endorsed and the driving licence is not in the possession of the Court or authority by which the endorsement is to be made, then—
(a) if the person in respect of whom the endorsement is to be made is at the time the holder of a driving licence, he shall produce the driving licence to the Court or authority within five days, or such longer time as the Court or authority may fix; or
(b) if, not being then the holder of a driving licence, he subsequently obtains a driving
licence, he shall within five days after obtaining the driving licence produce it to the Court or authority, and if the driving licence is not produced within the time specified, it shall, on the expiration of such time, be of no effect until it is produced for the purpose of endorsement.
(3) A person whose driving licence has been endorsed shall, if during a continuous period of three years after such endorsement no further endorsement has been made against him, be entitled on surrendering his driving licence and on payment of a fee of five rupees, to receive a new driving licence free from all endorsements:
Provided that if the endorsement is only in respect of an offence contravening the speed limits referred to in section 112, such person shall be entitled to receive a new driving licence free from such endorsements on the expiration of one year of the date of the endorsement:
Provided further that in reckoning the said period of three years and one year, respectively, any period during which the said person was disqualified for holding or obtaining a driving licence shall be excluded.
26. Maintenance of State Registers of Driving Licences.—(1) Each State Government shall maintain, in such form as may be prescribed by the Central Government, a register to be known as the State Register of Driving Licences, in respect of driving licences issued and renewed by the licensing authorities of the State Government, containing the following particulars, namely:—
(a) names and addresses of holders of driving licences;
(b) licence numbers;
(c) dates of issue or renewal of licences;
(d) dates of expiry of licences;
(e) classes and types of vehicles authorised to be driven; and
(f) such other particulars as the Central Government may prescribe.
(2) Each State Government shall supply to the Central Government a 1 [printed copy or copy in such other form as the Central Government may require] of the State Register of Driving Licences and shall inform the Central Government without delay of all additions to and other amendments in such register made from time to time.
(3) The State Register of Driving Licences shall be maintained in such manner as may be prescribed by the State Government.
27. Power of Central Government to make rules.—The Central Government may make rules—
[(a) specifications relating to e-cart and e-rickshaw under sub-section (2) of section 2A;]
[(aa)] regarding conditions referred to in sub-section (2) of section 3;
(b) providing for the form in which the application for learner’s licence may be made, the information it shall contain and the documents to be submitted with the application referred to in sub-section (2) of section 8;
(c) providing for the form of medical certificate referred to in sub-section (3) of section 8;
(d) providing for the particulars for the test referred to in sub-section (5) of section 8;
(e) providing for the form in which the application for driving licence may be made, the information it shall contain and the documents to be submitted with the application referred to in sub-section (2) of section 9;
(f) providing for the particulars regarding test of competence to drive, referred to in sub-section (3) of section 9;
[(ff) the manner and the conditions subject to which the driving licence may be issued under sub-section (10) of section 9;]
(g) specifying the minimum educational qualifications of persons to whom licences to drive transport vehicles may be issued under this Act and the time within which such qualifications are to be acquired by such persons;
(h) providing for the form and contents of the licences referred to in sub-section (1) of section 10;
(i) providing for the form and contents of the application referred to in sub-section (1) of section 11 and documents to be submitted with the application and the fee to be charged;
(j) providing for the conditions subject to which section 9 shall apply to an application made under section 11;
(k) providing for the form and contents of the application referred to in sub-section (1) of section 15 and the documents to accompany such application under sub-section (2) of section 15;
(l) providing for the authority to grant licences under sub-section (1) of section 18;
(m) specifying the fees payable under sub-section (2) of section 8, sub-section (2) of section 9 and sub-sections (3) and (4) of section 15 for the grant of learner’s licences, and for the grant and renewal of driving licences and licences for the purpose of regulating the schools or establishment for imparting instructions in driving motor vehicles;
(n) specifying the acts for the purposes of clause (f) of sub-section (1) of section 19;
(o) specifying the offences under this Act for the purposes of sub-section (2) of section 24;
(p) to provide for all or any of the matters referred to in sub-section (1) of section 26;
(q) any other matter which is, or has to be, prescribed by the Central Government.
28. Power of State Government to make rules.—(1) A State Government may make rules for the purpose of carrying into effect the provisions of this Chapter other than the matters specified in section 27.
(2) Without prejudice to the generality of the foregoing power, such rules may provide for— (a) the appointment, jurisdiction, control and functions of licensing authorities and other prescribed authorities;
(b) the conduct and hearing of appeals that may be preferred under this Chapter, the fees to be paid in respect of such appeals and the refund of such fees: Provided that no fee so fixed shall exceed twenty-five rupees;
(c) the issue of duplicate licences to replace licences lost, destroyed or mutilated, the replacement of photographs which have become obsolete and the fees to be charged therefor;
(d) the badges and uniform to be worn by drivers of transport vehicles and the fees to be paid in respect of badges;
(e) the fee payable for the issue of a medical certificate under sub-section (3) of section 8;
(f) the exemption of prescribed persons, or prescribed classes of persons, from payment of all or any portion of the fees payable under this Chapter;
(g) the communication of particulars of licences granted by one licensing authority to other licensing authorities;
(h) the duties, functions and conduct of such persons to whom licences to drive transport vehicles are issued;
(i) the exemption of drivers of road-rollers from all or any of the provisions of this Chapter or of the rules made thereunder;
(j) the manner in which the State Register of Driving Licences shall be maintained under section 26; (k) any other matter which is to be, or may be, prescribed.
CHAPTER III
LICENSING OF CONDUCTORS OF STAGE CARRIAGES
29. Necessity for conductor’s licence.—(1) No person shall act as a conductor of a stage carriage unless he holds an effective conductor’s licence issued to him authorising him to act as such conductor; and no person shall employ or permit any person who is not so licensed to act as a conductor of a stage carriage.
(2) A State Government may prescribe the conditions subject to which sub-section (1) shall not apply to a driver of a stage carriage performing the functions of a conductor or to a person employed to act as a conductor for a period not exceeding one month.
30. Grant of conductor’s licence.—(1) Any person who possesses such minimum educational qualification as may be prescribed by the State Government and is not disqualified under sub-section (1) of section 31 and who is not for the time being disqualified for holding or obtaining a conductor’s licence may apply to the licensing authority having jurisdiction in the area in which he ordinarily resides or carries on business for the issue to him of a conductor’s licence.
(2) Every application under sub-section (1) shall be in such form and shall contain such information as may be prescribed.
(3) Every application for a conductor’s licence shall be accompanied by a medical certificate in such form as may be prescribed, signed by a registered medical practitioner and shall also be accompanied by two clear copies of a recent photograph of the applicant.
(4) A conductor’s licence issued under this Chapter shall be in such form and contain such particulars as may be prescribed and shall be effective throughout the State in which it is issued.
(5) The fee for a conductor’s licence and for each renewal thereof shall be one-half of that for a driving licence.
31. Disqualifications for the grant of conductor’s licence.—(1) No person under the age of eighteen years shall hold, or be granted, a conductor’s licence.
(2) The licensing authority may refuse to issue a conductor’s licence—
(a) if the applicant does not possess the minimum educational qualification;
(b) if the medical certificate produced by the applicant discloses that he is physically unfit to act as a conductor; and
(c) if any previous conductor’s licence held by the applicant was revoked.
32. Revocation of a conductor’s licence on grounds of disease or disability.—A conductor’s licence may at any time be revoked by any licensing authority if that authority has reasonable grounds to believe that the holder of the licence is suffering from any disease or disability which is likely to render him permanently unfit to hold such a licence and where the authority revoking a conductor’s licence is not the authority which issued the same, it shall intimate the fact of such revocation to the authority which issued that licence:
Provided that before revoking any licence, the licensing authority shall give the person holding such licence a reasonable opportunity of being heard.
33. Orders refusing, etc., conductor’s licences and appeals therefrom.—(1) Where a licensing authority refuses to issue or renew, or revokes any conductor’s licence, it shall do so by an order communicated to the applicant or the holder, as the case may be, giving the reasons in writing for such refusal or revocation.
(2) Any person aggrieved by an order made under sub-section (1) may, within thirty days of the service on him of the order, appeal to the prescribed authority which shall decide the appeal after giving such person and the authority which made the order an opportunity of being heard and the decision of the appellate authority shall be binding on the authority which made the order.
34. Power of licensing authority to disqualify.—(1) If any licensing authority is of opinion that it is necessary to disqualify the holder of a conductor’s licence for holding or obtaining such a licence on account of his previous conduct as a conductor, it may, for reasons to be recorded, make an order disqualifying that person for a specified period, not exceeding one year, for holding or obtaining a conductor’s licence: Provided that before disqualifying the holder of a licence, the licensing authority shall give the person holding such licence a reasonable opportunity of being heard.
(2) Upon the issue of any such order, the holder of the conductor’s licence shall forthwith surrender the licence to the authority making the order, if the licence has not already been surrendered, and the authority shall keep the licence until the disqualification has expired or has been removed.
(3) Where the authority disqualifying the holder of a conductor’s licence under this section is not the authority which issued the licence, it shall intimate the fact of such disqualification to the authority which issued the same.
(4) Any person aggrieved by an order made under sub-section (1) may, within thirty days of the service on him of the order, appeal to the prescribed authority which shall decide the appeal after giving such person and the authority which made the order an opportunity of being heard and the decision of the appellate authority shall be binding on the authority which made the order.
35. Power of Court to disqualify.—(1) Where any person holding a conductor’s licence is convicted of an offence under this Act, the Court by which such person is convicted may, in addition to imposing any other punishment authorised by law, declare the person so convicted to be disqualified for such period as the Court may specify for holding a conductor’s licence.
(2) The Court to which an appeal lies from any conviction of an offence under this Act may set aside or vary any order of disqualification made by the Court below, and the Court to which appeals ordinarily lie from such Court, may set aside or vary any order of disqualification made by that Court, notwithstanding that no appeal lies against the conviction in connection with which such order was made.
36. Certain provisions of Chapter II to apply to conductor’s licence.—The provisions of sub-section (2) of section 6, sections 14, 15 and 23, sub-section (1) of section 24 and section 25 shall, so far as may be, apply in relation to a conductor’s licence, as they apply in relation to a driving licence.
37. Savings.—If any licence to act as a conductor of a stage carriage (by whatever name called) has been issued in any State and is effective immediately before the commencement of this Act, it shall continue to be effective, notwithstanding such commencement, for the period for which it would have been effective, if this Act had not been passed, and every such licence shall be deemed to be a licence issued under this Chapter as if this Chapter had been in force on the date on which that licence was granted.
38. Power of State Government to make rules—(1) A State Government may make rules for the purpose of carrying into effect the provisions of this Chapter.
(2) Without prejudice to the generality of the foregoing power, such rules may provide for—
(a) the appointment, jurisdiction, control and functions of licensing authorities and other prescribed authorities under this Chapter;
(b) the conditions subject to which drivers of stage carriages performing the functions of a conductor and persons temporarily employed to act as conductors may be exempted from the provisions of sub-section (1) of section 29;
(c) the minimum educational qualifications of conductors; their duties and functions and the conduct of persons to whom conductor’s licences are issued;
(d) the form of application for conductor’s licences or for renewal of such licences and the particulars it may contain;
(e) the form in which conductor’s licences may be issued or renewed and the particulars it may contain;
(f) the issue of duplicate licences to replace licences lost, destroyed or mutilated, the replacement of photographs which have become obsolete and the fees to be charged therefor;
(g) the conduct and hearing of appeals that may be preferred under this Chapter, the fees to be paid in respect of such appeals and the refund of such fees: Provided that no fee so fixed shall exceed twenty-five rupees;
(h) the badges and uniform to be worn by conductors of stage carriages and the fees to be paid in respect of such badges;
(i) the grant of the certificates referred to in sub-section (3) of section 30 by registered medical practitioners and the form of such certificates;
(j) the conditions subject to which, and the extent to which, a conductor’s licence issued in another State shall be effective in the State;
(k) the communication of particulars of conductor’s licences from one authority to other authorities; and
(l) any other matter which is to be, or may be, prescribed.
CHAPTER IV
REGISTRATION OF MOTOR VEHICLES
39. Necessity for registration.—No person shall drive any motor vehicle and no owner of a motor vehicle shall cause or permit the vehicle to be driven in any public place or in any other place unless the vehicle is registered in accordance with this Chapter and the certificate of registration of the vehicle has not been suspended or cancelled and the vehicle carries a registration mark displayed in the prescribed manner:
Provided that nothing in this section shall apply to a motor vehicle in possession of a dealer subject to such conditions as may be prescribed by the Central Government.
40. Registration, where to be made.—Subject to the provisions of section 42, section 43 and section 60, every owner of a motor vehicle shall cause the vehicle to be registered by a registering authority in whose jurisdiction he has the residence or place of business where the vehicle is normally kept.
41. Registration, how to be made.—(1) An application by or on behalf of the owner of a motor vehicle for registration shall be in such form and shall be accompanied by such documents, particulars and information and shall be made within such period as may be prescribed by the Central Government:
Provided that where a motor vehicle is jointly owned by more persons than one, the application shall be made by one of them on behalf of all the owners and such applicant shall be deemed to be the owner of the motor vehicle for the purposes of this Act.
(2) An application referred to in sub-section (1) shall be accompanied by such fee as may be prescribed by the Central Government.
(3) The registering authority shall issue to the owner of a motor vehicle registered by it a certificate of registration in such form and containing such particulars and information and in such manner as may be prescribed by the Central Government.
(4) In addition to the other particulars required to be included in the certificate of registration, it shall also specify the type of the motor vehicle, being a type as the Central Government may, having regard to the design, construction and use of the motor vehicle, by notification in the Official Gazette, specify.
(5) The registering authority shall enter the particulars of the certificate referred to in sub-section (3) in a register to be maintained in such form and manner as may be prescribed by the Central Government.
(6) The registering authority shall assign to the vehicle, for display thereon, a distinguishing mark (in this Act referred to as the registration mark) consisting of one of the groups of such of those letters and followed by such letters and figures as are allotted to the State by the Central Government from time to time by notification in the Official Gazette, and displayed and shown on the motor vehicle in such form and in such manner as may be prescribed by the Central Government.
(7) A certificate of registration issued under sub-section (3), whether before or after the commencement of this Act, in respect of a motor vehicle, other than a transport vehicle, shall, subject to the provisions contained in this Act, be valid only for a period of fifteen years from the date of issue of such certificate and shall be renewable.
(8) An application by or on behalf of the owner of a motor vehicle, other than a transport vehicle, for the renewal of a certificate of registration shall be made within such period and in such form, containing such particulars and information as may be prescribed by the Central Government.
(9) An application referred to in sub-section (8) shall be accompanied by such fee as may be prescribed by the Central Government.
(10) Subject to the provisions of section 56, the registering authority may, on receipt of an application under sub-section (8), renew the certificate of registration for a period of five years and intimate the fact to the original registering authority, if it is not the original registering authority.
(11) If the owner fails to make an application under sub-section (1), or, as the case may be, under sub-section (8) within the period prescribed, the registering authority may, having regard to the circumstances of the case, require the owner to pay, in lieu of any action that may be taken against him under section 177, such amount not exceeding one hundred rupees as may be prescribed under sub- section (13):
Provided that action under section 177 shall be taken against the owner where the owner fails to pay the said amount.
(12) Where the owner has paid the amount under sub-section (11), no action shall be taken against him under section 177.
(13) For the purposes of sub-section (11), the State Government may prescribe different amounts having regard to the period of delay on the part of the owner in making an application under sub-section (1) or sub-section (8).
(14) An application for the issue of a duplicate certificate of registration shall be made to the 1 [last registering authority] in such form, containing such particulars and information along with such fee as may be prescribed by the Central Government.
42. Special provision for registration of motor vehicles of diplomatic officers, etc.—(1) Where an application for registration of a motor vehicle is made under sub-section (1) of section 41 by or on behalf of any diplomatic officer or consular officer, then, notwithstanding anything contained in sub-section (3) or sub-section (6) of that section, the registering authority shall register the vehicle in such manner and in accordance with such procedure as may be provided by rules made in this behalf by the Central Government under sub-section (3) and shall assign to the vehicle for display thereon a special registration mark in accordance with the provisions contained in those rules and shall issue a certificate (hereafter in this section referred to as the certificate of registration) that the vehicle has been registered under this section; and any vehicle so registered shall not, so long as it remains the property of any diplomatic officer or consular officer, require to be registered otherwise under this Act.
(2) If any vehicle registered under this section ceases to be the property of any diplomatic officer or consular officer, the certificate of registration issued under this section shall also cease to be effective, and the provisions of sections 39 and 40 shall thereupon apply.
(3) The Central Government may make rules for the registration of motor vehicles belonging to diplomatic officers and consular officers regarding the procedure to be followed by the registering authority for registering such vehicles, the form in which the certificates of registration of such vehicles are to be issued, the manner in which such certificates of registration are to be sent to the owners of the vehicles and the special registration marks to be assigned to such vehicles.
(4) For the purposes of this section, “diplomatic officer” or “consular officer” means any person who is recognised as such by the Central Government and if any question arises as to whether a person is or is not such an officer, the decision of the Central Government thereon shall be final.
43. Temporary registration.—(1) Notwithstanding anything contained in section 40 the owner of a motor vehicle may apply to any registering authority or other prescribed authority to have the vehicle temporarily registered in the prescribed manner and for the issue in the prescribed manner of a temporary certificate of registration and a temporary registration mark.
(2) A registration made under this section shall be valid only for a period not exceeding one month, and shall not be renewable: Provided that where a motor vehicle so registered is a chassis to which a body has not been attached and the same is detained in a workshop beyond the said period of one month for being fitted [with a body or any unforeseen circumstances beyond the control of the owner], the period may, on payment of such fees, if any, as may be prescribed, be extended by such further period or periods as the registering authority or other prescribed authority, as the case may be, may allow.
[(3) In a case where the motor vehicle is held under hire-purchase agreement, lease or hypothecation, the registering authority or other prescribed authority shall issue a temporary certificate of registration of such vehicle, which shall incorporate legibly and prominently the full name and address of the person with whom such agreement has been entered into by the owner.]
44. Production of vehicle at the time of registration.—The registering authority shall before proceeding to register a motor vehicle or renew the certificate of registration in respect of a motor vehicle, other than a transport vehicle, require the person applying for registration of the vehicle or, as the case may be, for renewing the certificate of registration to produce the vehicle either before itself or such authority as the State Government may by order appoint in order that the registering authority may satisfy itself that the particulars contained in the application are true and that the vehicle complies with the requirements of this Act and of the rules made thereunder.
45. Refusal of registration or renewal of the certificate of registration.—The registering authority may, by order, refuse to register any motor vehicle, or renew the certificate of registration in respect of a motor vehicle (other than a transport vehicle), if in either case, the registering authority has reason to believe that it is a stolen motor vehicle or the vehicle is mechanically defective or fails to comply with the requirements of this Act or of the rules made thereunder, or if the applicant fails to furnish particulars of any previous registration of the vehicle or furnishes inaccurate particulars in the application for registration of the vehicle or, as the case may be, for renewal of the certificate or registration thereof and the registering authority shall furnish the applicant whose vehicle is refused registration, or whose application for renewal of the certificate of registration is refused, a copy of such order, together with the reasons for such refusal.
46. Effectiveness in India of registration.—Subject to the provisions of section 47, a motor vehicle registered in accordance with this Chapter in any State shall not require to be registered elsewhere in India and a certificate of registration issued or in force under this Act in respect of such vehicle shall be effective throughout India.
47. Assignment of new registration mark on removal to another State.—(1) When a motor vehicle registered in one State has been kept in another State, for a period exceeding twelve months, the owner of the vehicle shall, within such period and in such form containing such particulars as may be prescribed by the Central Government, apply to the registering authority, within whose jurisdiction the vehicle then is, for the assignment of a new registration mark and shall present the certificate of registration to that registering authority:
Provided that an application under this sub-section shall be accompanied—
(i) by the no objection certificate obtained under section 48, or
(ii) in a case where no such certificate has been obtained, by—
(a) the receipt obtained under sub-section (2) of section 48; or
(b) the postal acknowledgement received by the owner of the vehicle if he has sent an application in this behalf by registered post acknowledgement due to the registering authority referred to in section 48, together with a declaration that he has not received any communication from such authority refusing to grant such certificate or requiring him to comply with any direction subject to which such certificate may be granted:
Provided further that, in a case where a motor vehicle is held under a hire-purchase, lease or hypothecation agreement, an application under this sub-section shall be accompanied by a no objection certificate from the person with whom such agreement has been entered into, and the provisions of section 51, so far as may be, regarding obtaining of such certificate from the person with whom such agreement has been entered into, shall apply.
(2) The registering authority, to which application is made under sub-section (1), shall after making such verification, as it thinks fit, of the returns, if any, received under section 62, assign the vehicle a registration mark as specified in sub-section (6) of section 41 to be displayed and shown thereafter on the vehicle and shall enter the mark upon the certificate of registration before returning it to the applicant and shall, in communication with the registering authority by whom the vehicle was previously registered, arrange for the transfer of the registration of the vehicle from the records of that registering authority to its own records.
(3) Where a motor vehicle is held under a hire-purchase or lease or hypothecation agreement, the registering authority shall, after assigning the vehicle a registration mark under sub-section (2), inform the person whose name has been specified in the certificate of registration as the person with whom the registered owner has entered into the hire-purchase or lease or hypothecation agreement (by sending to such person a notice by registered post acknowledgement due at the address of such person entered in the certificate of registration the fact of assignment of the said registration mark).
(4) A State Government may make rules under section 65 requiring the owner of a motor vehicle not registered within the State, which is brought into or is for the time being in the State, to furnish to the prescribed authority in the State such information with respect to the motor vehicle and its registration as may be prescribed.
(5) If the owner fails to make an application under sub-section (1) within the period prescribed, the registering authority may, having regard to the circumstances of the case, require the owner to pay, in lieu of any action that may be taken against him under section 177, such amount not exceeding one hundred rupees as may be prescribed under sub-section (7):
Provided that action under section 177 shall be taken against the owner where the owner fails to pay the said amount.
(6) Where the owner has paid the amount under sub-section (5), no action shall be taken against him under section 177. (7) For the purposes of sub-section (5), the State Government may prescribe different amounts having regard to the period of delay on the part of the owner in making an application under sub-section (1).
48. No objection certificate.—(1) The owner of a motor vehicle when applying for the assignment of a new registration mark under sub-section (1) of section 47, or where the transfer of a motor vehicle is to be effected in a State other than the State of its registration, the transferor of such vehicle when reporting the transfer under sub-section (1) of section 50, shall make an application in such form and in such manner as may be prescribed by the Central Government to the registering authority by which the vehicle was registered for the issue of a certificate (hereafter in this section referred to as the no objection certificate), to the effect that the registering authority has no objection for assigning a new registration mark to the vehicle or, as the case may be, for entering the particulars of the transfer of ownership in the certificate of registration.
(2) The registering authority shall, on receipt of an application under sub-section (1), issue a receipt in such form as may be prescribed by the Central Government.
(3) On receipt of an application under sub-section (1), the registering authority may, after making such inquiry and requiring the applicant to comply with such directions as it deems fit and within thirty days of the receipt thereof, by order in writing, communicate to the applicant that it has granted or refused to grant the no objection certificate:
Provided that a registering authority shall not refuse to grant the no objection certificate unless it has recorded in writing the reasons for doing so and a copy of the same has been communicated to the applicant.
(4) Where within a period of thirty days referred to in sub-section (3), the registering authority does not refuse to grant the no objection certificate or does not communicate the refusal to the applicant, the registering authority shall be deemed to have granted the no objection certificate.
(5) Before granting or refusing to grant the no objection certificate, the registering authority shall obtain a report in writing from the police that no case relating to the theft of the motor vehicle concerned has been reported or is pending, verify whether all the amounts due to Government including road tax in respect of that motor vehicle have been paid and take into account such other factors as may be prescribed by the Central Government.
[(6)The owner of the vehicle shall also inform at the earliest, in writing, the registering authority about the theft of his vehicle together with the name of the police station where the theft report was lodged, and the registering authority shall take into account such report while disposing of any application for no objection certification, registration, transfer of ownership or issue of duplicate registration certificate.]
- Change of residence or place of business.—(1) If the owner of a motor vehicle ceases to reside or have his place of business at the address recorded in the certificate of registration of the vehicle, he shall, within thirty days of any such change of address, intimate in such form accompanied by such documents as may be prescribed by the Central Government, his new address, to the registering authority by which the certificate of registration was issued, or, if the new address is within the jurisdiction of another registering authority, to that other registering authority, and shall at the same time forward the certificate of registration to the registering authority or, as the case may be, to the other registering authority in order that the new address may be entered therein.(2) If the owner of a motor vehicle fails to intimate his new address to the concerned registering authority within the period specified in sub-section (1), the registering authority may, having regard to the circumstances of the case, require the owner to pay, in lieu of any action that may be taken against him under section 177 such amount not exceeding one hundred rupees as may be prescribed under sub-section (4):Provided that action under section 177 shall be taken against the owner where he fails to pay the said amount.
(3) Where a person has paid the amount under sub-section (2), no action shall be taken against him under section 177.
(4) For the purposes of sub-section (2), a State Government may prescribe different amounts having regard to the period of delay in intimating his new address.
(5) On receipt of intimation under sub-section (1), the registering authority may, after making such verification as it may think fit, cause the new address to be entered in the certificate of registration.
(6) A registering authority other than the original registering authority making any such entry shall communicate the altered address to the original registering authority.
(7) Nothing in sub-section (1) shall apply where the change of the address recorded in the certificate of registration is due to a temporary absence not intended to exceed six months in duration or where the motor vehicle is neither used nor removed from the address recorded in the certificate of registration
50. Transfer of ownership.—(1) Where the ownership of any motor vehicle registered under this Chapter is transferred,—
(a) the transferor shall,—
(i) in the case of a vehicle registered within the same State, within fourteen days of the transfer, report the fact of transfer, in such form with such documents and in such manner, as may be prescribed by the Central Government to the registering authority within whose jurisdiction the transfer is to be effected and shall simultaneously send a copy of the said report to the transferee; and
(ii) in the case of a vehicle registered outside the State, within forty-five days of the transfer, forward to the registering authority referred to in sub-clause (i)—
(A) the no objection certificate obtained under section 48; or
(B) in a case where no such certificate has been obtained,—
(I) the receipt obtained under sub-section (2) of section 48; or
(II) the postal acknowledgement received by the transferred if he has sent an application in this behalf by registered post acknowledgement due to the registering authority referred to in section 48, together with a declaration that he has not received any communication from such authority refusing to grant such certificate or requiring him to comply with any direction subject to which such certificate may be granted;
(b) the transferee shall, within thirty days of the transfer, report the transfer to the registering authority within whose jurisdiction he has the residence or place of business where the vehicle is normally kept, as the case may be, and shall forward the certificate of registration to that registering authority together with the prescribed fee and a copy of the report received by him from the transferor in order that particulars of the transfer of ownership may be entered in the certificate of registration.
(2) Where—
(a) the person in whose name a motor vehicle stands registered dies, or
(b) a motor vehicle has been purchased or acquired at a public auction conducted by, or on behalf of, Government,
the person succeeding to the possession of the vehicle or, as the case may be, who has purchased or acquired the motor vehicle, shall make an application for the purpose of transferring the ownership of the vehicle in his name, to the registering authority in whose jurisdiction he has the residence or place of business where the vehicle is normally kept, as the case may be, in such manner, accompanied with such fee, and within such period as may be prescribed by the Central Government.
(3) If the transferor or the transferee fails to report to the registering authority the fact of transfer within the period specified in clause (a) or clause (b) of sub-section (1), as the case may be, or if the person who is required to make an application under sub-section (2) (hereafter in this section referred to as the other person) fails to make such application within the period prescribed, the registering authority may, having regard to the circumstances of the case, require the transferor or the transferee, or the other person, as the case may be, to pay, in lieu of any action that may be taken against him under section 177 such amount not exceeding one hundred rupees as may be prescribed under sub-section (5):
Provided that action under section 177 shall be taken against the transferor or the transferee or the other person, as the case may be, where he fails to pay the said amount.
(4) Where a person has paid the amount under sub-section (3), no action shall be taken against him under section 177.
(5) For the purposes of sub-section (3), a State Government may prescribe different amounts having regard to the period of delay on the part of the transferor or the transferee in reporting the fact of transfer of ownership of the motor vehicle or of the other person in making the application under sub-section (2).
(6) On receipt of a report under sub-section (1), or an application under sub-section (2), the registering authority may cause the transfer of ownership to be entered in the certificate of registration.
(7) A registering authority making any such entry shall communicate the transfer of ownership to the transferor and to the original registering authority, if it is not the original registering authority.
51. Special provisions regarding motor vehicle subject to hire-purchase agreement, etc.—(1) Where an application for registration of a motor vehicle which is held under a hire-purchase, lease or hypothecation agreement (hereafter in this section referred to as the said agreement) is made, the registering authority shall make an entry in the certificate of registration regarding the existence of the said agreement.
(2) Where the ownership of any motor vehicle registered under this Chapter is transferred and the transferee enters into the said agreement with any person, the 1 [last registering authority] shall, on receipt of an application in such form as the Central Government may prescribe from the parties to the said agreement, make an entry as to the existence of the said agreement in the certificate of registration 2 [and an intimation in this behalf shall be sent to the original registering authority if the last registering authority is not the original registering authority].
(3) Any entry made under sub-section (1) or sub-section (2), may be cancelled by the [last registering authority] on proof of the termination of the said agreement by the parties concerned on an application being made in such form as the Central Government may prescribe [and an intimation in this behalf shall be sent to the original registering authority if the last registering authority is not the original registering authority].
(4) No entry regarding the transfer of ownership of any motor vehicle which is held under the said agreement shall be made in the certificate of registration except with the written consent of the person whose name has been specified in the certificate of registration as the person with whom the registered owner has entered into the said agreement.
(5) Where the person whose name has been specified in the certificate of registration as the person with whom the registered owner has entered into the said agreement, satisfies the registering authority that he has taken possession of the vehicle [from the registered owner] owing to the default of the registered owner under the provisions of the said agreement and that the registered owner refuses to deliver the certificate of registration or has absconded, such authority may, after giving the registered owner an opportunity to make such representation as he may wish to make (by sending to him a notice by registered post acknowledgement due at his address entered in the certificate of registration) and notwithstanding that the certificate of registration is not produced before it, cancel the certificate and issuea fresh certificate of registration in the name of the person with whom the registered owner has entered into the said agreement:
Provided that a fresh certificate of registration shall not be issued in respect of a motor vehicle, unless such person pays the prescribed fee:
Provided further that a fresh certificate of registration issued in respect of a motor vehicle, other than a transport vehicle, shall be valid only for the remaining period for which the certificate cancelled under this sub-section would have been in force.
(6) The registered owner shall, before applying to the appropriate authority, for the renewal of a permit under section 81 or for the issue of duplicate certificate of registration under sub-section (14) of section 41, or for the assignment of a new registration mark [under section 47, or removal of the vehicle to another State, or at the time of conversion of the vehicle from one class to another, or for issue of no objection certificate under section 48, or for change of residence or place of business under section 49, or for the alteration of the vehicle under section 52, make an application] to the person with whom the registered owner has entered into the said agreement (such person being hereafter in this section referred to as the financier) for the issue of a no objection certificate (hereafter in this section referred to as the certificate).
Explanation.—For the purposes of this sub-section and sub-sections (8) and (9), “appropriate authority” in relation to any permit means the authority which is authorised by this Act to renew such permit and, in relation to registration, means the authority which is authorised by this Act to issue duplicate certificate of registration or to assign a new registration mark.
(7) Within seven days of the receipt of an application under sub-section (6), the financier may issue, or refuse for reasons which shall be recorded in writing and communicated to the applicant, to issue, the certificate applied for and where the financier fails to issue the certificate and also fails to communicate the reasons for refusal to issue the certificate to the applicant within the said period of seven days, the certificate applied for shall be deemed to have been issued by the financier.
(8) The registered owner shall, while applying to the appropriate authority for the renewal of any permit under section 81, or for the issue of a duplicate certificate of registration under sub-section (14) of section 41, or while applying for assignment of a new registration mark under section 47, submit with such application the certificate, if any, obtained under sub-section (7) or, where no such certificate has been obtained, the communication received from the financier under that sub-section, or, as the case may be a declaration that he has not received any communication from the financier within the period of seven days specified in that sub-section.
(9) On receipt of an application for the renewal of any permit or for the issue of duplicate certificate of registration or for assignment of a new registration mark in respect of a vehicle which is held under the said agreement, the appropriate authority may, subject to the other provisions of this Act,—
(a) in a case where the financier has refused to issue the certificate applied for, after giving the applicant an opportunity of being heard, either—
(i) renew or refuse to renew the permit, or
(ii) issue or refuse to issue the duplicate certificate of registration, or
(iii) assign or refuse to assign a new registration mark;
(b) in any other case,—
(i) renew the permit, or
(ii) issue duplicate certificate of registration, or
(iii) assign a new registration mark.
(10) A registering authority making an entry in the certificate of registration regarding—
(a) hire-purchase, lease or hypothecation agreement of a motor vehicle, or
(b) the cancellation under sub-section (3) of an entry, or
(c) recording transfer of ownership of motor vehicle, or
(d) any alteration in a motor vehicle, or
(e) suspension or cancellation of registration of a motor vehicle, or
(f) change of address,
shall communicate [by registered post acknowledgment due] to the financier that such entry has been made.
[(11) A registering authority registering the new vehicle, or issuing the duplicate certificate of registration or a no objectioncertificate or a temporary certificate of registration, or issuing or renewing, a fitness certificate or substituting entries relating toanother motor vehicle in the permit, shall intimate the financierof such transaction.
(12)The registering authority where it is not the original registering authority, when making entry under sub-section (1)or sub-section (2),or cancelling the said entry under sub-section (3) or issuing the fresh certificate of registration under sub-section (5) shall communicate the same to the original registering authority.]
[52. Alteration in motor vehicle.— (1) No owner of a motor vehicle shall so alter the vehicle that the particulars contained in the certificate of registration are at variance with those originally specified by the manufacturer:
Provided that where the owner of a motor vehicle makes modification of the engine, or any part thereof, of a vehicle for facilitating its operation by different type of fuel or source of energy including battery, compressed natural gas, solar power, liquid petroleum gas or any other fuel or source of energy, by fitment of a conversion kit, such modification shall be carried out subject to such conditions as may be prescribed:
Provided further that the Central Government may prescribe specifications, conditions for approval, retrofitment and other related matters for such conversion kits:
Provided also that the Central Government may grant exemption for alteration of vehicles in a manner other than specified above, for any specific purpose.
(2) Notwithstanding anything contained in sub-section (1), a State Government may, by notification in the Official Gazette, authorise, subject to such conditions as may be specified in the notification, and permit any person owning not less than ten transport vehicles to alter any vehicle owned by him so as to replace the engine thereof with engine of the same make and type, without the approval of registering authority.
(3) Where any alteration has been made in motor vehicle without the approval of registering authority or by reason of replacement of its engine without such approval under sub-section (2), the owner of the vehicle shall, within fourteen days of the making of the alteration, report the alteration to the registering authority within whose jurisdiction he resides and shall forward the certificate of registration to that authority together with the prescribed fee in order that particulars of registration may be entered therein.
(4) A registering authority other than the original registering authority making any such entry shall communicate the details of the entry to the original registering authority.
(5) Subject to the provisions made under sub-sections (1), (2), (3) and (4), no person holding a vehicle under a hire-purchase agreement shall make any alteration to the vehicle except with the written consent of the registered owner.
Explanation.—For the purposes of this section, “alteration” means a change in the structure of a vehicle which results in a change in its basic feature.]
53. Suspension of registration.—(1) If any registering authority or other prescribed authority has reason to believe that any motor vehicle within its jurisdiction—
(a) is in such a condition that its use in a public place would constitute a danger to the public, or that it fails to comply with the requirements of this Act or of the rules made thereunder, or
(b) has been, or is being, used for hire or reward without a valid permit for being used as such, the authority may, after giving the owner an opportunity of making any representation he may wish to make (by sending to the owner a notice by registered post acknowledgement due at his address entered in the certificate of registration), for reasons to be recorded in writing, suspend the certificate of registration of the vehicle—
(i) in any case falling under clause (a), until the defects are rectified to its satisfaction; and
(ii) in any case falling under clause (b), for a period not exceeding four months.
(2) An authority other than a registering authority shall, when making a suspension order under sub-section (1), intimate in writing the fact of such suspension and the reasons therefor to the registering authority within whose jurisdiction the vehicle is at the time of the suspension.
(3) Where the registeration of a motor vehicle has been suspended under sub-section (1), for a continuous period of not less than one month, the registering authority, within whose jurisdiction the vehicle was when the registration was suspended, shall, if it is not the original registering authority, inform that authority of the suspension.
(4) The owner of a motor vehicle shall, on the demand of a registering authority or other prescribed authority which has suspended the certificate of registration of the vehicle under this section, surrender the certificate of registration.
(5) A certificate of registration surrendered under sub-section (4) shall be returned to the owner when the order suspending registration has been rescinded and not before.
54. Cancellation of registration suspended under section 53.—Where the suspension of registration of a vehicle under section 53 has continued without interruption for a period of not less than six months, the registering authority within whose jurisdiction the vehicle was when the registration was suspended, may, if it is the original registering authority, cancel the registration, and if it is not the original registering authority, shall forward the certificate of registration to that authority which may cancel the registration.
55. Cancellation of registration.—(1) If a motor vehicle has been destroyed or has been rendered permanently incapable of use, the owner shall, within fourteen days or as soon as may be, report the fact to the registering authority within whose jurisdiction he has the residence or place of business where the vehicle is normally kept, as the case may be, and shall forward to that authority the certificate of registration of the vehicle.
(2) The registering authority shall, if it is the original registering authority, cancel the registration and the certificate of registration, or, if it is not, shall forward the report and the certificate of registration to the original registering authority and that authority shall cancel the registration.
(3) Any registering authority may order the examination of a motor vehicle within its jurisdiction by such authority as the State Government may by order appoint and, if, upon such examination and after giving the owner an opportunity to make any representation he may wish to make (by sending to the owner a notice by registered post acknowledgement due at his address entered in the certificate of registration), it is satisfied that the vehicle is in such a condition that it is incapable of being used or its use in a public place would constitute a danger to the public and that it is beyond reasonable repair, may cancel the registration.
(4) If a registering authority is satisfied that a motor vehicle has been permanently removed out of India, the registering authority shall cancel the registration.
(5) If a registering authority is satisfied that the registration of a motor vehicle has been obtained on the basis of documents which were, or by representation of facts which was, false in any material particular, or the engine number or the chassis number embossed thereon are different from such number entered in the certificate of registration, the registering authority shall after giving the owner an opportunity to make such representation as he may wish to make (by sending to the owner a notice by registered post acknowledgement due at his address entered in the certificate of registration), and for reasons to be recorded in writing cancel the registration.
(6) A registering authority cancelling the registration of a motor vehicle under section 54 or under this section shall communicate such fact in writing to the owner of the vehicle, and the owner of the vehicle shall forthwith surrender to that authority the certificate of registration of the vehicle.
(7) A registering authority making an order of cancellation under section 54 or under this section shall, if it is the original registering authority, cancel the certificate of registration and the entry relating to the vehicle in its records, and, if it is not the original registering authority, forward the certificate of registration to that authority, and that authority shall cancel the certificate of registration and the entry relating to the motor vehicle in its records.
(8) The expression “original registering authority” in this section and in sections 41, 49, 50, 51, 52, 53 and 54 means the registering authority in whose records the registration of the vehicle is recorded.
(9) In this section, “certificate of registration” includes a certificate of registration renewed under the provisions of this Act.
56. Certificate of fitness of transport vehicles.—(1) Subject to the provisions of sections 59 and 60, a transport vehicle shall not be deemed to be validly registered for the purposes of section 39, unless it carries a certificate of fitness in such form containing such particulars and information as may be prescribed by the Central Government, issued by the prescribed authority, or by an authorised testing station mentioned in sub-section (2), to the effect that the vehicle complies for the time being with all the requirements of this Act and the rules made thereunder:
Provided that where the prescribed authority or the authorised testing station refuses is issue such certificate, it shall supply the owner of the vehicle with its reasons in writing for such refusal.
(2) The “authorised testing station” referred to in sub-section (1) means a vehicle service station or public or private garage which the State Government, having regard to the experience, training and ability of the operator of such station or garage and the testing equipment and the testing personnel therein, may specify in accordance with the rules made by the Central Government for regulation and control of such stations or garages.
(3) Subject to the provisions of sub-section (4), a certificate of fitness shall remain effective for such period as may be prescribed by the Central Government having regard to the objects of this Act.
(4) The prescribed authority may for reasons to be recorded in writing cancel a certificate of fitness at any time, if satisfied that the vehicle to which it relates no longer complies with all the requirements of this Act and the rules made thereunder; and on such cancellation the certificate of registration of the vehicle and any permit granted in respect of the vehicle under Chapter V shall be deemed to be suspended until a new certificate of fitness has been obtained:
[Provided that no such cancellation shall be made by the prescribed authority unless such prescribed authority holds such technical qualification as may be prescribed or where the prescribed authority does not hold such technical qualification on the basis of the report of an officer having such qualifications.]
(5) A certificate of fitness issued under this Act shall, while it remains effective, be valid throughout India.
57. Appeals.— [(1) Any person aggrieved by an order of the registering authority under section 41, 42, 43, 45, 47, 48, 49, 50, 52, 53, 55 or 56 may, within thirty days of the date on which he has received notice of such order, appeal against the order to the prescribed authority.]
(2) The appellate authority shall give notice of the appeal to the original authority and after giving an opportunity to the original authority and the appellant to be heard in the appeal pass such orders as it thinks fit.
58. Special provisions in regard to transport vehicles.—(1) The Central Government may, having regard to the number, nature and size of the tyres attached to the wheels of a transport vehicle, (other than a motorcab), and its make and model and other relevant considerations, by notification in the Official Gazette, specify, in relation to each make and model of a transport vehicle, the 3 [maximum gross vehicle weight] of such vehicle and the maximum safe axle weight of each axle of such vehicle.
(2) A registering authority, when registering a transport vehicle, other than a motorcab, shall enter in the record of registration and shall also enter in the certificate of registration of the vehicle the following particulars, namely:—
(a) the unladen weight of the vehicle;
(b) the number, nature and size of the tyres attached to each wheel;
(c) the gross vehicle weight of the vehicle and the registered axle weights pertaining to the several axles thereof; and
(d) if the vehicle is used or adapted to be used for the carriage of passengers solely or in addition to goods, the number of passengers for whom accommodation is provided, and the owner of the vehicle shall have the same particulars exhibited in the prescribed manner on the vehicle.
(3) There shall not be entered in the certificate of registration of any such vehicle any gross vehicle weight or a registered axle weight of any of the axles different from that specified in the notification under sub-section (1) in relation to the make and model of such vehicle and to the number, nature and size of the tyres attached to its wheels:
Provided that where it appears to the Central Government that heavier weights than those specified in the notification under sub-section (1) may be permitted in a particular locality for vehicles of a particular type, the Central Government may, by order in the Official Gazette direct that the provisions of this sub-section shall apply with such modifications as may be specified in the order.
1 * * * * *
(5) In order that the gross vehicle weight entered in the certificate of registration of a vehicle may be revised in accordance with the provisions of sub-section (3), the registering authority may require the owner of transport vehicle in accordance with such procedure as may be prescribed to produce the certificate of registration within such time as may be specified by the registering authority.
59. Power to fix the age limit of motor vehicle.—(1) The Central Government may, having regard to the public safety, convenience and objects of this Act, by notification in the Official Gazette, specify the life of a motor vehicle reckoned from the date of its manufacture, after the expiry of which the motor vehicle shall not be deemed to comply with the requirements of this Act and the rules made thereunder:
Provided that the Central Government may specify different ages for different classes or different types of motor vehicles.
(2) Notwithstanding anything contained in sub-section (1), the Central Government may, having regard to the purpose of a motor vehicle, such as, display or use for the purposes of a demonstration in any exhibition, use for the purposes of technical research or taking part in a vintage car rally, by notification in the Official Gazette, exempt, by a general or special order, subject to such conditions as may be specified in such notification, any class or type of motor vehicle from the operation of sub-section (1) for the purpose to be stated in the notification.
(3) Notwithstanding anything contained in section 56, no prescribed authority or authorised testing station shall grant a certificate of fitness to a motor vehicle in contravention of the provisions of any notification issued under sub-section (1).
60. Registration of vehicles belonging to the Central Government.—(1) Such authority as the Central Government may, by notification in the Official Gazette, specify, may register any motor vehicle which is the property or for the time being under the exclusive control of the Central Government and is used for Government purposes relating to the defence of the country and unconnected with any commercial enterprise and any vehicle so registered shall not, so long as it remains the property or under the exclusive control of the Central Government, require to be registered otherwise under this Act.
(2) The authority registering a vehicle under sub-section (1) shall assign a registration mark in accordance with the provisions contained in the rules made in this behalf by the Central Government and shall issue a certificate in respect of that vehicle to the effect that such vehicle complies for the time being with all the requirements of this Act and the rules made thereunder and that the vehicle has been registered under this section.
(3) A vehicle registered under this section shall carry the certificate issued under sub-section (2).
(4) If a vehicle registered under this section ceases to be the property or under the exclusive control of the Central Government, the provisions of sections 39 and 40 shall thereupon apply.
(5) The authority registering a vehicle under sub-section (1) shall furnish to any State Government all such information regarding the general nature, overall dimensions and axle weights of the vehicle as the State Government may at any time require.
61. Application of Chapter to trailers.—(1) The provisions of this Chapter shall apply to the registration of trailers as they apply to the registration of any other motor vehicle.
(2) The registration mark assigned to a trailer shall be displayed in such manner on the side of the drawing vehicle, as may be prescribed by the Central Government.
(3) No person shall drive a motor vehicle to which a trailer is or trailers are attached unless the registration mark of the motor vehicle so driven is displayed on the trailer or on the last trailer in the train, as the case may be, in such manner as may be prescribed by the Central Government.
62. Information regarding stolen and recovered motor vehicles to be furnished by the police to the State Transport Authority.—The State Government may, if it thinks necessary or expedient so to do in the public interest, direct the submission by the Inspector General of Police (by whatever designation called) and such other police officers as the State Government may specify in this behalf, of such returns containing the information regarding vehicles which have been stolen and stolen vehicles which have been recovered of which the police are aware, to the State Transport Authority, and may prescribe the form in which and the period within which such returns shall be made.
63. Maintenance of State Registers of Motor Vehicles.—(1) Each State Government shall maintain in such form as may be prescribed by the Central Government a register to be known as the State Register of Motor Vehicle, in respect of the motor vehicles in that State, containing the following particulars, namely:—
(a) registration numbers;
(b) years of manufacture;
(c) classes and types;
(d) names and addresses of registered owners; and
(e) such other particulars as may be prescribed by the Central Government.
(2) Each State Government shall supply to the Central Government1 [if so desired by it] a printed copy of the State Register of Motor Vehicles and shall also inform the Central Government without delay of all additions to and other amendments in such register made from time to time.
(3) The State Register of Motor Vehicles shall be maintained in such manner as may be prescribed by the State Government.
64. Power of Central Government to make rules.—The Central Government may make rules to provide for all or any of the following matters, namely:—
(a) the period within which and the form in which an application shall be made and the documents, particulars and information it shall accompany under sub-section (1) of section 41;
(b) the form in which the certificate of registration shall be made and the particulars and information it shall contain and the manner in which it shall be issued under sub-section (3) of section 41;
(c) the form and manner in which the particulars of the certificate of registration shall be entered in the records of the registering authority under sub-section (5) of section 41;
(d) the manner in which and the form in which the registration mark, the letters and figures and other particulars referred to in sub-section (6) of section 41 shall be displayed and shown;
(e) the period within which and the form in which the application shall be made and the particulars and information it shall contain under sub-section (8) of section 41;
(f) the form in which the application referred to in sub-section (14) of section 41 shall be made, the particulars and information it shall contain and the fee to be charged;
(g) the form in which the period within which the application referred to in sub-section (1) of section 47 shall be made and the particulars it shall contain;
(h) the form in which and the manner in which the application for “No Objection Certificate” shall be made under sub-section (1) of section 48 and the form of receipt to be issued under sub-section (2) of section 48;
(i) the matters that are to be complied with by an applicant before no objection certificate may be issued under section 48;
(j) the form in which the intimation of change of address shall be made under sub-section (1) of section 49 and the documents to be submitted along with the application;
(k) the form in which and the manner in which the intimation of transfer of ownership shall be made under sub-section (1) of section 50 or under sub-section (2) of section 50 and the document to be submitted along with the application;
(l) the form in which the application under sub-section (2) or sub-section (3) of section 51 shall be made;
(m) the form in which the certificate of fitness shall be issued under sub-section (1) of section 56 and the particulars and information it shall contain;
(n) the period for which the certificate of fitness granted or renewed under section 56 shall be effective;
(o) the fees to be charged for the issue or renewal or alteration of certificates of registration, for making an entry regarding transfer of ownership on a certificate of registration, for making or cancelling an endorsement in respect of agreement of hire-purchase or lease or hypothecation on a certificate of registration, for certificates of fitness for registration marks, and for the examination or inspection of motor vehicles, and the refund of such fees.
(p) any other matter which is to be, or may be, prescribed by the Central Government.
65. Power of State Government to make rules.—(1) A State Government may make rules for the purpose of carrying into effect the provisions of this Chapter other than the matters specified in section 64.
(2) Without prejudice to the generality of the foregoing power, such rules may provide for—
(a) the conduct and hearing of appeals that may be preferred under this Chapter (the fees to be paid in respect of such appeals and the refund of such fees);
(b) the appointment, functions and jurisdiction of registering and other prescribed authorities;
(c) the exemption of road-rollers, graders and other vehicles designed and used solely for the construction, repair and cleaning of roads from all or any of the provisions of this Chapter and the rules made thereunder and the conditions governing such exemption;
(d) the issue or renewal of certificates of registration and fitness and duplicates of such certificates to replace the certificates lost, destroyed or mutilated;
(e) the production of certificates of registration before the registering authority for the revision of entries therein of particulars relating to the gross vehicle weight;
(f) the temporary registration of motor vehicles, and the issue of temporary certificate of registration and marks;
(g) the manner in which the particulars referred to in sub-section (2) of section 58 and other prescribed particulars shall be exhibited;
(h) the exemption of prescribed persons or prescribed classes of persons from payment of all or any portion of the fees payable under this Chapter;
(i) the forms, other than those prescribed by the Central Government, to be used for the purpose of this Chapter;
(j) the communication between registering authorities of particulars of certificates of registration and by owners of vehicles registered outside the State of particulars of such vehicles and of their registration;
(k) the amount or amounts under sub-section (13) of section 41 or sub-section (7) of section 47 or sub-section (4) of section 49 or sub-section (5) of section 50;
(l) the extension of the validity of certificates of fitness pending consideration of applications for their renewal;
(m) the exemption from the provisions of this Chapter, and the conditions and fees for exemption, of motor vehicles in the possession of dealers;
(n) the form in which and the period within which the return under section 62 shall be sent;
(o) the manner in which the State Register of Motor Vehicles shall be maintained under section 63;
(p) any other matter which is to be or may be prescribed.
CHAPTER V
CONTROL OF TRANSPORT VEHICLES
66. Necessity for permits.—(1) No owner of a motor vehicle shall use or permit the use of the vehicle as a transport vehicle in any public place whether or not such vehicle is actually carrying any passengers or goods save in accordance with the conditions of a permit granted or countersigned by a Regional or State Transport Authority or any prescribed authority authorising him the use of the vehicle in that place in the manner in which the vehicle is being used: Provided that a stage carriage permit shall, subject to any conditions that may be specified in the permit, authorise the use of the vehicle as a contract carriage:
Provided further that a stage carriage permit may, subject to any conditions that may be specified in the permit, authorise the use of the vehicle as a goods carriage either when carrying passengers or not: Provided also that a goods carriage permit shall, subject to any conditions that may be specified in the permit, authorise the use of the vehicle for the carriage of goods for or in connection with a trade or business carried on by him.
(2) The holder of a goods carriage permit may use the vehicle, for the drawing of any public or semitrailer not owned by him, subject to such conditions as may be prescribed.
[Provided that the holder of a permit of any articulated vehicle may use the prime-mover of that articulated vehicle for any other semi-trailor:]
(3) The provisions of sub-section (1) shall not apply—
(a) to any transport vehicle owned by the Central Government or a State Government and used for Government purposes unconnected with any commercial enterprise;
(b) to any transport vehicle owned by a local authority or by a person acting under contract with a local authority and used solely for road cleansing, road watering or conservancy purposes;
(c) to any transport vehicle used solely for police, fire brigade or ambulance purposes;
(d) to any transport vehicle used solely for the conveyance of corpses and the mourners accompanying the corpses;
(e) to any transport vehicle used for towing a disabled vehicle or for removing goods from a disabled vehicle to a place of safety;
(f) to any transport vehicle used for any other public purpose as may be prescribed by the State Government in this behalf;
(g) to any transport vehicle used by a person who manufactures or deals in motor vehicles or builds bodies for attachment to chassis, solely for such purposes and in accordance with such conditions as the Central Government may, by notification in the Official Gazette, specify in this behalf;
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(i) to any goods vehicle, the gross vehicle weight of which does not exceed 3,000 kilograms;
(j) subject to such conditions as the Central Government may, by notification in the Official Gazette, specify, to any transport vehicle purchased in one State and proceeding to a place, situated in that State or in any other State, without carrying any passenger or goods;
(k) to any transport vehicle which has been temporarily registered under section 43 while proceeding empty to any place for the purpose of registration of the vehicle;
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(m) to any transport vehicle which, owing to flood, earthquake or any other natural calamity, obstruction on road, or unforeseen circumstances is required to be diverted through any other route, whether within or outside the State, with a view to enabling it to reach its destination;
(n) to any transport vehicle used for such purposes as the Central or State Government may, by order, specify;
(o) to any transport vehicle which is subject to a hire-purchase, lease or hypothecation agreement and which owing to the default of the owner has been taken possession of by or on behalf of, the person with whom the owner has entered into such agreement, to enable such motor vehicle to reach its destination; or
(p) to any transport vehicle while proceeding empty to any place for purpose of repair. (4) Subject to the provisions of sub-section (3), sub-section (1) shall if the State Government by rule made under section 96 so prescribes, apply to any motor vehicle adapted to carry more than nine persons excluding the driver.
67. Power to State Government to control road transport.—(1) A State Government, having regard to—
(a) the advantages offered to the public, trade and industry by the development of motor transport,
(b) the desirability of co-ordinating road and rail transport,
(c) the desirability of preventing the deterioration of the road system, and
(d) the desirability of preventing uneconomic competition among holders of permits, may, from time to time, by notification in the Official Gazette, issue directions both to the State Transport Authority and Regional Transport Authority—
(i) regarding the fixing of fares and freights (including the maximum and minimum in respect thereof) for stage carriages, contract carriages and goods carriages;
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(ii) regarding the prohibition or restriction, subject to such conditions as may be specified in the directions, of the conveying of long distance goods traffic generally, or of specified classes of goods by goods carriages;
(iii) regarding any other matter which may appear to the State Government necessary or expedient for giving effect to any agreement entered into with the Central Government or any other State Government or the Government of any other country relating to the regulation of motor transport generally, and in particular to its coordination with other means of transport and the conveying of long distance goods traffic:
Provided that no such notification in respect of the matters referred to in clause (ii) or clause (iii) shall be issued unless a draft of the proposed directions is published in the Official Gazette specifying therein a date being not less than one month after such publication, on or after which the draft will be taken into consideration and any objection or suggestion which may be received has, in consultation with the State Transport Authority, been considered after giving the representatives of the interests affected an opportunity of being heard.
(2) Any direction under sub-section (1) regarding the fixing of fares and freights for stage carriages, contract carriages and goods carriages may provide that such fares or freights shall be inclusive of the tax payable by the passengers or the consignors of the goods, as the case may be, to the operators of the stage carriages, contract carriages or goods carriages under any law for the time being in force relating to tax on passengers and goods.
68. Transport Authorities.—(1) The State Government shall, by notification in the Official Gazette, constitute for the State a State Transport Authority to exercise and discharge the powers and functions specified in sub-section (3), and shall in like manner constitute Regional Transport Authorities to exercise and discharge throughout such areas (in this Chapter referred to as regions) as may be specified in the notification, in respect of each Regional Transport Authority; the powers and functions conferred by or under this Chapter on such Authorities:
Provided that in the Union territories, the Administrator may abstain from constituting any Regional Transport Authority.
(2) A State Transport Authority or a Regional Transport Authority shall consist of a Chairman who has had judicial experience or experience as an appellate or a revisional authority or as an adjudicating authority competent to pass any order or take any decision under any law and in the case of a State Transport Authority, such other persons (whether officials or not), not being more than four and, in the case of a Regional Transport Authority, such other persons (whether officials or not), not being more than two, as the State Government may think fit to appoint; but no person who has any financial interest whether as proprietor, employee or otherwise in any transport undertaking shall be appointed, or continue to be, a member of a State or Regional Transport Authority, and, if any person being a member of any such Authority acquires a financial interest in any transport undertaking, he shall within four weeks of so doing, give notice in writing to the State Government of the acquisition of such interest and shall vacate office:
Provided that nothing in this sub-section shall prevent any of the members of the State Transport Authority or a Regional Transport Authority, as the case may be, to preside over a meeting of such Authority during the absence of the Chairman, notwithstanding that such member does not possess judicial experience or experience as an appellate or a revisional authority or as an adjudicating authority competent to pass any order or take any decision under any law:
Provided further that the State Government may,—
(i) where it considers necessary or expedient so to do, constitute the State Transport Authority or a Regional Transport Authority for any region so as to consist of only one member who shall be an official with judicial experience or experience as an appellate or a revisional authority or as an adjudicating authority competent to pass any order or take any decision under any law;
(ii) by rules made in this behalf, provide for the transaction of business of such authorities in the absence of the Chairman or any other member and specify the circumstances under which, and the manner in which, such business could be so transacted:
Provided also that nothing in this sub-section shall be construed as debarring an official (other than an official connected directly with the management or operation of a transport undertaking) from being appointed or continuing as a member of any such authority merely by reason of the fact that the Government employing the official has, or acquires, any financial interest in a transport undertaking.
(3) The State Transport Authority and every Regional Transport Authority shall give effect to any directions issued under section 67 and the State Transport Authority shall, subject to such directions and save as otherwise provided by or under this Act, exercise and discharge throughout the State the following powers and functions, namely:—
(a) to co-ordinate and regulate the activities and policies of the Regional Transport Authorities, if any, of the State;
(b) to perform the duties of a Regional Transport Authority where there is no such Authority and, if it thinks fit or if so required by a Regional Transport Authority, to perform those duties in respect of any route common to two or more regions;
(c) to settle all disputes and decide all matters on which differences of opinion arise between Regional Transport Authorities; and
[(ca) Government to formulate routes for plying stage carriages;]
(d) to discharge such other functions as may be prescribed.
(4) For the purpose of exercising and discharging the powers and functions specified in sub-section (3), a State Transport Authority may, subject to such conditions as may be prescribed, issue directions to any Regional Transport Authority, and the Regional Transport Authority shall, in the discharge of its functions under this Act, give effect to and be guided by such directions.
(5) The State Transport Authority and any Regional Transport Authority, if authorised in this behalf by rules made under section 96, may delegate such of its powers and functions to such authority or person subject to such restrictions, limitations and conditions as may be prescribed by the said rules.
69. General provision as to applications for permits.—(1) Every application for a permit shall be made to the Regional Transport Authority of the region in which it is proposed to use the vehicle or vehicles:
Provided that if it is proposed to use the vehicle or vehicles in two or more regions lying within the same State, the application shall be made to the Regional Transport Authority of the region in which the major portion of the proposed route or area lies, and in case the portion of the proposed route or area in each of the regions is approximately equal, to the Regional Transport Authority of the region in which it is proposed to keep the vehicle or vehicles:
Provided further that if it is proposed to use the vehicle or vehicles in two or more regions lying in different States, the application shall be made to the Regional Transport Authority of the region in which the applicant resides or has his principal place of business.
(2) Notwithstanding anything contained in sub-section (1), the State Government may, by notification in the Official Gazette, direct that in the case of any vehicle or vehicles proposed to be used in two or more regions lying in different States, the application under that sub-section shall be made to the State Transport Authority of the region in which the applicant resides or has his principal place of business.
70. Application for stage carriage permit.—(1) An application for a permit in respect of a stage carriage (in this Chapter referred to as a stage carriage permit) or as a reserve stage carriage shall, as far as may be, contain the following particulars, namely:—
(a) the route or routes or the area or areas to which the application relates;
(b) the type and seating capacity of each such vehicle;
(c) the minimum and maximum number of daily trips proposed to be provided and the time-table of the normal trips.
Explanation.—For the purposes of this section, section 72, section 80 and section 102, “trip” means a single journey from one point to another, and every return journey shall be deemed to be a separate trip;
(d) the number of vehicles intended to be kept in reserve to maintain the service and to provide for special occasions;
(e) the arrangements intended to be made for the housing, maintenance and repair of the vehicles, for the comfort and convenience of passengers and for the storage and safe custody of luggage;
(f) such other matters as may be prescribed.
(2) An application referred to in sub-section (1) shall be accompanied by such documents as may be prescribed.
71. Procedure of Regional Transport Authority in considering application for stage carriage permit.— (1) A Regional Transport Authority shall, while considering an application for a stage carriage permit, have regard to the objects of this Act:
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(2) A Regional Transport Authority shall refuse to grant a stage carriage permit if it appears from any time-table furnished that the provisions of this Act relating to the speed at which vehicles may be driven are likely to be contravened: Provided that before such refusal an opportunity shall be given to the applicant to amend the timetable so as to conform to the said provisions.
(3) (a) The State Government shall, if so directed by the Central Government having regard to the number of vehicles, road conditions and other relevant matters, by notification in the Official Gazette, direct a State Transport Authority and a Regional Transport Authority to limit the number of stage carriages generally or of any specified type, as may be fixed and specified in the notification, operating on city routes in towns with a population of not less than five lakhs.
(b) Where the number of stage carriages are fixed under clause (a), the Government of the State shall reserve in the State certain percentage of stage carriage permits for the scheduled castes and the scheduled tribes in the same ratio as in the case of appointments made by direct recruitment to public services in the State. (c) Where the number of stage carriages are fixed under clause (a), the Regional Transport Authority shall reserve such number of permits for the scheduled castes and the scheduled tribes as may be fixed by the State Government under sub-clause (b). (d) After reserving such number of permits as is referred to in clause (c), the Regional Transport Authority shall in considering an application have regard to the following matters, namely:—
(i) financial stability of the applicant;
(ii) satisfactory performance as a stage carriage operator including payment of tax if the applicant is or has been an operator of stage carriage service; and
(iii) such other matters as may be prescribed by the State Government:
Provided that, other conditions being equal, preference shall be given to applications for permits from—
(i) State transport undertakings;
(ii) co-operative societies registered or deemed to have been registered under any enactment for the time being in force;
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(iii) ex-servicemen;
[or]
[(iv) any other class or category of persons, as the State government may, for reasons to be recorded in writing consider necessary;]
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Explanation.—For the purposes of this section “company” means any body corporate, and includes a firm or other association of individuals; and “director”, in relation to a firm, means a partner in the firm.
72. Grant of stage carriage permits.—(1) Subject to the provisions of section 71, a Regional Transport Authority may, on an application made to it under section 70, grant a stage carriage permit in accordance with the application or with such modifications as it deems fit or refuse to grant such a permit: Provided that no such permit shall be granted in respect of any route or area not specified in the application.
(2) The Regional Transport Authority, if it decides to grant a stage carriage permit, may grant the permit for a stage carriage of a specified description and may, subject to any rules that may be made under this Act, attach to the permit any one or more of the following conditions, namely:—
(i) that the vehicles shall be used only in a specified area, or on a specified route or routes;
(ii) that the operation of the stage carriage shall be commenced with effect from a specified date;
(iii) the minimum and maximum number of daily trips to be provided in relation to any route or area generally or on specified days and occasions;
(iv) that copies of the time-table of the stage carriage approved by the Regional Transport Authority shall be exhibited on the vehicles and at specified stands and halts on the route or within the area;
(v) that the stage carriage shall be operated within such margins of deviation from the approved time-table as the Regional Transport Authority may from time to time specify;
(vi) that within municipal limits and such other areas and places as may be prescribed, passengers or goods shall not be taken up or set down except at specified points;
(vii) the maximum number of passengers and the maximum weight of luggage that may be carried on the stage carriage, either generally or on specified occasions or at specified times and seasons;
(viii) the weight and nature of passengers’ luggage that shall be carried free of charge, the total weight of luggage that may be carried in relation to each passenger, and the arrangements that shall be made for the carriage of luggage without causing inconvenience to passengers;
(ix) the rate of charge that may be levied for passengers’ luggage in excess of the free allowance;
(x) that vehicles of a specified type fitted with body conforming to approved specifications shall be used: Provided that the attachment of this condition to a permit shall not prevent the continued use, for a period of two years from the date of publication of the approved specifications, of any vehicle operating on that date;
(xi) that specified standards of comfort and cleanliness shall be maintained in the vehicles;
(xii) the conditions subject to which goods may be carried in the stage carriage in addition to or to the exclusion of passengers;
(xiii) that fares shall be charged in accordance with the approved fare table;
(xiv) that a copy of, or extract from, the fare table approved by the Regional Transport Authority and particulars of any special fares or rates of fares so approved for particular occasions shall be exhibited on the stage carriage and at specified stands and halts;
(xv) that tickets bearing specified particulars shall be issued to passengers and shall show the fares actually charged and that records of tickets issued shall be kept in a specified manner;
(xvi) that mails shall be carried on the vehicle subject to such conditions (including conditions as to the time in which mails are to be carried and the charges which may be levied) as may be specified;
(xvii) the vehicles to be kept as reserve by the holder of the permit to maintain the operation and to provide for special occasions;
(xviii) the conditions subject to which vehicle may be used as a contract carriage;
(xix) that specified arrangements shall be made for the housing, maintenance and repair of vehicle;
(xx) that any specified bus station or shelter maintained by Government or a local authority shall be used and that any specified rent or fee shall be paid for such use;
(xxi) that the conditions of the permit shall not be departed from, save with the approval of the Regional Transport Authority;
(xxii) that the Regional Transport Authority may, after giving notice of not less than one month,—
(a) vary the conditions of the permit;
(b) attach to the permit further conditions:
Provided that the conditions specified in pursuance of clause (i) shall not be varied so as to alter the distance covered by the original route by more than 24 kilometers, and any variation within such limits shall be made only after the Regional Transport Authority is satisfied that such variation will serve the convenience of the public and that it is not expedient to grant a separate permit in respect of the original route as so varied or any part thereof;
(xxiii) that the holder of a permit shall furnish to the Regional Transport Authority such periodical returns, statistics and other information as the State Government may from time to time prescribe;
(xxiv) any other conditions which may be prescribed.
73. Application for contract carriage permit.—An application for a permit in respect of a contract carriage (in this Chapter referred to as a contract carriage permit) shall contain the following particulars, namely:—
(a) the type and seating capacity of the vehicle;
(b) the area for which the permit is required;
(c) any other particulars which may be prescribed.
74. Grant of contract carriage permit.—(1) Subject to the provisions of sub-section (3), a Regional Transport Authority may, on an application made to it under section 73, grant a contract carriage permit in accordance with the application or with such modifications as it deems fit or refuse to grant such a permit:
Provided that no such permit shall be granted in respect of any area not specified in the application.
(2) The Regional Transport Authority, if it decides to grant a contract carriage permit, may, subject to any rules that may be made under this Act, attach to the permit any one or more of the following conditions, namely:—
(i) that the vehicles shall be used only in a specified area or on a specified route or routes;
(ii) that except in accordance with specified conditions, no contract of hiring, other than an extension or modification of a subsisting contract, may be entered into outside the specified area;
(iii) the maximum number of passengers and the maximum weight of luggage that may be carried on the vehicles, either generally or on specified occasions or at specified times and seasons;
(iv) the conditions subject to which goods may be carried in any contract carriage in addition to, or to the exclusion of, passengers;
(v) that, in the case of motor cabs, specified fares or rates of fares shall be charged and a copy of the fare table shall be exhibited on the vehicle;
(vi) that, in the case of vehicles other than motor cabs, specified rates of hiring not exceeding specified maximum shall be charged;
(vii) that, in the case of motor cabs, a special weight of passengers’ luggage shall be carried free of charge, and that the charge, if any, for any luggage in excess thereof shall be at a specified rate;
(viii) that, in the case of motor cabs, a taximeter shall be fitted and maintained in proper working order, if prescribed;
(ix) that the Regional Transport Authority may, after giving notice of not less than one month,—
(a) vary the conditions of the permit;
(b) attach to the permit further conditions;
(x) that the conditions of permit shall not be departed from save with the approval of the Regional Transport Authority;
(xi) that specified standards of comfort and cleanliness shall be maintained in the vehicles;
(xii) that, except in the circumstances of exceptional nature, the plying of the vehicle or carrying of the passengers shall not be refused;
(xiii) any other conditions which may be prescribed.
(3) (a) The State Government shall, if so directed by the Central Government, having regard to the number of vehicles, road conditions and other relevant matters, by notification in the Official Gazette, direct a State Transport Authority and a Regional Transport Authority to limit the number of contract carriages generally or of any specified type, as may be fixed and specified in the notification, operating on city routes in towns with a population of not less than five lakhs.
(b) Where the number of contract carriages are fixed under clause (a), the Regional Transport Authority shall, in considering an application for the grant of permit in respect of any such contract carriage, have regard to the following matters, namely:—
(i) financial stability of the applicant;
(ii) satisfactory performance as a contract carriage operator including payment of tax if the applicant is or has been an operator of contract carriages; and
(iii) such other matters as may be prescribed by the State Government:
Provided that, other conditions being equal, preference shall be given to applications for permits from—
(i) the India Tourism Development Corporation;
(ii) State Tourism Development Corporations;
(iii) State Tourism Departments;
(iv) State transport undertakings;
(v) co-operative societies registered or deemed to have been registered under any enactment for the time being in force;
(vi) ex-servicemen.
75. Scheme for renting of motor cabs.—(1) The Central Government may, by notification in the Official Gazette, make a scheme for the purpose of regulating the business of renting of
[motor cabs or motor cycles to persons desiring to drive either by themselves or through drivers, motor cabs or motor cycles] for their own use and for matters connected therewith.
(2) A scheme made under sub-section (1) may provide for all or any of the following matters, namely:—
(a) licensing of operators under the scheme including grant, renewal and revocation of such licences;
(b) form of application and form of licences and the particulars to be contained therein;
(c) fee to be paid with the application for such licences;
(d) the authorities to which the application shall be made;
(e) condition subject to which such licences may be granted, renewed or revoked;
(f) appeals against orders of refusal to grant or renew such licences and appeals against orders revoking such licences;
(g) conditions subject to which motor cabs may be rented;
(h) maintenance of records and inspection of such records;
(i) such other matters as may be necessary to carry out the purposes of this section.
76. Application for private service vehicle permit.—(1) A Regional Transport Authority may, on an application made to it, grant a private service vehicle permit in accordance with the application or with such modification as it deems fit or refuse to grant such permit:
Provided that no such permit shall be granted in respect of any area or route not specified in the application.
(2) An application for a permit to use a motor vehicle as a private service vehicle shall contain the following particulars, namely:—
(a) type and seating capacity of the vehicle;
(b) the area or the route or routes to which the application relates;
(c) the manner in which it is claimed that the purpose of carrying persons otherwise than for hire or reward or in connection with the trade or business carried on by the applicant will be served by the vehicle; and
(d) any other particulars which may be prescribed.
(3) The Regional Transport Authority if it decides to grant the permit may, subject to any rules that may be made under this Act, attach to the permit any one or more of the following conditions, namely:—
(i) that the vehicle be used only in a specified area or on a specified route or routes;
(ii) the maximum number of persons and the maximum weight of luggage that may be carried;
(iii) that the Regional Transport Authority may, after giving notice of not less than one month—
(a) vary the conditions of the permit;
(b) attach to the permit further conditions;
(iv) that the conditions of permit shall not be departed from, save with the approval of the Regional Transport Authority;
(v) that specified standards of comforts and cleanliness shall be maintained in the vehicle;
(vi) that the holder of the permit shall furnish to the Regional Transport Authority such periodical returns, statistics and other information as the State Government may, from time to time, specify; and
(vii) such other conditions as may be prescribed.
77. Application for goods carriage permit.—An application for a permit to use a motor vehicle for the carriage of goods for hire or reward or for the carriage of goods for or in connection with a trade or business carried on by the applicant (in this Chapter referred to as a goods carriage permit) shall, as far as may be, contain the following particulars, namely:—
(a) the area or the route or routes to which the application relates;
(b) the type and capacity of the vehicle;
(c) the nature of the goods it is proposed to carry;
(d) the arrangements intended to be made for the housing, maintenance and repair of the vehicle and for the storage and safe custody of the goods;
(e) such particulars as the Regional Transport Authority may require with respect to any business as a carrier of goods for hire or reward carried on by the applicant at any time before the making of the application, and of the rates charged by the applicant;
(f) particulars of any agreement, or arrangement, affecting in any material respect the provision within the region of the Regional Transport Authority of facilities for the transport of goods for hire or reward, entered into by the applicant with any other person by whom such facilities are provided, whether within or without the region;
(g) any other particulars which may be prescribed.
78. Consideration of application for goods carriage permit.—A Regional Transport Authority shall, in considering an application for a goods carriage permit, have regard to the following matters, namely:—
(a) the nature of the goods to be carried with special reference to their dangerous or hazardous nature to human life;
(b) the nature of the chemicals or explosives to be carried with special reference to the safety to human life.
79. Grant of goods carriage permit.—(1) A Regional Transport Authority may, on an application made to it under section 77, grant a goods carriage permit to be valid throughout the State or in accordance with the application or with such modifications as it deems fit or refuse to grant such a permit: Provided that no such permit shall be granted in respect of any area or route not specified in the application.
(2) The Regional Transport Authority, if it decides to grant a goods carriage permit, may grant the permit and may, subject to any rules that may be made under this Act, attach to the permit any one or more of the following conditions, namely:—
(i) that the vehicle shall be used only in a specified area or on a specified route or routes;
(ii) that the gross vehicle weight of any vehicle used shall not exceed a specified maximum;
(iii) that goods of a specified nature shall not be carried; (iv) that goods shall be carried at specified rates;
(v) that specified arrangement shall be made for the housing, maintenance and repair of the vehicle and the storage and safe custody of the goods carried;
(vi) that the holder of the permit shall furnish to the Regional Transport Authority such periodical returns, statistics and other information as the State Government may, from time to time, prescribe;
(vii) that the Regional Transport Authority may, after giving notice of not less than one month,—
(a) vary the conditions of the permit;
(b) attach to the permit further conditions;
(viii) that the conditions of the permit shall not be departed from, save with the approval of the Regional Transport Authority;
(ix) any other conditions which may be prescribed.
(3) The conditions referred to in sub-section (2) may include conditions relating to the packaging and carriage of goods of dangerous or hazardous nature to human life.
80. Procedure in applying for and granting permits.—(1) An application for a permit of any kind may be made at any time.
(2) A [Regional Transport Authority, State Transport Authority or any prescribed authority referred to in sub-section (1) of section 66] shall not ordinarily refuse to grant an application for permit of any kind made at any time under this Act:
Provided that the [Regional Transport Authority, State Transport Authority or any prescribed authority referred to in sub-section (1) of section 66] may summarily refuse the application if the grant of any permit in accordance with the application would have the effect of increasing the number of stage carriages as fixed and specified in a notification in the Official Gazette under clause (a) of sub-section (3) of section 71 or of contract carriages as fixed and specified in a notification in the Official Gazette under clause (a) of sub-section (3) of section 74:
Provided further that where a [Regional Transport Authority, State Transport Authority or any prescribed authority referred to in sub-section (1) of section 66] refuses an application for the grant of a permit of any kind under this Act, it shall give to the applicant in writing its reasons for the refusal of the same and an opportunity of being heard in the matter.
(3) An application to vary the conditions of any permit, other than a temporary permit, by the inclusion of a new route or routes or a new area or by altering the route or routes or area covered by it, or in the case of a stage carriage permit by increasing the number of trips above the specified maximum or by the variation, extension or curtailment of the route or routes or the area specified in the permit shall be treated as an application for the grant of a new permit: Provided that it shall not be necessary so to treat an application made by the holder of stage carriage permit who provides the only service on any route to increase the frequency of the service so provided without any increase in the number of vehicles:
Provided further that,—
(i) in the case of variation, the termini shall not be altered and the distance covered by the variation shall not exceed twenty-four kilometres;
(ii) in the case of extension, the distance covered by extension shall not exceed twenty-four kilometres from the termini, and any such variation or extension within such limits shall be made only after the transport authority is satisfied that such variation will serve the convenience of the public and that it is not expedient to grant a separate permit in respect of the original route as so varied or extended or any part thereof.
(4) A [Regional Transport Authority, State Transport Authority or any prescribed authority referred to in sub-section (1) of section 66] may, before such date as may be specified by it in this behalf, replace any permit granted by it before the said date by a fresh permit conforming to the provisions of section 72 or section 74 or section 76 or section 79, as the case may be, and the fresh permit shall be valid for the same route or routes or the same area for which the replaced permit was valid:
Provided that no condition other than a condition which was already attached to the replaced permit or which could have been attached thereto under the law in force when that permit was granted shall be attached to the fresh permit except with the consent in writing of the holder of the permit. (5) Notwithstanding anything contained in section 81, a permit issued under the provisions of sub-section (4) shall be effective without renewal for the remainder of the period during which the replaced permit would have been so effective.
81. Duration and renewal of permits.—(1) A permit other than a temporary permit issued under section 87 or a special permit issued under sub-section (8) of section 88 shall be effective 2 [from the date of issuance or renewal thereof] for a period of five years: Provided that where the permit is countersigned under sub-section (1) of section 88, such countersignature shall remain effective without renewal for such period so as to synchronise with the validity of the primary permit.
(2) A permit may be renewed on an application made not less than fifteen days before the date of its expiry.
(3) Notwithstanding anything contained in sub-section (2), the Regional Transport Authority or the State Transport Authority, as the case may be, may entertain an application for the renewal of a permit after the last date specified in that sub-section if it is satisfied that the applicant was prevented by good and sufficient cause from making an application within the time specified.
(4) The Regional Transport Authority or the State Transport Authority, as the case may be, may reject an application for the renewal of a permit on one or more of the following grounds, namely:—
(a) the financial condition of the applicant as evidenced by insolvency, or decrees for payment of debts remaining unsatisfied for a period of thirty days, prior to the date of consideration of the application;
(b) the applicant had been punished twice or more for any of the following offences within twelve months reckoned from fifteen days prior to the date of consideration of the application committed as a result of the operation of a stage carriage service by the applicant, namely:—
(i) plying any vehicle—
(1) without payment of tax due on such vehicle;
(2) without payment of tax during the grace period allowed for payment of such tax and then stop the plying of such vehicle;
(3) on any unauthorised route;
(ii) making unauthorised trips: Provided that in computing the number of punishments for the purpose of clause (b), any punishment stayed by the order of an appellate authority shall not be taken into account: Provided further that no application under this sub-section shall be rejected unless an opportunity of being heard is given to the applicant.
(5) Where a permit has been renewed under this section after the expiry of the period thereof, such renewal shall have effect from the date of such expiry irrespective of whether or not a temporary permit has been granted under clause (d) of section 87, and where a temporary permit has been granted, the fee paid in respect of such temporary permit shall be refunded.
82. Transfer of permit.—(1) Save as provided in sub-section (2), a permit shall not be transferable from one person to another except with the permission of the transport authority which granted the permit and shall not, without such permission, operate to confer on any person to whom a vehicle covered by the permit is transferred any right to use that vehicle in the manner authorised by the permit.
(2) Where the holder of a permit dies, the person succeeding to the possession of the vehicle covered by the permit may, for a period of three months, use the permit as if it had been granted to himself:
Provided that such person has, within thirty days of the death of the holder, informed the transport authority which granted the permit of the death of the holder and of his own intention to use the permit: Provided further that no permit shall be so used after the date on which it would have ceased to be effective without renewal in the hands of the deceased holder.
(3) The transport authority may, on application made to it within three months of the death of the holder of a permit, transfer the permit to the person succeeding to the possession of the vehicles covered by the permit: Provided that the transport authority may entertain an application made after the expiry of the said period of three months if it is satisfied that the applicant was prevented by good and sufficient cause from making an application within the time specified.
83. Replacement of vehicles.—The holder of a permit may, with the permission of the authority by which the permit was granted, replace any vehicle covered by the permit by any other vehicle of the same nature.
84. General conditions attaching to all permits.—The following shall be conditions of every permit—
(a) that the vehicle to which the permit relates carries valid certificate of fitness issued under section 56 and is at all times so maintained as to comply with the requirements of this Act and the rules made thereunder;
(b) that the vehicle to which the permit relates is not driven at a speed exceeding the speed permitted under this Act;
(c) that any prohibition or restriction imposed and any fares or freight fixed by notification made under section 67 are observed in connection with the vehicle to which the permit relates;
(d) that the vehicle to which the permit relates is not driven in contravention of the provisions of section 5 or section 113;
(e) that the provisions of this Act limiting the hours of work of drivers are observed in connection with any vehicle or vehicles to which the permit relates;
(f) that the provisions of Chapters X, XI and XII so far as they apply to the holder of the permit are observed; and
(g) that the name and address of the operator shall be painted or otherwise firmly affixed to every vehicle to which the permit relates on the exterior of the body of that vehicle on both sides thereof in a colour or colours vividly contrasting to the colour of the vehicle centered as high as practicable below the window line in bold letters.
85. General form of permits.—Every permit issued under this Act shall be complete in itself and shall contain all the necessary particulars of the permit and the conditions attached thereto.
86. Cancellation and suspension of permits.—(1) The transport authority which granted a permit may cancel the permit or may suspend it for such period as it thinks fit—
(a) on the breach of any condition specified in section 84 or of any condition contained in the permit, or
(b) if the holder of the permit uses or causes or allows a vehicle to be used in any manner not authorised by the permit, or
(c) if the holder of the permit ceases to own the vehicle covered by the permit, or
(d) if the holder of the permit has obtained the permit by fraud or misrepresentation, or
(e) if the holder of the goods carriage permit, fails without reasonable cause, to use the vehicle for the purposes for which the permit was granted, or
(f) if the holder of the permit acquires the citizenship of any foreign country:
Provided that no permit shall be suspended or cancelled unless an opportunity has been given to the holder of the permit to furnish his explanation.
(2) The transport authority may exercise the powers conferred on it under sub-section (1) in relation to a permit granted by any authority or person to whom power in this behalf has been delegated under sub-section (5) of section 68 as if the said permit was a permit granted by the transport authority.
(3) Where a transport authority cancels or suspends a permit, it shall give to the holder in writing its reasons for the action taken.
(4) The powers exercisable under sub-section (1) (other than the power to cancel a permit) by the transport authority which granted the permit may be exercised by any authority or person to whom such powers have been delegated under sub-section (5) of section 68.
(5) Where a permit is liable to be cancelled or suspended under clause (a) or clause (b) or clause (e) of sub-section (1) and the transport authority is of opinion that having regard to the circumstances of the case, it would not be necessary or expedient so to cancel or suspend the permit if the holder of the permit agrees to pay a certain sum of money, then, notwithstanding anything contained in sub-section (1), the transport authority may, instead of cancelling or suspending the permit, as the case may be, recover from the holder of the permit the sum of money agreed upon.
(6) The powers exercisable by the transport authority under sub-section (5) may, where an appeal has been preferred under section 89, be exercised also by the appellate authority. (7) In relation to a permit referred to in sub-section (9) of section 88, the powers exercisable under sub-section (1) (other than the power to cancel a permit) by the transport authority which granted the permit, may be exercised by any transport authority and any authority or persons to whom power in this behalf has been delegated under sub-section (5) of section 68, as if the said permit was a permit granted by any such authority or persons.
87. Temporary permits.—(1) A Regional Transport Authority and the State Transport Authority may without following the procedure laid down in section 80, grant permits, to be effective for a limited period which shall, not in any case exceed four months, to authorise the use of a transport vehicle temporarily—
(a) for the conveyance of passengers on special occasions such as to and from fairs and religious gatherings, or
(b) for the purposes of a seasonal business, or
(c) to meet a particular temporary need, or
(d) pending decision on an application for the renewal of a permit, and may attach to any such permit such condition as it may think fit:
Provided that a Regional Transport Authority or, as the case may be, State Transport Authority may, in the case of goods carriages, under the circumstances of an exceptional nature, and for reasons to be recorded in writing, grant a permit for a period exceeding four months, but not exceeding one year.
(2) Notwithstanding anything contained in sub-section (1), a temporary permit may be granted thereunder in respect of any route or area where—
(i) no permit could be issued under section 72 or section 74 or section 76 or section 79 in respect of that route or area by reason of an order of a court or other competent authority restraining the issue of the same, for a period not exceeding the period for which the issue of the permit has been so restrained; or
(ii) as a result of the suspension by a court or other competent authority of the permit of any vehicle in respect of that route or area, there is no transport vehicle of the same class with a valid permit in respect of that route or area, or there is no adequate number of such vehicles in respect of that route or area, for a period not exceeding the period of such suspension.
Provided that the number of transport vehicles in respect of which temporary permits are so granted shall not exceed the number of vehicles in respect of which the issue of the permits have been restrained or, as the case may be, the permit has been suspended.
88. Validation of permits for use outside region in which granted.—(1) Except as may be otherwise prescribed, a permit granted by the Regional Transport Authority of any one region shall not be valid in any other region, unless the permit has been countersigned by the Regional Transport Authority of that other rigion, and a permit granted in any one State shall not be valid in any other State unless countersigned by the State Transport Authority of that other State or by the Regional Transport Authority concerned:
Provided that a goods carriage permit, granted by the Regional Transport Authority of any one region, for any area in any other region or regions within the same State shall be valid in that area without the countersignature of the Regional Transport Authority of the other region or of each of the other regions concerned:
Provided further that where both the starting point and the terminal point of a route are situate within the same State, but part of such route lies in any other State and the length of such part does not exceed sixteen kilometres, the permit shall be valid in the other State in respect of that part of the route which is in that other State notwithstanding that such permit has not been countersigned by the State Transport Authority or the Regional Transport Authority of that other State: Provided also that—
(a) where a motor vehicle covered by a permit granted in one State is to be used for the purposes of defence in any other State, such vehicle shall display a certificate, in such form, and issued by such Authority, as the Central Government may, by notification in the Official Gazette, specify, to the effect that the vehicle shall be used for the period specified therein exclusively for the purposes of defence; and
(b) any such permit shall be valid in that other State notwithstanding that such permit has not been countersigned by the State Transport Authority or the Regional Transport Authority of that other State.
(2) Notwithstanding anything contained in sub-section (1), a permit granted or countersigned by a State Transport Authority shall be valid in the whole State or in such regions within the State as may be specified in the permit.
(3) A Regional Transport Authority when countersigning the permit may attach to the permit any condition which it might have imposed if it had granted the permit and may likewise vary any condition attached to the permit by the authority by which the permit was granted.
(4) The provisions of this Chapter relating to the grant, revocation and suspension of permits shall apply to the grant, revocation and suspension of countersignatures of permits:
Provided that it shall not be necessary to follow the procedure laid down in section 80 for the grant of countersignatures of permits, where the permits granted in any one State are required to be countersigned by the State Transport Authority of another State or by the Regional Transport Authority concerned as a result of any agreement arrived at between the States after complying with the requirements of sub-section (5).
(5) Every proposal to enter into an agreement between the States to fix the number of permits which is proposed to be granted or countersigned in respect of each route or area, shall be published by each of the State Governments concerned in the Official Gazette and in any one or more of the newspapers in regional language circulating in the area or route proposed to be covered by the agreement together with a notice of the date before which representations in connection therewith may be submitted, and the date not being less than thirty days from the date of publication in the Official Gazette, on which, and the authority by which, and the time and place at which, the proposal and any representation received in connection therewith will be considered.
(6) Every agreement arrived at between the States shall, in so far as it relates to the grant of countersignature of permits, be published by each of the State Governments concerned in the Official Gazette and in any one or more of the newspapers in the regional language circulating in the area or route covered by the agreement and the State Transport Authority of the State and the Regional Transport Authority concerned shall give effect to it.
(7) Notwithstanding anything contained in sub-section (1), a Regional Transport Authority of one region may issue a temporary permit under section 87 to be valid in another region or State with the concurrence, given generally or for the particular occasion, of the Regional Transport Authority of that other region or of the State Transport Authority of that other State, as the case may be.
(8) Notwithstanding anything contained in sub-section (1), but subject to any rules that may be made under this Act by the Central Government, the Regional Transport Authority of any one region or, as the case may be, the State Transport Authority, may, for the convenience of the public, 1 [grant a special permit to any public service vehicle including any vehicle covered] by a permit issued under section 72 (including a reserve stage carriage) or under section 74 or under sub-section (9) of this section for carrying a passenger or passengers for hire or reward under a contract, express or implied, for the use of the vehicle as a whole without stopping to pick up or set down along the line of route passengers not included in the contract, and in every case where such special permit is granted, the Regional Transport Authority shall assign to the vehicle, for display thereon, a special distinguishing mark in the form and manner specified by the Central Government and such special permit shall be valid in any other region or State without the countersignature of the Regional Transport Authority of the other region or of the State Transport Authority of the other State, as the case may be.
(9) Notwithstanding anything contained in sub-section (1) but subject to any rules that may be made by the Central Government under sub-section (14), any State Transport Authority may, for the purpose of promoting tourism, grant permits in respect of tourist vehicles valid for the whole of India, or in such contiguous States not being less than three in number including the State in which the permit is issued as may be specified in such permit in accordance with the choice indicated in the application and the provisions of sections 73, 74, 80, 81, 82, 83, 84, 85, 862 [clause (d) of sub-section (1) of section 87 and section 89] shall, as far as may be, apply in relation to such permits.
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(11) The following shall be conditions of every permit granted under sub-section (9), namely:—
(i) every motor vehicle in respect of which such permit is granted shall conform to such description, requirement regarding the seating capacity, standards of comforts, amenities and other matters, as the Central Government may specify in this behalf;
(ii) every such motor vehicle shall be driven by a person having such qualifications and satisfying such conditions as may be specified by the Central Government; and
(iii) such other conditions as may be prescribed by the Central Government.
(12) Notwithstanding anything contained in sub-section (1), but, subject to the rules that may be made by the Central Government under sub-section (14), the appropriate authority may, for the purpose of encouraging long distance inter-State road transport, grant in a State, national permits in respect of goods carriages and the provisions of sections 69, 77, 79, 80, 81, 82, 83, 84, 85, 86 1 [clause (d) of sub-section (1) of section 87 and section 89] shall, as far as may be, apply to or in relation to the grant of national permits.
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(14) (a) The Central Government may make rules for carrying out the provisions of this section.
(b) In particular, and without prejudice to the generality of the foregoing power, such rules may provide for all or any of the following matters, namely:—
(i) the authorisation fee payable for the issue of a permit referred to in sub-sections (9) and (12);
(ii) the fixation of the laden weight of the motor vehicle;
(iii) the distinguishing particulars or marks to be carried or exhibited in or on the motor vehicle;
(iv) the colour or colours in which the motor vehicle is to be painted;
(v) such other matters as the appropriate authority shall consider in granting a national permit.
Explanation.—In this section,—
(a) “appropriate authority”, in relation to a national permit, means the authority which is authorised under this Act to grant a goods carriage permit;
(b) “authorisation fee” means the annual fee, not exceeding one thousand rupees, which may be charged by the appropriate authority of a State to enable a motor vehicle, covered by the permit referred to in sub-sections (9) and (12) to be used in other States subject to the payment of taxes or fees, if any, levied by the States concerned;
(c) “national permit” means a permit granted by the appropriate authority to goods carriages to operate throughout the territory of India or in such contiguous States, not being less than four in number, including the State in which the permit is issued as may be specified in such permit in accordance with the choice indicated in the application.
89. Appeals.—(1) Any person—
(a) aggrieved by the refusal of the State or a Regional Transport Authority to grant a permit, or by any condition attached to a permit granted to him, or
(b) aggrieved by the revocation or suspension of the permit or by any variation of the conditions thereof, or
(c) aggrieved by the refusal to transfer the permit under section 82, or
(d) aggrieved by the refusal of the State or a Regional Transport Authority to countersign a permit, or by any condition attached to such countersignature, or
(e) aggrieved by the refusal of renewal of a permit, or
(f) aggrieved by the refusal to grant permission under section 83, or
(g) aggrieved by any other order which may be prescribed, may, within the prescribed time and in the prescribed manner, appeal to the State Transport Appellate Tribunal constituted under sub-section
(2), who shall, after giving such person and the original authority an opportunity of being heard, give a decision thereon which shall be final.
[(2) The State Government shall constitute such number of Transport Appellate Tribunals as it thinks fit and each such Tribunal shall consist of a judicial officer who is not below the rank of a District Judge or who is qualified to be a Judge of the High Court and it shall exercise jurisdiction within such area as may be notified by that Government.]
(3) Notwithstanding anything contained in sub-section (1) or sub- section (2), every appeal pending at the commencement of this Act, shall continue to be proceeded with and disposed of as if this Act had not been passed.
Explanation.—For the removal of doubts, it is hereby declared that when any order is made by the State Transport Authority or the Regional Transport Authority in pursuance of a direction issued by the Inter-State Transport Commission under clause (c) of sub-section (2) of section 63A of the Motor Vehicles Act, 1939 (4 of 1939),as it stood immediately before the commencement of this Act, and any person feels aggrieved by such order on the ground that it is not in consonance with such direction, he may appeal under sub-section (1) to the State Transport Appellate Tribunal against such order but not against the direction so issued.
90. Revision.—The State Transport Appellate Tribunal may, on an application made to it, call for the record of any case in which an order has been made by a State Transport Authority or Regional Transport Authority against which no appeal lies, and if it appears to the State Transport Appellate Tribunal that the order made by the State Transport Authority or Regional Transport Authority is improper or illegal, the State Transport Appellate Tribunal may pass such order in relation to the case as it deems fit and every such order shall be final:
Provided that the State Transport Appellate Tribunal shall not entertain any application from a person aggrieved by an order of a State Transport Authority or Regional Transport Authority, unless the application is made within thirty days from the date of the order:
Provided further that the State Transport Appellate Tribunal may entertain the application after the expiry of the said period of thirty days, if it is satisfied that the applicant was prevented by good and sufficient cause from making the application in time:
Provided also that the State Transport Appellate Tribunal shall not pass an order under this section prejudicial to any person without giving him a reasonable opportunity of being heard.
91. Restriction of hours of work of drivers.—1 [(1) The hours of work of any person engaged for operating a transport vehicle shall be such as provided in the Motor Transport Workers Act, 1961 (27 of 1961).]
(2) A State Government may, by notification in the Official Gazette, grant such exemptions from the provisions of sub-section (1) as it thinks fit, to meet cases of emergency or of delays by reason of circumstances which could not be foreseen.
(3) A State Government or, if authorised in this behalf by the State Government by rules made under section 96, the State or a Regional Transport Authority may require persons employing any person whose work is subject to any of the provisions of sub-section (1) to fix beforehand the hours of work of such persons so as to conform to those provisions, and may provide for the recording of the hours so fixed.
(4) No person shall work or shall cause or allow any other person to work outside the hours fixed or recorded for the work of such persons under sub-section (3).
(5) A State Government may prescribe the circumstances under which and the period during which the driver of a vehicle although not engaged in work is required to remain on or near the vehicle may be deemed to be an interval for rest within the meaning of sub-section (1).
92. Voidance of contracts restrictive of liability.—Any contract for the conveyance of a passenger in a stage carriage or contract carriage, in respect of which a permit has been issued under this Chapter, shall, so far as it purports to negative or restrict the liability of any person in respect of any claim made against that person in respect of the death of, or bodily injury to, the passenger while being carried in, entering or alighting from the vehicle, or purports to impose any conditions with respect to the enforcement of any such liability, be void.
93. Agent or canvasser to obtain licence.—(1) No person shall engage himself—
(i) as an agent or a canvasser, in the sale of tickets for travel by public service vehicles or in otherwise soliciting custom for such vehicles, or
(ii) as an agent in the business of collecting, forwarding or distributing goods carried by goods carriages, unless he has obtained a licence from such authority and subject to such conditions as may be prescribed by the State Government.
(2) The conditions referred to in sub-section (1) may include all or any of the following matters, namely:—
(a) the period for which a licence may be granted or renewed;
(b) the fee payable for the issue or renewal of the licence;
(c) the deposit of security—
(i) of a sum not exceeding rupees fifty thousand in the case of an agent in the business of collecting, forwarding or distributing goods carried by goods carriages;
(ii) of a sum not exceeding rupees five thousand in the case of any other agent or canvasser, and the circumstances under which the security may be forfeited;
(d) the provisions by the agent of insurance of goods in transit;
(e) the authority by which and the circumstances under which the licence may be suspended or revoked;
(f) such other conditions as may be prescribed by the State Government.
(3) It shall be a condition of every licence that no agent or canvasser to whom the licence is granted shall advertise in any newspaper, book, list, classified directory or other publication unless there is contained in such advertisement appearing in such newspaper, book, list, classified directory or other publication the licence number, the date of expiry of licence and the particulars of the authority which granted the licence.
94. Bar on jurisdiction of Civil Courts.—No Civil Court shall have jurisdiction to entertain any question relating to the grant of a permit under this Act, and no injunction in respect of any action taken or to be taken by the duly constituted authorities under this Act with regard to the grant of a permit, shall be entertained by any Civil Court.
95. Power of State Government to make rules as to stage carriages and contract carriages.—(1) A State Government may make rules to regulate, in respect of stage carriages and contract carriages and the conduct of passengers in such vehicles.
(2) Without prejudice to the generality of the foregoing provision, such rules may—
(a) authorise the removal from such vehicle of any person contravening the rules by the driver or conductor of the vehicle, or, on the request of the driver or conductor, or any passenger, by any police officer;
(b) require a passenger who is reasonably suspected by the driver or conductor of contraventing the rules to give his name and address to a police officer or to the driver or conductor on demand;
(c) require a passenger to declare, if so demanded by the driver or conductor, the journey he intends to take or has taken in the vehicle and to pay the fare for the whole of such journey and to accept any ticket issued therefor;
(d) require, on demand being made for the purpose by the driver or conductor or other person authorised by the owners of the vehicle, production during the journey and surrender at the end of the journey by the holder thereof of any ticket issued to him;
(e) require a passenger, if so requested by the driver or conductor, to leave the vehicle on the completion of the journey the fare for which he has paid
(f) require the surrender by the holder thereof on the expiry of the period for which it is issued of a ticket issued to him;
(g) require a passenger to abstain from doing anything which is likely to obstruct or interfere with the working of the vehicle or to cause damage to any part of the vehicle or its equipment or to cause injury or discomfort to any other passenger;
(h) require a passenger not to smoke in any vehicle on which a notice prohibiting smoking is exhibited;
(i) require the maintenance of complaint books in stage carriages and prescribe the conditions under which passengers can record any complaints in the same.
96. Power of State Government to make rules for the purposes of this Chapter.—(1) A State Government may make rules for the purpose of carrying into effect the provisions of this Chapter.
(2) Without prejudice to the generality of the foregoing power, rules under this section may be made with respect to all or any of the following matters, namely:—
(i) the period of appointment and the terms of appointment of and the conduct of business by Regional and State Transport Authorities and the reports to be furnished by them;
(ii) the conduct of business by any such authority in the absence of any member (including the Chairman) thereof and the nature of business which, the circumstances under which and the manner in which, business could be so conducted;
(iii) the conduct and hearing of appeals that may be preferred under this Chapter, the fees to be paid in respect of such appeals and the refund of such fees;
(iv) the forms to be used for the purposes of this Chapter, including the forms of permits;
(v) the issue of copies of permits in place of permits lost, destroyed or multilated;
(vi) the documents, plates and marks to be carried by transport vehicles, the manner in which they are to be carried and the languages in which any such documents are to be expressed;
(vii) the fees to be paid in respect of applications for permits,duplicate permits and plates;
(vii) the exemption of prescribed persons or prescribed classes of persons from payment of all or any or any portion of the fees payable under this Chapter;
(ix) the custody, production and cancellation on revocation or expiration of permits, and the return of permits which have been cancelled;
(x) the conditions subject to which, and the extent to which, a permit granted in another State shall be valid in the State without countersignature;
(xi) the conditions subject to which, and the extent to which, a permit granted in one region shall be valid in another region within the State without countersignature;
(xii) the conditions to be attached to permits for the purpose of giving effect to any agreement such as is referred to in clause (iii) of sub-section (1) of section 67;
(xiii) the authorities to whom, the time within which and the manner in which appeals may be made;
(xiv) the construction and fittings of, and the equipment to be carried by, stage and contract carriage, whether generally or in specified areas;
(xv) the determination of the number of passengers a stage or contract carriage is adapted to carry and the number which may be carried;
(xvi) the conditions subject to which goods may be carried on stage and contract carriages partly or wholly in lieu of passengers;
(xvii) the safe custody and disposal of property left in a stage or contract carriage;
(xviii) regulating the painting or marking of transport vehicles and the display of advertising matter thereon, and in particular prohibiting the painting or marking of transport vehicles in such colour or manner as to induce any person to believe that the vehicle is used for the transport of mails;
(xix) the conveyance in stage or contract carriages of corpses or persons suffering from any infectious or contagious disease or goods likely to cause discomfort or injury to passengers and the inspection and disinfection of such carriage; if used for such purposes;
(xx) the provision of taxi meters on motor cabs requiring approval or standard types of taxi meters to be used and examining testing and sealing taxi meters;
(xxi) prohibiting the picking up or setting down of passengers by stage or contract carriages at specified places or in specified areas or at places other than duly notified stands or halting places and requiring the driver of a stage carriage to stop and remain stationary for a reasonable time when so required by a passenger desiring to board or alight from the vehicle at a notified halting place;
(xxii) the requirements which shall be complied with in the construction or use of any duly notified stand or halting place, including the provision of adequate equipment and facilities for the convenience of all users thereof; the fees, if any, which may be charged for the use of such facilities, the records which shall be maintained at such stands or places, the staff to be employed thereat, and the duties and conduct of such staff, and generally for maintaining such stands and places in a serviceable and clean condition;
(xxiii) the regulation of motor cab ranks;
(xxiv) requiring the owners of transport vehicles to notify any change of address or to report the failure of or damage to any vehicle used for the conveyance of passengers for hire or reward;
(xxv) authorising specified persons to enter at all reasonable times and inspect all premises used by permit holders for the purposes of their business;
(xxvi) requiring the person in charge of a stage carriage to carry any person tendering the legal or customary fare;
(xxvii) the conditions under which and the types of containers or vehicles in which animals or birds may be carried and the seasons during which animals or birds may or may not be carried;
(xxviii) the licensing of and the regulation of the conduct of agents or canvassers who engage in the sale of tickets for travel by public service vehicles or otherwise solicit custom for such vehicles;
(xxix) the licensing of agents engaged in the business of collecting for forwarding and distributing goods carried by goods carriages;
(xxx) the inspection of transport vehicles and their contents and of the permits relating to them;
(xxxi) the carriage of persons other than the driver in goods carriages;
(xxxii) the records to be maintained and the returns to be furnished by the owners of transport vehicles; and
(xxxiii) any other matter which is to be or may be prescribed.
CHAPTER VI
SPECIAL PROVISIONS RELATING TO STATE TRANSPORT UNDERTAKINGS
97. Definition.—In this Chapter, unless the context otherwise requires, “road transport service” means a service of motor vehicles carrying passengers or goods or both by road for hire or reward.
98. Chapter to override Chapter V and other laws.—The provisions of this Chapter and the rules and orders made thereunder shall have effect notwithstanding anything inconsistent therewith contained in Chapter V or in any other law for the time being in force or in any instrument having effect by virtue of any such law.
99. Preparation and publication of proposal regarding road transport service of a State transport undertaking.—1 [(1)]Where any State Government is of opinion that for the purpose of providing an efficient, adequate, economical and properly co-ordinated road transport service, it is necessary in the public interest that road transport services in general or any particular class of such service in relation to any area or route or portion thereof should be run and operated by the State transport undertaking, whether to the exclusion, complete or partial, of other persons or otherwise, the State Government may formulate a proposal regarding a scheme giving particulars of the nature of the services proposed to be rendered, the area or route proposed to be covered and other relevant particulars respecting thereto and shall publish such proposal in the Official Gazette of the State formulating such proposal and in not less than one newspaper in the regional language circulating in the area or route proposed to be covered by such scheme and also in such other manner as the State Government formulating such proposal deem fit.
2 [(2) Notwithstanding anything contained in sub-section (1), when a proposal is published under that sub-section, then from the date of publication of such proposal, no permit shall be granted to any person, except a temporary permit during the pendency of the proposal and such temporary permit shall be valid only for a period of one year from the date of its issue of till the date of final publication of the scheme under section 100, whichever is earlier.] 100. Objection to the proposal.—
(1) On the publication of any proposal regarding a scheme in the Official Gazette and in not less than one newspaper in the regional language circulating in the area or route which is to be covered by such proposal any person may, within thirty days from the date of its publication in the Official Gazette, file objections to it before the State Government.
2) The State Government may, after considering the objections and after giving an opportunity to the objector or his representatives and the representatives of the State transport undertaking to be heard in the matter, if they so desire, approve or modify such proposal.
(3) The scheme relating to the proposal as approved or modified under sub-section (2) shall then be published in the Official Gazette by the State Government making such scheme and in not less than one newspaper in the regional language circulating in the area or route covered by such scheme and the same shall thereupon become final on the date of its publication in the Official Gazette and shall be called the approved scheme and the area or route to which it relates shall be called the notified area or notified route: Provided that no such scheme which relates to any inter-State route shall be deemed to be an approved scheme unless it has the previous approval of the Central Government.
(4) Notwithstanding anything contained in this section, where a scheme is not published as an approved scheme under sub-section (3) in the Official Gazette within a period of one year from the date of publication of the proposal regarding the scheme in the Official Gazette under sub-section (1), the proposal shall be deemed to have lapsed.
Explanation.—In computing the period of one year referred to in this sub-section, any period or periods during which the publication of the approved scheme under sub-section (3) was held up on account of any stay or injunction by the order of any court shall be excluded.
101. Operation of additional services by a State transport undertaking in certain circumstances.— Notwithstanding anything contained in section 87, a State transport undertaking may, in the public interest operate additional services for the conveyance of the passengers on special occasions such as to and from fairs and religious gatherings:
Provided that the State transport undertaking shall inform about the operation of such additional services to the concerned Transport Authority without delay.
102. Cancellation or modification of scheme.—(1) The State Government may, at any time, if it considers necessary, in the public interest so to do, modify any approved scheme after giving—
(i) the State transport undertaking; and
(ii) any other person who, in the opinion of the State Government, is likely to be affected by the proposed modification,
an opportunity of being heard in respect of the proposed modification.
(2) The State Government shall publish any modification proposed under sub-section (1) in the Official Gazette and in one of the newspapers in the regional languages circulating in the area in which it is proposed to be covered by such modification, together with the date, not being less than thirty days from such publication in the Official Gazette, and the time and place at which any representation received in this behalf will be heard by the State Government.
- Issue of permits to State transport undertakings.—(1) Where, in pursuance of an approved scheme, any State transport undertaking applies in such manner as may be prescribed by the State Government in this behalf for a stage carriage permit or a goods carriage permit or a contract carriage permit in respect of a notified area or notified route, the State Transport Authority in any case where the said area or route lies in more than one region and the Regional Transport Authority in any other case shall issue such permit to the State transport undertaking, notwithstanding anything to the contrary contained in Chapter V.(2) For the purpose of giving effect to the approved scheme in respect of a notified area or notified route, the State Transport Authority or, as the case may be, the Regional Transport Authority concerned may, by order,—
(a) refuse to entertain any application for the grant or renewal of any other permit or reject any such application as may be pending;
(b) cancel any existing permit;
(c) modify the terms of any existing permit so as to—
(i) render the permit ineffective beyond a specified date;
(ii) reduce the number of vehicles authorised to be used under the permit;
(iii) curtail the area or route covered by the permit in so far as such permit relates to the notified area or notified route.
(3) For the removal of doubts, it is hereby declared that no appeal shall lie against any action taken, or order passed, by the State Transport Authority or any Regional Transport Authority under sub-section (1) or sub-section (2).
- Restriction on grant of permits in respect of a notified area or notified route.—Where a
scheme has been published under sub-section (3) of section 100 in respect of any notified area or notified route, the State Transport Authority or the Regional Transport Authority, as the case may be, shall not grant any permit except in accordance with the provisions of the scheme:
Provided that where no application for a permit has been made by the State transport undertaking in respect of any notified area or notified route in pursuance of an approved scheme, the State Transport Authority or the Regional Transport Authority, as the case may be, may grant temporary permits to any person in respect of such notified area or notified route subject to the condition that such permit shall cease to be effective on the issue of a permit to the State transport undertaking in respect of that area or route.
- Principles and method of determining compensation and payment thereof.—(1) Where, in exercise of the powers conferred by clause (b) or clause (c) of sub-section (2) of section 103, any existing permit is cancelled or the terms thereof are modified, there shall be paid by the State transport undertaking to the holder of the permit, compensation, the amount of which shall be determined in accordance with the provisions of sub-section (4) or sub-section (5), as the case may be.
(2) Notwithstanding anything contained in sub-section (1), no compensation shall be payable on account of the cancellation of any existing permit or any modification of the terms thereof, when a permit for an alternative route or area in lieu thereof has been offered by the State Transport Authority or the Regional Transport Authority, as the case may be and accepted by the holder of the permit.
(3) For the removal of doubts, it is hereby declared that no compensation shall be payable on account of the refusal to renew a permit under clause (a) of sub-section (2) of section 103.
(4) Where, in exercise of the powers conferred by clause (b) or sub-clause (i) or sub-clause (ii) of clause (c) of sub-section (2) of section 103, any existing permit is cancelled or the terms thereof are modified so as to prevent the holder of the permit from using any vehicle authorised to be used thereunder for the full period from which the permit, would otherwise have been effective, the compensation payableto the holder of the permit for each vehicle affected by such cancellation or modification shall be computed as follows:—
(a) for every complete month or part of a month exceeding fifteen days of the unexpired period of the permit Two hundred rupees;
(b) for part of a month not exceeding fifteen days of the unexpired period of the permit One hundred rupees:
Provided that the amount of compensation shall, in no case, be less than four hundred rupees.
(5) Where, in exercise of the powers conferred by sub-clause (iii) of clause (c) of sub-section (2) of section 103, the terms of an existing permit are modified so as to curtail the area or route of any vehicle authorised to be used thereunder, the compensation payable to the holder of the permit on account of such curtailment shall be an amount computed in accordance with the following formula, namely:—
Explanation.—In this formula,— (i) “Y” means the length or area by which the route or area covered by the permit is curtailed; (ii) “A” means the amount computed in accordance with sub-section (4); (iii) “R” means the total length of the route or the total area covered by the permit.
(6) The amount of compensation payable under this section shall be paid by the State transport undertaking to the person or persons entitled thereto within one month from the date on which the cancellation or modification of the permit becomes effective: Provided that where the State transport undertaking fails to make the payment within the said period of one month, it shall pay interest at the rate of seven per cent. per annum from the date on which it falls due.
106. Disposal of article found in vehicles.—Where any article found in any transport vehicle operated by the State transport undertaking is not claimed by its owner within the prescribed period, the State transport undertaking may sell the article in the prescribed manner and the sale proceeds thereof, after deducting the costs incidental to sale, shall be paid to the owner on demand.
107. Power of State Government to make rules.—(1) The State Government may make rules for the purpose of carrying into effect the provisions of this Chapter. (2) In particular and without prejudice to the generality of the foregoing power, such rules may provide for all or any of the following matters, namely:—
(a) the form in which any proposal regarding a scheme may be published under section 99;
(b) the manner in which objections may be filed under sub-section (1) of section 100;
(c) the manner in which objections may be considered and disposed of under sub-section (2) of section 100;
(d) the form in which any approved scheme may be published under sub-section (3) of section 100;
(e) the manner in which application under sub-section (1) of section 103 may be made;
(f) the period within which the owner may claim any article found left in any transport vehicle under section 106 and the manner of sale of such article;
(g) the manner of service of orders under this Chapter;
(h) any other matter which has to be, or may be, prescribed.
108. Certain powers of State Government exercisable by the Central Government.—The powers conferred on the State Government under this Chapter shall, in relation to a corporation or company owned or controlled by the Central Government or by the Central Government and one or more State Governments, be exercisable only by the Central Government in relation to an inter-State route or area.
CHAPTER VII
CONSTRUCTION, EQUIPMENT AND MAINTENANCE OF MOTOR VEHICLES
109. General provision regarding construction and maintenance of vehicles.—(1) Every motor vehicle shall be so constructed and so maintained as to be at all times under the effective control of the person driving the vehicle.
(2) Every motor vehicle shall be so constructed as to have right hand steering control unless it is equipped with a mechanical or electrical signalling device of a prescribed nature.
[(3) If the Central Government is of the opinion that it is necessary or expedient so to do in the public interest, it may by order published in the Official Gazette, notify that any article or process used by a manufacturer shall conform to such standard as may be specified in that order.]
110. Power of Central Government to make rules.—(1) The Central Government may make rules regulating the construction, equipment and maintenance of motor vehicles and trailers with respect to all or any of the following matters, namely:—
(a) the width, height, length and overhang of vehicles and of the loads carried;
[(b) the size, nature, maximum retail price and condition of tyres, including embossing thereon of date and year of manufacture and the maximum load carrying capacity;]
(c) brakes and steering gear;
(d) the use of safety glasses including prohibition of the use of tinted safety glasses;
(e) signalling appliances, lamps and reflectors;
(f) speed governors;
(g) the emission of smoke, visible vapour, sparks, ashes, grit or oil;
(h) the reduction of noise emitted by or caused by vehicles;
(i) the embossment of chassis number and engine number and the date of manufacture;
(j) safety belts, handle bars of motor cycles, auto-dippers and other equipments essential for safety of drivers, passengers and other road users;
(k) standards of the components used in the vehicle as inbuilt safety devices;
(l) provision for transportation of goods of dangerous or hazardous nature to human life;
(m) standards for emission of air pollutants;
[(n) installation of catalytic convertors in the class of vehicles to be prescribed;
(o) the placement of audio-visual or radio or tape recorder type of device in public vehicles;
(p) warranty after sale of vehicle and norms therefor:] Provided that any rules relating to the matters dealing with the protection of environment, so far as may be, shall be made after consultation with the Ministry of the Government of India dealing with environment.
(2) Rules may be made under sub-section (1) governing the matters mentioned therein, including the manner of ensuring the compliance with such matters and the maintenance of motor vehicles in respect of such matters, either generally in respect of motor vehicles or trailers or in respect of motor vehicles or trailers of a particular class or in particular circumstances.
(3) Notwithstanding anything contained in this section,— (a) the Central Government may exempt any class of motor vehicles from the provisions of this Chapter; (b) a State Government may exempt any motor vehicle or any class or description of motor vehicles from the rules made under sub-section (1) subject to such conditions as may be prescribed by the Central Government.
111. Power of State Government to make rules.—(1) A State Government may make rules regulating the construction, equipment and maintenance of motor vehicles and trailers with respect to all matters other than the matters specified in sub-section (1) of section 110.
(2) Without prejudice to the generality of the foregoing power, rules may be made under this section governing all or any of the following matters either generally in respect of motor vehicles or trailers or in respect of motor vehicles or trailers of a particular class or description or in particular circumstances, namely:—
(a) seating arrangements in public service vehicles and the protection of passengers against the weather;
(b) prohibiting or restricting the use of audible signals at certain times or in certain places;
(c) prohibiting the carrying of appliances likely to cause annoyance or danger;
(d) the periodical testing and inspection of vehicles by prescribed authorities1 [and fees to be charged for such test];
(e) the particulars other than registration marks to be exhibited by vehicles and the manner in which they shall be exhibited;
(f) the use of trailers with motor vehicles; and
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CHAPTER VIII
CONTROL OF TRAFFIC
112. Limits of speed.—(1) No person shall drive a motor vehicle or cause or allow a motor vehicle to be driven in any public place at a speed exceeding the maximum speed or below the minimum speed fixed for the vehicle under this Act or by or under any other law for the time being in force:
Provided that such maximum speed shall in no case exceed the maximum fixed for any motor vehicle or class or description of motor vehicles by the Central Government by notification in the Official Gazette.
(2) The State Government or any authority authorised in this behalf by the State Government may, if satisfied that it is necessary to restrict the speed of motor vehicles in the interest of public safety or convenience or because of the nature of any road or bridge, by notification in the Official Gazette, and by causing appropriate traffic signs to be placed or erected under section 116 at suitable places, fix such maximum speed limits or minimum speed limits as it thinks fit for motor vehicles or any specified class or description of motor vehicles or for motor vehicles to which a trailer is attached, either generally or in a particular area or on a particular road or roads:
Provided that no such notification is necessary if any restriction under this section is to remain in force for not more than one month.
(3) Nothing in this section shall apply to any vehicle registered under section 60 while it is being used in the execution of military manoeuvres within the area and during the period specified in the notification under sub-section (1) of section 2 of the Manoeuvres, Field Firing and Artillery Practice Act, 1938 (5 of 1938).
113. Limits of weight and limitations on use.—(1) The State Government may prescribe the conditions for the issue of permits for 1 [transport vehicles] by the State or Regional Transport Authorities and may prohibit or restrict the use of such vehicles in any area or route.
(2) Except as may be otherwise prescribed, no person shall drive or cause or allow to be driven in any public place any motor vehicle which is not fitted with pneumatic tyres.
(3) No person shall drive or cause or allow to be driven in any public place any motor vehicle or trailer— (a) the unladen weight of which exceeds the unladen weight specified in the certificate of registration of the vehicle, or (b) the laden weight of which exceeds the gross vehicle weight specified in the certificate of registration.
(4) Where the driver or person in charge of a motor vehicle or trailer driven in contravention of sub-section (2) or clause (a) of sub-section (3) is not the owner, a Court may presume that the offence was committed with the knowledge of or under the orders of the owner of the motor vehicle or trailer.
114. Power to have vehicle weighed.—(1) 2 [Any officer of the Motor Vehicles Department authorized in this behalf by the State Government shall, if he has reason to believe that a goods vehicle or trailor is being used in contravention of section 113] require the driver to convey the vehicle to a weighing device, if any, within a distance of ten kilometres from any point on the forward route or within a distance of twenty kilometres from the destination of the vehicle for weighment; and if on such weighment the vehicle is found to contravene in any respect the provisions of section 113 regarding weight, he may, by order in writing, direct the driver to off-load the excess weight at his own risk and not to remove the vehicle or trailer from that place until the laden weight has been reduced or the vehicle or trailer has otherwise been dealt with so that it complies with section 113 and on receipt of such notice, the driver shall comply with such directions.
(2) Where the person authorised under sub-section (1) makes the said order in writing, he shall also endorse the relevant details of the overloading on the goods carriage permit and also intimate the fact of such endorsement to the authority which issued that permit.
115. Power to restrict the use of vehicles.—The State Government or any authority authorised in this behalf by the State Government, if satisfied that it is necessary in the interest of public safety or convenience, or because of the nature of any road or bridge, may by notification in the Official Gazette, prohibit or restrict, subject to such exceptions and conditions as may be specified in notification, the driving of motor vehicles or of any specified class or description of motor vehicles or the use of trailers either generally in a specified area or on a specified road and when any such prohibition or restriction is imposed, shall cause appropriate traffic signs to be placed or erected under section 116 at suitable places:
Provided that where any prohibition or restriction under this section is to remain in force for not more than one month, notification thereof in the Official Gazette shall not be necessary, but such local publicity as the circumstances may permit, shall be given of such prohibition or restriction.
116. Power to erect traffic signs.—(1) (a) The State Government or any authority authorised in this behalf by the State Government may cause or permit traffic signs to be placed or erected in any public place for the purpose of bringing to public notice any speed limits fixed under sub-section (2) of section 112 or any prohibitions or restrictions imposed under section 115 or generally for the purpose of regulating motor vehicle traffic.
(b) A State Government or any authority authorised in this behalf by the State Government may, by notification in the Official Gazette or by the erection at suitable places of the appropriate traffic sign referred to in Part A of the Schedule, designate certain roads as main roads for the purposes of the driving regulations made by the Central Government.
(2) Traffic signs placed or erected under sub-section (1) for any purpose for which provision is made in the Schedule shall be of the size, colour and type and shall have the meanings set forth in the Schedule, but the State Government or any authority empowered in this behalf by the State Government may make or authorise the addition to any sign set forth in the said Schedule, of transcriptions of the words, letters or figures thereon in such script as the State Government may think fit, provided that the transcriptions shall be of similar size and colour to the words, letters or figures set forth in the Schedule.
(3) Except as provided by sub-section (1), no traffic sign shall, after the commencement of this Act, be placed or erected on or near any road; but all traffic signs placed or erected prior to the commencement of this Act by any competent authority shall for the purpose of this Act be deemed to be traffic signs placed or erected under the provisions of sub-section (1).
(4) A State Government may, by notification in the Official Gazette, empower any police officer not below the rank of a Superintendent of Police to remove or cause to be removed any sign or advertisement which is so placed in his opinion as to obscure any traffic sign from view or any sign or advertisement which is in his opinion so similar in appearance to a traffic sign as to be misleading or which in his opinion is likely to distract the attention or concentration of the driver.
(5) No person shall wilfully remove, alter, deface, or in any way tamper with, any traffic signs placed or erected under this section.
(6) If any person accidentally causes such damage to a traffic sign as renders it useless for the purpose for which it is placed or erected under this section, he shall report the circumstances of the occurrence to a police officer or at a police station as soon as possible, and in any case within twenty-four hours of the occurrence.
(7) For the purpose of bringing the signs set forth in 1 [the First Schedule] in conformity with any International Convention relating to motor traffic to which the Central Government is for the time being a party, the Central Government may, by notification in the Official Gazette, make any addition or alteration to any such sign and on the issue of any such notification,1 [the First Schedule] shall be deemed to be amended accordingly.
117. Parking places and halting stations.—The State Government or any authority authorised in this behalf by the State Government may, in consultation with the local authority having jurisdiction in the area concerned, determine places at which motor vehicles may stand either indefinitely or for a specified period of time, and may determine the places at which public service vehicles may stop for a longer time than is necessary for the taking up and setting down of passengers.
118. Driving regulations.—The Central Government may, by notification in the Official Gazette, make regulations for the driving of motor vehicles.
119. Duty to obey traffic signs.—(1) Every driver of a motor vehicle shall drive the vehicle in conformity with any indication given by mandatory traffic sign and in conformity with the driving regulations made by the Central Government, and shall comply with all directions given to him by any police officer for the time being engaged in the regulation of traffic in any public place.
(2) In this section “mandatory traffic sign” means a traffic sign included in Part A of the Schedule, or any traffic sign of similar form (that is to say, consisting of or including a circular disc diplaying a device, word or figure and having a red ground or border) placed or erected for the purpose of regulating motor vehicle traffic under sub-section (1) of section 116.
120. Vehicles with left hand control.—No person shall drive or cause or allow to be driven in any public place any motor vehicle with a left-hand steering control unless it is equipped with a mechanical or electrical signalling device of a prescribed nature and in working order.
121. Signals and signalling devices.—The driver of a motor vehicle shall make such signals and on such occasions as may be prescribed by the Central Government: Provided that the signal of an intention to turn to the right or left or to stop—
(a) in the case of a motor vehicle with a right-hand steering control, may be given by a mechanical or electrical device of a prescribed nature affixed to the vehicle; and
(b) in the case of a motor vehicle with a left hand steering control, shall be given by a mechanical or electrical device of a prescribed nature affixed to the vehicle:
Provided further that the State Government may, having regard to the width and condition of the roads in any area or route, by notification in the Official Gazette, exempt subject to such conditions as may be specified therein any motor vehicle or class or description of motor vehicles from the operation of this section for the purpose of plying in that area or route.
122. Leaving vehicle in dangerous position.—No person in charge of a motor vehicle shall cause or allow the vehicle or any trailer to be abandoned or to remain at rest on any public place in such a position or in such a condition or in such circumstances as to cause or likely to cause danger, obstruction or undue inconvenience to other users of the public place or to the passengers.
123. Riding on running board, etc.—(1) No person driving or in charge of a motor vehicle shall carry any person or permit any person to be carried on the running board or otherwise than within the body of the vehicle. (2) No person shall travel on the running board or on the top or on the bonnet of a motor vehicle.
124. Prohibition against travelling without pass or ticket.—No person shall enter or remain in any stage carriage for the purposes of travelling therein unless he has with him a proper pass or ticket:
Provided that where arrangements for the supply of tickets are made in the stage carriage by which a person has to travel, a person may enter such stage carriage but as soon as may be after his entry therein, be shall make the payment of his fare to the conductor or the driver who performs the functions of a conductor and obtain from such conductor or driver, as the case may be, a ticket for his journey.
Explanation.—In this section,—
(a) “pass” means a duty, privilege or courtesy pass entitling the person to whom it is given to travel in a stage carriage gratuitously and includes a pass issued on payment for travel in a stage carriage for the period specified therein;
(b) “ticket” includes a single ticket, a return ticket or a season ticket.
125. Obstruction of driver.—No person driving a motor vehicle shall allow any person to stand or sit or to place anything in such a manner or position as to hamper the driver in his control of the vehicle.
126. Stationary vehicles.—No person driving or in charge of a motor vehicle shall cause or allow the vehicle to remain stationary in any public place, unless there is in the driver’s seat a person duly licensed to drive the vehicle or unless the mechanism has been stopped and a brake or brakes applied or such other measures taken as to ensure that the vehicle cannot accidentally be put in motion in the absence of the driver.
127. Removal of motor vehicles abandoned or left unattended on a public place.—1 [(1) Where any motor vehicle is abandoned, or left unattended, on a public place for ten hours or more or is parked in a place where parking is legally prohibited, its removal by a towing service or its immobilisations by any means including wheel clamping may be authorised by a police officer in uniform having jurisdiction.]
(2) Where an abandoned, unattended, wrecked, burnt or partially dismantled vehicle is creating a traffic hazard, because of its position in relation to the 1 [public place], or its physical appearance is causing the impediment to the traffic, its immediate removal from the1 [public place] by a towing service may be authorised by a police officer having jurisdiction.
(3) Where a vehicle is authorised to be removed under sub-section (1) or sub-section (2) by a police officer, the owner of the vehicle shall be responsible for all towing costs, besides any other penalty.
128. Safety measures for drivers and pillion riders.—(1) No driver of a two-wheeled motor cycle shall carry more than one person in addition to himself on the motor cycle and no such person shall be carried otherwise than sitting on a proper seat securely fixed to the motor cycle behind the driver’s seat with appropriate safety measures.
(2) In addition to the safety measures mentioned in sub-section (1), the Central Government may, prescribe other safety measures for the drivers of two-wheeled motor cycles and pillion riders thereon.
129. Wearing of protective headgear.—Every person driving or riding (otherwise than in a side car, on a motor cycle of any class or description) shall, while in a public place, wear 2 [protective headgear conforming to the standards of Bureau of Indian Standards]:
Provided that the provisions of this section shall not apply to a person who is a Sikh, if he is, while driving or riding on the motor cycle, in a public place, wearing a turban:
Provided further that the State Government may, by such rules, provide for such exceptions as it may think fit.
Explanation.—”Protective headgear” means a helmet which,— (a) by virtue of its shape, material and construction, could reasonably be expected to afford to the person driving or riding on a motor cycle a degree of protection from injury in the event of an accident; and
(b) is securely fastened to the head of the wearer by means of straps or other fastenings provided on the headgear.
130. Duty to produce licence and certificate of registration.—(1) The driver of a motor vehicle in any public place shall, on demand by any police officer in uniform, produce his licence for examination:
Provided that the driver may, if his licence has been submitted to, or has been seized by, any officer or authority under this or any other Act, produce in lieu of the licence a receipt or other acknowledgment issued by such officer or authority in respect thereof and thereafter produce the licence within such period, in such manner as the Central Government may prescribe to the police officer making the demand.
[(2) The conductor, if any, of a motor vehicle on any public place shall on demand by any officer of the Motor Vehicles Department authorised in this behalf, produce the licence for examination.]
[(3) The owner of a motor vehicle (other than a vehicle registered under section 60), or in his absence the driver or other person in charge of the vehicle, shall, on demand by a registering authority or any other officer of the Motor Vehicles Department duly authorised in this behalf, produce the certificate of insurance of the vehicle and, where the vehicle is a transport vehicle, also the certificate of fitness referred to in section 56 and the permit; and if any or all of the certificates or the permit are not in his possession, he shall, within fifteen days from the date of demand, submit photo copies of the same, duly attested in person or send the same by registered post to the officer who demanded it.
Explanation.—For the purposes of this sub-section, “certificate of insurance” means the certificate issued under sub-section (3) of section 147.]
(4) If the licence referred to in sub-section (2) or the certificates or permit referred to in sub-section (3), as the case may be, are not at the time in the possession of the person to whom demand is made, it shall be a sufficient compliance with this section if such person produces the licence or certificates or permit within such period in such manner as the Central Government may prescribe, to the police officer or authority making the demand: Provided that, except to such extent and with such modifications as may be prescribed, the provisions of this sub-section shall not apply to any person required to produce the certificate of registration or the certificate of fitness of a transport vehicle.
131. Duty of the driver to take certain precautions at unguarded railway level crossing.—Every driver of a motor vehicle at the approach of any unguarded railway level crossing shall cause the vehicle to stop and the driver of the vehicle shall cause the conductor or cleaner or attendant or any other person in the vehicle to walk up to the level crossing and ensure that no train or trolley is approaching from either side and then pilot the motor vehicle across such level crossing, and where no conductor or cleaner or attendant or any other person is available in the vehicle, the driver of the vehicle shall get down from the vehicle himself to ensure that no train or trolley is approaching from either side before the railway track is crossed.
132. Duty of driver to stop in certain cases.—(1) The driver of a motor vehicle shall cause the vehicle to stop and remain stationary so long as 1 [may for such reasonable time as may be necessary, but not exceeding twenty-four hours]— 2 [(a) when required to do so by any police officer not below the rank of a Sub-Inspector in uniform, in the event of the vehicle being involved in the occurrence of an accident to a person, animal or vehicle or of damage to property, or] (b) when required to do so by any person in charge of an animal if such person apprehends that the animal is, or being alarmed by the vehicle will become, unmanageable, or
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and he shall give his name and address and the name and address of the owner of the vehicle to any person affected by any such accident or damage who demands it provided such person also furnishes his name and address.
(2) The driver of a motor vehicle shall, on demand by a person giving his own name and address and alleging that the driver has committed an offence punishable under section 184 give his name and address to that person.
(3) In this section the expression “animal” means any horse, cattle, elephant, camel, ass, mule, sheep or goat.
133. Duty of owner of motor vehicle to give information.—The owner of a motor vehicle, the driver or conductor of which is accused of any offence under this Act shall, on the demand of any police officer authorised in this behalf by the State Government, give all information regarding the name and address of, and the licence held by, the driver or conductor which is in his possession or could by reasonable diligence be ascertained by him.
134. Duty of driver in case of accident and injury to a person.—When any person is injured or any property of a third party is damaged, as a result of an accident in which a motor vehicle is involved, the driver of the vehicle or other person in charge of the vehicle shall—
(a) unless it is not practicable to do so on account of mob fury or any other reason beyond his control, take all reasonable steps to secure medical attention for the injured person, 4 [by conveying him to the nearest medical practitioner or hospital, and it shall be the duty of every registered medical practitioner or the doctor on the duty in the hospital immediately to attend to the injured person and render medical aid or treatment without waiting for any procedural formalities], unless the injured person or his guardian, in case he is a minor, desires otherwise;
(b) give on demand by a police officer any information required by him, or, if no police officer is present, report the circumstances of the occurrence, including the circumstances, if any, for not taking reasonable steps to secure medical attention as required under clause (a), at the nearest police station as soon as possible, and in any case within twenty-four hours of the occurrence.
[(c) give the following information in writing to the insurer, who has issued the certificates of insurance, about the occurrence of the accident, namely:—
(i) insurance policy number and period of its validity;
(ii) date, time and place of accident;
(iii) particulars of the persons injured or killed in the accident;
(iv) name of the driver and the particulars of his driving licence.
Explanation.—For the purposes of this section the expression “driver” includes the owner of the vehicle.]
135. Schemes to be framed for the investigation of accident cases and wayside amenities, etc.— (1) The State Government may, by notification in the Official Gazette, make one or more schemes to provide for—
(a) an in depth study on causes and analysis of motor vehicle accidents;
(b) wayside amenities on highways;
(c) traffic aid posts on highways; and
(d) truck parking complexes along highways.
(2) Every scheme made under this section by any State Government shall be laid, as soon as may be after it is made, before the State Legislature.
136. Inspection of vehicle involved in accident.—When any accident occurs in which a motor vehicle is involved, any person authorised in this behalf by the State Government may, on production if so required of his authority, inspect the vehicle and for that purpose may enter at any reasonable time any premises where the vehicle may be, and may remove the vehicle for examination:
Provided that the place to which the vehicle is so removed shall be intimated to the owner of the vehicle and the vehicle shall be returned 2 [after completion of the formalities to the owner, driver or the person in charge of the vehicle within twenty-four hours].
137. Power of Central Government to make rules.—The Central Government may make rules to provide for all or any of the following matters, namely:—
(a) the occasions on which signals shall be made by drivers of motor vehicles and such signals under section 121;
(b) the manner in which the licences and certificates may be produced to the police officer under section 130.
138. Power of State Government to make rules.—(1) The State Government may make rules for the purpose of carrying into effect the provisions of this Chapter other than the matters specified in section 137.
(2) Without prejudice to the generality of the foregoing power, such rules may provide for—
(a) the removal and the safe custody of vehicles including their loads which have broken down or which have been left standing or have been abandoned on roads;
(b) the installation and use of weighing devices;
(c) the maintenance and management of wayside amenities complexes;
(d) the exemption from all or any of the provisions of this Chapter of fire brigade vehicles, ambulances and other special classes or descriptions of vehicle, subject to such conditions as may be prescribed;
(e) the maintenance and management of parking places and stands and the fees, if any, which may be charged for their use;
(f) prohibiting the driving downhill of a motor vehicle with the gear disengaged either generally or in a specified place;
(g) prohibiting the taking hold of or mounting of a motor vehicle in motion;
(h) prohibiting the use of foot-paths or pavements by motor vehicles;
(i) generally, the prevention of danger, injury or annoyance to the public or any person, or of danger or injury to property or of abstruction to traffic; and
(j) any other matter which is to be, or may be, prescribed.
CHAPTER IX
MOTOR VEHICLES TEMPORARILY LEAVING OR VISITING INDIA
139. Power of Central Government to make rules.—(1) The Central Government may, by notification in the Official Gazette, make rules for all or any of the following purposes, namely:—
(a) the grant and authentication of travelling passes, certificates or authorisations to persons temporarily taking motor vehicles out of India to any place outside India or to persons temporarily proceeding out of India to any place outside India and desiring to drive a motor vehicle during their absence from India;
(b) prescribing the conditions subject to which motor vehicles brought temporarily into India from outside India by persons intending to make a temporary stay in India may be possessed and used in India; and
(c) prescribing the conditions subject to which persons entering India from any place outside India for a temporary stay in India may drive motor vehicles in India.
(2) For the purpose of facilitating and regulating the services of motor vehicles operating between India and any other country under any reciprocal arrangement and carrying passengers or goods or both by road for hire or reward, the Central Government may, by notification in the Official Gazette, make rules with respect to all or any of the following matters, namely:—
(a) the conditions subject to which motor vehicles carrying on such services may be brought into India from outside India and possessed and used in India;
(b) the conditions subject to which motor vehicles may be taken from any place in India to any place outside India;
(c) the conditions subject to which persons employed as drivers and conductors of such motor vehicles may enter or leave India;
(d) the grant and authentication of travelling passes, certificates or authorisations to persons employed as drivers and conductors of such motor vehicles;
(e) the particulars (other than registration marks) to be exhibited by such motor vehicles and the manner in which such particulars are to be exhibited;
(f) the use of trailers with such motor vehicles;
(g) the exemption of such motor vehicles and their drivers and conductors from all or any of the provisions of this Act [other than those referred to in sub-section (4)] or the rules made thereunder;
(h) the identification of the drivers and conductors of such motor vehicles;
(i) the replacement of the travelling passes, certificates or authorisations, permits, licences or any other prescribed documents lost or defaced, on payment of such fee as may be prescribed;
(j) the exemption from the provisions of such laws as relate to customs, police or health with a view to facilitate such road transport services;
(k) any other matter which is to be, or may be, prescribed.
(3) No rule made under this section shall operate to confer on any person any immunity in any State from the payment of any tax levied in that State on motor vehicles or their users.
(4) Nothing in this Act or in any rule made thereunder by a State Government relating to:—
(a) the registration and identification of motor vehicles, or
(b) the requirements as to construction, maintenance and equipment of motor vehicles, or
(c) the licensing and the qualifications of drivers and conductors of motor vehicles, shall apply—
(i) to any motor vehicle to which or to any driver of a motor vehicle to whom any rules made under clause (b) or clause (c) of sub-section (1) or under sub-section (2) apply; or
(ii) to any conductor of a motor vehicle to whom any rules made under sub-section (2) apply
CHAPTER X
LIABILITY WITHOUT FAULT IN CERTAIN CASES
140. Liability to pay compensation in certain cases on the principle of no fault.—(1) Where death or permanent disablement of any person has resulted from an accident arising out of the use of a motor vehicle or motor vehicles, the owner of the vehicle shall, or, as the case may be, the owners of the vehicles shall, jointly and severally, be liable to pay compensation in respect of such death or disablement in accordance with the provisions of this section.
(2) The amount of compensation which shall be payable under sub-section (1) in respect of the death of any person shall be a fixed sum of 1 [fifty thousand rupees] and the amount of compensation payable under that sub-section in respect of the permanent disablement of any person shall be a fixed sum of 2 [twenty-five thousand rupees].
(3) In any claim for compensation under sub-section (1), the claimant shall not be required to plead and establish that the death or permanent disablement in respect of which the claim has been made was due to any wrongful act, neglect or default of the owner or owners of the vehicle or vehicles concerned or of any other person.
(4) A claim for compensation under sub-section (1) shall not be defeated by reason of any wrongful act, neglect or default of the person in respect of whose death or permanent disablement the claim has been made nor shall the quantum of compensation recoverable in respect of such death or permanent disablement be reduced on the basis of the share of such person in the responsibility for such death or permanent disablement.
[(5) Notwithstanding anything contained in sub-section (2) regarding death or bodily injury to any person, for which the owner of the vehicle is liable to give compensation for relief, he is also liable to pay compensation under any other law for the time being in force:
Provided that the amount of such compensation to be given under any other law shall be reduced from the amount of compensation payable under this section or under section 163A.]
141. Provisions as to other right to claim compensation for death or permanent disablement.— (1) The right to claim compensation under section 140 in respect of death or permanent disablement of any person shall be in addition to 1 [any other right, except the right to claim under the scheme referred to in section 163A (such other right hereafter] in this section referred to as the right on the principle of fault) to claim compensation in respect thereof under any other provision of this Act or of any other law for the time being in force.
(2) A claim for compensation under section 140 in respect of death or permanent disablement of any person shall be disposed of as expeditiously as possible and where compensation is claimed in respect of such death or permanent disablement under section 140 and also in pursuance of any right on the principle of fault, the claim for compensation under section 140 shall be disposed of as aforesaid in the first place.
(3) Notwithstanding anything contained in sub-section (1), where in respect of the death or permanent disablement of any person, the person liable to pay compensation under section 140 is also liable to pay compensation in accordance with the right on the principle of fault, the person so liable shall pay the first-mentioned compensation and—
(a) if the amount of the first-mentioned compensation is less than the amount of the second-mentioned compensation, he shall be liable to pay (in addition to the first-mentioned compensation) only so much of the second-mentioned compensation as is equal to the amount by which it exceeds the first-mentioned compensation;
(b) if the amount of the first-mentioned compensation is equal to or more than the amount of the second-mentioned compensation, he shall not be liable to pay the second-mentioned compensation.
142. Permanent disablement.—For the purposes of this Chapter, permanent disablement of a person shall be deemed to have resulted from an accident of the nature referred to in sub-section (1) of section 140 if such person has suffered by reason of the accident, any injury or injuries involving—
(a) permanent privation of the sight of either eye or the hearing of either ear, or privation of any member or joint; or
(b) destruction or permanent impairing of the powers of any member or joint; or
(c) permanent disfiguration of the head or face.
143. Applicability of Chapter to certain claims under Act 8 of 1923.—The provisions of this Chapter shall also apply in relation to any claim for compensation in respect of death or permanent disablement of any person under the Workmen’s Compensation Act, 1923 resulting from an accident of the nature referred to in sub-section (1) of section 140 and for this purpose, the said provisions shall, with necessary modifications, be deemed to form part of that Act.
144. Overriding effect.—The provisions of this Chapter shall have effect notwithstanding anything contained in any other provision of this Act or of any other law for the time being in force.
CHAPTER XI
INSURANCE OF MOTOR VEHICLES AGAINST THIRD PARTY RISKS
145. Definitions.—In this Chapter,—
(a) “authorised insurer” means an insurer for the time being carrying on general insurance business in India under the General Insurance Business (Nationalisation) Act, 1972, (57 of 1972) and any Government insurance fund authorised to do general insurance business under that Act;
(b) “certificate of insurance” means a certificate issued by an authorised insurer in pursuance of sub-section (3) of section 147 and includes a cover note complying with such requirements as may be prescribed, and where more than one certificate has been issued in connection with a policy, or where a copy of a certificate has been issued, all those certificates or that copy, as the case may be;
(c) “liability”, wherever used in relation to the death of or bodily injury to any person, includes liability in respect thereof under section 140;
(d) “policy of insurance” includes “certificate of insurance”;
(e) “property” includes goods carried in the motor vehicle, roads, bridges, culverts, causeways, trees, posts and mile- stones;
(f) “reciprocating country” means any such country as may on the basis of reciprocity be notified by the Central Government in the Official Gazette to be a reciprocating country for the purposes of this Chapter;
(g) “third party” includes the Government.
146. Necessity for insurance against third party risk.—(1) No person shall use, except as a passenger, or cause or allow any other person to use, a motor vehicle in a public place, unless there is in force in relation to the use of the vehicle by that person or that other person, as the case may be, a policy of insurance complying with the requirements of this Chapter:
[Provided that in the case of a vehicle carrying, or meant to carry, dangerous or hazardous goods, there shall also be a policy of insurance under the Public Liability Insurance Act, 1991 (6 of 1991).]
Explanation.—A person driving a motor vehicle merely as a paid employee, while there is in force in relation to the use of the vehicle no such policy as is required by this sub-section, shall not be deemed to act in contravention of the sub-section unless he knows or has reason to believe that there is no such policy in force.
(2) Sub-section (1) shall not apply to any vehicle owned by the Central Government or a State Government and used for Government purposes unconnected with any commercial enterprise.
(3) The appropriate Government may, by order, exempt from the operation of sub-section (1) any vehicle owned by any of the following authorities, namely:—
(a) the Central Government or a State Government, if the vehicle is used for Government purposes connected with any commercial enterprise;
(b) any local authority;
(c) any State transport undertaking:
Provided that no such order shall be made in relation to any such authority unless a fund has been established and is maintained by that authority in accordance with the rules made in that behalf under this Act for meeting any liability arising out of the use of any vehicle of that authority which that authority or any person in its employment may incur to third parties.
Explanation.—For the purposes of this sub-section, “appropriate Government” means the Central Government or a State Government, as the case may be, and—
(i) in relation to any corporation or company owned by the Central Government or any State Government, means the Central Government or that State Government;
(ii) in relation to any corporation or company owned by the Central Government and one or more State Governments, means the Central Government;
(iii) in relation to any other State transport undertaking or any local authority, means that Government which has control over that undertaking or authority.
147. Requirements of policies and limits of liability.—(1) In order to comply with the requirements of this Chapter, a policy of insurance must be a policy which—
(a) is issued by a person who is an authorised insurer; and
(b) insures the person or classes of persons specified in the policy to the extent specified in sub-section (2)—
(i) against any liability which may be incurred by him in respect of the death of or bodily 1 [injury to any person, including owner of the goods or his authorized representative carried in the vehicle]or damage to any property of a third party caused by or arising out of the use of the vehicle in a public place;
(ii) against the death of or bodily injury to any passenger of a public service vehicle caused by or arising out of the use of the vehicle in a public place: Provided that a policy shall not be required—
(i) to cover liability in respect of the death, arising out of and in the course of his employment, of the employee of a person insured by the policy or in respect of bodily injury sustained by such an employee arising out of and in the course of his employment other than a liability arising under the Workmen’s Compensation Act, 1923 (8 of 1923), in respect of the death of, or bodily injury to, any such employee—
(a) engaged in driving the vehicle, or
(b) if it is a public service vehicle engaged as a conductor of the vehicle or in examining tickets on the vehicle, or
(c) if it is a goods carriage, being carried in the vehicle, or (ii) to cover any contractual liability.
Explanation.—For the removal of doubts, it is hereby declared that the death of or bodily injury to any person or damage to any property of a third party shall be deemed to have been caused by or to have arisen out of, the use of a vehicle in a public place notwithstanding that the person who is dead or injured or the property which is damaged was not in a public place at the time of the accident, if the act or omission which led to the accident occurred in a public place.
(2) Subject to the proviso to sub-section (1), a policy of insurance referred to in sub-section (1), shall cover any liability incurred in respect of any accident, up to the following limits, namely:— (a) save as provided in clause (b), the amount of liability incurred; (b) in respect of damage to any property of a third party, a limit of rupees six thousand:
Provided that any policy of insurance issued with any limited liability and in force, immediately before the commencement of this Act, shall continue to be effective for a period of four months after such commencement or till the date of expiry of such policy whichever is earlier.
(3) A policy shall be of no effect for the purposes of this Chapter unless and until there is issued by the insurer in favour of the person by whom the policy is effected a certificate of insurance in the prescribed form and containing the prescribed particulars of any condition subject to which the policy is issued and of any other prescribed matters; and different forms, particulars and matters may be prescribed in different cases.
(4) Where a cover note issued by the insurer under the provisions of this Chapter or the rules made thereunder is not followed by a policy of insurance within the prescribed time, the insurer shall, within seven days of the expiry of the period of the validity of the cover note, notify the fact to the registering authority in whose records the vehicle to which the cover note relates has been registered or to such other authority as the State Government may prescribe.
(5) Notwithstanding anything contained in any law for the time being in force, an insurer issuing a policy of insurance under this section shall be liable to indemnify the person or classes of persons specified in the policy in respect of any liability which the policy purports to cover in the case of that person or those classes of persons.
148. Validity of policies of insurance issued in reciprocating countries.—Where, in pursuance of an arrangement between India and any reciprocating country, any motor vehicle registered in the reciprocating country operates on any route or within any area common to the two countries and there is in force in relation to the use of the vehicle in the reciprocating country, a policy of insurance complying with the requirements of the law of insurance in force in that country, then, notwithstanding anything contained in section 147 but subject to any rules which may be made under section 164, such policy of insurance shall be effective throughout the route or area in respect of which, the arrangement has been made, as if the policy of insurance had complied with the requirements of this Chapter.
149. Duty of insurers to satisfy judgments and awards against persons insured in respect of third party risks.—(1) If, after a certificate of insurance has been issued under sub-section (3) of section 147 in favour of the person by whom a policy has been effected, judgment or award in respect of any such liability as is required to be covered by a policy under clause (b) of sub-section (1) of section 147 (being a liability covered by the terms of the policy) 1 [or under the provisions of section 163A] is obtained against any person insured by the policy, then, notwithstanding that the insurer may be entitled to avoid or cancel or may have avoided or cancelled the policy, the insurer shall, subject to the provisions of this section, pay to the person entitled to the benefit of the decree any sum not exceeding the sum assured payable thereunder, as if he were the judgment debtor, in respect of the liability, together with any amount payable in respect of costs and any sum payable in respect of interest on that sum by virtue of any enactment relating to interest on judgments.
(2) No sum shall be payable by an insurer under sub-section (1) in respect of any judgment or award unless, before the commencement of the proceedings in which the judgment or award is given the insurer had notice through the Court or, as the case may be, the Claims Tribunal of the bringing of the proceedings, or in respect of such judgment or award so long as execution is stayed thereon pending an appeal; and an insurer to whom notice of the bringing of any such proceedings is so given shall be entitled to be made a party thereto and to defend the action on any of the following grounds, namely:—
(a) that there has been a breach of a specified condition of the policy, being one of the following conditions, namely:—
(i) a condition excluding the use of the vehicle—
(a) for hire or reward, where the vehicle is on the date of the contract of insurance a vehicle not covered by a permit to ply for hire or reward, or
(b) for organised racing and speed testing, or
(c) for a purpose not allowed by the permit under which the vehicle is used, where the vehicle is a transport vehicle, or
(d) without side-car being attached where the vehicle is a motor cycle; or
(ii) a condition excluding driving by a named person or persons or by any person who is not duly licensed, or by any person who has been disqualified for holding or obtaining a driving licence during the period of disqualification; or
(iii) a condition excluding liability for injury caused or contributed to by conditions of war, civil war, riot or civil commotion; or
(b) that the policy is void on the ground that it was obtained by the non-disclosure of a material fact or by a representation of fact which was false in some material particular.
(3) Where any such judgment as is referred to in sub-section (1) is obtained from a Court in a reciprocating country and in the case of a foreign judgment is, by virtue of the provisions of section 13 of the Code of Civil Procedure, 1908 (5 of 1908) conclusive as to any matter adjudicated upon by it, the insurer (being an insurer registered under the Insurance Act, 1938 (4 of 1938) and whether or not he is registered under the corresponding law of the reciprocating country) shall be liable to the person entitled to the benefit of the decree in the manner and to the extent specified in sub-section (1), as if the judgment were given by a Court in India:
Provided that no sum shall be payable by the insurer in respect of any such judgment unless, before the commencement of the proceedings in which the judgment is given, the insurer had notice through the Court concerned of the bringing of the proceedings and the insurer to whom notice is so given is entitled under the corresponding law of the reciprocating country, to be made a party to the proceedings and to defend the action on grounds similar to those specified in sub-section (2).
(4) Where a certificate of insurance has been issued under sub-section (3) of section 147 to the person by whom a policy has been effected, so much of the policy as purports to restrict the insurance of the persons insured thereby by reference to any conditions other than those in clause (b) of sub-section (2) shall, as respects such liabilities as are required to be covered by a policy under clause (b) of sub-section (1) of section 147, be of no effect:
Provided that any sum paid by the insurer in or towards the discharge of any liability of any person which is covered by the policy by virtue only of this sub-section shall be recoverable by the insurer from that person.
(5) If the amount which an insurer becomes liable under this section to pay in respect of a liability incurred by a person insured by a policy exceeds the amount for which the insurer would apart from the provisions of this section be liable under the policy in respect of that liability, the insurer shall be entitled to recover the excess from that person.
(6) In this section the expressions “material fact” and “material particular” means, respectively a fact or particular of such a nature as to influence the judgment of a prudent insurer in determining whether he will take the risk and, if so at what premium and on what conditions and the expression “liability covered by the terms of the policy” means a liability which is covered by the policy or which would be so covered but for the fact that the insurer is entitled to avoid or cancel or has avoided or cancelled the policy.
(7) No insurer to whom the notice referred to in sub-section (2) or sub-section (3) has been given shall be entitled to avoid his liability to any person entitled to the benefit of any such judgment or award as is referred to in sub-section (1) or in such judgment as is referred to in sub-section (3) otherwise than in the manner provided for in sub-section (2) or in the corresponding law of the reciprocating country, as the case may be.
Explanation.—For the purpose of this section, “Claims Tribunal” means a Claims Tribunal constituted under section 165 and “award” means an award made by that Tribunal under section 168.
150. Rights of third parties against insurers on insolvency of the insured.—(1) Where under any contract of insurance effected in accordance with the provisions of this Chapter, a person is insured against liabilities which he may incur to third parties, then—
(a) in the event of the person becoming insolvent or making a composition or arrangement with his creditors, or
(b) where the insured person is a company, in the event of a winding up order being made or a resolution for a voluntary winding up being passed with respect to the company or of a receiver or manager of the company’s business or undertaking being duly appointed, or of possession being taken by or on behalf of the holders of any debentures secured by a floating charge of any property comprised in or subject to the charge, if, either before or after that event, any such liability is incurred by the insured person, his rights against the insurer under the contract in respect of the liability shall, notwithstanding anything to the contrary in any provision of law, be transferred to and vest in the third party to whom the liability was so incurred.
(2) Where an order for the administration of the estate of a deceased debtor is made according to the law of insolvency, then, if any debt provable in insolvency is owing by the deceased in respect of a liability to a third party against which he was insured under a contract of insurance in accordance with the provisions of this Chapter, the deceased debtor’s rights against the insurer in respect of that liability shall, notwithstanding anything to the contrary in any provision of law, be transferred to and vest in the person to whom the debt is owing.
(3) Any condition in a policy issued for the purposes of this Chapter purporting either directly or indirectly to avoid the policy or to alter the rights of the parties thereunder upon the happening to the insured person of any of the events specified in clause (a) or clause (b) of sub-section (1) or upon the making of an order for the administration of the estate of a deceased debtor according to the law of insolvency shall be of no effect.
(4) Upon a transfer under sub-section (1) or sub-section (2), the insurer shall be under the same liability to the third party as he would have been to the insured person, but—
(a) if the liability of the insurer to the insured person exceeds the liability of the insured person to the third party, nothing in this Chapter shall affect the rights of the insured person against the insurer in respect of the excess, and
(b) if the liability of the insurer to the insured person is less than the liability of the insured person to the third party, nothing in this Chapter shall affect the rights of the third party against the insured person in respect of the balance.
151. Duty to give information as to insurance.—(1) No person against whom a claim is made in respect of any liability referred to in clause (b) of sub-section (1) of section 147 shall on demand by or on behalf of the person making the claim refuse to state whether or not he was insured in respect of that liability by any policy issued under the provisions of this Chapter, or would have been so insured if the insurer had not avoided or cancelled the policy, nor shall he refuse, if he was or would have been so insured, to give such particulars with respect to that policy as were specified in the certificate of insurance issued in respect thereof.
(2) In the event of any person becoming insolvent or making a composition or arrangement with his creditors or in the event of an order being made for the administration of the estate of a deceased person according to the law of insolvency, or in the event of a winding up order being made or a resolution for a voluntary winding up being passed with respect to any company or of a receiver or manager of the company’s business or undertaking being duly appointed or of possession being taken by or on behalf of the holders of any debentures secured by a floating charge on any property comprised in or subject to the charge, it shall be the duty of the insolvent debtor, personal representative of the deceased debtor or company, as the case may be, or the official assignee or receiver in insolvency, trustee, liquidator, receiver or manager, or person in possession of the property to give at the request of any person claiming that the insolvent debtor, deceased debtor or company is under such liability to him as is covered by the provisions of this Chapter, such information as may reasonably be required by him for the purpose of ascertaining whether any rights have been transferred to and vested in him by section 150, and for the purpose of enforcing such rights, if any; and any such contract of insurance as purports whether directly or indirectly to avoid the contract or to alter the rights of the parties thereunder upon the giving of such information in the events aforesaid, or otherwise to prohibit or prevent the giving thereof in the said events, shall be of no effect.
(3) If, from the information given to any person in pursuance of sub-section (2) or otherwise, he has reasonable ground for supporting that there have or may have been transferred to him under this Chapter rights against any particular insurer, that insurer shall be subject to the same duty as is imposed by the said sub-section on the persons therein mentioned.
(4) The duty to give the information imposed by this section shall include a duty to allow all contracts of insurance, receipts for premiums, and other relevant documents in the possession or power of the person on whom the duty is so imposed to be inspected and copies thereof to be taken.
152. Settlement between insurers and insured persons.—(1) No settlement made by an insurer in respect of any claim which might be made by a third party in respect of any liability of the nature referred to in clause (b) of sub-section (1) of section 147 shall be valid unless such third party is a party to the settlement.
(2) Where a person who is insured under a policy issued for the purposes of this Chapter has become insolvent, or where, if such insured person is a company, a winding up order has been made or a resolutionfor a voluntary winding up has been passed with respect to the company, no agreement made between the insurer and the insured person after the liability has been incurred to a third party and after the commencement of the insolvency or winding up, as the case may be, nor any waiver, assignment or other disposition made by or payment made to the insured person after the commencement aforesaid shall be effective to defeat the rights transferred to the third party under this Chapter, but those rights shall be the same as if no such agreement, waiver, assignment or disposition or payment has been made.
153. Saving in respect of sections 150, 151 and 152.—(1) For the purposes of sections 150, 151 and 152 a reference to “liabilities to third parties” in relation to a person insured under any policy of insurance shall not include a reference to any liability of that person in the capacity of insurer under some other policy of insurance. (2) The provisions of sections 150, 151 and 152 shall not apply where a company is wound up voluntarily merely for the purposes of reconstruction or of an amalgamation with another company.
154. Insolvency of insured persons not to affect liability of insured or claims by third parties.— Where a certificate of insurance has been issued to the person by whom a policy has been effected, the happening in relation to any person insured by the policy of any such event as is mentioned in sub-section (1) or sub-section (2) of section 150 shall, notwithstanding anything contained in this Chapter, not affect any liability of that person of the nature referred to in clause (b) of sub-section (1) of section 147; but nothing in this section shall affect any rights against the insurer conferred under the provisions of sections 150, 151 and 152 on the person to whom the liability was incurred.
155. Effect of death on certain causes of action.—Notwithstanding anything contained in section 306 of the Indian Succession Act, 1925 (39 of 1925), the death of a person in whose favour a certificate of insurance had been issued, if it occurs after the happening of an event which has given rise to a claim under the provisions of this Chapter, shall not be a bar to the survival of any cause of action arising out of the said event against his estate or against the insurer.
156. Effect of certificate of insurance.—When an insurer has issued a certificate of insurance in respect of a contract of insurance between the insurer and the insured person, then—
(a) if and so long as the policy described in the certificate has not been issued by the insurer to the insured, the insurer shall, as between himself and any other person except the insured, be deemed to have issued to the insured to the insured person a policy of insurance conforming in all respects with the description and particulars stated in such certificate; and
(b) if the insurer has issued to the insured the policy described in the certificate, but the actual terms of the policy are less favourable to persons claiming under or by virtue of the policy against the insurer either directly or through the insured than the particulars of the policy as stated in the certificate, the policy shall, as between the insurer and any other person except the insured, be deemed to be in terms conforming in all respects with the particulars stated in the said certificate
157. Transfer of certificate of insurance.—(1) Where a person in whose favour the certificate of insurance has been issued in accordance with the provisions of this Chapter transfers to another person the ownership of the motor vehicle in respect of which such insurance was taken together with the policy of insurance relating thereto, the certificate of insurance and the policy described in the certificate shall be deemed to have been transferred in favour of the person to whom the motor vehicle is transferred with effect from the date of its transfer.
[Explanation.—For the removal of doubts, it is hereby declared that such deemed transfer shall include transfer of rights and liabilities of the said certificate of insurance and policy of insurance.]
(2) The transferee shall apply within fourteen days from the date of transfer in the prescribed form to the insurer for making necessary changes in regard to the fact of transfer in the certificate of insurance and the policy described in the certificate in his favour and the insurer shall make the necessary changes in the certificate and the policy of insurance in regard to the transfer of insurance.
158. Production of certain certificates, licence and permit in certain cases.—(1) Any person driving a motor vehicle in any public place shall, on being so required by a police officer in uniform authorised in this behalf by the State Government, produce—
(a) the certificate of insurance;
(b) the certificate of registration;
(c) the driving licence; and
(d) in the case of a transport vehicle, also the certificate of fitness referred to in section 56 and the permit, relating to the use of the vehicle.
(2) If, where owing to the presence of a motor vehicle in a public place an accident occurs involving death or bodily injury to another person, the driver of the vehicle does not at the time produce the certificates, driving licence and permit referred to in sub-section (1) to a police officer, he shall produce the said certificates, licence and permit at the police station at which he makes the report required by section 134.
(3) No person shall be liable to conviction under sub-section (1) or sub-section (2) by reason only of the failure to produce the certificate of insurance if, within seven days from the date on which its production was required under sub-section (1), or as the case may be, from the date of occurrence of the accident, he produces the certificate at such police station as may have been specified by him to the police officer who required its production or, as the case may be, to the police officer at the site of the accident or to the officer in charge of the police station at which he reported the accident: Provided that except to such extent and with such modifications as may be prescribed, the provisions of this sub-section shall not apply to the driver of a transport vehicle.
(4) The owner of a motor vehicle shall give such information as he may be required by or on behalf of a police officer empowered in this behalf by the State Government to give for the purpose of determining whether the vehicle was or was not being driven in contravention of section 146 and on any occasion when the driver was required under this section to produce his certificate of insurance.
(5) In this section, the expression “produce his certificate of insurance” means produce for examination the relevant certificate of insurance or such other evidence as may be prescribed that the vehicle was not being driven in contravention of section 146.
[(6) As soon as any information regarding any accident involving death or bodily injury to any person is recorded or report under this section is completed by a police officer, the officer incharge of the police station shall forward a copy of the same within thirty days from the date of recording of information or, as the case may be, on completion of such report to the Claims Tribunal having jurisdiction and a copy thereof to the concerned insurer, and where a copy is made available to the owner, he shall also within thirty days of receipt of such report, forward the same to such Claims Tribunal and Insurer.]
159. Production of certificate of Insurance on application for authority to use vehicle.—A State Government may make rules requiring the owner of any motor vehicle when applying whether by payment of a tax or otherwise for authority to use the vehicle in a public place to produce such evidence as may be prescribed by those rules to the effect that either—
(a) on the date when the authority to use the vehicle comes into operation there will be in force the necessary policy of insurance in relation to the use of the vehicle by the applicant or by other persons on his order or with his permission, or
(b) the vehicle is a vehicle to which section 146 does not apply.
160. Duty to furnish particulars of vehicle involved in accident.—A registering authority or the officer in charge of a police station shall, if so required by a person who alleges that he is entitled to claim compensation in respect of an accident arising out of the use of a motor vehicle, or if so required by an insurer against whom a claim has been made in respect of any motor vehicle, furnish to that person or to that insurer, as the case may be, on payment of the prescribed fee any information at the disposal of the said authority or the said authority or the said police officer relating to the identification marks and other particulars of the vehicle and the name and address of the person who was using the vehicle at the time of the accident or was injured by it and the property, if any damaged in such form and within such time as the Central Government may prescribe.
161. Special provisions as to compensation in case of hit and run motor accident.—(1) For the purposes of this section, section 162 and section 163—
(a) “grievous hurt” shall have the same meaning as in the Indian Penal Code (45 of 1860);
(b) “hit and run motor accident” means an accident arising out of the use of a motor vehicle or motor vehicles the identity whereof cannot be ascertained in spite of reasonable efforts for the purpose;
(c) “scheme” means the scheme framed under section 163.
(2) Notwithstanding anything contained in the General Insurance Business (Nationalisation) Act, 1972 (57 of 1972) or any other law for the time being in force or any instrument having the force of law, the General Insurance Corporation of India formed under section 9 of the said Act and the insurance companies for the time being carrying on general insurance business in India shall provide for paying in accordance with the provisions of this Act and the scheme, compensation in respect of the death of, or grievous hurt to, persons resulting from hit and run motor accidents.
(3) Subject to the provisions of this Act and the scheme, there shall be paid as compensation—
(a) in respect of the death of any person resulting from a hit and run motor accident, a fixed sum of 1 [twenty-five thousandrupees];
(b) in respect of grievous hurt to any person resulting from a hit and run motor accident, a fixed sum of 2 [twelve thousand and five hundred rupees].
(4) The provisions of sub-section (1) of section 166 shall apply for the purpose of making applications for compensation under this section as they apply for the purpose of making applications for compensation referred to in that sub-section.
162. Refund in certain cases of compensation paid under section 161.—(1) The payment of compensation in respect of the death of, or grievous hurt to, any person under section 161 shall be subject to the condition that if any compensation (hereafter in this sub-section referred to as the other compensation) or other amount in lieu of or by way of satisfaction of a claim for compensation is awarded or paid in respect of such death or grievous hurt under any other provision of this Act or any other law or otherwise so much of the other compensation or other amount aforesaid as is equal to the compensation paid under section 161 shall be refunded to the insurer.
(2) Before awarding compensation in respect of an accident involving the death of, or bodily injury to, any person arising out of the use of a motor vehicle or motor vehicles under any provision of this Act (other than section 161) or any other law, the tribunal, court or other authority awarding such compensation shall verify as to whether in respect of such death or bodily injury compensation has already been paid under section 161 or an application for payment of compensation is pending under that section, and such tribunal, court or other authority shall,—
(a) if compensation has already been paid under section 161, direct the person liable to pay the compensation awarded by it to refund to the insurer, so much thereof as is required to be refunded in accordance with the provisions of sub-section (1);
(b) if an application for payment of compensation is pending under section 161 forward the particulars as to the compensation awarded by it to the insurer.
Explanation.—For the purposes of this sub-section, an application for compensation under section 161 shall be deemed to be pending—
(i) if such application has been rejected, till the date of the rejection of the application, and
(ii) in any other case, till the date of payment of compensation in pursuance of the application.
163. Scheme for payment of compensation in case of hit and run motor accidents.—(1) The Central Government may, by notification in the Official Gazette, make a scheme specifying, the manner in which the scheme shall be administered by the General Insurance Corporation, the form, manner and the time within which applications for compensation may be made, the officers or authorities to whom such applications may be made, the procedure to be followed by such officers or authorities for considering and passing orders on such applications, and all other matters connected with, or incidental to, the administration of the scheme and the payment of compensation.
(2) A scheme made under sub-section (1) may provide that—
(a) a contravention of any provision thereof shall be punishable with imprisonment for such term as may be specified but in no case exceeding three months, or with fine which may extend to such amount as may be specified but in no case exceeding five hundred rupees or with both;
(b) the powers, functions or duties conferred or imposed on any officer or authority by such scheme may be delegated with the prior approval in writing of the Central Government, by such officer or authority to any other officer or authority;
(c) any provision of such scheme may operate with retrospective effect from a date not earlier than the date of establishment of the Solatium Fund under the Motor Vehicles Act, 1939 (4 of 1939), as it stood immediately before the commencement of this Act:
Provided that no such retrospective effect shall be given so as to prejudicially affect the interests of any person who may be governed by such provision. 1 [163A. Special provisions as to payment of compensation on structured formula basis.—
(1) Notwithstanding anything contained in this Act or in any other law for the time being in force or instrument having the force of law, the owner of the motor vehicle of the authorised insurer shall be liable to pay in the case of death or permanent disablement due to accident arising out of the use of motor vehicle, compensation, as indicated in the Second Schedule, to the legal heirs or the victim, as the case may be.
Explanation.—For the purposes of this sub-section, “permanent disability” shall have the same meaning and extent as in the Workmen’s Compensation Act, 1923 (8 of 1923).
(2) In any claim for compensation under sub-section (1), the claimant shall not be required to plead or establish that the death or permanent disablement in respect of which the claim has been made was due to any wrongful act or neglect or default of the owner of the vehicle or vehicles concerned or of any other person.
(3) The Central Government may, keeping in view the cost of living by notification in the Official Gazette, from time to time amend the Second Schedule.
163B. Option to file claim in certain cases.— Where a person is entitled to claim compensation under section 140 and section 163A, he shall file the claim under either of the said sections and not under both.]
164. Power of Central Government to make rules.—(1) The Central Government may make rules for the purpose of carrying into effect the provisions of this Chapter, other than the matters specified in section 159.
(2) Without prejudice to the generality of the foregoing power, such rules may provide for—
(a) the forms to be used for the purposes of this Chapter;
(b) the making of applications for and the issue of certificates of insurance;
(c) the issue of duplicates to replace certificates of insurance lost, destroyed or mutilated;
(d) the custody, production, cancellation and surrender of certificates of insurance;
(e) the records to be maintained by insurers of policies of insurance issued under this Chapter;
(f) the identification by certificates or otherwise of persons or vehicles exempted from the provisions of this Chapter;
(g) the furnishing of information respecting policies of insurance by insurers;
(h) adopting the provisions of this Chapter to vehicles brought into India by persons making only a temporary stay therein or to vehicles registered in a reciprocating country and operating on any route or within any area in India by applying those provisions with prescribed modifications;
(i) the form in which and the time limit within which the particulars referred to in section 160 may be furnished; and
(j) any other matter which is to be, or may be, prescribed.
CHAPTER XII
CLAIMS TRIBUNALS
165. Claims Tribunals.—(1) A State Government may, by notification in the Official Gazette, constitute one or more Motor Accidents Claims Tribunals (hereafter in this Chapter referred to as Claims Tribunal) for such area as may be specified in the notification for the purpose of adjudicating upon claims for compensation in respect of accidents involving the death of, or bodily injury to, persons arising out of the use of motor vehicles, or damages to any property of a third party so arising, or both.
Explanation.—For the removal of doubts, it is hereby declared that the expression “claims for compensation in respect of accidents involving the death of or bodily injury to persons arising out of the use of motor vehicles” includes claims for compensation under section 1401 [and section 163A].
(2) A Claims Tribunal shall consist of such number of members as the State Government may think fit to appoint and where it consists of two or more members, one of them shall be appointed as the Chairman thereof.
(3) A person shall not be qualified for appointment as a member of a Claims Tribunal unless he—
(a) is, or has been, a Judge of a High Court, or
(b) is, or has been, a District Judge, or
(c) is qualified for appointment as a Judge of a High Court1 [or as a District Judge].
(4) Where two or more Claims Tribunals are constituted for any area, the State Government, may by general or special order, regulate the distribution of business among them.
166. Application for compensation.—(1) An application for compensation arising out of an accident of the nature specified in sub-section (1) of section 165 may be made—
(a) by the person who has sustained the injury; or
(b) by the owner of the property; or
(c) where death has resulted from the accident, by all or any of the legal representatives of the deceased; or
(d) by any agent duly authorised by the person injured or all or any of the legal representatives of the deceased, as the case may be: Provided that where all the legal representatives of the deceased have not joined in any such application for compensation, the application shall be made on behalf of or for the benefit of all the legal representatives of the deceased and the legal representatives who have not so joined, shall be impleaded as respondents to the application.
[(2) Every application under sub-section (1) shall be made, at the option of the claimant, either to the Claims Tribunal having jurisdiction over the area in which the accident occurred or to the Claims Tribunal within the local limits of whose jurisdiction the claimant resides or carries on business or within the local limits of whose jurisdiction the defendant resides, and shall be in such form and contain such particulars as may be prescribed:
Provided that where no claim for compensation under section 140 is made in such application, the application shall contain a separate statement to that effect immediately before the signature of the applicant.]
2 * * * * *
[(4) The Claims Tribunal shall treat any report of accidents forwarded to it under sub-section (6) of section 158 as an application for compensation under this Act.]
167. Option regarding claims for compensation in certain cases.—Notwithstanding anything contained in the Workmen’s Compensation Act, 1923 (8 of 1923), where the death of, or bodily injury to, any person gives rise to a claim for compensation under this Act and also under the Workmen’s Compensation Act, 1923, the person entitled to compensation may without prejudice to the provisions of Chapter X claim such compensation under either of those Acts but not under both.
168. Award of the Claims Tribunal.—(1) On receipt of an application for compensation made under section 166, the Claims Tribunal shall, after giving notice of the application to the insurer and after giving the parties (including the insurer) an opportunity of being heard, hold an inquiry into the claim or, as the case may be, each of the claims and, subject to the provisions of section 162 may make an award determining the amount of compensation which appears to it to be just and specifying the person or persons to whom compensation shall be paid and in making the award the Claims Tribunal shall specify the amount which shall be paid by the insurer or owner or driver of the vehicle involved in the accident or by all or any of them, as the case may be:
Provided that where such application makes a claim for compensation under section 140 in respect of the death or permanent disablement of any person, such claim and any other claim (whether made in such application or otherwise) for compensation in respect of such death or permanent disablement shall be disposed of in accordance with the provisions of Chapter X.
(2) The Claims Tribunal shall arrange to deliver copies of the award to the parties concerned expeditiously and in any case within a period of fifteen days from the date of the award.
(3) When an award is made under this section, the person who is required to pay any amount in terms of such award shall, within thirty days of the date of announcing the award by the Claims Tribunal, deposit the entire amount awarded in such manner as the Claims Tribunal may direct.
169. Procedure and powers of Claims Tribunals.—(1) In holding any inquiry under section 168, the Claims Tribunal may, subject to any rules that may be made in this behalf, follow such summary procedure as it thinks fit.
(2) The Claims Tribunal shall have all the powers of a Civil Court for the purpose of taking evidence on oath and of enforcing the attendance of witnesses and of compelling the discovery and production of documents and material objects and for such other purposes as may be prescribed; and the Claims
Tribunal shall be deemed to be a Civil Court for all the purposes of section 195 and Chapter XXVI of the Code of Criminal Procedure, 1973 (2 of 1974).
(3) Subject to any rules that may be made in this behalf, the Claims Tribunal may, for the purpose of adjudicating upon any claim for compensation, choose one or more persons possessing special knowledge of any matter relevant to the inquiry to assist it in holding the inquiry.
170. Impleading insurer in certain cases.—Where in the course of any inquiry, the Claims Tribunal is satisfied that—
(a) there is collusion between the person making the claim and the person against whom the claim is made, or
(b) the person against whom the claim is made has failed to contest the claim, it may, for reasons to be recorded in writing, direct that the insurer who may be liable in respect of such claim, shall be impleaded as a party to the proceeding and the insurer so impleaded shall thereupon have, without prejudice to the provisions contained in sub-section (2) of section 149, the right to contest the claim on all or any of the grounds that are available to the person against whom the claim has been made.
171. Award of interest where any claim is allowed.—Where any Claims Tribunal allows a claim for compensation made under this Act, such Tribunal may direct that in addition to the amount of compensation simple interest shall also be paid at such rate and from such date not earlier than the date of making the claim as it may specify in this behalf.
172. Award of compensatory costs in certain cases.—(1) Any Claims Tribunal adjudicating upon any claim for compensation under this Act, may in any case where it is satisfied for reasons to be recorded by it in writing that—
(a) the policy of insurance is void on the ground that it was obtained by representation of fact which was false in any material particular, or
(b) any party or insurer has put forward a false or vexatious claim or defence, such Tribunal may make an order for the payment, by the party who is guilty of mis-representation or by whom such claim or defence has been put forward of special costs by way of compensation to the insurer or, as the case may be, to the party against whom such claim or defence has been put forward.
(2) No Claims Tribunal shall pass an order for special costs under sub-section (1) for any amount exceeding one thousand rupees.
(3) No person or insurer against whom an order has been made under this section shall, by reason thereof be exempted from any criminal liability in respect of such mis-representation, claim or defence as is referred to in sub-section (1).
(4) Any amount awarded by way of compensation under this section in respect of any misrepresentation, claim or defence, shall be taken into account in any subsequent suit for damages for compensation in respect of such mis-representation, claim or defence.
173. Appeals.—(1) Subject to the provisions of sub-section (2), any person aggrieved by an award of a Claims Tribunal may, within ninety days from the date of the award, prefer an appeal to the High Court:
Provided that no appeal by the person who is required to pay any amount in terms of such award shall be entertained by the High Court unless he has deposited with it twenty-five thousand rupees or fifty per cent. of the amount so awarded, whichever is less, in the manner directed by the High Court: Provided further that the High Court may entertain the appeal after the expiry of the said period of ninety days, if it is satisfied that the appellant was prevented by sufficient cause from preferring the appeal in time.
(2) No appeal shall lie against any award of a Claims Tribunal if the amount in dispute in the appeal is less than ten thousand rupees.
174. Recovery of money from insurer as arrear of land revenue.—Where any amount is due from any person under an award, the Claims Tribunal may, on an application made to it by the person entitled to the amount, issue a certificate for the amount to the Collector and the Collector shall proceed to recover the same in the same manner as an arrear of land revenue.
175. Bar on jurisdiction of Civil Courts.—Where any Claims Tribunal has been constituted for any area, no Civil Court shall have jurisdiction to entertain any question relating to any claim for compensation which may be adjudicated upon by the Claims Tribunal for that area, and no injunction in respect of any action taken or to be taken by or before the Claims Tribunal in respect of the claim for compensation shall be granted by the Civil Court.
176. Power of State Government to make rules.—A State Government may make rules for the purpose of carrying into effect the provisions of sections 165 to 174, and in particular, such rules may provide for all or any of the following matters, namely:—
(a) the form of application for claims for compensation and the particulars it may contain, and the fees, if any, to be paid in respect of such applications;
(b) the procedure to be followed by a Claims Tribunal in holding an inquiry under this Chapter;
(c) the powers vested in a Civil Court which may be exercised by a Claims Tribunal;
(d) the form and the manner in which and the fees (if any) on payment of which an appeal may be preferred against an award of a Claims Tribunal; and
(e) any other matter which is to be, or may be, prescribed.
CHAPTER XIII
OFFENCES, PENALTIES AND PROCEDURE
177. General provision for punishment of offences.—Whoever contravenes any provision of this Act or of any rule, regulation or notification made thereunder shall, if no penalty is provided for the offence be punishable for the first offence with fine which may extend to one hundred rupees, and for any second or subsequent offence with fine which may extend to three hundred rupees.
178. Penalty for travelling without pass or ticket and for dereliction of duty on the part of conductor and refusal to ply contract carriage, etc.—(1) Whoever travels in a stage carriage without having a proper pass or ticket with him or being in or having alighted from a stage carriage fails or refuses to present for examination or to deliver up his pass or ticket immediately on a requisition being made therefor, shall be punishable with fine which may extend to five hundred rupees.
Explanation.—In this section, “pass” and “ticket” have the meanings respectively assigned to them in section 124.
(2) If the conductor of a stage carriage, or the driver of a stage carriage performing the functions of a conductor in such stage carriage, whose duty is—
(a) to supply a ticket to a person travelling in a stage carriage on payment of fare by such person, either wilfully or negligently,—
(i) fails or refuses to accept the fare when tendered, or
(ii) fails or refuses to supply a ticket, or
(iii) supplies an invalid ticket, or
(iv) supplies a ticket of a lesser value, or
(b) to check any pass or ticket, either wilfully or negligently fails or refuses to do so, he shall be punishable with fine which may extend to five hundred rupees.
(3) If the holder of a permit or the driver of a contract carriage refuses, in contravention of the provisions of this Act or rules made thereunder, to ply the contract carriage or to carry the passengers, he shall,—
(a) in the case of two-wheeled or three-wheeled motor vehicles, be punishable with fine which may extend to fifty rupees; and (b) in any other case, be punishable with fine which may extend to two hundred rupees.
179. Disobedience of orders, obstruction and refusal of information.—(1) Whoever wilfully disobeys any direction lawfully given by any person or authority empowered under this Act to give such direction, or obstructs any person or authority in the discharge of any functions which such person or authority is required or empowered under this Act to discharge, shall, if no other penalty is provided for the offence be punishable with fine which may extend to five hundred rupees.
(2) Whoever, being required by or under this Act to supply any information, wilfully withholds such information or gives information which he knows to be false or which he does not believe to be true, shall, if no other penalty is provided for the offence, be punishable with imprisonment for a term which may extend to one month, or with fine which may extend to five hundred rupees, or with both.
180. Allowing unauthorised persons to drive vehicles.—Whenever, being the owner or person in charge of a motor vehicle, causes, or permits, any other person who does not satisfy the provisions of section 3 or section 4 to drive the vehicle shall be punishable with imprisonment for a term which may extend to three months, or with fine which may extend to one thousand rupees, or with both.
181. Driving vehicles in contravention of section 3 or section 4.—Whoever, drives a motor vehicle in contravention of section 3 or section 4 shall be punishable with imprisonment for a term which may extend to three months, or with fine which may extend to five hundred rupees, or with both.
182. Offences relating to licences.—(1) Whoever, being disqualified under this Act for holding or obtaining a driving licence drives a motor vehicle in a public place or in any other place, or applies for or obtains a driving licence or, not being entitled to have a driving licence issued to him free of endorsement, applies for or obtains a driving licence without disclosing the endorsement made on a driving licence previously held by him shall be punishable with imprisonment for a term which may extend to three months, or with fine which may extend to five hundred rupees or with both, and any driving incence so obtained by him shall be of no effect.
(2) Whoever, being disqualified under this Act for holding or obtaining a conductor’s licence, acts as a conductor of a stage carriage in a public place or applies for or obtains a conductor’s licence or, not being entitled to have a conductor’s licence issued to him free of endorsement, applies for or obtains a conductor’s licence without disclosing the endorsements made on a conductor’s licence previously held by him, shall be punishable with improsonment for a term which may extend to one month, or with fine which may extend to one hundred rupees, or with both, and any conductor’s licence so obtained by him shall be of no effect.
[182A. Punishment for offences relating to construction and maintenance of vehicles.—Any person who contravenes the provisions of sub-section (3) of section 109, shall be punishable with a fine of five thousand rupees for any subsequent offence.]
183. Driving at excessive speed, etc.—(1) Whoever, drives a motor vehicle in contravention of the speed limits referred to in section 112 shall be punishable with fine which may extend to four hundred rupees, or, if having been previously convicted of an offence under this sub-section is again convicted of an offence under this sub- section, with fine which may extend to one thousand rupees.
(2) Whoever, causes any person who is employed by him or is subject to his control in driving to drive a motor vehicle in contravention of the speed limits referred to in section 112 shall be punishable with fine which may extend to three hundred rupees, or, if having been previously convicted of an offence under this sub-section, is again convicted of an offence under this sub-section, with fine which may extend to five hundred rupees.
(3) No person shall be convicted of an offence punishable under sub-section (1) solely on the evidence of one witness to the effect that in the opinion of the witness such person was driving at a speed which was unlawful, unless that opinion is shown to be based on an estimate obtained by the use of some mechanical device.
(4) The publication of a time table under which, or the giving of any direction that, any journey or part of a journey is to be completed within a specified time shall, if in the opinion of the Court it is not practicable in the circumstances of the case for that journey or part of a journey to be completed in the specified time without contravening the speed limits referred to in section 112 be prima facie evidence that the person who published the time table or gave the direction has committed an offence punishable under sub- section (2).
184. Driving dangerously.—Whoever, drives a motor vehicle at a speed or in a manner which is dangerous to the public, having regard to all the circumstances of case including the nature, condition and use of the place where the vehicle is driven and the amount of traffic which actually is at the time or which might reasonably be expected to be in the place, shall be punishable for the first offence with imprisonment for a term which may extend to six months, or with fine which may extend to one thousand rupees, and for any second or subsequent offence if committed within three years of the commission of a previous similar offence with imprisonment for a term which may extend to two years, or with fine which may extend to two thousand rupees, or with both.
185. Driving by a drunken person or by a person under the influence of drugs.—Whoever, while driving, or attempting to drive, a motor vehicle,—
[(a) has, in his blood, alcohol exceeding 30 mg. per 100 ml. of blood detected in a test by a breath analyser, or]
(b) is under the influence of a drug to such an extent as to be incapable of exercising proper control over the vehicle. shall be punishable for the first offence with imprisonment for a term which may extend to six months, or with fine which may extend to two thousand rupees, or with both; and for a second or subsequent offence, if committed within three years of the commission of the previous similar offence, with imprisonment for term which may extend to two years, or with fine which may extend to three thousand rupees, or with both.
Explanation.—For the purposes of this section, the drug or drugs specified by the Central Government in this behalf, by notification in the Official Gazette, shall be deemed to render a person incapable of exercising proper control over a motor vehicle.
186. Driving when mentally or phycically unfit to drive.—Whoever drives a motor vehicle in any public place when he is to his knowledge suffering from any disease or disability calculated to cause his driving of the vehicle to be a source of danger to the public, shall be punishable for the first offence with fine which may extend to two hundred rupees and for a second or subsequent offence with fine which may extend to five hundred rupees.
187. Punishment for offences relating to accident.—Whoever fails to comply with the provisions of clause (c) of sub-section (1) of section 132 or section 133 or section 134 shall be punishable with imprisonment for a term which may extend to three months, or with fine which may extend to five hundred rupees, or with both or, if having been previously convicted of an offence under this section, he is again convicted of an offence under this section, with imprisonment for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both.
188. Punishment for abetment of certain offences.—Whoever abets the commission of an offence under section 184, section 185 or section 186 shall be punishable with the punishment provided for the offence.
189. Racing and trails of speed.—Whoever without the written consent of the State Government permits or takes part in a race or trial of speed of any kind between motor vehicles in any public place shall be punishable with imprisonment for a term which may extend to six months, or with fine which may extend to five hundred rupees, or with both.
190. Using vehicle in unsafe condition.—(1) Any person who drives or causes or allows to be driven in any public place a motor vehicle or trailer while the vehicle or trailer has any defect, which such person knows of or could have discovered by the exercise of ordinary care and which is calculated to render the driving of the vehicle a source of danger to persons and vehicles using such place, shall be punishable with fine which may extend to two hundred and fifty rupees or, if as a result of such defect an accident is caused causing bodily injury or damage to property, with imprisonment for a term which may extend to three months or with fine which may extend to one thousand rupees, or with both.
(2) Any person who drives or causes or allows to be driven, in any public place a motor vehicle, which violates the standards prescribed in relation to road safety, control of noise and air- pollution, shall be punishable for the first offence with a fine of one thousand rupees and for any second or subsequent offence with a fine of two thousand rupees.
(3) Any person who drives or causes or allows to be driven, in any public place a motor vehicle which violates the provisions of this Act or the rules made thereunder relating to the carriage of goods which are of dangerous or hazardous nature to human life, shall be punishable for the first offence which may extend to three thousand rupees, or withimprisonment for a term which may extend to one year, or with both, and for any second or subsequent offence with fine which may extend to five thousand rupees, or with imprisonment for a term which may extend to three years, or with both.
191. Sale of vehicle in or alteration of vehicle to condition contravening this Act.—Whoever being an importer of or dealer in motor vehicles, sells or delivers or offers to sell or deliver a motor vehicle or traller in such condition that the use thereof in a public place would be in contravention of Chapter VII or any rule made thereunder or alters the motor vehicle or trailer so as to render its condition such that its use in a public place would be in contravention of Chapter VII or any rule made thereunder shall be punishable with fine which may extend to five hundred rupees:
Provided that no person shall be convicted under this section if he proves that he had reasonable cause to believe that the vehicle would not be used in a public place until it had been put into a condition in which it might lawfully be so used.
[192. Using vehicle without registration.—(1) Whoever drives a motor vehicle or causes or allows a motor vehicle to be used in contravention of the provisions of section 39 shall be punishable for the first offence with a fine which may extend to five thousand rupees but shall not be less than two thousand rupees for a second or subsequent offence with imprisonment which may extend to one year or with fine which may extend to ten thousand rupees but shall not be less than five thousand rupees or with both:
Provided that the court may, for reasons to be recorded, impose a lesser punishment.
(2) Nothing in this section shall apply to the use of a motor vehicle in an emergency for the conveyance of persons suffering from sickness or injuries or for the transport of food or materials to relieve distress or of medical supplies for a like purpose: Provided that the person using the vehicle reports about the same to the Regional Transport Authority within seven days from the date of such use.
(3) The court to which an appeal lies from any conviction in respect of an offence of the nature specified in sub-section (1), may set aside or vary any order made by the court below, notwithstanding that no appeal lies against the conviction in connection with which such order was made.
192A. Using vehicle without permit—(1) Whoever drives a motor vehicle or causes or allows a motor vehicle to be used in contravention of the provisions of sub-section (1) of section 66 or in contravention of any condition of a permit relating to the route on which or the area in which or the purpose for which the vehicle may be used, shall be punishable for the first offence with a fine which may extend to five thousand rupees but shall not be less than two thousand rupees and for any subsequent offence with imprisonment which may extend to one year but shall not be less than three months or with fine which may extend to ten thousand rupees but shall not be less than five thousand rupees or with both:
Provided that the court may for reasons to be recorded, impose a lesser punishment.
(2) Nothing in this section shall apply to the use of a motor vehicle in an emergency for the conveyance of persons suffering from sickness or injury or for the transport of materials for repair or for the transport of food or materials to relieve distress or of medical supplies for a like purpose:
Provided that the person using the vehicle reports about the same to the Regional Transport Authority within seven days from the date of such use.
(3) The court to which an appeal lies from any conviction in respect of an offence of the nature specified in sub-section (1), may set aside or vary any order made by the court below, notwithstanding that no appeal lies against the conviction in connection with which such order was made.]
193. Punishment of agents and canvassers without proper authority.—Whoever engages himself as an agent or canvasser in contravention of the provisions of section 93 or of any rules made thereunder shall be punishable for the first offence with fine which may extend to one thousand rupees and for any second or subsequent offence with imprisonment which may extend to six months, or with fine which may extend to two thousand rupees, or with both.
194. Driving vehicle exceeding permissible weight.—[(1) Whoever drivers a motor vehicle or causes or allows a motor vehicle to be driven in contravention of the provisions of section 113 or section 114 or section 115 shall be punishable with minimum fine of two thousand rupees and an additional amount of one thousand rupees per tonne of excess load, together with the liability to pay charges for off-loading of the excess load.]
(2) Any driver of a vehicle who refuses to stop and submit his vehicle to weighing after being directed to do so by an officer authorised in this behalf under section 114 or removes or causes the removal of the load or part of it prior to weighing shall be punishable with fine which may extend to three thousand rupees.
195. Imposition of minimum fine under certain circumstances.—(1) Whoever having been convicted of an offence under this Act or the rules made thereunder commits a similar offence on a second or subsequent occasion within three years of the commission of the previous offence, no court shall, except for reasons to be recorded by it in writing, impose on him a fine of less than one-fourth of the maximum amount of the fine impossible for such offence.
(2) Nothing in sub-section (1) shall be construed as restricting the power of the court from awarding such imprisonment as it considers necessary in the circumstances of the case not exceeding the maximum specified in this Act in respect of that offence.
196. Driving uninsured vehicle.—Whoever drives a motor vehicle or causes or allows a motor vehicle to be driven in contravention of the provisions of section 146 shall be punishable with imprisonment which may extend to three months, or with fine which may extend to one thousand rupees, or with both.
197. Taking vehicle without authority.—(1) Whoever takes and drives away any motor vehicle without having either the consent of the owner thereof or other lawful authority shall be punishable with imprisonment which may extend to three months or with fine which may extend to five hundred rupees, or with both.
Provided that no person shall be convicted under this section if the Court is satisfied that such person acted in the reasonable belief that he had lawful authority or in the reasonable belief that the owner would in the circumstances of the case have given his consent if he had been asked therefor.
(2) Whoever, unlawfully by force or threat of force or by any other form of intimidation, seizes or exercises control of a motor vehicle, shall be punishable with imprisonment which may extend to three months, or with fine which may extend to five hundred rupees, or with both.
(3) Whoever attempts to commit any of the acts referred to in sub-section (1) or sub-section (2) in relation to any motor vehicle, or abets the commission of any such act, shall also be deemed to have committed an offence under sub-section (1) or, as the case may be, sub-section (2).
198. Unauthorised interference with vehicle.—Whoever otherwise than with lawful authority or reasonable execuse enters or mounts any stationary motor vehicle or tampers with the brake or any part of the mechanism of a motor vehicle shall be punishable with fine which may extend to one hundred rupees.
199. Offences by companies.—(1) Where an offence under this Act has been committed by a company, every person who at the time the offence was committed, was in charge of, and was responsible to, the company, for the conduct of the business of the company, as well as the company, shall be deemed to be guilty of the contravention and shall be liable to be proceeded against and punished accordingly: Provided that nothing in this sub-section shall render any such person liable to any punishment provided in this Act, if he proves that the offence was committed without his knowledge or that he exercised all due diligence to prevent the commission of such offence.
(2) Notwithstanding anything contained in sub-section (1), where an offence under this Act has been committed by a company, and it is proved that the offence was committed with the consent or connivance of, or is attributable to any neglect on the part of any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly.
Explanation.—For the purposes of this section—
(a) “company” means any body corporate and includes a firm or other association of individuals; and
(b) “director”, in relation to a firm, means a partner in the firm.
200. Composition of certain offences.—(1) Any offence whether committed before or after the commencement of this Act punishable under section 177, section 178, section 179, section 180, section 181, section 182, sub-section (1) or sub-section (2) of section 183, section 184, section 186,1 [section 189, sub-section (2) of section190]; section 191, section 192, section 194, section 196 or section 198 may either before or after the institution of the prosecution, be compounded by such officers or authorities and for such amount as the State Government may, by notification in the Official Gazette, specify in this behalf.
(2) Where an offence has been compounded under sub-section (1), the offender, if in custody, shall be discharged and no further proceedings shall be taken against him in respect of such offence.
201. Penalty for causing obstruction to free flow of traffic.—(1) Whoever keeps a disabled vehicle on any public place, in such a manner, so as to cause impediment to the free flow of traffic, shall be liable for penalty up to fifty rupees per hour, so long as it remains in that position: Provided that the vehicle involved in accidents shall be liable for penalty only from the time of completion of inspection formalities under the law.
2 [Provided further that where the vehicle is removed by a Government agency, towing charges shall be recovered from the vehicle owner or person in-charge of such vehicle.] 3 [(2) Penalties or towing charges under this section shall be recovered by such officer or authority as the State Government may, by notification in the Official Gazette, authorise.]
202. Power to arrest without warrant.—(1) A police officer in uniform may arrest without warrant any person who in his presence commits an offence punishable under section 184 or section 185 or section 197:
Provided that any person so arrested in connection with an offence punishable under section 185 shall, within two hours of his arrest, be subjected to a medical examination referred to in sections 203 and 204 by a registered medical practitioner failing which he shall be released from custody
[(2) A police officer in uniform may arrest without warrant any person, who has committed an offence under this Act, if such person refuses to give his name and address.]
(3) A police officer arresting without warrant the driver of a motor vehicle shall if the circumstances so require take or cause to be taken any steps he may consider proper for the temporary disposal of the vehicle.
203. Breath tests.—[(1) A police officer in uniform or an officer of the Motor Vehicles Department, as may be authorised in this behalf by that Department, may require any person driving or attempting to drive a motor vehicle in a public place to provide one or more specimens of breath for breath test there or nearby, if such police officer or officer has any reasonable cause to suspect him of having committed an offence under section 185:
Provided that requirement for breath test shall be made (unless, it is made) as soon as reasonably practicable after the commission of such offence.]
(2) If a motor vehicle is involved in an accident in a public place and a police officer in uniform has any reasonable cause to suspect that the person who was driving the motor vehicle at the time of the accident, had alcohol in his blood or that he was driving under the influence of a drug referred to in section 185 he may require the person so driving the motor vehicle, to provide a specimen of his breath for a breath test:—
(a) in the case of a person who is at a hospital as an indoor patient, at the hospital,
(b) in the case of any other person, either at or near the place where the requirement is made, or, if the police officer thinks fit, at a police station specified by the police officer:
Provided that a person shall not be required to provide such a specimen while at a hospital as an indoor patient if the registered medical practitioner in immediate charge of his case is not first notified of the proposal to make the requirement or objects to the provision of a specimen on the ground that its provision or the requirement to provide it would be prejudicial to the proper care or treatment of the patient.
(3) If it appears to a police officer in uniform, in consequence of a breath test carried out by him on any person under sub-section (1) or sub-section (2), that the device by means of which the test has been carried out indicates the presence of alcohol in the person’s blood, the police officer may arrest that person without warrant except while that person is at a hospital as an indoor patient.
(4) If a person, required by a police officer under sub-section (1) or sub-section (2) to provide a specimen of breath for a breath test, refuses or fails to do so and the police officer has reasonable cause to suspect him of having alcohol in his blood, the police officer may arrest him without warrant except while he is at a hospital as an indoor patient.
(5) A person arrested under this section shall while at a police station, be given an opportunityto provide a specimen of breath for a breath test there.
(6) The results of a breath test made in pursuance of the provisions of this section shall be admissible in evidence.
Explanation.—For the purposes of this section, “breath test”, means a test for the purpose of obtaining an indication of the presence of alcohol in a person’s blood carried out, on one or more specimens of breath provided by that person, by means of a device of a type approved by the Central Government, by notification in the Official Gazette, for the purpose of such a test.
204. Laboratory test.—(1) A person, who has been arrested under section 203 may, while at a police station, be required by a police officer to provide to such registered medical practitioner as may be produced by such police officer, a specimen of his blood for a Laboratory test,—
(a) it appears to the police officer that the device, by means of which breath test was taken in relation to such person, indicates the presence of alcohol in the blood of such person, or
(b) such person, when given the opportunity to submit to a breath test, has refused, omitted or failed to do so:
Provided that where the person required to provide such specimen is a female and the registered medical practitioner produced by such police officer is a male medical practitioner, the specimen shall be taken only in the presence of a female, whether a medical practitioner or not.
(2) A person while at a hospital as an indoor patient may be required by a police officer to provide at the hospital a specimen of his blood for a laboratory test:—
(a) if it appears to the police officer that the device by means of which test is carried out in relation to the breath of such person indicates the presence of alcohol in the blood of such person, or
(b) if the person having been required, whether at the hospital or elsewhere, to provide a specimen of breath for a breath test, has refused, omitted or failed to do so and a police officer has reasonable cause to suspect him of having alcohol in his blood:
Provided that a person shall not be required to provide a specimen of his blood for a laboratory test under this sub-section if the registered medical practitioner in immediate charge of his case is not first notified of the proposal to make the requirement or objects to the provision of such specimen on the ground that its provision or the requirement to provide it would be prejudicial to the proper care or treatment of the patient.
(3) The results of a laboratory test made in pursuance of this section shall be admissible in evidence.
Explanation.—For the purposes of this section, “laboratory test” means the analysis of a specimen of blood made at a laboratory established, maintained or recognised by the Central Government or a State Government.
205. Presumption of unfitness to drive.—In any proceeding for an offence punishable under section 185 if it is proved that the accused, when requested by a police officer at any time so to do, had refused, omitted or failed to consent to the taking of or providing a specimen of his breath for a breath test or a specimen of his blood for a laboratory test, his refusal, omission or failure may, unless reasonable cause therefor is shown, be presumed to be a circumstance supporting any evidence given on behalf of the prosecution, or rebutting any evidence given on behalf of the defence, with respect to his condition at that time.
206. Power of police officer to impound document.—(1) Any police officer or other person authorised in this behalf by the State Government may, if he has reason to believe that any identification mark carried on a motor vehicle or any licence, permit, certificate of registration, certificate of insurance or other document produced to him by the driver or person in charge of a motor vehicle is a false document within the meaning of section 464 of the Indian Penal Code (45 of 1860), seize the mark or document and call upon the driver or owner of the vehicle to account for his possession of or the presence in the vehicle of such mark or document.
(2) Any police officer or other person authorised in this behalf by the State Government may, if he has reason to believe that the driver of amotor vehicle who is charged with any offence under this Act may abscond or otherwise avoid the service of a summons, seize any licence held by such driver and forward it to the Court taking cognizance of the offence and the said Court shall on the first appearance of such driver before it, return the licence to him in exchange for the temporary acknowledgment given under sub-section (3).
(3) A police officer or other person seizing a licence under sub-section (2) shall give to the person surrendering the licence a temporary acknowledgment therefor and such acknowledgment shall authorise the holder to drive until the licence has been returned to him or until such date as may be specified by the police officer or other person in the acknowledgment, whichever is earlier:
Provided that if any magistrate, police officer or other person authorised by the State Government in this behalf is, on an application made to him, satisfied that the licence cannot be, or has not been, returned to the holder thereof before the date specified in the acknowledgment for any reason for which the holder is not responsible, the magistrate, police officer or other person, as the case may be, may extend the period of authorization to drive to such date as may be specified in the acknowledgment.
207. Power to detain vehicles used without certificate of registration permit, etc.—(1) Any police officer or other person authorised in this behalf by the State Government may, if he has reason to believe that a motor vehicle has been or is being used in contravention of the provisions of section 3 or section 4 or section 39 or without the permit required by sub-section (1) of section 66 or in contravention of any condition of such permit relating to the route on which or the area in which or the purpose for which the vehicle may be used, seize and detain the vehicle, in the prescribed manner and for this purpose take or cause to be taken any steps he may consider proper for the temporary safe custody of the vehicle:
Provided that where any such officer or person has reason to believe that a motor vehicle has been or is being used in contravention of section 3 or section 4 or without the permit required by sub-section (1) of section 66 he may, instead of seizing the vehicle, seize the certificate of registration of the vehicle and shall issue an acknowledgment in respect thereof.
(2) Where a motor vehicle has been seized and detained under sub-section (1), the owner or person in charge of the motor vehicle may apply to the transport authority or any officer authorised in this behalf by the State Government together with the relevant documents for the release of the vehicle and such authority or officer may, after verification of such documents, by order release the vehicle subject to such conditions as the authority or officer may deem fit to impose.
208. Summary disposal of cases.—(1) The Court taking cognizance of any offence (other than an offence which the Central Government may by rules specify in this behalf) under this Act,—
(i) may, if the offence is an offence punishable with imprisonment under this Act; and
(ii) shall, in any other case, state upon the summons to be served on the accused person that he—
(a) may appear by pleader or in person; or
(b) may, by a specified date prior to the hearing of the charge, plead guilty to the charge and remit to the Court, by money order, such sum (not exceeding the maximum fine that may be imposed for the offence) as the Court may specify, and the plea of guilt indicated in the money order coupon itself:
Provided that the Court shall, in the case of any of the offences referred to in sub-section (2), state upon the summons that the accused person, if he pleads guilty, shall so plead in the manner specified in clause (b) and shall forward his driving licence to the Court with his letter containing such plea.
(2) Where the offence dealt with in accordance with sub-section (1) is an offence specified by the Central Government by rules for the purposes of this sub-section, the Court shall, if the accused person pleads guilty to the charge and forward his driving licence to the Court with the letter containing his plea, make an endorsement of such conviction on his driving licence.
(3) Where an accused person pleads guilty and remits the sum specified and has complied with the provisions of sub-section (1), or as the case may be, sub-sections (1) and (2), no further proceedings in respect of the offence shall be taken against him nor shall he be liable, notwithstanding anything to the contrary contained in this Act, to be disqualified for holding or obtaining a licence by reason of his having pleaded guilty.
209. Restriction on conviction.—No person prosecuted for an offence punishable under section 183 or section 184 shall be convicted unless—
(a) he was warned at the time the offence was committed that the question of prosecuting him would be taken into consideration, or
(b) within fourteen days from the commission of the offence, a notice specifying the nature of the offence and the time and place where it is alleged to have been committed was served on or sent by registered post to him or the person registered as the owner of the vehicle at the time of the commission of the offence, or
(c) within twenty-eight days of the commission of the offence, a summons for the offence was served on him: Provided that nothing, in this section shall apply where the Court is satisfied that—
(a) the failure to serve the notice or summons referred to in this sub-section was due to the fact that neither the name and address of the accused nor the name and address of the registered owner of the vehicle could with reasonable diligence have been ascertained in time, or
(b) such failure was brought about by the conduct of the accused.
210. Courts to send intimation about conviction.—Every Court by which any person holding a driving licence is convicted of an offence under this Act or of an offence in the commission of which a motor vehicle was used, shall send intimation to—
(a) the licensing authority which issued the driving licence, and
(b) the licensing authority by whom the licence was last renewed, and every such intimation shall state the name and address of the holder of the licence, the licence number, the date of issue and renewal of the same, the nature of the offence, the punishment awarded for the same and such other particulars as may be prescribed.
CHAPTER XIV
MISCELLANEOUS
211. Power to levy fee.—Any rule which the Central Government or the State Government is empowered to make under this Act may, notwithstanding the absence of any express provision to that effect, provide for the levy of such fees in respect of applications, amendment of documents, issue of certificates, licences, permits, tests, endorsements, badges, plates, countersignatures, authorisation, supply of statistics or copies of documents or orders and for any other purpose or matter involving the rendering of any service by the officers or authorities under this Act or any rule made thereunder as may be considered necessary:
Provided that the Government may, if it considers necessary so to do, in the public interest, by general or special order, exempt any class of persons from the payment of any such fee either in part or in full.
212. Publication, commencement and laying of rules and notifications.—(1) The power to make rules under this Act is subject to the condition of the rules being made after previous publication.
(2) All rules made under this Act shall be published in the Official Gazette, and shall unless some later date is appointed, come into force on the date of such publication.
(3) Every rule made by any State Government shall be laid, as soon as may be after it is made before the State Legislature.
(4) Every rule made by the Central Government under this Act, every scheme made by the Central Government under sub-section (1) of section 75 and sub-section (1) of section 163 and every notification issued by the Central Government under sub-section (4) of section 41, sub-section (1) of section 58, sub-section (1) of section 59, the proviso to sub-section (1) of section 112, 1 [sub-section (4) of section 163A]and sub-section (4) of section 213 shall be laid, as soon as may be after it is made, before each House of Parliament while it is in session for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rule, scheme or notification or both Houses agree that the rule or scheme should not be made or the notification should not be issued, the rule, scheme or notification shall thereafter have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule, scheme or notification.
213. Appointment of motor vehicles officers.—(1) The State Government may, for the purpose of carrying into effect the provisions of this Act, establish a Motor Vehicles Department and appoint as officers thereof such persons as it thinks fit.
(2) Every such officer shall be deemed to be a public servant within the meaning of the Indian Penal Code (45 of 1860).
(3) The State Government may make rules to regulate the discharge by officers of the Motor Vehicles Department of their functions and in particular and without prejudice to the generality of the foregoing power to prescribe the uniform to be worn by them, the authorities to which they shall be subordinate, the duties to be performed by them, the powers (including the powers exercisable by police officers under this Act) to be exercised by them, and the conditions governing the exercise of such powers.
(4) The Central Government may, having regard to the objects of the Act, by notification in the Official Gazette, prescribe the minimum qualifications which the said officers or any class thereof shall possess for being appointed as such.
(5) In addition to the powers that may be conferred on any officer of the Motor Vehicles Department under sub-section (3), such officer as may be empowered by the State Government in this behalf shall also have the power to,—
(a) make such examination and inquiry as he thinks fit in order to ascertain whether the provisions of this Act and the rules made thereunder are being observed;
(b) with such assistance, if any, as he thinks fit, enter, inspect and search any premises which is in the occupation of a person who, he has reason to believe, has committed an offence under this Act or in which a motor vehicle in respect of which such offence has been committed is kept:
Provided that,—
(i) any such search without a warrant shall be made only by an officer of the rank of a gazetted officer;
(ii) where the offence is punishable with fine only the search shall not be made after sunset and before sunrise;
(iii) where the search is made without a warrant, the gazetted officer concerned shall record in writing the grounds for not obtaining a warrant and report to his immediate superior that such search has been made;
(c) examine any person and require the production of any register or other document maintained in pursuance of this Act, and take on the spot or otherwise statements of any person which he may consider necessary for carrying out the purposes of this Act;
(d) seize or take copies of any registers or documents or portions thereof as he may consider relevant in respect of an offence under this Act which he has reason to believe has been committed;
(e) launch prosecutions in respect of any offence under this Act and to take a bond for ensuring the attendance of the offender before any court;
(f) exercise such other powers as may be prescribed:
Provided that no person shall be compelled under this sub-section to answer any question or make any statement tending to incriminate himself.
(6) The provisions of the Code of Criminal Procedure, 1973 (2 of 1974) shall, so far as may be apply to any search or seizure under this section as they apply to any search or seizure under the authority of any warrant issued under section 94 of that Code.
214. Effect of appeal and revision on orders passed by original authority.—(1) Where an appeal has been preferred or an application for revision has been made against any order passed by an original authority under this Act, the appeal or the application for revision shall not operate as a stay of the order passed by the original authority and such order shall remain in force pending the disposal of the appeal or the application for revision, as the case may be, unless the prescribed appellate authority or revisional authority otherwise directs.
(2) Notwithstanding anything contained in sub-section (1), if an application made by a person for the renewal of permit has been rejected by the original authority and such person has preferred an appeal or made an application for revision under this Act against such rejection, the appellate authority or, as the case may be, the revisional authority may by order direct that the permit shall, notwithstanding the expiration of the term specified therein, continue to be valid until the appeal or application for revision is disposed of.
(3) No order made by a competent authority under this Act shall be reversed or altered on appeal or revision on account of any error, omission or irregularity in the proceedings, unless it appears to the prescribed appellate authority or revisional authority, as the case may be, that such error, omission or irregularity has, in fact, occasioned a failure of justice.
215. Road Safety Councils and Committees.— (1) The Central Government may, by notification in the Official Gazette, constitute for the country a National Road Safety Council consisting of a Chairman and such other members as that Government considers necessary and on such terms and conditions as that Government may determine.
(2) A State Government may, by notification in the Official Gazette, constitute for the State a State Road Safety Council consisting of a Chairman and such other members as that Government considers necessary and on such terms and conditions as that Government may determine.
(3) A State Government may, by notification in the Official Gazette, constitute District Road Safety Committee for each district in the State consisting of a Chairman and such other members as that Government considers necessary and on such terms and conditions as that Government may determine.
(4) The Councils and Committees referred to in this section shall discharge such functions relating to the road safety programmes as the Central Government or the State Government, as the case may be, may, having regard to the objects of the Act, specify.
216. Power to remove difficulties.—(1) If any difficulty arises in giving effect to the provisions of this Act, the Central Government may, by order published in the Official Gazette, make such provisions, not inconsistent with the provisions of this Act as appear to it to be necessary or expedient for removing the difficulty:
Provided that no such order shall be made after the expiry of a period of three years from the date of commencement of this Act. (2) Every order made under this section shall, as soon as may be after it is made, be laid before each House of Parliament.
217. Repeal and savings.—(1) The Motor Vehicles Act, 1939 (4 of 1939) and any law corresponding to that Act in force in any State immediately before the commencement of this Act in that State (hereafter in this section referred to as the repealed enactments) are hereby repealed.
(2) Notwithstanding the repeal by sub-section (1) of the repealed enactments,—
(a) any notification, rule, regulation, order or notice issued, or any appointment or declaration made, or exemption granted, or any confiscation made, or any penalty or fine imposed, any forfeiture, cancellation or any other thing done, or any other action taken under the repealed enactments, and in force immediately before such commencement shall, so far as it is not inconsistent with the provisions of this Act, be deemed to have been issued, made, granted, done or taken under the corresponding provision of this Act;
(b) any certificate of fitness or registration or licence or permit issued or granted under the repealed enactments shall continue to have effect after such commencement under the same conditions and for the same period as if this Act had not been passed;
(c) any document referring to any of the repealed enactments or the provisions thereof, shall be construed as referring to this Act or to the corresponding provision of this Act;
(d) the assignment of distinguishing marks by the registering authority and the manner of display on motor vehicles in accordance with the provision of the repealed enactments shall, after the commencement of this Act, continue to remain in force until a notification under sub-section (6) of section 41 of this Act is issued;
(e) any scheme made under section 68C of the Motor Vehicles Act, 1939 (4 of 1939) or under the corresponding law, if any, in force in any State and pending immediately before the commencement of this Act shall be disposed of in accordance with the provisions of section 100 of this Act;
(f) the permits issued under sub-section (1A) of section 68F of the Motor Vehicles Act, 1939 (4 of 1939), or under the corresponding provision, if any, in force in any State immediately before the commencement of this Act shall continue to remain in force until the approved scheme under Chapter VI of this Act is published.
(3) Any penalty payable under any of the repealed enactments may be recovered in the manner provided by or under this Act, but without prejudice to any action already taken for the recovery of such penalty under the repealed enactments.
(4) The mention of particular matters in this section shall not be held to prejudice or affect the general application of section 6 of the General Clauses Act, 1897 (10 of 1897), with regard to the effect of repeals.
[217A. Renewal of permits, driving licences and registration granted under the Motor Vehicles Act, 1939.—Notwithstanding the repeal by sub-section (1) of section 217 of the enactments referred to in that sub-section, any certificate of fitness or registration or licence or permit issued or granted under the said enactments may be renewed under this Act.]
Bharatiya Nyaya Sanhita, 2023 (BNS)
Act No. 45 Of 2023
[25th December, 2023]
An Act to consolidate and amend the provisions relating to offences and for matters connected therewith or incidentalthereto.
BE it enacted by Parliament in the Seventy-fourth Year of the Republic of India as follows:––
TABLE OF CONTENTS
PART I
CHAPTER I
Preliminary
(1) This Act may be called the Bharatiya Nyaya Sanhita, 2023.
(2) It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint, and different dates may be appointed for different provisions of this Sanhita.
(3) Every person shall be liable to punishment under this Sanhita and not otherwise for every act or omission contrary to the provisions thereof, of which he shall be guilty within India.
(4) Any person liable, by any law for the time being in force in India, to be tried for an offence committed beyond India shall be dealt with according to the provisions of this Sanhita for any act committed beyond India in the same manner as if such act had been committed within India.
(5) The provisions of this Sanhita shall also apply to any offence committed by—
(a) any citizen of India in any place without and beyond India;
(b) any person on any ship or aircraft registered in India wherever it may be;
(c) any person in any place without and beyond India committing offence targeting a computer resource located in India.
Explanation—In this section, the word “offence” includes every act committed outside India which, if committed in India, would be punishable under this Sanhita. Illustration. A, who is a citizen of India, commits a murder in any place without and beyond India. He can be tried and convicted of murder in any place in India in which he may be found.
(6) Nothing in this Sanhita shall affect the provisions of any Act for punishing mutiny and desertion of officers, soldiers, sailors or airmen in the service of the Government of India or the provisions of any special or local law. 2. In this Sanhita, unless the context otherwise requires,––
(1) “act” denotes as well a series of acts as a single act;
(2) “animal” means any living creature, other than a human being;
(3) “child” means any person below the age of eighteen years;
(4) “counterfeit”.––A person is said to “counterfeit” who causes one thing to resemble another thing, intending by means of that resemblance to practise deception, or knowing it to be likely that deception will thereby be practised.
Explanation 1—It is not essential to counterfeiting that the imitation should be exact.
Explanation 2—When a person causes one thing to resemble another thing, and the resemblance is such that a person might be deceived thereby, it shall be presumed, until the contrary is proved, that the person so causing the one thing to resemble the other thing intended by means of that resemblance to practise deception or knew it to be likely that deception would thereby be practised;
(5) “Court” means a Judge who is empowered by law to act judicially alone, or a body of Judges which is empowered by law to act judicially as a body, when such Judge or body of Judges is acting judicially;
(6) “death” means the death of a human being unless the contrary appears from the context;
(7) “dishonestly” means doing anything with the intention of causing wrongful gain to one person or wrongful loss to another person;
(8) “document” means any matter expressed or described upon any substance by means of letters, figures or marks, or by more than one of those means, and includes electronic and digital record, intended to be used, or which may be used, as evidence of that matter.
Explanation 1—It is immaterial by what means or upon what substance the letters, figures or marks are formed, or whether the evidence is intended for, or may be used in a Court or not.
Illustrations
(a) A writing expressing the terms of a contract, which may be used as evidence of the contract, is a document.
(b) A cheque upon a banker is a document.
(c) A power-of-attorney is a document.
(d) A map or plan which is intended to be used or which may be used as evidence, is a document.
(e) A writing containing directions or instructions is a document.
Explanation 2—Whatever is expressed by means of letters, figures or marks as explained by mercantile or other usage, shall be deemed to be expressed by such letters, figures or marks within the meaning of this section, although the same may not be actually expressed. Illustration. A writes his name on the back of a bill of exchange payable to his order. The meaning of the endorsement, as explained by mercantile usage, is that the bill is to be paid to the holder. The endorsement is a document, and shall be construed in the same manner as if the words “pay to the holder” or words to that effect had been written over the signature;
(9) “fraudulently” means doing anything with the intention to defraud but not otherwise;
(10) “gender”.—The pronoun “he” and its derivatives are used of any person, whether male, female or transgender.
Explanation–– “transgender” shall have the meaning assigned to it in clause (k) of section 2 of the Transgender Persons (Protection of Rights) Act, 2019;
(11) “good faith”.—Nothing is said to be done or believed in “good faith” which is done or believed without due care and attention;
(12) “Government” means the Central Government or a State Government;
(13) “harbour” includes supplying a person with shelter, food, drink, money, clothes, arms, ammunition or means of conveyance, or the assisting a person by any means, whether of the same kind as those enumerated in this clause or not, to evade apprehension;
(14) “injury” means any harm whatever illegally caused to any person, in body, mind, reputation or property;
(15) “illegal” and “legally bound to do”.—The word “illegal” is applicable to everything which is an offence or which is prohibited by law, or which furnishes ground for a civil action; and a person is said to be “legally bound to do” whatever it is illegal in him to omit;
(16) “Judge” means a person who is officially designated as a Judge and includes a person,––
(i) who is empowered by law to give, in any legal proceeding, civil or criminal, a definitive judgment, or a judgment which, if not appealed against, would be definitive, or a judgment which, if confirmed by some other authority, would be definitive; or
(ii) who is one of a body or persons, which body of persons is empowered by law to give such a judgment.
Illustration
A Magistrate exercising jurisdiction in respect of a charge on which he has power to sentence to fine or imprisonment, with or without appeal, is a Judge;
(17) “life” means the life of a human being, unless the contrary appears from the context;
(18) “local law” means a law applicable only to a particular part of India;
(19) “man” means male human being of any age;
(20) “month” and “year”.––Wherever the word “month” or the word “year” is used, it is to be understood that the month or the year is to be reckoned according to the Gregorian calendar;
(21) “movable property” includes property of every description, except land and things attached to the earth or permanently fastened to anything which is attached to the earth;
(22) “number”.—Unless the contrary appears from the context, words importing the singular number include the plural number, and words importing the plural number include the singular number;
(23) “oath” includes a solemn affirmation substituted by law for an oath, and any declaration required or authorised by law to be made before a public servant or to be used for the purpose of proof, whether in a Court or not;
(24) “offence”.—Except in the Chapters and sections mentioned in sub-clauses (a) and (b), the word “offence” means a thing made punishable by this Sanhita, but––
(a) in Chapter III and in the following sections, namely, sub-sections (2), (3), (4) and (5) of section 8, sections 9, 49, 50, 52, 54, 55, 56, 57, 58, 59, 60, 61, 119, 120, 123, sub-sections (7) and (8) of section 127, 222, 230, 231, 240, 248, 250, 251, 259, 260, 261, 262, 263, sub-sections (6) and (7) of section 308 and sub-section (2) of section 330, the word “offence” means a thing punishable under this Sanhita, or under any special law or local law; and
(b) in sub-section (1) of section 189, sections 211, 212, 238, 239, 249, 253 and sub-section (1) of section 329, the word “offence” shall have the same meaning when the act punishable under the special law or local law is punishable under such law with imprisonment for a term of six months or more, whether with or without fine;
(25) “omission” denotes as well as a series of omissions as a single omission;
(26) “person” includes any company or association or body of persons, whether incorporated or not;
(27) “public” includes any class of the public or any community;
(28) “public servant” means a person falling under any of the descriptions, namely:—
(a) every commissioned officer in theArmy, Navy orAir Force;
(b) every Judge including any person empowered by law to discharge, whether by himself or as a member of any body of persons, any adjudicatory functions;
(c) every officer of a Court including a liquidator, receiver or commissioner whose duty it is, as such officer, to investigate or report on any matter of law or fact, or to make, authenticate, or keep any document, or to take charge or dispose
of any property, or to execute any judicial process, or to administer any oath, or to interpret, or to preserve order in the Court, and every person specially authorised by a Court to perform any of such duties;
(d) every assessor or member of a panchayat assisting a Court or public servant;
(e) every arbitrator or other person to whom any cause or matter has been referred for decision or report by any Court, or by any other competent public authority;
(f) every person who holds any office by virtue of which he is empowered to place or keep any person in confinement;
(g) every officer of the Government whose duty it is, as such officer, to prevent offences, to give information of offences, to bring offenders to justice, or to protect the public health, safety or convenience;
(h) every officer whose duty it is, as such officer, to take, receive, keep or expend any property on behalf of the Government, or to make any survey, assessment or contract on behalf of the Government, or to execute any revenue-process, or to investigate, or to report, on any matter affecting the pecuniary interests of the Government, or to make, authenticate or keep any document relating to the pecuniary interests of the Government, or to prevent the infraction of any law for the protection of the pecuniary interests of the Government;
(i) every officer whose duty it is, as such officer, to take, receive, keep or expend any property, to make any survey or assessment or to levy any rate or tax for any secular common purpose of any village, town or district, or to make, authenticate or keep any document for the ascertaining of the rights of the people of any village, town or district;
(j) every person who holds any office by virtue of which he is empowered to prepare, publish, maintain or revise an electoral roll or to conduct an election or part of an election;
(k) every person—
(i) in the service or pay of the Government or remunerated by fees or commission for the performance of any public duty by the Government;
(ii) in the service or pay of a local authority as defined in clause (31) of section 3 of the General ClausesAct, 1897, a corporation established by or under a Central or State Act or a Government company as defined in clause (45) of section 2 of the Companies Act, 2013.
Explanation— (a) persons falling under any of the descriptions made in this clause are public servants, whether appointed by the Government or not;
(b) every person who is in actual possession of the situation of a public servant, whatever legal defect there may be in his right to hold that situation is a public servant;
(c) “election” means an election for the purpose of selecting members of any legislative, municipal or other public authority, of whatever character, the method of selection to which is by, or under any law for the time being in force.
Illustration
A Municipal Commissioner is a public servant;
(29) “reason to believe”.—A person is said to have “reason to believe” a thing, if he has sufficient cause to believe that thing but not otherwise;
(30) “special law” means a law applicable to a particular subject;
(31) “valuable security” means a document which is, or purports to be, a document whereby any legal right is created, extended, transferred, restricted, extinguished or released, or whereby any person acknowledges that he lies under legal liability, or has not a certain legal right.
Illustration
A writes his name on the back of a bill of exchange. As the effect of this endorsement is to transfer the right to the bill to any person who may become the lawful holder of it, the endorsement is a “valuable security”;
(32) “vessel” means anything made for the conveyance by water of human beings or of property;
(33) “voluntarily”.—A person is said to cause an effect “voluntarily” when he causes it by means whereby he intended to cause it, or by means which, at the time of employing those means, he knew or had reason to believe to be likely to cause it.
Illustration
A sets fire, by night, to an inhabited house in a large town, for the purpose of facilitating a robbery and thus causes the death of a person. Here, A may not have intended to cause death; and may even be sorry that death has been caused by his act; yet, if he knew that he was likely to cause death, he has caused death voluntarily;
(34) “will” means any testamentary document;
(35) “woman” means a female human being of any age;
(36) “wrongful gain” means gain by unlawful means of property to which the person gaining is not legally entitled;
(37) “wrongful loss” means the loss by unlawful means of property to which the person losing it is legally entitled;
(38) “gaining wrongfully” and “losing wrongfully”.—A person is said to gain wrongfully when such person retains wrongfully, as well as when such person acquires wrongfully. A person is said to lose wrongfully when such person is wrongfully kept out of any property, as well as when such person is wrongfully deprived of property; and
(39) words and expressions used but not defined in this Sanhita but defined in the Information TechnologyAct, 2000 and the Bharatiya Nagarik Suraksha Sanhita, 2023 shall have the meanings respectively assigned to them in that Act and Sanhita.
3. (1) Throughout this Sanhita every definition of an offence, every penal provision, and every Illustration of every such definition or penal provision, shall be understood subject to the exceptions contained in the Chapter entitled “General Exceptions”, though those exceptions are not repeated in such definition, penal provision, or Illustration.
Illustration
(a) The sections in this Sanhita, which contain definitions of offences, do not express that a child under seven years of age cannot commit such offences; but the definitions are to be understood subject to the general exception which provides that nothing shall be an offence which is done by a child under seven years of age.
(b) A, a police officer, without warrant, apprehends Z, who has committed murder. Here A is not guilty of the offence of wrongful confinement; for he was bound by law to apprehend Z, and therefore the case falls within the general exception which provides that “nothing is an offence which is done by a person who is bound by law to do it”.
(2) Every expression which is explained in any Part of this Sanhita, is used in every Part of this Sanhita in conformity with the explanation.
(3) When property is in the possession of a person’s spouse, clerk or servant, on account of that person, it is in that person’s possession within the meaning of this Sanhita.
Explanation—A person employed temporarily or on a particular occasion in the capacity of a clerk or servant, is a clerk or servant within the meaning of this sub-section.
(4) In every Part of this Sanhita, except where a contrary intention appears from the context, words which refer to acts done extend also to illegal omissions.
(5) When a criminal act is done by several persons in furtherance of the common intention of all, each of such persons is liable for that act in the same manner as if it were done by him alone.
(6) Whenever an act, which is criminal only by reason of its being done with a criminal knowledge or intention, is done by several persons, each of such persons who joins in the act with such knowledge or intention is liable for the act in the same manner as if the act were done by him alone with that knowledge or intention.
(7) Wherever the causing of a certain effect, or an attempt to cause that effect, by an act or by an omission, is an offence, it is to be understood that the causing of that effect partly by an act and partly by an omission is the same offence.
Illustration
A intentionally causes Z’s death, partly by illegally omitting to give Z food, and partly by beating Z. A has committed murder.
(8) When an offence is committed by means of several acts, whoever intentionally cooperates in the commission of that offence by doing any one of those acts, either singly or jointly with any other person, commits that offence.
Illustration
(a) Aand B agree to murder Z by severally and at different times giving him small doses of poison.A and B administer the poison according to the agreement with intent to murder Z. Z dies from the effects the several doses of poison so administered to him. Here A and B intentionally cooperate in the commission of murder and as each of them does an act by which the death is caused, they are both guilty of the offence though their acts are separate.
(b) A and B are joint jailors, and as such have the charge of Z, a prisoner, alternatively for six hours at a time. A and B, intending to cause Z’s death, knowingly cooperate in causing that effect by illegally omitting, each during the time of his attendance, to furnish Z with food supplied to them for that purpose. Z dies of hunger. Both A and B are guilty of the murder of Z.
(c) A, a jailor, has the charge of Z, a prisoner. A, intending to cause Z’s death, illegally omits to supply Z with food; in consequence of which Z is much reduced in strength, but the starvation is not sufficient to cause his death. A is dismissed from his office, and B succeeds him. B, without collusion or cooperation with A, illegally omits to supply Z with food, knowing that he is likely thereby to cause Z’s death. Z dies of hunger. B is guilty of murder, but, as A did not cooperate with B. A is guilty only of an attempt to commit murder.
(9) Where several persons are engaged or concerned in the commission of a criminal act, they may be guilty of different offences by means of that act. Illustration. A attacks Z under such circumstances of grave provocation that his killing of Z would be only culpable homicide not amounting to murder. B, having ill-will towards Z and intending to kill him, and not having been subject to the provocation, assists A in killing Z. Here, though A and B are both engaged in causing Z’s death, B is guilty of murder, and Ais guilty only of culpable homicide.
CHAPTER II
OF PUNISHMENTS
4. The punishments to which offenders are liable under the provisions of this Sanhita are—
(a) Death;
(b) Imprisonment for life;
(c) Imprisonment, which is of two descriptions, namely:—
(1) Rigorous, that is, with hard labour;
(2) Simple;
(d) Forfeiture of property;
(e) Fine;
(f) Community Service.
5. The appropriate Government may, without the consent of the offender, commute any punishment under this Sanhita to any other punishment in accordance with section 474 of the Bharatiya Nagarik Suraksha Sanhita, 2023.
Explanation––For the purposes of this section the expression “appropriate Government” means,––
(a) in cases where the sentence is a sentence of death or is for an offence against any law relating to a matter to which the executive power of the Union extends, the Central Government; and
(b) in cases where the sentence (whether of death or not) is for an offence against any law relating to a matter to which the executive power of the State extends, the Government of the State within which the offender is sentenced.
6. In calculating fractions of terms of punishment, imprisonment for life shall be reckoned as equivalent to imprisonment for twenty years unless otherwise provided.
7. In every case in which an offender is punishable with imprisonment which may be of either description, it shall be competent to the Court which sentences such offender to direct in the sentence that such imprisonment shall be wholly rigorous, or that such imprisonment shall be wholly simple, or that any part of such imprisonment shall be rigorous and the rest simple.
8. (1) Where no sum is expressed to which a fine may extend, the amount of fine to which the offender is liable is unlimited, but shall not be excessive.
(2) In every case of an offence––
(a) punishable with imprisonment as well as fine, in which the offender is sentenced to a fine, whether with or without imprisonment;
(b) punishable with imprisonment or fine, or with fine only, in which the offender is sentenced to a fine,
it shall be competent to the Court which sentences such offender to direct by the sentence that, in default of payment of the fine, the offender shall suffer imprisonment for a certain term, in which imprisonment shall be in excess of any other imprisonment to which he may have been sentenced or to which he may be liable under a commutation of a sentence.
(3) The term for which the Court directs the offender to be imprisoned in default of payment of a fine shall not exceed one-fourth of the term of imprisonment which is the maximum fixed for the offence, if the offence be punishable with imprisonment as well as fine.
(4) The imprisonment which the Court imposes in default of payment of a fine or in default of community service may be of any description to which the offender might have been sentenced for the offence.
(5) If the offence is punishable with fine or community service, the imprisonment which the Court imposes in default of payment of the fine or in default of community service shall be simple, and the term for which the Court directs the offender to be imprisoned, in default of payment of fine or in default of community service, shall not exceed,—
(a) two months when the amount of the fine does not exceed five thousand rupees; (b) four months when the amount of the fine does not exceed ten thousand rupees; and (c) one year in any other case.
(6) (a) The imprisonment which is imposed in default of payment of a fine shall terminate whenever that fine is either paid or levied by process of law;
(b) If, before the expiration of the term of imprisonment fixed in default of payment, such a proportion of the fine be paid or levied that the term of imprisonment suffered in default of payment is not less than proportional to the part of the fine still unpaid, the imprisonment shall terminate.
Illustration
A is sentenced to a fine of one thousand rupees and to four months’ imprisonment in default of payment. Here, if seven hundred and fifty rupees of the fine be paid or levied before the expiration of one month of the imprisonment, A will be discharged as soon as the first month has expired. If seven hundred and fifty rupees be paid or levied at the time of the expiration of the first month, or at any later time whileA continues in imprisonment, Awill be immediately discharged. If five hundred rupees of the fine be paid or levied before the expiration of two months of the imprisonment, A will be discharged as soon as the two months are completed. If five hundred rupees be paid or levied at the time of the expiration of those two months, or at any later time whileAcontinues in imprisonment, Awill be immediately discharged.
(7) The fine, or any part thereof which remains unpaid, may be levied at any time within six years after the passing of the sentence, and if, under the sentence, the offender be liable to imprisonment for a longer period than six years, then at any time previous to the expiration of that period; and the death of the offender does not discharge from the liability any property which would, after his death, be legally liable for his debts.
9. (1) Where anything which is an offence is made up of parts, any of which parts is itself an offence, the offender shall not be punished with the punishment of more than one of such his offences, unless it be so expressly provided.
(2) Where— (a) anything is an offence falling within two or more separate definitions of any law in force for the time being by which offences are defined or punished; or
(b) several acts, of which one or more than one would by itself or themselves constitute an offence, constitute, when combined, a different offence, the offender shall not be punished with a more severe punishment than the Court which tries him could award for any one of such offences.
Illustration
(a) A gives Z fifty strokes with a stick. Here A may have committed the offence of voluntarily causing hurt to Z by the whole beating, and also by each of the blows which make up the whole beating. If A were liable to punishment for every blow, he might be imprisoned for fifty years, one for each blow. But he is liable only to one punishment for the whole beating.
(b) But, if, while A is beating Z, Y interferes, and A intentionally strikes Y, here, as the blow given to Y is no part of the act whereby A voluntarily causes hurt to Z, A is liable to one punishment for voluntarily causing hurt to Z, and to another for the blow given to Y.
10. In all cases in which judgment is given that a person is guilty of one of several offences specified in the judgment, but that it is doubtful of which of these offences he is guilty, the offender shall be punished for the offence for which the lowest punishment is provided if the same punishment is not provided for all.
11. Whenever any person is convicted of an offence for which under this Sanhita the Court has power to sentence him to rigorous imprisonment, the Court may, by its sentence, order that the offender shall be kept in solitary confinement for any portion or portions of the imprisonment to which he is sentenced, not exceeding three months in the whole, according to the following scale, namely:—
(a) a time not exceeding one month if the term of imprisonment shall not exceed six months;
(b) a time not exceeding two months if the term of imprisonment shall exceed six months and shall not exceed one year;
(c) a time not exceeding three months if the term of imprisonment shall exceed one year.
12. In executing a sentence of solitary confinement, such confinement shall in no case exceed fourteen days at a time, with intervals between the periods of solitary confinement of not less duration than such periods; and when the imprisonment awarded shall exceed three months, the solitary confinement shall not exceed seven days in any one month of the whole imprisonment awarded, with intervals between the periods of solitary confinement of not less duration than such periods.
13. Whoever, having been convicted by a Court in India, of an offence punishable under Chapter X or Chapter XVII of this Sanhita with imprisonment of either description for a term of three years or upwards, shall be guilty of any offence punishable under either of those Chapters with like imprisonment for the like term, shall be subject for every such subsequent offence to imprisonment for life, or to imprisonment of either description for a term which may extend to ten years.
CHAPTER III
GENERAL EXCEPTIONS
14. Nothing is an offence which is done by a person who is, or who by reason of a mistake of fact and not by reason of a mistake of law in good faith believes himself to be, bound by law to do it.
Illustration
(a) A, a soldier, fires on a mob by the order of his superior officer, in conformity with the commands of the law. A has committed no offence.
(b) A, an officer of a Court, being ordered by that Court to arrest Y, and, after due enquiry, believing Z to be Y, arrests Z. A has committed no offence.
15. Nothing is an offence which is done by a Judge when acting judicially in the exercise of any power which is, or which in good faith he believes to be, given to him by law.
16. Nothing which is done in pursuance of, or which is warranted by the judgment or order of, a Court; if done whilst such judgment or order remains in force, is an offence, notwithstanding the Court may have had no jurisdiction to pass such judgment or order, provided the person doing the act in good faith believes that the Court had such jurisdiction.
17. Nothing is an offence which is done by any person who is justified by law, or who by reason of a mistake of fact and not by reason of a mistake of law in good faith, believes himself to be justified by law, in doing it.
Illustration
A sees Z commit what appears to A to be a murder. A, in the exercise, to the best of his judgment exerted in good faith, of the power which the law gives to all persons of apprehending murderers in the fact, seizes Z, in order to bring Z before the proper authorities. A has committed no offence, though it may turn out that Z was acting in self-defence.
18. Nothing is an offence which is done by accident or misfortune, and without any criminal intention or knowledge in the doing of a lawful act in a lawful manner by lawful means and with proper care and caution. Illustration. A is at work with a hatchet; the head flies off and kills a man who is standing by. Here, if there was no want of proper caution on the part of A, his act is excusable and not an offence.
19. Nothing is an offence merely by reason of its being done with the knowledge that it is likely to cause harm, if it be done without any criminal intention to cause harm, and in good faith for the purpose of preventing or avoiding other harm to person or property.
Explanation—It is a question of fact in such a case whether the harm to be prevented or avoided was of such a nature and so imminent as to justify or excuse the risk of doing the act with the knowledge that it was likely to cause harm.
Illustration
(a) A, the captain of a vessel, suddenly and without any fault or negligence on his part, finds himself in such a position that, before he can stop his vessel, he must inevitably run down a boat B, with twenty or thirty passengers on board, unless he changes the course of his vessel, and that, by changing his course, he must incur risk of running down a boat C with only two passengers on board, which he may possibly clear.
Here, if A alters his course without any intention to run down the boat C and in good faith for the purpose of avoiding the danger to the passengers in the boat B, he is not guilty of an offence, though he may run down the boat C by doing an act which he knew was likely to cause that effect, if it be found as a matter of fact that the danger which he intended to avoid was such as to excuse him in incurring the risk of running down the boat C.
(b) A, in a great fire, pulls down houses in order to prevent the conflagration from spreading. He does this with the intention in good faith of saving human life or property. Here, if it be found that the harm to be prevented was of such a nature and so imminent as to excuse A’s act, A is not guilty of the offence.
20. Nothing is an offence which is done by a child under seven years of age.
21. Nothing is an offence which is done by a child above seven years of age and under twelve years of age, who has not attained sufficient maturity of understanding to judge of the nature and consequences of his conduct on that occasion.
22. Nothing is an offence which is done by a person who, at the time of doing it, by reason of unsoundness of mind, is incapable of knowing the nature of the act, or that he is doing what is either wrong or contrary to law.
23. Nothing is an offence which is done by a person who, at the time of doing it, is, by reason of intoxication, incapable of knowing the nature of the act, or that he is doing what is either wrong, or contrary to law; provided that the thing which intoxicated him was administered to him without his knowledge or against his will.
24. In cases where an act done is not an offence unless done with a particular knowledge or intent, a person who does the act in a state of intoxication shall be liable to be dealt with as if he had the same knowledge as he would have had if he had not been intoxicated, unless the thing which intoxicated him was administered to him without his knowledge or against his will.
25. Nothing which is not intended to cause death, or grievous hurt, and which is not known by the doer to be likely to cause death or grievous hurt, is an offence by reason of any harm which it may cause, or be intended by the doer to cause, to any person, above eighteen years of age, who has given consent, whether express or implied, to suffer that harm; or by reason of any harm which it may be known by the doer to be likely to cause to any such person who has consented to take the risk of that harm.
Illustration
A and Z agree to fence with each other for amusement. This agreement implies the consent of each to suffer any harm which, in the course of such fencing, may be caused without foul play; and if A, while playing fairly, hurts Z, A commits no offence.
26. Nothing, which is not intended to cause death, is an offence by reason of any harm which it may cause, or be intended by the doer to cause, or be known by the doer to be likely to cause, to any person for whose benefit it is done in good faith, and who has given a consent, whether express or implied, to suffer that harm, or to take the risk of that harm.
Illustration
A, a surgeon, knowing that a particular operation is likely to cause the death of Z, who suffers under the painful complaint, but not intending to cause Z’s death, and intending, in good faith, Z’s benefit, performs that operation on Z, with Z’s consent. A has committed no offence.
27. Nothing which is done in good faith for the benefit of a person under twelve years of age, or person of unsound mind, by, or by consent, either express or implied, of the guardian or other person having lawful charge of that person, is an offence by reason of any harm which it may cause, or be intended by the doer to cause or be known by the doer to be likely to cause to that person:
Provided that this exception shall not extend to––
(a) the intentional causing of death, or to the attempting to cause death;
(b) the doing of anything which the person doing it knows to be likely to cause death, for any purpose other than the preventing of death or grievous hurt, or the curing of any grievous disease or infirmity;
(c) the voluntary causing of grievous hurt, or to the attempting to cause grievous hurt, unless it be for the purpose of preventing death or grievous hurt, or the curing of any grievous disease or infirmity;
(d) the abetment of any offence, to the committing of which offence it would not extend.
Illustration
A, in good faith, for his child’s benefit without his child’s consent, has his child cut for the stone by a surgeon knowing it to be likely that the operation will cause the child’s death, but not intending to cause the child’s death. A is within the exception, in as much as his object was the cure of the child.
28. A consent is not such a consent as is intended by any section of this Sanhita,––
(a) if the consent is given by a person under fear of injury, or under a misconception of fact, and if the person doing the act knows, or has reason to believe, that the consent was given in consequence of such fear or misconception; or
(b) if the consent is given by a person who, from unsoundness of mind, or intoxication, is unable to understand the nature and consequence of that to which he gives his consent; or
(c) unless the contrary appears from the context, if the consent is given by a person who is under twelve years of age.
29. The exceptions in sections 25, 26 and 27 do not extend to acts which are offences independently of any harm which they may cause, or be intended to cause, or be known to be likely to cause, to the person giving the consent, or on whose behalf the consent is given.
Illustration
Causing miscarriage (unless caused in good faith for the purpose of saving the life of the woman) is an offence independently of any harm which it may cause or be intended to cause to the woman. Therefore, it is not an offence “by reason of such harm”; and the consent of the woman or of her guardian to the causing of such miscarriage does not justify the act.
30. Nothing is an offence by reason of any harm which it may cause to a person for whose benefit it is done in good faith, even without that person’s consent, if the circumstances are such that it is impossible for that person to signify consent, or if that person is incapable of giving consent, and has no guardian or other person in lawful charge of him from whom it is possible to obtain consent in time for the thing to be done with benefit:
Provided that this exception shall not extend to––
(a) the intentional causing of death, or the attempting to cause death;
(b) the doing of anything which the person doing it knows to be likely to cause death, for any purpose other than the preventing of death or grievous hurt, or the curing of any grievous disease or infirmity;
(c) the voluntary causing of hurt, or to the attempting to cause hurt, for any purpose other than the preventing of death or hurt; (d) the abetment of any offence, to the committing of which offence it would not extend.
Illustration
(1) Z is thrown from his horse, and is insensible. A, a surgeon, finds that Z requires to be trepanned. A, not intending Z’s death, but in good faith, for Z’s benefit, performs the trepan before Z recovers his power of judging for himself. A has committed no offence.
(2) Z is carried off by a tiger. A fires at the tiger knowing it to be likely that the shot may kill Z, but not intending to kill Z, and in good faith intending Z’s benefit. A’s bullet gives Z a mortal wound. A has committed no offence.
(3) A, a surgeon, sees a child suffer an accident which is likely to prove fatal unless an operation be immediately performed. There is no time to apply to the child’s guardian. A performs the operation in spite of the entreaties of the child, intending, in good faith, the child’s benefit. A has committed no offence.
(4) A is in a house which is on fire, with Z, a child. People below hold out a blanket. A drops the child from the house top, knowing it to be likely that the fall may kill the child, but not intending to kill the child, and intending, in good faith, the child’s benefit. Here, even if the child is killed by the fall, A has committed no offence.
Explanation—Mere pecuniary benefit is not benefit within the meaning of sections 26, 27 and this section.
31. No communication made in good faith is an offence by reason of any harm to the person to whom it is made, if it is made for the benefit of that person.
Illustration
A, a surgeon, in good faith, communicates to a patient his opinion that he cannot live. The patient dies in consequence of the shock. A has committed no offence, though he knew it to be likely that the communication might cause the patient’s death.
32. Except murder, and offences against the State punishable with death, nothing is an offence which is done by a person who is compelled to do it by threats, which, at the time of doing it, reasonably cause the apprehension that instant death to that person will otherwise be the consequence:
Provided that the person doing the act did not of his own accord, or from a reasonable apprehension of harm to himself short of instant death, place himself in the situation by which he became subject to such constraint.
Explanation 1—A person who, of his own accord, or by reason of a threat of being beaten, joins a gang of dacoits, knowing their character, is not entitled to the benefit of this exception, on the ground of his having been compelled by his associates to do anything that is an offence by law.
Explanation 2—A person seized by a gang of dacoits, and forced, by threat of instant death, to do a thing which is an offence by law; for example, a smith compelled to take his tools and to force the door of a house for the dacoits to enter and plunder it, is entitled to the benefit of this exception.
33. Nothing is an offence by reason that it causes, or that it is intended to cause, or that it is known to be likely to cause, any harm, if that harm is so slight that no person of ordinary sense and temper would complain of such harm. Of right of private defence
34. Nothing is an offence which is done in the exercise of the right of private defence.
35. Every person has a right, subject to the restrictions contained in section 37, to defend—
(a) his own body, and the body of any other person, against any offence affecting the human body;
(b) the property, whether movable or immovable, of himself or of any other person, against any act which is an offence falling under the definition of theft, robbery, mischief or criminal trespass, or which is an attempt to commit theft, robbery, mischief or criminal trespass.
36. When an act, which would otherwise be a certain offence, is not that offence, by reason of the youth, the want of maturity of understanding, the unsoundness of mind or the intoxication of the person doing that act, or by reason of any misconception on the part of that person, every person has the same right of private defence against that act which he would have if the act were that offence.
Illustration
(a) Z, a person of unsound mind, attempts to kill A; Z is guilty of no offence. ButA has the same right of private defence which he would have if Z were sane.
(b) A enters by night a house which he is legally entitled to enter. Z, in good faith, taking A for a house-breaker, attacks A. Here Z, by attacking A under this misconception, commits no offence. But A has the same right of private defence against Z, which he would have if Z were not acting under that misconception.
37. (1) There is no right of private defence,––
(a) against an act which does not reasonably cause the apprehension of death or of grievous hurt, if done, or attempted to be done, by a public servant acting in good faith under colour of his office, though that act, may not be strictly justifiable by law;
(b) against an act which does not reasonably cause the apprehension of death or of grievous hurt, if done, or attempted to be done, by the direction of a public servant acting in good faith under colour of his office, though that direction may not be strictly justifiable by law;
(c) in cases in which there is time to have recourse to the protection of the public authorities.
(2) The right of private defence in no case extends to the inflicting of more harm than it is necessary to inflict for the purpose of defence.
Explanation 1—A person is not deprived of the right of private defence against an act done, or attempted to be done, by a public servant, as such, unless he knows or has reason to believe, that the person doing the act is such public servant.
Explanation 2—A person is not deprived of the right of private defence against an act done, or attempted to be done, by the direction of a public servant, unless he knows, or has reason to believe, that the person doing the act is acting by such direction, or unless such person states the authority under which he acts, or if he has authority in writing, unless he produces such authority, if demanded.
38. The right of private defence of the body extends, under the restrictions specified in section 37, to the voluntary causing of death or of any other harm to the assailant, if the offence which occasions the exercise of the right be of any of the descriptions hereinafter enumerated, namely:—
(a) such an assault as may reasonably cause the apprehension that death will otherwise be the consequence of such assault;
(b) such an assault as may reasonably cause the apprehension that grievous hurt will otherwise be the consequence of such assault;
(c) an assault with the intention of committing rape;
(d) an assault with the intention of gratifying unnatural lust;
(e) an assault with the intention of kidnapping or abducting;
(f) an assault with the intention of wrongfully confining a person, under circumstances which may reasonably cause him to apprehend that he will be unable to have recourse to the public authorities for his release;
(g) an act of throwing or administering acid or an attempt to throw or administer acid which may reasonably cause the apprehension that grievous hurt will otherwise be the consequence of such act.
39. If the offence be not of any of the descriptions specified in section 38, the right of private defence of the body does not extend to the voluntary causing of death to the assailant, but does extend, under the restrictions specified in section 37, to the voluntary causing to the assailant of any harm other than death.
40. The right of private defence of the body commences as soon as a reasonable apprehension of danger to the body arises from an attempt or threat to commit the offence though the offence may not have been committed; and it continues as long as such apprehension of danger to the body continues.
41. The right of private defence of property extends, under the restrictions specified in section 37, to the voluntary causing of death or of any other harm to the wrong-doer, if the offence, the committing of which, or the attempting to commit which, occasions the exercise of the right, be an offence of any of the descriptions hereinafter enumerated, namely:—
(a) robbery;
(b) house-breaking after sunset and before sunrise;
(c) mischief by fire or any explosive substance committed on any building, tent or vessel, which building, tent or vessel is used as a human dwelling, or as a place for the custody of property;
(d) theft, mischief, or house-trespass, under such circumstances as may reasonably cause apprehension that death or grievous hurt will be the consequence, if such right of private defence is not exercised.
42. If the offence, the committing of which, or the attempting to commit which occasions the exercise of the right of private defence, be theft, mischief, or criminal trespass, not of any of the descriptions specified in section 41, that right does not extend to the voluntary causing of death, but does extend, subject to the restrictions specified in section 37, to the voluntary causing to the wrong-doer of any harm other than death.
43. The right of private defence of property,––
(a) commences when a reasonable apprehension of danger to the property commences;
(b) against theft continues till the offender has effected his retreat with the property or either the assistance of the public authorities is obtained, or the property has been recovered;
(c) against robbery continues as long as the offender causes or attempts to cause to any person death or hurt or wrongful restraint or as long as the fear of instant death or of instant hurt or of instant personal restraint continues;
(d) against criminal trespass or mischief continues as long as the offender continues in the commission of criminal trespass or mischief;
(e) against house-breaking after sunset and before sunrise continues as long as the house-trespass which has been begun by such house-breaking continues.
44. If in the exercise of the right of private defence against an assault which reasonably causes the apprehension of death, the defender be so situated that he cannot effectually
exercise that right without risk of harm to an innocent person, his right of private defence extends to the running of that risk.
Illustration
A is attacked by a mob who attempt to murder him. He cannot effectually exercise his right of private defence without firing on the mob, and he cannot fire without risk of harming young children who are mingled with the mob. A commits no offence if by so firing he harms any of the children.
CHAPTER IV
OF ABETMENT, CRIMINAL CONSPIRACY AND ATTEMPT
of abetment
45. A person abets the doing of a thing, who—
(a) instigates any person to do that thing; or
(b) engages with one or more other person or persons in any conspiracy for the doing of that thing, if an act or illegal omission takes place in pursuance of that conspiracy, and in order to the doing of that thing; or
(c) intentionally aids, by any act or illegal omission, the doing of that thing.
Explanation 1—A person who, by wilful misrepresentation, or by wilful concealment of a material fact which he is bound to disclose, voluntarily causes or procures, or attempts to cause or procure, a thing to be done, is said to instigate the doing of that thing. Illustration. A, a public officer, is authorised by a warrant from a Court to apprehend Z. B, knowing that fact and also that C is not Z, wilfully represents toAthat C is Z, and thereby intentionally causes A to apprehend C. Here B abets by instigation the apprehension of C.
Explanation 2—Whoever, either prior to or at the time of the commission of an act, does anything in order to facilitate the commission of that act, and thereby facilitates the commission thereof, is said to aid the doing of that act.
46. A person abets an offence, who abets either the commission of an offence, or the commission of an act which would be an offence, if committed by a person capable by law of committing an offence with the same intention or knowledge as that of the abettor.
Explanation 1—The abetment of the illegal omission of an act may amount to an offence although the abettor may not himself be bound to do that act.
Explanation 2—To constitute the offence of abetment it is not necessary that the act abetted should be committed, or that the effect requisite to constitute the offence should be caused.
Illustration
(a) A instigates B to murder C. B refuses to do so. A is guilty of abetting B to commit murder.
(b) A instigates B to murder D. B in pursuance of the instigation stabs D. D recovers from the wound. Ais guilty of instigating B to commit murder.
Explanation 3—It is not necessary that the person abetted should be capable by law of committing an offence, or that he should have the same guilty intention or knowledge as that of the abettor, or any guilty intention or knowledge.
Illustration
(a) A, with a guilty intention, abets a child or a person of unsound mind to commit an act which would be an offence, if committed by a person capable by law of committing an offence, and having the same intention as A. Here A, whether the act be committed or not, is guilty of abetting an offence.
(b) A, with the intention of murdering Z, instigates B, a child under seven years of age, to do an act which causes Z’s death. B, in consequence of the abetment, does the act in the absence of A and thereby causes Z’s death. Here, though B was not capable by law of committing an offence, Ais liable to be punished in the same manner as if B had been capable by law of committing an offence, and had committed murder, and he is therefore subject to the punishment of death.
(c) Ainstigates B to set fire to a dwelling-house. B, in consequence of his unsoundness of mind, being incapable of knowing the nature of the act, or that he is doing what is wrong or contrary to law, sets fire to the house in consequence of A’s instigation. B has committed no offence, but A is guilty of abetting the offence of setting fire to a dwelling-house, and is liable to the punishment provided for that offence.
(d) A, intending to cause a theft to be committed, instigates B to take property belonging to Z out of Z’s possession. Ainduces B to believe that the property belongs to A. B takes the property out of Z’s possession, in good faith, believing it to be A’s property. B, acting under this misconception, does not take dishonestly, and therefore does not commit theft. But A is guilty of abetting theft, and is liable to the same punishment as if B had committed theft.
Explanation 4—The abetment of an offence being an offence, the abetment of such an abetment is also an offence. Illustration. A instigates B to instigate C to murder Z. B accordingly instigates C to murder Z, and C commits that offence in consequence of B’s instigation. B is liable to be punished for his offence with the punishment for murder; and, as A instigated B to commit the offence, A is also liable to the same punishment.
Explanation 5—It is not necessary to the commission of the offence of abetment by conspiracy that the abettor should concert the offence with the person who commits it. It is sufficient if he engages in the conspiracy in pursuance of which the offence is committed.
Illustration
A concerts with B a plan for poisoning Z. It is agreed thatA shall administer the poison. B then explains the plan to C mentioning that a third person is to administer the poison, but without mentioning A’s name. C agrees to procure the poison, and procures and delivers it to B for the purpose of its being used in the manner explained. A administers the poison; Z dies in consequence. Here, though A and C have not conspired together, yet C has been engaged in the conspiracy in pursuance of which Z has been murdered. C has therefore committed the offence defined in this section and is liable to the punishment for murder.
47. A person abets an offence within the meaning of this Sanhita who, in India, abets the commission of any act without and beyond India which would constitute an offence if committed in India.
Illustration
A, in India, instigates B, a foreigner in country X, to commit a murder in that country, A is guilty of abetting murder.
48. A person abets an offence within the meaning of this Sanhita who, without and beyond India, abets the commission of any act in India which would constitute an offence if committed in India.
Illustration
A, in country X, instigates B, to commit a murder in India,Ais guilty of abetting murder.
49. Whoever abets any offence shall, if the act abetted is committed in consequence of the abetment, and no express provision is made by this Sanhita for the punishment of such abetment, be punished with the punishment provided for the offence.
Explanation—An act or offence is said to be committed in consequence of abetment, when it is committed in consequence of the instigation, or in pursuance of the conspiracy, or with the aid which constitutes the abetment.
Illustration
(a) Ainstigates B to give false evidence. B, in consequence of the instigation, commits that offence. A is guilty of abetting that offence, and is liable to the same punishment as B.
(b) A and B conspire to poison Z. A, in pursuance of the conspiracy, procures the poison and delivers it to B in order that he may administer it to Z. B, in pursuance of the conspiracy, administers the poison to Z in A’s absence and thereby causes Z’s death. Here B is guilty of murder. A is guilty of abetting that offence by conspiracy, and is liable to the punishment for murder.
50. Whoever abets the commission of an offence shall, if the person abetted does the act with a different intention or knowledge from that of the abettor, be punished with the punishment provided for the offence which would have been committed if the act had been done with the intention or knowledge of the abettor and with no other.
51. When an act is abetted and a different act is done, the abettor is liable for the act done, in the same manner and to the same extent as if he had directly abetted it:
Provided that the act done was a probable consequence of the abetment, and was committed under the influence of the instigation, or with the aid or in pursuance of the conspiracy which constituted the abetment.
Illustration
(a) A instigates a child to put poison into the food of Z, and gives him poison for that purpose. The child, in consequence of the instigation, by mistake puts the poison into the food of Y, which is by the side of that of Z. Here, if the child was acting under the influence of A’s instigation, and the act done was under the circumstances a probable consequence of the abetment,A is liable in the same manner and to the same extent as if he had instigated the child to put the poison into the food of Y.
(b) A instigates B to burn Z’s house, B sets fire to the house and at the same time commits theft of property there. A, though guilty of abetting the burning of the house, is not guilty of abetting the theft; for the theft was a distinct act, and not a probable consequence of the burning.
(c) A instigates B and C to break into an inhabited house at midnight for the purpose of robbery, and provides them with arms for that purpose. B and C break into the house, and being resisted by Z, one of the inmates, murder Z. Here, if that murder was the probable consequence of the abetment, A is liable to the punishment provided for murder.
52. If the act for which the abettor is liable under section 51 is committed in addition to the act abetted, and constitute a distinct offence, the abettor is liable to punishment for each of the offences.
Illustration
A instigates B to resist by force a distress made by a public servant. B, in consequence, resists that distress. In offering the resistance, B voluntarily causes grievous hurt to the officer executing the distress. As B has committed both the offence of resisting the distress, and the offence of voluntarily causing grievous hurt, B is liable to punishment for both these offences; and, if A knew that B was likely voluntarily to cause grievous hurt in resisting the distress, A will also be liable to punishment for each of the offences.
53. When an act is abetted with the intention on the part of the abettor of causing a particular effect, and an act for which the abettor is liable in consequence of the abetment, causes a different effect from that intended by the abettor, the abettor is liable for the effect caused, in the same manner and to the same extent as if he had abetted the act with the intention of causing that effect, provided he knew that the act abetted was likely to cause that effect.
Illustration
A instigates B to cause grievous hurt to Z. B, in consequence of the instigation, causes grievous hurt to Z. Z dies in consequence. Here, if A knew that the grievous hurt abetted was likely to cause death, A is liable to be punished with the punishment provided for murder.
54. Whenever any person, who is absent would be liable to be punished as an abettor, is present when the act or offence for which he would be punishable in consequence of the abetment is committed, he shall be deemed to have committed such act or offence.
55. Whoever abets the commission of an offence punishable with death or imprisonment for life, shall, if that offence be not committed in consequence of the abetment, and no express provision is made under this Sanhita for the punishment of such abetment, be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine; and if any act for which the abettor is liable in consequence of the abetment, and which causes hurt to any person, is done, the abettor shall be liable to imprisonment of either description for a term which may extend to fourteen years, and shall also be liable to fine.
Illustration
A instigates B to murder Z. The offence is not committed. If B had murdered Z, he would have been subject to the punishment of death or imprisonment for life. Therefore, Ais liable to imprisonment for a term which may extend to seven years and also to a fine; and if any hurt be done to Z in consequence of the abetment, he will be liable to imprisonment for a term which may extend to fourteen years, and to fine.
56. Whoever abets an offence punishable with imprisonment shall, if that offence be not committed in consequence of the abetment, and no express provision is made under this Sanhita for the punishment of such abetment, be punished with imprisonment of any description provided for that offence for a term which may extend to one-fourth part of the longest term provided for that offence; or with such fine as is provided for that offence, or with both; and if the abettor or the person abetted is a public servant, whose duty it is to prevent the commission of such offence, the abettor shall be punished with imprisonment of any description provided for that offence, for a term which may extend to one-half of the longest term provided for that offence, or with such fine as is provided for the offence, or with both.
Illustration
(a) A instigates B to give false evidence. Here, if B does not give false evidence, A has nevertheless committed the offence defined in this section, and is punishable accordingly
(b) A, a police officer, whose duty it is to prevent robbery, abets the commission of robbery. Here, though the robbery be not committed, A is liable to one-half of the longest term of imprisonment provided for that offence, and also to fine.
(c) B abets the commission of a robbery by A, a police officer, whose duty it is to prevent that offence. Here, though the robbery be not committed, B is liable to one-half of the longest term of imprisonment provided for the offence of robbery, and also to fine.
57. Whoever abets the commission of an offence by the public generally or by any number or class of persons exceeding ten, shall be punished with imprisonment of either description for a term which may extend to seven years and with fine.
Illustration
A affixes in a public place a placard instigating a sect consisting of more than ten members to meet at a certain time and place, for the purpose of attacking the members of an adverse sect, while engaged in a procession. A has committed the offence defined in this section.
58. Whoever intending to facilitate or knowing it to be likely that he will thereby facilitate the commission of an offence punishable with death or imprisonment for life, voluntarily conceals by any act or omission, or by the use of encryption or any other information hiding tool, the existence of a design to commit such offence or makes any representation which he knows to be false respecting such design shall,––
(a) if that offence be committed, be punished with imprisonment of either description for a term which may extend to seven years; or
(b) if the offence be not committed, with imprisonment of either description, for a term which may extend to three years, and shall also be liable to fine.
Illustration
A, knowing that dacoity is about to be committed at B, falsely informs the Magistrate that a dacoity is about to be committed at C, a place in an opposite direction, and thereby misleads the Magistrate with intent to facilitate the commission of the offence. The dacoity is committed at B in pursuance of the design. A is punishable under this section.
59. Whoever, being a public servant, intending to facilitate or knowing it to be likely that he will thereby facilitate the commission of an offence which it is his duty as such public servant to prevent, voluntarily conceals, by any act or omission or by the use of encryption or any other information hiding tool, the existence of a design to commit such offence, or makes any representation which he knows to be false respecting such design shall,–– (
a) if the offence be committed, be punished with imprisonment of any description provided for the offence, for a term which may extend to one-half of the longest term of such imprisonment, or with such fine as is provided for that offence, or with both; or
(b) if the offence be punishable with death or imprisonment for life, with imprisonment of either description for a term which may extend to ten years; or
(c) if the offence be not committed, shall be punished with imprisonment of any description provided for the offence for a term which may extend to one-fourth part of the longest term of such imprisonment or with such fine as is provided for the offence, or with both.
Illustration
A, an officer of police, being legally bound to give information of all designs to commit robbery which may come to his knowledge, and knowing that B designs to commit robbery, omits to give such information, with intent to so facilitate the commission of that offence.
Here A has by an illegal omission concealed the existence of B’s design, and is liable to punishment according to the provision of this section. 60. Whoever, intending to facilitate or knowing it to be likely that he will thereby facilitate the commission of an offence punishable with imprisonment, voluntarily conceals, by any act or illegal omission, the existence of a design to commit such offence, or makes any representation which he knows to be false respecting such design shall,––
(a) if the offence be committed, be punished with imprisonment of the description provided for the offence, for a term which may extend to one-fourth; and
(b) if the offence be not committed, to one-eighth, of the longest term of such imprisonment, or with such fine as is provided for the offence, or with both. Of criminal conspiracy
61. (1) When two or more persons agree with the common object to do, or cause to be done––
(a) an illegal act; or
(b) an act which is not illegal by illegal means, such an agreement is designated a criminal conspiracy: Provided that no agreement except an agreement to commit an offence shall amount to a criminal conspiracy unless some act besides the agreement is done by one or more parties to such agreement in pursuance thereof.
Explanation—It is immaterial whether the illegal act is the ultimate object of such agreement, or is merely incidental to that object.
(2) Whoever is a party to a criminal conspiracy,––
(a) to commit an offence punishable with death, imprisonment for life or rigorous imprisonment for a term of two years or upwards, shall, where no express provision is made in this Sanhita for the punishment of such a conspiracy, be punished in the same manner as if he had abetted such offence;
(b) other than a criminal conspiracy to commit an offence punishable as aforesaid shall be punished with imprisonment of either description for a term not exceeding six months, or with fine or with both. Of attempt
62. Whoever attempts to commit an offence punishable by this Sanhita with imprisonment for life or imprisonment, or to cause such an offence to be committed, and in such attempt does any act towards the commission of the offence, shall, where no express provision is made by this Sanhita for the punishment of such attempt, be punished with imprisonment of any description provided for the offence, for a term which may extend to one-half of the imprisonment for life or, as the case may be, one-half of the longest term of imprisonment provided for that offence, or with such fine as is provided for the offence, or with both.
Illustration
(a) A makes an attempt to steal some jewels by breaking open a box, and finds after so opening the box, that there is no jewel in it. He has done an act towards the commission of theft, and therefore is guilty under this section.
(b) A makes an attempt to pick the pocket of Z by thrusting his hand into Z’s pocket.A fails in the attempt in consequence of Z’s having nothing in his pocket. Ais guilty under this section.
CHAPTER V
OF OFFENCES AGAINST WOMAN AND CHILD Of
sexual offences
63. A man is said to commit “rape” if he—
(a) penetrates his penis, to any extent, into the vagina, mouth, urethra or anus of a woman or makes her to do so with him or any other person; or
(b) inserts, to any extent, any object or a part of the body, not being the penis, into the vagina, the urethra or anus of a woman or makes her to do so with him or any other person; or
(c) manipulates any part of the body of a woman so as to cause penetration into the vagina, urethra, anus or any part of body of such woman or makes her to do so with him or any other person; or
(d) applies his mouth to the vagina, anus, urethra of a woman or makes her to do so with him or any other person, under the circumstances falling under any of the following seven descriptions:—
(i) against her will;
(ii) without her consent;
(iii) with her consent, when her consent has been obtained by putting her or any person in whom she is interested, in fear of death or of hurt;
(iv) with her consent, when the man knows that he is not her husband and that her consent is given because she believes that he is another man to whom she is or believes herself to be lawfully married;
(v) with her consent when, at the time of giving such consent, by reason of unsoundness of mind or intoxication or the administration by him personally or through another of any stupefying or unwholesome substance, she is unable to understand the nature and consequences of that to which she gives consent;
(vi) with or without her consent, when she is under eighteen years of age;
(vii) when she is unable to communicate consent.
Explanation 1—For the purposes of this section, “vagina” shall also include labia majora.
Explanation 2—Consent means an unequivocal voluntary agreement when the woman by words, gestures or any form of verbal or non-verbal communication, communicates willingness to participate in the specific sexual act: Provided that a woman who does not physically resist to the act of penetration shall not by the reason only of that fact, be regarded as consenting to the sexual activity.
Exception 1––A medical procedure or intervention shall not constitute rape.
Exception 2––Sexual intercourse or sexual acts by a man with his own wife, the wife not being under eighteen years of age, is not rape.
64. (1) Whoever, except in the cases provided for in sub-section
(2), commits rape, shall be punished with rigorous imprisonment of either description for a term which shall not be less than ten years, but which may extend to imprisonment for life, and shall also be liable to fine.
(2) Whoever,—
(a) being a police officer, commits rape,—
(i) within the limits of the police station to which such police officer is appointed; or
(ii) in the premises of any station house; or
(iii) on a woman in such police officer’s custody or in the custody of a police officer subordinate to such police officer; or
(b) being a public servant, commits rape on a woman in such public servant’s custody or in the custody of a public servant subordinate to such public servant; or
(c) being a member of the armed forces deployed in an area by the Central Government or a State Government commits rape in such area; or
(d) being on the management or on the staff of a jail, remand home or other place of custody established by or under any law for the time being in force or of a women’s or children’s institution, commits rape on any inmate of such jail, remand home, place or institution; or
(e) being on the management or on the staff of a hospital, commits rape on a woman in that hospital; or
(f) being a relative, guardian or teacher of, or a person in a position of trust or authority towards the woman, commits rape on such woman; or
(g) commits rape during communal or sectarian violence; or
(h) commits rape on a woman knowing her to be pregnant; or
(i) commits rape, on a woman incapable of giving consent; or
(j) being in a position of control or dominance over a woman, commits rape on such woman; or
(k) commits rape on a woman suffering from mental or physical disability; or
(l) while committing rape causes grievous bodily harm or maims or disfigures or endangers the life of a woman; or
(m) commits rape repeatedly on the same woman, shall be punished with rigorous imprisonment for a term which shall not be less than ten years, but which may extend to imprisonment for life, which shall mean imprisonment for the remainder of that person’s natural life, and shall also be liable to fine.
Explanation—For the purposes of this sub-section,—
(a) “armed forces” means the naval, army and air forces and includes any member of the Armed Forces constituted under any law for the time being in force, including the paramilitary forces and any auxiliary forces that are under the control of the Central Government or the State Government;
(b) “hospital” means the precincts of the hospital and includes the precincts of any institution for the reception and treatment of persons during convalescence or of persons requiring medical attention or rehabilitation;
(c) “police officer” shall have the same meaning as assigned to the expression “police” under the Police Act, 1861;
(d) “women’s or children’s institution” means an institution, whether called an orphanage or a home for neglected women or children or a widow’s home or an institution called by any other name, which is established and maintained for the reception and care of women or children.
65. (1) Whoever, commits rape on a woman under sixteen years of age shall be punished with rigorous imprisonment for a term which shall not be less than twenty years, but which may extend to imprisonment for life, which shall mean imprisonment for the remainder of that person’s natural life, and shall also be liable to fine:
Provided that such fine shall be just and reasonable to meet the medical expenses and rehabilitation of the victim:
Provided further that any fine imposed under this sub-section shall be paid to the victim.
(2) Whoever, commits rape on a woman under twelve years of age shall be punished with rigorous imprisonment for a term which shall not be less than twenty years, but which may extend to imprisonment for life, which shall mean imprisonment for the remainder of that person’s natural life, and with fine or with death:
Provided that such fine shall be just and reasonable to meet the medical expenses and rehabilitation of the victim:
Provided further that any fine imposed under this sub-section shall be paid to the victim.
66. Whoever, commits an offence punishable under sub-section
(1) or sub-section
(2) of section 64 and in the course of such commission inflicts an injury which causes the death of the woman or causes the woman to be in a persistent vegetative state, shall be punished with rigorous imprisonment for a term which shall not be less than twenty years, but which may extend to imprisonment for life, which shall mean imprisonment for the remainder of that person’s natural life, or with death.
67. Whoever has sexual intercourse with his own wife, who is living separately, whether under a decree of separation or otherwise, without her consent, shall be punished with imprisonment of either description for a term which shall not be less than two years but which may extend to seven years, and shall also be liable to fine.
Explanation—In this section, “sexual intercourse” shall mean any of the acts mentioned in clauses (a) to (d) of section 63.
68. Whoever, being—
(a) in a position of authority or in a fiduciary relationship; or
(b) a public servant; or
(c) superintendent or manager of a jail, remand home or other place of custody established by or under any law for the time being in force, or a women’s or children’s institution; or
(d) on the management of a hospital or being on the staff of a hospital, abuses such position or fiduciary relationship to induce or seduce any woman either in his custody or under his charge or present in the premises to have sexual intercourse with him, such sexual intercourse not amounting to the offence of rape, shall be punished with rigorous imprisonment of either description for a term which shall not be less than five years, but which may extend to ten years, and shall also be liable to fine.
Explanation 1—In this section, “sexual intercourse” shall mean any of the acts mentioned in clauses (a) to (d) of section 63.
Explanation 2—For the purposes of this section, Explanation 1 to section 63 shall also be applicable.
Explanation 3—“Superintendent”, in relation to a jail, remand home or other place of custody or a women’s or children’s institution, includes a person holding any other office in such jail, remand home, place or institution by virtue of which such person can exercise any authority or control over its inmates.
Explanation 4—The expressions “hospital” and “women’s or children’s institution” shall respectively have the same meanings as in clauses (b) and (d) of the Explanation to sub-section (2) of section 64.
69. Whoever, by deceitful means or by making promise to marry to a woman without any intention of fulfilling the same, has sexual intercourse with her, such sexual intercourse not amounting to the offence of rape, shall be punished with imprisonment of either description for a term which may extend to ten years and shall also be liable to fine.
Explanation—“deceitful means” shall include inducement for, or false promise of employment or promotion, or marrying by suppressing identity.
70. (1) Where a woman is raped by one or more persons constituting a group or acting in furtherance of a common intention, each of those persons shall be deemed to have committed the offence of rape and shall be punished with rigorous imprisonment for a term which shall not be less than twenty years, but which may extend to imprisonment for life which shall mean imprisonment for the remainder of that person’s natural life, and with fine:
Provided that such fine shall be just and reasonable to meet the medical expenses and rehabilitation of the victim:
Provided further that any fine imposed under this sub-section shall be paid to the victim.
(2) Where a woman under eighteen years of age is raped by one or more persons constituting a group or acting in furtherance of a common intention, each of those persons shall be deemed to have committed the offence of rape and shall be punished with imprisonment for life, which shall mean imprisonment for the remainder of that person’s natural life, and with fine, or with death:
Provided that such fine shall be just and reasonable to meet the medical expenses and rehabilitation of the victim: Provided further that any fine imposed under this sub-section shall be paid to the victim.
71. Whoever has been previously convicted of an offence punishable under section 64 or section 65 or section 66 or section 70 and is subsequently convicted of an offence punishable under any of the said sections shall be punished with imprisonment for life which shall mean imprisonment for the remainder of that person’s natural life, or with death.
72. (1) Whoever prints or publishes the name or any matter which may make known the identity of any person against whom an offence under section 64 or section 65 or section 66 or section 67 or section 68 or section 69 or section 70 or section 71 is alleged or found to have been committed (hereafter in this section referred to as the victim) shall be punished with imprisonment of either description for a term which may extend to two years and shall also be liable to fine.
(2) Nothing in sub-section (1) extends to any printing or publication of the name or any matter which may make known the identity of the victim if such printing or publication is—
(a) by or under the order in writing of the officer-in-charge of the police station or the police officer making the investigation into such offence acting in good faith for the purposes of such investigation; or
(b) by, or with the authorisation in writing of, the victim; or
(c) where the victim is dead or a child or of unsound mind, by, or with the authorisation in writing of, the next of kin of the victim:
Explanation—For the purposes of this sub-section, “recognised welfare institution or organisation” means a social welfare institution or organisation recognised in this behalf by the Central Government or the State Government.
73. Whoever prints or publishes any matter in relation to any proceeding before a Court with respect to an offence referred to in section 72 without the previous permission of such Court shall be punished with imprisonment of either description for a term which may extend to two years and shall also be liable to fine.
Explanation—The printing or publication of the judgment of any High Court or the Supreme Court does not amount to an offence within the meaning of this section. Of criminal force and assault against woman
74. Whoever assaults or uses criminal force to any woman, intending to outrage or knowing it to be likely that he will thereby outrage her modesty, shall be punished with imprisonment of either description for a term which shall not be less than one year but which may extend to five years, and shall also be liable to fine.
75. (1) Aman committing any of the following acts:—
(i) physical contact and advances involving unwelcome and explicit sexual overtures; or
(ii) a demand or request for sexual favours; or
(iii) showing pornography against the will of a woman; or
(iv) making sexually coloured remarks, shall be guilty of the offence of sexual harassment.
(2) Any man who commits the offence specified in clause
(i) or clause
(ii) or clause
(iii) of sub-section
(1) shall be punished with rigorous imprisonment for a term which may extend to three years, or with fine, or with both.
(3) Any man who commits the offence specified in clause
(iv) of sub-section (1) shall be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both.
76. Whoever assaults or uses criminal force to any woman or abets such act with the intention of disrobing or compelling her to be naked, shall be punished with imprisonment of either description for a term which shall not be less than three years but which may extend to seven years, and shall also be liable to fine.
77. Whoever watches, or captures the image of a woman engaging in a private act in circumstances where she would usually have the expectation of not being observed either by the perpetrator or by any other person at the behest of the perpetrator or disseminates such image shall be punished on first conviction with imprisonment of either description for a term which shall not be less than one year, but which may extend to three years, and shall also be liable to fine, and be punished on a second or subsequent conviction, with imprisonment of either description for a term which shall not be less than three years, but which may extend to seven years, and shall also be liable to fine.
Explanation 1—For the purposes of this section, “private act” includes an act of watching carried out in a place which, in the circumstances, would reasonably be expected to provide privacy and where the victim’s genitals, posterior or breasts are exposed or covered only in underwear; or the victim is using a lavatory; or the victim is doing a sexual act that is not of a kind ordinarily done in public.
Provided that no such authorisation shall be given by the next of kin to anybody other than the chairman or the secretary, by whatever name called, of any recognised welfare institution or organisation.
Explanation 2—Where the victim consents to the capture of the images or any act, but not to their dissemination to third persons and where such image or act is disseminated, such dissemination shall be considered an offence under this section.
78. (1) Any man who—
(i) follows a woman and contacts, or attempts to contact such woman to foster personal interaction repeatedly despite a clear indication of disinterest by such woman; or
(ii) monitors the use by a woman of the internet, e-mail or any other form of electronic communication, commits the offence of stalking:
Provided that such conduct shall not amount to stalking if the man who pursued it proves that—
(i) it was pursued for the purpose of preventing or detecting crime and the man accused of stalking had been entrusted with the responsibility of prevention and detection of crime by the State; or
(ii) it was pursued under any law or to comply with any condition or requirement imposed by any person under any law; or
(iii) in the particular circumstances such conduct was reasonable and justified.
(2) Whoever commits the offence of stalking shall be punished on first conviction with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine; and be punished on a second or subsequent conviction, with imprisonment of either description for a term which may extend to five years, and shall also be liable to fine.
79. Whoever, intending to insult the modesty of any woman, utters any words, makes any sound or gesture, or exhibits any object in any form, intending that such word or sound shall be heard, or that such gesture or object shall be seen, by such woman, or intrudes upon the privacy of such woman, shall be punished with simple imprisonment for a term which may extend to three years, and also with fine. Of offences relating to marriage
80. (1) Where the death of a woman is caused by any burns or bodily injury or occurs otherwise than under normal circumstances within seven years of her marriage and it is shown that soon before her death she was subjected to cruelty or harassment by her husband or any relative of her husband for, or in connection with, any demand for dowry, such death shall be called “dowry death”, and such husband or relative shall be deemed to have caused her death.
Explanation—For the purposes of this sub-section, “dowry” shall have the same meaning as in section 2 of the Dowry Prohibition Act, 1961.
(2) Whoever commits dowry death shall be punished with imprisonment for a term which shall not be less than seven years but which may extend to imprisonment for life.
81. Every man who by deceit causes any woman who is not lawfully married to him to believe that she is lawfully married to him and to cohabit or have sexual intercourse with him in that belief, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
82. (1) Whoever, having a husband or wife living, marries in any case in which such marriage is void by reason of its taking place during the life of such husband or wife, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
Exception—This sub-section does not extend to any person whose marriage with such husband or wife has been declared void by a Court of competent jurisdiction, nor to any person who contracts a marriage during the life of a former husband or wife, if such husband or wife, at the time of the subsequent marriage, shall have been continually absent from such person for the space of seven years, and shall not have been heard of by such person as being alive within that time provided the person contracting such subsequent marriage shall, before such marriage takes place, inform the person with whom such marriage is contracted of the real state of facts so far as the same are within his or her knowledge.
(2) Whoever commits the offence under sub-section (1) having concealed from the person with whom the subsequent marriage is contracted, the fact of the former marriage, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
83. Whoever, dishonestly or with a fraudulent intention, goes through the ceremony of being married, knowing that he is not thereby lawfully married, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
84. Whoever takes or entices away any woman who is and whom he knows or has reason to believe to be the wife of any other man, with intent that she may have illicit intercourse with any person, or conceals or detains with that intent any such woman, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
85. Whoever, being the husband or the relative of the husband of a woman, subjects such woman to cruelty shall be punished with imprisonment for a term which may extend to three years and shall also be liable to fine.
86. For the purposes of section 85, “cruelty” means—
(a) any wilful conduct which is of such a nature as is likely to drive the woman to commit suicide or to cause grave injury or danger to life, limb or health (whether mental or physical) of the woman; or
(b) harassment of the woman where such harassment is with a view to coercing her or any person related to her to meet any unlawful demand for any property or valuable security or is on account of failure by her or any person related to her to meet such demand.
87. Whoever kidnaps or abducts any woman with intent that she may be compelled, or knowing it to be likely that she will be compelled, to marry any person against her will, or in order that she may be forced or seduced to illicit intercourse, or knowing it to be likely that she will be forced or seduced to illicit intercourse, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine; and whoever, by means of criminal intimidation as defined in this Sanhita or of abuse of authority or any other method of compulsion, induces any woman to go from any place with intent that she may be, or knowing that it is likely that she will be, forced or seduced to illicit intercourse with another person shall also be punishable as aforesaid. Of causing miscarriage, etc.
88. Whoever voluntarily causes a woman with child to miscarry, shall, if such miscarriage be not caused in good faith for the purpose of saving the life of the woman, be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both; and, if the woman be quick with child, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
Explanation—A woman who causes herself to miscarry, is within the meaning of this section.
89. Whoever commits the offence under section 88 without the consent of the woman, whether the woman is quick with child or not, shall be punished with imprisonment for life, or with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
90. (1) Whoever, with intent to cause the miscarriage of a woman with child, does any act which causes the death of such woman, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
(2) Where the act referred to in sub-section (1) is done without the consent of the woman, shall be punishable either with imprisonment for life, or with the punishment specified in said sub-section.
Explanation—It is not essential to this offence that the offender should know that the act is likely to cause death.
91. Whoever before the birth of any child does any act with the intention of thereby preventing that child from being born alive or causing it to die after its birth, and does by such act prevent that child from being born alive, or causes it to die after its birth, shall, if such act be not caused in good faith for the purpose of saving the life of the mother, be punished with imprisonment of either description for a term which may extend to ten years, or with fine, or with both.
92. Whoever does any act under such circumstances, that if he thereby caused death he would be guilty of culpable homicide, and does by such act cause the death of a quick unborn child, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
Illustrations
A, knowing that he is likely to cause the death of a pregnant woman, does an act which, if it caused the death of the woman, would amount to culpable homicide. The woman is injured, but does not die; but the death of an unborn quick child with which she is pregnant is thereby caused. A is guilty of the offence defined in this section. Of offences against child
93. Whoever being the father or mother of a child under the age of twelve years, or having the care of such child, shall expose or leave such child in any place with the intention of wholly abandoning such child, shall be punished with imprisonment of either description for a term which may extend to seven years, or with fine, or with both.
Explanation—This section is not intended to prevent the trial of the offender for murder or culpable homicide, as the case may be, if the child die in consequence of the exposure.
94. Whoever, by secretly burying or otherwise disposing of the dead body of a child whether such child die before or after or during its birth, intentionally conceals or endeavours to conceal the birth of such child, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
95. Whoever hires, employs or engages any child to commit an offence shall be punished with imprisonment of either description which shall not be less than three years but which may extend to ten years, and with fine; and if the offence be committed shall also be punished with the punishment provided for that offence as if the offence has been committed by such person himself.
Explanation—Hiring, employing, engaging or using a child for sexual exploitation or pornography is covered within the meaning of this section.
96. Whoever, by any means whatsoever, induces any child to go from any place or to do any act with intent that such child may be, or knowing that it is likely that such child will be, forced or seduced to illicit intercourse with another person shall be punishable with imprisonment which may extend to ten years, and shall also be liable to fine.
97. Whoever kidnaps or abducts any child under the age of ten years with the intention of taking dishonestly any movable property from the person of such child, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
98. Whoever sells, lets to hire, or otherwise disposes of any child with intent that such child shall at any age be employed or used for the purpose of prostitution or illicit intercourse with any person or for any unlawful and immoral purpose, or knowing it to be likely that such child will at any age be employed or used for any such purpose, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
Explanation 1—When a female under the age of eighteen years is sold, let for hire, or otherwise disposed of to a prostitute or to any person who keeps or manages a brothel, the person so disposing of such female shall, until the contrary is proved, be presumed to have disposed of her with the intent that she shall be used for the purpose of prostitution.
Explanation 2—For the purposes of this section “illicit intercourse” means sexual intercourse between persons not united by marriage or by any union or tie which, though not amounting to a marriage, is recognised by the personal law or custom of the community to which they belong or, where they belong to different communities, of both such communities, as constituting between them a quasi-marital relation.
99. Whoever buys, hires or otherwise obtains possession of any child with intent that such child shall at any age be employed or used for the purpose of prostitution or illicit intercourse with any person or for any unlawful and immoral purpose, or knowing it to be likely that such child will at any age be employed or used for any such purpose, shall be punished with imprisonment of either description for a term which shall not be less than seven years but which may extend to fourteen years, and shall also be liable to fine.
Explanation 1—Any prostitute or any person keeping or managing a brothel, who buys, hires or otherwise obtains possession of a female under the age of eighteen years shall, until the contrary is proved, be presumed to have obtained possession of such female with the intent that she shall be used for the purpose of prostitution.
Explanation 2—“Illicit intercourse” has the same meaning as in section 98.
CHAPTER VI
OF OFFENCES AFFECTING THE HUMAN BODY Of
offences affecting life
100. Whoever causes death by doing an act with the intention of causing death, or with the intention of causing such bodily injury as is likely to cause death, or with the knowledge that he is likely by such act to cause death, commits the offence of culpable homicide.
Illustrations
(a) Alays sticks and turf over a pit, with the intention of thereby causing death, or with the knowledge that death is likely to be thereby caused. Z, believing the ground to be firm, treads on it, falls in and is killed. A has committed the offence of culpable homicide.
(b) A knows Z to be behind a bush. B does not know it. A, intending to cause, or knowing it to be likely to cause Z’s death, induces B to fire at the bush. B fires and kills Z. Here B may be guilty of no offence; but A has committed the offence of culpable homicide.
(c) A, by shooting at a fowl with intent to kill and steal it, kills B, who is behind a bush; A not knowing that he was there. Here, although A was doing an unlawful act, he was not guilty of culpable homicide, as he did not intend to kill B, or to cause death by doing an act that he knew was likely to cause death.
Explanation 1—A person who causes bodily injury to another who is labouring under a disorder, disease or bodily infirmity, and thereby accelerates the death of that other, shall be deemed to have caused his death.
Explanation 2—Where death is caused by bodily injury, the person who causes such bodily injury shall be deemed to have caused the death, although by resorting to proper remedies and skilful treatment the death might have been prevented.
Explanation 3—The causing of the death of a child in the mother’s womb is not homicide. But it may amount to culpable homicide to cause the death of a living child, if any part of that child has been brought forth, though the child may not have breathed or been completely born.
101. Except in the cases hereinafter excepted, culpable homicide is murder,––
(a) if the act by which the death is caused is done with the intention of causing death; or
(b) if the act by which the death is caused is done with the intention of causing such bodily injury as the offender knows to be likely to cause the death of the person to whom the harm is caused; or
(c) if the act by which the death is caused is done with the intention of causing bodily injury to any person and the bodily injury intended to be inflicted is sufficient in the ordinary course of nature to cause death; or
(d) if the person committing the act by which the death is caused, knows that it is so imminently dangerous that it must, in all probability, cause death, or such bodily injury as is likely to cause death, and commits such act without any excuse for incurring the risk of causing death or such injury as aforesaid.
Illustrations
(a) A shoots Z with the intention of killing him. Z dies in consequence. A commits murder.
(b) A, knowing that Z is labouring under such a disease that a blow is likely to cause his death, strikes him with the intention of causing bodily injury. Z dies in consequence of the blow. A is guilty of murder, although the blow might not have been sufficient in the ordinary course of nature to cause the death of a person in a sound state of health. But if A, not knowing that Z is labouring under any disease, gives him such a blow as would not in the ordinary course of nature kill a person in a sound state of health, here A, although he may intend to cause bodily injury, is not guilty of murder, if he did not intend to cause death, or such bodily injury as in the ordinary course of nature would cause death.
(c) A intentionally gives Z a sword-cut or club-wound sufficient to cause the death of a man in the ordinary course of nature. Z dies in consequence. Here A is guilty of murder, although he may not have intended to cause Z’s death.
(d) A without any excuse fires a loaded cannon into a crowd of persons and kills one of them.Ais guilty of murder, although he may not have had a premeditated design to kill any particular individual.
Exception 1—Culpable homicide is not murder if the offender, whilst deprived of the power of self-control by grave and sudden provocation, causes the death of the person who gave the provocation or causes the death of any other person by mistake or accident: Provided that the provocation is not,––
(a) sought or voluntarily provoked by the offender as an excuse for killing or doing harm to any person;
(b) given by anything done in obedience to the law, or by a public servant in the lawful exercise of the powers of such public servant;
(c) given by anything done in the lawful exercise of the right of private defence.
Explanation—Whether the provocation was grave and sudden enough to prevent the offence from amounting to murder is a question of fact.
Illustrations
(a) A, under the influence of passion excited by a provocation given by Z, intentionally kills Y, Z’s child. This is murder, in as much as the provocation was not given by the child, and the death of the child was not caused by accident or misfortune in doing an act caused by the provocation.
(b) Y gives grave and sudden provocation to A. A, on this provocation, fires a pistol at Y, neither intending nor knowing himself to be likely to kill Z, who is near him, but out of sight. A kills Z. HereA has not committed murder, but merely culpable homicide.
(c) A is lawfully arrested by Z, a bailiff. A is excited to sudden and violent passion by the arrest, and kills Z. This is murder, in as much as the provocation was given by a thing done by a public servant in the exercise of his powers.
(d) A appears as a witness before Z, a Magistrate. Z says that he does not believe a word of A’s deposition, and that A has perjured himself. A is moved to sudden passion by these words, and kills Z. This is murder.
(e) A attempts to pull Z’s nose. Z, in the exercise of the right of private defence, lays hold of A to prevent him from doing so. A is moved to sudden and violent passion in consequence, and kills Z. This is murder, in as much as the provocation was giving by a thing done in the exercise of the right of private defence.
(f) Z strikes B. B is by this provocation excited to violent rage.A, a bystander, intending to take advantage of B’s rage, and to cause him to kill Z, puts a knife into B’s hand for that purpose. B kills Z with the knife. Here B may have committed only culpable homicide, but A is guilty of murder.
Exception 2—Culpable homicide is not murder if the offender in the exercise in good faith of the right of private defence of person or property, exceeds the power given to him by law and causes the death of the person against whom he is exercising such right of defence without premeditation, and without any intention of doing more harm than is necessary for the purpose of such defence.
Illustrations
Z attempts to horsewhip A, not in such a manner as to cause grievous hurt to A. A draws out a pistol. Z persists in the assault. A believing in good faith that he can by no other means prevent himself from being horsewhipped, shoots Z dead. A has not committed murder, but only culpable homicide.
Exception 3—Culpable homicide is not murder if the offender, being a public servant or aiding a public servant acting for the advancement of public justice, exceeds the powers given to him by law, and causes death by doing an act which he, in good faith, believes to be lawful and necessary for the due discharge of his duty as such public servant and without ill-will towards the person whose death is caused.
Exception 4—Culpable homicide is not murder if it is committed without premeditation in a sudden fight in the heat of passion upon a sudden quarrel and without the offender’s having taken undue advantage or acted in a cruel or unusual manner.
Explanation—It is immaterial in such cases which party offers the provocation or commits the first assault.
Exception 5—Culpable homicide is not murder when the person whose death is caused, being above the age of eighteen years, suffers death or takes the risk of death with his own consent.
Illustrations
A, by instigation, voluntarily causes Z, a child to commit suicide. Here, on account of Z’s youth, he was incapable of giving consent to his own death; A has therefore abetted murder.
If a person, by doing anything which he intends or knows to be likely to cause death, commits culpable homicide by causing the death of any person, whose death he neither intends nor knows himself to be likely to cause, the culpable homicide committed by the offender is of the description of which it would have been if he had caused the death of the person whose death he intended or knew himself to be likely to cause.
103. (1) Whoever commits murder shall be punished with death or imprisonment for life, and shall also be liable to fine.
(2) When a group of five or more persons acting in concert commits murder on the ground of race, caste or community, sex, place of birth, language, personal belief or any other similar ground each member of such group shall be punished with death or with imprisonment for life, and shall also be liable to fine.
104.Whoever, being under sentence of imprisonment for life, commits murder, shall be punished with death or with imprisonment for life, which shall mean the remainder of that person’s natural life.
105. Whoever commits culpable homicide not amounting to murder, shall be punished with imprisonment for life, or imprisonment of either description for a term which shall not be less than five years but which may extend to ten years, and shall also be liable to fine, if the act by which the death is caused is done with the intention of causing death, or of causing such bodily injury as is likely to cause death; or with imprisonment of either description for a term which may extend to ten years and with fine, if the act is done with the knowledge that it is likely to cause death, but without any intention to cause death, or to cause such bodily injury as is likely to cause death.
106. (1) Whoever causes death of any person by doing any rash or negligent act not amounting to culpable homicide, shall be punished with imprisonment of either description for a term which may extend to five years, and shall also be liable to fine; and if such act is done by a registered medical practitioner while performing medical procedure, he shall be punished with imprisonment of either description for a term which may extend to two years, and shall also be liable to fine.
Explanation— For the purposes of this sub-section, “registered medical practitioner” means a medical practitioner who possesses any medical qualification recognised under the National Medical Commission Act, 2019 and whose name has been entered in the National Medical Register or a State Medical Register under that Act.
(2) Whoever causes death of any person by rash and negligent driving of vehicle not amounting to culpable homicide, and escapes without reporting it to a police officer or a Magistrate soon after the incident, shall be punished with imprisonment of either description of a term which may extend to ten years, and shall also be liable to fine.
107. If any child, any person of unsound mind, any delirious person or any person in a state of intoxication, commits suicide, whoever abets the commission of such suicide, shall be punished with death or imprisonment for life, or imprisonment for a term not exceeding ten years, and shall also be liable to fine.
108. If any person commits suicide, whoever abets the commission of such suicide, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
109. (1) Whoever does any act with such intention or knowledge, and under such circumstances that, if he by that act caused death, he would be guilty of murder, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine; and if hurt is caused to any person by such act, the offender shall be liable either to imprisonment for life, or to such punishment as is hereinbefore mentioned.
(2) When any person offending under sub-section (1) is under sentence of imprisonment for life, he may, if hurt is caused, be punished with death or with imprisonment for life, which shall mean the remainder of that person’s natural life.
Illustrations
(a) A shoots at Z with intention to kill him, under such circumstances that, if death ensued, A would be guilty of murder. A is liable to punishment under this section.
(b) A, with the intention of causing the death of a child of tender years, exposes it in a desert place. A has committed the offence defined by this section, though the death of the child does not ensue.
(c) A, intending to murder Z, buys a gun and loads it. A has not yet committed the offence. A fires the gun at Z. He has committed the offence defined in this section, and, if by such firing he wounds Z, he is liable to the punishment provided by the latter part of sub-section (1).
(d) A, intending to murder Z by poison, purchases poison and mixes the same with food which remains in A’s keeping; A has not yet committed the offence defined in this section. A places the food on Z’s table or delivers it to Z’s servants to place it on Z’s table. A has committed the offence defined in this section.
110. Whoever does any act with such intention or knowledge and under such circumstances that, if he by that act caused death, he would be guilty of culpable homicide not amounting to murder, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both; and, if hurt is caused to any person by such act, shall be punished with imprisonment of either description for a term which may extend to seven years, or with fine, or with both.
Illustrations
A, on grave and sudden provocation, fires a pistol at Z, under such circumstances that if he thereby caused death, he would be guilty of culpable homicide not amounting to murder. A has committed the offence defined in this section.
111. (1) Any continuing unlawful activity including kidnapping, robbery, vehicle theft, extortion, land grabbing, contract killing, economic offence, cyber-crimes, trafficking of persons, drugs, weapons or illicit goods or services, human trafficking for prostitution or ransom, by any person or a group of persons acting in concert, singly or jointly, either as a member of an organised crime syndicate or on behalf of such syndicate, by use of violence, threat of violence, intimidation, coercion, or by any other unlawful means to obtain direct or indirect material benefit including a financial benefit, shall constitute organised crime.
Explanation—For the purposes of this sub-section,––
(i) “organised crime syndicate” means a group of two or more persons who, acting either singly or jointly, as a syndicate or gang indulge in any continuing unlawful activity;
(ii) “continuing unlawful activity” means an activity prohibited by law which is a cognizable offence punishable with imprisonment of three years or more, undertaken by any person, either singly or jointly, as a member of an organised crime syndicate or on behalf of such syndicate in respect of which more than one charge-sheets have been filed before a competent Court within the preceding period of ten years and that Court has taken cognizance of such offence, and includes economic offence;
(iii) “economic offence” includes criminal breach of trust, forgery, counterfeiting of currency-notes, bank-notes and Government stamps, hawala transaction, mass-marketing fraud or running any scheme to defraud several persons or doing any act in any manner with a view to defraud any bank or financial institution or any other institution or organisation for obtaining monetary benefits in any form.
(2) Whoever commits organised crime shall,—
(a) if such offence has resulted in the death of any person, be punished with death or imprisonment for life, and shall also be liable to fine which shall not be less than ten lakh rupees;
(b) in any other case, be punished with imprisonment for a term which shall not be less than five years but which may extend to imprisonment for life, and shall also be liable to fine which shall not be less than five lakh rupees.
(3) Whoever abets, attempts, conspires or knowingly facilitates the commission of an organised crime, or otherwise engages in any act preparatory to an organised crime, shall be punished with imprisonment for a term which shall not be less than five years but which may extend to imprisonment for life, and shall also be liable to fine which shall not be less than five lakh rupees.
(4) Any person who is a member of an organised crime syndicate shall be punished with imprisonment for a term which shall not be less than five years but which may extend to imprisonment for life, and shall also be liable to fine which shall not be less than five lakh rupees.
(5) Whoever, intentionally, harbours or conceals any person who has committed the offence of an organised crime shall be punished with imprisonment for a term which shall not be less than three years but which may extend to imprisonment for life, and shall also be liable to fine which shall not be less than five lakh rupees:
Provided that this sub-section shall not apply to any case in which the harbour or concealment is by the spouse of the offender.
(6) Whoever possesses any property derived or obtained from the commission of an organised crime or proceeds of any organised crime or which has been acquired through the organised crime, shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to imprisonment for life and shall also be liable to fine which shall not be less than two lakh rupees.
(7) If any person on behalf of a member of an organised crime syndicate is, or at any time has been in possession of movable or immovable property which he cannot satisfactorily account for, shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to imprisonment for ten years and shall also be liable to fine which shall not be less than one lakh rupees.
112. (1) Whoever, being a member of a group or gang, either singly or jointly, commits any act of theft, snatching, cheating, unauthorised selling of tickets, unauthorised betting or gambling, selling of public examination question papers or any other similar criminal act, is said to commit petty organised crime.
Explanation—For the purposes of this sub-section “theft” includes trick theft, theft from vehicle, dwelling house or business premises, cargo theft, pick pocketing, theft through card skimming, shoplifting and theft of Automated Teller Machine.
(2) Whoever commits any petty organised crime shall be punished with imprisonment for a term which shall not be less than one year but which may extend to seven years, and shall also be liable to fine.
113. (1) Whoever does any act with the intent to threaten or likely to threaten the unity, integrity, sovereignty, security, or economic security of India or with the intent to strike terror or likely to strike terror in the people or any section of the people in India or in any foreign country,––
(a) by using bombs, dynamite or other explosive substance or inflammable substance or firearms or other lethal weapons or poisonous or noxious gases or other chemicals or by any other substance (whether biological, radioactive, nuclear or otherwise) of a hazardous nature or by any other means of whatever nature to cause or likely to cause,—
(i) death of, or injury to, any person or persons; or
(ii) loss of, or damage to, or destruction of, property; or
(iii) disruption of any supplies or services essential to the life of the community in India or in any foreign country; or
(iv) damage to, the monetary stability of India by way of production or smuggling or circulation of counterfeit Indian paper currency, coin or of any other material; or
(v) damage or destruction of any property in India or in a foreign country used or intended to be used for the defence of India or in connection with any other purposes of the Government of India, any State Government or any of their agencies; or
(b) overawes by means of criminal force or the show of criminal force or attempts to do so or causes death of any public functionary or attempts to cause death of any public functionary; or
(c) detains, kidnaps or abducts any person and threatening to kill or injure such person or does any other act in order to compel the Government of India, any State Government or the Government of a foreign country or an international or inter-governmental organisation or any other person to do or abstain from doing any act, commit a terrorist act.
Explanation—For the purpose of this sub-section,—
(a) “public functionary” means the constitutional authorities or any other functionary notified in the Official Gazette by the Central Government as public functionary;
(b) “counterfeit Indian currency” means the counterfeit currency as may be declared after examination by an authorised or notified forensic authority that such currency imitates or compromises with the key security features of Indian currency.
(2) Whoever commits a terrorist act shall,—
(a) if such offence has resulted in the death of any person, be punished with death or imprisonment for life, and shall also be liable to fine;
(b) in any other case, be punished with imprisonment for a term which shall not be less than five years but which may extend to imprisonment for life, and shall also be liable to fine.
(3) Whoever conspires or attempts to commit, or advocates, abets, advises or incites, directly or knowingly facilitates the commission of a terrorist act or any act preparatory to the commission of a terrorist act, shall be punished with imprisonment for a term which shall not be less than five years but which may extend to imprisonment for life, and shall also be liable to fine.
(4) Whoever organises or causes to be organised any camp or camps for imparting training in terrorist act, or recruits or causes to be recruited any person or persons for commission of a terrorist act, shall be punished with imprisonment for a term which shall not be less than five years but which may extend to imprisonment for life, and shall also be liable to fine.
(5) Any person who is a member of an organisation which is involved in terrorist act, shall be punished with imprisonment for a term which may extend to imprisonment for life, and shall also be liable to fine.
(6) Whoever voluntarily harbours or conceals, or attempts to harbour or conceal any person knowing that such person has committed a terrorist act shall be punished with imprisonment for a term which shall not be less than three years but which may extend to imprisonment for life, and shall also be liable to fine: Provided that this sub-section shall not apply to any case in which the harbour or concealment is by the spouse of the offender.
(7) Whoever knowingly possesses any property derived or obtained from commission of any terrorist act or acquired through the commission of any terrorist act shall be punished with imprisonment for a term which may extend to imprisonment for life, and shall also be liable to fine.
Explanation—For the removal of doubts, it is hereby declared that the officer not below the rank of Superintendent of Police shall decide whether to register the case under this section or under the Unlawful Activities (Prevention) Act, 1967. Of hurt
114. Whoever causes bodily pain, disease or infirmity to any person is said to cause hurt.
115. (1) Whoever does any act with the intention of thereby causing hurt to any person, or with the knowledge that he is likely thereby to cause hurt to any person, and does thereby cause hurt to any person, is said “voluntarily to cause hurt”.
(2)Whoever, except in the case provided for by sub-section (1) of section 122 voluntarily causes hurt, shall be punished with imprisonment of either description for a term which may extend to one year, or with fine which may extend to ten thousand rupees, or with both.
116. The following kinds of hurt only are designated as “grievous”, namely:––
(a) Emasculation;
(b) Permanent privation of the sight of either eye;
(c) Permanent privation of the hearing of either ear;
(d) Privation of any member or joint;
(e) Destruction or permanent impairing of the powers of any member or joint;
(f) Permanent disfiguration of the head or face;
(g) Fracture or dislocation of a bone or tooth;
(h) Any hurt which endangers life or which causes the sufferer to be during the space of fifteen days in severe bodily pain, or unable to follow his ordinary pursuits.
117. (1) Whoever voluntarily causes hurt, if the hurt which he intends to cause or knows himself to be likely to cause is grievous hurt, and if the hurt which he causes is grievous hurt, is said “voluntarily to cause grievous hurt”.
Explanation—A person is not said voluntarily to cause grievous hurt except when he both causes grievous hurt and intends or knows himself to be likely to cause grievous hurt. But he is said voluntarily to cause grievous hurt, if intending or knowing himself to be likely to cause grievous hurt of one kind, he actually causes grievous hurt of another kind.
Illustrations
A, intending of knowing himself to be likely permanently to disfigure Z’s face, gives Z a blow which does not permanently disfigure Z’s face, but which causes Z to suffer severe bodily pain for the space of fifteen days. A has voluntarily caused grievous hurt.
(2)Whoever, except in the case provided for by sub-section (2) of section 122, voluntarily causes grievous hurt, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
(3) Whoever commits an offence under sub-section (1) and in the course of such commission causes any hurt to a person which causes that person to be in permanent disability or in persistent vegetative state, shall be punished with rigorous imprisonment for a term which shall not be less than ten years but which may extend to imprisonment for life, which shall mean imprisonment for the remainder of that person’s natural life.
(4) When a group of five or more persons acting in concert, causes grievous hurt to a person on the ground of his race, caste or community, sex, place of birth, language, personal belief or any other similar ground, each member of such group shall be guilty of the offence of causing grievous hurt, and shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
118. (1) Whoever, except in the case provided for by sub-section (1) of section 122, voluntarily causes hurt by means of any instrument for shooting, stabbing or cutting, or any instrument which, used as a weapon of offence, is likely to cause death, or by means of fire or any heated substance, or by means of any poison or any corrosive substance, or by means of any explosive substance, or by means of any substance which it is deleterious to the human body to inhale, to swallow, or to receive into the blood, or by means of any animal, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine which may extend to twenty thousand rupees, or with both.
(2)Whoever, except in the case provided for by sub-section (2) of section 122, voluntarily causes grievous hurt by any means referred to in sub–section (1), shall be punished with imprisonment for life, or with imprisonment of either description for a term which shall not be less than one year but which may extend to ten years, and shall also be liable to fine.
119. (1)Whoever voluntarily causes hurt for the purpose of extorting from the sufferer, or from any person interested in the sufferer, any property or valuable security, or of constraining the sufferer or any person interested in such sufferer to do anything which is illegal or which may facilitate the commission of an offence, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
(2) Whoever voluntarily causes grievous hurt for any purpose referred to in sub-section (1), shall be punished with imprisonment for life, or imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
120. (1) Whoever voluntarily causes hurt for the purpose of extorting from the sufferer or from any person interested in the sufferer, any confession or any information which may lead to the detection of an offence or misconduct, or for the purpose of constraining the sufferer or any person interested in the sufferer to restore or to cause the restoration of any property or valuable security or to satisfy any claim or demand, or to give information which may lead to the restoration of any property or valuable security, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
Illustrations
(a) A, a police officer, tortures Z in order to induce Z to confess that he committed a crime. A is guilty of an offence under this section.
(b) A, a police officer, tortures B to induce him to point out where certain stolen property is deposited. A is guilty of an offence under this section.
(c) A, a revenue officer, tortures Z in order to compel him to pay certain arrears of revenue due from Z. A is guilty of an offence under this section. (2) Whoever voluntarily causes grievous hurt for any purpose referred to in sub-section (1), shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
121. (1) Whoever voluntarily causes hurt to any person being a public servant in the discharge of his duty as such public servant, or with intent to prevent or deter that person or any other public servant from discharging his duty as such public servant or in consequence of anything done or attempted to be done by that person in the lawful discharge of his duty as such public servant, shall be punished with imprisonment of either description for a term which may extend to five years, or with fine, or with both.
(2) Whoever voluntarily causes grievous hurt to any person being a public servant in the discharge of his duty as such public servant, or with intent to prevent or deter that person or any other public servant from discharging his duty as such public servant or in consequence of anything done or attempted to be done by that person in the lawful discharge of his duty as such public servant, shall be punished with imprisonment of either description for a term which shall not be less than one year but which may extend to ten years, and shall also be liable to fine.
122. (1) Whoever voluntarily causes hurt on grave and sudden provocation, if he neither intends nor knows himself to be likely to cause hurt to any person other than the person who gave the provocation, shall be punished with imprisonment of either description for a term which may extend to one month, or with fine which may extend to five thousand rupees, or with both.
(2) Whoever voluntarily causes grievous hurt on grave and sudden provocation, if he neither intends nor knows himself to be likely to cause grievous hurt to any person other than the person who gave the provocation, shall be punished with imprisonment of either description for a term which may extend to five years, or with fine which may extend to ten thousand rupees, or with both.
Explanation—This section is subject to the same proviso as Exception 1 of section 101.
123. Whoever administers to or causes to be taken by any person any poison or any stupefying, intoxicating or unwholesome drug, or other thing with intent to cause hurt to such person, or with intent to commit or to facilitate the commission of an offence or knowing it to be likely that he will thereby cause hurt, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
124. (1) Whoever causes permanent or partial damage or deformity to, or burns or maims or disfigures or disables, any part or parts of the body of a person or causes grievous hurt by throwing acid on or by administering acid to that person, or by using any other means with the intention of causing or with the knowledge that he is likely to cause such injury or hurt or causes a person to be in a permanent vegetative state shall be punished with imprisonment of either description for a term which shall not be less than ten years but which may extend to imprisonment for life, and with fine:
Provided that such fine shall be just and reasonable to meet the medical expenses of the treatment of the victim:
Provided further that any fine imposed under this sub-section shall be paid to the victim.
(2) Whoever throws or attempts to throw acid on any person or attempts to administer acid to any person, or attempts to use any other means, with the intention of causing permanent or partial damage or deformity or burns or maiming or disfigurement or disability or grievous hurt to that person, shall be punished with imprisonment of either description for a term which shall not be less than five years but which may extend to seven years, and shall also be liable to fine.
Explanation 1—For the purposes of this section, “acid” includes any substance which has acidic or corrosive character or burning nature, that is capable of causing bodily injury leading to scars or disfigurement or temporary or permanent disability.
Explanation 2—For the purposes of this section, permanent or partial damage or deformity or permanent vegetative state shall not be required to be irreversible.
125. Whoever does any act so rashly or negligently as to endanger human life or the personal safety of others, shall be punished with imprisonment of either description for a term which may extend to three months or with fine which may extend to two thousand five hundred rupees, or with both, but—
(a) where hurt is caused, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both;
(b) where grievous hurt is caused, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine which may extend to ten thousand rupees, or with both. Of wrongful restraint and wrongful confinement
126. (1) Whoever voluntarily obstructs any person so as to prevent that person from proceeding in any direction in which that person has a right to proceed, is said wrongfully to restrain that person.
Exception—The obstruction of a private way over land or water which a person in good faith believes himself to have a lawful right to obstruct, is not an offence within the meaning of this section.
Illustrations
A obstructs a path along which Z has a right to pass, A not believing in good faith that he has a right to stop the path. Z is thereby prevented from passing. A wrongfully restrains Z.
(2) Whoever wrongfully restrains any person shall be punished with simple imprisonment for a term which may extend to one month, or with fine which may extend to five thousand rupees, or with both.
127. (1) Whoever wrongfully restrains any person in such a manner as to prevent that person from proceedings beyond certain circumscribing limits, is said “wrongfully to confine” that person.
Illustrations
(a) A causes Z to go within a walled space, and locks Z in. Z is thus prevented from proceeding in any direction beyond the circumscribing line of wall.A wrongfully confines Z.
(b) A places men with firearms at the outlets of a building, and tells Z that they will fire at Z if Z attempts to leave the building. A wrongfully confines Z.
(2) Whoever wrongfully confines any person shall be punished with imprisonment of either description for a term which may extend to one year, or with fine which may extend to five thousand rupees, or with both.
(3) Whoever wrongfully confines any person for three days, or more, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine which may extend to ten thousand rupees, or with both.
(4) Whoever wrongfully confines any person for ten days or more, shall be punished with imprisonment of either description for a term which may extend to five years, and shall also be liable to fine which shall not be less than ten thousand rupees.
(5) Whoever keeps any person in wrongful confinement, knowing that a writ for the liberation of that person has been duly issued, shall be punished with imprisonment of either description for a term which may extend to two years in addition to any term of imprisonment to which he may be liable under any other section of this Chapter and shall also be liable to fine.
(6) Whoever wrongfully confines any person in such manner as to indicate an intention that the confinement of such person may not be known to any person interested in the person so confined, or to any public servant, or that the place of such confinement may not be known to or discovered by any such person or public servant as hereinbefore mentioned, shall be punished with imprisonment of either description for a term which may extend to three years in addition to any other punishment to which he may be liable for such wrongful confinement and shall also be liable to fine.
(7) Whoever wrongfully confines any person for the purpose of extorting from the person confined, or from any person interested in the person confined, any property or valuable security or of constraining the person confined or any person interested in such person to do anything illegal or to give any information which may facilitate the commission of an offence, shall be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine.
(8) Whoever wrongfully confines any person for the purpose of extorting from the person confined or any person interested in the person confined any confession or any information which may lead to the detection of an offence or misconduct, or for the purpose of constraining the person confined or any person interested in the person confined to restore or to cause the restoration of any property or valuable security or to satisfy any claim or demand, or to give information which may lead to the restoration of any property or valuable security, shall be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine. Of criminal force and assault
128. A person is said to use force to another if he causes motion, change of motion, or cessation of motion to that other, or if he causes to any substance such motion, or change of motion, or cessation of motion as brings that substance into contact with any part of that other’s body, or with anything which that other is wearing or carrying, or with anything so situated that such contact affects that other’s sense of feeling: Provided that the person causing the motion, or change of motion, or cessation of motion, causes that motion, change of motion, or cessation of motion in one of the following three ways, namely:––
(a) by his own bodily power;
(b) by disposing any substance in such a manner that the motion or change or cessation of motion takes place without any further act on his part, or on the part of any other person;
(c) by inducing any animal to move, to change its motion, or to cease to move.
129. Whoever intentionally uses force to any person, without that person’s consent, in order to the committing of any offence, or intending by the use of such force to cause, or knowing it to be likely that by the use of such force he will cause injury, fear or annoyance to the person to whom the force is used, is said to use criminal force to that other.
Illustrations
(a) Z is sitting in a moored boat on a river. A unfastens the moorings, and thus intentionally causes the boat to drift down the stream. Here A intentionally causes motion to Z, and he does this by disposing substances in such a manner that the motion is produced without any other action on any person’s part. A has therefore intentionally used force to Z; and if he has done so without Z’s consent, in order to the committing of any offence, or intending or knowing it to be likely that this use of force will cause injury, fear or annoyance to Z, A has used criminal force to Z.
(b) Z is riding in a chariot. A lashes Z’s horses, and thereby causes them to quicken their pace. Here A has caused change of motion to Z by inducing the animals to change their motion. A has therefore used force to Z; and ifA has done this without Z’s consent, intending or knowing it to be likely that he may thereby injure, frighten or annoy Z,A has used criminal force to Z.
(c) Z is riding in a palanquin. A, intending to rob Z, seizes the pole and stops the palanquin. Here A has caused cessation of motion to Z, and he has done this by his own bodily power. A has therefore used force to Z; and as A has acted thus intentionally, without Z’s consent, in order to the commission of an offence. A has used criminal force to Z.
(d) A intentionally pushes against Z in the street. Here A has by his own bodily power moved his own person so as to bring it into contact with Z. He has therefore intentionally used force to Z; and if he has done so without Z’s consent, intending or knowing it to be likely that he may thereby injure, frighten or annoy Z, he has used criminal force to Z.
(e) A throws a stone, intending or knowing it to be likely that the stone will be thus brought into contact with Z, or with Z’s clothes, or with something carried by Z, or that it will strike water and dash up the water against Z’s clothes or something carried by Z. Here, if the throwing of the stone produce the effect of causing any substance to come into contact with Z, or Z’s clothes, A has used force to Z, and if he did so without Z’s consent, intending thereby to injure, frighten or annoy Z, he has used criminal force to Z.
(f) Aintentionally pulls up a woman’s veil. HereAintentionally uses force to her, and if he does so without her consent intending or knowing it to be likely that he may thereby injure, frighten or annoy her, he has used criminal force to her.
(g) Z is bathing. A pours into the bath water which he knows to be boiling. Here A intentionally by his own bodily power causes such motion in the boiling water as brings that water into contact with Z, or with other water so situated that such contact must affect Z’s sense of feeling; A has therefore intentionally used force to Z; and if he has done this without Z’s consent intending or knowing it to be likely that he may thereby cause injury, fear or annoyance to Z, A has used criminal force.
(h) A incites a dog to spring upon Z, without Z’s consent. Here, if A intends to cause injury, fear or annoyance to Z, he uses criminal force to Z. 130. Whoever makes any gesture, or any preparation intending or knowing it to be likely that such gesture or preparation will cause any person present to apprehend that he who makes that gesture or preparation is about to use criminal force to that person, is said to commit an assault.
Explanation—Mere words do not amount to an assault. But the words which a person uses may give to his gestures or preparation such a meaning as may make those gestures or preparations amount to an assault.
Illustrations
(a) A shakes his fist at Z, intending or knowing it to be likely that he may thereby cause Z to believe that A is about to strike Z. A has committed an assault.
(b) A begins to unloose the muzzle of a ferocious dog, intending or knowing it to be likely that he may thereby cause Z to believe that he is about to cause the dog to attack Z. A has committed an assault upon Z.
(c) Atakes up a stick, saying to Z, “I will give you a beating”. Here, though the words used by Acould in no case amount to an assault, and though the mere gesture, unaccompanied by any other circumstances, might not amount to an assault, the gesture explained by the words may amount to an assault.
131. Whoever assaults or uses criminal force to any person otherwise than on grave and sudden provocation given by that person, shall be punished with imprisonment of either description for a term which may extend to three months, or with fine which may extend to one thousand rupees, or with both.
Explanation 1—Grave and sudden provocation will not mitigate the punishment for an offence under this section,—
(a) if the provocation is sought or voluntarily provoked by the offender as an excuse for the offence; or
(b) if the provocation is given by anything done in obedience to the law, or by a public servant, in the lawful exercise of the powers of such public servant; or
(c) if the provocation is given by anything done in the lawful exercise of the right of private defence.
Explanation 2—Whether the provocation was grave and sudden enough to mitigate the offence, is a question of fact.
132. Whoever assaults or uses criminal force to any person being a public servant in the execution of his duty as such public servant, or with intent to prevent or deter that person from discharging his duty as such public servant, or in consequence of anything done or attempted to be done by such person in the lawful discharge of his duty as such public servant, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
133. Whoever assaults or uses criminal force to any person, intending thereby to dishonour that person, otherwise than on grave and sudden provocation given by that person, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
134. Whoever assaults or uses criminal force to any person, in attempting to commit theft on any property which that person is then wearing or carrying, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
135. Whoever assaults or uses criminal force to any person, in attempting wrongfully to confine that person, shall be punished with imprisonment of either description for a term which may extend to one year, or with fine which may extend to five thousand rupees, or with both.
136. Whoever assaults or uses criminal force to any person on grave and sudden provocation given by that person, shall be punished with simple imprisonment for a term which may extend to one month, or with fine which may extend to one thousand rupees, or with both.
Explanation—This section is subject to the same Explanation as section 131. Of kidnapping, abduction, slavery and forced labour
137. (1) Kidnapping is of two kinds: kidnapping from India, and kidnapping from lawful guardianship––
(a) whoever conveys any person beyond the limits of India without the consent of that person, or of some person legally authorised to consent on behalf of that person, is said to kidnap that person from India;
(b) whoever takes or entices any child or any person of unsound mind, out of the keeping of the lawful guardian of such child or person of unsound mind, without the consent of such guardian, is said to kidnap such child or person from lawful guardianship.
Explanation––The words “lawful guardian” in this clause include any person lawfully entrusted with the care or custody of such child or other person.
Exception—This clause does not extend to the act of any person who in good faith believes himself to be the father of an illegitimate child, or who in good faith believes himself to be entitled to the lawful custody of such child, unless such act is committed for an immoral or unlawful purpose.
(2) Whoever kidnaps any person from India or from lawful guardianship shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
138. Whoever by force compels, or by any deceitful means induces, any person to go from any place, is said to abduct that person.
139. (1) Whoever kidnaps any child or, not being the lawful guardian of such child, obtains the custody of the child, in order that such child may be employed or used for the purposes of begging shall be punishable with rigorous imprisonment for a term which shall not be less than ten years but which may extend to imprisonment for life, and shall also be liable to fine.
(2) Whoever maims any child in order that such child may be employed or used for the purposes of begging shall be punishable with imprisonment which shall not be less than twenty years, but which may extend to life which shall mean imprisonment for the remainder of that person’s natural life, and with fine.
(3) Where any person, not being the lawful guardian of a child employs or uses such child for the purposes of begging, it shall be presumed, unless the contrary is proved, that he kidnapped or otherwise obtained the custody of such child in order that such child might be employed or used for the purposes of begging.
(4) In this section “begging” means—
(i) soliciting or receiving alms in a public place, whether under the pretence of singing, dancing, fortune telling, performing tricks or selling articles or otherwise;
(ii) entering on any private premises for the purpose of soliciting or receiving alms;
(iii) exposing or exhibiting, with the object of obtaining or extorting alms, any sore, wound, injury, deformity or disease, whether of himself or of any other person or of an animal;
(iv) using such child as an exhibit for the purpose of soliciting or receiving alms.
140. (1) Whoever kidnaps or abducts any person in order that such person may be murdered or may be so disposed of as to be put in danger of being murdered, shall be punished with imprisonment for life or rigorous imprisonment for a term which may extend to ten years, and shall also be liable to fine.
Illustrations
(a) A kidnaps Z from India, intending or knowing it to be likely that Z may be sacrificed to an idol. A has committed the offence defined in this section.
(b) A forcibly carries or entices B away from his home in order that B may be murdered. A has committed the offence defined in this section.
(2) Whoever kidnaps or abducts any person or keeps a person in detention after such kidnapping or abduction, and threatens to cause death or hurt to such person, or by his conduct gives rise to a reasonable apprehension that such person may be put to death or hurt, or causes hurt or death to such person in order to compel the Government or any foreign State or international inter-governmental organisation or any other person to do or abstain from doing any act or to pay a ransom, shall be punishable with death, or imprisonment for life, and shall also be liable to fine.
(3) Whoever kidnaps or abducts any person with intent to cause that person to be secretly and wrongfully confined, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
(4) Whoever kidnaps or abducts any person in order that such person may be subjected, or may be so disposed of as to be put in danger of being subjected to grievous hurt, or slavery, or to the unnatural lust of any person, or knowing it to be likely that such person will be so subjected or disposed of, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
141. Whoever imports into India from any country outside India any girl under the age of twenty-one years or any boy under the age of eighteen years with intent that girl or boy may be, or knowing it to be likely that girl or boy will be, forced or seduced to illicit intercourse with another person, shall be punishable with imprisonment which may extend to ten years and shall also be liable to fine.
142. Whoever, knowing that any person has been kidnapped or has been abducted, wrongfully conceals or confines such person, shall be punished in the same manner as if he had kidnapped or abducted such person with the same intention or knowledge, or for the same purpose as that with or for which he conceals or detains such person in confinement.
143. (1)Whoever, for the purpose of exploitation recruits, transports, harbours, transfers, or receives a person or persons, by—
(a) using threats; or
(b) using force, or any other form of coercion; or
(c) by abduction; or
(d) by practising fraud, or deception; or
(e) by abuse of power; or
(f) by inducement, including the giving or receiving of payments or benefits, in order to achieve the consent of any person having control over the person recruited, transported, harboured, transferred or received, commits the offence of trafficking.
Explanation 1—The expression “exploitation” shall include any act of physical exploitation or any form of sexual exploitation, slavery or practices similar to slavery, servitude, beggary or forced removal of organs.
Explanation 2—The consent of the victim is immaterial in determination of the offence of trafficking.
(2) Whoever commits the offence of trafficking shall be punished with rigorous imprisonment for a term which shall not be less than seven years, but which may extend to ten years, and shall also be liable to fine.
(3) Where the offence involves the trafficking of more than one person, it shall be punishable with rigorous imprisonment for a term which shall not be less than ten years but which may extend to imprisonment for life, and shall also be liable to fine.
(4) Where the offence involves the trafficking of a child, it shall be punishable with rigorous imprisonment for a term which shall not be less than ten years, but which may extend to imprisonment for life, and shall also be liable to fine.
(5) Where the offence involves the trafficking of more than one child, it shall be punishable with rigorous imprisonment for a term which shall not be less than fourteen years, but which may extend to imprisonment for life, and shall also be liable to fine.
(6) If a person is convicted of the offence of trafficking of a child on more than one occasion, then such person shall be punished with imprisonment for life, which shall mean imprisonment for the remainder of that person’s natural life, and shall also be liable to fine.
(7) When a public servant or a police officer is involved in the trafficking of any person then, such public servant or police officer shall be punished with imprisonment for life, which shall mean imprisonment for the remainder of that person’s natural life, and shall also be liable to fine.
144. (1)Whoever, knowingly or having reason to believe that a child has been trafficked, engages such child for sexual exploitation in any manner, shall be punished with rigorous imprisonment for a term which shall not be less than five years, but which may extend to ten years, and shall also be liable to fine.
(2) Whoever, knowingly or having reason to believe that a person has been trafficked, engages such person for sexual exploitation in any manner, shall be punished with rigorous imprisonment for a term which shall not be less than three years, but which may extend to seven years, and shall also be liable to fine.
145. Whoever habitually imports, exports, removes, buys, sells, traffics or deals in slaves, shall be punished with imprisonment for life, or with imprisonment of either description for a term not exceeding ten years, and shall also be liable to fine.
146. Whoever unlawfully compels any person to labour against the will of that person, shall be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both.
CHAPTER VII
OF OFFENCES AGAINST THE STATE
147. Whoever wages war against the Government of India, or attempts to wage such war, or abets the waging of such war, shall be punished with death, or imprisonment for life and shall also be liable to fine.
Illustrations
A joins an insurrection against the Government of India. A has committed the offence defined in this section.
148. Whoever within or without and beyond India conspires to commit any of the offences punishable by section 147, or conspires to overawe, by means of criminal force or the show of criminal force, the Central Government or any State Government, shall be punished with imprisonment for life, or with imprisonment of either description which may extend to ten years, and shall also be liable to fine.
Explanation—To constitute a conspiracy under this section, it is not necessary that any act or illegal omission shall take place in pursuance thereof.
149. Whoever collects men, arms or ammunition or otherwise prepares to wage war with the intention of either waging or being prepared to wage war against the Government of India, shall be punished with imprisonment for life or imprisonment of either description for a term not exceeding ten years, and shall also be liable to fine.
150. Whoever by any act, or by any illegal omission, conceals the existence of a design to wage war against the Government of India, intending by such concealment to facilitate, or knowing it to be likely that such concealment will facilitate, the waging of such war, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
151. Whoever, with the intention of inducing or compelling the President of India, or Governor of any State, to exercise or refrain from exercising in any manner any of the lawful powers of such President or Governor, assaults or wrongfully restrains, or attempts wrongfully to restrain, or overawes, by means of criminal force or the show of criminal force, or attempts so to overawe, such President or Governor, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
152. Whoever, purposely or knowingly, by words, either spoken or written, or by signs, or by visible representation, or by electronic communication or by use of financial mean, or otherwise, excites or attempts to excite, secession or armed rebellion or subversive activities, or encourages feelings of separatist activities or endangers sovereignty or unity and integrity of India; or indulges in or commits any such act shall be punished with imprisonment for life or with imprisonment which may extend to seven years, and shall also be liable to fine.
Explanation.––Comments expressing disapprobation of the measures, or administrative or other action of the Government with a view to obtain their alteration by lawful means without exciting or attempting to excite the activities referred to in this section do not constitute an offence under this section.
153. Whoever wages war against the Government of any foreign State at peace with the Government of India or attempts to wage such war, or abets the waging of such war, shall be punished with imprisonment for life, to which fine may be added, or with imprisonment of either description for a term which may extend to seven years, to which fine may be added, or with fine.
154. Whoever commits depredation, or makes preparations to commit depredation, on the territories of any foreign State at peace with the Government of India, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine and to forfeiture of any property used or intended to be used in committing such depredation, or acquired by such depredation.
155. Whoever receives any property knowing the same to have been taken in the commission of any of the offences mentioned in sections 153 and 154, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine and to forfeiture of the property so received.
156. Whoever, being a public servant and having the custody of any State prisoner or prisoner of war, voluntarily allows such prisoner to escape from any place in which such prisoner is confined, shall be punished with imprisonment for life, or imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
157. Whoever, being a public servant and having the custody of any State prisoner or prisoner of war, negligently suffers such prisoner to escape from any place of confinement in which such prisoner is confined, shall be punished with simple imprisonment for a term which may extend to three years, and shall also be liable to fine.
158. Whoever knowingly aids or assists any State prisoner or prisoner of war in escaping from lawful custody, or rescues or attempts to rescue any such prisoner, or harbours or conceals any such prisoner who has escaped from lawful custody, or offers or attempts to offer any resistance to the recapture of such prisoner, shall be punished with imprisonment for life, or with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
Explanation—A State prisoner or prisoner of war, who is permitted to be at large on his parole within certain limits in India, is said to escape from lawful custody if he goes beyond the limits within which he is allowed to be at large.
CHAPTER VIII
OF OFFENCES RELATING TO THE ARMY, NAVY AND AIR FORCE
159. Whoever abets the committing of mutiny by an officer, soldier, sailor or airman, in the Army, Navy or Air Force of the Government of India or attempts to seduce any such officer, soldier, sailor or airman from his allegiance or his duty, shall be punished with imprisonment for life, or with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
160. Whoever abets the committing of mutiny by an officer, soldier, sailor or airman, in the Army, Navy or Air Force of the Government of India, shall, if mutiny be committed in consequence of that abetment, be punished with death or with imprisonment for life, or imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
161. Whoever abets an assault by an officer, soldier, sailor or airman, in the Army, Navy or Air Force of the Government of India, on any superior officer being in the execution of his office, shall be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine.
162. Whoever abets an assault by an officer, soldier, sailor or airman, in the Army, Navy orAir Force of the Government of India, on any superior officer being in the execution of his office, shall, if such assault be committed in consequence of that abetment be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
163. Whoever abets the desertion of any officer, soldier, sailor or airman, in theArmy, Navy orAir Force of the Government of India, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
164. Whoever, except as hereinafter excepted, knowing or having reason to believe that an officer, soldier, sailor or airman, in theArmy, Navy or Air Force of the Government of India, has deserted, harbours such officer, soldier, sailor or airman, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine or with both.
Exception—This provision does not extend to the case in which the harbour is given by the spouse of the deserter.
165. The master or person in charge of a merchant vessel, on board of which any deserter from the Army, Navy or Air Force of the Government of India is concealed, shall, though ignorant of such concealment, be liable to a penalty not exceeding three thousand rupees, if he might have known of such concealment but for some neglect of his duty as such master or person in charge, or but for some want of discipline on board of the vessel.
166. Whoever abets what he knows to be an act of insubordination by an officer, soldier, sailor or airman, in theArmy, Navy or Air Force, of the Government of India, shall, if such act of insubordination be committed in consequence of that abetment, be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
167. No person subject to the Air Force Act, 1950, the Army Act, 1950 and the Navy Act, 1957, or shall be subject to punishment under this Sanhita for any of the offences defined in this Chapter.
168.Whoever, not being a soldier, sailor or airman in theArmy, Naval or Air service of the Government of India, wears any garb or carries any token resembling any garb or token used by such a soldier, sailor or airman with the intention that it may be believed that he is such a soldier, sailor or airman, shall be punished with imprisonment of either description for a term which may extend to three months, or with fine which may extend to two thousand rupees, or with both.
CHAPTER IX
OF OFFENCES RELATING TO ELECTIONS
169. For the purposes of this Chapter—
(a) “candidate” means a person who has been nominated as a candidate at any election;
(b) “electoral right” means the right of a person to stand, or not to stand as, or to withdraw from being, a candidate or to vote or refrain from voting at an election.
170. (1) Whoever—
(i) gives a gratification to any person with the object of inducing him or any other person to exercise any electoral right or of rewarding any person for having exercised any such right; or
(ii) accepts either for himself or for any other person any gratification as a reward for exercising any such right or for inducing or attempting to induce any other person to exercise any such right, commits the offence of bribery: Provided that a declaration of public policy or a promise of public action shall not be an offence under this section.
(2)A person who offers, or agrees to give, or offers or attempts to procure, a gratification shall be deemed to give a gratification.
(3) A person who obtains or agrees to accept or attempts to obtain a gratification shall be deemed to accept a gratification, and a person who accepts a gratification as a motive for doing what he does not intend to do, or as a reward for doing what he has not done, shall be deemed to have accepted the gratification as a reward.
171. (1) Whoever voluntarily interferes or attempts to interfere with the free exercise of any electoral right commits the offence of undue influence at an election.
(2)Without prejudice to the generality of the provisions of sub-section (1), whoever—
(a) threatens any candidate or voter, or any person in whom a candidate or voter is interested, with injury of any kind; or
(b) induces or attempts to induce a candidate or voter to believe that he or any person in whom he is interested will become or will be rendered an object of Divine displeasure or of spiritual censure, shall be deemed to interfere with the free exercise of the electoral right of such candidate or voter, within the meaning of sub-section (1).
(3) A declaration of public policy or a promise of public action or the mere exercise or a legal right without intent to interfere with an electoral right, shall not be deemed to be interference within the meaning of this section.
172. Whoever at an election applies for a voting paper on votes in the name of any other person, whether living or dead, or in a fictitious name, or who having voted once at such election applies at the same election for a voting paper in his own name, and whoever abets, procures or attempts to procure the voting by any person in any such way, commits the offence of personation at an election: Provided that nothing in this section shall apply to a person who has been authorised to vote as proxy for an elector under any law for the time being in force in so far as he votes as a proxy for such elector.
173. Whoever commits the offence of bribery shall be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both: Provided that bribery by treating shall be punished with fine only.
Explanation—“Treating” means that form of bribery where the gratification consists in food, drink, entertainment, or provision.
174. Whoever commits the offence of undue influence or personation at an election shall be punished with imprisonment of either description for a term which may extend to one year or with fine, or with both.
175. Whoever with intent to affect the result of an election makes or publishes any statement purporting to be a statement of fact which is false and which he either knows or believes to be false or does not believe to be true, in relation to the personal character or conduct of any candidate shall be punished with fine.
176. Whoever without the general or special authority in writing of a candidate incurs or authorises expenses on account of the holding of any public meeting, or upon any advertisement, circular or publication, or in any other way whatsoever for the purpose of promoting or procuring the election of such candidate, shall be punished with fine which may extend to ten thousand rupees:
Provided that if any person having incurred any such expenses not exceeding the amount of ten rupees without authority obtains within ten days from the date on which such expenses were incurred the approval in writing of the candidate, he shall be deemed to have incurred such expenses with the authority of the candidate.
177. Whoever being required by any law for the time being in force or any rule having the force of law to keep accounts of expenses incurred at or in connection with an election fails to keep such accounts shall be punished with fine which may extend to five thousand rupees.
CHAPTER X
OF OFFENCES RELATING TO COIN, CURRENCY-NOTES, BANK-NOTES, AND GOVERNMENT STAMPS
178. Whoever counterfeits, or knowingly performs any part of the process of counterfeiting, any coin, stamp issued by Government for the purpose of revenue, currency-note or bank-note, shall be punished with imprisonment for life, or with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
Explanation—For the purposes of this Chapter,—
(1) the expression “bank-note” means a promissory note or engagement for the payment of money to bearer on demand issued by any person carrying on the business of banking in any part of the world, or issued by or under the authority of any State or Sovereign Power, and intended to be used as equivalent to, or as a substitute for money;
(2) “coin” shall have the same meaning as assigned to it in section 2 of the CoinageAct, 2011 and includes metal used for the time being as money and is stamped and issued by or under the authority of any State or Sovereign Power intended to be so used;
(3) a person commits the offence of “counterfeiting Government stamp” who counterfeits by causing a genuine stamp of one denomination to appear like a genuine stamp of a different denomination;
(4) a person commits the offence of counterfeiting coin who intending to practise deception, or knowing it to be likely that deception will thereby be practised, causes a genuine coin to appear like a different coin; and
(5) the offence of “counterfeiting coin” includes diminishing the weight or alteration of the composition, or alteration of the appearance of the coin.
179. Whoever imports or exports, or sells or delivers to, or buys or receives from, any other person, or otherwise traffics or uses as genuine, any forged or counterfeit coin, stamp, currency-note or bank-note, knowing or having reason to believe the same to be forged or counterfeit, shall be punished with imprisonment for life, or with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
180. Whoever has in his possession any forged or counterfeit coin, stamp, currency-note or bank-note, knowing or having reason to believe the same to be forged or counterfeit and intending to use the same as genuine or that it may be used as genuine, shall be punished with imprisonment of either description for a term which may extend to seven years, or with fine, or with both.
Explanation—If a person establishes the possession of the forged or counterfeit coin, stamp, currency-note or bank-note to be from a lawful source, it shall not constitute an offence under this section.
181. Whoever makes or mends, or performs any part of the process of making or mending, or buys or sells or disposes of, or has in his possession, any machinery, die, or instrument or material for the purpose of being used, or knowing or having reason to believe that it is intended to be used, for forging or counterfeiting any coin, stamp issued by Government for the purpose of revenue, currency-note or bank-note, shall be punished with imprisonment for life, or with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
182. (1) Whoever makes, or causes to be made, or uses for any purpose whatsoever, or delivers to any person, any document purporting to be, or in any way resembling, or so nearly resembling as to be calculated to deceive, any currency-note or bank-note shall be punished with fine which may extend to three hundred rupees.
(2) If any person, whose name appears on a document the making of which is an offence under sub-section (1), refuses, without lawful excuse, to disclose to a police officer on being so required the name and address of the person by whom it was printed or otherwise made, he shall be punished with fine which may extend to six hundred rupees.
(3) Where the name of any person appears on any document in respect of which any person is charged with an offence under sub-section (1) or on any other document used or distributed in connection with that document it may, until the contrary is proved, be presumed that the person caused the document to be made.
183. Whoever, fraudulently or with intent to cause loss to the Government, removes or effaces from any substance, bearing any stamp issued by Government for the purpose of revenue, any writing or document for which such stamp has been used, or removes from any writing or document a stamp which has been used for such writing or document, in order that such stamp may be used for a different writing or document, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both.
184. Whoever, fraudulently or with intent to cause loss to the Government, uses for any purpose a stamp issued by Government for the purpose of revenue, which he knows to have been before used, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
185. Whoever, fraudulently or with intent to cause loss to Government, erases or removes from a stamp issued by Government for the purpose of revenue, any mark, put or impressed upon such stamp for the purpose of denoting that the same has been used, or knowingly has in his possession or sells or disposes of any such stamp from which such mark has been erased or removed, or sells or disposes of any such stamp which he knows to have been used, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both.
186. (1) Whoever—
(a) makes, knowingly utters, deals in or sells any fictitious stamp, or knowingly uses for any postal purpose any fictitious stamp; or
(b) has in his possession, without lawful excuse, any fictitious stamp; or
(c) makes or, without lawful excuse, has in his possession any die, plate, instrument or materials for making any fictitious stamp, shall be punished with fine which may extend to two hundred rupees.
(2) Any such stamp, die, plate, instrument or materials in the possession of any person for making any fictitious stamp may be seized and, if seized shall be forfeited.
(3) In this section “fictitious stamp” means any stamp falsely purporting to be issued by Government for the purpose of denoting a rate of postage, or any facsimile or imitation or representation, whether on paper or otherwise, of any stamp issued by Government for that purpose.
(4) In this section and also in sections 178 to 181 (both inclusive), and sections 183 to 185 (both inclusive) the word “Government”, when used in connection with, or in reference to any stamp issued for the purpose of denoting a rate of postage, shall, notwithstanding anything in clause (12) of section 2, be deemed to include the person or persons authorised by law to administer executive Government in any part of India or in any foreign country.
187. Whoever, being employed in any mint lawfully established in India, does any act, or omits what he is legally bound to do, with the intention of causing any coin issued from that mint to be of a different weight or composition from the weight or composition fixed by law, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
188. Whoever, without lawful authority, takes out of any mint, lawfully established in India, any coining tool or instrument, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
CHAPTER XI
OF OFFENCES AGAINST THE PUBLIC TRANQUILLITY
189. (1) An assembly of five or more persons is designated an “unlawful assembly”, if the common object of the persons composing that assembly is—
(a) to overawe by criminal force, or show of criminal force, the Central Government or any State Government or Parliament or the Legislature of any State, or any public servant in the exercise of the lawful power of such public servant; or
(b) to resist the execution of any law, or of any legal process; or
(c) to commit any mischief or criminal trespass, or other offence; or
(d) by means of criminal force, or show of criminal force, to any person, to take or obtain possession of any property, or to deprive any person of the enjoyment of a right of way, or of the use of water or other incorporeal right of which he is in possession or enjoyment, or to enforce any right or supposed right; or
(e) by means of criminal force, or show of criminal force, to compel any person to do what he is not legally bound to do, or to omit to do what he is legally entitled to do.
Explanation—An assembly which was not unlawful when it assembled, may subsequently become an unlawful assembly.
(2) Whoever, being aware of facts which render any assembly an unlawful assembly, intentionally joins that assembly, or continues in it, is said to be a member of an unlawful assembly and such member shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both.
(3) Whoever joins or continues in an unlawful assembly, knowing that such unlawful assembly has been commanded in the manner prescribed by law to disperse, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
(4) Whoever, being armed with any deadly weapon, or with anything which, used as a weapon of offence, is likely to cause death, is a member of an unlawful assembly, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
(5) Whoever knowingly joins or continues in any assembly of five or more persons likely to cause a disturbance of the public peace, after such assembly has been lawfully commanded to disperse, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both.
Explanation—If the assembly is an unlawful assembly within the meaning of sub-section (1), the offender shall be punishable under sub-section (3).
(6) Whoever hires or engages, or employs, or promotes, or connives at the hiring, engagement or employment of any person to join or become a member of any unlawful assembly, shall be punishable as a member of such unlawful assembly, and for any offence which may be committed by any such person as a member of such unlawful assembly in pursuance of such hiring, engagement or employment, in the same manner as if he had been a member of such unlawful assembly, or himself had committed such offence.
(7) Whoever harbours, receives or assembles, in any house or premises in his occupation or charge, or under his control any persons knowing that such persons have been hired, engaged or employed, or are about to be hired, engaged or employed, to join or become members of an unlawful assembly, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both.
(8) Whoever is engaged, or hired, or offers or attempts to be hired or engaged, to do or assist in doing any of the acts specified in sub-section (1), shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both.
(9) Whoever, being so engaged or hired as referred to in sub-section (8), goes armed, or engages or offers to go armed, with any deadly weapon or with anything which used as a weapon of offence is likely to cause death, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
190. If an offence is committed by any member of an unlawful assembly in prosecution of the common object of that assembly, or such as the members of that assembly knew to be likely to be committed in prosecution of that object, every person who, at the time of the committing of that offence, is a member of the same assembly, is guilty of that offence.
191. (1) Whenever force or violence is used by an unlawful assembly, or by any member thereof, in prosecution of the common object of such assembly, every member of such assembly is guilty of the offence of rioting.
(2) Whoever is guilty of rioting, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
(3) Whoever is guilty of rioting, being armed with a deadly weapon or with anything which, used as a weapon of offence, is likely to cause death, shall be punished with imprisonment of either description for a term which may extend to five years, or with fine, or with both.
192.Whoever malignantly, or wantonly by doing anything which is illegal, gives provocation to any person intending or knowing it to be likely that such provocation will cause the offence of rioting to be committed, shall, if the offence of rioting be committed in consequence of such provocation, be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both; and if the offence of rioting be not committed, with imprisonment of either description for a term which may extend to six months, or with fine, or with both.
193. (1) Whenever any unlawful assembly or riot takes place, the owner or occupier of the land upon which such unlawful assembly is held, or such riot is committed, and any person having or claiming an interest in such land, shall be punishable with fine not exceeding one thousand rupees, if he or his agent or manager, knowing that such offence is being or has been committed, or having reason to believe it is likely to be committed, do not give the earliest notice thereof in his or their power to the officer in charge at the nearest police station, and do not, in the case of his or their having reason to believe that it was about to be committed, use all lawful means in his or their power to prevent it and, in the event of its taking place, do not use all lawful means in his or their power to disperse or suppress the riot or unlawful assembly.
(2) Whenever a riot is committed for the benefit or on behalf of any person who is the owner or occupier of any land respecting which such riot takes place or who claims any interest in such land, or in the subject of any dispute which gave rise to the riot, or who has accepted or derived any benefit therefrom, such person shall be punishable with fine, if he or his agent or manager, having reason to believe that such riot was likely to be committed or that the unlawful assembly by which such riot was committed was likely to be held, shall not respectively use all lawful means in his or their power to prevent such assembly or riot from taking place, and for suppressing and dispersing the same.
(3) Whenever a riot is committed for the benefit or on behalf of any person who is the owner or occupier of any land respecting which such riot takes place, or who claims any interest in such land, or in the subject of any dispute which gave rise to the riot, or who has accepted or derived any benefit therefrom, the agent or manager of such person shall be punishable with fine, if such agent or manager, having reason to believe that such riot was likely to be committed, or that the unlawful assembly by which such riot was committed was likely to be held, shall not use all lawful means in his power to prevent such riot or assembly from taking place and for suppressing and dispersing the same.
194. (1) When two or more persons, by fighting in a public place, disturb the public peace, they are said to commit an affray.
(2)Whoever commits an affray, shall be punished with imprisonment of either description for a term which may extend to one month, or with fine which may extend to one thousand rupees, or with both.
195. (1) Whoever assaults or obstructs any public servant or uses criminal force on any public servant in the discharge of his duty as such public servant in endeavouring to disperse an unlawful assembly, or to suppress a riot or affray, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine which shall not be less than twenty-five thousand rupees, or with both.
(2) Whoever threatens to assault or attempts to obstruct any public servant or threatens or attempts to use criminal force to any public servant in the discharge of his duty as such public servant in endeavouring to disperse an unlawful assembly, or to suppress a riot or affray, shall be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both.
196. (1) Whoever—
(a) by words, either spoken or written, or by signs or by visible representations or through electronic communication or otherwise, promotes or attempts to promote, on grounds of religion, race, place of birth, residence, language, caste or community or any other ground whatsoever, disharmony or feelings of enmity, hatred or ill-will between different religious, racial, language or regional groups or castes or communities; or
(b) commits any act which is prejudicial to the maintenance of harmony between different religious, racial, language or regional groups or castes or communities, and which disturbs or is likely to disturb the public tranquillity; or
(c) organises any exercise, movement, drill or other similar activity intending that the participants in such activity shall use or be trained to use criminal force or violence or knowing it to be likely that the participants in such activity will use or be trained to use criminal force or violence, or participates in such activity intending to use or be trained to use criminal force or violence or knowing it to be likely that the participants in such activity will use or be trained to use criminal force or violence, against any religious, racial, language or regional group or caste or community and such activity for any reason whatsoever causes or is likely to cause fear or alarm or a feeling of insecurity amongst members of such religious, racial, language or regional group or caste or community, shall be punished with imprisonment which may extend to three years, or with fine, or with both.
(2) Whoever commits an offence specified in sub-section (1) in any place of worship or in any assembly engaged in the performance of religious worship or religious ceremonies, shall be punished with imprisonment which may extend to five years and shall also be liable to fine.
197. (1) Whoever, by words either spoken or written or by signs or by visible representations or through electronic communication or otherwise,—
(a) makes or publishes any imputation that any class of persons cannot, by reason of their being members of any religious, racial, language or regional group or caste or community, bear true faith and allegiance to the Constitution of India as by law established or uphold the sovereignty and integrity of India; or
(b) asserts, counsels, advises, propagates or publishes that any class of persons shall, by reason of their being members of any religious, racial, language or regional group or caste or community, be denied, or deprived of their rights as citizens of India; or
(c) makes or publishes any assertion, counsel, plea or appeal concerning the obligation of any class of persons, by reason of their being members of any religious, racial, language or regional group or caste or community, and such assertion, counsel, plea or appeal causes or is likely to cause disharmony or feelings of enmity or hatred or ill-will between such members and other persons; or
(d) makes or publishes false or misleading information, jeopardising the sovereignty, unity and integrity or security of India, shall be punished with imprisonment which may extend to three years, or with fine, or with both.
(2) Whoever commits an offence specified in sub-section (1) in any place of worship or in any assembly engaged in the performance of religious worship or religious ceremonies, shall be punished with imprisonment which may extend to five years and shall also be liable to fine.
CHAPTER XII
OF OFFENCES BY OR RELATING TO PUBLIC SERVANTS
198. Whoever, being a public servant, knowingly disobeys any direction of the law as to the way in which he is to conduct himself as such public servant, intending to cause, or knowing it to be likely that he will by such disobedience, cause injury to any person, shall be punished with simple imprisonment for a term which may extend to one year, or with fine, or with both.
Illustrations
A, being an officer directed by law to take property in execution, in order to satisfy a decree pronounced in Z’s favour by a Court, knowingly disobeys that direction of law, with the knowledge that he is likely thereby to cause injury to Z. A has committed the offence defined in this section.
199. Whoever, being a public servant,—
(a) knowingly disobeys any direction of the law which prohibits him from requiring the attendance at any place of any person for the purpose of investigation into an offence or any other matter; or
(b) knowingly disobeys, to the prejudice of any person, any other direction of the law regulating the manner in which he shall conduct such investigation; or
(c) fails to record any information given to him under sub-section (1) of section 173 of the Bharatiya Nagarik Suraksha Sanhita, 2023 in relation to cognizable offence punishable under section 64, section 65, section 66, section 67, section 68, section 70, section 71, section 74, section 76, section 77, section 79, section 124, section 143 or section 144, shall be punished with rigorous imprisonment for a term which shall not be less than six months but which may extend to two years, and shall also be liable to fine.
200. Whoever, being in charge of a hospital, public or private, whether run by the Central Government, the State Government, local bodies or any other person, contravenes the provisions of section 397 of the Bharatiya Nagarik Suraksha Sanhita, 2023, shall be punished with imprisonment for a term which may extend to one year, or with fine, or with both.
201. Whoever, being a public servant, and being, as such public servant, charged with the preparation or translation of any document or electronic record, frames, prepares or translates that document or electronic record in a manner which he knows or believes to be incorrect, intending thereby to cause or knowing it to be likely that he may thereby cause injury to any person, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both.
202. Whoever, being a public servant, and being legally bound as such public servant not to engage in trade, engages in trade, shall be punished with simple imprisonment for a term which may extend to one year, or with fine, or with both or with community service.
203. Whoever, being a public servant, and being legally bound as such public servant, not to purchase or bid for certain property, purchases or bids for that property, either in his own name or in the name of another, or jointly, or in shares with others, shall be punished with simple imprisonment for a term which may extend to two years, or with fine, or with both; and the property, if purchased, shall be confiscated.
204. Whoever pretends to hold any particular office as a public servant, knowing that he does not hold such office or falsely personates any other person holding such office, and in such assumed character does or attempts to do any act under colour of such office, shall be punished with imprisonment of either description for a term which shall not be less than six months but which may extend to three years and with fine.
205. Whoever, not belonging to a certain class of public servants, wears any garb or carries any token resembling any garb or token used by that class of public servants, with the intention that it may be believed, or with the knowledge that it is likely to be believed, that he belongs to that class of public servants, shall be punished with imprisonment of either description for a term which may extend to three months, or with fine which may extend to five thousand rupees, or with both.
CHAPTER XIII
OF CONTEMPTS OF THE LAWFUL AUTHORITY OF PUBLIC SERVANTS
206. Whoever absconds in order to avoid being served with a summons, notice or order proceeding from any public servant legally competent, as such public servant, to issue such summons, notice or order,––
(a) shall be punished with simple imprisonment for a term which may extend to one month, or with fine which may extend to five thousand rupees, or with both;
(b) where such summons or notice or order is to attend in person or by agent, or to produce a document or an electronic record in a Court shall be punished with simple imprisonment for a term which may extend to six months, or with fine which may extend to ten thousand rupees, or with both.
207. Whoever in any manner intentionally prevents the serving on himself, or on any other person, of any summons, notice or order proceeding from any public servant legally competent, as such public servant, to issue such summons, notice or order, or intentionally prevents the lawful affixing to any place of any such summons, notice or order or intentionally removes any such summons, notice or order from any place to which it is lawfully affixed or intentionally prevents the lawful making of any proclamation, under the authority of any public servant legally competent, as such public servant, to direct such proclamation to be made,––
(a) shall be punished with simple imprisonment for a term which may extend to one month, or with fine which may extend to five thousand rupees, or with both;
(b) where the summons, notice, order or proclamation is to attend in person or by agent, or to produce a document or electronic record in a Court, with simple imprisonment for a term which may extend to six months, or with fine which may extend to ten thousand rupees, or with both.
208. Whoever, being legally bound to attend in person or by an agent at a certain place and time in obedience to a summons, notice, order, or proclamation proceeding from any public servant legally competent, as such public servant, to issue the same, intentionally omits to attend at that place or time or departs from the place where he is bound to attend before the time at which it is lawful for him to depart,––
(a) shall be punished with simple imprisonment for a term which may extend to one month, or with fine which may extend to five thousand rupees, or with both;
(b) where the summons, notice, order or proclamation is to attend in person or by agent in a Court with simple imprisonment for a term which may extend to six months, or with fine which may extend to ten thousand rupees, or with both.
Illustrations
(a) A, being legally bound to appear before a High Court, in obedience to a subpoena issuing from that Court, intentionally omits to appear. A has committed the offence defined in this section.
(b) A, being legally bound to appear before a District Judge, as a witness, in obedience to a summons issued by that District Judge intentionally omits to appear. A has committed the offence defined in this section.
209. Whoever fails to appear at the specified place and the specified time as required by a proclamation published under sub-section (1) of section 84 of the Bharatiya Nagarik Suraksha Sanhita, 2023, shall be punished with imprisonment for a term which may extend to three years, or with fine, or with both, or with community service, and where a declaration has been made under sub-section (4) of that section pronouncing him as a proclaimed offender, he shall be punished with imprisonment for a term which may extend to seven years and shall also be liable to fine.
210. Whoever, being legally bound to produce or deliver up any document or electronic record to any public servant, as such, intentionally omits so to produce or deliver up the same,––
(a) shall be punished with simple imprisonment for a term which may extend to one month, or with fine which may extend to five thousand rupees, or with both;
(b) and where the document or electronic record is to be produced or delivered up to a Court with simple imprisonment for a term which may extend to six months, or with fine which may extend to ten thousand rupees, or with both.
Illustrations
A, being legally bound to produce a document before a District Court, intentionally omits to produce the same. A has committed the offence defined in this section.
211. Whoever, being legally bound to give any notice or to furnish information on any subject to any public servant, as such, intentionally omits to give such notice or to furnish such information in the manner and at the time required by law,––
(a) shall be punished with simple imprisonment for a term which may extend to one month, or with fine which may extend to five thousand rupees, or with both;
(b) where the notice or information required to be given respects the commission of an offence, or is required for the purpose of preventing the commission of an offence, or in order to the apprehension of an offender, with simple imprisonment for a term which may extend to six months, or with fine which may extend to ten thousand rupees, or with both;
(c) where the notice or information required to be given is required by an order passed under section 394 of the Bharatiya Nagarik Suraksha Sanhita, 2023 with imprisonment of either description for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both.
212. Whoever, being legally bound to furnish information on any subject to any public servant, as such, furnishes, as true, information on the subject which he knows or has reason to believe to be false,––
(a) shall be punished with simple imprisonment for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both;
(b) where the information which he is legally bound to give respects the commission of an offence, or is required for the purpose of preventing the commission of an offence, or in order to the apprehension of an offender, with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
Illustrations
(a) A, a landholder, knowing of the commission of a murder within the limits of his estate, wilfully misinforms the Magistrate of the district that the death has occurred by accident in consequence of the bite of a snake. Ais guilty of the offence defined in this section.
(b) A, a village watchman, knowing that a considerable body of strangers has passed through his village in order to commit a dacoity in the house of Z, a wealthy merchant residing in a neighbouring place, and being legally bound to give early and punctual information of the above fact to the officer of the nearest police station, wilfully misinforms the police officer that a body of suspicious characters passed through the village with a view to commit dacoity in a certain distant place in a different direction. Here A is guilty of the offence defined in this section.
Explanation—In section 211 and in this section the word “offence” include any act committed at any place out of India, which, if committed in India, would be punishable under any of the following sections, namely, 103, 105, 307, sub-sections (2), (3) and (4) of section 309, sub-sections (2), (3), (4) and (5) of section 310, 311, 312, clauses (f) and (g) of section 326, sub-sections (4), (6), (7) and (8) of section 331, clauses (a) and (b) of section 332 and the word “offender” includes any person who is alleged to have been guilty of any such act.
213. Whoever refuses to bind himself by an oath or affirmation to state the truth, when required so to bind himself by a public servant legally competent to require that he shall so bind himself, shall be punished with simple imprisonment for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.
214. Whoever, being legally bound to state the truth on any subject to any public servant, refuses to answer any question demanded of him touching that subject by such public servant in the exercise of the legal powers of such public servant, shall be punished with simple imprisonment for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.
215. Whoever refuses to sign any statement made by him, when required to sign that statement by a public servant legally competent to require that he shall sign that statement, shall be punished with simple imprisonment for a term which may extend to three months, or with fine which may extend to three thousand rupees, or with both.
216. Whoever, being legally bound by an oath or affirmation to state the truth on any subject to any public servant or other person authorised by law to administer such oath or affirmation, makes, to such public servant or other person as aforesaid, touching that subject, any statement which is false, and which he either knows or believes to be false or does not believe to be true, shall be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine.
217. Whoever gives to any public servant any information which he knows or believes to be false, intending thereby to cause, or knowing it to be likely that he will thereby cause, such public servant—
(a) to do or omit anything which such public servant ought not to do or omit if the true state of facts respecting which such information is given were known by him; or
(b) to use the lawful power of such public servant to the injury or annoyance of any person, shall be punished with imprisonment of either description for a term which may extend to one year, or with fine which may extend to ten thousand rupees, or with both.
Illustrations
(a) A informs a Magistrate that Z, a police officer, subordinate to such Magistrate, has been guilty of neglect of duty or misconduct, knowing such information to be false, and knowing it to be likely that the information will cause the Magistrate to dismiss Z. A has committed the offence defined in this section.
(b) A falsely informs a public servant that Z has contraband salt in a secret place, knowing such information to be false, and knowing that it is likely that the consequence of the information will be a search of Z’s premises, attended with annoyance to Z. A has committed the offence defined in this section.
(c) A falsely informs a policeman that he has been assaulted and robbed in the neighbourhood of a particular village. He does not mention the name of any person as one of his assailants, but knows it to be likely that in consequence of this information the police will make enquiries and institute searches in the village to the annoyance of the villagers or some of them. A has committed an offence under this section.
218. Whoever offers any resistance to the taking of any property by the lawful authority of any public servant, knowing or having reason to believe that he is such public servant, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to ten thousand rupees, or with both.
219. Whoever intentionally obstructs any sale of property offered for sale by the lawful authority of any public servant, as such, shall be punished with imprisonment of either description for a term which may extend to one month, or with fine which may extend to five thousand rupees, or with both.
220. Whoever, at any sale of property held by the lawful authority of a public servant, as such, purchases or bids for any property on account of any person, whether himself or any other, whom he knows to be under a legal incapacity to purchase that property at that sale, or bids for such property not intending to perform the obligations under which he lays himself by such bidding, shall be punished with imprisonment of either description for a term which may extend to one month, or with fine which may extend to two hundred rupees, or with both.
221. Whoever voluntarily obstructs any public servant in the discharge of his public functions, shall be punished with imprisonment of either description for a term which may extend to three months, or with fine which may extend to two thousand and five hundred rupees, or with both.
222. Whoever, being bound by law to render or furnish assistance to any public servant in the execution of his public duty, intentionally omits to give such assistance,––
(a) shall be punished with simple imprisonment for a term which may extend to one month, or with fine which may extend to two thousand and five hundred rupees, or with both;
(b) and where such assistance be demanded of him by a public servant legally competent to make such demand for the purposes of executing any process lawfully issued by a Court or of preventing the commission of an offence, or suppressing a riot, or affray, or of apprehending a person charged with or guilty of an offence, or of having escaped from lawful custody, shall be punished with simple imprisonment for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.
223. Whoever, knowing that, by an order promulgated by a public servant lawfully empowered to promulgate such order, he is directed to abstain from a certain act, or to take certain order with certain property in his possession or under his management, disobeys such direction,––
(a) shall, if such disobedience causes or tends to cause obstruction, annoyance or injury, or risk of obstruction, annoyance or injury, to any person lawfully employed, be punished with simple imprisonment for a term which may extend to six months, or with fine which may extend to two thousand and five hundred rupees, or with both;
(b) and where such disobedience causes or tends to cause danger to human life, health or safety, or causes or tends to cause a riot or affray, shall be punished with imprisonment of either description for a term which may extend to one year, or with fine which may extend to five thousand rupees, or with both.
Explanation—It is not necessary that the offender should intend to produce harm, or contemplate his disobedience as likely to produce harm. It is sufficient that he knows of the order which he disobeys, and that his disobedience produces, or is likely to produce, harm. Illustration. An order is promulgated by a public servant lawfully empowered to promulgate such order, directing that a religious procession shall not pass down a certain street. A knowingly disobeys the order, and thereby causes danger of riot. A has committed the offence defined in this section.
224. Whoever holds out any threat of injury to any public servant, or to any person in whom he believes that public servant to be interested, for the purpose of inducing that public servant to do any act, or to forbear or delay to do any act, connected with the exercise of the public functions of such public servant, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
225. Whoever holds out any threat of injury to any person for the purpose of inducing that person to refrain or desist from making a legal application for protection against any injury to any public servant legally empowered as such to give such protection, or to cause such protection to be given, shall be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both.
226. Whoever attempts to commit suicide with the intent to compel or restrain any public servant from discharging his official duty shall be punished with simple imprisonment for a term which may extend to one year, or with fine, or with both, or with community service.
CHAPTER XIV
OF FALSE EVIDENCE AND OFFENCES AGAINST PUBLIC JUSTICE
227. Whoever, being legally bound by an oath or by an express provision of law to state the truth, or being bound by law to make a declaration upon any subject, makes any statement which is false, and which he either knows or believes to be false or does not believe to be true, is said to give false evidence.
Explanation 1—A statement is within the meaning of this section, whether it is made verbally or otherwise.
Explanation 2—A false statement as to the belief of the person attesting is within the meaning of this section, and a person may be guilty of giving false evidence by stating that he believes a thing which he does not believe, as well as by stating that he knows a thing which he does not know.
Illustrations
(a) A, in support of a just claim which B has against Z for one thousand rupees, falsely swears on a trial that he heard Z admit the justice of B’s claim. A has given false evidence.
(b) A, being bound by an oath to state the truth, states that he believes a certain signature to be the handwriting of Z, when he does not believe it to be the handwriting of Z. Here A states that which he knows to be false, and therefore gives false evidence.
(c) A, knowing the general character of Z’s handwriting, states that he believes a certain signature to be the handwriting of Z; A in good faith believing it to be so. Here A’s statement is merely as to his belief, and is true as to his belief, and therefore, although the signature may not be the handwriting of Z, A has not given false evidence.
(d) A, being bound by an oath to state the truth, states that he knows that Z was at a particular place on a particular day, not knowing anything upon the subject. A gives false evidence whether Z was at that place on the day named or not.
(e) A, an interpreter or translator, gives or certifies as a true interpretation or translation of a statement or document which he is bound by oath to interpret or translate truly, that which is not and which he does not believe to be a true interpretation or translation. A has given false evidence.
228. Whoever causes any circumstance to exist or makes any false entry in any book or record, or electronic record or makes any document or electronic record containing a false statement, intending that such circumstance, false entry or false statement may appear in evidence in a judicial proceeding, or in a proceeding taken by law before a public servant as such, or before an arbitrator, and that such circumstance, false entry or false statement, so appearing in evidence, may cause any person who in such proceeding is to form an opinion upon the evidence, to entertain an erroneous opinion touching any point material to the result of such proceeding is said “to fabricate false evidence”.
Illustrations
(a) A puts jewels into a box belonging to Z, with the intention that they may be found in that box, and that this circumstance may cause Z to be convicted of theft. A has fabricated false evidence.
(b) A makes a false entry in his shop-book for the purpose of using it as corroborative evidence in a Court. A has fabricated false evidence.
(c) A, with the intention of causing Z to be convicted of a criminal conspiracy, writes a letter in imitation of Z’s handwriting, purporting to be addressed to an accomplice in such criminal conspiracy, and puts the letter in a place which he knows that the officers of the police are likely to search. A has fabricated false evidence.
229. (1) Whoever intentionally gives false evidence in any stage of a judicial proceeding, or fabricates false evidence for the purpose of being used in any stage of a judicial proceeding, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine which may extend to ten thousand rupees.
(2) Whoever intentionally gives or fabricates false evidence in any case other than that referred to in sub-section (1), shall be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine which may extend to five thousand rupees.
Explanation 1—A trial before a Court-martial is a judicial proceeding.
Explanation 2—An investigation directed by law preliminary to a proceeding before a Court, is a stage of a judicial proceeding, though that investigation may not take place before a Court.
Illustrations
A, in an enquiry before a Magistrate for the purpose of ascertaining whether Z ought to be committed for trial, makes on oath a statement which he knows to be false. As this enquiry is a stage of a judicial proceeding, A has given false evidence.
Explanation 3—An investigation directed by a Court according to law, and conducted under the authority of a Court, is a stage of a judicial proceeding, though that investigation may not take place before a Court.
Illustrations
A, in an enquiry before an officer deputed by a Court to ascertain on the spot the boundaries of land, makes on oath a statement which he knows to be false. As this enquiry is a stage of a judicial proceeding, A has given false evidence.
230. (1) Whoever gives or fabricates false evidence, intending thereby to cause, or knowing it to be likely that he will thereby cause, any person to be convicted of an offence which is capital by the law for the time being in force in India shall be punished with imprisonment for life, or with rigorous imprisonment for a term which may extend to ten years, and shall also be liable to fine which may extend to fifty thousand rupees.
(2) If an innocent person be convicted and executed in consequence of false evidence referred to in sub-section (1), the person who gives such false evidence shall be punished either with death or the punishment specified in sub-section (1).
231. Whoever gives or fabricates false evidence intending thereby to cause, or knowing it to be likely that he will thereby cause, any person to be convicted of an offence which by the law for the time being in force in India is not capital, but punishable with imprisonment for life, or imprisonment for a term of seven years or upwards, shall be punished as a person convicted of that offence would be liable to be punished.
Illustrations
A gives false evidence before a Court, intending thereby to cause Z to be convicted of a dacoity. The punishment of dacoity is imprisonment for life, or rigorous imprisonment for a term which may extend to ten years, with or without fine. A, therefore, is liable to imprisonment for life or imprisonment, with or without fine.
232. (1) Whoever threatens another with any injury to his person, reputation or property or to the person or reputation of any one in whom that person is interested, with intent to cause that person to give false evidence shall be punished with imprisonment of either description for a term which may extend to seven years, or with fine, or with both.
(2) If innocent person is convicted and sentenced in consequence of false evidence referred to in sub-section (1), with death or imprisonment for more than seven years, the person who threatens shall be punished with the same punishment and sentence in the same manner and to the same extent such innocent person is punished and sentenced.
- Whoever corruptly uses or attempts to use as true or genuine evidence any evidence which he knows to be false or fabricated, shall be punished in the same manner as if he gave or fabricated false evidence.234. Whoever issues or signs any certificate required by law to be given or signed, or relating to any fact of which such certificate is by law admissible in evidence, knowing or believing that such certificate is false in any material point, shall be punished in the same manner as if he gave false evidence.235. Whoever corruptly uses or attempts to use any such certificate as a true certificate, knowing the same to be false in any material point, shall be punished in the same manner as if he gave false evidence.236. Whoever, in any declaration made or subscribed by him, which declaration any Court or any public servant or other person, is bound or authorised by law to receive as evidence of any fact, makes any statement which is false, and which he either knows or believes to be false or does not believe to be true, touching any point material to the object for which the declaration is made or used, shall be punished in the same manner as if he gave false evidence.237. Whoever corruptly uses or attempts to use as true any such declaration, knowing the same to be false in any material point, shall be punished in the same manner as if he gave false evidence.Explanation—A declaration which is inadmissible merely upon the ground of some informality, is a declaration within the meaning of section 236 and this section.238. Whoever, knowing or having reason to believe that an offence has been committed, causes any evidence of the commission of that offence to disappear, with the intention of screening the offender from legal punishment, or with that intention gives any information respecting the offence which he knows or believes to be false shall,—(a) if the offence which he knows or believes to have been committed is punishable with death, be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine;(b) if the offence is punishable with imprisonment for life, or with imprisonment which may extend to ten years, be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine;(c) if the offence is punishable with imprisonment for any term not extending to ten years, be punished with imprisonment of the description provided for the offence, for a term which may extend to one-fourth part of the longest term of the imprisonment provided for the offence, or with fine, or with both.Illustration A, knowing that B has murdered Z, assists B to hide the body with the intention of screening B from punishment. A is liable to imprisonment of either description for seven years, and also to fine.239. Whoever, knowing or having reason to believe that an offence has been committed, intentionally omits to give any information respecting that offence which he is legally bound to give, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.
- Whoever, knowing or having reason to believe that an offence has been committed, gives any information respecting that offence which he knows or believes to be false, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.Explanation—In sections 238 and 239 and in this section the word “offence” includes any act committed at any place out of India, which, if committed in India, would be punishable under any of the following sections, namely, 103, 105, 307, sub-sections (2), (3) and (4) of section 309, sub-sections (2), (3), (4) and (5) of section 310, 311, 312, clauses (f) and (g) of section 326, sub-sections (4), (6), (7) and (8) of section 331, clauses (a) and (b) of section 332.241. Whoever secretes or destroys any document or electronic record which he may be lawfully compelled to produce as evidence in a Court or in any proceeding lawfully held before a public servant, as such, or obliterates or renders illegible the whole or any part of such document or electronic record with the intention of preventing the same from being produced or used as evidence before such Court or public servant as aforesaid, or after he shall have been lawfully summoned or required to produce the same for that purpose, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine which may extend to five thousand rupees, or with both.242. Whoever falsely personates another, and in such assumed character makes any admission or statement, or confesses judgment, or causes any process to be issued or becomes bail or security, or does any other act in any suit or criminal prosecution, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both.243. Whoever fraudulently removes, conceals, transfers or delivers to any person any property or any interest therein, intending thereby to prevent that property or interest therein from being taken as a forfeiture or in satisfaction of a fine, under a sentence which has been pronounced, or which he knows to be likely to be pronounced, by a Court or other competent authority, or from being taken in execution of a decree or order which has been made, or which he knows to be likely to be made by a Court in a civil suit, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine which may extend to five thousand rupees, or with both.244. Whoever fraudulently accepts, receives or claims any property or any interest therein, knowing that he has no right or rightful claim to such property or interest, or practises any deception touching any right to any property or any interest therein, intending thereby to prevent that property or interest therein from being taken as a forfeiture or in satisfaction of a fine, under a sentence which has been pronounced, or which he knows to be likely to be pronounced by a Court or other competent authority, or from being taken in execution of a decree or order which has been made, or which he knows to be likely to be made by a Court in a civil suit, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.245. Whoever fraudulently causes or suffers a decree or order to be passed against him at the suit of any person for a sum not due or for a larger sum than is due to such person or for any property or interest in property to which such person is not entitled, or fraudulently causes or suffers a decree or order to be executed against him after it has been satisfied, or for anything in respect of which it has been satisfied, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both
Illustrations
A institutes a suit against Z. Z, knowing that A is likely to obtain a decree against him, fraudulently suffers a judgment to pass against him for a larger amount at the suit of B, who has no just claim against him, in order that B, either on his own account or for the benefit of Z, may share in the proceeds of any sale of Z’s property which may be made under A’s decree. Z has committed an offence under this section.
246. Whoever fraudulently or dishonestly, or with intent to injure or annoy any person, makes in a Court any claim which he knows to be false, shall be punished with imprisonment of either description for a term which may extend to two years, and shall also be liable to fine.
247. Whoever fraudulently obtains a decree or order against any person for a sum not due, or for a larger sum than is due or for any property or interest in property to which he is not entitled, or fraudulently causes a decree or order to be executed against any person after it has been satisfied or for anything in respect of which it has been satisfied, or fraudulently suffers or permits any such act to be done in his name, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
248. Whoever, with intent to cause injury to any person, institutes or causes to be instituted any criminal proceeding against that person, or falsely charges any person with having committed an offence, knowing that there is no just or lawful ground for such proceeding or charge against that person,—
(a) shall be punished with imprisonment of either description for a term which may extend to five years, or with fine which may extend to two lakh rupees, or with both;
(b) if such criminal proceeding be instituted on a false charge of an offence punishable with death, imprisonment for life, or imprisonment for ten years or upwards, shall be punishable with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
249. Whenever an offence has been committed, whoever harbours or conceals a person whom he knows or has reason to believe to be the offender, with the intention of screening him from legal punishment shall,—
(a) if the offence is punishable with death, be punished with imprisonment of either description for a term which may extend to five years, and shall also be liable to fine;
(b) if the offence is punishable with imprisonment for life, or with imprisonment which may extend to ten years, be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine;
(c) if the offence is punishable with imprisonment which may extend to one year, and not to ten years, be punished with imprisonment of the description provided for the offence for a term which may extend to one-fourth part of the longest term of imprisonment provided for the offence, or with fine, or with both.
Explanation––“Offence” in this section includes any act committed at any place out of India, which, if committed in India, would be punishable under any of the following sections, namely, 103, 105, 307, sub-sections (2), (3) and (4) of section 309, sub-sections (2), (3), (4) and (5) of section 310, 311, 312, clauses (f) and (g) of section 326, sub-sections (4), (6), (7) and (8) of section 331, clauses (a) and (b) of section 332 and every such act shall, for the purposes of this section, be deemed to be punishable as if the accused person had been guilty of it in India.
Exception—This section shall not extend to any case in which the harbour or concealment is by the spouse of the offender.
Illustrations
A, knowing that B has committed dacoity, knowingly conceals B in order to screen him from legal punishment. Here, as B is liable to imprisonment for life, A is liable to imprisonment of either description for a term not exceeding three years, and is also liable to fine.
250. Whoever accepts or attempts to obtain, or agrees to accept, any gratification for himself or any other person, or any restitution of property to himself or any other person, in consideration of his concealing an offence or of his screening any person from legal punishment for any offence, or of his not proceeding against any person for the purpose of bringing him to legal punishment shall,––
(a) if the offence is punishable with death, be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine;
(b) if the offence is punishable with imprisonment for life, or with imprisonment which may extend to ten years, be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine;
(c) if the offence is punishable with imprisonment not extending to ten years, be punished with imprisonment of the description provided for the offence for a term which may extend to one-fourth part of the longest term of imprisonment provided for the offence, or with fine, or with both.
251. Whoever gives or causes, or offers or agrees to give or cause, any gratification to any person, or restores or causes the restoration of any property to any person, in consideration of that person’s concealing an offence, or of his screening any person from legal punishment for any offence, or of his not proceeding against any person for the purpose of bringing him to legal punishment shall,––
(a) if the offence is punishable with death, be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine;
(b) if the offence is punishable with imprisonment for life or with imprisonment which may extend to ten years, be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine;
(c) if the offence is punishable with imprisonment not extending to ten years, be punished with imprisonment of the description provided for the offence for a term which may extend to one-fourth part of the longest term of imprisonment provided for the offence, or with fine, or with both.
Exception—The provisions of this section and section 250 do not extend to any case in which the offence may lawfully be compounded.
252. Whoever takes or agrees or consents to take any gratification under pretence or on account of helping any person to recover any movable property of which he shall have been deprived by any offence punishable under this Sanhita, shall, unless he uses all means in his power to cause the offender to be apprehended and convicted of the offence, be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
253. Whenever any person convicted of or charged with an offence, being in lawful custody for that offence, escapes from such custody, or whenever a public servant, in the exercise of the lawful powers of such public servant, orders a certain person to be apprehended for an offence, whoever, knowing of such escape or order for apprehension, harbours or conceals that person with the intention of preventing him from being apprehended, shall be punished in the manner following, namely:––
(a) if the offence for which the person was in custody or is ordered to be apprehended is punishable with death, he shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine;
(b) if the offence is punishable with imprisonment for life or imprisonment for ten years, he shall be punished with imprisonment of either description for a term which may extend to three years, with or without fine;
(c) if the offence is punishable with imprisonment which may extend to one year and not to ten years, he shall be punished with imprisonment of the description provided for the offence for a term which may extend to one-fourth part of the longest term of the imprisonment provided for such offence, or with fine, or with both.
Explanation––“Offence” in this section includes also any act or omission of which a person is alleged to have been guilty out of India, which, if he had been guilty of it in India, would have been punishable as an offence, and for which he is, under any law relating to extradition, or otherwise, liable to be apprehended or detained in custody in India, and every such act or omission shall, for the purposes of this section, be deemed to be punishable as if the accused person had been guilty of it in India.
Exception—The provisions of this section do not extend to the case in which the harbour or concealment is by the spouse of the person to be apprehended.
254. Whoever, knowing or having reason to believe that any persons are about to commit or have recently committed robbery or dacoity, harbours them or any of them, with the intention of facilitating the commission of such robbery or dacoity, or of screening them or any of them from punishment, shall be punished with rigorous imprisonment for a term which may extend to seven years, and shall also be liable to fine.
Explanation—For the purposes of this section it is immaterial whether the robbery or dacoity is intended to be committed, or has been committed, within or without India.
Exception—The provisions of this section do not extend to the case in which the harbour is by the spouse of the offender.
255. Whoever, being a public servant, knowingly disobeys any direction of the law as to the way in which he is to conduct himself as such public servant, intending thereby to save, or knowing it to be likely that he will thereby save, any person from legal punishment, or subject him to a less punishment than that to which he is liable, or with intent to save, or knowing that he is likely thereby to save, any property from forfeiture or any charge to which it is liable by law, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
- Whoever, being a public servant, and being as such public servant, charged with the preparation of any record or other writing, frames that record or writing in a manner which he knows to be incorrect, with intent to cause, or knowing it to be likely that he will thereby cause, loss or injury to the public or to any person, or with intent thereby to save, or knowing it to be likely that he will thereby save, any person from legal punishment, or with intent to save, or knowing that he is likely thereby to save, any property from forfeiture or other charge to which it is liable by law, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both.257. Whoever, being a public servant, corruptly or maliciously makes or pronounces in any stage of a judicial proceeding, any report, order, verdict, or decision which he knows to be contrary to law, shall be punished with imprisonment of either description for a term which may extend to seven years, or with fine, or with both.258. Whoever, being in any office which gives him legal authority to commit persons for trial or to confinement, or to keep persons in confinement, corruptly or maliciously commits any person for trial or to confinement, or keeps any person in confinement, in the exercise of that authority knowing that in so doing he is acting contrary to law, shall be punished with imprisonment of either description for a term which may extend to seven years, or with fine, or with both.259. Whoever, being a public servant, legally bound as such public servant to apprehend or to keep in confinement any person charged with or liable to be apprehended for an offence, intentionally omits to apprehend such person, or intentionally suffers such person to escape, or intentionally aids such person in escaping or attempting to escape from such confinement, shall be punished,––(a) with imprisonment of either description for a term which may extend to seven years, with or without fine, if the person in confinement, or who ought to have been apprehended, was charged with, or liable to be apprehended for, an offence punishable with death; or(b) with imprisonment of either description for a term which may extend to three years, with or without fine, if the person in confinement, or who ought to have been apprehended, was charged with, or liable to be apprehended for, an offence punishable with imprisonment for life or imprisonment for a term which may extend to ten years; or(c) with imprisonment of either description for a term which may extend to two years, with or without fine, if the person in confinement, or who ought to have been apprehended, was charged with, or liable to be apprehended for, an offence punishable with imprisonment for a term less than ten years.260. Whoever, being a public servant, legally bound as such public servant to apprehend or to keep in confinement any person under sentence of a Court for any offence or lawfully committed to custody, intentionally omits to apprehend such person, or intentionally suffers such person to escape or intentionally aids such person in escaping or attempting to escape from such confinement, shall be punished,—(a) with imprisonment for life or with imprisonment of either description for a term which may extend to fourteen years, with or without fine, if the person in confinement, or who ought to have been apprehended, is under sentence of death; or
(b) with imprisonment of either description for a term which may extend to seven years, with or without fine, if the person in confinement or who ought to have been apprehended, is subject, by a sentence of a Court, or by virtue of a commutation of such sentence, to imprisonment for life or imprisonment for a term of ten years, or upwards; or
(c) with imprisonment of either description for a term which may extend to three years, or with fine, or with both, if the person in confinement or who ought to have been apprehended, is subject by a sentence of a Court to imprisonment for a term not extending to ten years or if the person was lawfully committed to custody.
261. Whoever, being a public servant legally bound as such public servant to keep in confinement any person charged with or convicted of any offence or lawfully committed to custody, negligently suffers such person to escape from confinement, shall be punished with simple imprisonment for a term which may extend to two years, or with fine, or with both.
262. Whoever intentionally offers any resistance or illegal obstruction to the lawful apprehension of himself for any offence with which he is charged or of which he has been convicted, or escapes or attempts to escape from any custody in which he is lawfully detained for any such offence, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
Explanation—The punishment in this section is in addition to the punishment for which the person to be apprehended or detained in custody was liable for the offence with which he was charged, or of which he was convicted.
263. Whoever, intentionally offers any resistance or illegal obstruction to the lawful apprehension of any other person for an offence, or rescues or attempts to rescue any other person from any custody in which that person is lawfully detained for an offence,—
(a) shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both; or
(b) if the person to be apprehended, or the person rescued or attempted to be rescued, is charged with or liable to be apprehended for an offence punishable with imprisonment for life or imprisonment for a term which may extend to ten years, shall be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine; or
(c) if the person to be apprehended or rescued, or attempted to be rescued, is charged with or liable to be apprehended for an offence punishable with death, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine; or
(d) if the person to be apprehended or rescued, or attempted to be rescued, is liable under the sentence of a Court or by virtue of a commutation of such a sentence, to imprisonment for life, or imprisonment for a term of ten years or upwards, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine; or
(e) if the person to be apprehended or rescued, or attempted to be rescued, is under sentence of death, shall be punished with imprisonment for life or imprisonment of either description for a term not exceeding ten years, and shall also be liable to fine.
- Whoever, being a public servant legally bound as such public servant to apprehend, or to keep in confinement, any person in any case not provided for in section 259, section 260 or section 261, or in any other law for the time being in force, omits to apprehend that person or suffers him to escape from confinement, shall be punished—(a) if he does so intentionally, with imprisonment of either description for a term which may extend to three years, or with fine, or with both; and(b) if he does so negligently, with simple imprisonment for a term which may extend to two years, or with fine, or with both.265. Whoever, in any case not provided for in section 262 or section 263 or in any other law for the time being in force, intentionally offers any resistance or illegal obstruction to the lawful apprehension of himself or of any other person, or escapes or attempts to escape from any custody in which he is lawfully detained, or rescues or attempts to rescue any other person from any custody in which that person is lawfully detained, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both.266. Whoever, having accepted any conditional remission of punishment, knowingly violates any condition on which such remission was granted, shall be punished with the punishment to which he was originally sentenced, if he has already suffered no part of that punishment, and if he has suffered any part of that punishment, then with so much of that punishment as he has not already suffered.267. Whoever, intentionally offers any insult, or causes any interruption to any public servant, while such public servant is sitting in any stage of a judicial proceeding, shall be punished with simple imprisonment for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.268. Whoever, by personation or otherwise, shall intentionally cause, or knowingly suffer himself to be returned, empanelled or sworn as an assessor in any case in which he knows that he is not entitled by law to be so returned, empanelled or sworn, or knowing himself to have been so returned, empanelled or sworn contrary to law, shall voluntarily serve as such assessor, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.269. Whoever, having been charged with an offence and released on bail bond or on bond, fails without sufficient cause (the burden of proving which shall lie upon him), to appear in Court in accordance with the terms of the bail or bond, shall be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both.Explanation—The punishment under this section is—(a) in addition to the punishment to which the offender would be liable on a conviction for the offence with which he has been charged; and(b) without prejudice to the power of the Court to order forfeiture of the bond.
CHAPTER XV
OF OFFENCES AFFECTING THE PUBLIC HEALTH, SAFETY, CONVENIENCE, DECENCY AND MORALS
270. A person is guilty of a public nuisance who does any act or is guilty of an illegal omission which causes any common injury, danger or annoyance to the public or to the people in general who dwell or occupy property in the vicinity, or which must necessarily cause injury, obstruction, danger or annoyance to persons who may have occasion to use any public right but a common nuisance is not excused on the ground that it causes some convenience or advantage.
- Whoever unlawfully or negligently does any act which is, and which he knows or has reason to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both.272. Whoever malignantly does any act which is, and which he knows or has reason to believe to be, likely to spread the infection of any disease dangerous to life, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.273. Whoever knowingly disobeys any rule made by the Government for putting any mode of transport into a state of quarantine, or for regulating the intercourse of any such transport in a state of quarantine or for regulating the intercourse between places where an infectious disease prevails and other places, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both.274. Whoever adulterates any article of food or drink, so as to make such article noxious as food or drink, intending to sell such article as food or drink, or knowing it to be likely that the same will be sold as food or drink, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.275. Whoever sells, or offers or exposes for sale, as food or drink, any article which has been rendered or has become noxious, or is in a state unfit for food or drink, knowing or having reason to believe that the same is noxious as food or drink, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.276. Whoever adulterates any drug or medical preparation in such a manner as to lessen the efficacy or change the operation of such drug or medical preparation, or to make it noxious, intending that it shall be sold or used for, or knowing it to be likely that it will be sold or used for, any medicinal purpose, as if it had not undergone such adulteration, shall be punished with imprisonment of either description for a term which may extend to one year, or with fine which may extend to five thousand rupees, or with both.277. Whoever, knowing any drug or medical preparation to have been adulterated in such a manner as to lessen its efficacy, to change its operation, or to render it noxious, sells the same, or offers or exposes it for sale, or issues it from any dispensary for medicinal purposes as unadulterated, or causes it to be used for medicinal purposes by any person not knowing of the adulteration, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.278.Whoever knowingly sells, or offers or exposes for sale, or issues from a dispensary for medicinal purposes, any drug or medical preparation, as a different drug or medical preparation, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.279. Whoever voluntarily corrupts or fouls the water of any public spring or reservoir, so as to render it less fit for the purpose for which it is ordinarily used, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.280. Whoever voluntarily vitiates the atmosphere in any place so as to make it noxious to the health of persons in general dwelling or carrying on business in the neighbourhood or passing along a public way, shall be punished with fine which may extend to one thousand rupees.281. Whoever drives any vehicle, or rides, on any public way in a manner so rash or negligent as to endanger human life, or to be likely to cause hurt or injury to any other person, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to one thousand rupees, or with both.
282. Whoever navigates any vessel in a manner so rash or negligent as to endanger human life, or to be likely to cause hurt or injury to any other person, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to ten thousand rupees, or with both.
283. Whoever exhibits any false light, mark or buoy, intending or knowing it to be likely that such exhibition will mislead any navigator, shall be punished with imprisonment of either description for a term which may extend to seven years, and with fine which shall not be less than ten thousand rupees.
284. Whoever knowingly or negligently conveys, or causes to be conveyed for hire, any person by water in any vessel, when that vessel is in such a state or so loaded as to endanger the life of that person, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.
285. Whoever, by doing any act, or by omitting to take order with any property in his possession or under his charge, causes danger, obstruction or injury to any person in any public way or public line of navigation, shall be punished with fine which may extend to five thousand rupees.
286. Whoever does, with any poisonous substance, any act in a manner so rash or negligent as to endanger human life, or to be likely to cause hurt or injury to any person or knowingly or negligently omits to take such order with any poisonous substance in his possession as is sufficient to guard against any probable danger to human life from such poisonous substance, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.
287.Whoever does, with fire or any combustible matter, any act so rashly or negligently as to endanger human life, or to be likely to cause hurt or injury to any other person or knowingly or negligently omits to take such order with any fire or any combustible matter in his possession as is sufficient to guard against any probable danger to human life from such fire or combustible matter, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to two thousand rupees, or with both.
288. Whoever does, with any explosive substance, any act so rashly or negligently as to endanger human life, or to be likely to cause hurt or injury to any other person, or knowingly or negligently omits to take such order with any explosive substance in his possession as is sufficient to guard against any probable danger to human life from that substance, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.
289.Whoever does, with any machinery, any act so rashly or negligently as to endanger human life or to be likely to cause hurt or injury to any other person or knowingly or negligently omits to take such order with any machinery in his possession or under his care as is sufficient to guard against any probable danger to human life from such machinery, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.
290. Whoever, in pulling down, repairing or constructing any building, knowingly or negligently omits to take such measures with that building as is sufficient to guard against any probable danger to human life from the fall of that building, or of any part thereof, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.
- Whoever knowingly or negligently omits to take such measures with any animal in his possession as is sufficient to guard against any probable danger to human life, or any probable danger of grievous hurt from such animal, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.292. Whoever commits a public nuisance in any case not otherwise punishable by this Sanhita shall be punished with fine which may extend to one thousand rupees.293. Whoever repeats or continues a public nuisance, having been enjoined by any public servant who has lawful authority to issue such injunction not to repeat or continue such nuisance, shall be punished with simple imprisonment for a term which may extend to six months, or with fine which may extend to five thousand rupees, or with both.294. (1) For the purposes of sub-section (2), a book, pamphlet, paper, writing, drawing, painting, representation, figure or any other object, including display of any content in electronic form shall be deemed to be obscene if it is lascivious or appeals to the prurient interest or if its effect, or (where it comprises two or more distinct items) the effect of any one of its items, is, if taken as a whole, such as to tend to deprave and corrupt persons who are likely, having regard to all relevant circumstances, to read, see or hear the matter contained or embodied in it. (2) Whoever—(a) sells, lets to hire, distributes, publicly exhibits or in any manner puts into circulation, or for purposes of sale, hire, distribution, public exhibition or circulation, makes, produces or has in his possession any obscene book, pamphlet, paper, drawing, painting, representation or figure or any other obscene object whatsoever in whatever manner; or(b) imports, exports or conveys any obscene object for any of the purposes aforesaid, or knowing or having reason to believe that such object will be sold, let to hire, distributed or publicly exhibited or in any manner put into circulation; or(c) takes part in or receives profits from any business in the course of which he knows or has reason to believe that any such obscene objects are, for any of the purposes aforesaid, made produced, purchased, kept, imported, exported, conveyed, publicly exhibited or in any manner put into circulation; or(d) advertises or makes known by any means whatsoever that any person is engaged or is ready to engage in any act which is an offence under this section, or that any such obscene object can be procured from or through any person; or(e) offers or attempts to do any act which is an offence under this section, shall be punished on first conviction with imprisonment of either description for a term which may extend to two years, and with fine which may extend to five thousand rupees, and, in the event of a second or subsequent conviction, with imprisonment of either description for a term which may extend to five years, and also with fine which may extend to ten thousand rupees.Exception—This section does not extend to—(a) any book, pamphlet, paper, writing, drawing, painting, representation or figure—(i) the publication of which is proved to be justified as being for the public good on the ground that such book, pamphlet, paper, writing, drawing, painting, representation or figure is in the interest of science, literature, art or learning or other objects of general concern; or
(ii) which is kept or used bona fide for religious purposes;
(b) any representation sculptured, engraved, painted or otherwise represented on or in—
(i) any ancient monument within the meaning of the Ancient Monuments and Archaeological Sites and RemainsAct, 1958; or
(ii) any temple, or on any car used for the conveyance of idols, or kept or used for any religious purpose.
295. Whoever sells, lets to hire, distributes, exhibits or circulates to any child any such obscene object as is referred to in section 294, or offers or attempts so to do, shall be punished on first conviction with imprisonment of either description for a term which may extend to three years, and with fine which may extend to two thousand rupees, and, in the event of a second or subsequent conviction, with imprisonment of either description for a term which may extend to seven years, and also with fine which may extend to five thousand rupees.
296. Whoever, to the annoyance of others,—
(a) does any obscene act in any public place; or
(b) sings, recites or utters any obscene song, ballad or words, in or near any public place, shall be punished with imprisonment of either description for a term which may extend to three months, or with fine which may extend to one thousand rupees, or with both.
297. (1) Whoever keeps any office or place for the purpose of drawing any lottery not being a State lottery or a lottery authorised by the State Government, shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both.
(2) Whoever publishes any proposal to pay any sum, or to deliver any goods, or to do or forbear from doing anything for the benefit of any person, on any event or contingency relative or applicable to the drawing of any ticket, lot, number or figure in any such lottery, shall be punished with fine which may extend to five thousand rupees.
CHAPTER XVI
OF OFFENCES RELATING TO RELIGION
298. Whoever destroys, damages or defiles any place of worship, or any object held sacred by any class of persons with the intention of thereby insulting the religion of any class of persons or with the knowledge that any class of persons is likely to consider such destruction, damage or defilement as an insult to their religion, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
299.Whoever, with deliberate and malicious intention of outraging the religious feelings of any class of citizens of India, by words, either spoken or written, or by signs or by visible representations or through electronic means or otherwise, insults or attempts to insult the religion or the religious beliefs of that class, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both.
300. Whoever voluntarily causes disturbance to any assembly lawfully engaged in the performance of religious worship, or religious ceremonies, shall be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both.
301.Whoever, with the intention of wounding the feelings of any person, or of insulting the religion of any person, or with the knowledge that the feelings of any person are likely to be wounded, or that the religion of any person is likely to be insulted thereby, commits any trespass in any place of worship or on any place of sepulchre, or any place set apart for the performance of funeral rites or as a depository for the remains of the dead, or offers any indignity to any human corpse, or causes disturbance to any persons assembled for the performance of funeral ceremonies, shall be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both.
302. Whoever, with the deliberate intention of wounding the religious feelings of any person, utters any word or makes any sound in the hearing of that person or makes any gesture in the sight of that person or places any object in the sight of that person, shall be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both.
CHAPTER XVII
OF OFFENCES AGAINST PROPERTY Of theft
303. (1) Whoever, intending to take dishonestly any movable property out of the possession of any person without that person’s consent, moves that property in order to such taking, is said to commit theft.
Explanation 1—A thing so long as it is attached to the earth, not being movable property, is not the subject of theft; but it becomes capable of being the subject of theft as soon as it is severed from the earth.
Explanation 2—A moving effected by the same act which affects the severance may be a theft.
Explanation 3—A person is said to cause a thing to move by removing an obstacle which prevented it from moving or by separating it from any other thing, as well as by actually moving it.
Explanation 4—A person, who by any means causes an animal to move, is said to move that animal, and to move everything which, in consequence of the motion so caused, is moved by that animal.
Explanation 5—The consent mentioned in this section may be express or implied, and may be given either by the person in possession, or by any person having for that purpose authority either express or implied.
Illustrations
(a) A cuts down a tree on Z’s ground, with the intention of dishonestly taking the tree out of Z’s possession without Z’s consent. Here, as soon as A has severed the tree in order to such taking, he has committed theft.
(b) A puts a bait for dogs in his pocket, and thus induces Z’s dog to follow it. Here, if A’s intention be dishonestly to take the dog out of Z’s possession without Z’s consent. A has committed theft as soon as Z’s dog has begun to follow A.
(c) A meets a bullock carrying a box of treasure. He drives the bullock in a certain direction, in order that he may dishonestly take the treasure. As soon as the bullock begins to move, A has committed theft of the treasure.
(d) A being Z’s servant, and entrusted by Z with the care of Z’s plate, dishonestly runs away with the plate, without Z’s consent. A has committed theft.
(e) Z, going on a journey, entrusts his plate to A, the keeper of a warehouse, till Z shall return. A carries the plate to a goldsmith and sells it. Here the plate was not in Z’s possession. It could not therefore be taken out of Z’s possession, and A has not committed theft, though he may have committed criminal breach of trust.
(f) A finds a ring belonging to Z on a table in the house which Z occupies. Here the ring is in Z’s possession, and if A dishonestly removes it, A commits theft.
(g) A finds a ring lying on the highroad, not in the possession of any person. A, by taking it, commits no theft, though he may commit criminal misappropriation of property.
(h) A sees a ring belonging to Z lying on a table in Z’s house. Not venturing to misappropriate the ring immediately for fear of search and detection, A hides the ring in a place where it is highly improbable that it will ever be found by Z, with the intention of taking the ring from the hiding place and selling it when the loss is forgotten. Here A, at the time of first moving the ring, commits theft.
(i) A delivers his watch to Z, a jeweler, to be regulated. Z carries it to his shop. A, not owing to the jeweler any debt for which the jeweler might lawfully detain the watch as a security, enters the shop openly, takes his watch by force out of Z’s hand, and carries it away. Here A, though he may have committed criminal trespass and assault, has not committed theft, in as much as what he did was not done dishonestly.
(j) If A owes money to Z for repairing the watch, and if Z retains the watch lawfully as a security for the debt, and A takes the watch out of Z’s possession, with the intention of depriving Z of the property as a security for his debt, he commits theft, in as much as he takes it dishonestly.
(k) Again, if A, having pawned his watch to Z, takes it out of Z’s possession without Z’s consent, not having paid what he borrowed on the watch, he commits theft, though the watch is his own property in as much as he takes it dishonestly.
(l) A takes an article belonging to Z out of Z’s possession without Z’s consent, with the intention of keeping it until he obtains money from Z as a reward for its restoration. Here A takes dishonestly; A has therefore committed theft.
(m) A, being on friendly terms with Z, goes into Z’s library in Z’s absence, and takes away a book without Z’s express consent for the purpose merely of reading it, and with the intention of returning it. Here, it is probable that A may have conceived that he had Z’s implied consent to use Z’s book. If this was A’s impression, A has not committed theft.
(n) A asks charity from Z’s wife. She givesA money, food and clothes, which A knows to belong to Z her husband. Here it is probable that Amay conceive that Z’s wife is authorised to give away alms. If this was A’s impression, A has not committed theft.
(o) A is the paramour of Z’s wife. She gives a valuable property, which A knows to belong to her husband Z, and to be such property as she has no authority from Z to give. If A takes the property dishonestly, he commits theft.
(p) A, in good faith, believing property belonging to Z to be A’s own property, takes that property out of Z’s possession. Here, as A does not take dishonestly, he does not commit theft.
(2) Whoever commits theft shall be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both and in case of second or subsequent conviction of any person under this section, he shall be punished with rigorous imprisonment for a term which shall not be less than one year but which may extend to five years and with fine:
Provided that in cases of theft where the value of the stolen property is less than five thousand rupees, and a person is convicted for the first time, shall upon return of the value of property or restoration of the stolen property, shall be punished with community service.
- (1) Theft is snatching if, in order to commit theft, the offender suddenly or quickly or forcibly seizes or secures or grabs or takes away from any person or from his possession any movable property.(2) Whoever commits snatching, shall be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine.305. Whoever commits theft—(a) in any building, tent or vessel used as a human dwelling or used for the custody of property; or(b) of any means of transport used for the transport of goods or passengers; or(c) of any article or goods from any means of transport used for the transport of goods or passengers; or(d) of idol or icon in any place of worship; or(e) of any property of the Government or of a local authority, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.306. Whoever, being a clerk or servant, or being employed in the capacity of a clerk or servant, commits theft in respect of any property in the possession of his master or employer, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.307. Whoever commits theft, having made preparation for causing death, or hurt, or restraint, or fear of death, or of hurt, or of restraint, to any person, in order to the committing of such theft, or in order to the effecting of his escape after the committing of such theft, or in order to the retaining of property taken by such theft, shall be punished with rigorous imprisonment for a term which may extend to ten years, and shall also be liable to fine.
Illustrations
(a) A commits theft on property in Z’s possession; and while committing this theft, he has a loaded pistol under his garment, having provided this pistol for the purpose of hurting Z in case Z should resist. A has committed the offence defined in this section.(b) A picks Z’s pocket, having posted several of his companions near him, in order that they may restrain Z, if Z should perceive what is passing and should resist, or should attempt to apprehend A. A has committed the offence defined in this section.Of extortion 308. (1) Whoever intentionally puts any person in fear of any injury to that person, or to any other, and thereby dishonestly induces the person so put in fear to deliver to any person any property, or valuable security or anything signed or sealed which may be converted into a valuable security, commits extortion.
Illustrations
(a) A threatens to publish a defamatory libel concerning Z unless Z gives him money. He thus induces Z to give him money. A has committed extortion.
(b) Athreatens Z that he will keep Z’s child in wrongful confinement, unless Z will sign and deliver to A a promissory note binding Z to pay certain monies to A. Z signs and delivers the note. A has committed extortion.
(c) A threatens to send club-men to plough up Z’s field unless Z will sign and deliver to B a bond binding Z under a penalty to deliver certain produce to B, and thereby induces Z to sign and deliver the bond. A has committed extortion.
(d) A, by putting Z in fear of grievous hurt, dishonestly induces Z to sign or affix his seal to a blank paper and deliver it to A. Z signs and delivers the paper to A. Here, as the paper so signed may be converted into a valuable security. A has committed extortion.
(e) A threatens Z by sending a message through an electronic device that “Your child is in my possession, and will be put to death unless you send me one lakh rupees.” A thus induces Z to give him money. A has committed extortion.
(2) Whoever commits extortion shall be punished with imprisonment of either description for a term which may extend to seven years, or with fine, or with both.
(3)Whoever, in order to the committing of extortion, puts any person in fear, or attempts to put any person in fear, of any injury, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
(4) Whoever, in order to the committing of extortion, puts or attempts to put any person in fear of death or of grievous hurt to that person or to any other, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
(5) Whoever commits extortion by putting any person in fear of death or of grievous hurt to that person or to any other, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
(6) Whoever, in order to the committing of extortion, puts or attempts to put any person in fear of an accusation, against that person or any other, of having committed, or attempted to commit, an offence punishable with death or with imprisonment for life, or with imprisonment for a term which may extend to ten years, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
(7) Whoever commits extortion by putting any person in fear of an accusation against that person or any other, of having committed or attempted to commit any offence punishable with death, or with imprisonment for life, or with imprisonment for a term which may extend to ten years, or of having attempted to induce any other person to commit such offence, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
Of robbery and dacoity
309. (1) In all robbery there is either theft or extortion.
(2) Theft is robbery if, in order to the committing of the theft, or in committing the theft, or in carrying away or attempting to carry away property obtained by the theft, the offender, for that end voluntarily causes or attempts to cause to any person death or hurt or wrongful restraint, or fear of instant death or of instant hurt, or of instant wrongful restraint.
(3) Extortion is robbery if the offender, at the time of committing the extortion, is in the presence of the person put in fear, and commits the extortion by putting that person in fear of instant death, of instant hurt, or of instant wrongful restraint to that person or to some other person, and, by so putting in fear, induces the person so put in fear then and there to deliver up the thing extorted.
Explanation—The offender is said to be present if he is sufficiently near to put the other person in fear of instant death, of instant hurt, or of instant wrongful restraint.
Illustrations
(a) A holds Z down, and fraudulently takes Z’s money and jewels from Z’s clothes, without Z’s consent. Here A has committed theft, and, in order to the committing of that theft, has voluntarily caused wrongful restraint to Z. A has therefore committed robbery.
(b) A meets Z on the high road, shows a pistol, and demands Z’s purse. Z, in consequence, surrenders his purse. Here A has extorted the purse from Z by putting him in fear of instant hurt, and being at the time of committing the extortion in his presence. A has therefore committed robbery.
(c) A meets Z and Z’s child on the high road. A takes the child, and threatens to fling it down a precipice, unless Z delivers his purse. Z, in consequence, delivers his purse. Here A has extorted the purse from Z, by causing Z to be in fear of instant hurt to the child who is there present. A has therefore committed robbery on Z.
(d) A obtains property from Z by saying—“Your child is in the hands of my gang, and will be put to death unless you send us ten thousand rupees”. This is extortion, and punishable as such; but it is not robbery, unless Z is put in fear of the instant death of his child.
(4) Whoever commits robbery shall be punished with rigorous imprisonment for a term which may extend to ten years, and shall also be liable to fine; and, if the robbery be committed on the highway between sunset and sunrise, the imprisonment may be extended to fourteen years.
(5) Whoever attempts to commit robbery shall be punished with rigorous imprisonment for a term which may extend to seven years, and shall also be liable to fine.
(6) If any person, in committing or in attempting to commit robbery, voluntarily causes hurt, such person, and any other person jointly concerned in committing or attempting to commit such robbery, shall be punished with imprisonment for life, or with rigorous imprisonment for a term which may extend to ten years, and shall also be liable to fine.
310. (1)When five or more persons conjointly commit or attempt to commit a robbery, or where the whole number of persons conjointly committing or attempting to commit a robbery, and persons present and aiding such commission or attempt, amount to five or more, every person so committing, attempting or aiding, is said to commit dacoity.
(2) Whoever commits dacoity shall be punished with imprisonment for life, or with rigorous imprisonment for a term which may extend to ten years, and shall also be liable to fine.
(3) If any one of five or more persons, who are conjointly committing dacoity, commits murder in so committing dacoity, every one of those persons shall be punished with death, or imprisonment for life, or rigorous imprisonment for a term which shall not be less than ten years, and shall also be liable to fine.
(4) Whoever makes any preparation for committing dacoity, shall be punished with rigorous imprisonment for a term which may extend to ten years, and shall also be liable to fine.
(5) Whoever is one of five or more persons assembled for the purpose of committing dacoity, shall be punished with rigorous imprisonment for a term which may extend to seven years, and shall also be liable to fine.
(6) Whoever belongs to a gang of persons associated for the purpose of habitually committing dacoity, shall be punished with imprisonment for life, or with rigorous imprisonment for a term which may extend to ten years, and shall also be liable to fine.
311. If, at the time of committing robbery or dacoity, the offender uses any deadly weapon, or causes grievous hurt to any person, or attempts to cause death or grievous hurt to any person, the imprisonment with which such offender shall be punished shall not be less than seven years.
312. If, at the time of attempting to commit robbery or dacoity, the offender is armed with any deadly weapon, the imprisonment with which such offender shall be punished shall not be less than seven years.
- Whoever belongs to any gang of persons associated in habitually committing theft or robbery, and not being a gang of dacoits, shall be punished with rigorous imprisonment for a term which may extend to seven years, and shall also be liable to fine. Of criminal misappropriation of property314. Whoever dishonestly misappropriates or converts to his own use any movable property, shall be punished with imprisonment of either description for a term which shall not be less than six months but which may extend to two years and with fine.
Illustrations
(a) A takes property belonging to Z out of Z’s possession, in good faith believing at the time when he takes it, that the property belongs to himself. A is not guilty of theft; but if A, after discovering his mistake, dishonestly appropriates the property to his own use, he is guilty of an offence under this section.(b) A, being on friendly terms with Z, goes into Z’s library in Z’s absence, and takes away a book without Z’s express consent. Here, if Awas under the impression that he had Z’s implied consent to take the book for the purpose of reading it, A has not committed theft. But, ifA afterwards sells the book for his own benefit, he is guilty of an offence under this section.(c) A and B, being, joint owners of a horse. A takes the horse out of B’s possession, intending to use it. Here, as A has a right to use the horse, he does not dishonestly misappropriate it. But, if A sells the horse and appropriates the whole proceeds to his own use, he is guilty of an offence under this section.Explanation 1—A dishonest misappropriation for a time only is a misappropriation within the meaning of this section. Illustration. A finds a Government promissory note belonging to Z, bearing a blank endorsement. A, knowing that the note belongs to Z, pledges it with a banker as a security for a loan, intending at a future time to restore it to Z. A has committed an offence under this section.
Explanation 2—A person who finds property not in the possession of any other person, and takes such property for the purpose of protecting it for, or of restoring it to, the owner, does not take or misappropriate it dishonestly, and is not guilty of an offence; but he is guilty of the offence above defined, if he appropriates it to his own use, when he knows or has the means of discovering the owner, or before he has used reasonable means to discover and give notice to the owner and has kept the property a reasonable time to enable the owner to claim it. What are reasonable means or what is a reasonable time in such a case, is a question of fact. It is not necessary that the finder should know who is the owner of the property, or that any particular person is the owner of it; it is sufficient if, at the time of appropriating it, he does not believe it to be his own property, or in good faith believe that the real owner cannot be found.
Illustrations
(a) A finds a rupee on the high road, not knowing to whom the rupee belongs, A picks up the rupee. Here A has not committed the offence defined in this section.
(b) A finds a letter on the road, containing a bank-note. From the direction and contents of the letter he learns to whom the note belongs. He appropriates the note. He is guilty of an offence under this section.
(c) A finds a cheque payable to bearer. He can form no conjecture as to the person who has lost the cheque. But the name of the person, who has drawn the cheque, appears. A knows that this person can direct him to the person in whose favour the cheque was drawn. A appropriates the cheque without attempting to discover the owner. He is guilty of an offence under this section.
(d) A sees Z drop his purse with money in it. A picks up the purse with the intention of restoring it to Z, but afterwards appropriates it to his own use. A has committed an offence under this section.
(e) A finds a purse with money, not knowing to whom it belongs; he afterwards discovers that it belongs to Z, and appropriates it to his own use. A is guilty of an offence under this section.
(f) A finds a valuable ring, not knowing to whom it belongs. A sells it immediately without attempting to discover the owner. A is guilty of an offence under this section.
315. Whoever dishonestly misappropriates or converts to his own use any property, knowing that such property was in the possession of a deceased person at the time of that person’s decease, and has not since been in the possession of any person legally entitled to such possession, shall be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine, and if the offender at the time of such person’s decease was employed by him as a clerk or servant, the imprisonment may extend to seven years.
Illustrations
Z dies in possession of furniture and money. His servant A, before the money comes into the possession of any person entitled to such possession, dishonestly misappropriates it. A has committed the offence defined in this section. Of criminal breach of trust
316. (1) Whoever, being in any manner entrusted with property, or with any dominion over property, dishonestly misappropriates or converts to his own use that property, or dishonestly uses or disposes of that property in violation of any direction of law prescribing the mode in which such trust is to be discharged, or of any legal contract, express or implied, which he has made touching the discharge of such trust, or wilfully suffers any other person so to do, commits criminal breach of trust.
Explanation 1—A person, being an employer of an establishment whether exempted under section 17 of the Employees’ Provident Funds and Miscellaneous Provisions Act, 1952 or not who deducts the employee’s contribution from the wages payable to the employee for credit to a Provident Fund or Family Pension Fund established by any law for the time being in force, shall be deemed to have been entrusted with the amount of the contribution so deducted by him and if he makes default in the payment of such contribution to the said Fund in violation of the said law, shall be deemed to have dishonestly used the amount of the said contribution in violation of a direction of law as aforesaid.
Explanation 2—A person, being an employer, who deducts the employees’ contribution from the wages payable to the employee for credit to the Employees’ State Insurance Fund held and administered by the Employees’ State Insurance Corporation established under the Employees’ State Insurance Act, 1948 shall be deemed to have been entrusted with the amount of the contribution so deducted by him and if he makes default in the payment of such contribution to the said Fund in violation of the said Act, shall be deemed to have dishonestly used the amount of the said contribution in violation of a direction of law as aforesaid.
Illustrations
(a) A, being executor to the will of a deceased person, dishonestly disobeys the law which directs him to divide the effects according to the will, and appropriates them to his own use. A has committed criminal breach of trust.
(b) A is a warehouse-keeper Z going on a journey, entrusts his furniture to A, under a contract that it shall be returned on payment of a stipulated sum for warehouse room. A dishonestly sells the goods. A has committed criminal breach of trust.
(c) A, residing in Kolkata, is agent for Z, residing at Delhi. There is an express or implied contract between A and Z, that all sums remitted by Z to A shall be invested by A, according to Z’s direction. Z remits one lakh of rupees to A, with directions toA to invest the same in Company’s paper. A dishonestly disobeys the directions and employs the money in his own business. A has committed criminal breach of trust.
(d) But if A, in illustration (c), not dishonestly but in good faith, believing that it will be more for Z’s advantage to hold shares in the Bank of Bengal, disobeys Z’s directions, and buys shares in the Bank of Bengal, for Z, instead of buying Company’s paper, here, though Z should suffer loss, and should be entitled to bring a civil action against A, on account of that loss, yet A, not having acted dishonestly, has not committed criminal breach of trust.
(e) A, a revenue-officer, is entrusted with public money and is either directed by law, or bound by a contract, express or implied, with the Government, to pay into a certain treasury all the public money which he holds. A dishonestly appropriates the money.A has committed criminal breach of trust.
(f) A, a carrier, is entrusted by Z with property to be carried by land or by water. A dishonestly misappropriates the property. A has committed criminal breach of trust.
(2) Whoever commits criminal breach of trust shall be punished with imprisonment of either description for a term which may extend to five years, or with fine, or with both.
(3) Whoever, being entrusted with property as a carrier, wharfinger or warehouse-keeper, commits criminal breach of trust in respect of such property, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
(4) Whoever, being a clerk or servant or employed as a clerk or servant, and being in any manner entrusted in such capacity with property, or with any dominion over property, commits criminal breach of trust in respect of that property, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
(5) Whoever, being in any manner entrusted with property, or with any dominion over property in his capacity of a public servant or in the way of his business as a banker, merchant, factor, broker, attorney or agent commits criminal breach of trust in respect of that property, shall be punished with imprisonment for life, or with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine. Of receiving stolen property
317. (1) Property, the possession whereof has been transferred by theft or extortion or robbery or cheating, and property which has been criminally misappropriated or in respect of which criminal breach of trust has been committed, is designated as stolen property, whether the transfer has been made, or the misappropriation or breach of trust has been committed, within or without India, but, if such property subsequently comes into the possession of a person legally entitled to the possession thereof, it then ceases to be stolen property.
(2) Whoever dishonestly receives or retains any stolen property, knowing or having reason to believe the same to be stolen property, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both.
(3) Whoever dishonestly receives or retains any stolen property, the possession whereof he knows or has reason to believe to have been transferred by the commission of dacoity, or dishonestly receives from a person, whom he knows or has reason to believe to belong or to have belonged to a gang of dacoits, property which he knows or has reason to believe to have been stolen, shall be punished with imprisonment for life, or with rigorous imprisonment for a term which may extend to ten years, and shall also be liable to fine.
(4) Whoever habitually receives or deals in property which he knows or has reason to believe to be stolen property, shall be punished with imprisonment for life, or with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
(5) Whoever voluntarily assists in concealing or disposing of or making away with property which he knows or has reason to believe to be stolen property, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both.
Of cheating
318. (1) Whoever, by deceiving any person, fraudulently or dishonestly induces the person so deceived to deliver any property to any person, or to consent that any person shall retain any property, or intentionally induces the person so deceived to do or omit to do anything which he would not do or omit if he were not so deceived, and which act or omission causes or is likely to cause damage or harm to that person in body, mind, reputation or property, is said to cheat.
Explanation—A dishonest concealment of facts is a deception within the meaning of this section.
Illustrations
(a) A, by falsely pretending to be in the Civil Service, intentionally deceives Z, and thus dishonestly induces Z to let him have on credit goods for which he does not mean to pay. A cheats.
(b) A, by putting a counterfeit mark on an article, intentionally deceives Z into a belief that this article was made by a certain celebrated manufacturer, and thus dishonestly induces Z to buy and pay for the article. A cheats
(c) A, by exhibiting to Z a false sample of an article intentionally deceives Z into believing that the article corresponds with the sample, and thereby dishonestly induces Z to buy and pay for the article. A cheats
(d) A, by tendering in payment for an article a bill on a house with which A keeps no money, and by which A expects that the bill will be dishonoured, intentionally deceives Z, and thereby dishonestly induces Z to deliver the article, intending not to pay for it. A cheats
(e)A, by pledging as diamonds articles which he knows are not diamonds, intentionally deceives Z, and thereby dishonestly induces Z to lend money. A cheats
(f) A intentionally deceives Z into a belief that A means to repay any money that Z may lend to him and thereby dishonestly induces Z to lend him money, A not intending to repay it. A cheats.
(g) A intentionally deceives Z into a belief that A means to deliver to Z a certain quantity of indigo plant which he does not intend to deliver, and thereby dishonestly induces Z to advance money upon the faith of such delivery. A cheats
but if A, at the time of obtaining the money, intends to deliver the indigo plant, and afterwards breaks his contract and does not deliver it, he does not cheat, but is liable only to a civil action for breach of contract.
(h) Aintentionally deceives Z into a belief that A has performedA’s part of a contract made with Z, which he has not performed, and thereby dishonestly induces Z to pay money. A cheats
(i) A sells and conveys an estate to B. A, knowing that in consequence of such sale he has no right to the property, sells or mortgages the same to Z, without disclosing the fact of the previous sale and conveyance to B, and receives the purchase or mortgage money from Z. A cheats.
(2) Whoever cheats shall be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both.
(3) Whoever cheats with the knowledge that he is likely thereby to cause wrongful loss to a person whose interest in the transaction to which the cheating relates, he was bound, either by law, or by a legal contract, to protect, shall be punished with imprisonment of either description for a term which may extend to five years, or with fine, or with both.
(4) Whoever cheats and thereby dishonestly induces the person deceived to deliver any property to any person, or to make, alter or destroy the whole or any part of a valuable security, or anything which is signed or sealed, and which is capable of being converted into a valuable security, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
319. (1) A person is said to cheat by personation if he cheats by pretending to be some other person, or by knowingly substituting one person for or another, or representing that he or any other person is a person other than he or such other person really is. Explanation.—The offence is committed whether the individual personated is a real or imaginary person.
Illustrations
(a) A cheats by pretending to be a certain rich banker of the same name. A cheats by personation.
(b)A cheats by pretending to be B, a person who is deceased. A cheats by personation.
(2) Whoever cheats by personation shall be punished with imprisonment of either description for a term which may extend to five years, or with fine, or with both. Of fraudulent deeds and dispositions of property
320. Whoever dishonestly or fraudulently removes, conceals or delivers to any person, or transfers or causes to be transferred to any person, without adequate consideration, any property, intending thereby to prevent, or knowing it to be likely that he will thereby prevent, the distribution of that property according to law among his creditors or the creditors of any other person, shall be punished with imprisonment of either description for a term which shall not be less than six months but which may extend to two years, or with fine, or with both.
321. Whoever dishonestly or fraudulently prevents any debt or demand due to himself or to any other person from being made available according to law for payment of his debts or the debts of such other person, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
322. Whoever dishonestly or fraudulently signs, executes or becomes a party to any deed or instrument which purports to transfer or subject to any charge any property, or any interest therein, and which contains any false statement relating to the consideration for such transfer or charge, or relating to the person or persons for whose use or benefit it is really intended to operate, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both.
- Whoever dishonestly or fraudulently conceals or removes any property of himself or any other person, or dishonestly or fraudulently assists in the concealment or removal thereof, or dishonestly releases any demand or claim to which he is entitled, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both. Of mischief324. (1) Whoever with intent to cause, or knowing that he is likely to cause, wrongful loss or damage to the public or to any person, causes the destruction of any property, or any such change in any property or in the situation thereof as destroys or diminishes its value or utility, or affects it injuriously, commits mischief.Explanation 1—It is not essential to the offence of mischief that the offender should intend to cause loss or damage to the owner of the property injured or destroyed. It is sufficient if he intends to cause, or knows that he is likely to cause, wrongful loss or damage to any person by injuring any property, whether it belongs to that person or not.Explanation 2—Mischief may be committed by an act affecting property belonging to the person who commits the act, or to that person and others jointly.
Illustrations
(a) A voluntarily burns a valuable security belonging to Z intending to cause wrongful loss to Z. A has committed mischief.(b) A introduces water into an ice-house belonging to Z and thus causes the ice to melt, intending wrongful loss to Z. A has committed mischief.(c) A voluntarily throws into a river a ring belonging to Z, with the intention of thereby causing wrongful loss to Z. A has committed mischief.(d) A, knowing that his effects are about to be taken in execution in order to satisfy a debt due from him to Z, destroys those effects, with the intention of thereby preventing Z from obtaining satisfaction of the debt, and of thus causing damage to Z. A has committed mischief.
(e) A having insured a ship, voluntarily causes the same to be cast away, with the intention of causing damage to the underwriters. A has committed mischief.
(f) A causes a ship to be cast away, intending thereby to cause damage to Z who has lent money on bottomry on the ship. A has committed mischief.
(g) A, having joint property with Z in a horse, shoots the horse, intending thereby to cause wrongful loss to Z. A has committed mischief.
(h) A causes cattle to enter upon a field belonging to Z, intending to cause and knowing that he is likely to cause damage to Z’s crop. A has committed mischief.
(2)Whoever commits mischief shall be punished with imprisonment of either description for a term which may extend to six months, or with fine, or with both.
(3) Whoever commits mischief and thereby causes loss or damage to any property including the property of Government or LocalAuthority shall be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both.
(4) Whoever commits mischief and thereby causes loss or damage to the amount of twenty thousand rupees and more but less than one lakh rupees shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
(5) Whoever commits mischief and thereby causes loss or damage to the amount of one lakh rupees or upwards, shall be punished with imprisonment of either description for a term which may extend to five years, or with fine, or with both.
(6) Whoever commits mischief, having made preparation for causing to any person death, or hurt, or wrongful restraint, or fear of death, or of hurt, or of wrongful restraint, shall be punished with imprisonment of either description for a term which may extend to five years, and shall also be liable to fine.
325. Whoever commits mischief by killing, poisoning, maiming or rendering useless any animal shall be punished with imprisonment of either description for a term which may extend to five years, or with fine, or with both.
326. Whoever commits mischief by,—
(a) doing any act which causes, or which he knows to be likely to cause, a diminution of the supply of water for agricultural purposes, or for food or drink for human beings or for animals which are property, or for cleanliness or for carrying on any manufacture, shall be punished with imprisonment of either description for a term which may extend to five years, or with fine, or with both;
(b) doing any act which renders or which he knows to be likely to render any public road, bridge, navigable river or navigable channel, natural or artificial, impassable or less safe for travelling or conveying property, shall be punished with imprisonment of either description for a term which may extend to five years, or with fine, or with both;
(c) doing any act which causes or which he knows to be likely to cause an inundation or an obstruction to any public drainage attended with injury or damage, shall be punished with imprisonment of either description for a term which may extend to five years, or with fine, or with both;
(d) destroying or moving any sign or signal used for navigation of rail, aircraft or ship or other thing placed as a guide for navigators, or by any act which renders any such sign or signal less useful as a guide for navigators, shall be punished with imprisonment of either description for a term which may extend to seven years, or with fine, or with both;
(e) destroying or moving any land-mark fixed by the authority of a public servant, or by any act which renders such land-mark less useful as such, shall be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both;
(f) fire or any explosive substance intending to cause, or knowing it to be likely that he will thereby cause, damage to any property including agricultural produce, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine;
(g) fire or any explosive substance, intending to cause, or knowing it to be likely that he will thereby cause, the destruction of any building which is ordinarily used as a place of worship or as a human dwelling or as a place for the custody of property, shall be punished with imprisonment for life, or with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
327. (1) Whoever commits mischief to any rail, aircraft, or a decked vessel or any vessel of a burden of twenty tons or upwards, intending to destroy or render unsafe, or knowing it to be likely that he will thereby destroy or render unsafe, that rail, aircraft or vessel, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
(2) Whoever commits, or attempts to commit, by fire or any explosive substance, such mischief as is described in sub-section (1), shall be punished with imprisonment for life or with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
- Whoever intentionally runs any vessel aground or ashore, intending to commit theft of any property contained therein or to dishonestly misappropriate any such property, or with intent that such theft or misappropriation of property may be committed, shall be punished with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine. Of criminal trespass329. (1) Whoever enters into or upon property in the possession of another with intent to commit an offence or to intimidate, insult or annoy any person in possession of such property or having lawfully entered into or upon such property, unlawfully remains there with intent thereby to intimidate, insult or annoy any such person or with intent to commit an offence is said to commit criminal trespass.(2) Whoever commits criminal trespass by entering into or remaining in any building, tent or vessel used as a human dwelling or any building used as a place for worship, or as a place for the custody of property, is said to commit house-trespass.Explanation—The introduction of any part of the criminal trespasser’s body is entering sufficient to constitute house-trespass.(3) Whoever commits criminal trespass shall be punished with imprisonment of either description for a term which may extend to three months, or with fine which may extend to five thousand rupees, or with both.(4) Whoever commits house-trespass shall be punished with imprisonment of either description for a term which may extend to one year, or with fine which may extend to five thousand rupees, or with both.330. (1) Whoever commits house-trespass having taken precautions to conceal such house-trespass from some person who has a right to exclude or eject the trespasser from the building, tent or vessel which is the subject of the trespass, is said to commit lurking house-trespass.(2) A person is said to commit house-breaking who commits house-trespass if he effects his entrance into the house or any part of it in any of the six ways hereinafter described; or if, being in the house or any part of it for the purpose of committing an offence, or having committed an offence therein, he quits the house or any part of it in any of the following ways, namely:––(a) if he enters or quits through a passage made by himself, or by any abettor of the house-trespass, in order to the committing of the house-trespass;(b) if he enters or quits through any passage not intended by any person, other than himself or an abettor of the offence, for human entrance; or through any passage to which he has obtained access by scaling or climbing over any wall or building;(c) if he enters or quits through any passage which he or any abettor of the house-trespass has opened, in order to the committing of the house-trespass by any means by which that passage was not intended by the occupier of the house to be opened;(d) if he enters or quits by opening any lock in order to the committing of the house-trespass, or in order to the quitting of the house after a house-trespass;(e) if he effects his entrance or departure by using criminal force or committing an assault, or by threatening any person with assault;(f) if he enters or quits by any passage which he knows to have been fastened against such entrance or departure, and to have been unfastened by himself or by an abettor of the house-trespass.
Explanation—Any out-house or building occupied with a house, and between which and such house there is an immediate internal communication, is part of the house within the meaning of this section.
Illustrations
(a) A commits house-trespass by making a hole through the wall of Z’s house, and putting his hand through the aperture. This is house-breaking.
(b) A commits house-trespass by creeping into a ship at a port-hole between decks. This is house-breaking.
(c) A commits house-trespass by entering Z’s house through a window. This is house-breaking.
(d) A commits house-trespass by entering Z’s house through the door, having opened a door which was fastened. This is house-breaking.
(e) A commits house-trespass by entering Z’s house through the door, having lifted a latch by putting a wire through a hole in the door. This is house-breaking.
(f) A finds the key of Z’s house door, which Z had lost, and commits house-trespass by entering Z’s house, having opened the door with that key. This is house-breaking.
(g) Z is standing in his doorway. A forces a passage by knocking Z down, and commits house-trespass by entering the house. This is house-breaking.
(h) Z, the door-keeper of Y, is standing in Y’s doorway. A commits house-trespass by entering the house, having deterred Z from opposing him by threatening to beat him. This is house-breaking.
331.(1) Whoever commits lurking house-trespass or house-breaking, shall be punished with imprisonment of either description for a term which may extend to two years, and shall also be liable to fine.
(2) Whoever commits lurking house-trespass or house-breaking after sunset and before sunrise, shall be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine.
(3) Whoever commits lurking house-trespass or house-breaking, in order to the committing of any offence punishable with imprisonment, shall be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine; and if the offence intended to be committed is theft, the term of the imprisonment may be extended to ten years.
(4) Whoever commits lurking house-trespass or house-breaking after sunset and before sunrise, in order to the committing of any offence punishable with imprisonment, shall be punished with imprisonment of either description for a term which may extend to five years, and shall also be liable to fine; and, if the offence intended to be committed is theft, the term of the imprisonment may be extended to fourteen years.
(5) Whoever commits lurking house-trespass, or house-breaking, having made preparation for causing hurt to any person, or for assaulting any person, or for wrongfully restraining any person, or for putting any person in fear of hurt or of assault or of wrongful restraint, shall be punished with imprisonment of either description or a term which may extend to ten years, and shall also be liable to fine.
(6) Whoever commits lurking house-trespass or house-breaking after sunset and before sunrise, having made preparation for causing hurt to any person or for assaulting any person, or for wrongfully restraining any person, or for putting any person in fear of hurt, or of assault, or of wrongful restraint, shall be punished with imprisonment of either description for a term which may extend to fourteen years, and shall also be liable to fine.
(7) Whoever, whilst committing lurking house-trespass or house-breaking, causes grievous hurt to any person or attempts to cause death or grievous hurt to any person, shall be punished with imprisonment for life, or imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
(8) If, at the time of the committing of lurking house-trespass or house-breaking after sunset and before sunrise, any person guilty of such offence shall voluntarily cause or attempt to cause death or grievous hurt to any person, every person jointly concerned in committing such lurking house-trespass or house-breaking after sunset and before sunrise, shall be punished with imprisonment for life, or with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
332. Whoever commits house-trespass in order to the committing of any offence––
(a) punishable with death, shall be punished with imprisonment for life, or with rigorous imprisonment for a term not exceeding ten years, and shall also be liable to fine;
(b) punishable with imprisonment for life, shall be punished with imprisonment of either description for a term not exceeding ten years, and shall also be liable to fine;
(c) punishable with imprisonment, shall be punished with imprisonment of either description for a term which may extend to two years, and shall also be liable to fine: Provided that if the offence intended to be committed is theft, the term of the imprisonment may be extended to seven years.
333. Whoever commits house-trespass, having made preparation for causing hurt to any person or for assaulting any person, or for wrongfully restraining any person, or for putting any person in fear of hurt, or of assault, or of wrongful restraint, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
334. (1) Whoever dishonestly or with intent to commit mischief, breaks open or unfastens any closed receptacle which contains or which he believes to contain property, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
(2) Whoever, being entrusted with any closed receptacle which contains or which he believes to contain property, without having authority to open the same, dishonestly, or with intent to commit mischief, breaks open or unfastens that receptacle, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both.
CHAPTER XVIII
OF OFFENCES RELATING TO DOCUMENTS AND TO PROPERTY MARKS
335. A person is said to make a false document or false electronic record—
(A) Who dishonestly or fraudulently—
(i) makes, signs, seals or executes a document or part of a document;
(ii) makes or transmits any electronic record or part of any electronic record;
(iii) affixes any electronic signature on any electronic record;
(iv) makes any mark denoting the execution of a document or the authenticity of the electronic signature, with the intention of causing it to be believed that such document or part of document, electronic record or electronic signature was made, signed, sealed, executed, transmitted or affixed by or by the authority of a person by whom or by whose authority he knows that it was not made, signed, sealed, executed or affixed; or
(B) Who without lawful authority, dishonestly or fraudulently, by cancellation or otherwise, alters a document or an electronic record in any material part thereof, after it has been made, executed or affixed with electronic signature either by himself or by any other person, whether such person be living or dead at the time of such alteration; or
(C) Who dishonestly or fraudulently causes any person to sign, seal, execute or alter a document or an electronic record or to affix his electronic signature on any electronic record knowing that such person by reason of unsoundness of mind or intoxication cannot, or that by reason of deception practised upon him, he does not know the contents of the document or electronic record or the nature of the alteration.
Illustrations
(a) A has a letter of credit upon B for rupees 10,000, written by Z. A, in order to defraud B, adds cipher to the 10,000, and makes the sum 1,00,000 intending that it may be believed by B that Z so wrote the letter. A has committed forgery.
(b)A, without Z’s authority, affixes Z’s seal to a document purporting to be a conveyance of an estate from Z to A, with the intention of selling the estate to B and thereby of obtaining from B the purchase-money. A has committed forgery.
(c) A picks up a cheque on a banker signed by B, payable to bearer, but without any sum having been inserted in the cheque. A fraudulently fills up the cheque by inserting the sum of ten thousand rupees. A commits forgery.
(d) A leaves with B, his agent, a cheque on a banker, signed byA, without inserting the sum payable and authorises B to fill up the cheque by inserting a sum not exceeding ten thousand rupees for the purpose of making certain payments. B fraudulently fills up the cheque by inserting the sum of twenty thousand rupees. B commits forgery.
(e) A draws a bill of exchange on himself in the name of B without B’s authority, intending to discount it as a genuine bill with a banker and intending to take up the bill on its maturity. Here, as A draws the bill with intent to deceive the banker by leading him to suppose that he had the security of B, and thereby to discount the bill, A is guilty of forgery.
(f) Z’s will contains these words—“I direct that all my remaining property be equally divided between A, B and C”.A dishonestly scratches out B’s name, intending that it may be believed that the whole was left to himself and C. A has committed forgery.
(g) A endorses a Government promissory note and makes it payable to Z or his order by writing on the bill the words “Pay to Z or his order” and signing the endorsement. B dishonestly erases the words “Pay to Z or his order”, and thereby converts the special endorsement into a blank endorsement. B commits forgery.
(h) A sells and conveys an estate to Z. A afterwards, in order to defraud Z of his estate, executes a conveyance of the same estate to B, dated six months earlier than the date of the conveyance to Z, intending it to be believed that he had conveyed the estate to B before he conveyed it to Z. A has committed forgery.
(i) Z dictates his will to A. A intentionally writes down a different legatee from the legatee named by Z, and by representing to Z that he has prepared the will according to his instructions, induces Z to sign the will. A has committed forgery.
(j) Awrites a letter and signs it with B’s name without B’s authority, certifying that A is a man of good character and in distressed circumstances from unforeseen misfortune, intending by means of such letter to obtain alms from Z and other persons. Here, as A made a false document in order to induce Z to part with property, A has committed forgery.
(k) A without B’s authority writes a letter and signs it in B’s name certifying to A’s character, intending thereby to obtain employment under Z. A has committed forgery in as much as he intended to deceive Z by the forged certificate, and thereby to induce Z to enter into an express or implied contract for service.
Explanation 1—A man’s signature of his own name may amount to forgery.
Illustrations
(a) A signs his own name to a bill of exchange, intending that it may be believed that the bill was drawn by another person of the same name. A has committed forgery.
(b) A writes the word “accepted” on a piece of paper and signs it with Z’s name, in order that B may afterwards write on the paper a bill of exchange drawn by B upon Z, and negotiate the bill as though it had been accepted by Z. A is guilty of forgery; and if B, knowing the fact, draws the bill upon the paper pursuant to A’s intention, B is also guilty of forgery.
(c) A picks up a bill of exchange payable to the order of a different person of the same name. A endorses the bill in his own name, intending to cause it to be believed that it was endorsed by the person to whose order it was payable; here A has committed forgery.
(d) A purchases an estate sold under execution of a decree against B. B, after the seizure of the estate, in collusion with Z, executes a lease of the estate, to Z at a nominal rent and for a long period and dates the lease six months prior to the seizure, with intent to defraud A, and to cause it to be believed that the lease was granted before the seizure. B, though he executes the lease in his own name, commits forgery by antedating it.
(e) A, a trader, in anticipation of insolvency, lodges effects with B for A’s benefit, and with intent to defraud his creditors; and in order to give a colour to the transaction, writes a promissory note binding himself to pay to B a sum for value received, and antedates the note, intending that it may be believed to have been made before A was on the point of insolvency. A has committed forgery under the first head of the definition.
Explanation 2—The making of a false document in the name of a fictitious person, intending it to be believed that the document was made by a real person, or in the name of a deceased person, intending it to be believed that the document was made by the person in his lifetime, may amount to forgery.
Illustrations
A draws a bill of exchange upon a fictitious person, and fraudulently accepts the bill in the name of such fictitious person with intent to negotiate it. A commits forgery.
Explanation 3—For the purposes of this section, the expression “affixing electronic signature” shall have the meaning assigned to it in clause (d) of sub-section (1) of section 2 of the Information Technology Act, 2000.
336. (1) Whoever makes any false document or false electronic record or part of a document or electronic record, with intent to cause damage or injury, to the public or to any person, or to support any claim or title, or to cause any person to part with property, or to enter into any express or implied contract, or with intent to commit fraud or that fraud may be committed, commits forgery.
(2) Whoever commits forgery shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
(3)Whoever commits forgery, intending that the document or electronic record forged shall be used for the purpose of cheating, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
(4)Whoever commits forgery, intending that the document or electronic record forged shall harm the reputation of any party, or knowing that it is likely to be used for that purpose, shall be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine.
337. Whoever forges a document or an electronic record, purporting to be a record or proceeding of or in a Court or an identity document issued by Government including voter identity card or Aadhaar Card, or a register of birth, marriage or burial, or a register kept by a public servant as such, or a certificate or document purporting to be made by a public servant in his official capacity, or an authority to institute or defend a suit, or to take any proceedings therein, or to confess judgment, or a power of attorney, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
Explanation—For the purposes of this section, “register” includes any list, data or record of any entries maintained in the electronic form as defined in clause (r) of sub-section (1) of section 2 of the Information Technology Act, 2000.
338. Whoever forges a document which purports to be a valuable security or a will, or an authority to adopt a son, or which purports to give authority to any person to make or transfer any valuable security, or to receive the principal, interest or dividends thereon, or to receive or deliver any money, movable property, or valuable security, or any document purporting to be an acquittance or receipt acknowledging the payment of money, or an acquittance or receipt for the delivery of any movable property or valuable security, shall be punished with imprisonment for life, or with imprisonment of either description for a term which may extend to ten years, and shall also be liable to fine.
339. Whoever has in his possession any document or electronic record, knowing the same to be forged and intending that the same shall fraudulently or dishonestly be used as genuine, shall, if the document or electronic record is one of the description mentioned in section 337 of this Sanhita, be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine; and if the document is one of the description mentioned in section 338, shall be punished with imprisonment for life, or with imprisonment of either description, for a term which may extend to seven years, and shall also be liable to fine.
340. (1) A false document or electronic record made wholly or in part by forgery is designated a forged document or electronic record. (2) Whoever fraudulently or dishonestly uses as genuine any document or electronic record which he knows or has reason to believe to be a forged document or electronic record, shall be punished in the same manner as if he had forged such document or electronic record.
341. (1) Whoever makes or counterfeits any seal, plate or other instrument for making an impression, intending that the same shall be used for the purpose of committing any forgery which would be punishable under section 338 of this Sanhita, or, with such intent, has in his possession any such seal, plate or other instrument, knowing the same to be counterfeit, shall be punished with imprisonment for life, or with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
(2) Whoever makes or counterfeits any seal, plate or other instrument for making an impression, intending that the same shall be used for the purpose of committing any forgery which would be punishable under any section of this Chapter other than section 338, or, with such intent, has in his possession any such seal, plate or other instrument, knowing the same to be counterfeit, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
(3) Whoever possesses any seal, plate or other instrument knowing the same to be counterfeit, shall be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine.
(4) Whoever fraudulently or dishonestly uses as genuine any seal, plate or other instrument knowing or having reason to believe the same to be counterfeit, shall be punished in the same manner as if he had made or counterfeited such seal, plate or other instrument.
342. (1) Whoever counterfeits upon, or in the substance of, any material, any device or mark used for the purpose of authenticating any document described in section 338, intending that such device or mark shall be used for the purpose of giving the appearance of authenticity to any document then forged or thereafter to be forged on such material, or who, with such intent, has in his possession any material upon or in the substance of which any such device or mark has been counterfeited, shall be punished with imprisonment for life, or with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
(2) Whoever counterfeits upon, or in the substance of, any material, any device or mark used for the purpose of authenticating any document or electronic record other than the documents described in section 338, intending that such device or mark shall be used for the purpose of giving the appearance of authenticity to any document then forged or thereafter to be forged on such material, or who with such intent, has in his possession any material upon or in the substance of which any such device or mark has been counterfeited, shall be punished with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
343. Whoever fraudulently or dishonestly, or with intent to cause damage or injury to the public or to any person, cancels, destroys or defaces, or attempts to cancel, destroy or deface, or secretes or attempts to secrete any document which is or purports to be a will, or an authority to adopt a son, or any valuable security, or commits mischief in respect of such document, shall be punished with imprisonment for life, or with imprisonment of either description for a term which may extend to seven years, and shall also be liable to fine.
344. Whoever, being a clerk, officer or servant, or employed or acting in the capacity of a clerk, officer or servant, wilfully, and with intent to defraud, destroys, alters, mutilates or falsifies any book, electronic record, paper, writing, valuable security or account which belongs to or is in the possession of his employer, or has been received by him for or on behalf of his employer, or wilfully, and with intent to defraud, makes or abets the making of any false entry in, or omits or alters or abets the omission or alteration of any material particular from or in, any such book, electronic record, paper, writing, valuable security or account, shall be punished with imprisonment of either description for a term which may extend to seven years, or with fine, or with both.
Explanation—It shall be sufficient in any charge under this section to allege a general intent to defraud without naming any particular person intended to be defrauded or specifying any particular sum of money intended to be the subject of the fraud, or any particular day on which the offence was committed. Of property marks
345. (1) Amark used for denoting that movable property belongs to a particular person is called a property mark.
(2) Whoever marks any movable property or goods or any case, package or other receptacle containing movable property or goods, or uses any case, package or other receptacle having any mark thereon, in a manner reasonably calculated to cause it to be believed that the property or goods so marked, or any property or goods contained in any such receptacle so marked, belong to a person to whom they do not belong, is said to use a false property mark.
(3) Whoever uses any false property mark shall, unless he proves that he acted without intent to defraud, be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both.
- Whoever removes, destroys, defaces or adds to any property mark, intending or knowing it to be likely that he may thereby cause injury to any person, shall be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both.347. (1) Whoever counterfeits any property mark used by any other person shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.(2) Whoever counterfeits any property mark used by a public servant, or any mark used by a public servant to denote that any property has been manufactured by a particular person or at a particular time or place, or that the property is of a particular quality or has passed through a particular office, or that it is entitled to any exemption, or uses as genuine any such mark knowing the same to be counterfeit, shall be punished with imprisonment of either description for a term which may extend to three years, and shall also be liable to fine.348. Whoever makes or has in his possession any die, plate or other instrument for the purpose of counterfeiting a property mark, or has in his possession a property mark for the purpose of denoting that any goods belong to a person to whom they do not belong, shall be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both. 349. Whoever sells, or exposes, or has in possession for sale, any goods or things with a counterfeit property mark affixed to or impressed upon the same or to or upon any case, package or other receptacle in which such goods are contained, shall, unless he proves—(a) that, having taken all reasonable precautions against committing an offence against this section, he had at the time of the commission of the alleged offence no reason to suspect the genuineness of the mark; and(b) that, on demand made by or on behalf of the prosecutor, he gave all the information in his power with respect to the persons from whom he obtained such goods or things; or(c) that otherwise he had acted innocently, be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both.350. (1) Whoever makes any false mark upon any case, package or other receptacle containing goods, in a manner reasonably calculated to cause any public servant or any other person to believe that such receptacle contains goods which it does not contain or that it does not contain goods which it does contain, or that the goods contained in such receptacle are of a nature or quality different from the real nature or quality thereof, shall, unless he proves that he acted without intent to defraud, be punished with imprisonment of either description for a term which may extend to three years, or with fine, or with both.(2) Whoever makes use of any false mark in any manner prohibited under sub-section (1) shall, unless he proves that he acted without intent to defraud, be punished as if he had committed the offence under sub-section (1).
CHAPTER XIX
OF CRIMINAL INTIMIDATION, INSULT, ANNOYANCE, DEFAMATION, ETC.
351. (1) Whoever threatens another by any means, with any injury to his person, reputation or property, or to the person or reputation of any one in whom that person is interested, with intent to cause alarm to that person, or to cause that person to do any act which he is not legally bound to do, or to omit to do any act which that person is legally entitled to do, as the means of avoiding the execution of such threat, commits criminal intimidation.
Explanation—A threat to injure the reputation of any deceased person in whom the person threatened is interested, is within this section.
Illustrations
A, for the purpose of inducing B to resist from prosecuting a civil suit, threatens to burn B’s house. Ais guilty of criminal intimidation.
(2) Whoever commits the offence of criminal intimidation shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
(3) Whoever commits the offence of criminal intimidation by threatening to cause death or grievous hurt, or to cause the destruction of any property by fire, or to cause an offence punishable with death or imprisonment for life, or with imprisonment for a term which may extend to seven years, or to impute unchastity to a woman, shall be punished with imprisonment of either description for a term which may extend to seven years, or with fine, or with both.
(4) Whoever commits the offence of criminal intimidation by an anonymous communication, or having taken precaution to conceal the name or abode of the person from whom the threat comes, shall be punished with imprisonment of either description for a term which may extend to two years, in addition to the punishment provided for the offence under sub-section (1).
352. Whoever intentionally insults in any manner, and thereby gives provocation to any person, intending or knowing it to be likely that such provocation will cause him to break the public peace, or to commit any other offence, shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
353. (1) Whoever makes, publishes or circulates any statement, false information, rumour, or report, including through electronic means—
(a) with intent to cause, or which is likely to cause, any officer, soldier, sailor or airman in the Army, Navy or Air Force of India to mutiny or otherwise disregard or fail in his duty as such; or
(b) with intent to cause, or which is likely to cause, fear or alarm to the public, or to any section of the public whereby any person may be induced to commit an offence against the State or against the public tranquillity; or
(c) with intent to incite, or which is likely to incite, any class or community of persons to commit any offence against any other class or community, shall be punished with imprisonment which may extend to three years, or with fine, or with both.
(2) Whoever makes, publishes or circulates any statement or report containing false information, rumour or alarming news, including through electronic means, with intent to create or promote, or which is likely to create or promote, on grounds of religion, race, place of birth, residence, language, caste or community or any other ground whatsoever, feelings of enmity, hatred or ill will between different religious, racial, language or regional groups or castes or communities, shall be punished with imprisonment which may extend to three years, or with fine, or with both.
(3) Whoever commits an offence specified in sub-section (2) in any place of worship or in any assembly engaged in the performance of religious worship or religious ceremonies, shall be punished with imprisonment which may extend to five years and shall also be liable to fine.
Exception—It does not amount to an offence, within the meaning of this section, when the person making, publishing or circulating any such statement, false information, rumour or report, has reasonable grounds for believing that such statement, false information, rumour or report is true and makes, publishes or circulates it in good faith and without any such intent as aforesaid.
354. Whoever voluntarily causes or attempts to cause any person to do anything which that person is not legally bound to do, or to omit to do anything which he is legally entitled to do, by inducing or attempting to induce that person to believe that he or any person in whom he is interested will become or will be rendered by some act of the offender an object of Divine displeasure if he does not do the thing which it is the object of the offender to cause him to do, or if he does the thing which it is the object of the offender to cause him to omit, shall be punished with imprisonment of either description for a term which may extend to one year, or with fine, or with both.
Illustrations
(a) A sits dharna at Z’s door with the intention of causing it to be believed that, by so sitting, he renders Z an object of Divine displeasure. A has committed the offence defined in this section.
(b) A threatens Z that, unless Z performs a certain act, A will kill one of A’s own children, under such circumstances that the killing would be believed to render Z an object of Divine displeasure. A has committed the offence defined in this section.
355. Whoever, in a state of intoxication, appears in any public place, or in any place which it is a trespass in him to enter, and there conducts himself in such a manner as to cause annoyance to any person, shall be punished with simple imprisonment for a term which may extend to twenty-four hours, or with fine which may extend to one thousand rupees, or with both or with community service.
Of defamation
356. (1) Whoever, by words either spoken or intended to be read, or by signs or by visible representations, makes or publishes in any manner, any imputation concerning any person intending to harm, or knowing or having reason to believe that such imputation will harm, the reputation of such person, is said, except in the cases hereinafter excepted, to defame that person.
Explanation 1—It may amount to defamation to impute anything to a deceased person, if the imputation would harm the reputation of that person if living, and is intended to be hurtful to the feelings of his family or other near relatives.
Explanation 2—It may amount to defamation to make an imputation concerning a company or an association or collection of persons as such.
Explanation 3—An imputation in the form of an alternative or expressed ironically, may amount to defamation.
Explanation 4—No imputation is said to harm a person’s reputation, unless that imputation directly or indirectly, in the estimation of others, lowers the moral or intellectual character of that person, or lowers the character of that person in respect of his caste or of his calling, or lowers the credit of that person, or causes it to be believed that the body of that person is in a loathsome state, or in a state generally considered as disgraceful.
Illustrations
(a) A says— “Z is an honest man; he never stole B’s watch”; intending to cause it to be believed that Z did steal B’s watch. This is defamation, unless it falls within one of the exceptions.
(b) A is asked who stole B’s watch. A points to Z, intending to cause it to be believed that Z stole B’s watch. This is defamation, unless it falls within one of the exceptions.
(c) A draws a picture of Z running away with B’s watch, intending it to be believed that Z stole B’s watch. This is defamation, unless it falls within one of the exceptions.
Exception 1—It is not defamation to impute anything which is true concerning any person, if it be for the public good that the imputation should be made or published. Whether or not it is for the public good is a question of fact.
Exception 2—It is not defamation to express in good faith any opinion whatever respecting the conduct of a public servant in the discharge of his public functions, or respecting his character, so far as his character appears in that conduct, and no further.
Exception 3—It is not defamation to express in good faith any opinion whatever respecting the conduct of any person touching any public question, and respecting his character, so far as his character appears in that conduct, and no further.
Illustrations
It is not defamation in A to express in good faith any opinion whatever respecting Z’s conduct in petitioning Government on a public question, in signing a requisition for a meeting on a public question, in presiding or attending at such meeting, in forming or joining any society which invites the public support, in voting or canvassing for a particular candidate for any situation in the efficient discharge of the duties of which the public is interested.
Exception 4––It is not defamation to publish substantially true report of the proceedings of a Court, or of the result of any such proceedings.
Explanation—A Magistrate or other officer holding an inquiry in open Court preliminary to a trial in a Court, is a Court within the meaning of the above section.
Exception 5—It is not defamation to express in good faith any opinion whatever respecting the merits of any case, civil or criminal, which has been decided by a Court, or respecting the conduct of any person as a party, witness or agent, in any such case, or respecting the character of such person, as far as his character appears in that conduct, and no further.
Illustrations
(a) A says—“I think Z’s evidence on that trial is so contradictory that he must be stupid or dishonest”. A is within this exception if he says this in good faith, in as much as the opinion which he expresses respects Z’s character as it appears in Z’s conduct as a witness, and no further.
(b) But if A says—“I do not believe what Z asserted at that trial because I know him to be a man without veracity”; A is not within this exception, in as much as the opinion which expresses of Z’s character, is an opinion not founded on Z’s conduct as a witness.
Exception 6—It is not defamation to express in good faith any opinion respecting the merits of any performance which its author has submitted to the judgment of the public, or respecting the character of the author so far as his character appears in such performance, and no further.
Explanation—A performance may be submitted to the judgment of the public expressly or by acts on the part of the author which imply such submission to the judgment of the public.
Illustrations
(a) A person who publishes a book, submits that book to the judgment of the public.
(b) A person who makes a speech in public, submits that speech to the judgment of the public.
(c) An actor or singer who appears on a public stage, submits his acting or singing to the judgment of the public.
(d) A says of a book published by Z—“Z’s book is foolish; Z must be a weak man. Z’s book is indecent; Z must be a man of impure mind”. Ais within the exception, if he says this in good faith, in as much as the opinion which he expresses of Z respects Z’s character only so far as it appears in Z’s book, and no further.
(e) But if A says “I am not surprised that Z’s book is foolish and indecent, for he is a weak man and a libertine”. A is not within this exception, in as much as the opinion which he expresses of Z’s character is an opinion not founded on Z’s book.
Exception 7—It is not defamation in a person having over another any authority, either conferred by law or arising out of a lawful contract made with that other, to pass in good faith any censure on the conduct of that other in matters to which such lawful authority relates.
Illustrations
A Judge censuring in good faith the conduct of a witness, or of an officer of the Court; a head of a department censuring in good faith those who are under his orders, a parent censuring in good faith a child in the presence of other children; a school master, whose authority is derived from a parent, censuring in good faith a pupil in the presence of other pupils; a master censuring a servant in good faith for remissness in service; a banker censuring in good faith the cashier of his bank for the conduct of such cashier as such cashier are within this exception.
Exception 8—It is not defamation to prefer in good faith an accusation against any person to any of those who have lawful authority over that person with respect to the subject-matter of accusation.
Illustration. If A in good faith accuses Z before a Magistrate; if A in good faith complains of the conduct of Z, a servant, to Z’s master; if A in good faith complains of the conduct of Z, a child, to Z’s father, A is within this exception.
Exception 9— It is not defamation to make an imputation on the character of another provided that the imputation be made in good faith for the protection of the interests of the person making it, or of any other person, or for the public good.
Illustrations
(a) A, a shopkeeper, says to B, who manages his business—“Sell nothing to Z unless he pays you ready money, for I have no opinion of his honesty”. A is within the exception, if he has made this imputation on Z in good faith for the protection of his own interests.
(b) A, a Magistrate, in making a report to his own superior officer, casts an imputation on the character of Z. Here, if the imputation is made in good faith, and for the public good, A is within the exception.
Exception 10— It is not defamation to convey a caution, in good faith, to one person against another, provided that such caution be intended for the good of the person to whom it is conveyed, or of some person in whom that person is interested, or for the public good.
(2) Whoever defames another shall be punished with simple imprisonment for a term which may extend to two years, or with fine, or with both, or with community service.
(3) Whoever prints or engraves any matter, knowing or having good reason to believe that such matter is defamatory of any person, shall be punished with simple imprisonment for a term which may extend to two years, or with fine, or with both.
(4) Whoever sells or offers for sale any printed or engraved substance containing defamatory matter, knowing that it contains such matter, shall be punished with simple imprisonment for a term which may extend to two years, or with fine, or with both.
Of breach of contract to attend on and supply wants of helpless person
357. Whoever, being bound by a lawful contract to attend on or to supply the wants of any person who, by reason of youth, or of unsoundness of mind, or of a disease or bodily weakness, is helpless or incapable of providing for his own safety or of supplying his own wants, voluntarily omits so to do, shall be punished with imprisonment of either description for a term which may extend to three months, or with fine which may extend to five thousand rupees, or with both.
CHAPTER XX
REPEAL AND SAVINGS
358. (1) The Indian Penal Code is hereby repealed.
(2) Notwithstanding the repeal of the Code referred to in sub-section (1), it shall not affect,—
(a) the previous operation of the Code so repealed or anything duly done or suffered thereunder; or
(b) any right, privilege, obligation or liability acquired, accrued or incurred under the Code so repealed; or
(c) any penalty, or punishment incurred in respect of any offences committed against the Code so repealed; or
(d) anyinvestigation or remedy in respect of any such penalty, or punishment; or
(e) any proceeding, investigation or remedy in respect of any such penalty or punishment as aforesaid, and any such proceeding or remedy may be instituted, continued or enforced, and any such penalty may be imposed as if that Code had not been repealed.
(3) Notwithstanding such repeal, anything done or any action taken under the said Code shall be deemed to have been done or taken under the corresponding provisions of this Sanhita.
(4) The mention of particular matters in sub-section (2) shall not be held to prejudice or affect the general application of section 6 of the General ClausesAct,1897 with regard to the effect of the repeal.
Bharatiya Sakshya Adhiniyam, 2023 (BSA)
ACT NO. 47 OF 2023
New Delhi, the 25th December, 2023
An Act to consolidate and to provide for general rules and principles of evidence for fair trial.
BE it enacted by Parliament in the Seventy-fourth Year of the Republic of India as follows:—
TABLE OF CONTENTS
PART I
CHAPTER I
PRELIMINARY
(3) It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint.
2. (1) In this Adhiniyam, unless the context otherwise requires,—
(a) “Court” includes all Judges and Magistrates, and all persons, except arbitrators, legally authorised to take evidence;
(b) “conclusive proof” means when one fact is declared by this Adhiniyam to be conclusive proof of another, the Court shall, on proof of the one fact, regard the other as proved, and shall not allow evidence to be given for the purpose of disproving it;
(c) “disproved” in relation to a fact, means when, after considering the matters before it, the Court either believes that it does not exist, or considers its non-existence so probable that a prudent man ought, under the circumstances of the particular case, to act upon the supposition that it does not exist;
(d) “document” means any matter expressed or described or otherwise recorded upon any substance by means of letters, figures or marks or any other means or by more than one of those means, intended to be used, or which may be used, for the purpose of recording that matter and includes electronic and digital records.
Illustrations
(i) A writing is a document.
(ii) Words printed, lithographed or photographed are documents.
(iii) A map or plan is a document.
(iv) An inscription on a metal plate or stone is a document.
(v) A caricature is a document.
(vi) An electronic record on emails, server logs, documents on computers, laptop or smartphone, messages, websites, locational evidence and voice mail messages stored on digital devices are documents;
(e) “evidence” means and includes—
(i) all statements including statements given electronically which the Court permits or requires to be made before it by witnesses in relation to matters of fact under inquiry and such statements are called oral evidence;
(ii) all documents including electronic or digital records produced for the inspection of the Court and such documents are called documentary evidence;
(f) “fact” means and includes—
(i) any thing, state of things, or relation of things, capable of being perceived by the senses; (ii) any mental condition of which any person is conscious.
Illustrations
(i) That there are certain objects arranged in a certain order in a certain place, is a fact.
(ii) That a person heard or saw something, is a fact.
(iii) That a person said certain words, is a fact.
(iv) That a person holds a certain opinion, has a certain intention, acts in good faith, or fraudulently, or uses a particular word in a particular sense, or is or was at a specified time conscious of a particular sensation, is a fact;
(g) “facts in issue” means and includes any fact from which, either by itself or in connection with other facts, the existence, non-existence, nature or extent of any right, liability or disability, asserted or denied in any suit or proceeding, necessarily follows.
Explanation—Whenever, under the provisions of the law for the time being in force relating to civil procedure, any Court records an issue of fact, the fact to be asserted or denied in the answer to such issue is a fact in issue.
Illustrations
A is accused of the murder of B. At his trial, the following facts may be in issue:—
(i) That A caused B’s death.
(ii) That A intended to cause B’s death.
(iii) That A had received grave and sudden provocation from B.
(iv) That A, at the time of doing the act which caused B’s death, was, by reason of unsoundness of mind, incapable of knowing its nature;
(h) “may presume”.—Whenever it is provided by thisAdhiniyam that the Court may presume a fact, it may either regard such fact as proved, unless and until it is disproved or may call for proof of it;
(i) “not proved”.—A fact is said to be not proved when it is neither proved nor disproved;
(j) “proved”.—A fact is said to be proved when, after considering the matters before it, the Court either believes it to exist, or considers its existence so probable that a prudent man ought, under the circumstances of the particular case, to act upon the supposition that it exists;
(k) “relevant”.—A fact is said to be relevant to another when it is connected with the other in any of the ways referred to in the provisions of this Adhiniyam relating to the relevancy of facts;
(l) “shall presume”.—Whenever it is directed by this Adhiniyam that the Court shall presume a fact, it shall regard such fact as proved, unless and until it is disproved.
(2) Words and expressions used herein and not defined but defined in the Information Technology Act, 2000, the Bharatiya Nagarik Suraksha Sanhita, 2023 and the Bharatiya Nyaya Sanhita, 2023 shall have the same meanings as assigned to them in the said Act and Sanhitas.
PART II
CHAPTER II
RELEVANCY OF FACTS
Evidence may be given in any suit or proceeding of the existence or non-existence of every fact in issue and of such other facts as are hereinafter declared to be relevant, and of no others.
Explanation—This section shall not enable any person to give evidence of a fact which he is disentitled to prove by any provision of the law for the time being in force relating to civil procedure.
Illustrations
(a) A is tried for the murder of B by beating him with a club with the intention of causing his death. At A’s trial the following facts are in issue:— A’s beating B with the club; A’s causing B’s death by such beating; A’s intention to cause B’s death.
(b) A suitor does not bring with him, and have in readiness for production at the first hearing of the case, a bond on which he relies. This section does not enable him to produce the bond or prove its contents at a subsequent stage of the proceedings, otherwise than in accordance with the conditions prescribed by the Code of Civil Procedure, 1908. Closely connected facts
4. Facts which, though not in issue, are so connected with a fact in issue or a relevant fact as to form part of the same transaction, are relevant, whether they occurred at the same time and place or at different times and places.
Illustrations
(a) A is accused of the murder of B by beating him. Whatever was said or done by A or B or the bystanders at the beating, or so shortly before or after it as to form part of the transaction, is a relevant fact.
(b) A is accused of waging war against the Government of India by taking part in an armed insurrection in which property is destroyed, troops are attacked and jails are broken open. The occurrence of these facts is relevant, as forming part of the general transaction, though A may not have been present at all of them.
(c) A sues B for a libel contained in a letter forming part of a correspondence. Letters between the parties relating to the subject out of which the libel arose, and forming part of the correspondence in which it is contained, are relevant facts, though they do not contain the libel itself.
(d) The question is, whether certain goods ordered from B were delivered to A. The goods were delivered to several intermediate persons successively. Each delivery is a relevant fact.
5. Facts which are the occasion, cause or effect, immediate or otherwise, of relevant facts, or facts in issue, or which constitute the state of things under which they happened, or which afforded an opportunity for their occurrence or transaction, are relevant.
Illustrations
(a) The question is, whether A robbed B. The facts that, shortly before the robbery, B went to a fair with money in his possession, and that he showed it, or mentioned the fact that he had it, to third persons, are relevant.
(b) The question is, whether A murdered B. Marks on the ground, produced by a struggle at or near the place where the murder was committed, are relevant facts.
(c) The question is, whether A poisoned B. The state of B’s health before the symptoms ascribed to poison, and habits of B, known to A, which afforded an opportunity for the administration of poison, are relevant facts.
6. (1) Any fact is relevant which shows or constitutes a motive or preparation for any fact in issue or relevant fact.
(2) The conduct of any party, or of any agent to any party, to any suit or proceeding, in reference to such suit or proceeding, or in reference to any fact in issue therein or relevant thereto, and the conduct of any person, an offence against whom is the subject of any proceeding, is relevant, if such conduct influences or is influenced by any fact in issue or relevant fact, and whether it was previous or subsequent thereto.
Explanation 1—The word “conduct” in this section does not include statements, unless those statements accompany and explain acts other than statements; but this explanation is not to affect the relevancy of statements under any other section of this Adhiniyam.
Explanation 2—When the conduct of any person is relevant, any statement made to him or in his presence and hearing, which affects such conduct, is relevant.
Illustrations
(a) Ais tried for the murder of B. The facts thatA murdered C, that B knew that A had murdered C, and that B had tried to extort money fromA by threatening to make his knowledge public, are relevant.
(b) A sues B upon a bond for the payment of money. B denies the making of the bond. The fact that, at the time when the bond was alleged to be made, B required money for a particular purpose, is relevant.
(c) A is tried for the murder of B by poison. The fact that, before the death of B, A procured poison similar to that which was administered to B, is relevant.
(d) The question is, whether a certain document is the will of A. The facts that, not long before, the date of the alleged will, A made inquiry into matters to which the provisions of the alleged will relate; that he consulted advocates in reference to making the will, and that he caused drafts of other wills to be prepared, of which he did not approve, are relevant.
(e) A is accused of a crime. The facts that, either before, or at the time of, or after the alleged crime, A provided evidence which would tend to give to the facts of the case an appearance favourable to himself, or that he destroyed or concealed evidence, or prevented the presence or procured the absence of persons who might have been witnesses, or suborned persons to give false evidence respecting it, are relevant.
(f) The question is, whether A robbed B. The facts that, after B was robbed, C said in A’s presence—”the police are coming to look for the person who robbed B”, and that immediately afterwardsA ran away, are relevant.
(g) The question is, whether A owes B ten thousand rupees. The facts that A asked C to lend him money, and that D said to C in A’s presence and hearing—”I advise you not to trust A, for he owes B ten thousand rupees”, and that A went away without making any answer, are relevant facts.
(h) The question is, whether A committed a crime. The fact that A absconded, after receiving a letter, warning A that inquiry was being made for the criminal, and the contents of the letter, are relevant.
(i) A is accused of a crime. The facts that, after the commission of the alleged crime, A absconded, or was in possession of property or the proceeds of property acquired by the crime, or attempted to conceal things which were or might have been used in committing it, are relevant.
(j) The question is, whether A was raped. The fact that, shortly after the alleged rape, A made a complaint relating to the crime, the circumstances under which, and the terms in which, the complaint was made, are relevant. The fact that, without making a complaint, A said that A had been raped is not relevant as conduct under this section, though it may be relevant as a dying declaration under clause (a) of section 26, or as corroborative evidence under section 160.
(k) The question is, whether A was robbed. The fact that, soon after the alleged robbery, A made a complaint relating to the offence, the circumstances under which, and the terms in which, the complaint was made, are relevant. The fact that A said he had been robbed, without making any complaint, is not relevant, as conduct under this section, though it may be relevant as a dying declaration under clause (a) of section 26, or as corroborative evidence under section 160.
7. Facts necessary to explain or introduce a fact in issue or relevant fact, or which support or rebut an inference suggested by a fact in issue or a relevant fact, or which establish the identity of anything, or person whose identity, is relevant, or fix the time or place at which any fact in issue or relevant fact happened, or which show the relation of parties by whom any such fact was transacted, are relevant in so far as they are necessary for that purpose.
Illustrations
(a) The question is, whether a given document is the will of A. The state of A’s property and of his family at the date of the alleged will may be relevant facts.
(b) A sues B for a libel imputing disgraceful conduct to A; B affirms that the matter alleged to be libellous is true. The position and relations of the parties at the time when the libel was published may be relevant facts as introductory to the facts in issue. The particulars of a dispute between A and B about a matter unconnected with the alleged libel are irrelevant, though the fact that there was a dispute may be relevant if it affected the relations between A and B.
(c) A is accused of a crime. The fact that, soon after the commission of the crime, A absconded from his house, is relevant under section 6, as conduct subsequent to and affected by facts in issue. The fact that, at the time when he left home, A had sudden and urgent business at the place to which he went, is relevant, as tending to explain the fact that he left home suddenly. The details of the business on which he left are not relevant, except in so far as they are necessary to show that the business was sudden and urgent.
(d) A sues B for inducing C to break a contract of service made by him with A. C, on leaving A’s service, says to A—”I am leaving you because B has made me a better offer”. This statement is a relevant fact as explanatory of C’s conduct, which is relevant as a fact in issue.
(e) A, accused of theft, is seen to give the stolen property to B, who is seen to give it to A’s wife. B says as he delivers it—”A says you are to hide this”. B’s statement is relevant as explanatory of a fact which is part of the transaction.
(f) Ais tried for a riot and is proved to have marched at the head of a mob. The cries of the mob are relevant as explanatory of the nature of the transaction.
8. Where there is reasonable ground to believe that two or more persons have conspired together to commit an offence or an actionable wrong, anything said, done or written by any one of such persons in reference to their common intention, after the time when such intention was first entertained by any one of them, is a relevant fact as against each of the persons believed to be so conspiring, as well for the purpose of proving the existence of the conspiracy as for the purpose of showing that any such person was a party to it. Illustration. Reasonable ground exists for believing that A has joined in a conspiracy to wage war against the State.
The facts that B procured arms in Europe for the purpose of the conspiracy, C collected money in Kolkata for a like object, D persuaded persons to join the conspiracy in Mumbai, E published writings advocating the object in view at Agra, and F transmitted from Delhi to G at Singapore the money which C had collected at Kolkata, and the contents of a letter written by H giving an account of the conspiracy, are each relevant, both to prove the existence of the conspiracy, and to prove A’s complicity in it, although he may have been ignorant of all of them, and although the persons by whom they were done were strangers to him, and although they may have taken place before he joined the conspiracy or after he left it.
9. Facts not otherwise relevant are relevant—
(1) if they are inconsistent with any fact in issue or relevant fact;
(2) if by themselves or in connection with other facts they make the existence or non-existence of any fact in issue or relevant fact highly probable or improbable. Illustrations. (a) The question is, whether A committed a crime at Chennai on a certain day. The fact that, on that day, A was at Ladakh is relevant. The fact that, near the time when the crime was committed, A was at a distance from the place where it was committed, which would render it highly improbable, though not impossible, that he committed it, is relevant.
(b) The question is, whether A committed a crime. The circumstances are such that the crime must have been committed either by A, B, C or D. Every fact which shows that the crime could have been committed by no one else, and that it was not committed by either B, C or D, is relevant.
10. In suits in which damages are claimed, any fact which will enable the Court to determine the amount of damages which ought to be awarded, is relevant.
11. Where the question is as to the existence of any right or custom, the following facts are relevant—
(a) any transaction by which the right or custom in question was created, claimed, modified, recognised, asserted or denied, or which was inconsistent with its existence;
(b) particular instances in which the right or custom was claimed, recognised or exercised, or in which its exercise was disputed, asserted or departed from. Illustration. The question is, whether A has a right to a fishery. A deed conferring the fishery on A’s ancestors, a mortgage of the fishery by A’s father, a subsequent grant of the fishery by A’s father, irreconcilable with the mortgage, particular instances in whichA’s father exercised the right, or in which the exercise of the right was stopped by A’s neighbours, are relevant facts.
12. Facts showing the existence of any state of mind, such as intention, knowledge, good faith, negligence, rashness, ill-will or goodwill towards any particular person, or showing the existence of any state of body or bodily feeling, are relevant, when the existence of any such state of mind or body or bodily feeling is in issue or relevant.
Explanation 1—A fact relevant as showing the existence of a relevant state of mind must show that the state of mind exists, not generally, but in reference to the particular matter in question.
Explanation 2—But where, upon the trial of a person accused of an offence, the previous commission by the accused of an offence is relevant within the meaning of this section, the previous conviction of such person shall also be a relevant fact.
Illustrations
(a) Ais accused of receiving stolen goods knowing them to be stolen. It is proved that he was in possession of a particular stolen article. The fact that, at the same time, he was in possession of many other stolen articles is relevant, as tending to show that he knew each and all of the articles of which he was in possession to be stolen.
(b) A is accused of fraudulently delivering to another person a counterfeit currency which, at the time when he delivered it, he knew to be counterfeit. The fact that, at the time of its delivery, A was possessed of a number of other pieces of counterfeit currency is relevant. The fact that A had been previously convicted of delivering to another person as genuine a counterfeit currency knowing it to be counterfeit is relevant.
(c) A sues B for damage done by a dog of B’s, which B knew to be ferocious. The fact that the dog had previously bitten X, Y and Z, and that they had made complaints to B, are relevant.
(d) The question is, whether A, the acceptor of a bill of exchange, knew that the name of the payee was fictitious. The fact that A had accepted other bills drawn in the same manner before they could have been transmitted to him by the payee if the payee had been a real person, is relevant, as showing that A knew that the payee was a fictitious person.
(e) A is accused of defaming B by publishing an imputation intended to harm the reputation of B. The fact of previous publications by A respecting B, showing ill-will on the part of A towards B is relevant, as proving A’s intention to harm B’s reputation by the particular publication in question. The facts that there was no previous quarrel between A and B, and that A repeated the matter complained of as he heard it, are relevant, as showing that A did not intend to harm the reputation of B.
(f) A is sued by B for fraudulently representing to B that C was solvent, whereby B, being induced to trust C, who was insolvent, suffered loss. The fact that, at the time when A represented C to be solvent, C was supposed to be solvent by his neighbours and by persons dealing with him, is relevant, as showing that A made the representation in good faith.
(g) A is sued by B for the price of work done by B, upon a house of which A is owner, by the order of C, a contractor. A’s defence is that B’s contract was with C. The fact that A paid C for the work in question is relevant, as proving that A did, in good faith, make over to C the management of the work in question, so that C was in a position to contract with B on C’s own account, and not as agent for A.
(h) A is accused of the dishonest misappropriation of property which he had found, and the question is whether, when he appropriated it, he believed in good faith that the real owner could not be found. The fact that public notice of the loss of the property had been given in the place where A was, is relevant, as showing that A did not in good faith believe that the real owner of the property could not be found. The fact that A knew, or had reason to believe, that the notice was given fraudulently by C, who had heard of the loss of the property and wished to set up a false claim to it, is relevant, as showing that the fact that A knew of the notice did not disprove A’s good faith.
(i) A is charged with shooting at B with intent to kill him. In order to show A’s intent, the fact of A’s having previously shot at B may be proved.
(j) A is charged with sending threatening letters to B. Threatening letters previously sent by A to B may be proved, as showing the intention of the letters.
(k) The question is, whether A has been guilty of cruelty towards B, his wife. Expressions of their feeling towards each other shortly before or after the alleged cruelty are relevant facts. (l) The question is, whether A’s death was caused by poison. Statements made by A during his illness as to his symptoms are relevant facts.
(m) The question is, what was the state of A’s health at the time when an assurance on his life was effected. Statements made by A as to the state of his health at or near the time in question are relevant facts.
(n) A sues B for negligence in providing him with a car for hire not reasonably fit for use, whereby A was injured. The fact that B’s attention was drawn on other occasions to the defect of that particular car is relevant. The fact that B was habitually negligent about the cars which he let to hire is irrelevant.
(o) Ais tried for the murder of B by intentionally shooting him dead. The fact that A on other occasions shot at B is relevant as showing his intention to shoot B. The fact that A was in the habit of shooting at people with intent to murder them is irrelevant.
(p) A is tried for a crime. The fact that he said something indicating an intention to commit that particular crime is relevant. The fact that he said something indicating a general disposition to commit crimes of that class is irrelevant.
13. When there is a question whether an act was accidental or intentional, or done with a particular knowledge or intention, the fact that such act formed part of a series of similar occurrences, in each of which the person doing the act was concerned, is relevant.
Illustrations
(a) A is accused of burning down his house in order to obtain money for which it is insured. The facts that A lived in several houses successively each of which he insured, in each of which a fire occurred, and after each of which fires A received payment from a different insurance company, are relevant, as tending to show that the fires were not accidental.
(b) Ais employed to receive money from the debtors of B. It is A’s duty to make entries in a book showing the amounts received by him. He makes an entry showing that on a particular occasion he received less than he really did receive. The question is, whether this false entry was accidental or intentional. The facts that other entries made by A in the same book are false, and that the false entry is in each case in favour of A, are relevant.
(c) A is accused of fraudulently delivering to B a counterfeit currency. The question is, whether the delivery of the currency was accidental. The facts that, soon before or soon after the delivery to B, A delivered counterfeit currency to C, D and E are relevant, as showing that the delivery to B was not accidental.
14. When there is a question whether a particular act was done, the existence of any course of business, according to which it naturally would have been done, is a relevant fact.
Illustrations
(a) The question is, whether a particular letter was dispatched. The facts that it was the ordinary course of business for all letters put in a certain place to be carried to the post, and that particular letter was put in that place are relevant.
(b) The question is, whether a particular letter reached A. The facts that it was posted in due course, and was not returned through the Return Letter Office, are relevant. Admissions
15. An admission is a statement, oral or documentary or contained in electronic form, which suggests any inference as to any fact in issue or relevant fact, and which is made by any of the persons, and under the circumstances, hereinafter mentioned.
16. (1) Statements made by a party to the proceeding, or by an agent to any such party, whom the Court regards, under the circumstances of the case, as expressly or impliedly authorised by him to make them, are admissions.
(2) Statements made by—
(i) parties to suits suing or sued in a representative character, are not admissions, unless they were made while the party making them held that character; or
(ii) (a) persons who have any proprietary or pecuniary interest in the subject matter of the proceeding, and who make the statement in their character of persons so interested; or
(b) persons from whom the parties to the suit have derived their interest in the subject matter of the suit, are admissions, if they are made during the continuance of the interest of the persons making the statements.
17. Statements made by persons whose position or liability, it is necessary to prove as against any party to the suit, are admissions, if such statements would be relevant as against such persons in relation to such position or liability in a suit brought by or against them, and if they are made whilst the person making them occupies such position or is subject to such liability. Illustration. A undertakes to collect rents for B. B sues A for not collecting rent due from C to B. A denies that rent was due from C to B. A statement by C that he owed B rent is an admission, and is a relevant fact as against A, if A denies that C did owe rent to B.
18. Statements made by persons to whom a party to the suit has expressly referred for information in reference to a matter in dispute are admissions. Illustration. The question is, whether a horse sold by A to B is sound. A says to B—”Go and ask C, C knows all about it”. C’s statement is an admission.
19. Admissions are relevant and may be proved as against the person who makes them, or his representative in interest; but they cannot be proved by or on behalf of the person who makes them or by his representative in interest, except in the following cases, namely:—
(1) an admission may be proved by or on behalf of the person making it, when it is of such a nature that, if the person making it were dead, it would be relevant as between third persons under section 26;
(2) an admission may be proved by or on behalf of the person making it, when it consists of a statement of the existence of any state of mind or body, relevant or in issue, made at or about the time when such state of mind or body existed, and is accompanied by conduct rendering its falsehood improbable;
(3) an admission may be proved by or on behalf of the person making it, if it is relevant otherwise than as an admission.
Illustrations
(a) The question between A and B is, whether a certain deed is or is not forged. A affirms that it is genuine, B that it is forged. A may prove a statement by B that the deed is genuine, and B may prove a statement by A that deed is forged; but A cannot prove a statement by himself that the deed is genuine, nor can B prove a statement by himself that the deed is forged.
(b) A, the captain of a ship, is tried for casting her away. Evidence is given to show that the ship was taken out of her proper course. A produces a book kept by him in the ordinary course of his business showing observations alleged to have been taken by him from day to day, and indicating that the ship was not taken out of her proper course. A may prove these statements, because they would be admissible between third parties, if he were dead, under clause (b) of section 26.
(c) A is accused of a crime committed by him at Kolkata. He produces a letter written by himself and dated at Chennai on that day, and bearing the Chennai post-mark of that day. The statement in the date of the letter is admissible, because, if A were dead, it would be admissible under clause (b) of section 26.
(d) A is accused of receiving stolen goods knowing them to be stolen. He offers to prove that he refused to sell them below their value. A may prove these statements, though they are admissions, because they are explanatory of conduct influenced by facts in issue.
(e) A is accused of fraudulently having in his possession counterfeit currency which he knew to be counterfeit. He offers to prove that he asked a skilful person to examine the currency as he doubted whether it was counterfeit or not, and that person did examine it and told him it was genuine. A may prove these facts.
20. Oral admissions as to the contents of a document are not relevant, unless and until the party proposing to prove them shows that he is entitled to give secondary evidence of the contents of such document under the rules hereinafter contained, or unless the genuineness of a document produced is in question.
21. In civil cases no admission is relevant, if it is made either upon an express condition that evidence of it is not to be given, or under circumstances from which the Court can infer that the parties agreed together that evidence of it should not be given.
Explanation—Nothing in this section shall be taken to exempt any advocate from giving evidence of any matter of which he may be compelled to give evidence under sub-sections (1) and (2) of section 132. 22. A confession made by an accused person is irrelevant in a criminal proceeding, if the making of the confession appears to the Court to have been caused by any inducement, threat, coercion or promise having reference to the charge against the accused person, proceeding from a person in authority and sufficient, in the opinion of the Court, to give the accused person grounds which would appear to him reasonable for supposing that by making it he would gain any advantage or avoid any evil of a temporal nature in reference to the proceedings against him:
Provided that if the confession is made after the impression caused by any such inducement, threat, coercion or promise has, in the opinion of the Court, been fully removed, it is relevant:
Provided further that if such a confession is otherwise relevant, it does not become irrelevant merely because it was made under a promise of secrecy, or in consequence of a deception practised on the accused person for the purpose of obtaining it, or when he was drunk, or because it was made in answer to questions which he need not have answered, whatever may have been the form of those questions, or because he was not warned that he was not bound to make such confession, and that evidence of it might be given against him.
23. (1) No confession made to a police officer shall be proved as against a person accused of any offence.
(2) No confession made by any person while he is in the custody of a police officer, unless it is made in the immediate presence of a Magistrate shall be proved against him:
Provided that when any fact is deposed to as discovered in consequence of information received from a person accused of any offence, in the custody of a police officer, so much of such information, whether it amounts to a confession or not, as relates distinctly to the fact discovered, may be proved.
24. When more persons than one are being tried jointly for the same offence, and a confession made by one of such persons affecting himself and some other of such persons is proved, the Court may take into consideration such confession as against such other person as well as against the person who makes such confession.
Explanation I—”Offence”, as used in this section, includes the abetment of, or attempt to commit, the offence.
Explanation II—A trial of more persons than one held in the absence of the accused who has absconded or who fails to comply with a proclamation issued under section 84 of the Bharatiya Nagarik Suraksha Sanhita, 2023 shall be deemed to be a joint trial for the purpose of this section.
Illustrations
(a) A and B are jointly tried for the murder of C. It is proved that A said—”B and I murdered C”. The Court may consider the effect of this confession as against B.
(b) Ais on his trial for the murder of C. There is evidence to show that C was murdered by A and B, and that B said—”A and I murdered C”. This statement may not be taken into consideration by the Court against A, as B is not being jointly tried.
25. Admissions are not conclusive proof of the matters admitted but they may operate as estoppels under the provisions hereinafter contained. Statements by persons who cannot be called as witnesses
26. Statements, written or verbal, of relevant facts made by a person who is dead, or who cannot be found, or who has become incapable of giving evidence, or whose attendance cannot be procured without an amount of delay or expense which under the circumstances of the case appears to the Court unreasonable, are themselves relevant facts in the following cases, namely:—
(a) when the statement is made by a person as to the cause of his death, or as to any of the circumstances of the transaction which resulted in his death, in cases in which the cause of that person’s death comes into question. Such statements are relevant whether the person who made them was or was not, at the time when they were made, under expectation of death, and whatever may be the nature of the proceeding in which the cause of his death comes into question;
(b) when the statement was made by such person in the ordinary course of business, and in particular when it consists of any entry or memorandum made by him in books kept in the ordinary course of business, or in the discharge of professional duty; or of an acknowledgement written or signed by him of the receipt of money, goods, securities or property of any kind; or of a document used in commerce written or signed by him; or of the date of a letter or other document usually dated, written or signed by him;
(c) when the statement is against the pecuniary or proprietary interest of the person making it, or when, if true, it would expose him or would have exposed him to a criminal prosecution or to a suit for damages;
(d) when the statement gives the opinion of any such person, as to the existence of any public right or custom or matter of public or general interest, of the existence of which, if it existed, he would have been likely to be aware, and when such statement was made before any controversy as to such right, custom or matter had arisen;
(e) when the statement relates to the existence of any relationship by blood, marriage or adoption between persons as to whose relationship by blood, marriage or adoption the person making the statement had special means of knowledge, and when the statement was made before the question in dispute was raised;
(f) when the statement relates to the existence of any relationship by blood, marriage or adoption between persons deceased, and is made in any will or deed relating to the affairs of the family to which any such deceased person belonged, or in any family pedigree, or upon any tombstone, family portrait or other thing on which such statements are usually made, and when such statement was made before the question in dispute was raised;
(g) when the statement is contained in any deed, will or other document which relates to any such transaction as is specified in clause (a) of section 11;
(h) when the statement was made by a number of persons, and expressed feelings or impressions on their part relevant to the matter in question.
Illustrations
(a) The question is, whether A was murdered by B; or A dies of injuries received in a transaction in the course of which she was raped. The question is whether she was raped by B; or the question is, whether A was killed by B under such circumstances that a suit would lie against B by A’s widow. Statements made by A as to the cause of his or her death, referring respectively to the murder, the rape and the actionable wrong under consideration, are relevant facts.
(b) The question is as to the date of A’s birth. An entry in the diary of a deceased surgeon regularly kept in the course of business, stating that, on a given day he attended A’s mother and delivered her of a son, is a relevant fact.
(c) The question is, whether A was in Nagpur on a given day. A statement in the diary of a deceased solicitor, regularly kept in the course of business, that on a given day the solicitor attended A at a place mentioned, in Nagpur, for the purpose of conferring with him upon specified business, is a relevant fact.
(d) The question is, whether a ship sailed from Mumbai harbour on a given day. A letter written by a deceased member of a merchant’s firm by which she was chartered to their correspondents in Chennai, to whom the cargo was consigned, stating that the ship sailed on a given day from Mumbai port, is a relevant fact.
(e) The question is, whether rent was paid to A for certain land. A letter from A’s deceased agent to A, saying that he had received the rent on A’s account and held it at A’s orders is a relevant fact.
(f) The question is, whether A and B were legally married. The statement of a deceased clergyman that he married them under such circumstances that the celebration would be a crime is relevant.
(g) The question is, whether A, a person who cannot be found, wrote a letter on a certain day. The fact that a letter written by him is dated on that day is relevant.
(h) The question is, what was the cause of the wreck of a ship. A protest made by the captain, whose attendance cannot be procured, is a relevant fact.
(i) The question is, whether a given road is a public way. A statement by A, a deceased headman of the village, that the road was public, is a relevant fact.
(j) The question is, what was the price of grain on a certain day in a particular market. A statement of the price, made by a deceased business person in the ordinary course of his business, is a relevant fact.
(k) The question is, whether A, who is dead, was the father of B. A statement byA that B was his son, is a relevant fact.
(l) The question is, what was the date of the birth of A. A letter from A’s deceased father to a friend, announcing the birth of A on a given day, is a relevant fact.
(m) The question is, whether, and when, A and B were married. An entry in a memorandum book by C, the deceased father of B, of his daughter’s marriage with A on a given date, is a relevant fact.
(n) A sues B for a libel expressed in a painted caricature exposed in a shop window. The question is as to the similarity of the caricature and its libellous character. The remarks of a crowd of spectators on these points may be proved.
27. Evidence given by a witness in a judicial proceeding, or before any person authorised by law to take it, is relevant for the purpose of proving, in a subsequent judicial proceeding, or in a later stage of the same judicial proceeding, the truth of the facts which it states, when the witness is dead or cannot be found, or is incapable of giving evidence, or is kept out of the way by the adverse party, or if his presence cannot be obtained without an amount of delay or expense which, under the circumstances of the case, the Court considers unreasonable:
Provided that the proceeding was between the same parties or their representatives in interest; that the adverse party in the first proceeding had the right and opportunity to cross-examine and the questions in issue were substantially the same in the first as in the second proceeding.
Explanation—A criminal trial or inquiry shall be deemed to be a proceeding between the prosecutor and the accused within the meaning of this section. Statements made under special circumstances
28. Entries in the books of account, including those maintained in an electronic form, regularly kept in the course of business are relevant whenever they refer to a matter into which the Court has to inquire, but such statements shall not alone be sufficient evidence to charge any person with liability.
Illustration
A sues B for one thousand rupees, and shows entries in his account books showing B to be indebted to him to this amount. The entries are relevant, but are not sufficient, without other evidence, to prove the debt.
29. An entry in any public or other official book, register or record or an electronic record, stating a fact in issue or relevant fact, and made by a public servant in the discharge of his official duty, or by any other person in performance of a duty specially enjoined by the law of the country in which such book, register or record or an electronic record, is kept, is itself a relevant fact.
30. Statements of facts in issue or relevant facts, made in published maps or charts generally offered for public sale, or in maps or plans made under the authority of the Central Government or any State Government, as to matters usually represented or stated in such maps, charts or plans, are themselves relevant facts.
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- When the Court has to form an opinion as to the existence of any fact of a public nature, any statement of it, made in a recital contained in any Central Act or State Act or in a Central Government or State Government notification appearing in the respective Official Gazette or in any printed paper or in electronic or digital form purporting to be such Gazette, is a relevant fact.
- When the Court has to form an opinion as to a law of any country, any statement of such law contained in a book purporting to be printed or published including in electronic or digital form under the authority of the Government of such country and to contain any such law, and any report of a ruling of the Courts of such country contained in a book including in electronic or digital form purporting to be a report of such rulings, is relevant. How much of a statement is to be proved33. When any statement of which evidence is given forms part of a longer statement, or of a conversation or part of an isolated document, or is contained in a document which forms part of a book, or is contained in part of electronic record or of a connected series of letters or papers, evidence shall be given of so much and no more of the statement, conversation, document, electronic record, book or series of letters or papers as the Court considers necessary in that particular case to the full understanding of the nature and effect of the statement, and of the circumstances under which it was made. Judgments of Courts when relevant34. The existence of any judgment, order or decree which by law prevents any Court from taking cognizance of a suit or holding a trial, is a relevant fact when the question is whether such Court ought to take cognizance of such suit or to hold such trial.35. (1) A final judgment, order or decree of a competent Court or Tribunal, in the exercise of probate, matrimonial, admiralty or insolvency jurisdiction, which confers upon or takes away from any person any legal character, or which declares any person to be entitled to any such character, or to be entitled to any specific thing, not as against any specified person but absolutely, is relevant when the existence of any such legal character, or the title of any such person to any such thing, is relevant.(2) Such judgment, order or decree is conclusive proof that—(i) any legal character, which it confers accrued at the time when such judgment, order or decree came into operation;
(ii) any legal character, to which it declares any such person to be entitled, accrued to that person at the time when such judgment, order or decree declares it to have accrued to that person;
(iii) any legal character which it takes away from any such person ceased at the time from which such judgment, order or decree declared that it had ceased or should cease; and (iv) anything to which it declares any person to be so entitled was the property of that person at the time from which such judgment, order or decree declares that it had been or should be his property.
36. Judgments, orders or decrees other than those mentioned in section 35 are relevant if they relate to matters of a public nature relevant to the enquiry; but such judgments, orders or decrees are not conclusive proof of that which they state. Illustration. A sues B for trespass on his land. B alleges the existence of a public right of way over the land, which A denies. The existence of a decree in favour of the defendant, in a suit by A against C for a trespass on the same land, in which C alleged the existence of the same right of way, is relevant, but it is not conclusive proof that the right of way exists.
37. Judgments or orders or decrees, other than those mentioned in sections 34, 35 and 36, are irrelevant, unless the existence of such judgment, order or decree is a fact in issue, or is relevant under some other provision of this Adhiniyam.
Illustrations
(a) A and B separately sue C for a libel which reflects upon each of them. C in each case says that the matter alleged to be libellous is true, and the circumstances are such that it is probably true in each case, or in neither. A obtains a decree against C for damages on the ground that C failed to make out his justification. The fact is irrelevant as between B and C. (b) A prosecutes B for stealing a cow from him. B is convicted. A afterwards sues C for the cow, which B had sold to him before his conviction. As between A and C, the judgment against B is irrelevant.
(c) A has obtained a decree for the possession of land against B. C, B’s son, murders A in consequence. The existence of the judgment is relevant, as showing motive for a crime.
(d) A is charged with theft and with having been previously convicted of theft. The previous conviction is relevant as a fact in issue.
(e) Ais tried for the murder of B. The fact that B prosecutedA for libel and that Awas convicted and sentenced is relevant under section 6 as showing the motive for the fact in issue.
38. Any party to a suit or other proceeding may show that any judgment, order or decree which is relevant under section 34, 35 or 36, and which has been proved by the adverse party, was delivered by a Court not competent to deliver it, or was obtained by fraud or collusion. Opinions of third persons when relevant
39. (1) When the Court has to form an opinion upon a point of foreign law or of science or art, or any other field, or as to identity of handwriting or finger impressions, the opinions upon that point of persons specially skilled in such foreign law, science or art, or any other field, or in questions as to identity of handwriting or finger impressions are relevant facts and such persons are called experts. Illustrations.
(a) The question is, whether the death of A was caused by poison. The opinions of experts as to the symptoms produced by the poison by which A is supposed to have died, are relevant.
(b) The question is, whether A, at the time of doing a certain act, was, by reason of unsoundness of mind, incapable of knowing the nature of the act, or that he was doing what was either wrong or contrary to law. The opinions of experts upon the question whether the symptoms exhibited by A commonly show unsoundness of mind, and whether such unsoundness of mind usually renders persons incapable of knowing the nature of the acts which they do, or of knowing that what they do is either wrong or contrary to law, are relevant.
(c) The question is, whether a certain document was written by A. Another document is produced which is proved or admitted to have been written by A. The opinions of experts on the question whether the two documents were written by the same person or by different persons, are relevant.
(2) When in a proceeding, the court has to form an opinion on any matter relating to any information transmitted or stored in any computer resource or any other electronic or digital form, the opinion of the Examiner of Electronic Evidence referred to in section 79A of the Information Technology Act, 2000, is a relevant fact.
Explanation—For the purposes of this sub-section, an Examiner of Electronic Evidence shall be an expert. 40. Facts, not otherwise relevant, are relevant if they support or are inconsistent with the opinions of experts, when such opinions are relevant.
Illustrations
(a) The question is, whether A was poisoned by a certain poison. The fact that other persons, who were poisoned by that poison, exhibited certain symptoms which experts affirm or deny to be the symptoms of that poison, is relevant.
(b) The question is, whether an obstruction to a harbour is caused by a certain sea-wall. The fact that other harbours similarly situated in other respects, but where there were no such sea-walls, began to be obstructed at about the same time, is relevant.
41. (1) When the Court has to form an opinion as to the person by whom any document was written or signed, the opinion of any person acquainted with the handwriting of the person by whom it is supposed to be written or signed that it was or was not written or signed by that person, is a relevant fact.
Explanation—A person is said to be acquainted with the handwriting of another person when he has seen that person write, or when he has received documents purporting to be written by that person in answer to documents written by himself or under his authority and addressed to that person, or when, in the ordinary course of business, documents purporting to be written by that person have been habitually submitted to him. Illustration. The question is, whether a given letter is in the handwriting of A, a merchant in Itanagar. B is a merchant in Bengaluru, who has written letters addressed to A and received letters purporting to be written by him. C, is B’s clerk whose duty it was to examine and file B’s correspondence. D is B’s broker, to whom B habitually submitted the letters purporting to be written by A for the purpose of advising him thereon. The opinions of B, C and D on the question whether the letter is in the handwriting of A are relevant, though neither B, C nor D ever saw A write.
(2) When the Court has to form an opinion as to the electronic signature of any person, the opinion of the Certifying Authority which has issued the Electronic Signature Certificate is a relevant fact.
42. When the Court has to form an opinion as to the existence of any general custom or right, the opinions, as to the existence of such custom or right, of persons who would be likely to know of its existence if it existed, are relevant.
Explanation—The expression “general custom or right” includes customs or rights common to any considerable class of persons. Illustration. The right of the villagers of a particular village to use the water of a particular well is a general right within the meaning of this section.
43. When the Court has to form an opinion as to—
(i) the usages and tenets of any body of men or family;
(ii) the constitution and governance of any religious or charitable foundation; or
(iii) the meaning of words or terms used in particular districts or by particular classes of people, the opinions of persons having special means of knowledge thereon, are relevant facts.
44. When the Court has to form an opinion as to the relationship of one person to another, the opinion, expressed by conduct, as to the existence of such relationship, of any person who, as a member of the family or otherwise, has special means of knowledge on the subject, is a relevant fact: Provided that such opinion shall not be sufficient to prove a marriage in proceedings under the Divorce Act, 1869, or in prosecution under sections 82 and 84 of the Bharatiya Nyaya Sanhita, 2023.
Illustrations
(a) The question is, whether A and B were married. The fact that they were usually received and treated by their friends as husband and wife, is relevant.
(b) The question is, whether A was the legitimate son of B. The fact that A was always treated as such by members of the family, is relevant.
45. Whenever the opinion of any living person is relevant, the grounds on which such opinion is based are also relevant. Illustration. An expert may give an account of experiments performed by him for the purpose of forming his opinion. Character when relevant
46. In civil cases the fact that the character of any person concerned is such as to render probable or improbable any conduct imputed to him, is irrelevant, except in so far as such character appears from facts otherwise relevant.
47. In criminal proceedings the fact that the person accused is of a good character, is relevant.
48. In a prosecution for an offence under section 64, section 65, section 66, section 67, section 68, section 69, section 70, section 71, section 74, section 75, section 76, section 77 or section 78 of the Bharatiya Nyaya Sanhita, 2023 or for attempt to commit any such offence, where the question of consent is in issue, evidence of the character of the victim or of such person’s previous sexual experience with any person shall not be relevant on the issue of such consent or the quality of consent.
49. In criminal proceedings, the fact that the accused has a bad character, is irrelevant, unless evidence has been given that he has a good character, in which case it becomes relevant.
Explanation 1—This section does not apply to cases in which the bad character of any person is itself a fact in issue.
Explanation 2—A previous conviction is relevant as evidence of bad character.
50. In civil cases, the fact that the character of any person is such as to affect the amount of damages which he ought to receive, is relevant.
Explanation—In this section and sections 46, 47 and 49, the word “character” includes both reputation and disposition; but, except as provided in section 49, evidence may be given only of general reputation and general disposition, and not of particular acts by which reputation or disposition has been shown.
PART III
ON PROOF
CHAPTER III
FACTS WHICH NEED NOT BE PROVED
51. No fact of which the Court will take judicial notice need be proved.
52. (1) The Court shall take judicial notice of the following facts, namely:—
(a) all laws in force in the territory of India including laws having extra-territorial operation;
(b) international treaty, agreement or convention with country or countries by India, or decisions made by India at international associations or other bodies;
(c) the course of proceeding of the Constituent Assembly of India, of Parliament of India and of the State Legislatures;
(d) the seals of all Courts and Tribunals;
(e) the seals of Courts ofAdmiralty and Maritime Jurisdiction, Notaries Public, and all seals which any person is authorised to use by the Constitution, or by an Act of Parliament or State Legislatures, or Regulations having the force of law in India;
(f) the accession to office, names, titles, functions, and signatures of the persons filling for the time being any public office in any State, if the fact of their appointment to such office is notified in any Official Gazette;
(g) the existence, title and national flag of every country or sovereign recognised by the Government of India;
(h) the divisions of time, the geographical divisions of the world, and public festivals, fasts and holidays notified in the Official Gazette;
(i) the territory of India;
(j) the commencement, continuance and termination of hostilities between the Government of India and any other country or body of persons;
(k) the names of the members and officers of the Court and of their deputies and subordinate officers and assistants, and also of all officers acting in execution of its process, and of advocates and other persons authorised by law to appear or act before it;
(l) the rule of the road on land or at sea.
(2) In the cases referred to in sub-section
(1) and also on all matters of public history, literature, science or art, the Court may resort for its aid to appropriate books or documents of reference and if the Court is called upon by any person to take judicial notice of any fact, it may refuse to do so unless and until such person produces any such book or document as it may consider necessary to enable it to do so.
53. No fact needs to be proved in any proceeding which the parties thereto or their agents agree to admit at the hearing, or which, before the hearing, they agree to admit by any writing under their hands, or which by any rule of pleading in force at the time they are deemed to have admitted by their pleadings:
Provided that the Court may, in its discretion, require the facts admitted to be proved otherwise than by such admissions.
CHAPTER IV
OF ORAL EVIDENCE
54. All facts, except the contents of documents may be proved by oral evidence.
55. Oral evidence shall, in all cases whatever, be direct; if it refers to,—
(i) a fact which could be seen, it must be the evidence of a witness who says he saw it;
(ii) a fact which could be heard, it must be the evidence of a witness who says he heard it;
(iii) a fact which could be perceived by any other sense or in any other manner, it must be the evidence of a witness who says he perceived it by that sense or in that manner;
(iv) an opinion or to the grounds on which that opinion is held, it must be the evidence of the person who holds that opinion on those grounds:
Provided that the opinions of experts expressed in any treatise commonly offered for sale, and the grounds on which such opinions are held, may be proved by the production of such treatises if the author is dead or cannot be found, or has become incapable of giving evidence, or cannot be called as a witness without an amount of delay or expense which the Court regards as unreasonable:
Provided further that, if oral evidence refers to the existence or condition of any material thing other than a document, the Court may, if it thinks fit, require the production of such material thing for its inspection.
CHAPTER V
OF DOCUMENTARY EVIDENCE
56. The contents of documents may be proved either by primary or by secondary evidence.
57. Primary evidence means the document itself produced for the inspection of the Court.
Explanation 1—Where a document is executed in several parts, each part is primary evidence of the document.
Explanation 2—Where a document is executed in counterpart, each counterpart being executed by one or some of the parties only, each counterpart is primary evidence as against the parties executing it.
Explanation 3—Where a number of documents are all made by one uniform process, as in the case of printing, lithography or photography, each is primary evidence of the contents of the rest; but, where they are all copies of a common original, they are not primary evidence of the contents of the original.
Explanation 4—Where an electronic or digital record is created or stored, and such storage occurs simultaneously or sequentially in multiple files, each such file is primary evidence.
Explanation 5—Where an electronic or digital record is produced from proper custody, such electronic and digital record is primary evidence unless it is disputed.
Explanation 6—Where a video recording is simultaneously stored in electronic form and transmitted or broadcast or transferred to another, each of the stored recordings is primary evidence.
Explanation 7—Where an electronic or digital record is stored in multiple storage spaces in a computer resource, each such automated storage, including temporary files, is primary evidence.
Illustration
A person is shown to have been in possession of a number of placards, all printed at one time from one original. Any one of the placards is primary evidence of the contents of any other, but no one of them is primary evidence of the contents of the original. 58. Secondary evidence includes—
(i) certified copies given under the provisions hereinafter contained;
(ii) copies made from the original by mechanical processes which in themselves ensure the accuracy of the copy, and copies compared with such copies;
(iii) copies made from or compared with the original;
(iv) counterparts of documents as against the parties who did not execute them;
(v) oral accounts of the contents of a document given by some person who has himself seen it;
(vi) oral admissions;
(vii) written admissions;
(viii) evidence of a person who has examined a document, the original of which consists of numerous accounts or other documents which cannot conveniently be examined in Court, and who is skilled in the examination of such documents.
Illustrations
(a) A photograph of an original is secondary evidence of its contents, though the two have not been compared, if it is proved that the thing photographed was the original.
(b) A copy compared with a copy of a letter made by a copying machine is secondary evidence of the contents of the letter, if it is shown that the copy made by the copying machine was made from the original.
(c) A copy transcribed from a copy, but afterwards compared with the original, is secondary evidence; but the copy not so compared is not secondary evidence of the original, although the copy from which it was transcribed was compared with the original.
(d) Neither an oral account of a copy compared with the original, nor an oral account of a photograph or machine-copy of the original, is secondary evidence of the original.
59. Documents shall be proved by primary evidence except in the cases hereinafter mentioned.
- Secondary evidence may be given of the existence, condition, or contents of a document in the following cases, namely: —(a) when the original is shown or appears to be in the possession or power—(i) of the person against whom the document is sought to be proved; or(ii) of any person out of reach of, or not subject to, the process of the Court; or(iii) of any person legally bound to produce it, and when, after the notice mentioned in section 64 such person does not produce it;(b) when the existence, condition or contents of the original have been proved to be admitted in writing by the person against whom it is proved or by his representative in interest;
(c) when the original has been destroyed or lost, or when the party offering evidence of its contents cannot, for any other reason not arising from his own default or neglect, produce it in reasonable time;
(d) when the original is of such a nature as not to be easily movable;
(e) when the original is a public document within the meaning of section 74;
(f) when the original is a document of which a certified copy is permitted by this Adhiniyam, or by any other law in force in India to be given in evidence;
(g) when the originals consist of numerous accounts or other documents which cannot conveniently be examined in Court, and the fact to be proved is the general result of the whole collection.
Explanation—For the purposes of—
(i) clauses (a), (c) and (d), any secondary evidence of the contents of the document is admissible;
(ii) clause (b), the written admission is admissible;
(iii) clause (e) or (f), a certified copy of the document, but no other kind of secondary evidence, is admissible;
(iv) clause (g), evidence may be given as to the general result of the documents by any person who has examined them, and who is skilled in the examination of such document.
61. Nothing in this Adhiniyam shall apply to deny the admissibility of an electronic or digital record in the evidence on the ground that it is an electronic or digital record and such record shall, subject to section 63, have the same legal effect, validity and enforceability as other document.
62. The contents of electronic records may be proved in accordance with the provisions of section 63.
63. (1) Notwithstanding anything contained in this Adhiniyam, any information contained in an electronic record which is printed on paper, stored, recorded or copied in optical or magnetic media or semiconductor memory which is produced by a computer or any communication device or otherwise stored, recorded or copied in any electronic form (hereinafter referred to as the computer output) shall be deemed to be also a document, if the conditions mentioned in this section are satisfied in relation to the information and computer in question and shall be admissible in any proceedings, without further proof or production of the original, as evidence or any contents of the original or of any fact stated therein of which direct evidence would be admissible.
(2) The conditions referred to in sub-section (1) in respect of a computer output shall be the following, namely:—
(a) the computer output containing the information was produced by the computer or communication device during the period over which the computer or communication device was used regularly to create, store or process information for the purposes of any activity regularly carried on over that period by the person having lawful control over the use of the computer or communication device;
(b) during the said period, information of the kind contained in the electronic record or of the kind from which the information so contained is derived was regularly fed into the computer or communication device in the ordinary course of the said activities;
(c) throughout the material part of the said period, the computer or communication device was operating properly or, if not, then in respect of any period in which it was not operating properly or was out of operation during that part of the period, was not such as to affect the electronic record or the accuracy of its contents; and
(d) the information contained in the electronic record reproduces or is derived from such information fed into the computer or communication device in the ordinary course of the said activities.
(3) Where over any period, the function of creating, storing or processing information for the purposes of any activity regularly carried on over that period as mentioned in clause (a) of sub-section (2) was regularly performed by means of one or more computers or communication device, whether—
(a) in standalone mode; or
(b) on a computer system; or
(c) on a computer network; or
(d) on a computer resource enabling information creation or providing information processing and storage; or
(e) through an intermediary, all the computers or communication devices used for that purpose during that period shall be treated for the purposes of this section as constituting a single computer or communication device; and references in this section to a computer or communication device shall be construed accordingly.
(4) In any proceeding where it is desired to give a statement in evidence by virtue of this section, a certificate doing any of the following things shall be submitted along with the electronic record at each instance where it is being submitted for admission, namely:—
(a) identifying the electronic record containing the statement and describing the manner in which it was produced;
(b) giving such particulars of any device involved in the production of that electronic record as may be appropriate for the purpose of showing that the electronic record was produced by a computer or a communication device referred to in clauses (a) to (e) of sub-section (3);
(c) dealing with any of the matters to which the conditions mentioned in sub-section (2) relate, and purporting to be signed by a person in charge of the computer or communication device or the management of the relevant activities (whichever is appropriate) and an expert shall be evidence of any matter stated in the certificate; and for the purposes of this sub-section it shall be sufficient for a matter to be stated to the best of the knowledge and belief of the person stating it in the certificate specified in the Schedule.
(5) For the purposes of this section,—
(a) information shall be taken to be supplied to a computer or communication device if it is supplied thereto in any appropriate form and whether it is so supplied directly or (with or without human intervention) by means of any appropriate equipment;
(b) a computer output shall be taken to have been produced by a computer or communication device whether it was produced by it directly or (with or without human intervention) by means of any appropriate equipment or by other electronic means as referred to in clauses (a) to (e) of sub-section (3).
64. Secondary evidence of the contents of the documents referred to in clause (a) of section 60, shall not be given unless the party proposing to give such secondary evidence has previously given to the party in whose possession or power the document is, or to his advocate or representative, such notice to produce it as is prescribed by law; and if no notice is prescribed by law, then such notice as the Court considers reasonable under the circumstances of the case: Provided that such notice shall not be required in order to render secondary evidence admissible in any of the following cases, or in any other case in which the Court thinks fit to dispense with it:—
(a) when the document to be proved is itself a notice;
(b) when, from the nature of the case, the adverse party must know that he will be required to produce it;
(c) when it appears or is proved that the adverse party has obtained possession of the original by fraud or force;
(d) when the adverse party or his agent has the original in Court;
(e) when the adverse party or his agent has admitted the loss of the document;
(f) when the person in possession of the document is out of reach of, or not subject to, the process of the Court.
65. If a document is alleged to be signed or to have been written wholly or in part by any person, the signature or the handwriting of so much of the document as is alleged to be in that person’s handwriting must be proved to be in his handwriting.
66. Except in the case of a secure electronic signature, if the electronic signature of any subscriber is alleged to have been affixed to an electronic record, the fact that such electronic signature is the electronic signature of the subscriber must be proved.
67. If a document is required by law to be attested, it shall not be used as evidence until one attesting witness at least has been called for the purpose of proving its execution, if there be an attesting witness alive, and subject to the process of the Court and capable of giving evidence: Provided that it shall not be necessary to call an attesting witness in proof of the execution of any document, not being a will, which has been registered in accordance with the provisions of the Indian Registration Act, 1908, unless its execution by the person by whom it purports to have been executed is specifically denied.
68. If no such attesting witness can be found, it must be proved that the attestation of one attesting witness at least is in his handwriting, and that the signature of the person executing the document is in the handwriting of that person.
-
- The admission of a party to an attested document of its execution by himself shall be sufficient proof of its execution as against him, though it be a document required by law to be attested.70. If the attesting witness denies or does not recollect the execution of the document, its execution may be proved by other evidence.71. An attested document not required by law to be attested may be proved as if it was unattested.72. (1) In order to ascertain whether a signature, writing or seal is that of the person by whom it purports to have been written or made, any signature, writing, or seal admitted or proved to the satisfaction of the Court to have been written or made by that person may be compared with the one which is to be proved, although that signature, writing or seal has not been produced or proved for any other purpose.(2) The Court may direct any person present in Court to write any words or figures for the purpose of enabling the Court to compare the words or figures so written with any words or figures alleged to have been written by such person.(3) This section applies also, with any necessary modifications, to finger impressions.
73. In order to ascertain whether a digital signature is that of the person by whom it purports to have been affixed, the Court may direct—
(a) that person or the Controller or the Certifying Authority to produce the Digital Signature Certificate;
(b) any other person to apply the public key listed in the Digital Signature Certificate and verify the digital signature purported to have been affixed by that person. Public documents
74. (1) The following documents are public documents:— (a) documents forming the acts, or records of the acts—
(i) of the sovereign authority;
(ii) of official bodies and tribunals; and
(iii) of public officers, legislative, judicial and executive of India or of a foreign country; (b) public records kept in any State or Union territory of private documents.
(2) All other documents except the documents referred to in sub-section (1) are private.
75. Every public officer having the custody of a public document, which any person has a right to inspect, shall give that person on demand a copy of it on payment of the legal fees therefor, together with a certificate written at the foot of such copy that it is a true copy of such document or part thereof, as the case may be, and such certificate shall be dated and subscribed by such officer with his name and his official title, and shall be sealed, whenever such officer is authorised by law to make use of a seal; and such copies so certified shall be called certified copies.
Explanation—Any officer who, by the ordinary course of official duty, is authorised to deliver such copies, shall be deemed to have the custody of such documents within the meaning of this section.
76. Such certified copies may be produced in proof of the contents of the public documents or parts of the public documents of which they purport to be copies.
77. The following public documents may be proved as follows:—
(a) Acts, orders or notifications of the Central Government in any of its Ministries and Departments or of any State Government or any Department of any State Government or Union territory Administration—
(i) by the records of the Departments, certified by the head of those Departments respectively; or
(ii) by any document purporting to be printed by order of any such Government;
(b) the proceedings of Parliament or a State Legislature, by the journals of those bodies respectively, or by published Acts or abstracts, or by copies purporting to be printed by order of the Government concerned;
(c) proclamations, orders or Regulations issued by the President of India or the Governor of a State or the Administrator or Lieutenant Governor of a Union territory, by copies or extracts contained in the Official Gazette;
(d) the Acts of the Executive or the proceedings of the Legislature of a foreign country, by journals published by their authority, or commonly received in that country as such, or by a copy certified under the seal of the country or sovereign, or by a recognition thereof in any Central Act;
(e) the proceedings of a municipal or local body in a State, by a copy of such proceedings, certified by the legal keeper thereof, or by a printed book purporting to be published by the authority of such body;
(f) public documents of any other class in a foreign country, by the original or by a copy certified by the legal keeper thereof, with a certificate under the seal of a Notary Public, or of an Indian Consul or diplomatic agent, that the copy is duly certified by the officer having the legal custody of the original, and upon proof of the character of the document according to the law of the foreign country. Presumptions as to documents
78. (1) The Court shall presume to be genuine every document purporting to be a certificate, certified copy or other document, which is by law declared to be admissible as evidence of any particular fact and which purports to be duly certified by any officer of the Central Government or of a State Government:
Provided that such document is substantially in the form and purports to be executed in the manner directed by law in that behalf.
(2) The Court shall also presume that any officer by whom any such document purports to be signed or certified, held, when he signed it, the official character which he claims in such paper.
79. Whenever any document is produced before any Court, purporting to be a record or memorandum of the evidence, or of any part of the evidence, given by a witness in a judicial proceeding or before any officer authorised by law to take such evidence or to be a statement or confession by any prisoner or accused person, taken in accordance with law,
and purporting to be signed by any Judge or Magistrate, or by any such officer as aforesaid, the Court shall presume that—
(i) the document is genuine;
(ii) any statements as to the circumstances under which it was taken, purporting to be made by the person signing it, are true; and
(iii) such evidence, statement or confession was duly taken.
80. The Court shall presume the genuineness of every document purporting to be the Official Gazette, or to be a newspaper or journal, and of every document purporting to be a document directed by any law to be kept by any person, if such document is kept substantially in the form required by law and is produced from proper custody.
Explanation—For the purposes of this section and section 92, document is said to be in proper custody if it is in the place in which, and looked after by the person with whom such document is required to be kept; but no custody is improper if it is proved to have had a legitimate origin, or if the circumstances of the particular case are such as to render that origin probable.
81. The Court shall presume the genuineness of every electronic or digital record purporting to be the Official Gazette, or purporting to be electronic or digital record directed by any law to be kept by any person, if such electronic or digital record is kept substantially in the form required by law and is produced from proper custody.
Explanation—For the purposes of this section and section 93 electronic records are said to be in proper custody if they are in the place in which, and looked after by the person with whom such document is required to be kept; but no custody is improper if it is proved to have had a legitimate origin, or the circumstances of the particular case are such as to render that origin probable.
82. The Court shall presume that maps or plans purporting to be made by the authority of the Central Government or any State Government were so made, and are accurate; but maps or plans made for the purposes of any cause must be proved to be accurate.
83. The Court shall presume the genuineness of, every book purporting to be printed or published under the authority of the Government of any country, and to contain any of the laws of that country, and of every book purporting to contain reports of decisions of the Courts of such country.
84. The Court shall presume that every document purporting to be a power-of-attorney, and to have been executed before, and authenticated by, a Notary Public, or any Court, Judge, Magistrate, Indian Consul or Vice-Consul, or representative of the Central Government, was so executed and authenticated.
85. The Court shall presume that every electronic record purporting to be an agreement containing the electronic or digital signature of the parties was so concluded by affixing the electronic or digital signature of the parties.
86. (1) In any proceeding involving a secure electronic record, the Court shall presume unless contrary is proved, that the secure electronic record has not been altered since the specific point of time to which the secure status relates.
(2) In any proceeding, involving secure electronic signature, the Court shall presume unless the contrary is proved that—
(a) the secure electronic signature is affixed by subscriber with the intention of signing or approving the electronic record;
(b) except in the case of a secure electronic record or a secure electronic signature, nothing in this section shall create any presumption, relating to authenticity and integrity of the electronic record or any electronic signature.
87. The Court shall presume, unless contrary is proved, that the information listed in an Electronic Signature Certificate is correct, except for information specified as subscriber information which has not been verified, if the certificate was accepted by the subscriber.
88. (1) The Court may presume that any document purporting to be a certified copy of any judicial record of any country beyond India is genuine and accurate, if the document purports to be certified in any manner which is certified by any representative of the Central Government in or for such country to be the manner commonly in use in that country for the certification of copies of judicial records.
(2) An officer who, with respect to any territory or place outside India is a Political Agent therefor, as defined in clause (43) of section 3 of the General Clauses Act, 1897, shall, for the purposes of this section, be deemed to be a representative of the Central Government in and for the country comprising that territory or place.
89. The Court may presume that any book to which it may refer for information on matters of public or general interest, and that any published map or chart, the statements of which are relevant facts, and which is produced for its inspection, was written and published by the person, and at the time and place, by whom or at which it purports to have been written or published.
90. The Court may presume that an electronic message, forwarded by the originator through an electronic mail server to the addressee to whom the message purports to be addressed corresponds with the message as fed into his computer for transmission; but the Court shall not make any presumption as to the person by whom such message was sent.
91. The Court shall presume that every document, called for and not produced after notice to produce, was attested, stamped and executed in the manner required by law.
92. Where any document, purporting or proved to be thirty years old, is produced from any custody which the Court in the particular case considers proper, the Court may presume that the signature and every other part of such document, which purports to be in the handwriting of any particular person, is in that person’s handwriting, and, in the case of a document executed or attested, that it was duly executed and attested by the persons by whom it purports to be executed and attested.
Explanation—The Explanation to section 80 shall also apply to this section. Illustrations.
(a) A has been in possession of landed property for a long time. He produces from his custody deeds relating to the land showing his titles to it. The custody shall be proper.
(b) A produces deeds relating to landed property of which he is the mortgagee. The mortgagor is in possession. The custody shall be proper.
(c) A, a connection of B, produces deeds relating to lands in B’s possession, which were deposited with him by B for safe custody. The custody shall be proper.
93. Where any electronic record, purporting or proved to be five years old, is produced from any custody which the Court in the particular case considers proper, the Court may presume that the electronic signature which purports to be the electronic signature of any particular person was so affixed by him or any person authorised by him in this behalf.
Explanation—The Explanation to section 81 shall also apply to this section.
CHAPTER VI
OF THE EXCLUSION OF ORAL EVIDENCE BY DOCUMENTARY EVIDENCE
94. When the terms of a contract, or of a grant, or of any other disposition of property, have been reduced to the form of a document, and in all cases in which any matter is required by law to be reduced to the form of a document, no evidence shall be given in proof of the terms of such contract, grant or other disposition of property, or of such matter, except the document itself, or secondary evidence of its contents in cases in which secondary evidence is admissible under the provisions hereinbefore contained.
Exception 1—When a public officer is required by law to be appointed in writing, and when it is shown that any particular person has acted as such officer, the writing by which he is appointed need not be proved.
Exception 2—Wills admitted to probate in India may be proved by the probate.
Explanation 1—This section applies equally to cases in which the contracts, grants or dispositions of property referred to are contained in one document, and to cases in which they are contained in more documents than one.
Explanation 2—Where there are more originals than one, one original only need be proved.
Explanation 3—The statement, in any document whatever, of a fact other than the facts referred to in this section, shall not preclude the admission of oral evidence as to the same fact. Illustrations.
(a) If a contract be contained in several letters, all the letters in which it is contained must be proved.
(b) If a contract is contained in a bill of exchange, the bill of exchange must be proved.
(c) If a bill of exchange is drawn in a set of three, one only need be proved.
(d) A contracts, in writing, with B, for the delivery of indigo upon certain terms. The contract mentions the fact that B had paid A the price of other indigo contracted for verbally on another occasion. Oral evidence is offered that no payment was made for the other indigo. The evidence is admissible.
(e) A gives B a receipt for money paid by B. Oral evidence is offered of the payment. The evidence is admissible.
95. When the terms of any such contract, grant or other disposition of property, or any matter required by law to be reduced to the form of a document, have been proved according to section 94, no evidence of any oral agreement or statement shall be admitted, as between the parties to any such instrument or their representatives in interest, for the purpose of contradicting, varying, adding to, or subtracting from, its terms:
Provided that any fact may be proved which would invalidate any document, or which would entitle any person to any decree or order relating thereto; such as fraud, intimidation, illegality, want of due execution, want of capacity in any contracting party, want or failure of consideration, or mistake in fact or law:
Provided further that the existence of any separate oral agreement as to any matter on which a document is silent, and which is not inconsistent with its terms, may be proved. In considering whether or not this proviso applies, the Court shall have regard to the degree of formality of the document:
Provided also that the existence of any separate oral agreement, constituting a condition precedent to the attaching of any obligation under any such contract, grant or disposition of property, may be proved: Provided also that the existence of any distinct subsequent oral agreement to rescind or modify any such contract, grant or disposition of property, may be proved, except in cases in which such contract, grant or disposition of property is by law required to be in writing, or has been registered according to the law in force for the time being as to the registration of documents:
Provided also that any usage or custom by which incidents not expressly mentioned in any contract are usually annexed to contracts of that description, may be proved:
Provided also that the annexing of such incident would not be repugnant to, or inconsistent with, the express terms of the contract:
Provided also that any fact may be proved which shows in what manner the language of a document is related to existing facts. Illustrations.
(a) A policy of insurance is effected on goods “in ships from Kolkata to Visakhapatnam”. The goods are shipped in a particular ship which is lost. The fact that particular ship was orally excepted from the policy, cannot be proved.
(b) A agrees absolutely in writing to pay B one thousand rupees on the 1st March, 2023. The fact that, at the same time, an oral agreement was made that the money should not be paid till the 31st March, 2023, cannot be proved.
(c) An estate called “the Rampur tea estate” is sold by a deed which contains a map of the property sold. The fact that land not included in the map had always been regarded as part of the estate and was meant to pass by the deed cannot be proved.
(d) A enters into a written contract with B to work certain mines, the property of B, upon certain terms. A was induced to do so by a misrepresentation of B’s as to their value. This fact may be proved.
(e) A institutes a suit against B for the specific performance of a contract, and also prays that the contract may be reformed as to one of its provisions, as that provision was inserted in it by mistake. Amay prove that such a mistake was made as would by law entitle him to have the contract reformed.
(f) A orders goods of B by a letter in which nothing is said as to the time of payment, and accepts the goods on delivery. B sues A for the price. A may show that the goods were supplied on credit for a term still unexpired.
(g) A sells B a horse and verbally warrants him sound. A gives B a paper in these words—”Bought of A a horse for thirty thousand rupees”. B may prove the verbal warranty.
(h) A hires lodgings of B, and gives B a card on which is written—”Rooms, ten thousand rupees a month”. A may prove a verbal agreement that these terms were to include partial board. A hires lodging of B for a year, and a regularly stamped agreement, drawn up by an advocate, is made between them. It is silent on the subject of board. A may not prove that board was included in the term verbally.
(i) A applies to B for a debt due to A by sending a receipt for the money. B keeps the receipt and does not send the money. In a suit for the amount, A may prove this.
(j) A and B make a contract in writing to take effect upon the happening of a certain contingency. The writing is left with B who sues A upon it. A may show the circumstances under which it was delivered.
96. When the language used in a document is, on its face, ambiguous or defective, evidence may not be given of facts which would show its meaning or supply its defects. Illustrations.
(a) A agrees, in writing, to sell a horse to B for “one lakh rupees or one lakh fifty thousand rupees”. Evidence cannot be given to show which price was to be given.
(b) A deed contains blanks. Evidence cannot be given of facts which would show how they were meant to be filled.
97. When language used in a document is plain in itself, and when it applies accurately to existing facts, evidence may not be given to show that it was not meant to apply to such facts. Illustration. A sells to B, by deed, “my estate at Rampur containing one hundred bighas”. A has an estate at Rampur containing one hundred bighas. Evidence may not be given of the fact that the estate meant to be sold was one situated at a different place and of a different size.
98. When language used in a document is plain in itself, but is unmeaning in reference to existing facts, evidence may be given to show that it was used in a peculiar sense. Illustration. A sells to B, by deed, “my house in Kolkata”. A had no house in Kolkata, but it appears that he had a house at Howrah, of which B had been in possession since the execution of the deed. These facts may be proved to show that the deed related to the house at Howrah.
99. When the facts are such that the language used might have been meant to apply to any one, and could not have been meant to apply to more than one, of several persons or things, evidence may be given of facts which show which of those persons or things it was intended to apply to. Illustrations.
(a) A agrees to sell to B, for one thousand rupees, “my white horse”. A has two white horses. Evidence may be given of facts which show which of them was meant.
(b) A agrees to accompany B to Ramgarh. Evidence may be given of facts showing whether Ramgarh in Rajasthan or Ramgarh in Uttarakhand was meant.
100. When the language used applies partly to one set of existing facts, and partly to another set of existing facts, but the whole of it does not apply correctly to either, evidence may be given to show to which of the two it was meant to apply.
Illustration
A agrees to sell to B “my land at X in the occupation of Y”. A has land at X, but not in the occupation of Y, and he has land in the occupation of Y but it is not at X. Evidence may be given of facts showing which he meant to sell.
101. Evidence may be given to show the meaning of illegible or not commonly intelligible characters, of foreign, obsolete, technical, local and regional expressions, of abbreviations and of words used in a peculiar sense.
Illustration.
A, sculptor, agrees to sell to B, “all my mods”. A has both models and modelling tools. Evidence may be given to show which he meant to sell.
102. Persons who are not parties to a document, or their representatives in interest, may give evidence of any facts tending to show a contemporaneous agreement varying the terms of the document. Illustration. A and B make a contract in writing that B shall sell A certain cotton, to be paid for on delivery. At the same time, they make an oral agreement that three months’ credit shall be given to A. This could not be shown as between A and B, but it might be shown by C, if it affected his interests.
103. Nothing in this Chapter shall be taken to affect any of the provisions of the Indian Succession Act, 1925 as to the construction of wills.
PART IV
PRODUCTION AND EFFECT OF EVIDENCE
CHAPTER VII
OF THE BURDEN OF PROOF
104. Whoever desires any Court to give judgment as to any legal right or liability dependent on the existence of facts which he asserts must prove that those facts exist, and when a person is bound to prove the existence of any fact, it is said that the burden of proof lies on that person.
Illustrations
(a) A desires a Court to give judgment that B shall be punished for a crime which A says B has committed. A must prove that B has committed the crime.
(b) A desires a Court to give judgment that he is entitled to certain land in the possession of B, by reason of facts which he asserts, and which B denies, to be true. A must prove the existence of those facts.
105. The burden of proof in a suit or proceeding lies on that person who would fail if no evidence at all were given on either side. Illustrations.
(a) A sues B for land of which B is in possession, and which, as A asserts, was left to A by the will of C, B’s father. If no evidence were given on either side, B would be entitled to retain his possession. Therefore, the burden of proof is on A.
(b) A sues B for money due on a bond. The execution of the bond is admitted, but B says that it was obtained by fraud, which A denies. If no evidence were given on either side, A would succeed, as the bond is not disputed and the fraud is not proved. Therefore, the burden of proof is on B.
106. The burden of proof as to any particular fact lies on that person who wishes the Court to believe in its existence, unless it is provided by any law that the proof of that fact shall lie on any particular person. Illustration. A prosecutes B for theft, and wishes the Court to believe that B admitted the theft to C. A must prove the admission. B wishes the Court to believe that, at the time in question, he was elsewhere. He must prove it.
107. The burden of proving any fact necessary to be proved in order to enable any person to give evidence of any other fact is on the person who wishes to give such evidence. Illustrations.
(a) A wishes to prove a dying declaration by B. A must prove B’s death.
(b) A wishes to prove, by secondary evidence, the contents of a lost document. A must prove that the document has been lost.
108. When a person is accused of any offence, the burden of proving the existence of circumstances bringing the case within any of the General Exceptions in the Bharatiya Nyaya Sanhita, 2023 or within any special exception or proviso contained in any other part of the said Sanhita, or in any law defining the offence, is upon him, and the Court shall presume the absence of such circumstances.
Illustrations
(a) A, accused of murder, alleges that, by reason of unsoundness of mind, he did not know the nature of the act. The burden of proof is on A.
(b) A, accused of murder, alleges that, by grave and sudden provocation, he was deprived of the power of self-control. The burden of proof is on A.
(c) Section 117 of the Bharatiya Nyaya Sanhita, 2023 provides that whoever, except in the case provided for by sub-section (2) of section 122, voluntarily causes grievous hurt, shall be subject to certain punishments. A is charged with voluntarily causing grievous hurt under section 117. The burden of proving the circumstances bringing the case under sub-section (2) of section 122 lies on A.
109. When any fact is especially within the knowledge of any person, the burden of proving that fact is upon him.
Illustrations
(a) When a person does an act with some intention other than that which the character and circumstances of the act suggest, the burden of proving that intention is upon him.
(b) A is charged with travelling on a railway without a ticket. The burden of proving that he had a ticket is on him.
110. When the question is whether a man is alive or dead, and it is shown that he was alive within thirty years, the burden of proving that he is dead is on the person who affirms it.
111. When the question is whether a man is alive or dead, and it is proved that he has not been heard of for seven years by those who would naturally have heard of him if he had been alive, the burden of proving that he is alive is shifted to the person who affirms it.
112. When the question is whether persons are partners, landlord and tenant, or principal and agent, and it has been shown that they have been acting as such, the burden of proving that they do not stand, or have ceased to stand, to each other in those relationships respectively, is on the person who affirms it.
113. When the question is whether any person is owner of anything of which he is shown to be in possession, the burden of proving that he is not the owner is on the person who affirms that he is not the owner.
114. Where there is a question as to the good faith of a transaction between parties, one of whom stands to the other in a position of active confidence, the burden of proving the good faith of the transaction is on the party who is in a position of active confidence. Illustrations.
(a) The good faith of a sale by a client to an advocate is in question in a suit brought by the client. The burden of proving the good faith of the transaction is on the advocate.
(b) The good faith of a sale by a son just come of age to a father is in question in a suit brought by the son. The burden of proving the good faith of the transaction is on the father.
115. (1) Where a person is accused of having committed any offence specified in sub-section (2), in—
(a) any area declared to be a disturbed area under any enactment for the time being in force, making provision for the suppression of disorder and restoration and maintenance of public order; or
(b) any area in which there has been, over a period of more than one month, extensive disturbance of the public peace, and it is shown that such person had been at a place in such area at a time when firearms or explosives were used at or from that place to attack or resist the members of any armed forces or the forces charged with the maintenance of public order acting in the discharge of their duties, it shall be presumed, unless the contrary is shown, that such person had committed such offence. (2) The offences referred to in sub-section (1) are the following, namely:—
(a) an offence under section 147, section 148, section 149 or section 150 of the Bharatiya Nyaya Sanhita, 2023;
(b) criminal conspiracy or attempt to commit, or abetment of, an offence under section 149 or section 150 of the Bharatiya Nyaya Sanhita, 2023.
116. The fact that any person was born during the continuance of a valid marriage between his mother and any man, or within two hundred and eighty days after its dissolution, the mother remaining unmarried, shall be conclusive proof that he is the legitimate child of that man, unless it can be shown that the parties to the marriage had no access to each other at any time when he could have been begotten.
117. When the question is whether the commission of suicide by a woman had been abetted by her husband or any relative of her husband and it is shown that she had committed suicide within a period of seven years from the date of her marriage and that her husband or such relative of her husband had subjected her to cruelty, the Court may presume, having regard to all the other circumstances of the case, that such suicide had been abetted by her husband or by such relative of her husband.
Explanation—For the purposes of this section, “cruelty” shall have the same meaning as in section 86 of the Bharatiya Nyaya Sanhita, 2023.
118. When the question is whether a person has committed the dowry death of a woman and it is shown that soon before her death, such woman had been subjected by such person to cruelty or harassment for, or in connection with, any demand for dowry, the Court shall presume that such person had caused the dowry death.
Explanation—For the purposes of this section, “dowry death” shall have the same meaning as in section 80 of the Bharatiya Nyaya Sanhita, 2023.
119. (1) The Court may presume the existence of any fact which it thinks likely to have happened, regard being had to the common course of natural events, human conduct and public and private business, in their relation to the facts of the particular case. Illustrations. The Court may presume that—
(a) a man who is in possession of stolen goods soon, after the theft is either the thief or has received the goods knowing them to be stolen, unless he can account for his possession;
(b) an accomplice is unworthy of credit, unless he is corroborated in material particulars;
(c) a bill of exchange, accepted or endorsed, was accepted or endorsed for good consideration;
(d) a thing or state of things which has been shown to be in existence within a period shorter than that within which such things or state of things usually cease to exist, is still in existence;
(e) judicial and official acts have been regularly performed;
(f) the common course of business has been followed in particular cases;
(g) evidence which could be and is not produced would, if produced, be unfavourable to the person who withholds it;
(h) if a man refuses to answer a question which he is not compelled to answer by law, the answer, if given, would be unfavourable to him;
(i) when a document creating an obligation is in the hands of the obligor, the obligation has been discharged.
(2) The Court shall also have regard to such facts as the following, in considering whether such maxims do or do not apply to the particular case before it:—
(i) as to Illustration (a)—a shop-keeper has in his bill a marked rupee soon after it was stolen, and cannot account for its possession specifically, but is continually receiving rupees in the course of his business;
(ii) as to Illustration (b)—A, a person of the highest character, is tried for causing a man’s death by an act of negligence in arranging certain machinery. B, a person of equally good character, who also took part in the arrangement, describes precisely what was done, and admits and explains the common carelessness of A and himself;
(iii) as to Illustration (b)—a crime is committed by several persons.A, B and C, three of the criminals, are captured on the spot and kept apart from each other. Each gives an account of the crime implicating D, and the accounts corroborate each other in such a manner as to render previous concert highly improbable;
(iv) as to Illustration (c)—A, the drawer of a bill of exchange, was a man of business. B, the acceptor, was a young and ignorant person, completely under A’s influence;
(v) as to Illustration (d)—it is proved that a river ran in a certain course five years ago, but it is known that there have been floods since that time which might change its course;
(vi) as to Illustration (e)—a judicial act, the regularity of which is in question, was performed under exceptional circumstances;
(vii) as to Illustration (f)—the question is, whether a letter was received. It is shown to have been posted, but the usual course of the post was interrupted by disturbances;
(viii) as to Illustration (g)—a man refuses to produce a document which would bear on a contract of small importance on which he is sued, but which might also injure the feelings and reputation of his family;
(ix) as to Illustration (h)—a man refuses to answer a question which he is not compelled by law to answer, but the answer to it might cause loss to him in matters unconnected with the matter in relation to which it is asked;
(x) as to Illustration (i)—a bond is in possession of the obligor, but the circumstances of the case are such that he may have stolen it.
120. In a prosecution for rape under sub-section (2) of section 64 of the Bharatiya Nyaya Sanhita, 2023, where sexual intercourse by the accused is proved and the question is whether it was without the consent of the woman alleged to have been raped and such woman states in her evidence before the Court that she did not consent, the Court shall presume that she did not consent.
Explanation—In this section, “sexual intercourse” shall mean any of the acts mentioned in section 63 of the Bharatiya Nyaya Sanhita, 2023.
CHAPTER VIII
ESTOPPEL
121. When one person has, by his declaration, act or omission, intentionally caused or permitted another person to believe a thing to be true and to act upon such belief, neither he nor his representative shall be allowed, in any suit or proceeding between himself and such person or his representative, to deny the truth of that thing. Illustration. A intentionally and falsely leads B to believe that certain land belongs to A, and thereby induces B to buy and pay for it. The land afterwards becomes the property of A, and A seeks to set aside the sale on the ground that, at the time of the sale, he had no title. He must not be allowed to prove his want of title.
122. No tenant of immovable property, or person claiming through such tenant, shall, during the continuance of the tenancy or any time thereafter, be permitted to deny that the landlord of such tenant had, at the beginning of the tenancy, a title to such immovable property; and no person who came upon any immovable property by the licence of the person in possession thereof shall be permitted to deny that such person had a title to such possession at the time when such licence was given.
123. No acceptor of a bill of exchange shall be permitted to deny that the drawer had authority to draw such bill or to endorse it; nor shall any bailee or licensee be permitted to deny that his bailor or licensor had, at the time when the bailment or licence commenced, authority to make such bailment or grant such licence.
Explanation 1—The acceptor of a bill of exchange may deny that the bill was really drawn by the person by whom it purports to have been drawn.
Explanation 2—If a bailee delivers the goods bailed to a person other than the bailor, he may prove that such person had a right to them as against the bailor.
CHAPTER IX
OF WITNESSES
124. All persons shall be competent to testify unless the Court considers that they are prevented from understanding the questions put to them, or from giving rational answers to those questions, by tender years, extreme old age, disease, whether of body or mind, or any other cause of the same kind.
Explanation—A person of unsound mind is not incompetent to testify, unless he is prevented by his unsoundness of mind from understanding the questions put to him and giving rational answers to them.
125. A witness who is unable to speak may give his evidence in any other manner in which he can make it intelligible, as by writing or by signs; but such writing must be written and the signs made in open Court and evidence so given shall be deemed to be oral evidence: Provided that if the witness is unable to communicate verbally, the Court shall take the assistance of an interpreter or a special educator in recording the statement, and such statement shall be videographed.
The Court shall presume, unless contrary is proved, that the information listed in an Electronic Signature Certificate is correct, except for information specified as subscriber information which has not been verified, if the certificate was accepted by the subscriber.
88. (1) The Court may presume that any document purporting to be a certified copy of any judicial record of any country beyond India is genuine and accurate, if the document purports to be certified in any manner which is certified by any representative of the Central Government in or for such country to be the manner commonly in use in that country for the certification of copies of judicial records.
(2) An officer who, with respect to any territory or place outside India is a Political Agent therefor, as defined in clause (43) of section 3 of the General Clauses Act, 1897, shall, for the purposes of this section, be deemed to be a representative of the Central Government in and for the country comprising that territory or place.
89. The Court may presume that any book to which it may refer for information on matters of public or general interest, and that any published map or chart, the statements of which are relevant facts, and which is produced for its inspection, was written and published by the person, and at the time and place, by whom or at which it purports to have been written or published.
90. The Court may presume that an electronic message, forwarded by the originator through an electronic mail server to the addressee to whom the message purports to be addressed corresponds with the message as fed into his computer for transmission; but the Court shall not make any presumption as to the person by whom such message was sent.
91. The Court shall presume that every document, called for and not produced after notice to produce, was attested, stamped and executed in the manner required by law.
92. Where any document, purporting or proved to be thirty years old, is produced from any custody which the Court in the particular case considers proper, the Court may presume that the signature and every other part of such document, which purports to be in the handwriting of any particular person, is in that person’s handwriting, and, in the case of a document executed or attested, that it was duly executed and attested by the persons by whom it purports to be executed and attested.
Explanation—The Explanation to section 80 shall also apply to this section. Illustrations.
(a) A has been in possession of landed property for a long time. He produces from his custody deeds relating to the land showing his titles to it. The custody shall be proper.
(b) A produces deeds relating to landed property of which he is the mortgagee. The mortgagor is in possession. The custody shall be proper.
(c) A, a connection of B, produces deeds relating to lands in B’s possession, which were deposited with him by B for safe custody. The custody shall be proper.
93. Where any electronic record, purporting or proved to be five years old, is produced from any custody which the Court in the particular case considers proper, the Court may presume that the electronic signature which purports to be the electronic signature of any particular person was so affixed by him or any person authorised by him in this behalf.
Explanation—The Explanation to section 81 shall also apply to this section.
CHAPTER X
OF EXAMINATION OF WITNESSES
140. The order in which witnesses are produced and examined shall be regulated by the law and practice for the time being relating to civil and criminal procedure respectively, and, in the absence of any such law, by the discretion of the Court.
141. (1) When either party proposes to give evidence of any fact, the Judge may ask the party proposing to give the evidence in what manner the alleged fact, if proved, would be relevant; and the Judge shall admit the evidence if he thinks that the fact, if proved, would be relevant, and not otherwise.
(2) If the fact proposed to be proved is one of which evidence is admissible only upon proof of some other fact, such last mentioned fact must be proved before evidence is given of the fact first mentioned, unless the party undertakes to give proof of such fact, and the Court is satisfied with such undertaking.
(3) If the relevancy of one alleged fact depends upon another alleged fact being first proved, the Judge may, in his discretion, either permit evidence of the first fact to be given before the second fact is proved, or require evidence to be given of the second fact before evidence is given of the first fact. Illustrations.
(a) It is proposed to prove a statement about a relevant fact by a person alleged to be dead, which statement is relevant under section 26. The fact that the person is dead must be proved by the person proposing to prove the statement, before evidence is given of the statement.
(b) It is proposed to prove, by a copy, the contents of a document said to be lost. The fact that the original is lost must be proved by the person proposing to produce the copy, before the copy is produced.
(c) A is accused of receiving stolen property knowing it to have been stolen. It is proposed to prove that he denied the possession of the property. The relevancy of the denial depends on the identity of the property. The Court may, in its discretion, either require the property to be identified before the denial of the possession is proved, or permit the denial of the possession to be proved before the property is identified.
(d) It is proposed to prove a fact A which is said to have been the cause or effect of a fact in issue. There are several intermediate facts B, C and D which must be shown to exist before the fact A can be regarded as the cause or effect of the fact in issue. The Court may either permit A to be proved before B, C or D is proved, or may require proof of B, C and D before permitting proof of A.
142. (1) The examination of a witness by the party who calls him shall be called his examination-in-chief.
(2) The examination of a witness by the adverse party shall be called his cross-examination.
(3) The examination of a witness, subsequent to the cross-examination, by the party who called him, shall be called his re-examination.
143. (1) Witnesses shall be first examined-in-chief, then (if the adverse party so desires) cross-examined, then (if the party calling him so desires) re-examined.
(2) The examination-in-chief and cross-examination must relate to relevant facts, but the cross-examination need not be confined to the facts to which the witness testified on his examination-in-chief.
(3) The re-examination shall be directed to the explanation of matters referred to in cross-examination; and, if new matter is, by permission of the Court, introduced in re-examination, the adverse party may further cross-examine upon that matter.
144. A person summoned to produce a document does not become a witness by the mere fact that he produces it, and cannot be cross-examined unless and until he is called as a witness.
145. Witnesses to character may be cross-examined and re-examined.
146. (1) Any question suggesting the answer which the person putting it wishes or expects to receive, is called a leading question.
(2) Leading questions must not, if objected to by the adverse party, be asked in an examination-in-chief, or in a re-examination, except with the permission of the Court.
(3) The Court shall permit leading questions as to matters which are introductory or undisputed, or which have, in its opinion, been already sufficiently proved.
(4) Leading questions may be asked in cross-examination.
147. Any witness may be asked, while under examination, whether any contract, grant or other disposition of property, as to which he is giving evidence, was not contained in a document, and if he says that it was, or if he is about to make any statement as to the contents of any document, which, in the opinion of the Court, ought to be produced, the adverse party may object to such evidence being given until such document is produced, or until facts have been proved which entitle the party who called the witness to give secondary evidence of it.
Explanation—A witness may give oral evidence of statements made by other persons about the contents of documents if such statements are in themselves relevant facts.
Illustration
The question is, whether A assaulted B. C deposes that he heard A say to D—”B wrote a letter accusing me of theft, and I will be revenged on him”. This statement is relevant, as showing A’s motive for the assault, and evidence may be given of it, though no other evidence is given about the letter.
148. A witness may be cross-examined as to previous statements made by him in writing or reduced into writing, and relevant to matters in question, without such writing being shown to him, or being proved; but, if it is intended to contradict him by the writing, his attention must, before the writing can be proved, be called to those parts of it which are to be used for the purpose of contradicting him.
149. When a witness is cross-examined, he may, in addition to the questions hereinbefore referred to, be asked any questions which tend—
(a) to test his veracity; or
(b) to discover who he is and what is his position in life; or
(c) to shake his credit, by injuring his character, although the answer to such questions might tend directly or indirectly to criminate him, or might expose or tend directly or indirectly to expose him to a penalty or forfeiture:
Provided that in a prosecution for an offence under section 64, section 65, section 66, section 67, section 68, section 69, section 70 or section 71 of the Bharatiya Nyaya Sanhita, 2023 or for attempt to commit any such offence, where the question of consent is an issue, it shall not be permissible to adduce evidence or to put questions in the cross-examination of the victim as to the general immoral character, or previous sexual experience, of such victim with any person for proving such consent or the quality of consent.
150. If any such question relates to a matter relevant to the suit or proceeding, the provisions of section 137 shall apply thereto.
151. (1) If any such question relates to a matter not relevant to the suit or proceeding, except in so far as it affects the credit of the witness by injuring his character, the Court shall decide whether or not the witness shall be compelled to answer it, and may, if it thinks fit, warn the witness that he is not obliged to answer it.
(2) In exercising its discretion, the Court shall have regard to the following considerations, namely:—
(a) such questions are proper if they are of such a nature that the truth of the imputation conveyed by them would seriously affect the opinion of the Court as to the credibility of the witness on the matter to which he testifies;
(b) such questions are improper if the imputation which they convey relates to matters so remote in time, or of such a character, that the truth of the imputation would not affect, or would affect in a slight degree, the opinion of the Court as to the credibility of the witness on the matter to which he testifies;
(c) such questions are improper if there is a great disproportion between the importance of the imputation made against the witness’s character and the importance of his evidence;
(d) the Court may, if it sees fit, draw, from the witness’s refusal to answer, the inference that the answer if given would be unfavourable.
152. No such question as is referred to in section 151 ought to be asked, unless the person asking it has reasonable grounds for thinking that the imputation which it conveys is well-founded. Illustrations.
(a) An advocate is instructed by another advocate that an important witness is a dacoit. This is a reasonable ground for asking the witness whether he is a dacoit.
(b) An advocate is informed by a person in Court that an important witness is a dacoit. The informant, on being questioned by the advocate, gives satisfactory reasons for his statement. This is a reasonable ground for asking the witness whether he is a dacoit.
(c) A witness, of whom nothing whatever is known, is asked at random whether he is a dacoit. There are here no reasonable grounds for the question.
(d) A witness, of whom nothing whatever is known, being questioned as to his mode of life and means of living, gives unsatisfactory answers. This may be a reasonable ground for asking him if he is a dacoit.
153. If the Court is of opinion that any such question was asked without reasonable grounds, it may, if it was asked by any advocate, report the circumstances of the case to the High Court or other authority to which such advocate is subject in the exercise of his profession.
154. The Court may forbid any questions or inquiries which it regards as indecent or scandalous, although such questions or inquiries may have some bearing on the questions before the Court, unless they relate to facts in issue, or to matters necessary to be known in order to determine whether or not the facts in issue existed.
155. The Court shall forbid any question which appears to it to be intended to insult or annoy, or which, though proper in itself, appears to the Court needlessly offensive in form.
156. When a witness has been asked and has answered any question which is relevant to the inquiry only in so far as it tends to shake his credit by injuring his character, no evidence shall be given to contradict him; but, if he answers falsely, he may afterwards be charged with giving false evidence.
Exception 1.—If a witness is asked whether he has been previously convicted of any crime and denies it, evidence may be given of his previous conviction.
Exception 2.—If a witness is asked any question tending to impeach his impartiality, and answers it by denying the facts suggested, he may be contradicted. Illustrations.
(a) A claim against an underwriter is resisted on the ground of fraud. The claimant is asked whether, in a former transaction, he had not made a fraudulent claim. He denies it. Evidence is offered to show that he did make such a claim. The evidence is inadmissible.
(b) A witness is asked whether he was not dismissed from a situation for dishonesty. He denies it. Evidence is offered to show that he was dismissed for dishonesty. The evidence is not admissible.
(c) A affirms that on a certain day he saw B at Goa. A is asked whether he himself was not on that day at Varanasi. He denies it. Evidence is offered to show that A was on that day at Varanasi. The evidence is admissible, not as contradicting A on a fact which affects his credit, but as contradicting the alleged fact that B was seen on the day in question in Goa. In each of these cases, the witness might, if his denial was false, be charged with giving false evidence.
(d) A is asked whether his family has not had a blood feud with the family of B against whom he gives evidence. He denies it. He may be contradicted on the ground that the question tends to impeach his impartiality.
157. (1) The Court may, in its discretion, permit the person who calls a witness to put any question to him which might be put in cross-examination by the adverse party.
(2) Nothing in this section shall disentitle the person so permitted under sub-section (1), to rely on any part of the evidence of such witness.
158. The credit of a witness may be impeached in the following ways by the adverse party, or, with the consent of the Court, by the party who calls him—
(a) by the evidence of persons who testify that they, from their knowledge of the witness, believe him to be unworthy of credit;
(b) by proof that the witness has been bribed, or has accepted the offer of a bribe, or has received any other corrupt inducement to give his evidence;
(c) by proof of former statements inconsistent with any part of his evidence which is liable to be contradicted.
Explanation—A witness declaring another witness to be unworthy of credit may not, upon his examination-in-chief, give reasons for his belief, but he may be asked his reasons in cross-examination, and the answers which he gives cannot be contradicted, though, if they are false, he may afterwards be charged with giving false evidence.
Illustrations
(a) A sues B for the price of goods sold and delivered to B. C says that he delivered the goods to B. Evidence is offered to show that, on a previous occasion, he said that he had not delivered goods to B. The evidence is admissible.
(b) A is accused of the murder of B. C says that B, when dying, declared that A had given B the wound of which he died. Evidence is offered to show that, on a previous occasion, C said that B, when dying, did not declare that A had given B the wound of which he died. The evidence is admissible.
159. When a witness whom it is intended to corroborate gives evidence of any relevant fact, he may be questioned as to any other circumstances which he observed at or near to the time or place at which such relevant fact occurred, if the Court is of opinion that such circumstances, if proved, would corroborate the testimony of the witness as to the relevant fact which he testifies.
Illustration
A, an accomplice, gives an account of a robbery in which he took part. He describes various incidents unconnected with the robbery which occurred on his way to and from the place where it was committed. Independent evidence of these facts may be given in order to corroborate his evidence as to the robbery itself.
160. In order to corroborate the testimony of a witness, any former statement made by such witness relating to the same fact, at or about the time when the fact took place, or before any authority legally competent to investigate the fact, may be proved.
161. Whenever any statement, relevant under section 26 or 27, is proved, all matters may be proved either in order to contradict or to corroborate it, or in order to impeach or confirm the credit of the person by whom it was made, which might have been proved if that person had been called as a witness and had denied upon cross-examination the truth of the matter suggested.
162. (1) A witness may, while under examination, refresh his memory by referring to any writing made by himself at the time of the transaction concerning which he is questioned, or so soon afterwards that the Court considers it likely that the transaction was at that time fresh in his memory:
Provided that the witness may also refer to any such writing made by any other person, and read by the witness within the time aforesaid, if when he read it, he knew it to be correct.
(2) Whenever a witness may refresh his memory by reference to any document, he may, with the permission of the Court, refer to a copy of such document:
Provided that the Court be satisfied that there is sufficient reason for the non-production of the original: Provided further that an expert may refresh his memory by reference to professional treatises.
163. A witness may also testify to facts mentioned in any such document as is mentioned in section 162, although he has no specific recollection of the facts themselves, if he is sure that the facts were correctly recorded in the document.
Illustration
A book-keeper may testify to facts recorded by him in books regularly kept in the course of business, if he knows that the books were correctly kept, although he has forgotten the particular transactions entered.
164. Any writing referred to under the provisions of the two last preceding sections shall be produced and shown to the adverse party if he requires it; such party may, if he pleases, cross-examine the witness thereupon.
165. (1) A witness summoned to produce a document shall, if it is in his possession or power, bring it to Court, notwithstanding any objection which there may be to its production or to its admissibility:
Provided that the validity of any such objection shall be decided on by the Court.
(2) The Court, if it sees fit, may inspect the document, unless it refers to matters of State, or take other evidence to enable it to determine on its admissibility.
(3) If for such a purpose it is necessary to cause any document to be translated, the Court may, if it thinks fit, direct the translator to keep the contents secret, unless the document is to be given in evidence and, if the interpreter disobeys such direction, he shall be held to have committed an offence under section 198 of the Bharatiya Nyaya Sanhita, 2023:
Provided that no Court shall require any communication between the Ministers and the President of India to be produced before it.
166. When a party calls for a document which he has given the other party notice to produce, and such document is produced and inspected by the party calling for its production, he is bound to give it as evidence if the party producing it requires him to do so.
167. When a party refuses to produce a document which he has had notice to produce, he cannot afterwards use the document as evidence without the consent of the other party or the order of the Court. Illustration. A sues B on an agreement and gives B notice to produce it. At the trial, A calls for the document and B refuses to produce it. A gives secondary evidence of its contents. B seeks to produce the document itself to contradict the secondary evidence given by A, or in order to show that the agreement is not stamped. He cannot do so.
168. The Judge may, in order to discover or obtain proof of relevant facts, ask any question he considers necessary, in any form, at any time, of any witness, or of the parties about any fact; and may order the production of any document or thing; and neither the parties nor their representatives shall be entitled to make any objection to any such question or order, nor, without the leave of the Court, to cross-examine any witness upon any answer given in reply to any such question:
Provided that the judgment must be based upon facts declared by this Adhiniyam to be relevant, and duly proved: Provided further that this section shall not authorise any Judge to compel any witness to answer any question, or to produce any document which such witness would be entitled to refuse to answer or produce under sections 127 to 136, both inclusive, if the question were asked or the document were called for by the adverse party; nor shall the Judge ask any question which it would be improper for any other person to ask under section 151 or 152; nor shall he dispense with primary evidence of any document, except in the cases hereinbefore excepted.
CHAPTER XI
OF IMPROPER ADMISSION AND REJECTION OF EVIDENCE
169. The improper admission or rejection of evidence shall not be ground of itself for a new trial or reversal of any decision in any case, if it shall appear to the Court before which such objection is raised that, independently of the evidence objected to and admitted, there was sufficient evidence to justify the decision, or that, if the rejected evidence had been received, it ought not to have varied the decision.
CHAPTER XII
REPEAL AND SAVINGS
170. (1) The Indian Evidence Act, 1872 is hereby repealed.
(2) Notwithstanding such repeal, if, immediately before the date on which this Adhiniyam comes into force, there is any application, trial, inquiry, investigation, proceeding or appeal pending, then, such application, trial, inquiry, investigation, proceeding or appeal shall be dealt with under the provisions of the Indian Evidence Act, 1872, as in force immediately before such commencement, as if this Adhiniyam had not come into force.
Bharatiya Nagarik Suraksha Sanhita, 2023 (BNSS)
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Create a safe and respectful workplace with expert-led POSH training, workshops, and compliance solutions. Our law firm specialises in helping businesses meet the legal requirements of the POSH Act, 2013 through structured training, policy drafting, and end-to-end compliance support.
Who Needs POSH Act Compliance?
As per the Prevention of Sexual Harassment (POSH) Act, 2013, all organisations with 10 or more employees are required to:
✔ Implement POSH policy
✔ Constitute an Internal Committee (IC)
✔ Conduct regular POSH training and awareness programs
✔ Submit an annual compliance report
Whether you’re a corporate entity, educational institution, NGO, or government organisation, POSH compliance is not just a legal mandate but a step toward fostering a safe workplace culture.
Why is POSH Compliance Important?
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Avoid hefty penalties and reputational risks by aligning with POSH regulations.
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Cultivate a professional, harassment-free environment for employees
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❌ Lack of awareness among employees and management
❌ Inadequate training and sensitisation
❌ Misconceptions about the POSH Act and reporting procedures
❌ Non-compliance with legal documentation and reporting
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Have questions? Explore our FAQs to get answers to common queries about POSH laws, training, and compliance requirements.
1. Is PoSH mandatory for every company?
Yes, as per the PoSH Act, 2013, all organisations with 10 or more employees must establish an Internal Committee (IC) to handle workplace sexual harassment complaints.
2. Can men file cases under the PoSH Act?
No, the PoSH Act only protects women from sexual harassment in the workplace. However, men can seek legal remedies under other labour and criminal laws.
3. What kinds of cases are not included in the PoSH Act?
The PoSH Act does not cover gender discrimination, workplace bullying, emotional abuse, or professional disagreements that are unrelated to sexual harassment.
4. What are the demerits of the PoSH Act?
Challenges of the PoSH Act include possible misuse through false allegations, lack of protection for male victims, employer liability concerns, and enforcement gaps in smaller organisations.
5. What is a false case under the PoSH Act 2013?
A false case refers to a maliciously filed complaint with no factual basis. If proven, the complainant may face disciplinary action as per the Act’s provisions.
6. What is the role of organisations under the PoSH Act 2013?
Organisations must constitute an Internal Committee (IC), conduct awareness training, establish grievance redressal mechanisms, and ensure a safe workplace free from sexual harassment.
7. What are the kinds of sexual harassment?
Sexual harassment includes verbal, non-verbal, physical, and psychological misconduct, such as inappropriate touching, unwelcome advances, sexually charged comments, or coercion.
8. How does the PoSH Act define sexual harassment?
The PoSH Act defines sexual harassment as any unwelcome sexual behaviour in the workplace, including physical contact, remarks, displaying explicit content, or requests for sexual favours.
9. Are freelancers or contractors covered under the PoSH Act?
Yes, the Act extends protection to freelancers, interns, consultants, and contractual workers who face sexual harassment at the workplace.
10. What steps should an organisation take to prevent sexual harassment?
Organisations should implement strict anti-harassment policies, conduct PoSH training, ensure quick grievance redressal, and foster a zero-tolerance work culture.
11. Can an employee file a complaint directly with the local police under the PoSH Act?
Yes, an employee can file a complaint with the Internal Committee (IC) or directly approach the police if the act of harassment is criminal in nature.
12. What happens if an organisation fails to comply with the PoSH Act?
Non-compliance can lead to a fine of up to ₹50,000, potential business license revocation, and reputational damage.
13. How long does an organisation have to resolve a complaint under the PoSH Act?
As per the Act, complaints should be resolved within 90 days from the date of filing.
14. Can an employer be held personally liable for sexual harassment committed by an employee?
No, unless the employer is directly involved or fails to act despite awareness of the complaint, the individual employee is primarily held accountable.
15. What support mechanisms are available for victims of sexual harassment under the PoSH Act?
Support includes counselling, legal assistance, interim relief (like transfers or leave), protection from retaliation, and strict action against the harasser.
16. Does the PoSH Act cover incidents of sexual harassment outside the workplace?
Yes, if the harassment occurs in work-related settings like conferences, off-site events, client locations, or virtual workspaces, the Act applies.
17. Can a third party or bystander file a complaint under the PoSH Act on behalf of the victim?
Yes, a colleague, bystander, or third party can file a complaint if the victim is unable or hesitant to report the harassment.
18. What role does the Internal Committee (IC) play in addressing complaints under the PoSH Act?
The IC is responsible for receiving, investigating, and resolving complaints, recommending action against the offender, and ensuring compliance with the Act.
19. Are anonymous complaints accepted under the PoSH Act?
No, the Act does not explicitly recognise anonymous complaints, but some organisations may allow them as part of their internal grievance mechanism.
20. Can an employee be transferred or retaliated against for filing a complaint under the PoSH Act?
No, retaliation is prohibited. Victims should be safeguarded from unfair transfers, demotions, or terminations after filing a complaint.
21. How often should organisations conduct awareness training on the PoSH Act?
Organisations must conduct PoSH training at least once a year to educate employees and management on workplace harassment policies.
22. What measures can organisations take to create a safer work environment beyond legal compliance?
Beyond compliance, organisations can foster an inclusive culture, encourage reporting, establish mentoring programs, and implement stricter workplace policies against harassment.
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The Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts (Amendment) Act, 2018
Act No. 28 of 2018
[20th August, 2018.]
An Act to amend the Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts Act, 2015.
BE it enacted by Parliament in the Sixty-ninth Year of the Republic of India as follows:
1. Short title and commencement.
(1) This Act may be called the Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts (Amendment) Act, 2018.
(2) Save as otherwise provided, it shall be deemed to have come into force on the 3rd day of May, 2018.
2. Amendment of long title
In the Commercial Courts, Commercial Division and Commercial Appellate
Division of High Courts Act, 2015 (hereinafter referred to as the principal Act), in the 4 of 2016. long title, after the words “Commercial Courts”, the words “Commercial Appellate
Courts,” shall be inserted.
3. Amendment of section 1
In section 1 of the principal Act, for sub-section (1), the following sub-section shall be substituted, namely:
“(1) This Act may be called the Commercial Courts Act, 2015.”.
4. Amendment of section 2
In section 2 of the principal Act, in sub-section (1),
(I) clause (a) shall be renumbered as clause (aa) thereof, and before clause (aa) as so renumbered, the following clause shall be inserted, namely:
‘(a) “Commercial Appellate Courts” means the Commercial Appellate Courts designated under section 3A;’;
(II) in clause (i), for the words “which shall not be less than one crore rupees”, the words “which shall not be less than three lakh rupees” shall be substituted.
5. Substitution of Chapter heading
In the principal Act, in Chapter II, for the Chapter heading, the following Chapter heading shall be substituted, namely:
“COMMERCIAL COURTS, COMMERCIAL APPELLATE COURTS, COMMERCIAL DIVISIONS AND COMMERCIALAPPELLATE DIVISIONS”.
6. Amendment of section 3
In section 3 of the principal Act,
(a) in sub-section (1), for the proviso, the following provisos shall be substituted, namely:
“Provided that with respect to the High Courts having ordinary original civil jurisdiction, the State Government may, after consultation with the concerned High Court, by notification, constitute Commercial Courts at the District Judge level:
Provided further that with respect to a territory over which the High Courts have ordinary original civil jurisdiction, the State Government may, by notification, specify such pecuniary value which shall not be less than three lakh rupees and not more than the pecuniary jurisdiction exercisable by the District Courts, as it may consider necessary.”;
(b) after sub-section (1), the following sub-section shall be inserted, namely:
“(1A) Notwithstanding anything contained in this Act, the State Government may, after consultation with the concerned High Court, by notification, specify such pecuniary value which shall not be less than three lakh rupees or such higher value, for whole or part of the State, as it may consider necessary.”;
(c) in sub-section (3),
(i) for the words “State Government shall”, the words “State Government may” shall be substituted;
(ii) for the words “Commercial Court, from amongst the cadre of Higher Judicial Service in the State”, the following words shall be substituted, namely:
“Commercial Court either at the level of District Judge or a court below the level of a District Judge”.
7. Insertion of new section 3A
After section 3 of the principal Act, the following section shall be inserted, namely:
“3A. Except the territories over which the High Courts have ordinary original civil jurisdiction, the State Government may, after consultation with the concerned High Court, by notification, designate such number of Commercial Appellate Courts at District Judge level, as it may deem necessary, for the purposes of exercising the jurisdiction and powers conferred on those Courts under this Act.”.
8. Amendment of section 4
In section 4 of the principal Act, in sub-section (1), for the words “ordinary civil jurisdiction”, the words “ordinary original civil jurisdiction” shall be substituted.
9. Omission of section 9
Section 9 of the principal Act shall be omitted.
10. Amendment of section 12
In section 12 of the principal Act, in sub-section (1),
(i) in clause (c), after the words “Specified Value;”, the word “and” shall be inserted;
(ii) in clause (d), the word “and”, occurring at the end, shall be omitted;
(iii) clause (e) shall be omitted.
11. Insertion of new Chapter IIIA
After Chapter III of the principal Act, the following Chapter shall be inserted, namely:
12A. (1) A suit, which does not contemplate any urgent interim relief under this Act, shall not be instituted unless the plaintiff exhausts the remedy of pre-institution mediation in accordance with such manner and procedure as may be prescribed by rules made by the Central Government.
(2) The Central Government may, by notification, authorise the Authorities constituted under the Legal Services Authorities Act, 1987, for the purposes ofpre-institution mediation.
(3) Notwithstanding anything contained in the Legal Services Authorities Act, 1987, the Authority authorised by the Central Government under sub-section (2) shall complete the process of mediation within a period of three months from the date of application made by the plaintiff under sub-section (1):
Provided that the period of mediation may be extended for a further period of two months with the consent of the parties:
Provided further that, the period during which the parties remained occupied with thepre-institution mediation, such period shall not be computed for the purpose of limitation under the Limitation Act, 1963.
(4) If the parties to the commercial dispute arrive at a settlement, the same shall be reduced into writing and shall be signed by the parties to the dispute and the mediator.
(5) The settlement arrived at under this section shall have the same status and effect as if it is an arbitral award on agreed terms under sub-section (4) of section 30 of the Arbitration and Conciliation Act, 1996.”.
12. Amendment of section 13
In section 13 of the principal Act, for sub-section (1), the following shall be substituted, namely:
“(1) Any person aggrieved by the judgment or order of a Commercial Court below the level of a District Judge may appeal to the Commercial Appellate Court within a period of sixty days from the date of judgment or order.
(1A) Any person aggrieved by the judgment or order of a Commercial Court at the level of District Judge exercising original civil jurisdiction or, as the case may be, Commercial Division of a High Court may appeal to the Commercial Appellate Division of that High Court within a period of sixty days from the date of the judgment or order:
Provided that an appeal shall lie from such orders passed by a Commercial Division or a Commercial Court that are specifically enumerated under Order XLIII of the Code of Civil Procedure, 1908 as amended by this Act and section 37 of the Arbitration and Conciliation Act, 1996.”.
13. Amendment of section 14
In section 14 of the principal Act, for the words “Commercial Appellate Division”, the words “Commercial Appellate Court and the Commercial Appellate Division” shall be substituted.
14. Amendment of section 15
In section 15 of the principal Act, in sub-section (4), for the words, figures and letter “with Order XIV-A”, the words, figures and letter “with Order XV-A” shall be substituted.
15. Amendment of section 17
In section 17 of the principal Act, for the words “Commercial Courts” and “Commercial Court”, wherever they occur, the words “Commercial Courts, Commercial Appellate Courts” shall be substituted.
16. Amendment of section 20
In section 20 of the principal Act, for the words “Commercial Court”, the words “Commercial Courts, Commercial Appellate Courts” shall be substituted.
17. Insertion of new section 21A
After section 21 of the principal Act, the following section shall be inserted, namely:
“21A. (1) The Central Government may, by notification, make rules for carrying out the provisions of this Act.
(2) In particular, and without prejudice to the generality of the foregoing power, such rules may provide for or any of the following matters, namely:
(a) the manner and procedure of pre-institution mediation under sub-section(1) of section 12A;
(b) any other matter which is required to be, or may be, prescribed or in respect of which provision is to be made by rules made by the Central Government.
(3) Every rule made by the Central Government under this Act shall be laid, as soon as may be after it is made, before each House of Parliament, while it is in session, for a total period of thirty days which may be comprised in one session, or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rule, or both Houses agree that the rule should not be made, the rule shall thereafter have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule.”.
18. Insertion of Schedule
In the Schedule to the principal Act,
(i) in Paragraph 4, in sub-paragraph (D), in item (iv),
(a) in the opening portion, the words “after the first proviso,”shall be omitted;
(b) for the words “Provided further that”, the words “Provided that” shall be substituted;
(ii) in Paragraph 11, for the words “Commercial Court”, the words “Commercial Court, Commercial Appellate Court” shall be substituted;
(iii) after Paragraph 11, the following shall be inserted and shall be deemed to have been inserted with effect from the 23rd October, 2015, namely:
’12. After Appendix H, the following Appendix shall be inserted, namely:
IÂ —–Â the deponent do hereby solemnly affirm and declare as under:
1. I am the party in the above suit and competent to swear this affidavit.
2. I am sufficiently conversant with the facts of the case and have also examined all relevant documents and records in relation thereto.
3. I say that the statements made in —–paragraphs are true to my knowledge and statements made in —–paragraphs are based on information received which I believe to be correct and statements made in —paragraphs are based on legal advice.
4. I say that there is no false statement or concealment of any material fact, document or record and I have included information that is according to me, relevant for the present suit.
5. I say that all documents in my power, possession, control or custody, pertaining to the facts and circumstances of the proceedings initiated by me have been disclosed and copies thereof annexed with the plaint, and that I do not have any other documents in my power, possession, control or custody.
6. I say that the above-mentioned pleading comprises of a total of —- pages, each of which has been duly signed by me.
7. I state that the Annexures hereto are true copies of the documents referred to and relied upon by me.
8. I say that I am aware that for any false statement or concealment, I shall be liable for action taken against me under the law for the time being in force.
Place:
Date:
DEPONENT
VERIFICATION
I, ………………………. do hereby declare that the statements made above are true to my knowledge.
Verified at [place] on this [date]
DEPONENT.”.’.
19. Application of provisions of this Act to cases filed on or after its commencement
Save as otherwise provided, the provisions of this Act shall apply only to cases relating to commercial disputes filed on or after the date of commencement of this Act.
20. Repeal and savings
(1) The Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts (Amendment) Ordinance, 2018 is hereby repealed.
(2) Notwithstanding the repeal of the said Ordinance, anything done or any action taken under the said Ordinance shall deemed to have been done or taken under the corresponding provisions of this Act.
The Commercial Courts Act, 2015
[31st December, 2015.]
An Act to provide for the constitution of Commercial Courts, 1[Commercial Appellate Courts,] Commercial Division and Commercial Appellate Division in the High Courts for adjudicating commercial disputes of specified value and matters connected therewith or incidental thereto.
BE it enacted by Parliament in the Sixty-sixth Year of the Republic of India as follows:—
CHAPTER I
PRELIMINARY
1. Short title, extent and commencement.—2[(1) This Act may be called the Commercial Courts Act, 2015.]
(2) It extends to the whole of India except the State of Jammu and Kashmir.
(3) It shall be deemed to have come into force on the 23rd day of October, 2015.
2. Definitions.—(1) In this Act, unless the context otherwise requires,–
3[(a) “Commercial Appellate Courts” means the Commercial Appellate Courts designated under section 3A;]
4[(aa)] “Commercial Appellate Division” means the Commercial Appellate Division in a High Court constituted under sub-section (1) of section 5;
(b) “Commercial Court” means the Commercial Court constituted under sub-section (1) of section 3;
(c) “commercial dispute” means a dispute arising out of-
(i) ordinary transactions of merchants, bankers, financiers and traders such as those relating to mercantile documents, including enforcement and interpretation of such documents;
(ii) export or import of merchandise or services;
(iii) issues relating to admiralty and maritime law;
(iv) transactions relating to aircraft, aircraft engines, aircraft equipment and helicopters, including sales, leasing and financing of the same;
(v) carriage of goods;
(vi) construction and infrastructure contracts, including tenders;
(vii) agreements relating to immovable property used exclusively in trade or commerce;
(viii) franchising agreements;
(ix) distribution and licensing agreements;
(x) management and consultancy agreements;
(xi) joint venture agreements;
(xii) shareholders agreements;
(xiii) subscription and investment agreements pertaining to the services industry including outsourcing services and financial services;
(xiv) mercantile agency and mercantile usage;
(xv) partnership agreements;
(xvi) technology development agreements;
(xvii) intellectual property rights relating to registered and unregistered trademarks, copyright, patent, design, domain names, geographical indications and semiconductor integrated circuits;
(xviii) agreements for sale of goods or provision of services;
(xix) exploitation of oil and gas reserves or other natural resources including electromagnetic spectrum;
(xx) insurance and re-insurance;
(xxi) contracts of agency relating to any of the above; and
(xxii) such other commercial disputes as may be notified by the Central Government.
Explanation.––A commercial dispute shall not cease to be a commercial dispute merely because-
(a) it also involves action for recovery of immovable property or for realisation of monies out of immovable property given as security or involves any other relief pertaining to immovable property;
(b) one of the contracting parties is the State or any of its agencies or instrumentalities, or a private body carrying out public functions;
(d) “Commercial Division” means the Commercial Division in a High Court constituted under sub-section (1) of section 4;
(e) “District Judge” shall have the same meaning as assigned to it in clause (a) of article 236 of the Constitution of India;
(f) “document” means any matter expressed or described upon any substance by means of letters, figures or marks, or electronic means, or by more than one of those means, intended to be used, or which may be used, for the purpose of recording that matter;
(g) “notification” means a notification published in the Official Gazette and the expression “notify” with its cognate meanings and grammatical variations shall be construed accordingly;
(h) “Schedule” means the Schedule appended to the Act; and
(i) “Specified Value”, in relation to a commercial dispute, shall mean the value of the subject-matter in respect of a suit as determined in accordance with section 12 5[which shall not be less than three lakh rupees] or such higher value, as may be notified by the Central Government.
(2) The words and expressions used and not defined in this Act but defined in the Code of Civil Procedure, 1908 (5 of 1908) and the Indian Evidence Act, 1872 (1 of 1872), shall have the same meanings respectively assigned to them in that Code and the Act.
CHAPTER II
6[COMMERCIAL COURTS, COMMERCIAL APPELLATE COURTS, COMMERCIAL DIVISIONS AND COMMERCIAL APPELLATE DIVISIONS].
3. Constitution of Commercial Courts.—(1) The State Government, may after consultation with the concerned High Court, by notification, constitute such number of Commercial Courts at District level, as it may deem necessary for the purpose of exercising the jurisdiction and powers conferred on those Courts under this Act:
7[Provided that with respect to the High Courts having ordinary original civil jurisdiction, the State Government may, after consultation with the concerned High Court, by notification, constitute Commercial Courts at the District Judge level:
Provided further that with respect to a territory over which the High Courts have ordinary original civil jurisdiction, the State Government may, by notification, specify such pecuniary value which shall not be less than three lakh rupees and not more than the pecuniary jurisdiction exercisable by the District Courts, as it may consider necessary.]
8[(1A) Notwithstanding anything contained in this Act, the State Government may, after consultation with the concerned High Court, by notification, specify such pecuniary value which shall not be less than three lakh rupees or such higher value, for whole or part of the State, as it may consider necessary.];
(2) The State Government shall, after consultation with the concerned High Court specify, by notification, the local limits of the area to which the jurisdiction of a Commercial Court shall extend and may, from time to time, increase, reduce or alter such limits.
(3) The 9[State Government may], with the concurrence of the Chief Justice of the High Court appoint one or more persons having experience in dealing with commercial disputes to be the Judge or Judges, of a 10[Commercial Court either at the level of District Judge or a court below the level of a District Judge].
11[3A. Designation of Commercial Appellate Courts.—Except the territories over which the High Courts have ordinary original civil jurisdiction, the State Government may, after consultation with the concerned High Court, by notification, designate such number of Commercial Appellate Courts at District Judge level, as it may deem necessary, for the purposes of exercising the jurisdiction and powers conferred on those Courts under this Act.]
4. Constitution of Commercial Division of High Court.—(1) In all High Courts, having 12[ordinary original civil jurisdiction], the Chief Justice of the High Court may, by order, constitute Commercial Division having one or more Benches consisting of a single Judge for the purpose of exercising the jurisdiction and powers conferred on it under this Act.
(2) The Chief Justice of the High Court shall nominate such Judges of the High Court who have experience in dealing with commercial disputes to be Judges of the Commercial Division.
5. Constitution of Commercial Appellate Division.—(1) After issuing notification under subsection (1) of section 3 or order under sub-section (1) of section 4, the Chief Justice of the concerned High Court shall, by order, constitute Commercial Appellate Division having one or more Division Benches for the purpose of exercising the jurisdiction and powers conferred on it by the Act.
(2) The Chief Justice of the High Court shall nominate such Judges of the High Court who have experience in dealing with commercial disputes to be Judges of the Commercial Appellate Division.
6. Jurisdiction of Commercial Court.—The Commercial Court shall have jurisdiction to try all suits and applications relating to a commercial dispute of a Specified Value arising out of the entire territory of the State over which it has been vested territorial jurisdiction.
Explanation.––For the purposes of this section, a commercial dispute shall be considered to arise out of the entire territory of the State over which a Commercial Court has been vested jurisdiction, if the suit or application relating to such commercial dispute has been instituted as per the provisions of sections 16 to 20 of the Code of Civil Procedure, 1908 (5 of 1908).
7. Jurisdiction of Commercial Divisions of High Courts.—All suits and applications relating to commercial disputes of a Specified Value filed in a High Court having ordinary original civil jurisdiction shall be heard and disposed of by the Commercial Division of that High Court:
Provided that all suits and applications relating to commercial disputes, stipulated by an Act to lie in a court not inferior to a District Court, and filed or pending on the original side of the High Court, shall be heard and disposed of by the Commercial Division of the High Court:
Provided further that all suits and applications transferred to the High Court by virtue of sub-section (4) of section 22 of the Designs Act, 2000 (16 of 2000) or section 104 of the Patents Act, 1970 (39 of 1970) shall be heard and disposed of by the Commercial Division of the High Court in all the areas over which the High Court exercises ordinary original civil jurisdiction.
8. Bar against revision application or petition against an interlocutory order.—Notwithstanding anything contained in any other law for the time being in force, no civil revision application or petition shall be entertained against any interlocutory order of a Commercial Court, including an order on the issue of jurisdiction, and any such challenge, subject to the provisions of section 13, shall be raised only in an appeal against the decree of the Commercial Court.
9. [Transfer of suit if counterclaim in a commercial dispute is of Specified Value].—Omitted by the Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts (Amendment) Act, 2018 (28 of 2018), s. 9 (w.e.f. 3-5-2018)
10. Jurisdiction in respect of arbitration matters.—Where the subject-matter of an arbitration is a commercial dispute of a Specified Value and––
(1) If such arbitration is an international commercial arbitration, all applications or appeals arising out of such arbitration under the provisions of the Arbitration and Conciliation Act, 1996 (26 of 1996) that have been filed in a High Court, shall be heard and disposed of by the Commercial Division where such Commercial Division has been constituted in such High Court.
(2) If such arbitration is other than an international commercial arbitration, all applications or appeals arising out of such arbitration under the provisions of the Arbitration and Conciliation Act, 1996 (26 of 1996) that have been filed on the original side of the High Court, shall be heard and disposed of by the Commercial Division where such Commercial Division has been constituted in such High Court.
(3) If such arbitration is other than an international commercial arbitration, all applications or appeals arising out of such arbitration under the provisions of the Arbitration and Conciliation Act, 1996 (26 of 1996) that would ordinarily lie before any principal civil court of original jurisdiction in a district (not being a High Court) shall be filed in, and heard and disposed of by the Commercial Court exercising territorial jurisdiction over such arbitration where such Commercial Court has been constituted.
11. Bar of jurisdiction of Commercial Courts and Commercial Divisions.—Notwithstanding anything contained in this Act, a Commercial Court or a Commercial Division shall not entertain or decide any suit, application or proceedings relating to any commercial dispute in respect of which the jurisdiction of the civil court is either expressly or impliedly barred under any other law for the time being in force.
CHAPTER III
SPECIFIED VALUE
12. Determination of Specified Value.—(1) The Specified Value of the subject-matter of the commercial dispute in a suit, appeal or application shall be determined in the following manner:––
(a) where the relief sought in a suit or application is for recovery of money, the money sought to be recovered in the suit or application inclusive of interest, if any, computed up to the date of filing of the suit or application, as the case may be, shall be taken into account for determining such Specified Value;
(b) where the relief sought in a suit, appeal or application relates to movable property or to a right therein, the market value of the movable property as on the date of filing of the suit, appeal or application, as the case may be, shall be taken into account for determining such Specified Value;
(c) where the relief sought in a suit, appeal or application relates to immovable property or to a right therein, the market value of the immovable property, as on the date of filing of the suit, appeal or application, as the case may be, shall be taken into account for determining Specified Value; 13[and]
(d) where the relief sought in a suit, appeal or application relates to any other intangible right, the market value of the said rights as estimated by the plaintiff shall be taken into account for determining Specified Value; 14* * *
15 * * * * *
(2) The aggregate value of the claim and counterclaim, if any as set out in the statement of claim and the counterclaim, if any, in an arbitration of a commercial dispute shall be the basis for determining whether such arbitration is subject to the jurisdiction of a Commercial Division, Commercial Appellate Division or Commercial Court, as the case may be.
(3) No appeal or civil revision application under section 115 of the Code of Civil Procedure, 1908 (5 of 1908), as the case may be, shall lie from an order of a Commercial Division or Commercial Court finding that it has jurisdiction to hear a commercial dispute under this Act.
16[CHAPTER IIIA
PRE-INSTITUTION MEDIATION AND SETTLEMENT
12A. Pre-Institution Mediation and Settlement—(1) A suit, which does not contemplate any urgent interim relief under this Act, shall not be instituted unless the plaintiff exhausts the remedy of preinstitution mediation in accordance with such manner and procedure as may be prescribed by rules made by the Central Government.
(2) The Central Government may, by notification, authorise the Authorities constituted under the Legal Services Authorities Act, 1987 (39 of 1987), for the purposes of pre-institution mediation.
(3) Notwithstanding anything contained in the Legal Services Authorities Act, 1987 (39 of 1987), the Authority authorised by the Central Government under sub-section (2) shall complete the process of mediation within a period of three months from the date of application made by the plaintiff under sub-section (1):
Provided that the period of mediation may be extended for a further period of two months with the consent of the parties:
Provided further that, the period during which the parties remained occupied with the pre-institution mediation, such period shall not be computed for the purpose of limitation under the Limitation Act, 1963 (36 of 1963).
(4) If the parties to the commercial dispute arrive at a settlement, the same shall be reduced into writing and shall be signed by the parties to the dispute and the mediator.
(5) The settlement arrived at under this section shall have the same status and effect as if it is an arbitral award on agreed terms under sub-section (4) of section 30 of the Arbitration and Conciliation Act, 1996 (26 of 1996).]
CHAPTER IV
APPEALS
13. Appeals from decrees of Commercial Courts and Commercial Divisions.—(1) 17[Any person aggrieved by the judgment or order of a Commercial Court below the level of a District Judge may appeal to the Commercial Appellate Court within a period of sixty days from the date of judgment or order.
(1A) Any person aggrieved by the judgment or order of a Commercial Court at the level of District Judge exercising original civil jurisdiction or, as the case may be, Commercial Division of a High Court may appeal to the Commercial Appellate Division of that High Court within a period of sixty days from the date of the judgment or order:
Provided that an appeal shall lie from such orders passed by a Commercial Division or a Commercial Court that are specifically enumerated under Order XLIII of the Code of Civil Procedure, 1908 (5 of 1908) as amended by this Act and section 37 of the Arbitration and Conciliation Act, 1996 (26 of 1996).]
(2) Notwithstanding anything contained in any other law for the time being in force or Letters Patent of a High Court, no appeal shall lie from any order or decree of a Commercial Division or Commercial Court otherwise than in accordance with the provisions of this Act.
14. Expeditious disposal of appeals.—The 18[Commercial Appellate Court and the Commercial Appellate Division] shall endeavour to dispose of appeals filed before it within a period of six months from the date of filing of such appeal.
CHAPTER V
TRANSFER OF PENDING SUITS
15. Transfer of pending cases.—(1) All suits and applications, including applications under the Arbitration and Conciliation Act, 1996 (26 of 1996), relating to a commercial dispute of a Specified Value pending in a High Court where a Commercial Division has been constituted, shall be transferred to the Commercial Division.
(2) All suits and applications, including applications under the Arbitration and Conciliation Act, 1996 (26 of 1996), relating to a commercial dispute of a Specified Value pending in any civil court in any district or area in respect of which a Commercial Court has been constituted, shall be transferred to such Commercial Court:
Provided that no suit or application where the final judgment has been reserved by the Court prior to the constitution of the Commercial Division or the Commercial Court shall be transferred either under sub-section (1) or sub-section (2).
(3) Where any suit or application, including an application under the Arbitration and Conciliation Act, 1996 (26 of 1996), relating to a commercial dispute of Specified Value shall stand transferred to the Commercial Division or Commercial Court under sub-section (1) or sub-section (2), the provisions of this Act shall apply to those procedures that were not complete at the time of transfer.
(4) The Commercial Division or Commercial Court, as the case may be, may hold case management hearings in respect of such transferred suit or application in order to prescribe new timelines or issue such further directions as may be necessary for a speedy and efficacious disposal of such suit or application in accordance 19[with Order XV-A] of the Code of Civil Procedure, 1908 (5 of 1908):
Provided that the proviso to sub-rule (1) of Rule 1 of Order V of the Code of Civil Procedure, 1908 (5 of 1908) shall not apply to such transferred suit or application and the court may, in its discretion, prescribe a new time period within which the written statement shall be filed.
(5) In the event that such suit or application is not transferred in the manner specified in sub-section (1), sub-section (2) or sub-section (3), the Commercial Appellate Division of the High Court may, on the application of any of the parties to the suit, withdraw such suit or application from the court before which it is pending and transfer the same for trial or disposal to the Commercial Division or Commercial Court, as the case may be, having territorial jurisdiction over such suit, and such order of transfer shall be final and binding.
CHAPTER VI
AMENDMENTS TO THE PROVISIONS OF THE CODE OF CIVIL PROCEDURE, 1908
16. Amendments to the Code of Civil Procedure, 1908 in its application to commercial disputes.—(1) The provisions of the Code of Civil Procedure, 1908 (5 of 1908) shall, in their application to any suit in respect of a commercial dispute of a Specified Value, stand amended in the manner as specified in the Schedule.
(2) The Commercial Division and Commercial Court shall follow the provisions of the Code of Civil Procedure, 1908 (5 of 1908), as amended by this Act, in the trial of a suit in respect of a commercial dispute of a Specified Value.
(3) Where any provision of any Rule of the jurisdictional High Court or any amendment to the Code of Civil Procedure, 1908 (5 of 1908), by the State Government is in conflict with the provisions of the Code of Civil Procedure, 1908, as amended by this Act, the provisions of the Code of Civil Procedure as amended by this Act shall prevail.
CHAPTER VII
MISCELLANEOUS
17. Collection and disclosure of data by 20[Commercial Courts, Commercial Appellate Courts], Commercial Divisions and Commercial Appellate Divisions.—The statistical data regarding the number of suits, applications, appeals or writ petitions filed before the 1 [Commercial Courts, Commercial Appellate Courts], Commercial Division, or Commercial Appellate Division, as the case may be, the pendency of such cases, the status of each case, and the number of cases disposed of, shall be maintained and updated every month by each 1 [Commercial Courts, Commercial Appellate Courts], Commercial Division, Commercial Appellate Division and shall be published on the website of the relevant High Court.
18. Power of High Court to issue directions.—The High Court may, by notification, issue practice directions to supplement the provisions of Chapter II of this Act or the Code of Civil Procedure, 1908 (5 of 1908) insofar as such provisions apply to the hearing of commercial disputes of a Specified Value.
19. Infrastructure facilities.—The State Government shall provide necessary infrastructure to facilitate the working of a Commercial Court or a Commercial Division of a High Court.
20. Training and continuous education.—The State Government may, in consultation with the High Court, establish necessary facilities providing for training of Judges who may be appointed to the 21[Commercial Courts, Commercial Appellate Courts], Commercial Division or the Commercial Appellate Division in a High Court.
21. Act to have overriding effect.—Save as otherwise provided, the provisions of this Act shall have effect, notwithstanding anything inconsistent therewith contained in any other law for the time being in force or in any instrument having effect by virtue of any law for the time being in force other than this Act.
22[21A. Power of Central Government to make rules.—(1) The Central Government may, by notification, make rules for carrying out the provisions of this Act.
(2) In particular, and without prejudice to the generality of the foregoing power, such rules may provide for or any of the following matters, namely:—
(a) the manner and procedure of pre-institution mediation under sub-section (1) of section 12A;
(b) any other matter which is required to be, or may be, prescribed or in respect of which provision is to be made by rules made by the Central Government.
(3) Every rule made by the Central Government under this Act shall be laid, as soon as may be after it is made, before each House of Parliament, while it is in session, for a total period of thirty days which may be comprised in one session, or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rule, or both Houses agree that the rule should not be made, the rule shall thereafter have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule.]
22. Power to remove difficulties.—(1) If any difficulty arises in giving effect to the provisions of this Act, the Central Government may, by order published in the Official Gazette, make such provisions, not inconsistent with the provisions of this Act as may appear to it to be necessary or expedient for removing the difficulty:
Provided that no such order shall be made under this section after the expiry of a period of two years from the date of commencement of this Act.
(2) Every order made under this section shall be laid, as soon as may be, after it is made, before each House of Parliament.
23. Repeal and savings.—(1) The Commercial Courts, Commercial Division and Commercial Appellate Division of High Courts Ordinance, 2015 (Ord. 8 of 2015) is hereby repealed.
(2) Notwithstanding such repeal, anything done or any action taken under the said Ordinance, shall be deemed to have been done or taken under the corresponding provisions of this Act.
SCHEDULE
1. Amendment of section 26.—In section 26 of the Code of Civil Procedure, 1908 (5 of 1908) (hereafter referred to as the Code), in sub-section (2), the following proviso shall be inserted, namely:––
“Provided that such an affidavit shall be in the form and manner as prescribed under Order VI of Rule 15A.”.
2. Substitution of new section for section 35.—For section 35 of the Code, the following section shall be substituted, namely:––
35. Costs.—(1) In relation to any commercial dispute, the Court, notwithstanding anything contained in any other law for the time being in force or Rule, has the discretion to determine:
(a) whether costs are payable by one party to another;
(b) the quantum of those costs; and
(c) when they are to be paid.
Explanation.—For the purpose of clause (a), the expression “costs” shall mean reasonable costs relating to—
(i) the fees and expenses of the witnesses incurred;
(ii) legal fees and expenses incurred;
(iii) any other expenses incurred in connection with the proceedings.
(2) If the Court decides to make an order for payment of costs, the general rule is that the unsuccessful party shall be ordered to pay the costs of the successful party:
Provided that the Court may make an order deviating from the general rule for reasons to be recorded in writing.
Illustration
The Plaintiff, in his suit, seeks a money decree for breach of contract, and damages. The Court holds that the Plaintiff is entitled to the money decree. However, it returns a finding that the claim for damages is frivolous and vexatious.
In such circumstances the Court may impose costs on the Plaintiff, despite the Plaintiff being the successful party, for having raised frivolous claims for damages.
(3) In making an order for the payment of costs, the Court shall have regard to the following circumstances, including—
(a) the conduct of the parties;
(b) whether a party has succeeded on part of its case, even if that party has not been wholly successful;
(c) whether the party had made a frivolous counterclaim leading to delay in the disposal of the case;
(d) whether any reasonable offer to settle is made by a party and unreasonably refused by the other party; and
(e) whether the party had made a frivolous claim and instituted a vexatious proceeding wasting the time of the Court.
(4) The orders which the Court may make under this provision include an order that a party must pay––
(a) a proportion of another party’s costs;
(b) a stated amount in respect of another party’s costs;
(c) costs from or until a certain date;
(d) costs incurred before proceedings have begun;
(e) costs relating to particular steps taken in the proceedings;
(f) costs relating to a distinct part of the proceedings; and
(g) interest on costs from or until a certain date.’.
3. Amendment of section 35A.—In section 35A of the Code, sub-section (2) shall be omitted.
4. Amendment of First Schedule.—In the First Schedule to the Code,––
(A) in the Order V, in Rule 1, in sub-rule (1), for the second proviso, the following proviso shall be substituted, namely:––
“Provided further that where the defendant fails to file the written statement within the said period of thirty days, he shall be allowed to file the written statement on such other day, as may be specified by the Court, for reasons to be recorded in writing and on payment of such costs as the Court deems fit, but which shall not be later than one hundred twenty days from the date of service of summons and on expiry of one hundred twenty days from the date of service of summons, the defendant shall forfeit the right to file the written statement and the Court shall not allow the written statement to be taken on record.”;
(B) in Order VI,––
(i) after Rule 3, the following Rule shall be inserted, namely:––
“3A. Forms of pleading in Commercial Courts––In a commercial dispute, where forms of pleadings have been prescribed under the High Court Rules or Practice Directions made for the purposes of such commercial disputes, pleadings shall be in such forms.”;
(ii) after Rule 15, the following Rule shall be inserted, namely:––
‘‘15A. Verification of pleadings in a commercial dispute.—
(1) Notwithstanding anything contained in Rule 15, every pleading in a commercial dispute shall be verified by an affidavit in the manner and form prescribed in the Appendix to this Schedule.
(2) An affidavit under sub-rule (1) above shall be signed by the party or by one of the parties to the proceedings, or by any other person on behalf of such party or parties who is proved to the satisfaction of the Court to be acquainted with the facts of the case and who is duly authorised by such party or parties.
(3) Where a pleading is amended, the amendments must be verified in the form and manner referred to in sub-rule (1) unless the Court orders otherwise.
(4) Where a pleading is not verified in the manner provided under sub-rule (1), the party shall not be permitted to rely on such pleading as evidence or any of the matters set out therein.
(5) The Court may strike out a pleading which is not verified by a Statement of Truth, namely, the affidavit set out in the Appendix to this Schedule.”;
(C) in Order VII, after Rule 2, the following Rule shall be inserted, namely:—
“2A. Where interest is sought in the suit,—
(1) Where the plaintiff seeks interest, the plaint shall contain a statement to that effect along with the details set out under sub-rules (2) and (3).
(2) Where the plaintiff seeks interest, the plaint shall state whether the plaintiff is seeking interest in relation to a commercial transaction within the meaning of section 34 of the Code of Civil Procedure, 1908 (5 of 1908) and, furthermore, if the plaintiff is doing so under the terms of a contract or under an Act, in which case the Act is to be specified in the plaint; or on some other basis and shall state the basis of that.
(3) Pleadings shall also state—
(a) the rate at which interest is claimed;
(b) the date from which it is claimed;
(c) the date to which it is calculated;
(d) the total amount of interest claimed to the date of calculation; and
(e) the daily rate at which interest accrues after that date.”;
(D) in Order VIII,––
(i) in Rule 1, for the proviso, the following proviso shall be substituted, namely:––
“Provided that where the defendant fails to file the written statement within the said period of thirty days, he shall be allowed to file the written statement on such other day, as may be specified by the Court, for reasons to be recorded in writing and on payment of such costs as the Court deems fit, but which shall not be later than one hundred twenty days from the date of service of summons and on expiry of one hundred twenty days from the date of service of summons, the defendant shall forfeit the right to file the written statement and the Court shall not allow the written statement to be taken on record.”;
(ii) after Rule 3, the following Rule shall be inserted, namely:––
“3A. Denial by the defendant in suits before the Commercial Division of the High Court or the Commercial Court—
(1) Denial shall be in the manner provided in sub-rules (2), (3), (4) and (5) of this Rule.
(2) The defendant in his written statement shall state which of the allegations in the particulars of plaint he denies, which allegations he is unable to admit or deny, but which he requires the plaintiff to prove, and which allegations he admits.
(3) Where the defendant denies an allegation of fact in a plaint, he must state his reasons for doing so and if he intends to put forward a different version of events from that given by the plaintiff, he must state his own version.
(4) If the defendant disputes the jurisdiction of the Court he must state the reasons for doing so, and if he is able, give his own statement as to which Court ought to have jurisdiction.
(5) If the defendant disputes the plaintiff’s valuation of the suit, he must state his reasons for doing so, and if he is able, give his own statement of the value of the suit.”;
(iii) in Rule 5, in sub-rule (1), after the first proviso, the following proviso shall be inserted, namely:—
‘‘Provided further that every allegation of fact in the plaint, if not denied in the manner provided under Rule 3A of this Order, shall be taken to be admitted except as against a person under disability.”;
(iv) in Rule 10, 23*** the following proviso shall be inserted, namely:––
“24[Provided that] no Court shall make an order to extend the time provided under Rule 1 of this Order for filing of the written statement.”;
(E) for Order XI of the Code, the following Order shall be substituted, namely:—
“ORDER XI
DISCLOSURE, DISCOVERY AND INSPECTION OF DOCUMENTS IN SUITS BEFORE THE COMMERCIAL DIVISION
OF A HIGH COURT OR A COMMERCIAL COURT
1. Disclosure and discovery of documents.—(1) Plaintiff shall file a list of all documents and photocopies of all documents, in its power, possession, control or custody, pertaining to the suit, along with the plaint, including:—
(a) documents referred to and relied on by the plaintiff in the plaint;
(b) documents relating to any matter in question in the proceedings, in the power, possession, control or custody of the plaintiff, as on the date of filing the plaint, irrespective of whether the same is in support of or adverse to the plaintiff’s case;
(c) nothing in this Rule shall apply to documents produced by plaintiffs and relevant only––
(i) for the cross-examination of the defendant’s witnesses, or
(ii) in answer to any case set up by the defendant subsequent to the filing of the plaint, or
(iii) handed over to a witness merely to refresh his memory.
(2) The list of documents filed with the plaint shall specify whether the documents in the power, possession, control or custody of the plaintiff are originals, office copies or photocopies and the list shall also set out in brief, details of parties to each document, mode of execution, issuance or receipt and line of custody of each document.
(3) The plaint shall contain a declaration on oath from the plaintiff that all documents in the power, possession, control or custody of the plaintiff, pertaining to the facts and circumstances of the proceedings initiated by him have been disclosed and copies thereof annexed with the plaint, and that the plaintiff does not have any other documents in its power, possession, control or custody.
Explanation.––A declaration on oath under this sub-rule shall be contained in the Statement of Truth as set out in the Appendix.
(4) In case of urgent filings, the plaintiff may seek leave to rely on additional documents, as part of the above declaration on oath and subject to grant of such leave by Court, the plaintiff shall file such additional documents in Court, within thirty days of filing the suit, along with a declaration on oath that the plaintiff has produced all documents in its power, possession, control or custody, pertaining to the facts and circumstances of the proceedings initiated by the plaintiff and that the plaintiff does not have any other documents, in its power, possession, control or custody.
(5) The plaintiff shall not be allowed to rely on documents, which were in the plaintiff’s power, possession, control or custody and not disclosed along with plaint or within the extended period set out above, save and except by leave of Court and such leave shall be granted only upon the plaintiff establishing reasonable cause for non–disclosure along with the plaint.
(6) The plaint shall set out details of documents, which the plaintiff believes to be in the power, possession, control or custody of the defendant and which the plaintiff wishes to rely upon and seek leave for production thereof by the said defendant.
(7) The defendant shall file a list of all documents and photocopies of all documents, in its power, possession, control or custody, pertaining to the suit, along with the written statement or with its counterclaim if any, including—
(a) the documents referred to and relied on by the defendant in the written statement;
(b) the documents relating to any matter in question in the proceeding in the power, possession, control or custody of the defendant, irrespective of whether the same is in support of or adverse to the defendant’s defence;
(c) nothing in this Rule shall apply to documents produced by the defendants and relevant only––
(i) for the cross-examination of the plaintiff’s witnesses,
(ii) in answer to any case set up by the plaintiff subsequent to the filing of the plaint, or
(iii) handed over to a witness merely to refresh his memory.
(8) The list of documents filed with the written statement or counterclaim shall specify whether the documents, in the power, possession, control or custody of the defendant, are originals, office copies or photocopies and the list shall also set out in brief, details of parties to each document being produced by the defendant, mode of execution, issuance or receipt and line of custody of each document.
(9) The written statement or counterclaim shall contain a declaration on oath made by the deponent that all documents in the power, possession, control or custody of the defendant, save and except for those set out in sub-rule (7) (c) (iii) pertaining to the facts and circumstances of the proceedings initiated by the plaintiff or in the counterclaim, have been disclosed and copies thereof annexed with the written statement or counterclaim and that the defendant does not have in its power, possession, control orcustody, any other documents.
(10) Save and except for sub-rule (7) (c) (iii), defendant shall not be allowed to rely on documents, which were in the defendant’s power, possession, control or custody and not disclosed along with the written statement or counterclaim, save and except by leave of Court and such leave shall be granted only upon the defendant establishing reasonable cause for non-disclosure along with the written statement or counterclaim.
(11) The written statement or counterclaim shall set out details of documents in the power, possession, control or custody of the plaintiff, which the defendant wishes to rely upon and which have not been disclosed with the plaint, and call upon the plaintiff to produce the same.
(12) Duty to disclose documents, which have come to the notice of a party, shall continue till disposal of the suit.
2. Discovery by interrogatories.—(1) In any suit the plaintiff or defendant by leave of the court may deliver interrogatories in writing for the examination of the opposite parties or any one or more of such parties, and such interrogatories when delivered shall have a note at the foot thereof stating which of such interrogatories each of such persons is required to answer:
Provided that no party shall deliver more than one set of interrogatories to the same party without an order for that purpose:
Provided further that interrogatories which do not relate to any matters in question in the suit shall be deemed irrelevant, notwithstanding that they might be admissible on the oral cross-examination of a witness.
(2) On an application for leave to deliver interrogatories, the particular interrogatories proposed to be delivered shall be submitted to the court, and that court shall decide within seven days from the day of filing of the said application, in deciding upon such application, the court shall take into account any offer, which may be made by the party sought to be interrogated to deliver particulars, or to make admissions, or to produce documents relating to the matters in question, or any of them, and leave shall be given as to such only of the interrogatories submitted as the court shall consider necessary either for
disposing fairly of the suit or for saving costs.
(3) In adjusting the costs of the suit inquiry shall at the instance of any party be made into the propriety of exhibiting such interrogatories, and if it is the opinion of the taxing officer or of the court, either with or without an application for inquiry, that such interrogatories have been exhibited unreasonably, vexatiously, or at improper length, the costs occasioned by the said interrogatories and the answers thereto shall be paid in any event by the party in fault.
(4) Interrogatories shall be in the form provided in Form No. 2 in Appendix C to the Code of Civil Procedure, 1908 (5 of 1908), with such variations as circumstances may require.
(5) Where any party to a suit is a corporation or a body of persons, whether incorporated or not, empowered by law to sue or be sued, whether in its own name or in the name of any officer of other person, any opposite party may apply for an order allowing him to deliver interrogatories to any member or officer of such corporation or body, and an order may be made accordingly.
(6) Any objection to answering any interrogatory on the ground that it is scandalous or irrelevant or not exhibited bona fide for the purpose of the suit, or that the matters inquired into are not sufficiently material at that stage, or on the ground of privilege or any other ground may be taken in the affidavit in answer.
(7) Any interrogatories may be set aside on the ground that they have been exhibited unreasonably or vexatiously, or struck out on the ground that they are prolix, oppressive, unnecessary or scandalous and any application for this purpose may be made within seven days after service of the interrogatories.
(8) Interrogatories shall be answered by affidavit to be filed within ten days, or within such other time as the court may allow.
(9) An affidavit in answer to interrogatories shall be in the form provided in Form No. 3 in Appendix C to the Code of Civil Procedure, 1908 (5 of 1908), with such variations as circumstances may require.
(10) No exceptions shall be taken to any affidavit in answer, but the sufficiency or otherwise of any such affidavit objected to as insufficient shall be determined by the court.
(11) Where any person interrogated omits to answer, or answers insufficiently, the party interrogating may apply to the court for an order requiring him to answer, or to answer further, as the case may be, and an order may be made requiring him to answer, or to answer further, either affidavit or by viva voce examination, as the court may direct.
3. Inspection.—(1) All parties shall complete inspection of all documents disclosed within thirty days of the date of filing of the written statement or written statement to the counterclaim, whichever is later. The Court may extend this time limit upon application at its discretion, but not beyond thirty days in any event.
(2) Any party to the proceedings may seek directions from the Court, at any stage of the proceedings, for inspection or production of documents by the other party, of which inspection has been refused by such party or documents have not been produced despite issuance of a notice to produce.
(3) Order in such application shall be disposed of within thirty days of filing such application, including filing replies and rejoinders (if permitted by Court) and hearing.
(4) If the above application is allowed, inspection and copies thereof shall be furnished to the party seeking it, within five days of such order.
(5) No party shall be permitted to rely on a document, which it had failed to disclose or of which inspection has not been given, save and except with leave of Court.
(6) The Court may impose exemplary costs against a defaulting party, who wilfully or negligently failed to disclose all documents pertaining to a suit or essential for a decision therein and which are in their power, possession, control or custody or where a Court holds that inspection or copies of any documents had been wrongfully or unreasonably withheld or refused.
4. Admission and denial of documents.—(1) Each party shall submit a statement of admissions or denials of all documents disclosed and of which inspection has been completed, within fifteen days of the completion of inspection or any later date as fixed by the Court.
(2) The statement of admissions and denials shall set out explicitly, whether such party was admitting or denying:—
(a) correctness of contents of a document;
(b) existence of a document;
(c) execution of a document;
(d) issuance or receipt of a document;
(e) custody of a document.
Explanation.––A statement of admission or denial of the existence of a document made in accordance with sub-rule (2) (b) shall include the admission or denial of the contents of a document.
(3) Each party shall set out reasons for denying a document under any of the above grounds and bare and unsupported denials shall not be deemed to be denials of a document and proof of such documents may then be dispensed with at the discretion of the Court.
(4) Any party may however submit bare denials for third party documents of which the party denying does not have any personal knowledge of, and to which the party denying is not a party to in any manner whatsoever.
(5) An Affidavit in support of the statement of admissions and denials shall be filed confirming the correctness of the contents of the statement.
(6) In the event that the Court holds that any party has unduly refused to admit a document under any of the above criteria,–costs (including exemplary costs) for deciding on admissibility of a document may be imposed by the Court on such party.
(7) The Court may pass orders with respect to admitted documents including for waiver of further proof thereon or rejection of any documents.
5. Production of documents.—(1) Any party to a proceeding may seek or the Court may order, at any time during the pendency of any suit, production by any party or person, of such documents in the possession or power of such party or person, relating to any matter in question in such suit.
(2) Notice to produce such document shall be issued in the Form provided in Form No. 7 in Appendix C to the Code of Civil Procedure, 1908 (5 of 1908).
(3) Any party or person to whom such notice to produce is issued shall be given not less than seven days and not more than fifteen days to produce such document or to answer to their inability to produce such document.
(4) The Court may draw an adverse inference against a party refusing to produce such document after issuance of a notice to produce and where sufficient reasons for such non–production are not given and order costs.
6. Electronic records.—(1) In case of disclosures and inspection of Electronic Records (as defined in the Information Technology Act, 2000 (21 of 2000)), furnishing of printouts shall be sufficient compliance of the above provisions.
(2) At the discretion of the parties or where required (when parties wish to rely on audio or video content), copies of electronic records may be furnished in electronic form either in addition to or in lieu of printouts.
(3) Where Electronic Records form part of documents disclosed, the declaration on oath to be filed by a party shall specify––
(a) the parties to such Electronic Record;
(b) the manner in which such electronic record was produced and by whom;
(c) the dates and time of preparation or storage or issuance or receipt of each such electronic record;
(d) the source of such electronic record and date and time when the electronic record was printed;
(e) in case of email ids, details of ownership, custody and access to such email ids;
(f) in case of documents stored on a computer or computer resource (including on external servers or cloud), details of ownership, custody and access to such data on the computer or computer resource;
(g) deponent’s knowledge of contents and correctness of contents;
(h) whether the computer or computer resource used for preparing or receiving or storing such document or data was functioning properly or in case of malfunction that such malfunction did not affect the contents of the document stored;
(i) that the printout or copy furnished was taken from the original computer or computer resource.
(4) The parties relying on printouts or copy in electronic form, of any electronic records, shall not be required to give inspection of electronic records, provided a declaration is made by such party that each such copy, which has been produced, has been made from the original electronic record.
(5) The Court may give directions for admissibility of Electronic Records at any stage of the proceedings.
(6) Any party may seek directions from the Court and the Court may of its motion issue directions for submission of further proof of any electronic record including metadata or logs before admission of such electronic record.
7. Certain provisions of the Code of Civil Procedure, 1908 not to apply.—For avoidance of doubt, it is hereby clarified that Order XIII Rule 1, Order VII Rule 14 and Order VIII Rule 1A of the Code of Civil Procedure, 1908 (5 of 1908) shall not apply to suits or applications before the Commercial Divisions of High Court or Commercial Courts.”.
5. Insertion of new Order XIII-A.—After Order XIII of the Code, the following Order shall be inserted, namely:—
‘ORDER XIII-A
SUMMARY JUDGMENT
1. Scope of and classes of suits to which this Order applies.—(1) This Order sets out the procedure by which Courts may decide a claim pertaining to any Commercial Dispute without recording oral evidence.
(2) For the purposes of this Order, the word “claim” shall include—
(a) part of a claim;
(b) any particular question on which the claim (whether in whole or in part) depends; or
(c) a counterclaim, as the case may be.
(3) Notwithstanding anything to the contrary, an application for summary judgment under this Order shall not be made in a suit in respect of any Commercial Dispute that is originally filed as a summary suit under Order XXXVII.
2. Stage for application for summary judgment.—An applicant may apply for summary judgment at any time after summons has been served on the defendant:
Provided that, no application for summary judgment may be made by such applicant after the Court has framed the issues in respect of the suit.
3. Grounds for summary judgment.—The Court may give a summary judgment against a plaintiff or defendant on a claim if it considers that––
(a) the plaintiff has no real prospect of succeeding on the claim or the defendant has no real prospect of successfully defending the claim, as the case may be; and
(b) there is no other compelling reason why the claim should not be disposed of before recording of oral evidence.
4. Procedure.—(1) An application for summary judgment to a Court shall, in addition to any other matters the applicant may deem relevant, include the matters set forth in sub-clauses (a) to (f) mentioned hereunder:—
(a) the application must contain a statement that it is an application for summary judgment made under this Order;
(b) the application must precisely disclose all material facts and identify the point of law, if any;
(c) in the event the applicant seeks to rely upon any documentary evidence, the applicant must,––
(i) include such documentary evidence in its application, and
(ii) identify the relevant content of such documentary evidence on which the applicant relies;
(d) the application must state the reason why there are no real prospects of succeeding on the claim or defending the claim, as the case may be;
(e) the application must state what relief the applicant is seeking and briefly state the grounds for seeking such relief.
(2) Where a hearing for summary judgment is fixed, the respondent must be given at least thirty days’ notice of:—
(a) the date fixed for the hearing; and
(b) the claim that is proposed to be decided by the Court at such hearing.
(3) The respondent may, within thirty days of the receipt of notice of application of summary judgment or notice of hearing (whichever is earlier), file a reply addressing the matters set forth in clauses (a) to (f) mentioned hereunder in addition to any other matters that the respondent may deem relevant:—
(a) the reply must precisely––
(i) disclose all material facts;
(ii) identify the point of law, if any; and
(iii) state the reasons why the relief sought by the applicant should not be granted;
(b) in the event the respondent seeks to rely upon any documentary evidence in its reply, the respondent must—
(i) include such documentary evidence in its reply; and
(ii) identify the relevant content of such documentary evidence on which the respondent relies;
(c) the reply must state the reason why there are real prospects of succeeding on the claim or defending the claim, as the case may be;
(d) the reply must concisely state the issues that should be framed for trial;
(e) the reply must identify what further evidence shall be brought on record at trial that could not be brought on record at the stage of summary judgment; and
(f) the reply must state why, in light of the evidence or material on record if any, the Court should not proceed to summary judgment.
5. Evidence for hearing of summary judgment.—(1) Notwithstanding anything in this Order, if the respondent in an application for summary judgment wishes to rely on additional documentary evidence during the hearing, the respondent must:—
(a) file such documentary evidence; and
(b) serve copies of such documentary evidence on every other party to the application at least fifteen days prior to the date of the hearing.
(2) Notwithstanding anything in this Order, if the applicant for summary judgment wishes to rely on documentary evidence in reply to the defendant’s documentary evidence, the applicant must:—
(a) file such documentary evidence in reply; and
(b) serve a copy of such documentary evidence on the respondent at least five days prior to the date of the hearing.
(3) Notwithstanding anything to the contrary, sub-rules (1) and (2) shall not require documentary evidence to be:—
(a) filed if such documentary evidence has already been filed; or
(b) served on a party on whom it has already been served.
6. Orders that may be made by Court.—(1) On an application made under this Order, the Court may make such orders that it may deem fit in its discretion including the following:—
(a) judgment on the claim;
(b) conditional order in accordance with Rule 7 mentioned hereunder;
(c) dismissing the application;
(d) dismissing part of the claim and a judgment on part of the claim that is not dismissed;
(e) striking out the pleadings (whether in whole or in part); or
(f) further directions to proceed for case management under Order XV-A.
(2) Where the Court makes any of the orders as set forth in sub-rule (1) (a) to (f), the Court shall record its reasons for making such order.
7. Conditional order.—(1) Where it appears to the Court that it is possible that a claim or defence may succeed but it is improbable that it shall do so, the Court may make a conditional order as set forth in Rule 6 (1) (b).
(2) Where the Court makes a conditional order, it may:—
(a) make it subject to all or any of the following conditions:—
(i) require a party to deposit a sum of money in the Court;
(ii) require a party to take a specified step in relation to the claim or defence, as the case may be;
(iii) require a party, as the case may be, to give such security or provide such surety for restitution of costs as the Court deems fit and proper;
(iv) impose such other conditions, including providing security for restitution of losses that any party is likely to suffer during the pendency of the suit, as the Court may deem fit in its discretion; and
(b) specify the consequences of the failure to comply with the conditional order, including passing a judgment against the party that have not complied with the conditional order.
8. Power to impose costs.—The Court may make an order for payment of costs in an application for summary judgment in accordance with the provisions of sections 35 and 35A of the Code.’.
6. Omission of Order XV.—Order XV of the Code shall be omitted.
7. Insertion of Order XV-A.—7. After Order XV of the Code, the following Order shall be inserted, namely:—
“ORDER XVA
CASE MANAGEMENT HEARING
1. First Case Management Hearing.—The Court shall hold the first Case Management Hearing, not later than four weeks from the date of filing of affidavit of admission or denial of documents by all parties to the suit.
2. Orders to be passed in a Case Management Hearing.—In a Case Management Hearing, after hearing the parties, and once it finds that there are issues of fact and law which require to be tried, the Court may pass an order––
(a) framing the issues between the parties in accordance with Order XIV of the Code of Civil Procedure, 1908 (5 of 1908) after examining pleadings, documents and documents produced before it, and on examination conducted by the Court under Rule 2 of Order X, if required;
(b) listing witnesses to be examined by the parties;
(c) fixing the date by which affidavit of evidence to be filed by parties;
(d) fixing the date on which evidence of the witnesses of the parties to be recorded;
(e) fixing the date by which written arguments are to be filed before the Court by the parties;
(f) fixing the date on which oral arguments are to be heard by the Court; and
(g) setting time limits for parties and their advocates to address oral arguments.
3. Time limit for the completion of a trial.—In fixing dates or setting time limits for the purposes of Rule 2 of this Order, the Court shall ensure that the arguments are closed not later than six months from the date of the first Case Management Hearing.
4. Recording of oral evidence on a day-to-day basis.—The Court shall, as far as possible, ensure that the recording of evidence shall be carried on, on a day-to-day basis until the cross-examination of all the witnesses is complete.
5. Case Management Hearings during a trial.—The Court may, if necessary, also hold Case Management Hearings anytime during the trial to issue appropriate orders so as to ensure adherence by the parties to the dates fixed under Rule 2 and facilitate speedy disposal of the suit.
6. Powers of the Court in a Case Management Hearing.—(1) In any Case Management Hearing held under this Order, the Court shall have the power to—
(a) prior to the framing of issues, hear and decide any pending application filed by the parties under Order XIII-A;
(b) direct parties to file compilations of documents or pleadings relevant and necessary for framing issues;
(c) extend or shorten the time for compliance with any practice, direction or Court order if it finds sufficient reason to do so;
(d) adjourn or bring forward a hearing if it finds sufficient reason to do so;
(e) direct a party to attend the Court for the purposes of examination under Rule 2 of Order X;
(f) consolidate proceedings;
(g) strike off the name of any witness or evidence that it deems irrelevant to the issues framed;
(h) direct a separate trial of any issue;
(i) decide the order in which issues are to be tried;
(j) exclude an issue from consideration;
(k) dismiss or give judgment on a claim after a decision on a preliminary issue;
(l) direct that evidence be recorded by a Commission where necessary in accordance with Order XXVI;
(m) reject any affidavit of evidence filed by the parties for containing irrelevant, inadmissible or argumentative material;
(o) delegate the recording of evidence to such authority appointed by the Court for this purpose;
(p) pass any order relating to the monitoring of recording the evidence by a commission or any other authority;
(q) order any party to file and exchange a costs budget;
(r) issue directions or pass any order for the purpose of managing the case and furthering the overriding objective of ensuring the efficient disposal of the suit.
(2) When the Court passes an order in exercise of its powers under this Order, it may—
(a) make it subject to conditions, including a condition to pay a sum of money into Court; and
(b) specify the consequence of failure to comply with the order or a condition.
(3) While fixing the date for a Case Management Hearing, the Court may direct that the parties also be present for such Case Management Hearing, if it is of the view that there is a possibility of settlement between the parties.
(n) strike off any parts of the affidavit of evidence filed by the parties containing irrelevant, inadmissible or argumentative material;
7. Adjournment of Case Management Hearing.—(1) The Court shall not adjourn the Case Management Hearing for the sole reason that the advocate appearing on behalf of a party is not present:
Provided that an adjournment of the hearing is sought in advance by moving an application, the Court may adjourn the hearing to another date upon the payment of such costs as the Court deems fit, by the party moving such application.
(2) Notwithstanding anything contained in this Rule, if the Court is satisfied that there is a justified reason for the absence of the advocate, it may adjourn the hearing to another date upon such terms and conditions it deems fit.
8. Consequences of non-compliance with orders.—Where any party fails to comply with the order of the Court passed in a Case Management Hearing, the Court shall have the power to—
(a) condone such non-compliance by payment of costs to the Court;
(b) foreclose the non-compliant party’s right to file affidavits, conduct cross-examination of witnesses, file written submissions, address oral arguments or make further arguments in the trial, as the case may be, or
(c) dismiss the plaint or allow the suit where such non-compliance is wilful, repeated and the imposition of costs is not adequate to ensure compliance.”.
8. Amendment of Order XVIII.—In Order XVIII of the Code, in Rule 2, for sub-rules (3A), (3B), (3C), (3D), (3E) and (3F), the following shall be substituted, namely:––
“(3A) A party shall, within four weeks prior to commencing the oral arguments, submit concisely and under distinct headings written arguments in support of his case to the Court and such written arguments shall form part of the record.
(3B) The written arguments shall clearly indicate the provisions of the laws being cited in support of the arguments and the citations of judgments being relied upon by the party and include copies of such judgments being relied upon by the party.
(03C) A copy of such written arguments shall be furnished simultaneously to the opposite party.
(3D) The Court may, if it deems fit, after the conclusion of arguments, permit the parties to file revised written arguments within a period of not more than one week after the date of conclusion of arguments.
(3E) No adjournment shall be granted for the purpose of filing the written arguments unless the Court, for reasons to be recorded in writing, considers it necessary to grant such adjournment.
(3F) It shall be open for the Court to limit the time for oral submissions having regard to the nature and complexity of the matter.”.
9. Amendment of Order XVIII.—In Order XVIII of the Code, in Rule 4, after sub-rule (1), the following sub-rules shall be inserted, namely:––
‘‘(1A) The affidavits of evidence of all witnesses whose evidence is proposed to be led by a party shall be filed simultaneously by that party at the time directed in the first Case Management Hearing.
(1B) A party shall not lead additional evidence by the affidavit of any witness (including of a witness who has already filed an affidavit) unless sufficient cause is made out in an application for that purpose and an order, giving reasons, permitting such additional affidavit is passed by the Court.
(1C) A party shall however have the right to withdraw any of the affidavits so filed at any time prior to commencement of cross-examination of that witness, without any adverse inference being drawn based on such withdrawal:
Provided that any other party shall be entitled to tender as evidence and rely upon any admission made in such withdrawn affidavit.”.
10. Amendment to Order XIX.—In Order XIX of the Code, after Rule 3, the following Rules shall be inserted, namely:––
“4. Court may control evidence.—(1) The Court may, by directions, regulate the evidence as to issues on which it requires evidence and the manner in which such evidence may be placed before the Court.
(2) The Court may, in its discretion and for reasons to be recorded in writing, exclude evidence that would otherwise be produced by the parties.
5. Redacting or rejecting evidence.—A Court may, in its discretion, for reasons to be recorded in writing––
(i) redact or order the redaction of such portions of the affidavit of examination-in-chief as do not, in its view, constitute evidence; or
(ii) return or reject an affidavit of examination-in-chief as not constituting admissible evidence.
6. Format and guidelines of affidavit of evidence.—An affidavit must comply with the form and requirements set forth below:—
(a) such affidavit should be confined to, and should follow the chronological sequence of, the dates and events that are relevant for proving any fact or any other matter dealt with;
(b) where the Court is of the view that an affidavit is a mere reproduction of the pleadings, or contains the legal grounds of any party’s case, the Court may, by order, strike out the affidavit or such parts of the affidavit, as it deems fit and proper;
(c) each paragraph of an affidavit should, as far as possible, be confined to a distinct portion of the subject;
(d) an affidavit shall state—
(i) which of the statements in it are made from the deponent’s own knowledge and which are matters of information or belief; and
(ii) the source for any matters of information or belief;
(e) an affidavit should—
(i) have the pages numbered consecutively as a separate document (or as one of several documents contained in a file);
(ii) be divided into numbered paragraphs;
(iii) have all numbers, including dates, expressed in figures; and
(iv) if any of the documents referred to in the body of the affidavit are annexed to the affidavit or any other pleadings, give the annexures and page numbers of such documents that are relied upon.”.
11. Amendment of Order XX.—In Order XX of the Code, for Rule 1, the following Rule shall be substituted, namely:––
“(1) The 25[Commercial Court, Commercial Appellate Court], Commercial Division, or Commercial Appellate Division, as the case may be, shall, within ninety days of the conclusion of arguments, pronounce judgment and copies thereof shall be issued to all the parties to the dispute through electronic mail or otherwise.”.
26[12. After Appendix H, the following Appendix shall be inserted, namely:—
‘‘APPENDIX-I
STATEMENT OF TRUTH
(Under First Schedule, Order VI- Rule 15A and Order XI- Rule 3)
I —– the deponent do hereby solemnly affirm and declare as under:
1. I am the party in the above suit and competent to swear this affidavit.
2. I am sufficiently conversant with the facts of the case and have also examined all relevant documents and records in relation thereto.
3. I say that the statements made in —–paragraphs are true to my knowledge and statements made in —–paragraphs are based on information received which I believe to be correct and statements made in —paragraphs are based on legal advice.
4. I say that there is no false statement or concealment of any material fact, document or record and I have included information that is according to me, relevant for the present suit.
5. I say that all documents in my power, possession, control or custody, pertaining to the facts and circumstances of the proceedings initiated by me have been disclosed and copies thereof annexed with the plaint, and that I do not have any other documents in my power, possession, control or custody.
6. I say that the above-mentioned pleading comprises of a total of —- pages, each of which has been duly signed by me.
7. I state that the Annexures hereto are true copies of the documents referred to and relied upon by me.
8. I say that I am aware that for any false statement or concealment, I shall be liable for action taken against me under the law for the time being in force.
Place:
Date:
DEPONENT
VERIFICATION
I, ………………………. do hereby declare that the statements made above are true to my knowledge.
Verified at [place] on this [date]
DEPONENT.”.]
- Ins. by Act 28 of 2018, s. 2 (w.e.f. 3-5-2018)
- Subs. by s. 3, ibid., for sub-section (1) (w.e.f. 3-5-2018).
- Ins. by s. 4, ibid., (w.e.f. 3-5-2018).
- Clause (a) renumbered as clause (aa) by s. 4, ibid., (w.e.f. 3-5-2018).
- Subs. by Act 28 of 2018, s. 4, for “which shall not be less than one crore rupees” (w.e.f. 3-5-2018).
- Subs. by Act 28 of 2018, s. 5, for “CONSTITUTION OF COMMERCIAL COURTS, COMMERCIAL DIVISIONS AND COMMERCIAL APPELLATE DIVISIONS” (w.e.f. 3-5-2018).
- Subs. by s. 6, ibid., for the proviso (w.e.f. 3-5-2018).
- Ins. by s. 6, ibid., (w.e.f. 3-5-2018).
- Subs. by s. 6, ibid., for “State Government shall” (w.e.f. 3-5-2018).
- Subs. by s. 6, ibid., for “Commercial Court, from amongst the cadre of Higher Judicial Service in the State”
(w.e.f. 3-5-2018).
- Ins. by s. 7, ibid., (w.e.f. 3-5-2018).
- Subs. by s. 8, ibid., for “ordinary civil jurisdiction” (w.e.f. 3-5-2018).
- Ins. by Act 28 of 2018, s. 10 (w.e.f. 3-5-2018).
- The word “and” omitted by s. 10, ibid., (w.e.f. 3-5-2018).
- Clause (e) omitted by s. 10, ibid., (w.e.f. 3-5-2018).
- Ins. by s. 11, ibid. (w.e.f. 3-5-2018).
- Subs. by Act 28 of 2018, s. 12, for sub-section (1) (w.e.f. 3-5-2018).
- Subs. by s. 13, ibid., for “Commercial Appellate Division” (w.e.f. 3-5-2018).
- Subs. by s. 14, ibid., for “with Order XIV-A” (w.e.f. 3-5-2018)
- Subs. by Act 28 of 2018, s. 15, for “Commercial Courts” and “Commercial Court” (w.e.f. 3-5-2018).
- Subs. by s. 16, ibid., for “Commercial Court” (w.e.f. 3-5-2018)
- Ins. by Act 28 of 2018, s. 17 (w.e.f. 3-5-2018).
- The words “after the first proviso” omitted by Act 28 of 2018, s. 18 (w.e.f. 3-5-2018).
- Subs. by Act 28 of 2018, s. 18, for “Provided further that” (w.e.f. 3-5-2018).
- Subs. by Act 28 of 2018, s. 18, for “Commercial Court” (w.e.f. 3-5-2018).
- Ins. by s. 18, ibid., (w.e.f. 23-10-2015).
The Mental Healthcare Act, 2017
Ministry of Law and Justice
(Legislative Department)
An Act to provide for mental healthcare and services for persons with mental illness and to protect, promote and fulfil the rights of such persons during delivery of mental healthcare and services and for matters connected therewith or incidental thereto.
Whereas the Convention on Rights of Persons with Disabilities and its Optional Protocol was adopted on the 13th December, 2006 at United Nations Headquarters in New York and came into force on the 3rd May, 2008;
And Whereas India has signed and ratified the said Convention on the 1st day of October, 2007;
And Whereas it is necessary to align and harmonise the existing laws with the said Convention.
Be it enacted by Parliament in the Sixty-eighth Year of the Republic of India as follows:-
CHAPTER I
Preliminary
1. Short title, extent and commencement. – (1) This Act may be called the Mental Healthcare Act, 2017.
(2) It shall extend to the whole of India.
(3) It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint; or on the date of completion of the period of nine months from the date on which the Mental Healthcare Act, 2017 receives the assent of the President.
2. Definitions. – (1) In this Act, unless the context otherwise requires,-
(a) “advance directive” means an advance directive made by a person under section 5;
(b) “appropriate Government” means,-
(i) in relation to a mental health establishment established, owned or controlled by the Central Government or the Administrator of a Union territory having no legislature, the Central Government;
(ii) in relation to a mental health establishment, other than an establishment referred to in sub-clause (i), established, owned or controlled within the territory of-
(A) a State, the State Government;
(B) a Union territory having legislature, the Government of that Union territory;
(c) “Authority” means the Central Mental Health Authority or the State Mental Health Authority, as the case may be;
(d) “Board” means the Mental Health Review Board constituted by the State Authority under sub-section (1) of section 80 in such manner as may be prescribed;
(e) “care-giver” means a person who resides with a person with mental illness and is responsible for providing care to that person and includes a relative or any other person who performs this function, either free or with remuneration;
(f) “Central Authority” means the Central Mental Health Authority constituted under section 33;
(g) “clinical psychologist” means a person-
(i) having a recognised qualification in Clinical Psychology from an institution approved and recognised, by the Rehabilitation Council of India, constituted under section 3 of the Rehabilitation Council of India Act, 1992; or
(ii) having a Post-Graduate degree in Psychology or Clinical Psychology or Applied Psychology and a Master of Philosophy in Clinical Psychology or Medical and Social Psychology obtained after completion of a full time course of two years which includes supervised clinical training from any University recognised by the University Grants Commission established under the University Grants Commission Act, 1956 and approved and recognised by the Rehabilitation Council of India Act, 1992 or such recognised qualifications as may be prescribed;
(h) “family” means a group of persons related by blood, adoption or marriage;
(i) “informed consent” means consent given for a specific intervention, without any force, undue influence, fraud, threat, mistake or misrepresentation, and obtained after disclosing to a person adequate information including risks and benefits of, and alternatives to, the specific intervention in a language and manner understood by the person;
(j) “least restrictive alternative” or “least restrictive environment” or “less restrictive option” means offering an option for treatment or a setting for treatment which-
(i) meets the person’s treatment needs; and
(ii) imposes the least restriction on the person’s rights;
(k) “local authority” means a Municipal Corporation or Municipal Council, or Zilla Parishad, or Nagar Panchayat, or Panchayat, by whatever name called, and includes such other authority or body having administrative control over the mental health establishment or empowered under any law for the time being in force, to function as a local authority in any city or town or village;
(l) “Magistrate” means-
(i) in relation to a metropolitan area within the meaning of clause (k) of section 2 of the Code of Criminal Procedure, 1973, a Metropolitan Magistrate;
(ii) in relation to any other area, the Chief Judicial Magistrate, Subdivisional Judicial Magistrate or such other Judicial Magistrate of the first class as the State Government may, by notification, empower to perform the functions of a Magistrate under this Act;
(m) “medical officer in charge” in relation to any mental health establishment means the psychiatrist or medical practitioner who, for the time being, is in charge of that mental health establishment;
(n) “medical practitioner” means a person who possesses a recognised medical qualification-
(i) as defined in clause (h) of section 2 of the Indian Medical Council Act, 1956, and whose name has been entered in the State Medical Register, as defined in clause (k) of that section; or
(ii) as defined in clause (h) of sub-section (1) of section 2 of the Indian Medicine Central Council Act, 1970, and whose name has been entered in a State Register of Indian Medicine, as defined in clause (j) of sub-section (1) of that section; or
(iii) as defined in clause (g) of sub-section (1) of section 2 of the Homoeopathy Central Council Act, 1973, and whose name has been entered in a State Register of Homoeopathy, as defined in clause (i) of sub-section (1) of that section;
(o) “Mental healthcare” includes analysis and diagnosis of a person’s mental condition and treatment as well as care and rehabilitation of such person for his mental illness or suspected mental illness;
(p) “mental health establishment” means any health establishment, including Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy establishment, by whatever name called, either wholly or partly, meant for the care of persons with mental illness, established, owned, controlled or maintained by the appropriate Government, local authority, trust, whether private or public, corporation, co-operative society, organisation or any other entity or person, where persons with mental illness are admitted and reside at, or kept in, for care, treatment, convalescence and rehabilitation, either temporarily or otherwise; and includes any general hospital or general nursing home established or maintained by the appropriate Government, local authority, trust, whether private or public, corporation, co-operative society, organisation or any other entity or person; but does not include a family residential place where a person with mental illness resides with his relatives or friends;
(q) “mental health nurse” means a person with a diploma or degree in general nursing or diploma or degree in psychiatric nursing recognised by the Nursing Council of India established under the Nursing Council of India Act, 1947 and registered as such with the relevant nursing council in the State;
(r) “mental health professional” means-
(i) a psychiatrist as defined in clause (x); or
(ii) a professional registered with the concerned State Authority under section 55; or
(iii) a professional having a post-graduate degree (Ayurveda) in Mano Vigyan Avum Manas Roga or a post-graduate degree (Homoeopathy) in Psychiatry or a post-graduate degree (Unani) in Moalijat (Nafasiyatt) or a post-graduate degree (Siddha) in Sirappu Maruthuvam;
(s) “mental illness” means a substantial disorder of thinking, mood, perception, orientation or memory that grossly impairs judgment, behaviour, capacity to recognise reality or ability to meet the ordinary demands of life, mental conditions associated with the abuse of alcohol and drugs, but does not include mental retardation which is a condition of arrested or incomplete development of mind of a person, specially characterised by subnormality of intelligence;
(t) “minor” means a person who has not completed the age of eighteen years;
(u) “notification” means a notification published in the Official Gazette and the expression “notify” shall be construed accordingly;
(v) “prescribed” means prescribed by rules made under this Act;
(w) “prisoner with mental illness” means a person with mental illness who is an under-trial or convicted of an offence and detained in a jail or prison;
(x) “psychiatric social worker” means a person having a post-graduate degree in Social Work and a Master of Philosophy in Psychiatric Social Work obtained after completion of a full time course of two years which includes supervised clinical training from any University recognised by the University Grants Commission established under the University Grants Commission Act, 1956 or such recognised qualifications, as may be prescribed;
(y) “psychiatrist” means a medical practitioner possessing a post-graduate degree or diploma in psychiatry awarded by an university recognised by the University Grants Commission established under the University Grants Commission Act, 1956, or awarded or recognised by the National Board of Examinations and included in the First Schedule to the Indian Medical Council Act, 1956, or recognised by the Medical Council of India, constituted under the Indian Medical Council Act, 1956, and includes, in relation to any State, any medical officer who having regard to his knowledge and experience in psychiatry, has been declared by the Government of that State to be a psychiatrist for the purposes of this Act;
(z) “regulations” means regulations made under this Act;
(za) “relative” means any person related to the person with mental illness by blood, marriage or adoption;
(zb) “State Authority” means the State Mental Health Authority established under section 45.
(2) The words and expressions used and not defined in this Act but defined in the Indian Medical Council Act, 1956 or the Indian Medicine Central Council Act, 1970 and not inconsistent with this Act shall have the meanings respectively assigned to them in those Acts.
CHAPTER II
Mental Illness and Capacity to make Mental Healthcare and Treatment Decisions
3. Determination of mental illness. – (1) Mental illness shall be determined in accordance with such nationally or internationally accepted medical standards (including the latest edition of the International Classification of Disease of the World Health Organisation) as may be notified by the Central Government.
(2) No person or authority shall classify a person as a person with mental illness, except for purposes directly relating to the treatment of the mental illness or in other matters as covered under this Act or any other law for the time being in force.
(3) Mental illness of a person shall not be determined on the basis of,-
(a) political, economic or social status or membership of a cultural, racial or religious group, or for any other reason not directly relevant to mental health status of the person;
(b) non-conformity with moral, social, cultural, work or political values or religious beliefs prevailing in a person’s community.
(4) Past treatment or hospitalisation in a mental health establishment though relevant, shall not by itself justify any present or future determination of the person’s mental illness.
(5) The determination of a person’s mental illness shall alone not imply or be taken to mean that the person is of unsound mind unless he has been declared as such by a competent court.
4. Capacity to make mental healthcare and treatment decisions. – (1) Every person, including a person with mental illness shall be deemed to have capacity to make decisions regarding his mental healthcare or treatment if such person has ability to-
(a) understand the information that is relevant to take a decision on the treatment or admission or personal assistance; or
(b) appreciate any reasonably foreseeable consequence of a decision or lack of decision on the treatment or admission or personal assistance; or
(c) communicate the decision under sub-clause (a) by means of speech, expression, gesture or any other means.
(2) The information referred to in sub-section (1) shall be given to a person using simple language, which such person understands or in sign language or visual aids or any other means to enable him to understand the information.
(3) Where a person makes a decision regarding his mental healthcare or treatment which is perceived by others as inappropriate or wrong, that by itself, shall not mean that the person does not have the capacity to make mental healthcare or treatment decision, so long as the person has the capacity to make mental healthcare or treatment decision under sub-section (1).
CHAPTER III
Advance Directive
5. Advance directive. – (1) Every person, who is not a minor, shall have a right to make an advance directive in writing, specifying any or all of the following, namely:-
(a) the way the person wishes to be cared for and treated for a mental illness;
(b) the way the person wishes not to be cared for and treated for a mental illness;
(c) the individual or individuals, in order of precedence, he wants to appoint as his nominated representative as provided under section 14.
(2) An advance directive under sub-section (1) may be made by a person irrespective of his past mental illness or treatment for the same.
(3) An advance directive made under sub-section (1), shall be invoked only when such person ceases to have capacity to make mental healthcare or treatment decisions and shall remain effective until such person regains capacity to make mental healthcare or treatment decisions.
(4) Any decision made by a person while he has the capacity to make mental healthcare and treatment decisions shall over-ride any previously written advance directive by such person.
(5) Any advance directive made contrary to any law for the time being in force shall be ab initio void.
6. Manner of making advance directive. – An advance directive shall be made in the manner as may be specified by the regulations made by the Central Authority.
7. Maintenance of online register. – Subject to the provisions contained in clause (a) of sub-section (1) of section 91, every Board shall maintain an online register of all advance directives registered with it and make them available to the concerned mental health professionals as and when required.
8. Revocation, amendment or cancellation of advance directive. – (1) An advance directive made under section 6 may be revoked, amended or cancelled by the person who made it at any time.
(2) The procedure for revoking, amending or cancelling an advance directive shall be the same as for making an advance directive under section 6.
9. Advance directive not to apply to emergency treatment. – The advance directive shall not apply to the emergency treatment given under section 103 to a person who made the advance directive.
10. Duty to follow advance directive. – It shall be the duty of every medical officer in charge of a mental health establishment and the psychiatrist in charge of a person’s treatment to propose or give treatment to a person with mental illness, in accordance with his valid advance directive, subject to section 11.
11. Power to review, alter, modify or cancel advance directive. – (1) Where a mental health professional or a relative or a care-giver of a person desires not to follow an advance directive while treating a person with mental illness, such mental health professional or the relative or the care-giver of the person shall make an application to the concerned Board to review, alter, modify or cancel the advance directive.
(2) Upon receipt of the application under sub-section (1), the Board shall, after giving an opportunity of hearing to all concerned parties (including the person whose advance directive is in question), either uphold, modify, alter or cancel the advance directive after taking into consideration the following, namely:-
(a) whether the advance directive was made by the person out of his own free will and free from force, undue influence or coercion; or
(b) whether the person intended the advance directive to apply to the present circumstances, which may be different from those anticipated; or
(c) whether the person was sufficiently well informed to make the decision; or
(d) whether the person had capacity to make decisions relating to his mental healthcare or treatment when such advanced directive was made; or
(e) whether the content of the advance directive is contrary to other laws or constitutional provisions.
(3) The person writing the advance directive and his nominated representative shall have a duty to ensure that the medical officer in charge of a mental health establishment or a medical practitioner or a mental health professional, as the case may be, has access to the advance directive when required.
(4) The legal guardian shall have right to make an advance directive in writing in respect of a minor and all the provisions relating to advance directive, mutatis mutandis, shall apply to such minor till such time he attains majority.
12. Review of advance directives. – (1) The Central Authority shall regularly and periodically review the use of advance directives and make recommendations in respect thereof.
(2) The Central Authority in its review under sub-section (1) shall give specific consideration to the procedure for making an advance directive and also examine whether the existing procedure protects the rights of persons with mental illness.
(3) The Central Authority may modify the procedure for making an advance directive or make additional regulations regarding the procedure for advance directive to protect the rights of persons with mental illness.
13. Liability of medical health professional in relation to advance directive. – (1) A medical practitioner or a mental health professional shall not be held liable for any unforeseen consequences on following a valid advance directive.
(2) The medical practitioner or mental health professional shall not be held liable for not following a valid advance directive, if he has not been given a copy of the valid advance directive.
CHAPTER IV
Nominated Representative
14. Appointment and revocation of nominated representative. – (1) Notwithstanding anything contained in clause (c) of sub-section (1) of section 5, every person who is not a minor, shall have a right to appoint a nominated representative.
(2) The nomination under sub-section (1) shall be made in writing on plain paper with the person’s signature or thumb impression of the person referred to in that sub-section.
(3) The person appointed as the nominated representative shall not be a minor, be competent to discharge the duties or perform the functions assigned to him under this Act, and give his consent in writing to the mental health professional to discharge his duties and perform the functions assigned to him under this Act.
(4) Where no nominated representative is appointed by a person under sub-section (1), the following persons for the purposes of this Act in the order of precedence shall be deemed to be the nominated representative of a person with mental illness, namely:-
(a) the individual appointed as the nominated representative in the advance directive under clause (c) of sub-section (1) of section 5; or
(b) a relative, or if not available or not willing to be the nominated representative of such person; or
(c) a care-giver, or if not available or not willing to be the nominated representative of such person; or
(d) a suitable person appointed as such by the concerned Board; or
(e) if no such person is available to be appointed as a nominated representative, the Board shall appoint the Director, Department of Social Welfare, or his designated representative, as the nominated representative of the person with mental illness:
Provided that a person representing an organisation registered under the Societies Registration Act, 1860 or any other law for the time being in force, working for persons with mental illness, may temporarily be engaged by the mental health professional to discharge the duties of a nominated representative pending appointment of a nominated representative by the concerned Board.
(5) The representative of the organisation, referred to in the proviso to sub-section (4), may make a written application to the medical officer in-charge of the mental health establishment or the psychiatrist in-charge of the person’s treatment, and such medical officer or psychiatrist, as the case may be, shall accept him as the temporary nominated representative, pending appointment of a nominated representative by the concerned Board.
(6) A person who has appointed any person as his nominated representative under this section may revoke or alter such appointment at any time in accordance with the procedure laid down for making an appointment of nominated representative under sub-section (1).
(7) The Board may, if it is of the opinion that it is in the interest of the person with mental illness to do so, revoke an appointment made by it under this section, and appoint a different representative under this section.
(8) The appointment of a nominated representative, or the inability of a person with mental illness to appoint a nominated representative, shall not be construed as the lack of capacity of the person to take decisions about his mental healthcare or treatment.
(9) All persons with mental illness shall have capacity to make mental healthcare or treatment decisions but may require varying levels of support from their nominated representative to make decisions.
15. Nominated representative of minor. – (1) Notwithstanding anything contained in section 14, in case of minors, the legal guardian shall be their nominated representative, unless the concerned Board orders otherwise under sub-section (2).
(2) Where on an application made to the concerned Board, by a mental health professional or any other person acting in the best interest of the minor, and on evidence presented before it, the concerned Board is of the opinion that,-
(a) the legal guardian is not acting in the best interests of the minor; or
(b) the legal guardian is otherwise not fit to act as the nominated representative of the minor, it may appoint, any suitable individual who is willing to act as such, the nominated representative of the minor with mental illness:
Provided that in case no individual is available for appointment as a nominated representative, the Board shall appoint the Director in the Department of Social Welfare of the State in which such Board is located, or his nominee, as the nominated representative of the minor with mental illness.
16. Revocation, alteration, etc., of nominated representative by Board. – The Board, on an application made to it by the person with mental illness, or by a relative of such person, or by the psychiatrist responsible for the care of such person, or by the medical officer in-charge of the mental health establishment where the individual is admitted or proposed to be admitted, may revoke, alter or modify the order made under clause (e) of sub-section (4) of section 14 or under sub-section (2) of section 15.
17. Duties of nominated representative. – While fulfilling his duties under this Act, the nominated representative shall-
(a) consider the current and past wishes, the life history, values, cultural background and the best interests of the person with mental illness;
(b) give particular credence to the views of the person with mental illness to the extent that the person understands the nature of the decisions under consideration;
(c) provide support to the person with mental illness in making treatment decisions under section 89 or section 90;
(d) have right to seek information on diagnosis and treatment to provide adequate support to the person with mental illness;
(e) have access to the family or home based rehabilitation services as provided under clause (c) of sub-section (4) of section 18 on behalf of and for the benefit of the person with mental illness;
(f) be involved in discharge planning under section 98;
(g) apply to the mental health establishment for admission under section 87 or section 89 or section 90;
(h) apply to the concerned Board on behalf of the person with mental illness for discharge under section 87 or section 89 or section 90;
(i) apply to the concerned Board against violation of rights of the person with mental illness in a mental health establishment;
(j) appoint a suitable attendant under sub-section (5) or sub-section (6) of section 87;
(k) have the right to give or withhold consent for research under circumstances mentioned under sub-section (3) of section 99.
CHAPTER V
Rights of Persons with Mental Illness
18. Right to access mentalhealth care. – (1) Every person shall have a right to access mental healthcare and treatment from mental health services run or funded by the appropriate Government.
(2) The right to access mental healthcare and treatment shall mean mental health services of affordable cost, of good quality, available in sufficient quantity, accessible geographically, without discrimination on the basis of gender, sex, sexual orientation, religion, culture, caste, social or political beliefs, class, disability or any other basis and provided in a manner that is acceptable to persons with mental illness and their families and care-givers.
(3) The appropriate Government shall make sufficient provision as may be necessary, for a range of services required by persons with mental illness.
(4) Without prejudice to the generality of range of services under sub-section (3), such services shall include-
(a) provision of acute mental healthcare services such as outpatient and inpatient services;
(b) provision of half-way homes, sheltered accommodation, supported accommodation as may be prescribed;
(c) provision for mental health services to support family of person with mental illness or home based rehabilitation;
(d) hospital and community based rehabilitation establishments and services as may be prescribed;
(e) provision for child mental health services and old age mental health services.
(5) The appropriate Government shall,-
(a) integrate mental health services into general healthcare services at all levels of healthcare including primary, secondary and tertiary healthcare and in all health programmes run by the appropriate Government;
(b) provide treatment in a manner, which supports persons with mental illness to live in the community and with their families;
(c) ensure that the long term care in a mental health establishment for treatment of mental illness shall be used only in exceptional circumstances, for as short a duration as possible, and only as a last resort when appropriate community based treatment has been tried and shown to have failed;
(d) ensure that no person with mental illness (including children and older persons) shall be required to travel long distances to access mental health services and such services shall be available close to a place where a person with mental illness resides;
(e) ensure that as a minimum, mental health services run or funded by Government shall be available in each district;
(f) ensure, if minimum mental health services specified under sub-clause (e) of sub-section (4) are not available in the district where a person with mental illness resides, that the person with mental illness is entitled to access any other mental health service in the district and the costs of treatment at such establishments in that district will be borne by the appropriate Government:
Provided that till such time the services under this sub-section are made available in a health establishment run or funded by the appropriate Government, the appropriate Government shall make rules regarding reimbursement of costs of treatment at such mental health establishment.
(6) The appropriate Government shall make available a range of appropriate mental health services specified under sub-section (4) of section 18 at all general hospitals run or funded by such Government and basic and emergency mental healthcare services shall be available at all community health centres and upwards in the public health system run or funded by such Government.
(7) Persons with mental illness living below the poverty line whether or not in possession of a below poverty line card, or who are destitute or homeless shall be entitled to mental health treatment and services free of any charge and at no financial cost at all mental health establishments run or funded by the appropriate Government and at other mental health establishments designated by it.
(8) The appropriate Government shall ensure that the mental health services shall be of equal quality to other general health services and no discrimination be made in quality of services provided to persons with mental illness.
(9) The minimum quality standards of mental health services shall be as specified by regulations made by the State Authority.
(10) Without prejudice to the generality of range of services under sub-section (3) of section 18, the appropriate Government shall notify Essential Drug List and all medicines on the Essential Drug List shall be made available free of cost to all persons with mental illness at all times at health establishments run or funded by the appropriate Government starting from Community Health Centres and upwards in the public health system:
Provided that where the health professional of ayurveda, yoga, unani, siddha, homoeopathy or naturopathy systems recognised by the Central Government are available in any health establishment, the essential medicines from any similar list relating to the appropriate ayurvada, yoga, unani, siddha, homoeopathy or naturopathy systems shall also be made available free of cost to all persons with mental illness.
(11) The appropriate Government shall take measures to ensure that necessary budgetary provisions in terms of adequacy, priority, progress and equity are made for effective implementation of the provisions of this section.
Explanation. – For the purposes of sub-section (11), the expressions-
(i) “adequacy” means in terms of how much is enough to offset inflation;
(ii) “priority” means in terms of compared to other budget heads;
(iii) “equity” means in terms of fair allocation of resources taking into account the health, social and economic burden of mental illness on individuals, their families and care-givers;
(iv) “progress” means in terms of indicating an improvement in the State’s response.
19. Right to community living. – (1) Every person with mental illness shall,-
(a) have a right to live in, be part of and not be segregated from society; and
(b) not continue to remain in a mental health establishment merely because he does not have a family or is not accepted by his family or is homeless or due to absence of community based facilities.
(2) Where it is not possible for a mentally ill person to live with his family or relatives, or where a mentally ill person has been abandoned by his family or relatives, the appropriate Government shall provide support as appropriate including legal aid and to facilitate exercising his right to family home and living in the family home.
(3) The appropriate Government shall, within a reasonable period, provide for or support the establishment of less restrictive community based establishments including half-way homes, group homes and the like for persons who no longer require treatment in more restrictive mental health establishments such as long stay mental hospitals.
20. Right to protection from cruel, inhuman and degrading treatment. – (1) Every person with mental illness shall have a right to live with dignity.
(2) Every person with mental illness shall be protected from cruel, inhuman or degrading treatment in any mental health establishment and shall have the following rights, namely:-
(a) to live in safe and hygienic environment;
(b) to have adequate sanitary conditions;
(c) to have reasonable facilities for leisure, recreation, education and religious practices;
(d) to privacy;
(e) for proper clothing so as to protect such person from exposure of his body to maintain his dignity;
(f) to not be forced to undertake work in a mental health establishment and to receive appropriate remuneration for work when undertaken;
(g) to have adequate provision for preparing for living in the community;
(h) to have adequate provision for wholesome food, sanitation, space and access to articles of personal hygiene, in particular, women’s personal hygiene be adequately addressed by providing access to items that may be required during menstruation;
(i) to not be subject to compulsory tonsuring (shaving of head hair);
(j) to wear own personal clothes if so wished and to not be forced to wear uniforms provided by the establishment; and
(k) to be protected from all forms of physical, verbal, emotional and sexual abuse.
21. Right to equality and non- discrimination. – (1) Every person with mental illness shall be treated as equal to persons with physical illness in the provision of all healthcare which shall include the following, namely:-
(a) there shall be no discrimination on any basis including gender, sex, sexual orientation, religion, culture, caste, social or political beliefs, class or disability;
(b) emergency facilities and emergency services for mental illness shall be of the same quality and availability as those provided to persons with physical illness;
(c) persons with mental illness shall be entitled to the use of ambulance services in the same manner, extent and quality as provided to persons with physical illness;
(d) living conditions in health establishments shall be of the same manner, extent and quality as provided to persons with physical illness; and
(e) any other health services provided to persons with physical illness shall be provided in same manner, extent and quality to persons with mental illness.
(2) A child under the age of three years of a woman receiving care, treatment or rehabilitation at a mental health establishment shall ordinarily not be separated from her during her stay in such establishment:
Provided that where the treating Psychiatrist, based on his examination of the woman, and if appropriate, on information provided by others, is of the opinion that there is risk of harm to the child from the woman due to her mental illness or it is in the interest and safety of the child, the child shall be temporarily separated from the woman during her stay at the mental health establishment:
Provided further that the woman shall continue to have access to the child under such supervision of the staff of the establishment or her family, as may be appropriate, during the period of separation.
(3) The decision to separate the woman from her child shall be reviewed every fifteen days during the woman’s stay in the mental health establishment and separation shall be terminated as soon as conditions which required the separation no longer exist:
Provided that any separation permitted as per the assessment of a mental health professional, if it exceeds thirty days at a stretch, shall be required to be approved by the respective Authority.
(4) Every insurer shall make provision for medical insurance for treatment of mental illness on the same basis as is available for treatment of physical illness.
22. Right to information. – (1) A person with mental illness and his nominated representative shall have the rights to the following information, namely:-
(a) the provision of this Act or any other law for the time being in force under which he has been admitted, if he is being admitted, and the criteria for admission under that provision;
(b) of his right to make an application to the concerned Board for a review of the admission;
(c) the nature of the person’s mental illness and the proposed treatment plan which includes information about treatment proposed and the known side effects of the proposed treatment;
(d) receive the information in a language and form that such person receiving the information can understand.
(2) In case complete information cannot be given to the person with mental illness at the time of the admission or the start of treatment, it shall be the duty of the medical officer or psychiatrist in-charge of the person’s care to ensure that full information is provided promptly when the individual is in a position to receive it:
Provided that where the information has not been given to the person with mental illness at the time of the admission or the start of treatment, the medical officer or psychiatrist in charge of the person’s care shall give the information to the nominated representative immediately.
23. Right to confidentiality. – (1) A person with mental illness shall have the right to confidentiality in respect of his mental health, mental healthcare, treatment and physical healthcare.
(2) All health professionals providing care or treatment to a person with mental illness shall have a duty to keep all such information confidential which has been obtained during care or treatment with the following exceptions, namely:-
(a) release of information to the nominated representative to enable him to fulfil his duties under this Act;
(b) release of information to other mental health professionals and other health professionals to enable them to provide care and treatment to the person with mental illness;
(c) release of information if it is necessary to protect any other person from harm or violence;
(d) only such information that is necessary to protect against the harm identified shall be released;
(e) release only such information as is necessary to prevent threat to life;
(f) release of information upon an order by concerned Board or the Central Authority or High Court or Supreme Court or any other statutory authority competent to do so; and
(g) release of information in the interests of public safety and security.
24. Restriction on release of information in respect of mental illness. – (1) No photograph or any other information relating to a person with mental illness undergoing treatment at a mental health establishment shall be released to the media without the consent of the person with mental illness.
(2) The right to confidentiality of person with mental illness shall also apply to all information stored in electronic or digital format in real or virtual space.
25. Right to access medical records. – (1) All persons with mental illness shall have the right to access their basic medical records as may be prescribed.
(2) The mental health professional in charge of such records may withhold specific information in the medical records if disclosure would result in,-
(a) serious mental harm to the person with mental illness; or
(b) likelihood of harm to other persons.
(3) When any information in the medical records is withheld from the person, the mental health professional shall inform the person with mental illness of his right to apply to the concerned Board for an order to release such information.
26. Right to personal contacts and communication. – (1) A person with mental illness admitted to a mental health establishment shall have the right to refuse or receive visitors and to refuse or receive and make telephone or mobile phone calls at reasonable times subject to the norms of such mental health establishment.
(2) A person with mental illness admitted in a mental health establishment may send and receive mail through electronic mode including through e-mail.
(3) Where a person with mental illness informs the medical officer or mental health professional in charge of the mental health establishment that he does not want to receive mail or email from any named person in the community, the medical officer or mental health professional in charge may restrict such communication by the named person with the person with mental illness.
(4) Nothing contained in sub-sections (1) to (3) shall apply to visits from, telephone calls to, and from mail or e-mail to, and from individuals, specified under clauses (a) to (f) under any circumstances, namely:-
(a) any Judge or officer authorised by a competent court;
(b) members of the concerned Board or the Central Authority or the State Authority;
(c) any member of the Parliament or a Member of State Legislature;
(d) nominated representative, lawyer or legal representative of the person;
(e) medical practitioner in charge of the person’s treatment;
(f) any other person authorised by the appropriate Government.
27. Right to legal aid. – (1) A person with mental illness shall be entitled to receive free legal services to exercise any of his rights given under this Act.
(2) It shall be the duty of magistrate, police officer, person in charge of such custodial institution as may be prescribed or medical officer or mental health professional in charge of a mental health establishment to inform the person with mental illness that he is entitled to free legal services under the Legal Services Authorities Act, 1987 or other relevant laws or under any order of the court if so ordered and provide the contact details of the availability of services.
28. Right to make complaints about deficiencies in provision of services. – (1) Any person with mental illness or his nominated representative, shall have the right to complain regarding deficiencies in provision of care, treatment and services in a mental health establishment to,-
(a) the medical officer or mental health professional in charge of the establishment and if not satisfied with the response;
(b) the concerned Board and if not satisfied with the response;
(c) the State Authority.
(2) The provisions for making complaint in sub-section (1), is without prejudice to the rights of the person to seek any judicial remedy for violation of his rights in a mental health establishment or by any mental health professional either under this Act or any other law for the time being in force.
CHAPTER VI
Duties of Appropriate Government
29. Promotion of mental health and preventive programmes. – (1) The appropriate Government shall have a duty to plan, design and implement programmes for the promotion of mental health and prevention of mental illness in the country. – (2) Without prejudice to the generality of the provisions contained in sub-section (1), the appropriate Government shall, in particular, plan, design and implement public health programmes to reduce suicides and attempted suicides in the country.
30. Creating awareness about mental health and illness and reducing stigma associated with mental illness. – The appropriate Government shall take all measures to ensure that,-
(a) the provisions of this Act are given wide publicity through public media, including television, radio, print and online media at regular intervals;
(b) the programmes to reduce stigma associated with mental illness are planned, designed, funded and implemented in an effective manner;
(c) the appropriate Government officials including police officers and other officers of the appropriate Government are given periodic sensitisation and awareness training on the issues under this Act.
31. Appropriate Government to take measures as regard to human resource development and training, etc. – (1) The appropriate Government shall take measures to address the human resource requirements of mental health services in the country by planning, developing and implementing educational and training programmes in collaboration with institutions of higher education and training, to increase the human resources available to deliver mental health interventions and to improve the skills of the available human resources to better address the needs of persons with mental illness.
(2) The appropriate Government shall, at the minimum, train all medical officers in public healthcare establishments and all medical officers in the prisons or jails to provide basic and emergency mental healthcare.
(3) The appropriate Government shall make efforts to meet internationally accepted guidelines for number of mental health professionals on the basis of population, within ten years from the commencement of this Act.
32. Co-ordination within appropriate Government. – The appropriate Government shall take all measures to ensure effective co-ordination between services provided by concerned Ministries and Departments such as those dealing with health, law, home affairs, human resources, social justice, employment, education, women and child development, medical education to address issues of mental health care.
CHAPTER VII
Central Mental Health Authority
33. Establishment of Central Authority. – The Central Government shall, within a period of nine months from the date on which this Act receives the assent of the President, by notification, establish, for the purposes of this Act, an Authority to be known as the Central Mental Health Authority.
34. Composition of Central Authority. – (1) The Central Authority shall consist of the following, namely:-
(a) Secretary or Additional Secretary to the Government of India in the Department of Health and Family Welfare-chairperson ex officio;
(b) Joint Secretary to the Government of India in the Department of Health and Family Welfare, in charge of mental health-member ex officio;
(c) Joint Secretary to the Government of India in the Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homeopathy-member ex officio;
(d) Director General of Health Services-member ex officio;
(e) Joint Secretary to the Government of India in the Department of Disability Affairs of the Ministry of Social Justice and Empowerment-member ex officio;
(f) Joint Secretary to the Government of India in the Ministry of Women and Child Development-member ex officio;
(g) Directors of the Central Institutions for Mental Health-members ex officio;
(h) such other ex officio representatives from the relevant Central Government Ministries or Departments;
(i) one mental health professional as defined in item (iii) of clause (r) of sub-section (1) of section 2 having at least fifteen years experience in the field, to be nominated by the Central Government-member;
(j) one psychiatric social worker having at least fifteen years experience in the field, to be nominated by the Central Government-member;
(k) one clinical psychologist having at least fifteen years experience in the field, to be nominated by the Central Government-member;
(l) one mental health nurse having at least fifteen years experience in the field of mental health, to be nominated by the Central Government-member;
(m) two persons representing persons who have or have had mental illness, to be nominated by the Central Government-members;
(n) two persons representing care-givers of persons with mental illness or organisations representing care-givers, to be nominated by the Central Government-members;
(o) two persons representing non-governmental organisations which provide services to persons with mental illness, to be nominated by the Central Government-members;
(p) two persons representing areas relevant to mental health, if considered necessary.
(2) The members referred to in clauses (h) to (p) of sub-section (1), shall be nominated by the Central Government in such manner as may be prescribed.
35. Term of office, salaries and allowances of chairperson and members. – (1) The members of the Central Authority referred to in clauses (h) to (p) of sub-section (1) of section 34 shall hold office as such for a term of three years from the date of nomination and shall be eligible for reappointment:
Provided that a member shall not hold office as such after he has attained the age of seventy years.
(2) The chairperson and other ex officio members of the Authority shall hold office as such chairperson or member, as the case may be, so long as he holds the office by virtue of which he is nominated.
(3) The salaries and allowances payable to, and the other terms and conditions of service of, the chairperson and other members shall be such as may be prescribed.
36. Resignation. – A member of the Central Authority may, by notice in writing under his hand addressed to the Central Government, resign his office:
Provided that a member shall, unless he is permitted by the Central Government to relinquish his office sooner, continue to hold office until the expiry of three months from the date of receipt of such notice or until a person duly appointed as his successor enters upon the office or until the expiry of his term of office, whichever is the earliest.
37. Filling of vacancies. – The Central Government shall, within two months from the date of occurrence of any vacancy by reason of death, resignation or removal of a member of the Authority and three months before the superannuation or completion of the term of office of any member of that Authority, make nomination for filling up of the vacancy.
38. Vacancies, etc., not to invalidate proceedings of Central Authority. – No act or proceeding of the Central Authority shall be invalid merely by reason of-
(a) any vacancy in, or any defect in the constitution of, the Authority; or
(b) any defect in the appointment of a person as a member of the Authority; or
(c) any irregularity in the procedure of the Authority not affecting the merits of the case.
39. Member not to participate in meetings in certain cases. – Any member having any direct or indirect interest, whether pecuniary or otherwise, in any matter coming up for consideration at a meeting of the Central Authority, shall, as soon as possible after the relevant circumstances have come to his knowledge, disclose the nature of his interest at such meeting and such disclosure shall be recorded in the proceedings of the Central Authority, and the member shall not take any part in any deliberation or decision of the Authority with respect to that matter.
40. Officers and other employees of Central Authority. – (1) There shall be a chief executive officer of the Authority, not below the rank of the Director to the Government of India, to be appointed by the Central Government.
(2) The Authority may, with the approval of the Central Government, determine the number, nature and categories of other officers and employees required by the Central Authority in the discharge of its functions.
(3) The salaries and allowances payable to, and the other terms and conditions of service (including the qualifications, experience and manner of appointment) of, the chief executive officer and other officers and employees of the Central Authority shall be such as may be specified by regulations with the approval of the Central Government.
41. Functions of chief executive officer of Central Authority. – (1) The chief executive officer shall be the legal representative of the Central Authority and shall be responsible for-
(a) the day-to-day administration of the Central Authority;
(b) implementing the work programmes and decisions adopted by the Central Authority;
(c) drawing up of proposal for the Central Authority’s work programmes;
(d) the preparation of the statement of revenue and expenditure and the execution of the budget of the Central Authority.
(2) Every year, the chief executive officer shall submit to the Central Authority for approval-
(a) a general report covering all the activities of the Central Authority in the previous year;
(b) programmes of work;
(c) the annual accounts for the previous year; and
(d) the budget for the coming year.
(3) The chief executive officer shall have administrative control over the officers and other employees of the Central Authority.
42. Transfer of assets, liabilities of Central Authority. – On the establishment of the Central Authority-
(a) all the assets and liabilities of the Central Authority for Mental Health Services constituted under sub-section (1) of section 3 of the Mental Health Act, 1987 shall stand transferred to, and vested in, the Central Authority.
Explanation. – The assets of such Central Authority for Mental Health Services shall be deemed to include all rights and powers, and all properties, whether movable or immovable, including, in particular, cash balances, deposits and all other interests and rights in, or arising out of, such properties as may be in the possession of such Unique Identification Authority of India and all books of account and other documents relating to the same; and liabilities shall be deemed to include all debts, liabilities and obligations of whatever kind;
(b) without prejudice to the provisions of clause (a), all data and information collected during enrolment, all details of authentication performed, debts, obligations and liabilities incurred, all contracts entered into and all matters and things engaged to be done by, with or for such Central Authority for Mental Health Services immediately before that day, for or in connection with the purpose of the said Central Authority for Mental Health Services, shall be deemed to have been incurred, entered into or engaged to be done by, with or for, the Central Authority;
(c) all sums of money due to the Central Authority for Mental Health Services immediately before that day shall be deemed to be due to the Central Authority; and
(d) all suits and other legal proceedings instituted or which could have been instituted by or against such Central Authority for Mental Health Services immediately before that day may be continued or may be instituted by or against the Central Authority.
43. Functions of Central Authority. – (1) The Central Authority shall-
(a) register all mental health establishments under the control of the Central Government and maintain a register of all mental health establishments in the country based on information provided by all State Mental Health Authorities of registered establishments and compile update and publish (including online on the internet) a register of such establishments;
(b) develop quality and service provision norms for different types of mental health establishments under the Central Government;
(c) supervise all mental health establishments under the Central Government and receive complaints about deficiencies in provision of services;
(d) maintain a national register of clinical psychologists, mental health nurses and psychiatric social workers based on information provided by all State Authorities of persons registered to work as mental health professionals for the purpose of this Act and publish the list (including online on the internet) of such registered mental health professionals;
(e) train all persons including law enforcement officials, mental health professionals and other health professionals about the provisions and implementation of this Act;
(f) advise the Central Government on all matters relating to mental healthcare and services;
(g) discharge such other functions with respect to matters relating to mental health as the Central Government may decide:
Provided that the mental health establishments under the control of the Central Government, before the commencement of this Act, registered under the Mental Health Act, 1987 or any other law for the time being in force, shall be deemed to have been registered under the provisions of this Act and copy of such registration shall be furnished to the Central Authority.
(2) The procedure for registration (including the fees to be levied for such registration) of the mental health establishments under this section shall be such as may be prescribed by the Central Government.
44. Meetings of Central Authority. – (1) The Central Authority shall meet at such times (not less than twice in a year) and places and shall observe such rules of procedure in regard to the transaction of business at its meetings (including quorum at such meetings) as may be specified by regulations made by the Central Authority.
(2) If the chairperson, for any reason, is unable to attend a meeting of the Central Authority, the senior-most member shall preside over the meeting of the Authority.
(3) All questions which come up before any meeting of the Authority shall be decided by a majority of votes by the members present and voting and in the event of an equality of votes, the chairperson or in his absence the member presiding over shall have a second or casting vote.
(4) All decisions of the Central Authority shall be authenticated by the signature of the chairperson or any other member authorised by the Central Authority in this behalf.
(5) If any member, who is a director of a company and who as such director, has any direct or indirect pecuniary interest in any manner coming up for consideration at a meeting of the Central Authority, he shall, as soon as possible after relevant circumstances have come to his knowledge, disclose the nature of his interest at such meeting and such disclosure shall be recorded in the proceedings of the Authority, and the member shall not take part in any deliberation or decision of the Authority with respect to that matter.
CHAPTER VIII
State Mental Health Authority
45. Establishment of State Authority. – Every State Government shall, within a period of nine months from the date on which this Act receives the assent of the President, by notification, establish, for the purposes of this Act, an Authority to be known as the State Mental Health Authority.
46. Composition of State Authority. – (1) The State Authority shall consist of the following chairperson and members:-
(a) Secretary or Principal Secretary in the Department of Health of State Government-chairperson ex officio;
(b) Joint Secretary in the Department of Health of the State Government, in charge of mental health-member ex officio;
(c) Director of Health Services or Medical Education-member ex officio;
(d) Joint Secretary in the Department of Social Welfare of the State Government- member ex officio;
(e) such other ex officio representatives from the relevant State Government Ministries or Departments;
(f) Head of any of the Mental Hospitals in the State or Head of Department of Psychiatry at any Government Medical College, to be nominated by the State Government-member;
(g) one eminent psychiatrist from the State not in Government service to be nominated by the State Government-member;
(h) one mental health professional as defined in item (iii) of clause (q) of sub-section (1) of section 2 having at least fifteen years experience in the field, to be nominated by the State Government-member;
(i) one psychiatric social worker having at least fifteen years experience in the field, to be nominated by the State Government-member;
(j) one clinical psychologist having at least fifteen years experience in the field, to be nominated by the State Government-member;
(k) one mental health nurse having at least fifteen years experience in the field of mental health, to be nominated by the State Government-member;
(l) two persons representing persons who have or have had mental illness, to be nominated by the State Government-member;
(m) two persons representing care-givers of persons with mental illness or organisations representing care-givers, to be nominated by the State Government-members;
(n) two persons representing non-governmental organisations which provide services to persons with mental illness, to be nominated by the State Government- members.
(2) The members referred to in clauses (e) to (n) of sub-section (1), shall be nominated by the State Government in such manner as may be prescribed.
47. Term of office, salaries and allowances of chairperson and other members. – (1) The members of the State Authority referred to in clauses (e) to (n) of sub-section (1) of section 46 shall hold office as such for a term of three years from the date of nomination and shall be eligible for reappointment:
Provided that a member shall not hold office as such after he has attained the age of seventy years.
(2) The chairperson and other ex officio members of the State Authority shall hold office as such chairperson or member, as the case may be, so long as he holds the office by virtue of which he is nominated.
(3) The salaries and allowances payable to, and the other terms and conditions of service of, the chairperson and other members shall be such as may be prescribed.
48. Resignation. – A member of the State Authority may, by notice in writing under his hand addressed to the State Government, resign his office:
Provided that a member shall, unless he is permitted by the State Government to relinquish his office sooner, continue to hold office until the expiry of three months from the date of receipt of such notice or until a person duly appointed as his successor enters upon office or until the expiry of his term of office, whichever is the earliest.
49. Filling of vacancies. – The State Government shall, within two months from the date of occurrence of any vacancy by reason of death, resignation or removal of a member of the Authority and three months before the superannuation or completion of the term of office of any member of that Authority, make nomination for filling up of the vacancy.
50. Vacancies, etc., not to invalidate proceedings of State Authority. – No act or proceeding of the State Authority shall be invalid merely by reason of-
(a) any vacancy in, or any defect in the constitution of, the State Authority; or
(b) any defect in the appointment of a person as a member of the State Authority; or
(c) any irregularity in the procedure of the Authority not affecting the merits of the case.
51. Member not to participate in meetings in certain cases. – Any member having any direct or indirect interest, whether pecuniary or otherwise, in any matter coming up for consideration at a meeting of the State Authority, shall, as soon as possible after the relevant circumstances have come to his knowledge, disclose the nature of his interest at such meeting and such disclosure shall be recorded in the proceedings of the State Authority, and the member shall not take any part in any deliberation or decision of the State Authority with respect to that matter.
52. Officers and other employees of State Authority. – (1) There shall be a chief executive officer of the State Authority, not below the rank of the Deputy Secretary to the State Government, to be appointed by the State Government.
(2) The State Authority may, with the approval of the State Government, determine the number, nature and categories of other officers and employees required by the State Authority in the discharge of its functions.
(3) The salaries and allowances payable to, and the other terms and conditions of service (including the qualifications, experience and manner of appointment) of, the chief executive officer and other officers and employees of the State Authority shall be such as may be specified by regulations with the approval of the State Government.
53. Functions of chief executive officer of State Authority. – (1) The chief executive officer shall be the legal representative of the State Authority and shall be responsible for-
(a) the day-to-day administration of the State Authority;
(b) implementing the work programmes and decisions adopted by the State Authority;
(c) drawing up of proposal for the State Authority’s work programmes;
(d) the preparation of the statement of revenue and expenditure and the execution of the budget of the State Authority.
(2) Every year, the chief executive officer shall submit to the State Authority for approval-
(a) a general report covering all the activities of the Authority in the previous year;
(b) programmes of work;
(c) the annual accounts for the previous year; and
(d) the budget for the coming year.
(3) The chief executive officer shall have administrative control over the officers and other employees of the State Authority.
54. Transfer of assets, liabilities of State Authority. – On and from the establishment of the State Authority-
(a) all the assets and liabilities of the State Authority for Mental Health Services constituted under sub-section (1) of section 4 of the Mental Health Act, 1987 shall stand transferred to, and vested in, the State Authority.
Explanation. – The assets of such State Authority for Mental Health Services shall be deemed to include all rights and powers, and all properties, whether movable or immovable, including, in particular, cash balances, deposits and all other interests and rights in, or arising out of, such properties as may be in the possession of such State Authority for Mental Health Services and all books of account and other documents relating to the same; and liabilities shall be deemed to include all debts, liabilities and obligations of whatever kind;
(b) without prejudice to the provisions of clause (a), all data and information collected during enrolment, all details of authentication performed, debts, obligations and liabilities incurred, all contracts entered into and all matters and things engaged to be done by, with or for such State Authority for Mental Health Services immediately before that day, for or in connection with the purpose of the said State Authority for Mental Health Services, shall be deemed to have been incurred, entered into or engaged to be done by, with or for, the State Authority;
(c) all sums of money due to the State Authority for Mental Health Services immediately before that day shall be deemed to be due to the State Authority; and
(d) all suits and other legal proceedings instituted or which could have been instituted by or against such State Authority for Mental Health Services immediately before that day may be continued or may be instituted by or against the State Authority.
55. Functions of State Authority. – (1) The State Authority shall-
(a) register all mental health establishments in the State except those referred to in section 43 and maintain and publish (including online on the internet) a register of such establishments;
(b) develop quality and service provision norms for different types of mental health establishments in the State;
(c) supervise all mental health establishments in the State and receive complaints about deficiencies in provision of services;
(d) register clinical psychologists, mental health nurses and psychiatric social workers in the State to work as mental health professionals, and publish the list of such registered mental health professionals in such manner as may be specified by regulations by the State Authority;
(e) train all relevant persons including law enforcement officials, mental health professionals and other health professionals about the provisions and implementation of this Act;
(f) discharge such other functions with respect to matters relating to mental health as the State Government may decide:
Provided that the mental health establishments in the State (except those referred to in section 43), registered, before the commencement of this Act, under the Mental Health Act, 1987 or any other law for the time being in force, shall be deemed to have been registered under the provisions of this Act and copy of such registration shall be furnished to the State Authority.
(2) The procedure for registration (including the fees to be levied for such registration) of the mental health establishments under this section shall be such as may be prescribed by the State Government.
56. Meetings of State Authority. – (1) The State Authority shall meet at such times (not less than four times in a year) and places and shall observe such rules of procedure in regard to the transaction of business at its meetings (including quorum at such meetings) as may be specified by regulations made by the State Authority.
(2) If the chairperson, for any reason, is unable to attend a meeting of the State Authority, the senior- most member shall preside over the meetings of the Authority.
(3) All questions which come up before any meeting of the State Authority shall be decided by a majority of votes by the members present and voting and in the event of an equality of votes, the chairperson or in his absence the member presiding over shall have a second or casting vote.
(4) All decisions of the State Authority shall be authenticated by the signature of the chairperson or any other member authorised by the State Authority in this behalf.
(5) If any member, who is a director of a company and who as such director, has any direct or indirect pecuniary interest in any manner coming up for consideration at a meeting of the State Authority, he shall, as soon as possible after relevant circumstances have come to his knowledge, disclose the nature of his interest at such meeting and such disclosure shall be recorded in the proceedings of the Authority, and the member shall not take part in any deliberation or decision of the State Authority with respect to that matter.
CHAPTER IX
Finance, Accounts and Audit
57. Grants by Central Government to Central Authority. – The Central Government may, after due appropriation made by Parliament by law in this behalf, make to the Central Authority grants of such sums of money as the Central Government may think fit for being utilised for the purposes of this Act.
58. Central Mental Health Authority Fund. – (1) There shall be constituted a Fund to be called the Central Mental Health Authority Fund and there shall be credited thereto-
(i) any grants and loans made to the Authority by the Central Government;
(ii) all fees and charges received by the Authority under this Act; and
(iii) all sums received by the Authority from such other sources as may be decided upon by the Central Government.
(2) The Fund referred to in sub-section (1) shall be applied for meeting the salary, allowances and other remuneration of the chairperson, other members, chief executive officer, other officers and employees of the Authority and the expenses of the Authority incurred in the discharge of its functions and for purposes of this Act.
59. Accounts and audit of Central Authority. – (1) The Central Authority shall maintain proper accounts and other relevant records and prepare an annual statement of accounts in such form as may be prescribed by the Central Government, in consultation with the Comptroller and Auditor-General of India.
(2) The accounts of the Authority shall be audited by the Comptroller and Auditor-General of India at such intervals as may be specified by him and any expenditure incurred in connection with such audit shall be payable by the Authority to the Comptroller and Auditor-General of India.
(3) The Comptroller and Auditor-General of India and any other person appointed by him in connection with the audit of the accounts of the Authority shall have the same rights and privileges and authority in connection with such audit as the Comptroller and Auditor- General generally has in connection with the audit of the Government accounts and, in particular, shall have the right to demand the production of books, accounts, connected vouchers and other documents and papers and to inspect any of the office of the Authority.
(4) The accounts of the Authority as certified by the Comptroller and Auditor-General of India or any other person appointed by him in this behalf together with the audit report thereon, shall be forwarded annually to the Central Government by the Authority and the Central Government shall cause the same to be laid before each House of Parliament.
60. Annual report of Central Authority. – The Central Authority shall prepare in every year, in such form and at such time as may be prescribed by the Central Government, an annual report giving a full account of its activities during the previous year, and copies thereof along with copies of its annual accounts and auditor’s report shall be forwarded to the Central Government and the Central Government shall cause the same to be laid before both Houses of Parliament.
61. Grants by State Government. – The State Government may, after due appropriation made by State Legislature by law in this behalf, make to the State Authority grants of such sums of money as the State Government may think fit for being utilised for the purposes of this Act.
62. State Mental Health Authority Fund. – (1) There shall be constituted a Fund to be called the State Mental Health Authority Fund and there shall be credited thereto-
(i) any grants and loans made to the State Authority by the State Government;
(ii) all fees and charges received by the Authority under this Act; and
(iii) all sums received by the State Authority from such other sources as may be decided upon by the State Government.
(2) The Fund referred to in sub-section (1) shall be applied for meeting the salary, allowances and other remuneration of the chairperson, other members, chief executive officer, other officers and employees of the State Authority and the expenses of the State Authority incurred in the discharge of its functions and for purposes of this Act.
63. Accounts and audit of State Authority. – (1) The State Authority shall maintain proper accounts and other relevant records and prepare an annual statement of accounts in such form as may be prescribed by the State Government, in consultation with the Comptroller and Auditor-General of India.
(2) The accounts of the State Authority shall be audited by the Comptroller and Auditor-General of India at such intervals as may be specified by him and any expenditure incurred in connection with such audit shall be payable by the State Authority to the Comptroller and Auditor-General of India.
(3) The Comptroller and Auditor-General of India and any other person appointed by him in connection with the audit of the accounts of the State Authority shall have the same rights and privileges and authority in connection with such audit as the Comptroller and Auditor-General generally has in connection with the audit of the Government accounts and, in particular, shall have the right to demand the production of books, accounts, connected vouchers and other documents and papers and to inspect any of the office of the State Authority.
64. Annual report of State Authority. – The State Authority shall prepare in every year, in such form and at such time as may be prescribed by the State Government, an annual report giving a full account of its activities during the previous year, and copies thereof along with copies of its annual accounts and auditor’s report shall be forwarded to the State Government and the Government shall cause the same to be laid before the State Legislature.
CHAPTER X
Mental Health Establishments
65. Registration of mental health establishment. – (1) No person or organisation shall establish or run a mental health establishment unless it has been registered with the Authority under the provisions of this Act.
Explanation. – For the purposes of this Chapter, the expression “Authority” means-
(a) in respect of the mental health establishments under the control of the Central Government, the Central Authority;
(b) in respect of the mental health establishments in the State [not being the health establishments referred to in clause (a)], the State Authority.
(2) Every person or organisation who proposes to establish or run a mental health establishment shall register the said establishment with the Authority under the provisions of this Act:
Provided that the Central Government, may, by notification, exempt any category or class of existing mental health establishments from the requirement of registration under this Act.
Explanation. – In case a mental health establishment has been registered under the Clinical Establishments (Registration and Regulation) Act, 2010 or any other law for the time being in force in a State, such mental health establishment shall submit a copy of the said registration along with an application in such form as may be prescribed to the Authority with an undertaking that the mental health establishment fulfils the minimum standards, if any, specified by the Authority for the specific category of mental health establishment.
(3) The Authority shall, on receipt of application under sub-section (2), on being satisfied that such mental health establishment fulfils the standards specified by the Authority, issue a certificate of registration in such form as may be prescribed:
Provided that till the period the Authority specifies the minimum standards for different categories of mental health establishments, it shall issue a provisional certificate of registration to the mental health establishment:
Provided further that on specifying the minimum standards for different categories of mental health establishments, the mental health establishment referred to in the first proviso shall, within a period of six months from the date such standards are specified, submit to the Authority an undertaking stating therein that such establishment fulfils the specified minimum standards and on being satisfied that such establishment fulfils the minimum standards, the Authority shall issue a certificate of registration to such mental health establishment.
(4) Every mental health establishment shall, for the purpose of registration and continuation of registration, fulfil-
(a) the minimum standards of facilities and services as may be specified by regulations made by the Authority;
(b) the minimum qualifications for the personnel engaged in such establishment as may be specified by regulations made by the Authority;
(c) provisions for maintenance of records and reporting as may be specified by regulations made by the Authority; and
(d) any other conditions as may be specified by regulations made by the Authority.
(5) The Authority may-
(a) classify mental health establishments into such different categories, as may be specified by regulations made by the Central Authority;
(b) specify different standards for different categories of mental health establishments;
(c) while specifying the minimum standards for mental health establishments, have regard to local conditions.
(6) Notwithstanding anything in this section, the Authority shall, within a period of eighteen months from the commencement of this Act, by notification, specify the minimum standards for different categories of mental health establishments.
66. Procedure for registration, inspection and inquiry of mental health establishments. – (1) The mental health establishment shall, for the purpose of registration, submit an application, in such form, accompanied with such details and fees, as may be prescribed, to the Authority.
(2) The mental health establishment may submit the application in person or by post or online.
(3) Every mental health establishment, existing on the date of commencement of this Act, shall, within a period of six months from the date of constitution of the Authority, submit an application for its provisional registration to the Authority.
(4) The Authority shall, within a period of ten days from the date of receipt of such application, issue to the mental health establishment a certificate of provisional registration in such form and containing such particulars and information as may be prescribed.
(5) The Authority shall not be required to conduct any inquiry prior to issue of provisional registration.
(6) The Authority shall, within a period of forty-five days from the date of provisional registration, publish in print and in digital form online, all particulars of the mental health establishment.
(7) A provisional registration shall be valid for a period of twelve months from the date of its issue and be renewable.
(8) Where standards for particular categories of mental health establishments have been specified under this Act, the mental health establishments in that category shall, within a period of six months from date of notifying such standards, apply for that category and obtain permanent registration.
(9) The Authority shall publish the standards in print and online in digital format.
(10) Until standards for particular categories of mental health establishments are specified under this Act, every mental health establishment shall, within thirty days before the expiry of the validity of certificate of provisional registration, apply for a renewal of provisional registration.
(11) If the application is made after the expiry of provisional registration, the Authority shall allow renewal of registration on payment of such fees, as may be prescribed.
(12) A mental health establishment shall make an application for permanent registration to the Authority in such form and accompanied with such fees as may be specified by regulations.
(13) The mental health establishment shall submit evidence that the establishment has complied with the specified minimum standards in such manner as may be specified by regulations by the Authority.
(14) As soon as the mental health establishment submits the required evidence of the mental health establishment having complied with the specified minimum standards, the Authority shall give public notice and display the same on its website for a period of thirty days, for filing objections, if any, in such manner as may be specified by regulations.
(15) The Authority shall, communicate the objections, if any, received within the period referred to in sub-section (14), to the mental health establishment for response within such period as the Authority may determine.
(16) The mental health establishment shall submit evidence of compliance with the standards with reference to the objections communicated to such establishment under sub-section (15), to the Authority within the specified period.
Procedure for registration, inspection and inquiry of mental health establishments.
(17) The Authority shall on being satisfied that the mental health establishment fulfils the specified minimum standards for registration, grant permanent certificate of registration to such establishment.
(18) The Authority shall, within a period of forty-five days after the expiry of the period specified under this section, pass an order, either-
(a) grant permanent certificate of registration; or
(b) reject the application after recording the reasons thereof:
Provided that in case the Authority rejects the application under clause (b), it shall grant such period not exceeding six months, to the mental health establishment for rectification of the deficiencies which have led to rejection of the application and such establishment may apply afresh for registration.
(19) Notwithstanding anything contained in this section, if the Authority has neither communicated any objections received by it to the mental health establishment under sub-section (15), nor has passed an order under sub-section (18), the registration shall be deemed to have been granted by the Authority and the Authority shall provide a permanent certificate of registration.
67. Audit of mental health establishment. – (1) The Authority shall cause to be conducted an audit of all registered mental health establishments by such person or persons (including representatives of the local community) as may be prescribed, every three years, so as to ensure that such mental health establishments comply with the requirements of minimum standards for registration as a mental health establishment.
(2) The Authority may charge the mental health establishment such fee as may be prescribed, for conducting the audit under this section.
(3) The Authority may issue a show cause notice to a mental health establishment as to why its registration under this Act not be cancelled, if the Authority is satisfied that-
(a) the mental health establishment has failed to maintain the minimum standards specified by the Authority; or
(b) the person or persons or entities entrusted with the management of the mental health establishment have been convicted of an offence under this Act; or
(c) the mental health establishment violates the rights of any person with mental illness.
(4) The Authority may, after giving a reasonable opportunity to the mental health establishment, if satisfied that the mental health establishment falls under clause (a) or clause (b) or clause (c) of sub-section (3), without prejudice to any other action which it may take against the mental health establishment, cancel its registration.
(5) Every order made under sub-section (4) shall take effect-
(a) where no appeal has been preferred against such order, immediately on the expiry of the period specified for preferring of appeal; and
(b) where the appeal has been preferred against such an order and the appeal has been dismissed, from the date of the order of dismissal.
(6) The Authority shall, on cancellation of the registration for reasons to be recorded in writing, restrain immediately the mental health establishment from carrying on its operations, if there is imminent danger to the health and safety of the persons admitted in the mental health establishment.
(7) The Authority may cancel the registration of a mental health establishment if recommended by the Board to do so.
68. Inspection and inquiry. – (1) The Authority may, suo motu or on a complaint received from any person with respect to non-adherence of minimum standards specified by or under this Act or contravention of any provision thereof, order an inspection or inquiry of any mental health establishment, to be made by such person as may be prescribed.
(2) The mental health establishment shall be entitled to be represented at such inspection or inquiry.
(3) The Authority shall communicate to the mental health establishment the results of such inspection or inquiry and may after ascertaining the opinion of the mental health establishment, order the establishment to make necessary changes within such period as may be specified by it.
(4) The mental health establishment shall comply with the order of the Authority made under sub-section (3).
(5) If the mental health establishment fails to comply with the order of the Authority made under sub-section (3), the Authority may cancel the registration of the mental health establishment.
(6) The Authority or any person authorised by it may, if there is any reason to suspect that any person is operating a mental health establishment without registration, enter and search in such manner as may be prescribed, and the mental health establishment shall co-operate with such inspection or inquiry and be entitled to be represented at such inspection or inquiry.
69. Appeal to High Court against order of Authority. – Any mental health establishment aggrieved by an order of the Authority refusing to grant registration or renewal of registration or cancellation of registration, may, within a period of thirty days from such order, prefer an appeal to the High Court in the State:
Provided that the High Court may entertain an appeal after the expiry of the said period of thirty days, if it is satisfied that the appellant had sufficient cause for not preferring the appeal within the period of thirty days.
70. Certificates, fees and register of mental health establishments. – (1) Every mental health establishment shall display the certificate of registration in a conspicuous place in the mental health establishment in such manner so as to be visible to everyone visiting the mental health establishment.
(2) In case the certificate is destroyed or lost or mutilated or damaged, the Authority may issue a duplicate certificate on the request of the mental health establishment and on the payment of such fees as may be prescribed.
(3) The certificate of registration shall be non-transferable and valid in case of change of ownership of the establishment.
(4) Any change of ownership of the mental health establishment shall be intimated to the Authority by the new owner within one month from the date of change of ownership.
(5) In the event of change of category of the mental health establishment, such establishment shall surrender the certificate of registration to the Authority and the mental health establishment shall apply afresh for grant of certificate of registration in that category.
71. Maintenance of register of mental health establishment in digital format. – The Authority shall maintain in digital format a register of mental health establishments, registered by the Authority, to be called the Register of Mental Health Establishments and shall enter the particulars of the certificate of registration so granted in a separate register to be maintained in such form and manner as may be prescribed.
72. Duty of mental health establishment to display information. – (1) Every mental health establishment shall display within the establishment at conspicuous place (including on its website), the contact details including address and telephone numbers of the concerned Board.
(2) Every mental health establishment shall provide the person with necessary forms to apply to the concerned Board and also give free access to make telephone calls to the Board to apply for a review of the admission.
CHAPTER XI
Mental Health Review Boards
73. Constitution of Mental Health Review Boards – (1) The State Authority shall, by notification, constitute Boards to be called the Mental Health Review Boards, for the purposes of this Act.
(2) The requisite number, location and the jurisdiction of the Boards shall be specified by the State Authority in consultation with the State Governments concerned.
(3) The constitution of the Boards by the State Authority for a district or group of districts in a State under this section shall be such as may be prescribed by the Central Government.
(4) While making rules under sub-section (3), the Central Government shall have regard to the following, namely:-
(a) the expected or actual workload of the Board in the State in which such Board is to be constituted;
(b) number of mental health establishments existing in the State;
(c) the number of persons with mental illness;
(d) population in the district in which the Board is to be constituted;
(e) geographical and climatic conditions of the district in which the Board is to be constituted.
74. Composition of Board. – (1) Each Board shall consist of-
(a) a District Judge, or an officer of the State judicial services who is qualified to be appointed as District Judge or a retired District Judge who shall be chairperson of the Board;
(b) representative of the District Collector or District Magistrate or Deputy Commissioner of the districts in which the Board is to be constituted;
(c) two members of whom one shall be a psychiatrist and the other shall be a medical practitioner.
(d) two members who shall be persons with mental illness or care-givers or persons representing organisations of persons with mental illness or care-givers or non-governmental organisations working in the field of mental health.
(2) A person shall be disqualified to be appointed as the chairperson or a member of a Board or be removed by the State Authority, if he-
(a) has been convicted and sentenced to imprisonment for an offence which involves moral turpitude; or
(b) is adjudged as an insolvent; or
(c) has been removed or dismissed from the service of the Government or a body corporate owned or controlled by the Government; or
(d) has such financial or other interest as is likely to prejudice the discharge of his functions as a member; or
(e) has such other disqualifications as may be prescribed by the Central Government.
(3) A chairperson or member of a Board may resign his office by notice in writing under his hand addressed to the Chairperson of the State Authority and on such resignation being accepted, the vacancy shall be filled by appointment of a person, belonging to the category under sub-section (1) of section 74.
75. Terms and conditions of service of chairperson and members of Board. – (1) The chairperson and members of the Board shall hold office for a term of five years or up to the age of seventy years, whichever is earlier and shall be eligible for reappointment for another term of five years or up to the age of seventy years whichever is earlier.
(2) The appointment of chairperson and members of every Board shall be made by the Chairperson of the State Authority.
(3) The honorarium and other allowances payable to, and the other terms and conditions of service of, the chairperson and members of the Board shall be such as may be prescribed by the Central Government.
76. Decisions of Authority and Board. – (1) The decisions of the Authority or the Board, as the case may be, shall be by consensus, failing which by a majority of votes of members present and voting and in the event of equality of votes, the president or the chairperson, as the case may be, shall have a second or casting vote.
(2) The quorum of a meeting of the Authority or the Board, as the case may be, shall be three members.
77. Applications to Board. – (1) Any person with mental illness or his nominated representative or a representative of a registered non-governmental organisation, with the consent of such a person, being aggrieved by the decision of any of the mental health establishment or whose rights under this Act have been violated, may make an application to the Board seeking redressal or appropriate relief.
(2) There shall be no fee or charge levied for making such an application.
(3) Every application referred to in sub-section (1) shall contain the name of applicant, his contact details, the details of the violation of his rights, the mental health establishment or any other place where such violation took place and the redressal sought from the Board.
(4) In exceptional circumstances, the Board may accept an application made orally or over telephone from a person admitted to a mental health establishment.
78. Proceedings before Board to be judicial proceedings. – All proceedings before the Board shall be deemed to be judicial proceedings within the meaning of sections 193, 219 and 228 of the Indian Penal Code.
79. Meetings. – The Board shall meet at such times and places and shall observe such rules of procedure in regard to the transaction of business at its meetings as may be specified by regulations made by the Central Authority.
80. Proceedings before Board. – (1) The Board, on receipt of an application under sub-section (1) of section 85, shall, subject to the provisions of this section, endeavour to hear and dispose of the same within a period of ninety days.
(2) The Board shall dispose of an application-
(a) for appointment of nominated representative under clause (d) of sub-section (4) of section 14;
(b) challenging admission of a minor under section 87;
(c) challenging supported admission under sub-section (10) or sub-section (11) of section 89, within a period of seven days from the date of receipt of such applications.
(3) The Board shall dispose of an application challenging supported admission under section 90 within a period of twenty-one days from the date of receipt of the application.
(4) The Board shall dispose of an application, other than an application referred to in sub-section (3), within a period of ninety days from the date of filing of the application.
(5) The proceeding of the Board shall be held in camera.
(6) The Board shall not ordinarily grant an adjournment for the hearing.
(7) The parties to an application may appear in person or be represented by a counsel or a representative of their choice.
(8) In respect of any application concerning a person with mental illness, the Board shall hold the hearings and conduct the proceedings at the mental health establishment where such person is admitted.
(9) The Board may allow any persons other than those directly interested with the application, with the permission of the person with mental illness and the chairperson of the Board, to attend the hearing.
(10) The person with mental illness whose matter is being heard shall have the right to give oral evidence to the Board, if such person desires to do so.
(11) The Board shall have the power to require the attendance and testimony of such other witnesses as it deems appropriate.
(12) The parties to a matter shall have the right to inspect any document relied upon by any other party in its submissions to the Board and may obtain copies of the same.
(13) The Board shall, within five days of the completion of the hearing, communicate its decision to the parties in writing.
(14) Any member who is directly or indirectly involved in a particular case, shall not sit on the Board during the hearings with respect to that case.
81. Central Authority to appoint Expert Committee to prepare guidance document. – (1) The Central Authority shall appoint an Expert Committee to prepare a guidance document for medical practitioners and mental health professionals, containing procedures for assessing, when necessary or the capacity of persons to make mental health care or treatment decisions.
(2) Every medical practitioner and mental health professional shall, while assessing capacity of a person to make mental healthcare or treatment decisions, comply with the guidance document referred to in sub-section (1) and follow the procedure specified therein.
82. Powers and functions of Board. – (1) Subject to the provisions of this Act, the powers and functions of the Board shall, include all or any of the following matters, namely:-
(a) to register, review, alter, modify or cancel an advance directive;
(b) to appoint a nominated representative;
(c) to receive and decide application from a person with mental illness or his nominated representative or any other interested person against the decision of medical officer or mental health professional in charge of mental health establishment or mental health establishment under section 87 or section 89 or section 90;
(d) to receive and decide applications in respect non-disclosure of information specified under sub-section (3) of section 25;
(e) to adjudicate complaints regarding deficiencies in care and services specified under section 28;
(f) to visit and inspect prison or jails and seek clarifications from the medical officer in-charge of health services in such prison or jail.
(2) Where it is brought to the notice of a Board or the Central Authority or State Authority, that a mental health establishment violates the rights of persons with mental illness, the Board or the Authority may conduct an inspection and inquiry and take action to protect their rights.
(3) Notwithstanding anything contained in this Act, the Board, in consultation with the Authority, may take measures to protect the rights of persons with mental illness as it considers appropriate.
(4) If the mental health establishment does not comply with the orders or directions of the Authority or the Board or wilfully neglects such order or direction, the Authority or the Board, as the case may be, may impose penalty which may extend up to five lakh rupees on such mental health establishment and the Authority on its own or on the recommendations of the Board may also cancel the registration of such mental health establishment after giving an opportunity of being heard.
83. Appeal to High Court against order of Authority or Board. – Any person or establishment aggrieved by the decision of the Authority or a Board may, within a period of thirty days from such decision, prefer an appeal to the High Court of the State in which the Board is situated:
Provided that the High Court may entertain an appeal after the expiry of the said period of thirty days, if it is satisfied that the appellant had sufficient cause for not preferring the appeal within the period of thirty days.
84. Grants by Central Government. – (1) The Central Government may, make to the Central Authority grants of such sums of money as the Central Government may think fit for being utilised for the purposes of this Act.
(2) The grants referred to in sub-section (1) shall be applied for,-
(a) meeting the salary, allowances and other remuneration of the chairperson, members, officers and other employees of the Central Authority;
(b) meeting the salary, allowances and other remuneration of the chairperson, members, officers and other employees of the Boards; and
(c) the expenses of the Central Authority and the Boards incurred in the discharge of their functions and for the purposes of this Act.
CHAPTER XII
Admission, Treatment and Discharge
85. Admission of person with mental illness as independent patient in mental health establishment. – (1) For the purposes of this Act, “independent patient or an independent admission” refers to the admission of person with mental illness, to a mental health establishment, who has the capacity to make mental healthcare and treatment decisions or requires minimal support in making decisions.
(2) All admissions in the mental health establishment shall, as far as possible, be independent admissions except when such conditions exist as make supported admission unavoidable.
86. Independent admission and treatment. – (1) Any person, who is not a minor and who considers himself to have a mental illness and desires to be admitted to any mental health establishment for treatment may request the medical officer or mental health professional in charge of the establishment to be admitted as an independent patient.
(2) On receipt of such request under sub-section (1), the medical officer or mental health professional in charge of the establishment shall admit the person to the establishment if the medical officer or mental health professional is satisfied that-
(a) the person has a mental illness of a severity requiring admission to a mental health establishment;
(b) the person with mental illness is likely to benefit from admission and treatment to the mental health establishment;
(c) the person has understood the nature and purpose of admission to the mental health establishment, and has made the request for admission of his own free will, without any duress or undue influence and has the capacity to make mental healthcare and treatment decisions without support or requires minimal support from others in making such decisions.
(3) If a person is unable to understand the purpose, nature, likely effects of proposed treatment and of the probable result of not accepting the treatment or requires a very high level of support approaching hundred per cent. support in making decisions, he or she shall be deemed unable to understand the purpose of the admission and therefore shall not be admitted as independent patient under this section.
(4) A person admitted as an independent patient to a mental health establishment shall be bound to abide by order and instructions or bye-laws of the mental health establishment.
(5) An independent patient shall not be given treatment without his informed consent.
(6) The mental health establishment shall admit an independent patient on his own request, and shall not require the consent or presence of a nominated representative or a relative or care-giver for admitting the person to the mental health establishment.
(7) Subject to the provisions contained in section 88 an independent patient may get himself discharged from the mental health establishment without the consent of the medical officer or mental health professional in charge of such establishment.
87. Admission of minor. – (1) A minor may be admitted to a mental health establishment only after following the procedure laid down in this section.
(2) The nominated representative of the minor shall apply to the medical officer in charge of a mental health establishment for admission of the minor to the establishment.
(3) Upon receipt of such an application, the medical officer or mental health professional in charge of the mental health establishment may admit such a minor to the establishment, if two psychiatrists, or one psychiatrist and one mental health professional or one psychiatrist and one medical practitioner, have independently examined the minor on the day of admission or in the preceding seven days and both independently conclude based on the examination and, if appropriate, on information provided by others, that,-
(a) the minor has a mental illness of a severity requiring admission to a mental health establishment;
(b) admission shall be in the best interests of the minor, with regard to his health, well-being or safety, taking into account the wishes of the minor if ascertainable and the reasons for reaching this decision;
(c) the mental healthcare needs of the minor cannot be fulfilled unless he is admitted; and
(d) all community based alternatives to admission have been shown to have failed or are demonstrably unsuitable for the needs of the minor.
(4) A minor so admitted shall be accommodated separately from adults, in an environment that takes into account his age and developmental needs and is at least of the same quality as is provided to other minors admitted to hospitals for other medical treatments.
(5) The nominated representative or an attendant appointed by the nominated representative shall under all circumstances stay with the minor in the mental health establishment for the entire duration of the admission of the minor to the mental health establishment.
(6) In the case of minor girls, where the nominated representative is male, a female attendant shall be appointed by the nominated representative and under all circumstances shall stay with the minor girl in the mental health establishment for the entire duration of her admission.
(7) A minor shall be given treatment with the informed consent of his nominated representative.
(8) If the nominated representative no longer supports admission of the minor under this section or requests discharge of the minor from the mental health establishment, the minor shall be discharged by the mental health establishment.
(9) Any admission of a minor to a mental health establishment shall be informed by the medical officer or mental health professional in charge of the mental health establishment to the concerned Board within a period of seventy-two hours.
(10) The concerned Board shall have the right to visit and interview the minor or review the medical records if the Board desires to do so.
(11) Any admission of a minor which continues for a period of thirty days shall be immediately informed to the concerned Board.
(12) The concerned Board shall carry out a mandatory review within a period of seven days of being informed, of all admissions of minors continuing beyond thirty days and every subsequent thirty days.
(13) The concerned Board shall at minimum, review the clinical records of the minor and may interview the minor if necessary.
88. Discharge of independent patients. – (1) The medical officer or mental health professional in charge of a mental health establishment shall discharge from the mental health establishment any person admitted under section 86 as an independent patient immediately on request made by such person or if the person disagrees with his admission under section 86 subject to the provisions of sub-section (3).
(2) Where a minor has been admitted to a mental health establishment under section 87 and attains the age of eighteen years during his stay in the mental health establishment, the medical officer in charge of the mental health establishment shall classify him as an independent patient under section 86 and all provisions of this Act as applicable to independent patient who is not minor, shall apply to such person.
(3) Notwithstanding anything contained in this Act, a mental health professional may prevent discharge of a person admitted as an independent person under section 86 for a period of twenty-four hours so as to allow his assessment necessary for admission under section 89 if the mental health professional is of the opinion that-
(a) such person is unable to understand the nature and purpose of his decisions and requires substantial or very high support from his nominated representative; or
(b) has recently threatened or attempted or is threatening or attempting to cause bodily harm to himself; or
(c) has recently behaved or is behaving violently towards another person or has caused or is causing another person to fear bodily harm from him; or
(d) has recently shown or is showing an inability to care for himself to a degree that places the individual at risk of harm to himself.
(4) The person referred to in sub-section (3) shall be either admitted as a supported patient under section 89, or discharged from the establishment within a period of twenty-four hours or on completion of assessments for admission for a supported patient under section 89, whichever is earlier.
89. Admission and treatment of persons with mental illness, with high support needs, in mental health establishment, up to thirty days (supported admission). – (1) The medical officer or mental health professional in charge of a mental health establishment shall admit every such person to the establishment, upon application by the nominated representative of the person, under this section, if-
(a) the person has been independently examined on the day of admission or in the preceding seven days, by one psychiatrist and the other being a mental health professional or a medical practitioner, and both independently conclude based on the examination and, if appropriate, on information provided by others, that the person has a mental illness of such severity that the person,-
(i) has recently threatened or attempted or is threatening or attempting to cause bodily harm to himself; or
(ii) has recently behaved or is behaving violently towards another person or has caused or is causing another person to fear bodily harm from him; or
(iii) has recently shown or is showing an inability to care for himself to a degree that places the individual at risk of harm to himself;
(b) the psychiatrist or the mental health professionals or the medical practitioner, as the case may be, certify, after taking into account an advance directive, if any, that admission to the mental health establishment is the least restrictive care option possible in the circumstances; and
(c) the person is ineligible to receive care and treatment as an independent patient because the person is unable to make mental healthcare and treatment decisions independently and needs very high support from his nominated representative in making decisions.
(2) The admission of a person with mental illness to a mental health establishment under this section shall be limited to a period of thirty days.
(3) At the end of the period mentioned under sub-section (2), or earlier, if the person no longer meets the criteria for admission as stated in sub-section (1), the patient shall no longer remain in the establishment under this section.
(4) On the expiry of the period of thirty days referred to in sub-section (2), the person may continue to remain admitted in the mental health establishment in accordance with the provisions of section 90.
(5) If the conditions under section 90 are not met, the person may continue to remain in the mental health establishment as an independent patient under section 86 and the medical officer or mental health professional in charge of the mental health establishment shall inform the person of his admission status under this Act, including his right to leave the mental health establishment.
(6) Every person with mental illness admitted under this section shall be provided treatment after taking into account,-
(a) an advance directive if any; or
(b) informed consent of the patient with the support of his nominated representative subject to the provisions of sub-section (7).
(7) If a person with the mental illness admitted under this section requires nearly hundred per cent. support from his nominated representative in making a decision in respect of his treatment, the nominated representative may temporarily consent to the treatment plan of such person on his behalf.
(8) In case where consent has been given under sub-section (7), the medical officer or mental health professional in charge of the mental health establishment shall record such consent in the medical records and review the capacity of the patient to give consent every seven days.
(9) The medical officer or mental health professional in charge of the mental health establishment shall report the concerned Board,-
(a) within three days the admissions of a woman or a minor;
(b) within seven days the admission of any person not being a woman or minor.
(10) A person admitted under this section or his nominated representative or a representative of a registered non-governmental organisation with the consent of the person, may apply to the concerned Board for review of the decision of the medical officer or mental health professional in charge of the mental health establishment to admit the person to the mental health establishment under this section.
(11) The concerned Board shall review the decision of the medical officer or mental health professional in charge of the mental health establishment and give its findings thereon within seven days of receipt of request for such review which shall be binding on all the concerned parties.
(12) Notwithstanding anything contained in this Act, it shall be the duty of the medical officer or mental health professional in charge of the mental health establishment to keep the condition of the person with mental illness admitted under this section on going review.
(13) If the medical officer or mental health professional in charge of the mental health establishment is of the opinion that the conditions specified under sub-section (1) are no longer applicable, he shall terminate the admission under this section, and inform the person and his nominated representative accordingly.
(14) Non applicability of conditions referred to in sub-section (13) shall not preclude the person with mental illness remaining as an independent patient.
(15) In a case, a person with the mental illness admitted under this section has been discharged, such person shall not be readmitted under this section within a period of seven days from the date of his discharge.
(16) In case a person referred to in sub-section (15) requires readmission within a period of seven days referred to in that sub-section, such person shall be considered for readmission in accordance with the provisions of section 90.
(17) If the medical officer or mental health professional in charge of the mental health establishment is of the opinion that the person with mental illness admitted under this section in the mental health establishment requires or is likely to require further treatment beyond the period of thirty days, then such medical officer or mental health professional shall be duty bound to refer the matter to be examined by two psychiatrists for his admission beyond thirty days.
90. Admission and treatment of persons with mental illness, with high support needs, in mental health establishment, beyond thirty days (supported admission beyond thirty days). – (1) If a person with mental illness admitted under section 89 requires continuous admission and treatment beyond thirty days or a person with mental illness discharged under sub-section (15) of that section requires readmission within seven days of such discharge, he shall be admitted in accordance with the provisions of this section.
(2) The medical officer or mental health professional in charge of a mental health establishment, upon application by the nominated representative of a person with mental illness, shall continue admission of such person with mental illness, if-
(a) two psychiatrists have independently examined the person with mental illness in the preceding seven days and both independently conclude based on the examination and, on information provided by others that the person has a mental illness of a severity that the person-
(i) has consistently over time threatened or attempted to cause bodily harm to himself; or
(ii) has consistently over time behaved violently towards another person or has consistently over time caused another person to fear bodily harm from him; or
(iii) has consistently over time shown an inability to care for himself to a degree that places the individual at risk of harm to himself;
(b) both psychiatrists, after taking into account an advance directive, if any, certify that admission to a mental health establishment is the least restrictive care option possible under the circumstances; and
(c) the person continues to remain ineligible to receive care and treatment as a independent patient as the person cannot make mental healthcare and treatment decisions independently and needs very high support from his nominated representative, in making decisions.
(3) The medical officer or mental health professional in charge of the mental health establishment shall report all admissions or readmission under this section, within a period of seven days of such admission or readmission, to the concerned Board.
(4) The Board shall, within a period of twenty-one days from the date of last admission or readmission of person with mental illness under this section, permit such admission or readmission or order discharge of such person.
(5) While permitting admission or readmission or ordering discharge of such person under sub-section (4), the Board shall examine-
(a) the need for institutional care to such person;
(b) whether such care cannot be provided in less restrictive settings based in the community.
(6) In all cases of application for readmission or continuance of admission of a person with mental illness in the mental health establishment under this section, the Board may require the medical officer or psychiatrist in charge of treatment of such person with mental illness to submit a plan for community based treatment and the progress made, or likely to be made, towards realising this plan.
(7) The person referred to in sub-section (4) shall not be permitted to continue in the mental health establishment in which he had been admitted or his readmission in such establishment merely on the ground of non-existence of community based services at the place where such person ordinarily resides.
(8) The admission of a person with mental illness to a mental health establishment under this section shall be limited to a period up to ninety days in the first instance.
(9) The admission of a person with mental illness to a mental health establishment under this section beyond the period of ninety days may be extended for a period of one hundred and twenty days at the first instance and thereafter for a period of one hundred and eighty days each time after complying with the provisions of sub-sections (1) to (7).
(10) If the Board refuses to permit admission or continuation thereof or readmission under sub-section (9), or on the expiry of the periods referred to in sub-section (9) or earlier if such person no longer falls within the criteria for admission under sub-section (1), such person shall be discharged from such mental health establishment.
(11) Every person with mental illness admitted under this section shall be provided treatment, after taking into account-
(a) an advance directive; or
(b) informed consent of the person with the support from his nominated representative subject to the provision of sub-section (12).
(12) If a person with mental illness admitted under this section, requires nearly hundred per cent. support from his nominated representative, in making decision in respect of his treatment, the nominated representative may temporarily consent to the treatment plan of such person on his behalf.
(13) In a case where consent has been given under sub-section (12), the medical officer or mental health professional in charge of the mental health establishment shall record such consent in the medical records of such person with mental illness and review on the expiry of every fortnight, the capacity of such person to give consent.
(14) A person with mental illness admitted under this section, or his nominated representative or a representative of a registered non-governmental organisation with the consent of the person, may apply to the concerned Board for review of the decision of the medical officer or mental health professional in charge of medical health establishment to admit such person in such establishment and the decision of the Board thereon shall be binding on all parties.
(15) Notwithstanding anything contained in this Act, if the medical officer or mental health professional in charge of the mental health establishment is of the opinion that the conditions under sub-section (1) are no longer applicable, such medical officer or mental health professional shall discharge such person from such establishment and inform such person and his nominated representative accordingly.
(16) The person with mental illness referred to in sub-section (15) may continue to remain in the mental health establishment as an independent patient.
91. Leave of absence. – The medical officer or mental health professional in charge of the mental health establishment may grant leave to any person with mental illness admitted under section 87 or section 89 or section 90, to be absent from the establishment subject to such conditions, if any, and for such duration as such medical officer or psychiatrist may consider necessary.
92. Absence without leave or discharge. – If any person to whom section 103 applies absents himself without leave or without discharge from the mental health establishment, he shall be taken into protection by any Police Officer at the request of the medical officer or mental health professional in-charge of the mental health establishment and shall be sent back to the mental health establishment immediately.
93. Transfer of persons with mental illness from one mental health establishment to another mental health establishment. – (1) A person with mental illness admitted to a mental health establishment under section 87 or section 89 or section 90 or section 103, as the case may be, may subject to any general or special order of the Board be removed from such mental health establishment and admitted to another mental health establishment within the State or with the consent of the Central Authority to any mental health establishment in any other State:
Provided that no person with mental illness admitted to a mental health establishment under an order made in pursuance of an application made under this Act shall be so removed unless intimation and reasons for the transfer have been given to the person with mental illness and his nominated representative.
(2) The State Government may make such general or special order as it thinks fit directing the removal of any prisoner with mental illness from the place where he is for the time being detained, to any mental health establishment or other place of safe custody in the State or to any mental health establishment or other place of safe custody in any other State with the consent of the Government of that other State.
94. Emergency treatment. – (1) Notwithstanding anything contained in this Act, any medical treatment, including treatment for mental illness, may be provided by any registered medical practitioner to a person with mental illness either at a health establishment or in the community, subject to the informed consent of the nominated representative, where the nominated representative is available, and where it is immediately necessary to prevent-
(a) death or irreversible harm to the health of the person; or
(b) the person inflicting serious harm to himself or to others; or
(c) the person causing serious damage to property belonging to himself or to others where such behaviour is believed to flow directly from the person’s mental illness.
Explanation. – For the purposes of this section, “emergency treatment” includes transportation of the person with mental illness to a nearest mental health establishment for assessment.
(2) Nothing in this section shall allow any medical officer or psychiatrist to give to the person with mental illness medical treatment which is not directly related to the emergency treatment specified under sub-section (1).
(3) Nothing in this section shall allow any medical officer or psychiatrist to use electroconvulsive therapy as a form of treatment.
(4) The emergency treatment referred to in this section shall be limited to seventy-two hours or till the person with mental illness has been assessed at a mental health establishment, whichever is earlier:
Provided that during a disaster or emergency declared by the appropriate Government, the period of emergency treatment referred to in this sub-section may extend up to seven days.
95. Prohibited procedures. – (1) Notwithstanding anything contained in this Act, the following treatments shall not be performed on any person with mental illness-
(a) electro-convulsive therapy without the use of muscle relaxants and anaesthesia;
(b) electro-convulsive therapy for minors;
(c) sterilisation of men or women, when such sterilisation is intended as a treatment for mental illness;
(d) chained in any manner or form whatsoever.
(2) Notwithstanding anything contained in sub-section (1), if, in the opinion of psychiatrist in charge of a minor’s treatment, electro-convulsive therapy is required, then, such treatment shall be done with the informed consent of the guardian and prior permission of the concerned Board.
96. Restriction on psychosurgery for persons with mental illness. – (1) Notwithstanding anything contained in this Act, psychosurgery shall not be performed as a treatment for mental illness unless-
(a) the informed consent of the person on whom the surgery is being performed; and
(b) approval from the concerned Board to perform the surgery, has been obtained.
(2) The Central Authority may make regulations for the purpose of carrying out the provisions of this section.
97. Restraints and seclusion. – (1) A person with mental illness shall not be subjected to seclusion or solitary confinement, and, where necessary, physical restraint may only be used when,-
(a) it is the only means available to prevent imminent and immediate harm to person concerned or to others;
(b) it is authorised by the psychiatrist in charge of the person’s treatment at the mental health establishment.
(2) Physical restraint shall not be used for a period longer than it is absolutely necessary to prevent the immediate risk of significant harm.
(3) The medical officer or mental health professional in charge of the mental health establishment shall be responsible for ensuring that the method, nature of restraint justification for its imposition and the duration of the restraint are immediately recorded in the person’s medical notes.
(4) The restraint shall not be used as a form of punishment or deterrent in any circumstance and the mental health establishment shall not use restraint merely on the ground of shortage of staff in such establishment.
(5) The nominated representative of the person with mental illness shall be informed about every instance of restraint within a period of twenty-four hours.
(6) A person who is placed under restraint shall be kept in a place where he can cause no harm to himself or others and under regular ongoing supervision of the medical personnel at the mental health establishment.
(7) The mental health establishment shall include all instances of restraint in the report to be sent to the concerned Board on a monthly basis.
(8) The Central Authority may make regulations for the purpose of carrying out the provisions of this section.
(9) The Board may order a mental health establishment to desist from applying restraint if the Board is of the opinion that the mental health establishment is persistently and wilfully ignoring the provisions of this section.
98. Discharge planning. – (1) Whenever a person undergoing treatment for mental illness in a mental health establishment is to be discharged into the community or to a different mental health establishment or where a new psychiatrist is to take responsibility of the person’s care and treatment, the psychiatrist who has been responsible for the person’s care and treatment shall consult with the person with mental illness, the nominated representative, the family member or care-giver with whom the person with mental illness shall reside on discharge from the hospital, the psychiatrist expected to be responsible for the person’s care and treatment in the future, and such other persons as may be appropriate, as to what treatment or services would be appropriate for the person.
(2) The psychiatrist responsible for the person’s care shall in consultation with the persons referred to in sub-section (1) ensure that a plan is developed as to how treatment or services shall be provided to the person with mental illness.
(3) The discharge planning under this section shall apply to all discharges from a mental health establishment.
99. Research. – (1) The professionals conducting research shall obtain free and informed consent from all persons with mental illness for participation in any research involving interviewing the person or psychological, physical, chemical or medicinal interventions.
(2) In case of research involving any psychological, physical, chemical or medicinal interventions to be conducted on person who is unable to give free and informed consent but does not resist participation in such research, permission to conduct such research shall be obtained from concerned State Authority.
(3) The State Authority may allow the research to proceed based on informed consent being obtained from the nominated representative of persons with mental illness, if the State Authority is satisfied that-
(a) the proposed research cannot be performed on persons who are capable of giving free and informed consent;
(b) the proposed research is necessary to promote the mental health of the population represented by the person;
(c) the purpose of the proposed research is to obtain knowledge relevant to the particular mental health needs of persons with mental illness;
(d) a full disclosure of the interests of persons and organisations conducting the proposed research is made and there is no conflict of interest involved; and
(e) the proposed research follows all the national and international guidelines and regulations concerning the conduct of such research and ethical approval has been obtained from the institutional ethics committee where such research is to be conducted.
(4) The provisions of this section shall not restrict research based study of the case notes of a person who is unable to give informed consent, so long as the anonymity of the persons is secured.
(5) The person with mental illness or the nominated representative who gives informed consent for participation in any research under this Act may withdraw the consent at any time during the period of research.
CHAPTER XIII
Responsibilities of other Agencies
100. Duties of police officers in respect of persons with mental illness. – (1) Every officer in-charge of a police station shall have a duty-
(a) to take under protection any person found wandering at large within the limits of the police station whom the officer has reason to believe has mental illness and is incapable of taking care of himself; or
(b) to take under protection any person within the limits of the police station whom the officer has reason to believe to be a risk to himself or others by reason of mental illness.
(2) The officer in-charge of a police station shall inform the person who has been taken into protection under sub-section (1), the grounds for taking him into such protection or his nominated representative, if in the opinion of the officer such person has difficulty in understanding those grounds.
(3) Every person taken into protection under sub-section (1) shall be taken to the nearest public health establishment as soon as possible but not later than twenty-four hours from the time of being taken into protection, for assessment of the person’s healthcare needs.
(4) No person taken into protection under sub-section (1) shall be detained in the police lock up or prison in any circumstances.
(5) The medical officer in-charge of the public health establishment shall be responsible for arranging the assessment of the person and the needs of the person with mental illness will be addressed as per other provisions of this Act as applicable in the particular circumstances.
(6) The medical officer or mental health professional in-charge of the public mental health establishment if on assessment of the person finds that such person does not have a mental illness of a nature or degree requiring admission to the mental health establishment, he shall inform his assessment to the police officer who had taken the person into protection and the police officer shall take the person to the person’s residence or in case of homeless persons, to a Government establishment for homeless persons.
(7) In case of a person with mental illness who is homeless or found wandering in the community, a First Information Report of a missing person shall be lodged at the concerned police station and the station house officer shall have a duty to trace the family of such person and inform the family about the whereabouts of the person.
101. Report to Magistrate of person with mental illness in private residence who is ill-treated or neglected. – (1) Every officer in-charge of a police station, who has reason to believe that any person residing within the limits of the police station has a mental illness and is being illtreated or neglected, shall forthwith report the fact to the Magistrate within the local limits of whose jurisdiction the person with mental illness resides.
(2) Any person who has reason to believe that a person has mental illness and is being ill-treated or neglected by any person having responsibility for care of such person, shall report the fact to the police officer in-charge of the police station within whose jurisdiction the person with mental illness resides.
(3) If the Magistrate has reason to believe based on the report of a police officer or otherwise, that any person with mental illness within the local limits of his jurisdiction is being ill-treated or neglected, the Magistrate may cause the person with mental illness to be produced before him and pass an order in accordance with the provisions of section 102.
102. Conveying or admitting person with mental illness to mental health establishment by Magistrate. – (1) When any person with mental illness or who may have a mental illness appears or is brought before a Magistrate, the Magistrate may, order in writing-
(a) that the person is conveyed to a public mental health establishment for assessment and treatment, if necessary and the mental health establishment shall deal with such person in accordance with the provisions of the Act; or
(b) to authorise the admission of the person with mental illness in a mental health establishment for such period not exceeding ten days to enable the medical officer or mental health professional in charge of the mental health establishment to carry out an assessment of the person and to plan for necessary treatment, if any.
(2) On completion of the period of assessment referred to in sub-section (1), the medical officer or mental health professional in charge of the mental health establishment shall submit a report to the Magistrate and the person shall be dealt with in accordance with the provisions of this Act.
103. Prisoners with mental illness. – (1) An order under section 30 of the Prisoners Act, 1900 or under section 144 of the Air Force Act, 1950, or under section 145 of the Army Act, 1950, or under section 143 or section 144 of the Navy Act, 1957, or under section 330 or section 335 of the Code of Criminal Procedure, 1973, directing the admission of a prisoner with mental illness into any suitable mental health establishment, shall be sufficient authority for the admission of such person in such establishment to which such person may be lawfully transferred for care and treatment therein:
Provided that transfer of a prisoner with mental illness to the psychiatric ward in the medical wing of the prison shall be sufficient to meet the requirements under this section:
Provided further that where there is no provision for a psychiatric ward in the medical wing, the prisoner may be transferred to a mental health establishment with prior permission of the Board.
(2) The method, modalities and procedure by which the transfer of a prisoner under this section is to be effected shall be such as may be prescribed.
(3) The medical officer of a prison or jail shall send a quarterly report to the concerned Board certifying therein that there are no prisoners with mental illness in the prison or jail.
(4) The Board may visit the prison or jail and ask the medical officer as to why the prisoner with mental illness, if any, has been kept in the prison or jail and not transferred for treatment to a mental health establishment.
(5) The medical officer in-charge of a mental health establishment wherein any person referred to in sub-section (1) is detained, shall once in every six months, make a special report regarding the mental and physical condition of such person to the authority under whose order such person is detained.
(6) The appropriate Government shall setup mental health establishment in the medical wing of at least one prison in each State and Union territory and prisoners with mental illness may ordinarily be referred to and cared for in the said mental health establishment.
(7) The mental health establishment setup under sub-section (5) shall be registered under this Act with the Central or State Mental Health Authority, as the case may be, and shall conform to such standards and procedures as may be prescribed.
104. Persons in custodial institutions. – (1) If it appears to the person in-charge of a State run custodial institution (including beggars homes, orphanages, women’s protection homes and children homes) that any resident of the institution has, or is likely to have, a mental illness, then, he shall take such resident of the institution to the nearest mental health establishment run or funded by the appropriate Government for assessment and treatment, as necessary.
(2) The medical officer in-charge of a mental health establishment shall be responsible for assessment of the person with mental illness, and the treatment required by such persons shall be decided in accordance with the provisions of this Act.
105. Question of mental illness in judicial process. – If during any judicial process before any competent court, proof of mental illness is produced and is challenged by the other party, the court shall refer the same for further scrutiny to the concerned Board and the Board shall, after examination of the person alleged to have a mental illness either by itself or through a committee of experts, submit its opinion to the court.
CHAPTER XIV
Restriction to Discharge Functions by Professionals not Covered by Profession
106. Restriction to discharge functions by professionals not covered by profession. – No mental health professional or medical practitioner shall discharge any duty or perform any function not authorised by this Act or specify or recommend any medicine or treatment not authorised by the field of his profession.
CHAPTER XV
Offences and Penalties
107. Penalties for establishing or maintaining mental health establishment in contravention of provisions of this Act. – (1) Whoever carries on a mental health establishment without registration shall be liable to a penalty which shall not be less than five thousand rupees but which may extend to fifty thousand rupees for first contravention or a penalty which shall not be less than fifty thousand rupees but which may extend to two lakh rupees for a second contravention or a penalty which shall not be less than two lakh rupees but which may extend to five lakh rupees for every subsequent contravention.
(2) Whoever knowingly serves in the capacity as a mental health professional in a mental health establishment which is not registered under this Act, shall be liable to a penalty which may extend to twenty-five thousand rupees.
(3) Save as otherwise provided in this Act, the penalty under this section shall be adjudicated by the State Authority.
(4) Whoever fails to pay the amount of penalty, the State Authority may forward the order to the Collector of the district in which such person owns any property or resides or carries on his business or profession or where the mental health establishment is situated, and the Collector shall recover from such persons or mental health establishment the amount specified thereunder, as if it were an arrear of land revenue.
(5) All sums realised by way of penalties under this Chapter shall be credited to the Consolidated Fund of India.
108. Punishment for contravention of provisions of the Act or rules or regulations made thereunder. – Any person who contravenes any of the provisions of this Act, or of any rule or regulation made thereunder shall for first contravention be punishable with imprisonment for a term which may extend to six months, or with a fine which may extend to ten thousand rupees or with both, and for any subsequent contravention with imprisonment for a term which may extend to two years or with fine which shall not be less than fifty thousand rupees but which may extend to five lakh rupees or with both.
109. Offences by companies. – (1) Where an offence under this Act has been committed by a company, every person who at the time the offence was committed was in-charge of, and was responsible to, the company for the conduct of the business of the company, as well as the company, shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly:
Provided that nothing contained in this sub-section shall render any such person liable to any punishment provided in this Act, if he proves that the offence was committed without his knowledge or that he has exercised all due diligence to prevent the commission of such offence.
(2) Notwithstanding anything contained in sub-section (1), where an offence under this Act has been committed by a company and it is proved that the offence has been committed with the consent or connivance of, or is attributable to, any neglect on the part of any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall also be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly.
Explanation. – For the purposes of this section,-
(a) “company” means any body corporate and includes a firm or other association of individuals; and
(b) “director”, in relation to a firm, means a partner in the firm.
CHAPTER XVI
Miscellaneous
110. Power to call for information. – (1) The Central Government may, by a general or special order, call upon the Authority or the Board to furnish, periodically or as and when required any information concerning the activities carried on by the Authority or the Board, as the case may be, in such form as may be prescribed, to enable that Government, to carry out the purposes of this Act.
(2) The State Government may, by a general or special order, call upon the State Authority or the Board to furnish, periodically or as and when required any information concerning the activities carried on by the State Authority or the Board in such form as may be prescribed, to enable that Government, to carry out the purposes of this Act.
111. Power of Central Government to issue directions. – (1) Without prejudice to the foregoing provisions of this Act, the Authority shall, in exercise of its powers or the performance of its functions under this Act, be bound by such directions on questions of policy, other than those relating to technical and administrative matters, as the Central Government may give in writing to it from time to time:
Provided that the Authority shall, as far as practicable, be given an opportunity to express its views before any direction is given under this sub-section.
(2) The decision of the Central Government whether a question is one of policy or not shall be final.
112. Power of Central Government to supersede Central Authority. – (1) If at any time the Central Government is of the opinion-
(a) that on account of circumstances beyond the control of the Central Authority, it is unable to discharge the functions or perform the duties imposed on it by or under the provisions of this Act; or
(b) that the Central Authority has persistently defaulted in complying with any direction given by the Central Government under this Act or in the discharge of the functions or performance of the duties imposed on it by or under the provisions of this Act; or
(c) that circumstances exist which render it necessary in the public interest so to do, the Central Government may, by notification and for reasons to be specified therein, supersede the Central Authority for such period, not exceeding six months, as may be specified in the notification:
Provided that before issuing any such notification, the Central Government shall give a reasonable opportunity to the Central Authority to make representations against the proposed supersession and shall consider representations, if any, of the Central Authority.
(2) Upon the publication of a notification under sub-section (1), superseding the Central Authority,-
(a) the chairperson and other members shall, as from the date of supersession, vacate their offices as such;
(b) all the powers, functions and duties which may, by or under the provisions of this Act, be exercised or discharged by or on behalf of the Central Authority shall, until the Central Authority is reconstituted under sub-section (3), be exercised and discharged by the Central Government or such authority as the Central Government may specify in this behalf;
(c) all properties owned or controlled by the Central Authority shall, until the Central Authority is reconstituted under sub-section (3), vest in the Central Government.
(3) On or before the expiration of the period of supersession specified in the notification issued under sub-section (1), the Central Government shall reconstitute the Central Authority by a fresh appointment of its chairperson and other members and in such case any person who had vacated his office under clause (a) of sub-section (2) shall not be deemed to be disqualified for re-appointment.
(4) The Central Government shall cause a notification issued under sub-section (1) and a full report of any action taken under this section and the circumstances leading to such action to be laid before each House of Parliament at the earliest.
113. Power of State Government to supersede State Authority. – (1) If at any time the State Government is of the opinion-
(a) that on account of circumstances beyond the control of the State Authority, it is unable to discharge the functions or perform the duties imposed on it by or under the provisions of this Act; or
(b) that the State Authority has persistently defaulted in complying with any direction given by the State Government under this Act or in the discharge of the functions or performance of the duties imposed on it by or under the provisions of this Act; or
(c) that circumstances exist which render it necessary in the public interest so to do, the State Government may, by notification and for reasons to be specified therein, supersede the State Authority for such period, not exceeding six months, as may be specified in the notification:
Provided that before issuing any such notification, the State Government shall give a reasonable opportunity to the State Authority to make representations against the proposed supersession and shall consider representations, if any, of the State Authority.
(2) Upon the publication of a notification under sub-section (1) superseding the State Authority,-
(a) the chairperson and other members shall, as from the date of supersession, vacate their offices as such;
(b) all the powers, functions and duties which may, by or under the provisions of this Act, be exercised or discharged by or on behalf of the State Authority shall, until the State Authority is reconstituted under sub-section (3), be exercised and discharged by the State Government or such authority as the State Government may specify in this behalf;
(c) all properties owned or controlled by the State Authority shall, until the State Authority is reconstituted under sub-section (3), vest in the State Government.
(3) On or before the expiration of the period of supersession specified in the notification issued under sub-section (1), the State Government shall reconstitute the State Authority by a fresh appointment of its chairperson and other members and in such case any person who had vacated his office under clause (a) of sub-section (2) shall not be deemed to be disqualified for re-appointment.
(4) The State Government shall cause a notification issued under sub-section (1) and a full report of any action taken under this section and the circumstances leading to such action to be laid before the State Legislature at the earliest.
114. Special provisions for States in north-east and hill States. – (1) Notwithstanding anything contained in this Act, the provisions of this Act shall, taking into consideration the communication, travel and transportation difficulties, apply to the States of Assam, Meghalaya, Tripura, Mizoram, Manipur, Nagaland, Arunachal Pradesh and Sikkim, with following modifications, namely:-
(a) under sub-section (3) of section 73, the chairperson of the Central Authority may constitute one or more Boards for all the States;
(b) in sub-section (2) of section 80, reference to the period of “seven days”, and in sub-section (3) of that section, reference to the period of “twenty-one days” shall be construed as “ten days” and “thirty days”, respectively;
(c) in sub-section (9) of section 87, reference to the period of “seventy-two hours” shall be construed as “one hundred twenty hours”, and in sub-sections (3) and (12) of that section, reference to a period of “seven days” shall be construed as “ten days”;
(d) in sub-section (3) of section 88, reference to the period of “twenty-four hours” shall be construed as “seventy-two hours”;
(e) in clauses (a) and (b) of sub-section (9) of section 89, reference to the period of “three days” and “seven days” shall be construed as “seven days” and “ten days” respectively;
(f) in sub-section (3) of section 90, reference to the period of “seven days” and in sub-section (4) of that section, reference to the period of “twenty-one days” shall be construed as “ten days” and “thirty days” respectively;
(g) in sub-section (4) of section 94, reference to the period of “seventy-two hours” shall be construed as “one hundred twenty hours”.
(2) The provisions of clauses (b) to (g) of sub-section (1) shall also apply to the States of Uttarakhand, Himachal Pradesh and Jammu and Kashmir and the Union territories of Lakshadweep and Andaman and Nicobar Islands.
(3) The provisions of this section shall cease to have effect on the expiry of a period of ten years from the commencement of this Act, except as respects things done or omitted to be done before such cesser, and upon such cesser section 6 of the General Clauses Act, 1897, shall apply as if this Act had then been repealed by a Central Act.
115. Presumption of severe stress in case of attempt to commit suicide. – (1) Notwithstanding anything contained in section 309 of the Indian Penal Code any person who attempts to commit suicide shall be presumed, unless proved otherwise, to have severe stress and shall not be tried and punished under the said Code.
(2) The appropriate Government shall have a duty to provide care, treatment and rehabilitation to a person, having severe stress and who attempted to commit suicide, to reduce the risk of recurrence of attempt to commit suicide.
116. Bar of jurisdiction. – No civil court shall have jurisdiction to entertain any suit or proceeding in respect of any matter which the Authority or the Board is empowered by or under this Act to determine, and no injunction shall be granted by any court or other authority in respect of any action taken or to be taken in pursuance of any power conferred by or under this Act.
117. Transitory provisions. – The Central Government may, if it considers so necessary in the interest of persons with mental illness being governed by the Mental Health Act, 1987, take appropriate interim measures by making necessary transitory schemes.
118. Chairperson, members and staff of Authority and Board to be public servants. – The chairperson, and other members and the officers and other employees of the Authority and Board shall be deemed to be public servants within the meaning of section 21 of the Indian Penal Code.
119. Protection of action taken in good faith. – No suit, prosecution or other legal proceeding shall lie against the appropriate Government or against the chairperson or any other member of the Authority or the Board, as the case may be, for anything which is in good faith done or intended to be done in pursuance of this Act or any rule or regulation made thereunder in the discharge of official duties.
120. Act to have overriding effect. – The provisions of this Act shall have overriding effect notwithstanding anything inconsistent therewith contained in any other law for the time being in force or in any instrument having effect by virtue of any law other than this Act.
121. Power of Central Government and State Governments to make rules. – (1) The Central Government may, by notification, make rules for carrying out the provisions of this Act.
(2) Subject to the provisions of sub-section (1), the State Government may, with the previous approval of the Central Government, by notification, make rules for carrying out the provisions of this Act:
Provided that the first rules shall be made by the Central Government, by notification.
(3) In particular, and without prejudice to the generality of the foregoing power, rules made under sub-section (1) may provide for all or any of the following matters, namely:-
(a) qualifications relating to clinical psychologist under sub-clause (ii) of clause (f) of sub-section (1) of section 2;
(b) qualifications relating to psychiatric social worker under clause (w) of sub-section (1) of section 2;
(c) the manner of nomination of members of the Central Authority under sub-section (2) of section 34;
(d) the salaries and allowances payable to, and the other terms and conditions of service of, the chairperson and other members of the Central Authority under sub-section (3) of section 35;
(e) the procedure for registration (including the fees to be levied for such registration) of the mental health establishments under sub-section (2) of section 43;
(f) the manner of nomination of members of the State Authority under sub-section (2) of section 46;
(g) the salaries and allowances payable to, and the other terms and conditions of service of, the chairperson and other members of the State Authority under sub-section (3) of section 47;
(h) the procedure for registration (including the fees to be levied for such registration) of the mental health establishments under sub-section (2) of section 55;
(i) the form of accounts and other relevant records and annual statement of accounts under sub-section (1) of section 59;
(j) the form in, and the time within which, an annual report shall be prepared under section 60;
(k) the form of accounts and other relevant records and annual statement of accounts under sub-section (1) of section 63;
(l) the form in, and the time within which, an annual report shall be prepared under section 64;
(m) manner of constitution of the Board by the State Authority for a district or groups of districts in a State;
(n) other disqualifications of chairperson or members of the Board under clause (e) of sub-section (2) of section 82;
(o) any other matter which is required to be, or may be, specified by rules or in respect for which provision is to be made by rules.
(4) In particular, and without prejudice to the generality of the foregoing power, rules made under sub-section (2) may provide for all or any of the following matters, namely:-
(a) the manner of proof of mental healthcare and treatment under sub-section (1) of section 4;
(b) provision of half-way homes, sheltered accommodation and supported accommodation under clause (b) of sub-section (4) of section 18;
(c) hospitals and community based rehabilitation establishment and services under clause (d) of sub-section (4) of section 18;
(d) basic medical records of which access is to be given to a person with mental illness under sub-section (1) of section 25;
(e) custodial institutions under sub-section (2) of section 27;
(f) the form of application to be submitted by the mental health establishment with the undertaking that the mental health establishment fulfils the minimum standards, if any, specified by the Authority, under the Explanation to sub-section (2) of section 65;
(g) the form of certificate of registration under sub-section (3) of section 65;
(h) the form of application, the details, the fees to be accompanied with it under sub-section (1) of section 66;
(i) the form of certificate of provisional registration containing particulars and information under sub-section (4) of section 66;
(j) the fees for renewal of registration under sub-section (11) of section 66;
(k) the person or persons (including representatives of the local community) for the purpose of conducting an audit of the registered mental health establishments under sub-section (1) and fees to be charged by the Authority for conducting such audit under sub-section (2) of section 67;
(l) the person or persons for the purpose of conducting and inspection or inquiry of the mental health establishments under sub-section (1) of section 68;
(m) the manner to enter and search of a mental health establishment operating without registration under sub-section (6) of section 68;
(n) the fees for issuing a duplicate certificate under sub-section (2) of section 70;
(o) the form and manner in which the Authority shall maintain in digital format a register of mental health establishments, the particulars of the certificate of registration so granted in a separate register to be maintained under section 71;
(p) constitution of the Boards under sub-section (3) of section 73;
(q) the honorarium and other allowances payable to, and the other terms and conditions of service of, the chairperson and members of the Board under sub-section (3) of section 75;
(r) method, modalities and procedure for transfer of prisoners under sub-section (2) of section 103;
(s) the standard and procedure to which the Central or State Health Authority shall confirm under sub-section (6) of section 103;
(t) the form for furnishing periodical information under section 110; and
(u) any other matter which is required to be, or may be, specified by rules or in respect for which provision is to be made by rules.
122. Power of Central Authority to make regulations. – (1) The Central Authority may, by notification, make regulations, consistent with the provisions of this Act and the rules made thereunder, to carry out the provisions of this Act.
(2) In particular, and without prejudice to the generality of the foregoing power, such regulations may provide for all or any of the following matters, namely:-
(a) manner of making an advance directive under section 6;
(b) additional regulations, regarding the procedure of advance directive to protect the rights of persons with mental illness under sub-section (3) of section 12;
(c) the salaries and allowances payable to, and the other terms and conditions of service (including the qualifications, experience and manner of appointment) of, the chief executive officer and other officers and employees of the Central Authority under sub-section (3) of section 40;
(d) the times and places of meetings of the Central Authority and rules of procedure in regard to the transaction of business at its meetings (including quorum at such meetings) under sub-section (1) of section 44;
(e) the minimum standards of facilities and services under clause (a) of sub-section (4) of section 65;
(f) the minimum qualifications for the personnel engaged in mental health establishment under clause (b) of sub-section (4) of section 65;
(g) provisions for maintenance of records and reporting under clause (c) of sub-section (4) of section 65;
(h) any other conditions under clause (d) of sub-section (4) of section 65;
(i) categories of different mental health establishment under clause (a) of sub-section (5) of section 65;
(j) the form of application to be made by the mental health establishment and the fees to be accompanied with it under sub-section (12) of section 66;
(k) manner of submitting evidence under sub-section (13) of section 66;
(l) the manner of filing objections under sub-section (14) of section 66;
(m) the time and places and rules of procedure in regard to the transaction of business at its meetings to be observed by the Central Authority and the Board under section 87;
(n) regulations under sub-section (2) of section 96 and under sub-section (8) of section 97;
(o) any other matter which is required to be, or may be, specified by regulations or in respect of which provision is to be made by regulations.
123. Power of State Authority to make regulations. – (1) The State Authority may, by notification, make regulations, consistent with the provision of this Act and the rules made thereunder, to carry out the provisions of this Act.
(2) In particular, and without prejudice to the generality of the foregoing power, such regulations may provide for all or any of the following matters, namely:-
(a) the minimum quality standards of mental health services under sub-section (9) of section 18;
(b) the salaries and allowances payable to, and the other terms and conditions of service (including the qualifications, experience and manner of appointment) of the chief executive officer and other officers and employees of the State Authority under sub-section (3) of section 52;
(c) the manner in which the State Authority shall publish the list of registered mental health professionals under clause (d) of sub-section (1) of section 55;
(d) the times and places of meetings of the State Authority and rules of procedure in regard to the transaction of business at its meetings (including quorum at such meetings) under sub-section (1) of section 56;
(e) the form of application to be made by the mental health establishment and the fees to be accompanied with it under sub-section (12) of section 66;
(f) the manner of filing objections under sub-section (14) of section 66;
(g) any other matter which is required to be, or may be, specified by regulations or in respect of which provision is to be made by regulations.
124. Laying of rules and regulations. – (1) Every rule made by the Central Government and every regulation made by the Central Authority under this Act shall be laid, as soon as may be after it is made, before each House of Parliament while it is in session, for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rule or regulation, as the case may be, or both Houses agree that the rule or regulation, as the case may be, should not be made, the rule or regulation, as the case may be, shall thereafter have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule or regulation, as the case may be.
(2) Every rule made by the State Government and every regulation made by the State Authority under this Act shall be laid, as soon as may be after it is made, before each House of the State Legislature where it consists of two Houses, or where such Legislature consists of one House, before that House.
125. Power to remove difficulties. – (1) If any difficulty arises in giving effect to the provisions of this Act, the Central Government may, by order, published in the Official Gazette, make such provisions, not inconsistent with the provisions of this Act, as may appear to be necessary or expedient for removing the difficulty:
Provided that no order shall be made under this section after the expiry of two years from the date of commencement of this Act.
(2) Every order made under this section shall, as soon as may be after it is made, be laid before each House of Parliament.
126. Repeal and saving. – (1) The Mental Health Act, 1987 is hereby repealed.
(2) Notwithstanding such repeal,-
(a) anything done or any action taken or purported to have been done or taken (including any rule, notification, inspection, order or declaration made or any document or instrument executed or any direction given or any proceedings taken or any penalty or fine imposed) under the repealed Act shall, in so far as it is not inconsistent with the provisions of this Act, be deemed to have been done or taken under the corresponding provisions of this Act;
(b) the Central Authority for Mental Health Services, and the State Authority for Mental Health Services established under the repealed Act shall, continue to function under the corresponding provisions of this Act, unless and until the Central Authority and the State Authority are constituted under this Act;
(c) any person appointed in the Central Authority for Mental Health Services, or the State Authority for Mental Health Services or any person appointed as the visitor under the repealed Act and holding office as such immediately before the commencement of this Act, shall, on such commencement continue to hold their respective offices under the corresponding provisions of this Act, unless they are removed or until superannuated;
(d) any person appointed under the provisions of the repealed Act and holding office as such immediately before the commencement of this Act, shall, on such commencement continue to hold his office under the corresponding provisions of this Act, unless they are removed or until superannuated;
(e) any licence granted under the provisions of the repealed Act, shall be deemed to have been granted under the corresponding provisions of this Act unless the same are cancelled or modified under this Act;
(f) any proceeding pending in any court under the repealed Act on the commencement of this Act may be continued in that court as if this Act had not been enacted;
(g) any appeal preferred from the order of a Magistrate under the repealed Act but not disposed of before the commencement of this Act may be disposed of by the court as if this Act had not been enacted.
(3) The mention of the particular matters in sub-section (2) shall not be held to prejudice or affect the general application of section 6 of the General Clauses Act, 1897 with regard to the effect of repeal.
The U.P. Prevention of Cow Slaughter Act 1955
(U.P. Act No. 1 of 1956)
[Dated 30th December, 1955]
Received the assent of the President on December 30, 1955, under article 201 of the Constitution of India, 1950 and was published in the Uttar Pradesh Gazette, Extraordinary, dated January 6, 1956. For Statement of Object and Reasons, see the Uttar Pradesh Gazette, Extraordinary, dated March 30, 1955. Passed in Hindi by the Uttar Pradesh Legislative Assembly on September 8, 1955 and by the Uttar Pradesh Legislative Council on September, 21, 1955, with certain amendments and then again by the U.P. Legislative Council on April, 1956.
An Act to prohibit and prevent the slaughter Uttar Pradesh of cow and its progeny in Uttar Pradesh
Whereas it is expedient to prohibit and prevent the slaughter of cow and progeny in Uttar Pradesh:
It is hereby enacted in the sixth year of the Republic of India as follows :
1. Short title, extent and commencement. – (1) This Act may be called the Uttar Pradesh Prevention of Cow Slaughter Act, 1955.
(2) It extends to the whole of Uttar Pradesh.
(3) It shall come into force at once.
2. Definitions. – In this Act unless there is anything repugnant in the subject or context,-
[(a) “beef” means flesh of cow and of such bull or bullock, whose slaughter is prohibited under this Act, but does not include such flesh contained in sealed containers and imported as such into Uttar Pradesh;]
(b) “cow” includes a [* * *] heifer, or calf;
(c) “prescribed” means prescribed by rules made under this Act;
[(cc) “competent authority” means the person or persons appointed in this behalf by the State Government by notification in the official Gazette to exercise the powers and perform the functions of a competent authority under this Act or the Rules made thereunder for such area or areas and for such period as may be specified in the notification.]
(d) “slaughter” means killing by any method whatsoever and includes maiming and inflicting of physical injury which in the ordinary course will cause death;
(e) “State Government” means the Government of Uttar Pradesh, and
(f) “uneconomic cow” includes stray, unprotected, infirm, disabled, diseased or barren cow.
3. Prohibition of cow slaughter. – (1) Except as hereinafter provided, no person shall slaughter or cause to be slaughtered, or offer or cause to be offered for slaughter-
(a) a cow, or
(b) a bull or bullock, unless he has obtained in respect thereof a certificate in writing, from the competent authority of the area in which the bull or bullock is to be slaughtered, certifying that it is fit for slaughter, in any place in Uttar Pradesh; anything contained in any other law for the time being in force or an usage or custom to the contrary notwithstanding.
(2) No bull or bullock, in respect of which a certificate has been issued under sub-section (1) (b) shall be slaughtered at any place other than the place indicated in the certificate. [* * *]
(3) A certificate under sub-section (1) (b) shall be issued by the competent authority, only after it has, for reasons to be recorded in writing; certified that-
(a) the bull or bullock is over the age of [fifteen years] or
(b) in the case of a bull, it has become permanently unfit and unserviceable for the purpose of breeding and, in the case of bullock, it. has become permanently unfit and unserviceable for the purposes of daughter and any kind of agricultural operation :
Provided that the permanent unfitness or un-serviceability has not been caused deliberately.
(4) The competent authority, shall, before issuing the certificate under sub-section (3) or refusing to issue the same, record its order in writing [***].
(5) The State Government may, at any time, for the purposes of satisfying itself as to the legality or propriety of the action taken under this section call for and examine the record of any case and may pass such order thereon as it may deem fit.
[(6) Subject to the provisions herein contained, and action taken under this section, shall be final and conclusive and shall not be called in question.]
4. Section 3 not to apply to diseased, or under experimentation cows. – (1) Nothing in Section 3 shall apply to the slaughter of a [cow, bull or bullock]-
(a) which is suffering from any contagious or infectious disease notified as such by the State Government; or
(b) which is subjected to experimentation in the interest of medical and public health research;
where the slaughtering is done in accordance with the conditions and circumstances to be prescribed.
(2) Where a [cow, bull or bullock] is slaughtered for the reasons stated in clause (a) of sub-section (1) the person who slaughters of causes to be slaughtered such [cow, bull or bullock] shall within twenty-four hours of the slaughter, lodge information of the same at the nearest Police Station or before such Officer or authority as may be prescribed.
(3) The carcass of the [cow, bull or bullock] slaughtered under clause (a) of sub-section (1) shall be buried or disposed of in such manner as may be prescribed.
5. Prohibition on sale of beef. – Except as herein excepted and notwithstanding anything contained in any other law for the time being in force, no person shall sell or transport or offer for sale or transport or cause to be sold or transported beef or beef-products in any form except for such medicinal purposes as may be prescribed.
Exception. – A person may sell and serve or cause to be sold and served beef or beef-products for consumption by a bona fide passenger in an air-craft or railway train.
[5A. Regulation on transport of cow, etc. – (1) No person shall transport or offer for transport or cause to be transported any cow, or bull or bullock, the slaughter whereof in any place in Uttar Pradesh is punishable under this Act, from any place within the State to any place outside the State, except under a permit issued by an officer authorised by the State Government in this behalf by notified order and except in accordance with the terms and conditions of such permit.
(2) Such officer shall issue the permit on payment of such fee not exceeding five rupees for every cow, bull or bullock as may be prescribed :
Provided that no fee shall be chargeable where the permit is for transport of the cow, bull or bullock for a limited period not exceeding six months as may be specified in the permit.
(3) Where the person transporting a cow, bull or bullock on a permit for a limited period does not bring back such cow, bull or bullock into the State within the period specified in the permit, he shall be deemed to have contravened the provision of sub-section (1).
(4) The form of permit, the form of application therefor and the procedure for disposal of such application shall be such as may be prescribed.
(5) The State Government or any officer authorised by it in this behalf by general or special notified order, may, at any time, for the purpose of satisfying itself, or himself, as to the legality or propriety of the action taken under this section, call for and examine the record of any case and pass such orders thereon as it or he may deem fit].
6. [* * *]
7. Levy of charges or fees. – The State Government or the local authority, as the case may be, may levy such charges or fees as may be prescribed for keeping uneconomic cows in the institutions.
8. Penalty. – (1) Whoever contravenes or attempts to contravene or abets the contravention of the provisions of Section 3 or 5 shall be guilty of an offence punishable with rigorous imprisonment for a term which may extend to two years or with fine which may extend to one thousand rupees or with both.
(2) Whoever fails to lodge the information in the manner and within the time stated in sub-section (2) of Section 4 [or contravenes the provision of sub-section (1) of Section 5-A] shall be guilty of an offence punishable with simple imprisonment for a term which may be extend to one year or with fine which may extend to two hundred rupees or with both.
(3) In any trial for an offence punishable under sub-section (1) or sub-section (2) the burden of proving that the slaughtered cow belonged to the class specified in clause (a) of sub-section (1) of Section 4 shall be on the accused.
9. Offences to be cognizable and non-bailable. – Notwithstanding anything contained in the [Code of Criminal Procedure, 1898], an offence punishable under sub-section (1) of Section 8 shall be cognizable and non-bailable.
10. Power to make rules. – (1) The State Government may make rules for the purpose of carrying into effect the provisions of this Act.
(2) Without prejudice to the generality of foregoing powers, such rules may provide for-
(a) the conditions and the circumstances under which [cows, bulls or bullocks] are to be slaughtered under sub-section (1) of Section 4;
[(aa) form of certificate, and the procedure for disposal of the applications [* * *] under Section 3;]
(b) the manner in which diseases shall be notified under sub-section (1) (a) of Section 4;
(c) the manner in which the information shall be lodged under sub-section (2) of Section 4;
(d) the manner in which and conditions under which beef or beef-products are to be sold or sold and served under Section 5;
(e) the matters relating to the establishment, maintenance, management, supervision and control of institutions referred to in Section 6;
(f) the duties of any officer or authority having jurisdiction under this Act, the procedure to be followed by such officer or authority; and
(g) the matters which are to be and may be prescribed.
Kerala Land Reforms Act 1963
(Act No. 1 of 1964)
Last Updated 15th November, 2019 [ker062]
An Act to enact a comprehensive legislation relating to land reforms in the State of Kerala. Preamble.- Whereas it is expedient to enact a comprehensive legislation relating to land reforms in the State of Kerala; Be it enacted in the Fourteenth Year of the Republic of India as follows:-
CHAPTER I Preliminary
1. Short title, extent and commencement.- (1) This Act may be called the Kerala Land Reforms Act, 1963. (2) It extends to the whole of the State of Kerala. (3) The provisions of this Act, except this section which shall come into force at once, shall come into force on such date as the Government may, by notification in the Gazette, appoint; Provided that different dates may be appointed for different provisions of this Act, and any reference in any such provision to the commencement of this Act, shall be construed as a reference to the coming into force of that provision. 2. Definitions.- In this Act, unless the context otherwise requires,- (1) “adult unmarried person” moans an unmarried person who has attained eighteen years of age; [(1A) “agricultural labourer” means a person whose principal means of livelihood Is the income he gets as wages, in connection with the agricultural operations he performs;] (2) “agricultural year” means the year commencing with the 1st April in any year and ending with the 31st March of the year next succeeding, except in the case of kole mlams in which case it shall be the year commencing with the 15th June in any year and ending with the 14th June of the year next succeeding: Provided that the District Collector may, with respect to any crop., area or category of land within his district, by notification in the Gazette, specify the year between such other dates as he may deem fit as an agricultural year; [(2A) “appellate authority” means an appellate authority constituted under Section 99A]; (3) “ceiling area” means the extent of land specified in Section 82 as the ceiling area; (4) “Cochin” means the area comprising- (i) the portion of the State of Kerala which before the first day of July, 1949, formed the State of Cochin, excluding the enclaves absorbed in the Malabar district under the Provinces and States (Absorption of Enclaves) Order, 1950; and (ii) the enclaves which formed part of the Malabar district absorbed in the State of Travancore-Cochin under the said Order; (5) “commercial site” means any land [not being a kudiyiruppu or a kudikidappu or karaima] which is used principally for the purposes of any trade, commerce, industry manufacture or business; (6) “Court means, where a particular Court is not specifically mentioned, the Court having jurisdiction under the Code of Civil Procedure, 1908, to entertain a suit for the possession of the holding of part thereof to which any legal proceeding under this Act relates; (7) “cultivate” with its grammatical variations means cultivate either solely by one’s own labour or with the help of the members of his family or hired labourers or both, or personally direct or supervise cultivation by such members or hired labourers or both, provided that such members or hired labourers have not agreed to pay or to take any fixed proportion of the produce of the land they cultivate as compensation for being allowed to cultivate it or as remuneration for cultivating it [and in the case of a member of the Armed Forces or a seaman, “cultivation” includes cultivation on his behalf by any other person.] Explanation.- For the purposes of this clause, “members of family” shall mean,- (i) in the case of lands held by a joint family, members of such family; and (ii) in any other case, wife or husband, as the case may be, and the lineal descendants; (8) “cultivating tenant” means a tenant who is in actual possession of, and is entitled to cultivate, the land comprised in his holding; (9) “customary dues” means anything, other than rent, michavaram or renewal fees- (i) landlord; or (ii) allowed to be taken by the landlord from the holding, periodically or on the happening of any event or on the occasion of any festival, and includes onakazhcha, utsavakoppu, perunnalkazcha and aradiantharam; (10) “double-crop nilam” means nilam on which more than one crop of paddy is ordinarily raised in an agricultural year; (11) “dry land” means land which is not nilam, garden, palliyal land or plantation: (12) “eviction” means the recovery of possession of land from a tenant or the recovery of a kudikidappu from the occupation of the kudikidappukaran; (13) “fair rent” means the rent payable by a cultivating tenant under Section 27 or Section 33; (14) “family” means husband, wife and their unmarried minor children or such of them as exist; (15) “garden” means land used principally for growing coconut trees, arecanut trees or pepper vines, or any two or more of the same; (16) “gross produce” in the case of a nilam, means the normal produce of that nilam less the cost of harvesting and, in the case of a garden or dry land, means the normal produce of that garden or dry lands; [***] [(17) “holding” means a parcel cr parcels of land held under a single transaction by a tenant from a landlord and shall include any portion of a holding as above defined which the landlord and the tenant have agreed or are bound to treat as a separate holding.] Explanation I.- Whore by act of parties or by operation of law, the interest of the tenant in his holding has been severed before the commencement of the Kerala Lana Reforms (Amendment) Act, 1969, splitting up the holding into two or more parts, or where a portion of the holding has been sub-leased, before the commencement of this Act, each such part or, as the case may be, each of the portions retained by the tenant and subleased, shall be deemed to be a separate holding. Explanation II.- Any land in respect of which a person is deemed to be a tenant under Section 4, Section 4A, Section 5, Section 6, Section 6A, Section 6B. Section 7, Section 7A, Section 7B, Section 7C, Section 7D, Section 8, Section 9 or Section 10 or, presumed to be a tenant under Section 11 shall be a holding for the purposes of this Act; (18) the term “improvement” means any work or product of a work which adds to the value of the holding, and includes- (a) the erection of dwelling houses, buildings appurtenant thereto and farm buildings; (b) the construction of tanks, wells, channels, dams and other works for the storage or supply of water for agricultural or domestic purposes; (c) the preparation of land for irrigation; (d) the conversion of single-crop into double-crop land; (e) the drainage, reclamation from rivers or other waters or protection from floods or from erosion or other damage by water, of land used for agricultural purposes, or of wasteland which is culturable; (f) the reclamation, clearance, enclosure, or permanent improvement of land for agricultural purposes; (g) the renewal or reconstruction of any of the foregoing works or alterations therein or additions thereto; and (h) the planting or protection and maintenance of fruit trees, timber trees and other useful trees and plants; (19) “intermediary” means any person who, not being a landowner, has an interest in the land and is entitled, by reason of such interest, to possession thereof, but has transferred such possession to any other person. Explanation.- Where such a person has transferred possession only of a portion ; of the land which he is so entitled to possess, he shall be deemed to be an intermediary in respect of that portion; (20) “joint family” means a Hindu undivided family, a Marumakkathayam tarwad or tavazhi, an Aliasanthana Kudumba or Kavaru or a Nambudiri lllam; [(21) “kaipad system of cultivation” means the system of cultivation, by whatever name called, under which paddy is cultivated on land which is saline either throughout the year or during any part of the year, by raising small mounds of earth and sowing seeds or planting seedlings thereon, whether the mounds are demolished after such sowing or planting or not;] (22) “kanam” means,- (a) the transfer for consideration, in money or in kind or in both, by a person of an interest in specific immovable property to another person, and described in the document evidencing the transaction as kanam or kanapattam the incidents of which transfer include- (i) a right in the transferee to hold the said property liable for the consideration paid by him or due to him; (ii) the liability of the transferor to pay to the transferee interest on such consideration unless otherwise agreed to by the parties; and (iii) payment of michavaram or customary dues, or renewal on the expiry of any specified period; or (b) the transfer for consideration in money or in kind or in both by a person of an interest in specific immovable property to another person for the latter’s enjoyment, whether described in the document evidencing the transaction as otti, karipanayam, panayam, pattapanayam, nerpanayam or by any other name and which has the incidents specified in sub-clauses (a)(1) and (a)(ii) and also one or more of the following incidents:- (A) renewal on the expiry of any specified period; (B) payment of michavaram; (C) payment of customary dues; [***] Explanation.- For the purposes of this clause, where there has been no stipulation in the document evidencing the transaction for renewal on the expiry of any specified period, but there has been a renewal or payment of renewal fees, it shall be deemed that there has been a provision for such renewal in the document;] (23) [“Kanam-Kuzhikanam” means a transfer by a landlord to another person of garden lands or of other lands or of both- (i) with all or any of the trees, if any, standing there on at the time of the transfer; or (ii) without such trees, for the purpose of planting trees or pepper vines or both thereon and for the enjoyment of the trees transferred, if any, the incidents of which transfer include-] (a) a right in the transferee to hold the said lands liable for the consideration paid by him or due to him which consideration is called ‘Kanartham’; and (b) the liability of the transferor to pay to the transferee interest on the kanartham unless otherwise agreed to by the parties; [***] [(23A) “Karaima” means a transfer of lands situate in the Kozhikode district or in the Malappuram district, in consideration of ground rent, principally for the purpose of erecting a homestead, and described in the document, if any, evidencing the transfer, as Karaima or Panayapattom, Panayachit, or by whatever name called which possesses the characteristics of Karaima:] [Explanation.- For the purposes of this clause, so much of the land appurtenant to the land under tho Karaima belonging to the landlord or any person claiming through him and in the possession and beneficial enjoyment of the Karaima holder or his legal representative or any other person claiming through him as on the 1st day of January 1970 shall, subject to a maximum of three cents in Municipal Corporation area, five cents in Municipal Council area, and ten cents in Panchayat area, inclusive of the land under Karaima, be deemed to be Karaima: Provided that where the extent of the land appurtenant in the possession and beneficial enjoyment is in excess of the extent specified above as on the 1st day of January 1970, such land shall also be deemed to be Karaima;] [(23B) “Karinilam1” means- (a) lands generally known as karinilam and situate in the district of Kottayam, Alleppey or Ernakulam; and (b) lands, by whatever name known,- (i) reclaimed from swampy areas called “kari” with black and loose peaty soil, the sub-soil of which consists of partially decomposed organic matter; and (ii) in which paddy is cultivated, and situate in any part of the State;] (24) “kole nilam” means land in the bed of any kayal, or lake, or any waterlogged land in areas adjoining or lying within the vicinity of any kayal, fake or river, on which paddy is cultivated by raising bunds on one or more sides and draining the water away by mechanical or other means, and includes- (i) kole or punjakole nilam in the districts of Palghat and Trichur; and (ii) water-logged land in the taluks of Hosdrug and Kasargod commonly known as “Avi” land, on which paddy is cultivated by raising bunds on one or more sides and draining the water away by baling; [(25) “kudikidappukaran” means a person who has neither a homestead nor any land exceeding in extent three cents in any city or major municipality or five cents in any other municipality or ten cents in any panchayat area or township, in possession either as owner or as tenant, on which he could erect a homestead and- (a) who has been permitted with or without an obligation to pay rent by a person in lawful possession of any land to have the use and occupation of a portion of such land for the purpose of erecting a homestead; or (b) who has been permitted by a person in lawful possession of any land to occupy, with or without an obligation to pay rent, a hut belonging to such person and situate in the said land; and “kudikidappu” means the land and the homestead or the hut so permitted to be erected or occupied together with the easements attached thereto:] [***] Explanation I.- In calculating the total extent of the land of a kudikidappuxaran for the purposes of this clause, three cents in a city or major municipality, shall be deemed to be equivalent to five cents in any other municipality, and three cents in a city or major municipality or five cents in any other municipality shall be deemed to be equivalent to ten cents in a panchayat area or township. Explanation II.- For the purposes of this clause,- (a) “hut” means any dwelling house constructed by a person other than the person permitted to occupy it- (i) at a cost, at the time of construction, not exceeding seven hundred and fifty rupees; or (ii) which could have at the time of construction, yielded a monthly rent not exceeding five rupees, and includes any such dwelling house reconstructed by the kudikidappukaran in accordance with the provisions of Section 79; and (b) “homestead” means, unless the context otherwise requires, any dwelling house erected by the person permitted to have the use and occupation of any land for the purpose of such erection, and includes any such dwelling house reconstructed by the kudikidappukaran in accordance with the provisions of Section 79. [Explanation IIA.- Notwithstanding any judgement, decree or order of any Court, a person, who, on the 16th day of August, 1968, was in occupation of any land and the dwelling house thereon (whether constructed by him or by any of his predecessors-in-interest or belonging to any other person) and continued to be in such occupation till the 1st day of January, 1970, shall be deemed to be a kudikidappukaran; Provided that no such person shall be deemed to be a kudikidappukaran- (a) in cases where the dwelling house has not been constructed by such person or by any of his predecessors-in-interest, if- (i) such dwelling house was constructed at a cost, at the time of construction, exceeding seven hundred and fifty rupees; or (ii) such dwelling house could have, at the time of construction, yielded a monthly rent exceeding five rupees; or (b) if he has a building or is in possession of any land exceeding in extent three cents in any city or major municipality or five cents in any other municipality or ten cents in any panchayat area or township, either as owner or as tenant, on which he could erect a building.] Explanation III.- Where any kudikidappukaran secures any mortgage with possession of the land in which the kudikidappu is situate, his kudikidappu right shall revive on the redemption of the mortgage, provided that he has at the time of redemption no other homestead or any land exceeding three cents in any city or major municipality or five cents in any other municipality or ten cents in any panchayat area or township, in possession either as owner or as tenant, on which he could erect a homestead. Explanation IV.- Where a mortgagee with possession erects for his residence a homestead, or resides in a hut already in existence, on the land to which the mortgage relates, he shall, not with standing the redemption of the mortgage, be deemed to be a kudikidappukaran in respect of such homestead or hut, provided that at the time of the redemption- (a) he has no other kudikidappu or residential building belonging to him, or any land exceeding three cents in any city or major municipality or five cents in any other municipality or ten cents in any panchayat area or township, in possession either as owner or as tenant, on which he could erect a homestead; and (b) his annual income does not exceed two thousand rupees. Explanation V.- Where a Kudikidappukaran transfers his right in the kudikidappu to another person, such person shall be deemed to be a kudikidappukaran, if- (a) he has no other homestead or any land in possession, either as owner or as tenant, on which he could erect a homestead; and (b) his annual income does not exceed two thousand rupees. Explanation VI.- For the purposes of this clause, a person occupying any hut belonging to the owner of a plantation and situate in the plantation shall not be deemed to be a kudikidappukaran if such person was permitted to occupy that hut in connection with his employment in the plantation, unless- (a) he was, immediately before the commencement of this Act, entitled to the rights of a kudikidappukaran or the holder of a protected ulkudi or kudikidappu under any law then in force; or (b) he would have been entitled to the rights of a kudikidappukaran if the area in which that hut is situate had not been converted into a plantation subsequent to his occupation of that hut;] [Explanation VII.- For the removal of doubts it is hereby declared that a person occupying a homestead or hut situate on a land held or owned by the Government of Kerala or the Government of any other State in India or the Government of India shall not be deemed to be a kudikidappukaran;] (26) “kudiyiruppu” means a holding or part of a holding consisting of the site of any residential building, the site or sites of other buildings appurtenant thereto, such other lands as are necessary for the convenient enjoyment of such residential building and easements attached thereto, but does not include a kudikidappu; (27) “Kuttanad area” means the area covered by the villages specified in Schedule-I; [(27A) “Kuzhichuvaipum kudiyiruppum” means a transfer by a landlord to another person of garden lands or of other lands or of both situate in Malabar, reserving the right to enjoy the fruit-bearing trees standing thereon at the time of the transfer, for the purpose of making Improvements thereon, and described as such in the contract of tenancy;] [(28) “Kuzhikariam” means a transfer by a landlord to another person of garden lands or of other lands or of both with all or any of the trees, if any, standing thereon at the time of the transfer or without such trees, for the purpose of planting trees or pepper vines or both thereon, and for the enjoyment of the trees transferred, if any;] (29) “landlord” means a person under whom a tenant holds and includes a landowner; (30) “landowner” means the owner of the land comprised in a holding and includes- (i) a landholder holding Sree Pandaravaka lands on pattam, otti, jenmam, kudijenmam, danam or any other tenure; and (ii) a landholder holding Sreepadam lands on Sreepadam-pattam or other favourable tenure; (31) “Land Board” means the Land Board constituted under Section 100; (32) “Land Tribunal” means a Land Tribunal constituted under Section 99; (33) “licensee” means any person who is in occupation of any nilam belonging to another and who, under any local custom or usage or under an agreement, cultivates that nilam with paddy for a remuneration and with the risk of cultivation, but does not include a person who cultivates the nilam of another merely as an agent or servant: [(33A) “local authority” means a municipal corporation or a municipal council or a township committee or a panchayat or a cantonment board; (33B) “major municipality” means any of the municipalities of Cannanore, Tellichery, Trichur, Palghat, Alleppey, Quilon and Kottayam and includes- (a) any of the municipalities of Ernakulam, Fort Cochin and Mattancherry as they existed immediately before the corstitution of the Corporation of Cochin; (b) the municipality of Calicut as it existed immediately before the constitution of the Corporation of Calicut; (c) the Cannanore cantonment.] Explanation.- Where any area has been included in a city or a municipality after the 1st day of April, 1960, such area shall not be deemed, except for the purposes of Section 76, to be an area within the limits of a city or municipality, as the case may be, [but shall be deemed,- (i) where such area was within the limits of a local authority immediately before such inclusion, to continue within the limits of that local authority; and (ii) where such area was not within the limits of a local authority immediately before such inclusion, to be within the limits of a panchayat; (ii) where such area was not within the limits of a local authority immediately before such inclusion, to be within the limits of a panchayat;] (34) “Malabar” means the Malabar district referred to in sub-section (2) of Section 5 of the States Reorganisation Act, 1956; (35) “member of the Armed Forces” means a person in the service of the Air Force, Army or Navy of the Union of India; [(36) “michavaram” means the money or produce or both specified as michavaram in the document evidencing the transfer by a person of an interest in specific immovable properly to another person, and includes the balance of money or produce or both payable periodically under the document evidencing such transfer after deducting from the money or produce or both due to the transferor, the interest due on the amount advanced to the transferor, but does not include customary dues: (36A) “minor” means a person who has not attained the age of eighteen years;] (37) “net income” means income derived from any property after deducting therefrom the cultivation expenses or charges for maintaining fruit trees, timber trees or other useful trees and plants, and taxes and cesses due to the Government or any local authority: (38) “nilam” means land adapted for the cultivation of paddy; [(38A) “normal produce” in respect of any land means the produce which would be raised on that land if the rainfall and the seasons were of a normal character: Provided that the normal produce in respect of any nilam irrigated with water for the first time after the commencement of the tenancy in respect of that nilam from an irrigation work constructed, repaired or maintained wholly at the cost of the Government or a local authority or a co-operative society or by the tenant shall be determined as if the nilam had not been so irrigated: Provided further that in determining the normal produce in the case of any double crop nilam, account shall be taken as though only a single paddy crop which shall be the principal crop has been raised on the land if it had been converted from single-crop into double-crop nilam at the tenant’s expense and as though two paddy crops have been raised on the land in other cases. Explanation.- In ascertaining the normal produce in areas where the Malabar Tenancy Act, 1929, or the Madras Cultivating Tenants (Payment of Fair Rent) Act, 1956, was applicable, the yield of the second crop shall be deemed to be half of that of the principal crop which shall be deemed to be tho first crop:] (39) “odacharthu” means an agreement for cutting bamboos in Malabar; [(39A) “ollikuzhikanam” means a transfer for consideration by a person to another of any land other than nilam for the enjoyment of that land and for the purpose of making improvements thereon, but shall not include a mortgage within the meaning of the Transfer of Property Act, 1882;] (40) “owner” means a person entitled to the absolute proprietorship of land and includes- (a) a trustee in respect thereof; (b) a pattadar of ryotwari land; [(c) a kanam tenant as defined in the kanam Tenancy Act 1955, but does not include a jenmi as defined in that Act;] (41) “palliyal land” means land which is used ordinarily for raising seedlings of paddy and Includes land so used and known as pallimanayal, myal, potta, njal, njattadi or banabettu; (42) “pay” with its grammatical variations includes deliver; (43) “person” shall include a company, family, joint family, association or other body of individuals, whether incorporated or not, and any institution capable of holding property; (44) “plantation” means any land used by a person principally for the cultivation of tea, coffee, cocoa, rubber, cardamom or cinnamon (hereinafter in this clause referred to as ‘plantation crops’) and includes- (a) land used by the said person for any purpose ancillary to the cultivation of plantation crops or for the preparation of the same for the market; (b) [*** x] (c) agricultural lands interspersed within the boundaries of the area cultivated by the said person with plantation crops, not exceeding such extent as may be determined by the Land Board [or the Taluk Land Board, as the case may be] as necessary for the protection and efficient management of such cultivation. Explanation.- Lands used for the construction of office buildings, god owns, factories, quarters for workmen, hospitals, schools and play grounds shall be deemed to be lands used for the purposes of sub-clause (a); (45) “possession” in relation to land includes occupation of land by a person deemed to be a tenant under Section 4, Section 4A, Section 5, Section 6, Section 6A, Section 6B, Section 7, Section 7A, Section 7B, Section 7C, Section 7D, Section 8, Section 9 or Section 10, or presumed to be a tenant under Section 11; (46) “prescribed” means prescribed by rules made under this Act; [(47) “private forest” means a forest which is not owned by the Government, but does not include-] (i) areas which are waste and are not enclaves within wooded areas; (ii) areas which are gardens or nilams; (iii) areas which are planted with tea, coffee, cocoa, rubber, cardamom or cinnamon; and (iv) other areas which are cultivated with pepper, arecanut, coconut, cashew or other fruit-bearing trees or are cultivated with any other agricultural crop; (48) (i) “punam or kumri cultivation” means fugitive or intermittent cultivation of paddy on drylands in Malabar; (ii) “punam or kumri cultivator” means a person who has raised crops by punam or kumri cultivation in any year between 1953 and 1959 and, where there are successive cultivators in respect of the same land, the cultivator who raised crops last by such cultivation during the said period; (49) “rent” means whatever is lawfully payable In money or in kind or in both by a person permitted to have the use and occupation of any land to the person so permitting, and includes michavaram, but does not include customary dues; (50) “resumption” means the recovery of possession of land from a tenant; (51) “seaman” means every person (including a master, pilot or apprentice) employed or engaged as a member of the crew of a ship or a sailing vessel to which the Merchant Shipping Act, 1958 (Central Act 44 of 1958), applies; (52) “small holder” means a landlord who does not have interest in land exceeding eight standard acres or [ten acres] in extent, whichever is less, as owner, intermediary, or cultivating tenant, or in two or more of the above capacities, so however that the extent of non-resumable land in his possession as owner, or as cultivating tenant, or partly as owner and partly as cultivating tenant, does not exceed- (i) [two and a half standard acres]; or (ii) four acres in extent, whichever is greater. Explanation.- For the purposes of this clause, a person who was in possession of, or had interest in, land exceeding the limits specified in this clause immediately before the 18th December, 1957, but such extent of land was reduced to the said limits or below by partition or transfer effected after the date mentioned above, shall not be deemed to be a small holder; nor shall such partition or transfer entitle the allottee or transferee to exercise the rights of a small holder in respect of the land allotted or transferred to him; (53) “Sreepadam lands” means the lands registered in the revenue records as “sreepadam vaka” and known as sreepadam lands, but does not include sreepadam thanathu lands, (54) “Sree Pandaravaka lands” means the lands owned by the Sree Padmanabhaswamy; (55) “standard acre” means, in relation to any class of land specified in Schedule II situate in the district or taluk mentioned therein, the extent of land specified against it in that Schedule; (56) “State” means the State of Kerala; [(56A) “Taluk Land Board” means a Taluk Land Board constituted under Section 100A;] [(57) “tenant” moans any person who has paid or has agreed to pay rent or other consideration for his being allowed to possess and to enjoy any land by a person entitled to lease that land, and includes-] [(a) the heir, assignee or legal representative of, or any person deriving rights through, any such person who has paid or has agreed to pay rent or other consideration,] [(aa) an intermediary,] (b) a kanamdar, (c) a kanam-kuzhikanamdar, (d) a kuzhikanamdar, [(dd) an ottikuzhikanamdar,] (e) a mulgenidar, (f) a verumpattamdarof any description (including a customary verumpattamdar), (g) the holder of a chalgeni lease, (h) the holder of a kudiyiruppu, [(hh) a person holding lands under a kuzhichuvaipum kudiyiruppum, (hhh) the holder of a karairna,] (i) the holder of a vaidageni lease, and [(j) a person who is deemed to be a tenant under Section 4, Section 4A, Section 5, Section 6, Section 6A. Section 6B, Section 7, Section 7A, Section 7B, Section 7C, Section 7D, [Section 7E] Section 8, Section 9 or Section 10, or presumed to be a tenant under Section 11.] Explanation.- For the purposes of this clause,- (i) “holder of a chalgeni lease” means a lessee or sub-lessee of specific immovable property situate in the taluk of Hosdrug or Kasaragod in the district of Cannanore, who has contracted either expressly or impliedly to hold the same under a lease, whether fer a specified period or not; (ii) “mulgeni” means a tonancy in perpetuity at a fixed invariable, rent created in favour of a person called mulgenidar; (iii) “vaidageni lease ” means a lease for a term of years; (58) “timber trees” means trees, the yield or income from which has not to be taken into account for the determination of fair rent; (59) “to hold land” means to be in possession of land as owner or as tenant or partly as owner and partly as tenant; [or, in respect of any land owned by the Government, to be in occupation either as lessee or otherwise]; (60) “varam” means an arrangement for the cultivation of nilam with paddy and sharing the produce, made between the owner or other person in lawful possession of the nilam and the person who undertakes cultivation under such arrangement, and includes the arrangements known as pathivaram, pankuvaram and pankupattam; and ‘Varamdar” means the person who undertakes cultivation under a varam arrangement; (61) “vechupakuthy” means a transaction where under a landowner permits another person to be in joint possession with him of any land with th6 following stipulations:- (i) the vechupakuthidar shall improve the land within a specified period; (ii) at the end of the period so specified- (a) the land shall be partitioned between the land owner and the vechupakuthidar in a specified proportion; (and) (b) upon such partition, all the rights of either party over the portion of the land set apart for the other shall stand transferred to and vest in the other; (iii) [***] (62) (i) “verumpattamdar” means a lessee or sub-lessee of immovable property, whether called verumpattamdar, or venpattamdar, who has expressly or impliedly contracted to hold the same under a lease with or without security for rent, and includes a tharikuthukaran in the Palghat district, but does not include a Kanamdar, kanam-kuzhikanamdar, or kuzhikanamdar; (ii) “customary verumpattamdar” means any verumpattamdar of immovable property situate in any area to which the Malabar Tenancy Act, 1929, extended, who, before the commencement of the Malabar Tenancy (Amendment) Act, 1951, was entitled by the custom of tho locality in which the land was situated, to possession of the said land for a definite period of years, and for whose continuance thereon, after the termination of that period, for a further period, a renewal fee had to be paid to the landlord as an incident of the tenure; [(62A) “village officer” means the person appointed as a village officer in respect of a village and includes an additional village officer, a village assistant and an additional village assistant;] [(63) “wakf” means the permanent dedication by a person professing Islam of any movable or immovable property for any purpose recognised by the Muslim Lav/ or any other law in force as pious, religious, or charitable, and includes a wakf by user, but does not include a wakf such as is described in Section 3 of the Musalman Wakf Validating Act, 1913, under which any benefit is for the time being claimable for himself by the person by whom the wakf was created or by any member of his family or descendants.]
CHAPTER II Provisions Regarding Tenancies Exemptions Exemptions
3. Exemptions.- (1) Nothing in this Chapter shad apply to: (i) leases of lands or of buildings or of both belonging to or vested in the Government of Kerala or the Government of any other Stale in India or the Government of India or a local authority for the Cochin Port Trust or a corporation owned or controlled by the Government of Kerala or the Government of any other State in India Or the Government of India: [Provided that in the case of a such lease of Kandukrishi lands or a mortgage of such lands falling under Section 4A, granted or created by a tenant holding such lands under the Government. the provisions of Sections 13 to 26 shall, so long as the lease granted by the Government subsists, apply to the tenant or mortgagee holding under the sub-lease Or mortgage, as the case may he, as they apply to a tenant holding lands other than Government lands.] Explanation I.- “Lands belonging to or vested in the Government of Kerala” shall, for the purposes of this clause, have the same meaning as Government lands under Sub-section (1) of Section 2 of the Kerala Government Land Assignment Act, 1960, but leases subsisting at the commencement of this Act of lands escheated to the Government shall not be deemed to be leases of lands belonging to or vested in the Government of Kerala if the lessees or their predecessors-in-interest were in possession of the lands at the time of escheat as tenants under leases whether current or time expired. [Explanation IA.- Lands, the right, title and interest in respect of which have vested in the Government under Sub-section (9) of Section 66 or Section 72, shall not be deemed to be lands belonging to or vested in the Government of Kerala for the purposes of this clause. Explanation IB.- For the purposes of this clause, lands held under leases whether current or lime expired at the time when such lands came to belong to or vested in a local authority shall not be deemed to be lands belonging to or vested in a local authority if the lessee or his successor-in-interest was continuing in possession of such lands at the commencement of this Act.] Explanation II.- For the purposes of this clause, kandukrishi lands means lands covered by the Kandukrishi Proclamation 1124, and includes kandukrishi pattam and kandukrishi thanathu lands, but shall not include lands assigned on registry under the Kandukrishi Land Assignment Rules, 1958; or (ii) leases only of buildings, including a house, shop or ware-house and the site thereof, with the land, if any, appurtenant thereto. Explanation.- Permission given to a kudikidappukaran to occupy a hut shall not be deemed to be a lease of building for the purposes of this clause; or (iii) leases of land or of buildings or of both specifically granted for industrial or commercial purposes; or (iv) tenancies of land or of buildings or of both created by the Administrator-General or the Official Trustee or an Official Receiver or Officer appointed by a court under the provisions of any law, or by the court of wards, or by any person holding under or deriving title from any of the officers or the court aforesaid: [Provided that the provisions of this clause shall not apply to: (a) a tenancy created in favour of a person who was a tenant under a lease whether current or time-expired on the date on which the land or building or both came under the control of any of the said officers or the court of wards; or (b) a tenancy renewed in favour of any such person; or (e) a tenancy created not less than thirty years before the commencement of the Kerala Lands Reforms (Amendment) Act, 1969 (whether subsequently renewed or not). by an officer appointed by a court under the provisions of any law, if such officer was, before the commencement of the legal proceedings in which he was so appointed, entitled to lease the land to which the tenancy relates: Provided further that the provisions of this clause shall not apply or shall cease to apply to: (a) tenancy created by the court of wards, where the land-lord on whose behalf the tenancy was created has not terminated or docs not terminate the tenancy by registered notice within a period of six months from the date on which the property was released from superintendence of the court of wards; or (b) any tenancy created by an officer appointed by a court under the provisions of any law, where the person declared or found by the court to be entitled to possess the land or any person acting on his behalf has not instituted or does not institute legal proceedings to put him in possession of such land within ‘a period of five years from the date on which such declaration or finding became final; or] (v) tenancies in respect of land or of buildings or of both created by mortgagees in possession or by person deriving title from such mortgagees: [Provided that nothing in this clause shall apply to such tenancies: (i) created before the commencement of this Act in Malabar; or (ii) created before the 3rd day of March, 1943, in any area to which the Cochin Verumpattamdars Act, VIII. of 1118, extended; or (iii) created before the commencement of this Act, where the lessee is entitled to fixity of tenure under Section 4A; or (iv) where the mortgagee or his successor-in interest has acquired or acquires equity of redemption; or] (v) tenancies in respect of land or of buildings or of both created by persons having only life interest or other limited interest in the land or in the buildings or in both: [Provided that this clause shall not apply to a tenancy created by any person who was governed by the Madras Aliyasanthana Act, 1949;] Provided further that the provisions of this Chapter other than Sections 53 to 72S shall apply to tenancies falling under clauses (v) and (vi) so long as the mortgage or, as the case may be, the life interest or other limited interest subsists). Explanation.- For the Purpose of clause (vi), a sthani or trustee or owner of any temple, mosque, church, or other place of public religious worship or of any other public religious or charitable institution’or endowment shall not be deemed to be a person having only life interest or other limited interest in ownership; or (vii) Leases-Of private forests: [Provided that nothing in clauses (i) to (vii) shall apply in the cases of persons who were entitled to fixity of tenure immediately before the 21st January, 1961, under any law then in force or persons claiming under such persons; or] (viii) tenancies in respect of plantations exceeding thirty acres in extent: Provided that the provisions of this Chapter, other than Sections 53 to 72S shall apply to tenancies in respect of agricultural lands which are treated as plantations under sub-clause (c) of clause (44) or Section 2; or [(ix) ***] (x) tenancies in respect of sites, tanks and premises of any temple, mosque or church [(including sites belonging to a temple, mosque or church on which religious ceremonies are conducted)] and sites of office buildings and other buildings attached to such temple, mosque or church, created by the owner, trustee or manager of such temple, mosque or church; Provided that nothing in this clause shall affect the right to which a tenant was entitled immediately before the commencement of this Act under the contract of tenancy or under any taw then in force; or (xi) lands transferred for felling trees; or (xii) any transaction relating only to the usufruct of trees or to the tapping of coconut or other palm trees or to the tapping of rubber trees. [(xiii) ***] Deemed Tenants 4. Certain odacharthudars and person claiming under odacharthudars to be deemed tenants.- Notwithstanding anything to the contrary contained in any law or in any contract, custom or usage, or in any judgement, decree or order of court: (i) an odacharthudar; or (ii) a person claiming under an odacharthudar, [shall if he or his predecessor-in-interest was actually cultivating on the 11th day of April, 1957, the land or any portion of the to which the odacharthu relates and he was cultivating such land or portion at the commencement of this Act, be deemed to be a tenant in respect of such land or portion, as the case may be.] [4A. Certain mortgagees and lessees of mortgagees to be deemed tenants.- (1) Notwithstanding anything to the contrary contained in any law or in any contract custom or usage, or in any judgement, degree or order of court, a mortgagee with possession of land, other than land principally planted with rubber, coffee, tea or cardamom, or the lessee of a mortgagee of such land shall be deemed to be tenant if- (a) the mortgagee or lessee was holding the land comprised in the mortgage for a continuous period of not less than fifty years immediately preceding the commencement of the Kerala Land Reforms (Amendment) Act, 1969; or (b) the mortgagee of lessee has constructed a building for his own, evidence in the land comprised in the mortgage and he was occupying such building for such purpose tor a continuous period of not less than twenty years immediately preceding such commencement: Provided that a mortgagee or lessee falling under this cause shall not he deemed to be a tenant if he, or, where he is a member of a family, such family was holding any other hand exceeding two acres in extent on the date of publication of the Kerala Land Reforms Amendment Bill, 1968, in the Gazette; or (c) the land comprised in the mortgage was waste land at the time of mortgage or land to which the Madras Preservation of Private Forests Act, 1949, would have applied if that Act had been in force at the time of mortgage, and: (i) the mortgagee or lessee was holding such land far a period of not less than thirty years immediately preceding the commencement of the Kerala Land Reforms (Amendment) Act, 1969; and (ii) the mortgagee or lessee has effected substantial improvements on such land before such commencement. Explanation I.- For the purposes of this Sub-section, in computing the period of continuous possession or occupation by a lessee, the period during which the mortgagee was in possession or occupation, as the case may be, shall also be taken into account. Explanation II.- in computing the period of fifty years referred to in clause (a) or the period of thirty years referred to in clause (c), the period during which the predecessor-in-interest or predecessors-in-interest of the mortgagee or lessee was or were holding the property shad also be taken into account. Explanation III.- For the purposes of clause (b),: (i) “mortgagee” or “lessee” shall include a predecessor-in-interest of the mortgagee or lessee, as the case may be; (ii) “building” includes a hut. Explanation IV.- In computing the period of twenty years referred to in clause (b), occupation of the building by any member of the family of the mortgagee or lessee for residential purpose shall be deemed to be occupation by the mortgagee or lessee, as the case may be, for such purpose. Explanation V.- In calculating the extent of land held by a family for the purposes of clause (b), all the lands held individually by the members of the family or jointly by some or all of the members of such family shall be deemed to be deemed to be held by the family. Explanation VI.- For the purposes of sub-clause (ii) of clause (c): (i) improvements made by the mortgagee shall be deemed to be improvements made by the lesser,: (ii) “mortgagee” or “lessee” shall include a predecessor-in-interest of the mortgagee or lessee, as the case may be. Explanation VII.- For the purposes of clause (c): (i) improvements shall be deemed to be substantial improvements if the value thereof on the date of commencement of the Kerala Land Reforms (Amendment) Act, 1969. is not less than twenty five per cent of the market value of the land on that date; (ii) a land shall be deemed to be waste land notwithstanding the existence of scattered trees thereon. (2) Nothing contained in Sub-section (1) shall apply to a lessee if the lease was granted on or after the commencement of this Act.] 5. Certain mortgagees with possession to be deemed tenants.- (1) Notwithstanding anything to the contrary contained in any law or in any contract, custom or usage, or in any judgement, decree or order of court, a mortgagee with possession of immovable property situate in Cochin shall be deemed to be a tenant, if : (a) the property comprised in the mortgage consists of agricultural land other than land planted with rubber, coffee, tea or cashew; and (b) the interest on the mortgage amount is less than forty per cent of the total rent fixed in the mortgage document. [(2) ***] 6. Certain mortgagees who were holding land on verumpattam on or after 1st Chingam, 1111 to be deemed tenants.- (1) Notwithstanding anything to the contrary contained in any law or in any con-tract, custom or usage, or in any judgment, decree or order of court, a mortgagee with possession of immovable property situate in Cochin shall be deemed to be a tenant, if: (a) the property comprised in the mortgage consists of agricultural land; (b) he or his predecessor-in-interest was holding the property comprised in the mortgage as verumpattamdar on or after the first day of Chingam, 1111; and (c) the verumpattam was terminated after the first day of Chingam, 1111 and before the commencement of this Act, but he or his predecessor-in-interest continued in possession of the property without interruption, as mortgagee with possession from the date of such termination till commencement of this Act. [6A. Certain persons who were holding land on or after 1st December, 1930, to be deemed tenants.- Notwithstanding anything to the contrary contained in any law, or in any contract, custom or usage, or in any judgement, decree or order of court, a person in possession of immovable property in any area in the State to which the Malabar Tenancy Act, 1929, extended, whether as mortgagee or otherwise, shall be deemed to be a tenant if: (a) the property in his possession consists of agricultural land; (b) he or any of his predecessors-in-interest was holding the property as a tenant on or after the 1st day of December 1930: and (c) the tenancy was terminated after the 1st day of December, 1930 and before the commencement of this Act, but his predecessors-in-interest or himself continued in possession of the property, without interruption, whether as a mortgagee with possession or otherwise, from the date of such termination till the commencement of this Act. Explanation I.- For the purposes of clause (b), “tenant” means a tenant as defined in the Malabar Tenancy Act, 1929, as in force on the 1st day of November, 1956. Explanation II.- An interruption for a period not exceeding an agricultural year immediately following the termination of the tenancy shall not deemed to be an interruption for the purpose of clause (c). 6B. Certain mortgagees in areas to which Malabar Tenancy Act ex-tended to be deemed tenants.- Notwithstanding anything to the contrary contained in any law, or in any contract, custom or usage, or in any judgment, decree or order of court, a mortgagee with possession of immovable property at the commencement of the Kerala Land Re-forms (Amendment) Act, 1969, in any area in the State to which the Malabar Tenancy Act, 1929, extended, shall be deemed to be a tenant, if: (a) he was holding such property in consideration of payment of customary dues, or any amount specified as michavaram in the document evidencing the transaction; or (b) there is a provision in such document for renewal on the expiry of a specified period.] [6C. Certain lessees who have made substantial improvements etc. to be deemed tenants.- Notwithstanding anything contained in section 74, or in any contract, or in any judgment, decree or order of any court or other authority, any person in occupation at the commencement of the Kerala Land Reforms (Amendment) Act, 1969, of the land of another person on the basis of a lease deed executed after the 1st day of April, 1964, shall be deemed to be a tenant if- (a) he (including any member of his family) did not own or hold land in excess of four acres in extent on the date of execution of the lease deed; and (b) he or any member of his family has made substantial improvements on the land. Explanation.- For the purposes of this section, improvements shall be deemed to be substantial improvements if the value of such improvements is more than fifty per cent of the value of the land on the date of execution of the lease deed.] [7. Certain persons occupying land honestly believing to be tenants, to be deemed tenants.- Notwithstanding anything to the contrary contained in Section 52 or any other provision of the Transfer of Property Act, 1882, or any other law, or in any contract, custom or usage, or in any judgement, decree or order of court, any person in occupation at the commencement of the Kerala Land Reforms (Amendment) Act, 1969, of the land of another situate in Malabar shall be deemed to be a tenant if he or his predecessor-in-interest was continuously in occupation of such land honestly believing himself to be a tenant for not less than two years within a period of twelve years immediately preceding the 11th day of April, 1967. Explanation.- Notwithstanding anything contained in the Indian Evidence Act 1872, where a person has be continuously in occupation of any such land for two years within the said period of twelve years, it shall be presumed until the contrary is provided that he has been in such occupation honestly believing himself to be a tenant.] [7A. Certain persons occupying land for not less than ten year, to be deemed tenants.- Notwithstanding anything to the contrary contained in Section 52 or any other provision of the Transfer of property Act, 1882, or in any other law, or in any contract, custom or usage, or in any judgment, decree or order of court, a person shall be deemed to be a tenant in respect of the land of another in his occupation if : (a) he or his predecessor-in-interest occupied such land believing it to be the property of the Government; (b) subsequent to such occupation such land has become the property of such other person as a consequence of any judgement, decree or order of any civil court; and (c) such land has been in the continuous occupation of such person for a period of not less than ten years preceding the commencement of the Kerala Land Reforms (Amendment) Act, 1969, Explanation I.- In computing the period of occupation of a per-son for the purposes of clause (c), the period during which the predecessor-in-interest or predecessors-in- interest of such person was or were in occupation shall also be taken into account. Explanation II.- For the purposes of this Section, a person shall be deemed to be in continuous occupation notwithstanding any order of court for delivery of possession to another person or any court record of dispossession.] [7B. Certain persons occupying lands under leases granted by in-competent persons to be deemed tenants.- (1) Notwithstanding any-thing to the contrary contained in any law, or in any contract, custom or usage, or in any judgment, decree or order of court, any person in occupation of the land of another at the commencement of the Kerala Land Reforms (Amendment) Act, 1969, on the basis of a registered deed purporting to be a lease deed, shall be deemed to be a tenant if he or his predecessor-in-interest was in occupation of such land on the 11th of April, 1957, on the basis of that deed, notwithstanding the fact that the lease was granted by a person who had no right over the land or who was not competent to lease the rand. (2) Notwithstanding anything to the contrary contained in any law or in any contract, custom or usage, or in any judgement, decree or order of court, any person who on the 11th day of April, 1957, was in occupation of the land of another and continued to be in occupation of such land till the commencement of the Kerala Land Reforms (Amendment) Act, 1969, shall be deemed to be a tenant if the court has delivered a judgment or passed an order before the date of publication of the Kerala Lands Reforms (Amendment) Bill, 1968, in the Gazette that the occupation by such person was on the basis of an oral permission or an unregistered deed purporting to be a lease deed granted by a person who had no right over the land or who was not competent to lease the land.] [(3) Notwithstanding anything to the contrary contained in this Act or in any other law or in any contract, custom or usage or in any judgment, decree or order of any court, any person in occupation of land on the basis of an oral permission or a deed purporting to be lease deed, granted by a person governed by the Madras Aliasanthana Act, 1949 shall be deemed to be a tenant, if he or his predecessor-in-interest was in occupation of such land at the commencement of the Kerala Land Reforms (Amendment) Act, 1969.] [7C. Certain persons who have paid amounts for occupation of land shall be deemed to be tenants.- Notwithstanding anything to the contrary contained in any law, or in any contract, custom or usage, or in any judgement, decree or order of court, any person who is in occupation of the land of another at the commencement of the Kerala Land Reforms (Amendment) Act, 1969, shall be deemed to be a tenant if he or his predecessor-in-interest has paid within a period of ten years immediately preceding such commencement any amount in consideration of such occupation or for the use and occupation of such land and has obtained a receipt for such payment from any per-son entitled to lease that land or his authorised agent or a receiver appointed by a court describing the payment as modavaram or nashtavaram or modanashtavaram or a receipt described as M.R. receipt.] [7D. Certain persons occupying private forests or unsurveyed lands to be deemed tenants.- Notwithstanding anything to the contrary contained in Section 52 or any other provision of the Transfer of Property Act, 1882, or any other law, or in any contract, custom or usage, or in any judgement, decree or order of court, any person in occupation at the commencement of the Kerala Land Reforms (Amendment) Act, 1969, of the land of another situate in Malabar, to which the provisions of the Madras Preservation of Private Forests Act, 1949 (XXVII of 1949), were applicable on the 11th day of April, 1955 or which was unsurveyed on that date, shall be deemed to be a tenant if he or his predecessor-in-interest was continuously in occupation of such land for not less than two years within a period of twelve years immediately preceding the 11th day of April, 1967.] [7E. Certain persons who acquired lands to be deemed tenants.- Notwithstanding anything to the contrary contained in section 74 or section 84 or in any other provisions of this Act, or in any other law for the time being in force or in any contract, custom or usage, or in any judgment decree or order of any court, tribunal or other authority, a person who at the commencement of the Kerala Land Reforms (Amendment) Act, 2005, is in possession of any land, not exceeding [1 hectare 61 ares and 87 square metres] in extent acquired by him or his predecessor in interest by way of purchase or otherwise on payment of consideration from any persons holding land in excess of the ceiling area, during the period between the date of the commencement of the Kerala Land Reforms Act, 1963 (1 of 1964), and the date of commencement of the Kerala Land Reforms (Amendment) Act, 2005, shall be deemed to be a tenant.] 8. Certain persons who were cultivating land on Aram arrangement to be deemed tenants.- Notwithstanding anything to the contrary contained in any law, or in any contract, custom or usage, or in any judgement, decree or order of court, any person who, by virtue of the provisions of Section 6 of the Kerala Stay of Eviction Proceedings Act, 1957, was entitled to cultivating any nilam after the 11th day of April, 1957, and was cultivating the nilam at the commencement of this Act, shall be deemed to be a tenant, notwithstanding the expiry of the term fixed under the varam arrangement. 9. Certain persons who surrendered leasehold rights but continued in possession to he deemed tenants.- Notwithstanding anything to the contrary contained in any law, or in any contract, custom or usage, or in any judgement, degree or order of court, where, on or after the 11th day of April, 1957, a tenant holding lands less in extent than the ceiling area, had executed a deed surrendering his leasehold right to the landlord, but had not actually transferred possession of the land to the landlord before the commencement of this Act, such deed shall be deemed to be invalid and such person shall be deemed to be a tenant. [9A. Certain surrender documents to he inadmissible in evidence.- Where any tenant has executed before the 19th day of May, 1967, a deed surrendering or purporting to surrender to his landlord his lease-hold rights in any land situate in the Taluk of Hosdurg or Kasargode in the Cannanore District, such deed if unregistered shall, notwithstanding anything contained in the Indian Evidence Act, 1872, be inadmissible in evidence in any dispute regarding possession of such land between such tenant or any person claiming under or through him and such landlord or any person claiming under or through him.] 10. Certain other persons to be deemed tenants.- Notwithstanding anything to the contrary contained in any law, or in any contract, custom or usage, or in any judgment, decree.or order of court, the following classes of persons shall be deemed to be a tenants (i) a punam or kumri cultivator; (ii) a licensee, [***] (iii) a varamdar; (iv) a vechupakuthidar; and (v) a person holding land situated in any part of the Taluk of Hosdrug or Kasaragode to which the Malabar Tenancy Act, 1929, did not extent, under a transaction described in the document evidencing it as bhogya, otti, nattotti, arwar, illidarwar or krithasartha illirlarwar, but not being a usufructuary mortgage as defined in the Transfer or Property Act, 1882. [11. Sambalapattamdar, sambalachittudar etc, in certain areas to he presumed tenants.- Where in a document a person is described as a Sambalapattamdar, sambalachittudar or coolipattamdar, in respect of any nilam situate in the Palghat or Trichur District or in the Kuttanad area, or as a gaimakarardar or the holder of a gobrachittu or fazilichittu in respect of any land situate in the taluk of Hosdurg or Kasargode in the Cannanore District, he shall be presumed to be tenant for all purposes of this Act: Provided that such presumption shall be rebutted if it is proved, that the sambalapattamdar, sambalachittudar, coolipattamdar or gaimakaradar or the holder of a gobrachittu or fazilichittu, has not undertaken any risk of cultivation.] 12. Right to prow real nature of transaction.- [(1) Notwithstanding anything in the Indian Evidence Act, 1872, or in any other law for the time being in force, or in any judgment, decree or order of court, any person interested in any land may prove that a transaction our porting to be a mortgage, otti, akaripanayarn, panayam, nerpanayam or licence of that land is in substance a transaction by way of kanam, kanam-kuzhikanam, Kuzhikanam verumpattam or other lease, under which the transferee k entitled to fixity of tenure in accordance with the provisions or Section 13 and to the other rights of a tenant under this Act. (2) Where under Sub-section (1) the Land Tribunal holds that the transferee is entitled to fixity to tenure in accordance with the provisions of Section 13, it shall be lawful for the Land Tribunal in pass an order containing directions regarding the application of the sum, if any, advanced to the landlord and making other- suitable alterations in the terms recorded in the instruments executed by the parties.] (3) Notwithstanding anything in the Indian Evidence Act, 1872, or in any other law for the time bciii8 in force, a person described as an Agent or servant in a document evidencing the contract for the curation of any nilam, may prove that he is a licensee. 13. Right of tenants to fixity of tenure.- (1) Notwithstanding any thing to the contrary contained in any law, custom, usage or contract or in any decree or order of court, every tenant, shall have fixity of tenure in respect of his holding, and no land from the holding shall be Limited except as provided in Sections 14 to 22. (2) Nothing in Sub-section (1) shall confer fixity of tenure on a tenant holding under a landlord- (i) who is a member of the Armed Forces or is seaman, if the tenancy was treated by such landlord within a period or three months before he became a member of the Armed Forces or a seaman, or while he was serving as such member or seaman; or (ii) who is the legal representative of the landlord referred to in clause (i): Provided that no such landlord shall resume any land from his tenant, if he is already in possession of an extent of land not less than the ceiling area; and, where he is in possession of an teat of land less than the celling area, the extent of land that may be resumed shall not, together with land in his possession, exceed the ceiling area: [Provided further that a tenant holding under any such landlord shall have fixity of tenure in respect of his holding if the landlord does not claim resumption of the land comprised in the holding within six months from the commencement of the Kerala Land Reforms (Amendment) Act, 1969: Provided also that where any such landlord is prevented by sufficient cause from not claiming resumption within the said period of six months and he claims resumption at any time before the date notified under Section 72, the right of such tenant to fixity of tenure in respect of the holding or part thereof to which the claim for resumption relates shall cease from the date of the application claiming resumption; Provided also that such tenant shall have fixity of tenure in respect of his holding or part thereof from the date of the final rejection of such application in full or in part, as the case may be:] Provided also that the provisions of this Sub-section shall not apply to tenants who were entitled to fixity of tenure immediately before the 21st January, 1961, under any law then in force. [(3) Notwithstanding anything to the contrary contained in any law, or in any contract, but subject to the provisions of Sub-sections (21, the landlord referred to in clause (i) or clause 60 of Sub-section (2) shall be entitled to apply for the resumption from his tenant of the whole or part of his holding within six months from the commencement of the Kerala Land Reforms (Amendment) Act, 1969 or if such landlord is prevented by sufficient cause from applying for resumption within such period, at any time before the date notified under Section 72.] [13A. Restoration of possession of persons dispossessed on or after 1st April, 1964.- (1) Notwithstanding anything to the contrary contained in any law, or in any contract, custom or usage, or in any judgement, decree or order of court, where any person has been dis-possessed of the land in his occupation on or after the 1st day of April, 1964, such person shall, if he would have been a tenant under this Act as amended by the Kerala Land Reforms (Amendment) Act, 1969, at the time of such dispossession, he entitled subject to the provisions of this Section to restoration of possession of the land: Provided that nothing in this Sub-section shall: (a) apply in any case where the said land has been sold to a bonafide purchaser for consideration before the date of publication of the Kerala Land Reforms (Amendment) Bill 1968, in the Gazette; or (b) entitle any person to restoration of possession of any and which has been resumed under the provisions of this Act. (2) Any person entitled to restoration of possession under Sub-section (1) may, within a period of six months from the commencement of the Kerala Land Reforms (Amendment) Act, 1969, apply to the Land tribunal for the restoration of possession of the land. (3) The Land Tribunal may, after such inquiry as it deems fit; pass an order allowing the application for restoration and directing the applicant to deposit the compensation, if any, received by the applicant under any decree or order of court towards value of improvements or otherwise and the value of improvements, if any, effected on the land after the dispossession as may be determined by the Land Tribunal, within such period as may he specified in the order. (4) On the deposit of the compensation and value of improvements as required in the order under Sub-section (3), the Land Tribunal shall restore the applicant to possession of the land, if need be by removing any person who refuses to vacate the same.] [13B. Restoration of the possession of certain holdings sold for arrears of rent.- (1) Notwithstanding anything to the contrary contained in any law, or in any judgement, decree or order of court, where any holding has been sold in execution of any decree for arrears of rent, and the tenant has been dispossessed of the holding after the 1st day of April, 1964, and before the commencement of the Kerala Land Reforms (Amendment) Act, 1969, such sale shall stand set aside and such tenant shall be entitled to restoration of possession of the holding, subject to the provisions of this Section : Provided that nothing in this Sub-section shalt apply in any case where the holding has been sold to a bonafide purchaser for consideration after the date oi such dispossession and before the date of publication of the Kerala Land Reforms (Amendment) Bill, 1968. in the Gazette. (2) Any person entitled to restoration of possession of his holding under Sub-section (1) may, within a period of six months from the commencement of the Kerala Land Reforms (Amendment) Act, NO, deposit the purchase money together with interest at the rate of six per cent per annum in the court and apply to the court for setting aside the sate and for restoration of possession of his holding. (3) The court shall, if satisfied after such summary enquiry as the court deems fit, set aside the salt and restore the applicant to possession of his holding. (4) I he court may also order the applicant to deposit in court such amount as may be specified by the court towards costs of the decree-holder or the auction purchaser and the value of improvements, if any. effected on the holding after the sale. Explanation.- For the purposes of this Section, the term “holding” includes a pan of a holding.] [13C. Cancellation of certain sales for arrears of rent.- (1) Notwithstanding anything to the contrary contained in any law, or in any judgement, decree or order of court, where any holding has been saki in execution of any decree for arrears of rent accrued due before the 1st day of May, 1968, or any portion of such arrears, but the tenant has not been dispossessed, such tenant may, within six months from the commencement of the Kerala Land Reforms (Amendment) Act, 1969, deposit in court an amount equal to the amount which he is liable to pay under Section 73 and apply to the court for setting aside me sale. Explanation.- Where a tenant has been dispossessed by a receiver appointed by a court, such dispossession shall not he deemed to be dispossession for the purposes of this Sub section. (2) The court shall, if satisfied after such summary enquiry as the court deems fit, set aside the sale and may also order the applicant to deposit the costs, if ally, payable to the decree holder, (3) where the amount deposited under Subsection (1) is not found sufficient, the court shall not pass an order under subsection (2) unless the deficit amount is deposited in court within such period as the court may direct.] [13D. Cancellation of certain sales for damages.- (1) Notwithstanding anything to the contrary contained in any law, or in any judgement, decree or order of court, where any holding has been sold after the 1st day of April, 1964, and before the commencement of the Kerala Land Reforms (Amendment) Act 1969, for recovery of damages for committing waste on the holding, but the tenant has not been dispossessed, such tenant may, within six months from such commencement, deposit in court an amount equal to the purchase money together with interest at the rate of six per cent per annum and apply to the court for selling aside the sale. (2) I he court shall, if satisfied after such summary enquiry as the court deems fit, set aside the sale and may also order the applicant to deposit the costs, if any, payable to the decree-holder. (3) Where the amount deposited under Sub-section (1) is not fount sufficient, the court shall not pass an order under Subsection (2) unless the deficit amount is deposited in court within such period as the court may direct. (4) Where the holding has been sold to a purchaser other than the decree-holder, such person shall be entitle() to an order from the court for repayment of his purchase money, with or without interest as the court may direct, against any person to whom it has been paid.] 14. Resumption for extension of places of public religious worship.- A trustee or owner of a place of public religious worship may resume from a tenant the whole or any portion of his holding when the same is needed for the purpose of extending the place of public religious worship and the Collector of the district certifies that the same is so needed. 15. Resumption for construction of residential buildings.- A land-lord (other than a sthani or the trustee or owner of a place of public religious worship) who is not in possession of [any land other than nilam, or is in possession of less than two acres in extent of such land] and who needs the holding for the purpose of constructing a building bona fide for his own residence or for that of any member of his family may resume from his tenant: (i) an extent of land not exceeding 20 cents, where resumption is sought on behalf of one person; and (ii) an extent of land not exceeding 50 cents, where resumption is sought on behalf of two or more persons : [Provided that, by such resumption, the total extent of land other than nilam in the possession of the landlord shall not be raised above two acres and the total extent of land in the possession of the tenant shall not be reduced below fifty cents.] [***] Explanation.- For purposes of this Section and Section 16, “member of his family” shall mean- (i) in the case of a landlord who has granted a lease on behalf of a joint family, member of such family; and (ii) in any other case, wife or husband, as the case may be, or a lineal descendant of the landlord. 16. Resumption for personal cultivation from tenant holding more than ceiling area.- A landlord (other than a sthani or the trustee or owner of a place of public r6igious worship) who requires the holding bona fide for cultivation by himself, or any member of his family, may resume from his tenant, who is in possession of and exceeding the ceiling area, the whole or a portion of the holding, subject to the condition that, by such resumption, the total extent of land in the possession of the landlord is not raised above the ceiling area arid the total extent of land in the possession of the cultivating tenant is not reduced below the ceiling area. Explanation I.- In this Section, references to the ceiling area in relation to the landlord or the tenant shall, where such landlord or tenant is a member of a family, be construed as references to the ceiling area in relation to that family. [Explanation II.- The provisions of Section 82 shall, so far as may be, apply to the calculation of the ceiling area for the purposes of this Section and Section 16A, provided that if no date has been notified under Section 83, the date of the application for resumption shah be deemed to be the date notified under Section 83.] [16A. Resumption by small holder from tenants holding more than the ceiling area.- (1) Notwithstanding anything contained in the Section 17 or Section 18, a small holder (other than a sthanee or the trustee or owner of a place of public religious worship) may resume from his tenant, who is in possession of land exceeding the ceiling area, the whole or a portion of the holding, subject to the condition that by such resumption the total extent of land in the possession of the cultivating tenant is not reduced below the ceiling area and the total extent of land in the possession of the small holder is not raises above five acres: Provided that no small holder shah be entitled to resume under this Section any land in the possession of a tenant who is a member of a Scheduled Caste or a Scheduled Tribe. Explanation I.- In this Section, reference to the ceiling area in reflation to the tenant shall; where such tenant is a member of a family, be construed as reference to the ceiling area in relation to that family. Explanation II.- For the purposes of this Section and Section 18 : (a) “Scheduled Castes” means the Scheduled Castes in relation to the State as specified in the Constitution (Scheduled Castes) Order, 1950; (b) “Scheduled Tribes” means the Scheduled Tribes in relation to the State as specified in the Constitution (Scheduled Tribes) Order, 1950; (2) An application under Sub-section (1) shall be made within a period of six months from the commencement of the Kerala Land Reforms (Amendment) Act, 1969. (3) Where more small holders than one apply for resumption of land from the same tenant and the extent of land in the possession of the tenant in excess of the ceiling area is less than the aggregate of the extent of land applied to be resumed by the small holders, the holders, the Land Tribunal shall allow resumption by all the small holders equitably having regard to all circumstances.] 17. Resumption by small holder.- Without prejudice to the right of resumption under Section 16, a small holder (other than a sthani or the trustee or owner of a place of public religious worship) may resume from his tenant a portion of the holding not exceeding one half. Provided that, by such resumption, the total extent of land in the possession of the small holder shall not be raised above [two and a half standard acres of five acres] in extent, whichever is greater: Provided further that [***] no land shall be resumed under this Section from a tenant who was entitled to fixity of tenure in respect of his holding immediately before the 21st January, 1961, under any law then in force. 18. General conditions and restrictions applicable in resumption under Sections 14, 1 5, 16 and 17.- Resumption of land under Sections 14, 15, 16 and 1 7 shall also be subject to the following conditions and restrictions, namely,- (1) in respect of tenancies subsisting at the commencement of this Act, no application for resumption shall be made after a period of one year from such commencement ; [Provided that where the landlord is- (i) a minor; or (ii) a person of unsound mind; or (iii) a member of the Armed Forces or a seaman and the ten ant is entitled to fixity of tenure; or (iv) a legal representative of such member or seaman, and such member or seaman was the landlord of the land in respect of which resumption is claimed, the application for resumption may be made within six months from the commencement of the Kerala Land Reforms (Amendment) Act, 1969: Provided further that in case of a landlord referred to in clause (iii) or clause (iv) of the foregoing proviso, the application for resumption may be made after expiry of the said period of six months and before the date notified under Section 72, if such landlord was prevented by sufficient cause from making the application within the said period of six months;] (2) the right of resumption in respect of a holding shall be exercised only once, and the order of the Land Tribunal allowing resumption shall be given effect only at the end of an agricultural year; (3) no kudiyiruppu shall be resumed; [(4) no land in the possession of tenant who is a member of a Scheduled Caste or Scheduled Tribe shall be resumed.] [19. Resumption of agricultural lands interspersed within plantations.- A landlord may resume from a tenant any holding or part n a holding comprising agricultural lands of the description specifier in sub-clause (c) of clause (44) of Section 2, if such holding or part 1s in the opinion of the Land Board, [or the Taluk Land Board, as the case may be], absolutely necessary for the purposes of the plantation Provided that the order of the Land Tribunal allowing resumption shall be given effect to only after the expiry of the period, if any, fixed under the contract of tenancy and only at the end of an agricultural year:] 20. Tenants from whom land is resumed to be paid compensation for improvements and Solatium.- [(1) A tenant from whom land is resumed under the provisions of this Act shall be entitled to- (i) compensation for the improvements belonging to him; and (ii) a solatium of an amount equal to the value of the gross produce from the land resumed for a period of two years: whichever is greater: Provided that where the land resumed is comprised in a plantation the tenant shall be entitled to the aggregated of the compensation referred to in clause (i) and the solatium referred to in clause (ii).] (2) The compensation payable under clause (i) of Sub-section (1) shall be determined in accordance with the provisions of the Kerala Compensation for Tenants Improvements Act, 1958. 21. Priority for resumption.- Where in respect of any holding there are more landlords than one, the landlords mentioned below and in their order of priority shall be entitled to resumption:- (a) small holder; (b) any person, other than a small holder, entitled fixity of tenure in respect of the holding immediately before the 21st January, 1961, under any law then in force; (c) kanamdar not falling under item (a) or item (b): (d) landowner, not being a small-holder; Provided that where there are more landlords than one falling under the same category, the landlord nearer the cultivating tenant shall have preferential right over the landlord more remote. 22. Procedure for resumption.- (1) A landlord desiring to resume any land shall apply to the Land Tribunal within whose jurisdiction the land is situated for an order of resumption. The application shall be in such form and shall contain such particulars as may be prescribed. [Explanation.- For the purposes of this sub Section, “landlord” shall include a landlord referred to in the clause (i) or clause (ii) of Sub-section (2) of Section 13.] (2) The Land Tribunal shall duly enquire into the application and pass appropriate orders thereon. Where the order allows resumption, it shall specify the extent and location of the land allowed to be resumed, the rent payable in respect of the portion, if any, that would be left after resumption and such other particulars as may be prescribed and directing the landlord to make, within such time and in such manner as may be prescribed, payments to extinguish the rights of the cultivating tenant and the intermediaries, if any, who would be affected by such resumption. (3) Land Tribunal may, for sufficient reasons extend the time prescribed under Sub-section (2) for making payments by the land lord. [(4)The cultivating tenants shall be entitled to opt for the location of the portion of the holding which may be allowed to be resumed: and where the tenant has not so opted, the location of the portion to be resumed shall be decided by the Land Tribunal having regard to the nature, fertility and other conditions of the portion of the land which may be allowed to be resumed and the portion left with the cultivation tenant.] (5) Where the application is for resumption under Section 16 from a tenant who is in possession of land exceeding the ceiling area and there are other landlord under whom the tenant holds, the Land Tribunal shall give notice of the application to ail other landlords so far as known to it, specifying a date within which they may apply for resumption or any land from such tenant. The Land Tribunal shall consider all applications from landlords for resumption from such tenant received within the specified time together, and, where the extent of land in the possession of the tenant in excess of the ceiling area is less than the aggregate of the extent of land applied to be resumed by the landlords, the Land Tribunal shall allow resumption by all the landlords equitably having regard to all circumstances. (6) Where any land is resumed after making the payments as directed by the Land Tribunal, all the rights of the cultivating tenant and the intermediaries, if any, holding between the landlord resuming the land and the cultivating tenant in respect of the land, shall stand extinguished. [(7) Where a landlord deposits the amounts in accordance with the directions of the Land Tribunal, the Land Tribunal shall put the landlord in possession of the land allowed to be resumed, if need by removing any person who refuses to vacate the same.] (8) Where a landlord fails to deposit the amounts in the accordance with the directions of the Land Tribunal, the order of resumption shall be treated as cancelled and the landlord shall have no further right for resumption. 23. Tenant’s right to sue for restoration of possession of land.- (1) In any case in which any land has been resumed on the ground specified in Section 14 or Section 15 or Section 16 or [***] Section 19, if, within three years of such resumption, the person who resumed the land fails without reasonable excuse to use the land for the purpose for which it was resumed, the cultivating tenant shall, subject to the provisions of Section 24, be entitled to apply to the Land Tribunal for the restoration to him of the possession of the land or a portion of the land which was resumed and to hold it with all the rights and subject to all the liabilities of a cultivating tenant: Provided that a cultivating tenant shall not be entitled to restoration under this Sub-section if he is in possession of land equal to or exceeding the ceiling area, nor shall a cultivating tenant be entitled to restoration of an extent of land which together with the extend of land in his possession will exceed the ceiling area. (2) The provisions of Section 22, shall, mutatis mutandis, be applicable to the form and procedure in regard to the application for restoration and the manner of execution of the orders of restoration. 24. Limitation for application for restoration under Section 23.- An application for restoration under Section 23 shall be made within one year from the expiry of three years after the resumption. 25. Persons entitled to restoration.- (1) Where restoration of any land resumed is ordered under Section 23, the cultivating tenant shall hold the land directly under the landlord from whom restoration has been ordered and the rights of the intermediaries extinguished under Sub-section (6) of Section 22 shall not revive. (2) Before such restoration, the cultivating tenant shall pay to the person who resumed the land- (i) the amount paid by such person to the cultivating tenant and to the intermediary, if any, towards the value of the improvements effected by them and existing at the time of restoration : (ii) the value of the improvements, if any effected bonafide by such person between the date of resumption and the date of the application, and (iii) any amount other than solatium received by the cultivating tenant from such person on account of the resumption. (3) The rent payable by the cultivating tenant after the restoration of the holding shall be the fair rent. [25A. Contract rent in the case of certain tenants.- (1) Where a person who is a tenant for the purposes of this Act, as amended by Kerala Land Reforms (Amendment) Act, 1969, was before the commencement of the said Amendment Act, not under an obligation to pay rent, the contract rent for the purposes of this Act shall be deemed to be,- (a) where there has been a stipulation in the document for the periodical payment of any amount by such person, such amount; (b) in the case of a varamdar, the average of the share of the landlord in the paddy produce for the three years immediately preceding the commencement of this Act or where the varamdar was not cultivating the land continuously for the said period of three years, the share of the landlord for the year in which the varamdar cultivated the land last immediately before such commencement; (c) in any other case, four rupees per acre. (2) In the case of a cultivating tenant referred to in the Sub-section (3) of Section 25, the contract rent for the purposes of this Act shall be the contract rent or the proportionate contract rent in respect of the holding or part thereof which is resumed under this Act, at the time of resumption.] [25B. Determination of proportionate rent.- Where by an act of parties or by operation of law, the interest of the tenant in his holding has been served, splinting up the holding into two or more parts, or where a portion of the holding has been sub-leased, and there is dispute as to the contract rent payable in respect of any such part or, as the case may be, the portion retained by the tenant or the portion sub-leased the Land tribunal may, on application by any person interested, determine the contract rent payable in respect of each such part of portion, as the case may be, on the basis of the normal produce from each such part or portion.] [26. Recovery of arrears of rent by summary procedure.- (1) The Land Tribunal shall be competent to d1spose of applications for recovery of arrears of rent, where the amount of such arrears does not exceed five hundred rupees. (2) Any landlord may apply to the Land Tribunal for recovery of arrears of rent in such form as may be prescribed. [(3) The person liable to pay the amount determined under Sub-section (2) shall deposit the same with the Land Tribunal which determined the amount within a period of six months from the date of such determination. (3A) In the event of the failure to deposit the amount referred to in Sub-section (3) within the time specified in that Sub-section, such amount shall, on a written requisition from the Land Tribunal to the District collector, be recovered under the provisions of the Kerala Revenue Recovery Act, 1968, together with interest at the rate of six per cent per annum from the date determination of the amount under Sub-section (2).] (4) Notwithstanding anything contained in any law for the time being in force, no court or other authority or officer other than the Land Tribunal shall have jurisdiction to entertain any claim for arrears of rent.] 27. Fair rent.- (1) The fair rent in ,respect of a holding shall be the rent payable by the cultivating tenant to his landlord. (2) The fair rent shall be,- (a) in the case of nilams, 50 per cent of the contract rent, or 75 per cent of the fair rent determined under any law in force immediately before the 21st January, 1961, or the rent calculated at the rates specified in schedule III applicable to the class of lands comprised in the holding, whichever is less: (b) in the case of other lands, 75 per cent of the contract rent, or 75 per cent of the fair rent determined under any law in force immediately before the 21st January, 1961, or the rent calculated at the rates specified in schedule Ill applicable to the class of lands comprised in the holding, whichever is less: Provided that the tenant may, by notice sent to the landlord by registered post, opt to pay- (i) in the case of any nilam, 50 per cent of the contract rent, or 75 per cent of the fair rent determined under any law in force immediately before the 21st January, 1961, or the rent calculated at the rates specified in schedule III applicable to the class of lands comprised in the holding; (ii) in the case of other lands, 75 per cent of the contract rent, or the fair rent determined under any law in force immediately before the 21st January, 1961, or the rent calculated at the rates specified in scheduled III applicable to the class of lands comprised in the holding; and where the tenant has so opted, such rent shall be deemed to be the fair rent for all purposes of this Act with effect from the beginning of the agricultural year in which such notice was sent to the landlord. Explanation I.- Where in the case of a holding consisting of nilam and lands other than nilam, the rent for the nilam and the other lands is not separately specified in the contract of tenancy, the contract rent for the purposes of this Sub-section in respect of the nilam and the other lands shall be determined on the basis of the normal produce from the nilam and the normal produce from the lands other than nilam. [Explanation II.- Where in respect of a holding there is a stipulation in the contract of tenancy for the payment of interest by the transferor to the transferee, or for the payment by the transferee of land tax due to the Government or any tax or cess due to a local authority, the contract rent of that holding shall, for the purposes of this Section, be calculated after deducting such interest, tax and cess. Explanation III.- For the purposes of this Section “nilam” includes a nilam converted into garden by the tenant’s labour.] 28. Exclusion or certain lands from liability to fair rent.- Notwithstanding anything contained in Section 27, where any land included in a holding is set apart for communal purposes, and is used for such purposes, the extent of the land so set apart shall not be taken into account when determining the fair rent of the holding in accordance with that Section. [29. Preparation of record of rights.- (1) Any person interested in any land may at any time within ten years from the commencement of this Act or such further period as the Government, may, from time to time, by notification in the Gazette, specify in this behalf, apply to Tahsildar or the taluk in which that land is situate for the Preparation a record of rights in respect that land; Provided that no such application shall lie in cases where the (sic) is situate in an area notified by the Government under Section 3 the Kerala Record of Rights Act, 1968. (2) On receipt of an application under Sub-section (1) for the reparation of the record of rights in respect of am: land, the Tahsildar shall prepare the record of rights in respect of that land in such manner as may prescribed. (3) The record of rights shall contain- (a) the description and extent of the land; (b) the name and address of the owner; (c) the names and address of the intermediaries, if any, in respect of the land and the nature of the interest of each of such intermediaries; (d) the names and address of the cultivating tenants and Kudikidappukars if any, in respect of the land and the nature of the interest of each or them; (e) the names and address of other persons, if any, having, interest in the and and t1re nature of the interest of each such person; and (f) such other particulars as may be prescribed. (4) Any person aggrieved by any entry in the record of right prepared by the Tahsildar under Sub-section (2) may, within such period as may be prescribed, appeal to the Revenue Divisional Officer having jurisdiction over the area in which the land is situate. (5) An appeal under Sub-section (4) shall be in such form and shall contain such particulars as may be prescribed. (6) On receipt of an appeal under Sub-section (4), the Revenue Divisional Officer shall, after giving an opportunity to all persons interested in the land to which the record of rights relates, dispose the appeal in such manner as may he prescribed. (7) The Tahsildar and the Revenue Divisional Officer shall, for the purposes of the proceeding under this Section, have all the powers of a civil court while trying a suit under the Code of Civil Procedure, 1908, in respect of the following matters, namely,- (a) summoning and enforcing the attendance of any person and examining him on oath; (b) requiring the discovery and production of any document (c) receiving evidence on affidavit; (d) issuing commissions for the examination of witness, or for local investigation; and (e) any other matter which may be prescribed. (8) The record of rights prepared under this Section shall be admissible in evidence before any court or tribunal and every entry in any record of rights which has become final shall until the contrary is provided be presumed to be correct. (9) Where an application for the preparation of a record of rights in respect of a land is admitted, no application under Section 31 tor determination of the fair rent in respect of that land shall be disposed of till the record of rights prepared under this Section. (10) Where the proceeding for the preparation of a record of rights are pending before the Tahsildar or an appeal under this Section is pending before the Revenue Divisional Officer at the tin-re when the area in which the land to which the record of rights relates is situate in notified by the Government under Section 3 of the Kerala Record of Rights Act, 1968, the Tahsildar or the Revenue Divisional Officer as the case may be, shall transfer such proceeding or appeal to the Prescribed officer under the said Act for the preparation of the record of rights in accordance with the provisions of that Act.] [29A. Oar of proceedings under Chapter XII of the Code of Criminal Procedure in certain cases.- (1) Where a person claiming to be a tenant apples for the preparation of a record of rights or for the determination of the fair rent or for the purchase of the right, title and interest of the landowner and the intermediaries, if any, in respect of the land cultivated by him, then, notwithstanding anything contained in any other law, no Magistrate shall have jurisdiction under Chapter XII of the Code of Criminal Procedure, 1898, in respect of a dispute between that person and any other person claiming to be in possession of that land relating to that land, pending disposal of the application. (2) Where in respect of any land, proceedings under Chapter XII of the Code of Criminal Procedure, 1898, were initiated while proceedings for the determination of the fair rent in respect of that land were pending and the possession of the land was handed over to the landlord in the proceedings under the said chapter XII, and a suit to decare the right to possession of such land was pending in any civil court of competent jurisdiction on the date of publication of the Kerala Land Reforms (Amendment) Bill, 1960, in the Gazette, then notwithstanding anything contained in Chapter XII of the Code of Criminal Procedure, 1898, or order of any court or any record regarding possession, the person who applied for the determination u the fair rent his successor-in interest shall,- (a) if he was actually in possession on such date, be entitle to continue in possession of such land subject to the final decision in such suit: and (b) if he was not in possession on such date, be entitled restoration of possession and to continue such possession till the final decision in such suit. (3) Any person who is entitled to be restored to possession any land under Sub-section (2) may make an application in writing; within a period of six months from the commencement of the Kerala Land Reforms (Amendment) Act, 1969, to the Revenue Divisions’ Officer having jurisdiction over the area in which the land is situate for the restoration of possession of such land. (4) The Revenue Divisional Officer shall, on receipt of an application under Sub-section (3), make or cause to he made necessary enquiries in respect of such application and if he is satisfied that die applicant is entitled to restoration of possession under Sub-section (2), he shall by order direct the person in possession of the land to deliver possession of the same to the applicant within a period or Nay days from the date of service of the order: Provide that no order under this Sub-section shall be made unless the person who is in possession of the land has been given an opportunity of being heard in the matter. (5) Every order made under Sub-section (4) shall be served in such mariner as may be prescribed. (6) Any person aggrieved by an order of the Revenue Division Officer under Sub-section (4) may, within a period of thirty days from the date of service of the order, prefer an aPpeal to the Collector of the district in which the land is situate, and the order of the collector on such appeal be final. (7) Where an order made under Sub-section (4) has not been complied with, and (a) no appeal has been preferred within the lime allowed for such appeal; or (b) an appeal having been preferred has been dismissed, the Revenue Divisional Officer shall cause the land to be delivered to the applicant by putting him in possession of the land, and if need be, by removing any person who refuses to vacate the same.] [29B. Disputes regarding right to cultivate land.- (1) Any person claiming to be the cultivating tenant of any and, if prevented or obstructed from cultivating that land, may apply to the Tahsildar of the taluk in which the land is situate for an order that he is entitled to cultivate the land. (2) The Tahsildar shall, on receipt of an application under Sub-section (1) and after such enquiry as he deems necessary and after issue of notice to the opposite party, by order decide whether the applicant is entitled to cultivate the land, and if the applicant is entitled to cultivate, and ls not in possession of; the land, the Tahsildar shall also restore him to possession and allow him to cultivate that land. (3) In any suit relating to any land in respect of which an application has been presented before the Tahsildar under Sub-section (1) instituted by the opposite party after the date of such application, the court shall not grant an injunction restraining the applicant from cultivating the land, till the final decision in such suit.] 30. Rent payable by an intermediary.- Where in respect of a holding there is an intermediary at the commencement of this Act and as a result of the determination of the fair rent there has been a reduction [***] in the rent payable by the cultivating tenant, the rent payable by the intennerraly to his landlord shall be reduced [***] in the same pro-portion as the rent to which he was entitled was reduced [***]. [30A. Determination payable where rent payable to kanam tenant is reduced.- Notwithstanding anything to the contrary contained in any other law, where in respect of a holding the landowner is a kanam tenant as defined in the Kanam Tenancy Act, 1955, and as a result of the determination of the fair rent is respect of that holding there has been a reduction in tie rent payable to such landowner, the jenrnikaram payable by such landowner in respect of that holding and accrued due after the 1st day of May, 1966, land before the commencement of the Kanam Tenancy Abolition Act, 1976 shall be reduced in the same proportion as the rent to which he was entitled was reduced.] 31. Determination of fair rent by Land Tribunal.- (1) The cultivating tenant or any landlord may apply, in such form as may be prescribed, to the Land Tribunal for determining the lair rent in respect of a holding. (2) On receipt of an application under Sub-section (1), the to Tribunal shall issue notices to all persons interested and after, inquiry, determine by an order- (i) the fair rent in respect of the holding; (ii) if there is an intermediacy or intermediaries, it payable by such intermediary or intermediaries landlord or to their respective landlords; The instalments, if any, in which the rent shall be pay able; and (iv) the date or dates on which the said rent or instalment shall be payable. (3) In determining the fair rent under Sub-section (2), the Land Tribunal may take into account the statistics published under Section 44. 32. Bar of suits for eviction, etc., pending application for determination of fair rent.- During the pendency of an application for determination of fair rent before a Land Tribunal, no court shall enter-tain any suit for eviction of the applicant from the land to which the application relates, or pass any order of injunction prohibiting him from entering the [land] or pass any order staying the proceedings before the Land Tribunal. 33. Agreement as to fair rent.- Notwithstanding anything contained in the foregoing Sections, it shall be competent for the landlord and the tenant to agree as to what shall be the fair rent payable in respect of the holding and, where such an agreement signed by the landlord and tie tenant is filed with the Land Tribunal, the Land Tribunal shall pass orders determining such agreed rent as the fair rent in respect of the holding; Provided that the agreed rent shall not exceed the fair rent under Section 27, in respect of the holding: Provided further hat where there are intermediaries or other per-sons having an interest in the holding, the landowner, the cultivating tenant and all the intermediaries and other persons interested shall be panes so such an agreement: Provided also that this Section shall not apply to a case where the landlord is a religious, charitable or educational institution of a public nature. 34. Date from which order determining fair rent, etc, is to take effect.- The order determining the fair rent under Section 31 or Section 33 and the rent payable by an intermediary shall take effect from the beginning of the agricultural year in which the tenant or the landlord filed the application for such determination or the agreement under section 33 and any amount paid by the tenant in excess of the rent so determined to the landlord till the date of determination shall be adjusted towards the payment of future rent or the purchase price payable under Section 55, and, where the amount of rent paid to the landlord is less than the rent so determined, the balance payable by the tenant shall be paid along with the rent payable immediately after the determination of the rent. 35. Rent payable when Land Tribunal has not determined fair rent.- Where in a case the rent payable in respect of a holding has not been determined by the Land Tribunal, either under Section 31 or Section 33, the landlord shall he entitled to receive and the tenant shall be hound to pay at his option,- (a) at the case of nilams, 50 per cent of the contract rent, or 75 per cent of the-lair rent, if any, determined under any law in force immediately before the 21st January, 1961; (b) in the case of other lands, 75 per cent of the contract rent, or the fair rent, if any, determined under any taw in force immediately before the 21st January, 1961. [(c) ***] 36. Mode of payment of rent.- Where the rent is payable in kind, it shall be paid either in kind or in the money at the option of the tenant. [(2) The money value of the rent payable in kind, unless it is specified in the document evidencing the contract of tenancy, shall be commuted with reference to the rates published in the Gazette under Section 43 for the date on which the rent is payable and if no such rate is published for that date, at the rate for the nearest previous date for which a rate is so published: Provided that where in respect of any commodity the price has not been published in the Gazette, the money value of such commodity shall be calculated at the market rate prevailing on the date on which the rent is due.] (3) The tenant shall be entitled to sent by money order the rent payable by him to his landlord. 37. Liability for assessment.- (1) As between the tenant and landlord, the former shall be liable for any cess or special charges leviable by the Government for special or additional crops raised, where such special or additional crops have not been taken into account in fixing the fair rent. (2) A tenant making any payment to the Government or any local authority towards land revenue or any tax in respect of the land comprised in the holding and payable by the landlord, shall he entitled to deduct the same from the rent payable by him to the landlord: Provided that no such deduction shall be made if the rent payable by the tenant to the landlord is equal to or less than the land revenue or other tax so payable. 38. Remission of rent.- (1) Where there has been a damage to, or a failure of, crops owing to causes beyond the control of the tenant in any holding, the tenant shall be entitled to a remission of the rent payable by him in proportion to the extent of such damage or failure. [(2) The Tahsildar of the taluk in which the holding is situate or any other officer not below the rank of Tahsildar authorised by the Government in this behalf by notification in the Gazette may, either suo motu or on application by a tenant, determine, after such enquiry as may he prescribed, the extent of damage to, or failure of, crops under Sub-section (1) and order such remission of rent as appears to him just and proper.] [(3) Any person aggrieved by the order of the Tahsildar or the other officer under Sub-section (1) may, within a period of sixty days from the dale of the order, appeal against such order to the Revenue Divisional Officer having the jurisdiction over the area in which the holding is situate, and the Revenue Divisional Officer may pass such order on the appeal, as he thinks fit.] [(3A) The order of the Revenue Divisional Officer under Sub-section (3) and the order of the Tahsildar of the other officer under Sub-section (2) in cases where no appear has been preferred under Subsection (3) within the time specified therefor or the appeal preferred has been dismissed, shall be final and the tenant shall be entitled to get the benefit of the remission so ordered. (3B) If in any proceeding under Sub-section (2) or Sub-section (3), any question arises as lo whether a person is or is not a tenant, it shall be competent for the Tahsildar or the other officer or the Revenue Divisional Officer, as the case may be, to decide such question for the purposes of this Section.] (4) Where, in respect of a holding, there is an intermediary and the rent to which the intermediary is entitled is reduced as a result of the remission granted under sub-section (2) or Sub-section (3), the rent payable by the intermediary to his landlord shall be reduced in the same proportion. Explanation.- For the purposes of this Section, the term crops shall include cereal as well as cash crops. 39. Abatement or reduction of rent.- (1) The fair rent determined under this Act shall be liable to alteration or revision on the application made by the cultivating tenant to the Land Tribunal on any ground specified in Sub-section (2) or Sub-section (3). (2) Where a portion of the land comprised in the holding is acquired under any law for the time being in force for the compulsory acquisition of land for public purposes or relinquished under the Kerala Land Relinquishment Act, 1958, the tenant shall be entitled to abatement of rent in the same proportion as the yield from the portion acquired or relinquished bears to the yield from the entire holding. (3) Where any material pan of the holding is wholly destroyed or rendered substantially and permanently unfit for the purpose for which it was let, by fire or flood or any other act of God, the rent payable shall be proportionately reduced. (4) Where in respect of a holding, there is an intermediary and the rent to which the intermediary is entitled is reduced as a result of the abatement in the rent granted under Sub-section (2) or reduction of rent granted under Sub-section (3), the rent payable by the intermediary to his landlord shall he reduced in the same proportion. 40. Invalidity of claims of dues other than rent payable.- Not with standing any contract to the contrary, express or implied , no tenant shall be liable to pay to his landlord any customary dues or renewal fees or anything more or anything else than the rent payable under this Act. 41. Arrears of rent to bear interest.- Arrears of rent shall bear interest at the rate of six per cent per annum or at the contract rate whichever is less. 42. Priority of claim for arrears of rent.- Arrears of rent due to the landlord, together with interest thereon, shall be a charge on the interest of the tenant, from whom they are due, in the holding and shall, subject to the priority of the rights of the Government and any local authority for arrears of land revenue, tax, cess or other dues, be a first charge on such interest of the tenant. 43. Publication of prices of commodities.- The District Collector shall cause to be published every quarter, in such manner as may be prescribed, prices prevailing in each taluk of paddy, coconut, areca-nut, pepper, groundnut, tapioca, cashew-nut and any other crop notified by the Government in this behalf: Provided that, before publishing such prices, the District Collector shall cause notice to be given to the public, in such manner as he thinks fit, of the prices proposed to be published and consider objections, if any, received within two weeks from the date of the notice. 44. Publications of statistics relating to gross produce of lands.- The Government shall cause to be published statistics of gross produce of different crops for different classes of land for different areas. 45. Tenant’s right to obtain receipt.- (1) Every tenant paying any rent shall be entitled to receive and the landlord shall be bound to grant a receipt containing such particulars as may be prescribed. (2) If any landlord fails to grant a receipt as provided under Subsection (1), the tenant shall be entitled to send by money order, after deducting the charges for doing so, (i) the money, if the rent is payable in money; and (ii) the money value of the rent, if it is payable in kind. [45A. Rent appropriated for period of stay to be adjusted towards rent for period after 1st May, 1966.- (1) Where, after the 19th day of May, 1967 and before the commencement of the Kerala Land Reforms (Amendment) Act, 1969, any tenant has paid or deposited any amount by way of rent, and such amount has been appropriated towards arrears of rent accrued due for the period prior to the 1st day of May, 1966, then notwithstanding anything contained in any law, or in any contract, custom or usage, or in any judgment, decree or order of any court or Land Tribunal, such amount shall be adjusted towards the rent accrued due for the period commencing on the 1st day of May,1966. (2) Where, in any judgment, decree or order of any court or ‘Land Tribunal passed after the 19th day of May, 1967, any amount paid or deposited by way of rent has been allowed or ordered to be appropriated towards arrears of rent accrued due for the period prior to the 1st day of May, 1966, such judgement, decree or order shall, on application within sixty days from the commencement of the Kerala Land Reforms (Amendment) Act, 1969, be re-opened by the court of Land Tribunal, as the case may be which passed such judgement, decree or order, and disposed of in accordance with the provisions of Sub-section (1).] 46. Application to land Tribunal when landlord refuses to accept a tender.- [(1) The tenant may apply to the Land Tribunal in the prescribed manner for permission to pay the arrears of rent due by him for any period through the Land Tribunal: Provided that no.such application shall be made, if an application or other proceeding for the recovery of such arrears is pending before the Land Tribunal.] (2) Along with the application under Sub-section (1) the tenant shall deposit with the Land Tribunal the said dues together with interest, if any, accrued thereon. [47. Procedure on application under Section 46.- (1)When an application and deposit have been made under Section 46, the Land Tribunal shall cause written notice thereof to be given at the cost of the applicant to every person who, in the opinion of the Land Tribunal is entitled to be heard thereon, and after hearing such of them as appear, by order, determine- (a) the amount of arrears due from the tenant for the period specified in the application under Sub-section (1) of Section 46 together with interest up to the date of deposit and costs, if any; and (b) the person or persons who is or are entitled or bound to receive such amount. (2) If the amount deposited by the tenant under Sub-section (2) of Section 46 is less than the amount referred to in clause (a) of Sub-section (1), the tenant shall deposit the balance amount due within such time as may be directed by the Land Tribunal. (3) If the tenant fails to deposit any amount under Sub-section (2) within Ow time allowed by the Land Tribunal in that behalf, the application shall be dismissed. (4) The Land Tribunal may also make such directions regarding costs, if any, awarded to the applicant and such other matters as the Land Tribunal may deem fit. (5) The deposit of arrears of rent and interest and costs, if any, in accordance with the provisions of this Section and Section 46 shall be a full discharge of the liability of the tenant for the rent due by him for the period specified in the application. (6) Nothing in Sub-section (5) shall affect the right of any person to recover the amount deposited by the tenant towards arrears of rent and interest from the person to whom it is paid by the Land Tribunal.] 48. Apportionment of rent on serve rance of interest of landlord or tenant.- [(1) Where, by act of parties or by operation of law, the interest of the landlord or of the tenant in the land demised has been severed, or a portion of the land demised has been sub-leased, the landlord or the tenant may apply to the Land Tribunal for the apportionment of the rent and the security for rent, if any.] (2) The application shall be in such form as may be prescribed. (3) The Land Tribunal shall, after giving an opportunity to all persons interested to be heard, pass an order on such application apportioning the rent and the security for rent, if any, and directing the execution of a lease deed on the basis of such apportionment, within a specified period and make such order as to the costs of the application as it may deem fit. (4) If, within the time fixed by the Land Tribunal, such deed is not executed, the Land Tribunal shall, on the application of the person in whose favour such deed is to be executed and on the deposit by such person of such amount as the Land Tribunal may direct, execute the deed on behalf of the person in default; and the Land Tribunal shall, by order, direct that the cost of the execution of the deed may be realised by the applicant from the person in default. [***] 49. Notice to landlord and intermediary when the interest in the holding of the tenant is acquired.- (1) Any person deriving an interest in the holding or part of the holding of a tenant by virtue of a title acquired by act of parties or by operation of law shall, where such interest is acquired after the commencement of the Kerala Land Reforms (Amendment) Act, 1969, within sixty days from the date of such acquisition, give registered notice of his interest in the holding or part of the holding to the landlord and the intermediaries, if any. The said notice, shall contain particulars of the property, its extent, the nature of the interest acquired and the date of acquisition of such interest. (2) Where default is made by a tenant in the payment of rent, his landlord shall give registered notice of the default to the persons who have acquired interest in the holding or part of the holding prior to the date of such default and who have notified the existence of their interest under Sub-section (1). The persons having interest in the holding shall be entitled to pay the arrears and the landlord shall be bound to receive such payment: Provided that a person who has acquired interest only in a part of the holding, shall be bound to pay only so much of the rent or arrears of the same, as will on apportionment fall on such portion of the holding. (3) Where there has been no agreement among the persons interested as to the apportionment referred to in the provision to Sub-section (2), the person who has acquired interest in the part of the holding may, within sixty days from the date of service of the notice of default, apply to the Land Tribunal for the apportionment, and the Land Tribunal shall, by order, make the apportionment. [***] 50. Rights of tenant to be heritable and alienable.- Subject to the provisions of this Act, all rights which a tenant has in his holding shall be heritable and alienable, [50A. Extent of tenant’s right to use his holding.- Notwithstanding anything contained in any law or contract, or in any judgement, decree or order of court, a tenant entitled to fixity of tenure shall have the right to use his holding in any manner he thinks fit: Provided that nothing contained in this Section shall be deemed to empower the tenant to use the holding in contravention of any order issued under the Essential Commodities Act, 1955. (2) Notwithstanding anything contained in any law or contract, or in any judgement, decree or order of court, where the tenant in respect of a nilam is a varamdar and the fishing right in that nilam is exercised by the landlord, such right of the landlord shall cease to exist and the tenant shall be entitled to exercise such right.] 51. Surrender by tenant.- [(1)] Notwithstanding anything contained in this Act, a tenant may terminate the tenancy in respect of any land held by him at any time by surrender of his [interest therein: Provided that no such surrender shall be made in favour of any person other than the Government:] Provided further that such surrender shall not be effective unless it is made in writing and is admitted by the tenant before the Land Tribunal [***] and is registered in the office of the Land Tribunal in the prescribed manner: [***] [(2) The Government shall pay to the landlord fair rent of the tenancy surrendered to it under Sub-section (1).] (3) The Government may let any land surrendered to it under Sub-section (1) to any person, as far as may be, in accordance with such rules as may be made under this Act. (4) The tenant to whom any land is let under Sub-section (3) shall pay the fair rent thereof directly to the landlord and the Government s liability under Sub-section (2) with regard to the payment of the rent of that land shall, on and from the date of induction of the tenant on such land, cease. [51A. Abandonment by a tenant.- (1) No landlord shall enter on any land which has been abandoned by a tenant, [(2) If a tenant abandons his holding and ceases to cultivate the holding either by himself or by some other person, the Government may, after notice to the tenant and the landlord and after hearing objections, if any, take possession of the land comprised in the holding.] (3) The Government shall pay to the landlord fair rent for the land taken possession of by them under Sub-section (2), from the date on which they take possession of such land. (4) The Government may let to another tenant any land, possession of which has been taken under Sub-section (2), as far as may be in accordance with such rules as may be made under this Act. (5) The tenant to whom any land is let under Sub-section (4) shall pay the fair rent thereof directly to the landlord and the Governments liability under Sub-section (3) with regard to the payment of the fair rent for such land shall, on and from the date of induction of the tenant on the land cease.] [51B. Landlord not to enter on surrendered or abandoned land.- if any landlord enters into the possession of any abandoned land or any land which has not been surrendered in accordance with the provisions of Section 51, he shall be deemed to have contravened the provisions of Section 6 of the Kerala Prevention of Eviction Act, 1966, and shall be punished accordingly.] 52. Rights as to timber trees.- (1) Notwithstanding any law, custom or contract to the contrary, all timber trees planted by the cultivating tenant or his predecessor-in-interest or spontaneously sprouting and growing in the holding after the commencement of the tenancy in favour of the cultivating tenant or his predecessor-in-interest, shall belong to the cultivating tenant. [(2) Subject to the provisions of Sub-sections (3) and (5), in the case of timber trees standing in the holding of a cultivating tenant at the commencement of his tenancy, the cultivating tenant shall have the right to cut and remove such trees, and the landlord or the intermediary shall not have the right to cut and remove such trees.] (3) Where the cultivating tenant exercises his right under Subsection (2), he shall be liable to pay to the landowner or the intermediary, as the case may be, one-half of the market value of the timber trees so cut and removed. [[***] (5) The right conferred by Sub-section (2) shall not be exercisable unless reasonable notice thereof in writing is given to the party to he affected by the exercise of the said right. (6) If any dispute arises as to the rights of the landowner, intermediary and cultivating tenant over timber, trees, the Land Tribunal shall, on the application of the landowner, intermediary or cultivating tenant, by order, decide the question after hearing all the persons interested. Purchase of landlord’s rights by cultivating tenants 53. cultivating tenant’s right to purchase landlord’s rights.- (1) Cultivating tenant (including the holder of a kudiyiruppu, and the holder of a karaima), entitled to fixity of a tenure under Section 13, shall be entitled to purchase the right, title and interest of the landowner and the intermediaries, if any, in respect of the land comprised in his holding: Provided that- (i) if the landlord is entitled to resume any portion of the holding under this Act and he applies for such resumption, the cultivating tenant shall be entitled to purchase the right, title and interest of the landowner and the intermediaries only in respect of the remaining portion of the holding; (ii) no cultivating tenant shall be entitled ed to purchase the right, title and interest in respect of any land under this Section if he, or if he is a member of a family, such family, owns an extent of land riot less than the ceiling area; (iii) Where the cultivating tenant or, if he is a member of a family, such family, does not own any land or owns an extent of land which is less than the ceiling area, he shall be entitled to purchase the right, title and interest in respect of only such extent of land as well, together with the !and, if any, owned by him or his family, as the case may be, equal to the ceiling area. Explanation.- In calculating the extent of land owned by the cultivating tenant or, where he is a member of a family, by such family, for the purposes of clause (ii) or clause MO of the proviso to this Sub-section, the portion of the land owned by such cultivating tenant or by the family, which is liable to be purchased by the cultivating tenants holding under such tenant or family shall not be taken into account. [(2) The provisions of Section 82 shall, so far as may be, apply to the calculation of the ceiling area for the purposes of Sub-section: Provided that if no date has been notified under Section 83, the date of application by the cultivating tenant under Section 54 shall be deemed to be the date notified under Section 83.] 54. Application for purchase of landlord’s rights by cultivating tenants.- (1) A cultivating tenant entitled to purchase the right, title and interest of the landowner and the intermediaries under Section 53 may be apply to the Land Tribunal for the purchase of such right, title and interest. (2) The application for the purchase under Sub-section (1) shall be in such form and shall contain such particulars as may be prescribed. [(3) ***] (4) Where a cultivating tenant is entitled to purchase the right, title and interest in respect of only a portion of the land held by him, he may indicate in the application, his choice of the portion, the right, title and interest over which he desires to purchase. 55. Purchase price.- The price payable by the cultivating tenant for the purchase of the right, title and interest of the landowner and the intermediaries, if any, shall be the aggregate of: (i) sixteen times the fair rent in respect of the holding or part thereof to which the purchase relates; (ii) the value of structures, wells and embankments of a permanent nature belonging to the landowner or the intermediaries, if any; and (iii) one-half of the value of timber trees belonging to the landowner or the intermediaries, if any: [Provided that where the aggregate of the value of structures, wells and embankments and one-half of the value of timber trees referred to in clauses (ii) and (iii) exceeds sixteen times the fair rent in respect of the holding or part thereof to which the purchase relates, such aggregate value shall, for the purpose of calculating the purchase price, be limited to sixteen times, such fair rent.] Explanation.- For the purposes of this Section; where the rent is payable in kind, the money value of the rent shall be computed at the average of the prices of the commodity for the six years immediately preceding the year of determination of the purchase price, and, in calculating the average of the prices, the prices, if any, published under Section 43 may also be taken into account. 56. Purchase price to be distributed among the landowner and intermediaries.- (1) Where the right, title and interest of the landowner and the intermediaries in respect of a holding have been purchased by the cultivating tenant, the purchase price paid by the cultivating tenant shall be paid to the landowner or apportioned among the landowner and the intermediaries, as the case may be, in accordance with the provisions of Sub-sections (2)and(3). (2) Where there is no intermediary, the landowner shall be entitled to the entire purchase price paid by the cultivating tenant. (3) Where there is an intermediary or there are intermediaries- (i) the amount of 16 times the fair rent paid by the cultivating tenant shall be apportioned among the landowner and the intermediary or intermediaries in proportion to the profits derived by them from the holding; and (ii) the value of structures, wells and embankments of a permanent nature and half the value of the timber trees paid by the cultivating tenant shall be payable to the land-owner or the intermediary to whom such structures, wells, embankment, and timber trees belong: [Provided that where the aggregate of the value of structures, wells and embankments and one-half of the value of timber trees has been limited to sixteen times the fair rent under the proviso to Section 55, the amount payable under this clause to the landowner and the intermediary or intermediaries shall be sixteen times such fair rent apportioned among the landowner and intermediary or intermediaries in proportion to the value of the structures, wells, embankments and limber trees belonging to each of them.] Explanation.- “Profits derived from the holding” shall, for the purposes of this Sub-section, mean, in the case of the landowner, the rent to which he is entitled and, in the case of an intermediary, the difference between the rent due to him from his tenant and the rent for which the intermediary is liable to his landlord [and where there is no evidence as to the rent for which the intermediary is liable to his landlord, it shall be presumed that such rent is one-half of the rent payable to the intermediary by his tenant.] 57. Procedure before the land Tribunal.- (1) As soon as may be after the receipt of the application under Section 54, the Land Tribunal shall give notice to the landowner, the intermediaries and all other persons interested in the holding, to prefer claims or objections with regard to the application, [***] (2) The Land Tribunal shall, after considering the claims and objections received and hearing any person appearing in pursuance of the notice issued under Sub-section (1) and after making due enquiries, pass orders: (i) on the application, if any, pending before it from the landowner or intermediary for resumption, in accordance with the provisions of Section 22; and (ii) on the application for purchase under Section 54. (3) Where the cultivating tenant is entitled to purchase only a portion of the land left after resumption, the Land Tribunal shall, as far as possible, allow the purchase of the portion indicated in the application under Sub-section (3) of Section 54. [(3A) Where the right, title and interest of the landowner or the intermediary vested in the cultivating tenant form part of the security for any encumbrance or charge for maintenance or alimony, the Lond Tribunal shall, for the purpose of discharging the same apportion the entire encumbrance or of the charge for the maintenance or ,alimony between the portion of the land, the right, title and interest over which vested in the tenant and the portion remaining after such vesting, in proportion to the values of the two portions Of the property; and discharge only the liability pertaining to the portion to which the purchase relates.] (4) An order under clause (ii) of Sub-section (2) allowing the application shall specify: (i) the purchase price payable by the cultivating tenant; (ii) the amount due to the landowner and each of the intermediaries, if any, on the apportionment of the purchase price paid by the cultivating tenant: (iii) the value of encumbrances subsisting or claims for maintenance or alimony charged on the right, title and interest of the landowner and the intermediaries, if any; (iv) the amount payable to the holder of the encumbrance or the person entitled to the maintenance or alimony [and the order of priority in which such amount is payable;] and (v) the amount payable to the landowner and each of the intermediaries after deducting the value of the encumbrances or the claims for maintenance or alimony, (5) If the landowner or intermediary is liable to pay any amount to the cultivating tenant under this Act, the Land Tribunal shall, in passing orders on the application for purchase, set off such amount against the purchase price payable to the landowner or the intermediary. (6) The Land Tribunal shall, as soon as may be, forward a copy of the orders under Sub-section (2) to the Land Board. 58. Purchase price payable in instalments or hi lump.- The put chase price determined under Section 57 shall be payable in sixteen equal annual instalments: Provided that where the purchase price is less than Rs. 160, the number of instalments shall be so fixed by the Land Tribunal that the amount payable in each instalment shall not be less than Rs. 10: Provided further that it shall be open to the cultivating tenant to pay the entire purchase price in a Jump, in which case the amount payable shall be only seventy-five per cent of the purchase price. 59. Deposit of purchase price and issue of certificate of purchase.- (1) Where an application under Section 54 has been allowed and the purchase price determined under Section 57 by the Land Tribunal, the cultivating tenant shall deposit with the Land Tribunal to the credit of the Land Board:- (i) where the purchase price is proposed to be paid in a lump, the entire amount due within one year; or (ii) Where the purchase price is proposed to be paid in instalments, the first instalment thereof within [six months] from the date on which the order of the Land Tribunal under Section 57 has become final. [Provided that Land Tribunal may, on application by the cultivating tenant before the expiry of the said period of one year of six months as the case may he, extend the period for making such deposit, so however that the period so extended shall riot exceed three months.] (2) On the deposit of the purchase price in a lump or of the first instalment of such price, the Land Board shall issue a certificate of purchase to the cultivating tenant and thereupon the right, title and interest of the landowner and the intermediaries, if any, shall vest in the cultivating tenant free from all encumbrances with effect [from the date of the application under Section 54.] The certificate of purchase shall be conclusive proof as the purchase by the tenant of the right, title and interest of the landowner and intermediary, if any, over the holding or portion thereof. [Explanation.- For the removal of doubts, it is hereby declared that on the issue of the certificate of purchase, the landowner or any intermediary shall have no right in the land comprised in the holding and all his rights including rights, if any, in respect of trees reserved for his enjoyment shall stand extinguished.] (3) Where a cultivating tenant fails to deposit the purchase price in lump or the first instalment thereof, on or before the due date, the order of the Land Tribunal under Section 57 shall stand cancelled arid the cultivating tenant shall continue as cultivating tenant. (4) Where the purchase price is paid in instalments, the second and subsequent instalments shall be deposited in the Government treasury in the prescribed manner to the credit of the Land Board. [60. Interest on defaulted instalments.- lithe second or any subsequent instalment of the purchase price is not deposited on the due date, the amount of such instalment shall bear interest at the rate of 41/2 per cent per annum from that dare till the date of deposit of that instalment.] 61. cultivating tenant to pay rent pending determination of purchase price.- (1) Notwithstanding the filing of an application under Section 54, the cultivating tenant shall, pending the determination of the purchase price under Section 55 or, where there has been an appeal against the determination of the purchase price, pending orders on such appeal, deposit with the Land Tribunal an amount equal to the rent which would have been payable by him on the dates on which such rent would have become due if the land were not purchased: Provided that the Land Tribunal may:- (a) on application by the cultivating tenant for sufficient reason allow the applicant to make the deposit after the due date; (b) allow any cultivating tenant to deposit the balance amount, if any where the amount deposited is found to be less than the amount of rent. (2) the Land Tribunal shall, after intimating the Landlord, pay the amount deposited under Sub-section (1) to the landowner and intermediaries if any, as part payment of the purchase price on taking proper security in case it is found that they arc entitled to such amount. (3) The amount deposited under Sub-section (1) shall be deducted from the purchase price payable by the cultivating tenant and he shall’ be liable to pay only the balance. 62. Recovery of instalments of purchase price on default.- for the purchase price payable by the cultivating tenant, there shall be a first charge on the land to which the purchase relates, subject to the charges for any dues payable to the Government. Where the second or any subsequent install meat is not deposited on the due date, the Land Board may, on application from any person entitled to the instalment of the purchase price in default or any part thereof, pass an order directing the payment of the amount [together with interest thereon] and the order of the Land Board may be executed through the court as if it were a decree passed by it: Provided that where the right, title and interest of the landowner or intermediary which is a religious, charitable or educational institution of a public nature have vested in the Government under Section 66, the instalment of the purchase price in default or any part thereof due to the Government [together with interest thereon] shall be recoverable us an arrear of land revenue under the provisions of the Revenue Recovery Act for the time being in force. 63. Payment of purchase price, amount of encumbrance, maintenance or alimony.- (1) The purchase price payable to the landowner. arid the intermediaries shall be distributed by the Land Board according to the provisions of Sub-sections (2) to (9). (2) Where the right, title and interest of the landowner or the intermediaries are not subject to any encumbrance or charge for maintenance or alimony, the purchase price paid by the cultivating tenant shall be paid to the landowner or apportioned among the landowner and the intermediaries in the manner specified in Sub-section (2) or Sub-section (3), as the case may be, of Section 56. [(3) Where the right, title and interest of the landowner or any intermediary in respect of a holding are subject to any encumbrance or charge for maintenance or alimony, the purchase price paid by the cultivating tenant shall:- (i) if there is no intermediary, be paid to the landowner after deducting the value of encumbrance or charge for maintenance or alimony; (ii) if there is an intermediary, or there are intermediaries, be apportioned among the landowner and the intermediary or intermediaries in the manner specified in Subsection (2) or Sub-section (3), as the case may be, of Section 56, and the value of the encumbrance, maintenance or alimony shall be deducted from the purchase price payable to the landowner or the intermediary or intermediaries, as the case may be and the balance amount shall be paid to the landowner or intermediary or intermediaries. If the total amount of such encumbrance, maintenance or alimony is equal to or more than the amount of the purchase price payable to the landowner or the intermediary, the whole amount shall be reserved for payment to the holder of the encumbrance, Or the person entitled to the maintenance or alimony and no amount shall be paid to the landowner or the intermediary, as the case may be.] [(3) and (4) ***] (5) Where any amount has been deducted or reserved for payment to the holders of the encumbrances or the persons entitled to the maintenance or alimony, the same shall be paid in their order of priority to the persons entitled thereto. (6) Where the cultivating tenant pays the purchase price in instalments, the amount of each instalment shall be distributed in the manner specified above. The interest on the purchase price paid by the cultivating tenant shall also be paid to the landowner, intermediary, holder of the encumbrance or the person entitled to the maintenance or alimony, as the case may be. (7) Where a person entitled to the purchase price or the value of the encumbrance maintenance or alimony dies before it is paid to him, it shall be paid to his legal representatives: [Provided that if such person has, in accordance with the rules made in this behalf, nominated any member of his family to receive the amount, the same shall be paid to such nominee. Explanation.- For the purposes of the preceding proviso, “member of family” means wife or husband, son or daughter.] (8) Where the person entitled to receive the purchase price or the value of encumbrance is a private trust or endowment or a minor or a person suffering from some legal disability or a limited owner, the purchase price or the value of encumbrance may, notwithstanding anything contained in any law, but subject to any general directions that the Government may give be deposited for and on behalf of the person with such authority or bank as may be prescribed. (9) Where before any court or authority any suit or proceed in( is pending which directly or indirectly affects or is likely to affect the right of any person to receive the whole or part of the purchase price on the amount of encumbrances or maintenance or alimony payable authority. under this Act, the court or authority may require the land Board to place at its disposal the amount so payable and thereupon the same shall be disposed of in accordance with the orders of the court or the landowner or authority. 64. The payment of purchase price to the landowner or intermediary to be full discharge.- The payment of purchase price or the value of encumbrance, maintenance or alimony to the landowner or intermediary or other person entitled thereto in the manner specified in Section 63 shall be a full discharge of the liability for payment of purchase price to the landowner and the intermediaries, and no further claims for payment of purchase price shall lie. [65. Special provisions relating to religious charitable or educational institution of a nature.- (1) Notwithstanding anything contained in Sections 53 to 64, where in respect of a holding the landowner or the intermediary is a religious, charitable or educational institution of a public nature, such institution may, by application to the Land Board, choose whether the right, title and interest of the institution in respect of the holding should be vested in the Government in consideration of the payment of an annuity in perpetuity by the Government or whether it should be paid such annuity by the Government instead of purchase price in case the holding is purchased by the cultivating tenant under the provisions of this Act: Provided that no such application shall be entertained by the Land Board on or after the date notified by the Government under Section 72. [Explanation.- in this Sub-section, the expression institution of a public nature includes a public trust and a wakf.] (2) If any question arises as to whether an institution is a religious, charitable or educational institution of a public nature, the question shall be decided by the Land Board after such enquiry as it deems fit, and its decision thereon shall be final. (3) The annuity payable to an institution in respect of a holding shall be:- (a) Where such institution is the landowner, an amount equal to the rent to which it would be entitled if fair rent were determined in respect of the holding, after deducting 2 1/2 per cent thereof by way of collection charges: (b) Where such institution is the intermediary, an amount equal to the difference between the rent due to such institution from its tenant and the rent for which such institution is liable to its landlord if fair rent were determined in respect of the holding, after deducting 2 1/2 per cent of such difference by way of collection charges. Explanation I.- For the purpose of this Sub-section, “fair rent” means, the fair rent that would be determined under the provisions of this Act as amended by the Kerala Land Reforms (Amendment) Act, 1969. Explanation II.- Where the rent payable to a, institution is in kind, the annuity payable shall be commuted into money at the average of the prices of the commodity for six years immediately preceding the year in which the annuity is determined.] [66. Procedure for vesting of rights of religious, charitable or educational institutions in Government and for determination of annuity.- (1) An application under Sub-section (1) of Section 65 shall specify ail the holdings in respect of which the institution desires to be paid annuity. (2) The application shall be in such form as may be prescribed. (3) On receipt of such application, the Land Board shall direct any Land Tribunal, or the Land Tribunals within whose jurisdiction the holdings specified in the application are situate, to determine the annuity payable to the institution. (4) Notwithstanding anything contained in Sub-section (3), the Land Board shall have power to reject an application referred to in Sub-section (1) at any time before the date of the notification under Sub-section (9), if it is found that the institution is not a religious, charitable or educational institution of a public nature or on any other ground to be recorded in writing: Provided that, before rejecting the application, the institution shall be given an opportunity of being heard. (5) On receipt of a direction under Sub-section (3) the Land Tribunal shall, subject to such rules as may he made by the Government in this behalf, by order in the prescribed form determine;- (a) the fair rent in respect of the holding under the provisions of this Act as amended by the Kerala Land Reforms (Amendment) Act, 1969; (b) the annuity pay, the to the institution in respect of the holding; (c) where the right, title and interest of the institution in respect of the holding form security for any encumbrance the amount of the encumbrance and, where there are more encumbrances than one, the order of priority of each of such encumbrances; and (d) such other matters as may be prescribed. (6) The annuity determined under Sub-section (5) shall be paid:- (a) in the case of a holding included in a notification under Sub-section (9), from the date specified in that notification; (b) in the case of a holding, the right, title and interest of the landowner and intermediaries in respect of which have been purchased by the cultivating tenant, from the date on which the right, title and interest of the institution in respect of its other holdings have vested in the Government under Sub-section (9) of Section 72, whichever is earlier; (c) in the case of any other holding, from the date notified under Section 72. (7) The fair rent in respect of a holding determined under Subsection (5) shall, subject to the provisions of Section 5102 and 103, be the fair rent for the purposes of Section 72A and 72D. (8) As soon as may be after the determination of the annuity under Sub-section (5), the Land Tribunal shall forward a statement in the prescribed form together with a copy of the order under that Sub-section, to the Land Board, and the Land Board shall have power to return such statements to the Land Tribunal for the purpose of correcting patent mistakes or errors apparent on the face of the record, (9) As soon as may be after the determination of the annuity in respect of all holdings specified in the application under Sub-section (l) of Section 65 (other than holdings in respect of which certificates of purchase have been issued), the Government shall issue a notification in the Gazette declaring that the right, title and interest of the institution in respect of such holdings shall vest in the Government with effect from a date to be specified in the notification, and all such right, title and interest shall accordingly vest in the Government free from all encumbrances.] [67. Payment of annuity.- The Government shall pay the annuity payable to the institution every year in perpetuity on such date or dates and in such manner as may be prescribed: Provided that no annuity in respect of a holding shall be paid if the purchase price in respect of that holding has been paid, or deposited in pursuance of Sub-section (8) of Section 63: Provided further that where the right, title and interest of the institution are subject to any encumbrance on the date on which such right, title and interest have vested in the Government:- (i) the value of the encumbrance shall be paid to the holder of the encumbrance; and (ii) five per sent of the value of the encumbrance shall be deducted from the annuity and the balance, if any, alone shall be paid to the institution; Provided also that where the value of the encumbrance is more than sixteen times the annuity:- (i) if there is only one encumbrance, sixteen times the annuity shall be paid to the holder of the encumbrance; and (ii) if there are more than one encumbrance, sixteen times the annuity shall be paid to the holders of the encumbrances in their order of priority, and in either case, no amount by way of annuity shall be payable to the institution.] [68. Vesting of the rights of religious, charitable, or educational institutions in the Government not to operate as bar to the purchase of landlord’s rights by cultivating tenants.- The filing of an application by a religious, charitable or educational institution of a public nature under Sub-section (1) of Section 65 or the vesting of the right title and interest of the institution in the Government under Sub-section (9) of Section 66 shall not affect the right of the cultivating tenant to purchase such right, title and interest in accordance with the provisions of Section 53 to 64.] [69. Government entitled to purchase price in certain cases.- Where the right, title and interest of a religious, charitable or educational institution of a public nature in respect of a holding are purchased by the cultivating tenant and the institution has, under Sub-section (1) of Section 65, expressed its choice for annuity instead of purchase price in respect of that holding, the Government shall, notwithstanding any order of any court or Land Tribunal, be entitled, subject to the provisions of Section 70, to the purchase price payable to the institution.] [70. Institution entitled to rent for certain period.- Where the right, title and interest of a religious, charitable or educational institution of a public nature in respect of a holding arc purchased by the cultivating tenant and the institution is entitled to annuity in respect of that holding, the institution shall also be entitled from and out of the purchase price to an amount equal to the rent to which it would have been entitled for the period commencing on the date of application for purchase by the Cultivating tenant and ending with the date on which the institution is entitled to annuity, if fair rent had been deter-mined for the holding under this Act as amended by the Kerala Land Reforms (Amendment) Act, 1969, after deducting any amount received by the institution under Sob-section (2) of Section 61.] [71. Tenant holding under institution to Continue as tenant under the Government.- (1) Where a cultivating tenant does not apply for the pure hose of the right, title and interest in respect of his holding vested in the Government under Sub-section (9) of section 66 the tenant holding directly under the religious, charitable or educational institution of a public nature shall continue as tenant under rue Government. (2) The rent payable by such tenant to the Government shall, on default, be recoverable as an arrear of land revenue under the Revenue recovery Act for the time being in force.] [72. Vesting of landlord s fights its Government.- (1) On a date to be notified by the Government in this behalf in the Gazette, all right, title and interest of the landowners and intermediaries in respect of holdings held by cultivating tenants (including holders of kudiyirippus and holders karaimas) entitled to fixity of tenure under Section 13,and in respect of which certificates of purchase under Sub-section (2) of Section 59 have not been issued, shall, subject to the provisions of SH lion, vest in the government free from all encumbrances created by the landowners and intermediaries and subsisting thereon the said date: Provided that nothing contained in this Sub-section shall apply to a holding or part of a holding in respect of which an application for resumption under the provisions of this Act is pending on such date before ,my court or tribunal or in appeal or revision. (2) Where in the case of a holding or part of a holding mentioned in the proviso to Sub-section (I) the order rejecting the application for resumption, either in part or in full, has become final, the right, title and interest of the landowner and the intermediaries, if any, of the holding or part of the holding, as the case may be, in respect of which resumption has not been allowed shall, with effect from the date on which the application for resumption has been finally rejected, vest in the Government free from all encumbrances created by the landowner and the intermediaries, if any, and subsisting thereon on the said date. (3) Where any land or portion of a land is restored to the possession of any person under the provisions of this Act after the daily notified under Sub-section (1), the right, title and interest or the land-owner and intermediaries, if any, in respect of such land or portion of land shall, from the date of such restoration, vest in the Government free from all encumbrances created by the landowner and intermediaries and subsisting thereon on the said date. (4) Where in the case of a holding or part of a holding, the land owner or an intermediary is a minor or a person of unsound minor a member of the Armed Forces or a seaman or a legal representative of any such member or seaman, or a small holder, the not, title sand interest of the landowner and intermediaries, if any, in respect of such holding or part of a holding shall vest in the Government:- (a) on the expiry of six month, from the commencement of the Kerala Land Reforms (Amendment) Act, 1969, or on the date notified under Sub-section (1), whichever is later, in cases where no application for resumption of the holding or part of the holding has peen preferred; (b) in any case where application for resumption has been preferred, on the date on which the order rejecting such application either in part or in full, has become final or or, the date notified under Sub-section (1), whichever is later. (5) Where an intermediary has resumed any land under the pro-visions of the, Act, the right, title and interest-of the landowner and the other intermediaries in any, in respect of the said land shall vest in the Government free from all encumbrances created by the land owner and other intermediaries with effect from the date resumption or the date notified under the Sub-section (1) whichever is latter.] [72A. Compensation to landlords for vesting of their rights in Government.- (1) very landowner and intermediary whose right, title and interest in respect of any holding have vested in the Government under Section 72 shall be entitled to compensation as provided in Sub-sections (2), (3) and (4). (2) The compensation payable to the landowner and intermediaries under Sub-section (1) shall be the aggregate of:- (a) sixteen times the fair rent of the holding or part thereof, the right, title and interest in respect of which have vested in the Government; (b) the value of structures, wells and embankments of a permanent nature belonging to the landowner and the intermediaries, if any; and (c) one-half of the value of timber trees belonging to the landowner and the intermediaries, if any: Provided that where the aggregate of the value of structures, wells and embankments and one-half of the value of the timber trees referred to in clauses (b) and (c) exceeds sixteen times the fair rent in respect of the holding or part thereof, as the case may be, such aggregate value shall, for the purpose of calculating the compensation under this Sub-section, be limited to sixteen times such fair rent. Explanation I.- For the purposes of this Section and Section 72 D, “fair rent” means the fair rent under this Act as amended by the Kerala Land Reforms (Amendment) Act, 1969. Explanation II.- For the purposes of this Section, where the rent is payable in kind, the money value of the rent shall be commuted at the average of the prices of the commodity for the six years immediately preceding the year in which the right, title and interest of the land owner and the intermediaries have vested in the Government, and in calculating the average of the prices, the prices, if any, published under Section 43 may also be taken into account. (3) Notwithstanding anything contained in Sub-section (2), where the total compensation due to a landlord in respect of holdings held by cultivating tenants, after deducting the value of encumbrances and claims for maintenance or alimony, is more than twenty thousand rupees, the compensation payable to such landlord shall be limited to the amount specified in the Table below:-
Table Scales of Compensation
| Total Amount Of Compensation |
Rate |
| On the first Rs. 20,000 |
100 percent |
| On the next Rs. 10,000 |
95 per cent |
| On the next Rs. 10,000 |
90 per cent |
| On the next Rs. 10,000 |
85 percent |
| On the next Rs. 10,000 |
80 percent |
| On the next Rs. 10,000 |
75 per cent |
| On the next Rs. 10,000 |
70 per cent |
| On the next Rs. 10,000 |
65 per cent |
| On the next Rs. 10,000 |
60 per cent |
| On the next Rs. 10,000 |
55 percent |
| On the next Rs. 10,000 and above |
50 percent |
(4) Where the landowner or intermediary of a holding or part of a holding is entitled to receive fifty per cent of the compensation in respect of that holding or part in a lump under Section 72H, the compensation payable to such landowner or intermediary, as the case may be, in respect of that holding or part shall, subject to the provisions of Sub-section (3), be 75 per cent of the amount calculated under Sub-section (2).] [72B. Cultivating tenants right to assignment.- (1) The cultivating tenant of any holding or part of a holding, the right, title and interest in respect of which have vested in the Government under Section 72, shall be entitled to assignment of such right, title and interest: Provided that- (a) no cultivating tenant shall be entitled to assignment of the right, title and interest in respect of any holding or part of a holding under this Section if he, or if he is a member of a family, such family, owns an extent of land not less than-the ceiling area. (b) where the cultivating tenant or, if he is a member of a family, such family, does not own any land or owns an extent of land which is less than the ceiling area, he shall be entitled to the assignment of the right, title and interest in respect of only such extent of land as will, together with the land, if any, owned by him or his family, as the case may be, be equal to the ceiling area. Explanation.- In calculating the extent of land owned by the cultivating tenant or, where he is a member of a family, by such family, for the purposes of clauses (a) and (b) of the foregoing proviso, the portion of the land owned by such cultivating tenant or by the family, which is liable to be assigned to the cultivating tenants holding under him or such family, shall not be taken into account. (2) The provisions of Section 82 shall, so far as may be, apply to the calculation of the ceiling area for the purposes of the proviso to Sub-section (1); Provided that if no date has been notified under Section 83, the date notified under Section 72 shall be deemed to be the date notified under Section 83. (3) Any cultivating tenant entitled to assignment of the right, title and interest in respect of a holding or part of a holding under Sub-section (1) may apply to the Land Tribunal within whose jurisdiction such holding or part is situate within two years from the dote of vesting of such right, title and interest in the Government under Section 72, or such further time as may be allowed by the Government in this behalf, for such assignment to him. (4) An application under Sub-section (3) shall contain the following particulars, namely:- (a) the village, survey number and extent of the holding or part to which the assignment relates. (b) the name and address of the landowner and intermediaries and also of every other person interested in the land and the nature of their interest so far as they arc known to him; (c) the particulars regarding the other lands owned or held by him or if he is a member of a family; by such family; and (d) such other particulars as may be prescribed. (5) Where a cultivating tenant is entitled to the assignment of the right, title and interest in respect of only a portion of the holding held by him, he may indicate in the application under Sub-section (3) his choice of the portion to which the assignment shall relate.] [72BB. Right of landlord to apply for assignment and compensation.- (1) Any landowner or intermediary whose right, title and interest in respect of any holding have vested in the Government may apply to the Land Tribunal for the assignment of such right, title and interest to the cultivating tenant and for the payment of the compensation due to him under Section 72A. (2) An application under Sub-section (1) shall contain the following particulars, namely:- (a) the village, survey number and extent of the holding to which the assignment relates: (b) the name, and address of the cultivating tenant, landowner and intermediaries and also of every other person interested in the land and the nature of their interest, so far as they are known to the applicant; (c) the particulars regarding the other lands held by the cultivating tenant so far as may be known to the applicant; (d) the fair rent, if any, fixed, and the contract rent, if any, of the holding; (e) such other particulars as may be prescribed. [72C. Assignment where application is not made by cultivating tenant.- Notwithstanding anything contained in Sub-section (3) of Section 72B [or Section 72BB], the Land tribunal may, subject to such rules as may be made by the Government in this behalf, at any time after the vesting of the right, title and interest of the landowners and intermediaries in tile Government under Section 72, assign such right, title and interest to the cultivating tenants entitled thereto, and the cultivating tenants shall be bound to accept such assignment.] [72D. Purchase price.- (1) The cultivating tenant shall be liable to pay purchase price to the Government on the assignment to him of the right, title and interest of the landowner and the intermediaries, if any. [(1A) Where the total extent of land held as tenant by a cultivating tenant is one hectare or below, he shall not be liable to pay purchase price under Sub-section (1). Explanation.- For the removal of doubt it is hereby clarified that the benefit conferred to a cultivating tenant until r this Sub-section shall not affect the eligibility of the landowner or intermediary, if any, to receive compensation to which he is entitled under the Act.] (2) The purchase price referred to in Sub-section (1) shall be the aggregate of: (a) sixteen times the fair rent of the holding or part thereof, the right, title and interest in respect of which have been assigned to the cultivating tenant; (b) the value of structures, well and embankments of a permanent nature which belonged to the landowner and the intermediaries, if any, at the time of vesting in the Government: (c) one-half of the value of timber trees which belonged to the landowner and the intermediaries, if any, at the time of vesting in the Government; Provided that where the aggregate of the value of structures, wells and embankments and one-half of the value of timber trees referred to in clauses (b) and (c) exceeds sixteen times the fair it in respect of the holding or part thereof, as the case may be, such aggregate value shall, for the purpose of calculating the purchase price under this Sub-section, be limited to sixteen times such fair rent. Explanation.- For the purposes of this Section, where the rent is payable in kind, the money value of the rent shall be commuted at the average of the prices of the commodity for the six years immediately preceding; the year in which the right, title and interest of the landowner and intermediaries have vested in the Government, and in calculating the average of the prices, the prices, if any, published under Section 43 may also be taken into account.] [72E. Rent of holdings vested in Government but riot assigned to cultivating tenants.- Where in respect of any holding or part thereof, the right, title and interest of the landowner and intermediaries have vested in the Government under Section 72 and the cultivating tenant is not entitled to the assignment of such right, title and interest by virtue of Sub-section (1) of Section 728, the cultivating tenant shall be liable to pay to the Government the rent payable under this Act from the date of vesting under Section 72.] [72EE. Constitution a village committees.- (1) The Government shall by notification in the Gazette, constitute a village committee for each village for the purpose of performing the functions of the village committee under this Act. (2) The village committee shall consist of the village officer and six other members nominated by the Government. (3) The village officer shall be the convener of the village committee. (4) The village committee shall elect one of its members to be its chairman. (5) Three members of the village committee shall constitute the quorum at any meeting of the committee.] [72F. Land Tribunal to issue notices and determine the compensation and purchase price.- (1) As soon as may be after the right, title and interest of the landowner and the intermediaries, if any, in respect of a holding or part of a holding have vested in the Government under Section 72, or, where an application under Section 72B [or Section 72BB] has been received by the Land Tribunal, as soon as may be after the receipt of such application, the Land Tribunal shall publish or cause to be published a public notice in the prescribed form [in such manner] as may be prescribed, calling upon- (a) the landowner, the intermediaries, if any, and the cultivating tenant; and (b) all other persons interested in the land, the right, title and interest in respect of which have vested in the Government, to prefer claims and objections, if any, within such time as may be specified in the notice and to appear before it on the date specified in the notice with all relevant records to prove their respective claims or in support of their objections. (2) The Land Tribunal shall also issue a notice individually to the landowner, each of the intermediaries and the cultivating tenant and also, as far as practicable, to the other persons referred to in clause (b) of Sub-section (1) calling upon them to prefer claims and objections if any within such time as may be specified in the notice and to appear before it on the date specified in the notice with ail relevant records to prove their respective claims or in support of their objections. (3) Notwithstanding anything contained in Sub-section (2), the publication of a notice [in the manner referred to in Sub-section (1)] shall be deemed to be sufficient notice to the landowner, the intermediaries, if any, the cultivating tenant and all other persons interested in the land. [(3A) The Land Tribunal shall furnish a copy of the public notice under Sub-section (1), along with a statement containing the names and addresses of the persons to whom individual-notices have been issued under Sub-section (2).and such other particulars as may be prescribed, to the village committee of the village in which the holding is situate, or, where the holding is situate in more than one village, the village committee of each such village and require the village committee or village committees, as the case may be, to advise the Tribunal on the matters mentioned in Sub-section (3B) before such date as may be specified in the requisition. (3B) On receipt of the copy of the public notice and the statement from the Land Tribunal under Sub-section (3A), the village committee, or each of the village committees shall, after such inquiry as may be prescribed, advice the Land Tribunal in respect of the following matters, namely:- (a) The names and address of the landowner, the intermediaries, if any, and the cultivating tenant; (b) the names and address of all other persons interested in the land; (c) such particulars as are necessary for the identification of the land comprised in the holding, as may be prescribed; (d) the value of encumbrances subsisting or claims for maintenance or alimony charged on the right, title and interest of the landowner and intermediaries, if any; (e) the amount due to the holders of encumbrances or the persona entitled to maintenance or alimony and the order of priority in which the amount is payable; and (f) such other matters as may be prescribed.] (4) Any person interested in the land, to whom no notice under Sub-section (2) has been issued, may apply to the Land Tribunal stating the nature of his claim or objection and the relief he requires. [(5) The Land Tribunal shall, after considering the claims and objections received in pursuance of the nonce issued under Sub-section (1) or Sub-section (2) and the advice received from the village committee or village committee before the date specified therefore and hearing any person appearing in pursuance of the notice issued under Sub-section (1) or sub-Section (2) and after making due enquiries, pass an order specifying-] (a) the extent, survey number and such other particulars as may be prescribed, of the land, the right, title and interest in respect of which have vested in the Government under Section 72; (b) the compensation due to the landowner and intermediaries, if any; (c) the amount due to the landowner and each of the intermediaries, if any, on the apportionment of the compensation; (d) the value of encumbrances subsisting or claims for maintenance or alimony charged on the right, title and interest of the landowner and the intermediaries, if any; (e) the amount due to the holders of encumbrances or the persons entitled to maintenance or alimony, and the order of priority in which the amounts payable; (f) the amount payable to the landowner and each of the intermediaries after deducting the value of encumbrances of claims for maintenance or alimony; (g) the purchase price payable by the cultivating tenant; (h) the rent payable by the cultivating tenant to the Government in the cases falling under Section 72E; [***] [(hh) where the landowner or intermediary is a religious, charitable or educational institution of a public nature and is entitled to annuity instead of compensation, the amount of such annuity; and] (i) such other particulars as may be prescribed. (6) Where the right, title and interest of the landowner or the intermediaries in respect of a holding or part of a holding vested in the Government form part of the security’ for any encumbrance or charge for maintenance or alimony, the Land Tribunal shall, for the purpose of determining the value of the encumbrance or the claim for the maintenance alimony relating to that holding or part, as the case may be, apportion the entire encumbrance or the charge for the maintenance or alimony between such holding Or part and the remaining lands which form the security for the encumbrance or the charge for the maintenance or alimony, in proportion to the values of the two portions. (7) If the landowner or any intermediary is liable to pay any amount to the cultivating tenant under this Act, the Land Tribunal shall, in passing orders under this Section, set of such amount against the compensation payable to the landowner or that intermediary. (8) Where cultivating tenant is entitled to the assignment of the right, title and interest in respect only of a portion of the land held by him (whether included in one holding or not), the Land Tribunal shall, as far as possible, assign to the cultivating tenant the right, title and interest in respect of the portion of his choice.] [72G. Apportionment of compensation by the Land Tribunal.- (1) The compensation payable to the landowner and the intermediaries, if any, for the vesting of their right, title and interest in respect of a holdings in the Government under Section 72 shall be apportioned among the landowner and the intermediaries, as the case may be, in accordance with the provisions of Sub-sections (2) and (3). (2) The amount of sixteen times the fair rent of the holding or part, the right title and interest in respect of which have vested in the Government, shall be apportioned among the landowner, and the intermediary or intermediaries in proportion to the profits derived by them from the holding or part. Explanation.- “Profits derived from the holdings” shall, for the purpose of this Sub-section, mean in the case of the landowner the rent to which he is entitled and in the case of an intermediary, the difference between the rent due to him from his tenant and the rent for which the intermediary is liable to his landlord; and where there is no evidence as to the rent for which the intermediary is liable to his landlord, it shall be presumed that such rent is one-half of the rent payable to the intermediary by his tenant. (3) The value of the structures, veils and embankments of a permanent nature and one half of the value of timber trees shall be payable to the landowner or the intermediary to whom such structures, wells. embankments and timber trees belongs: Provided that where the aggregate of the value of structures, wells and embankments and one-half of the value of timber trees has been limited to sixteen times the fair rent under the proviso to Sub-section (2) of Section 72A, the amount payable under this Sub-section to the landowner and the intermediary or intermediaries shall be sixteen times such fair rent apportioned among the landowner and the intermediary or intermediaries in proportion to the value of the structures, wells, embankments and timber trees belonging to each of them. (4) Where the right, title and interest of the landowner or an intermediary in respect of the holding were subject to any encumbrance. or charge for maintenance or alimony, the value of such encumbrance, maintenance or alimony shall be deducted from the compensation payable to the landowner or the intermediary, as the case may be, and the landowner, or the intermediary shall be entitled only to the balance amount; and if the total amount of such encumbrance, maintenance or alimony is equal to or more than the amount of the compensation payable to the landowner or the intermediary, the whole amount shall be reserved for payment to the holder of the encumbrance or the person entitled to the maintenance or alimony and the landowner or the intermediary, as the case may be, shall not be entitled to any amount by way of compensation.] [72H. Part payment of compensation, discharge of encumbrance, etc., by Land Tribunal.- (1) The Land Tribunal shall pay to the landowner and each of the intermediaries of a holding fifty per cent of the compensation payable to them in respect of that holding in accordance with the provisions of this Section. [(2) The amount of compensation payable under Sub-section (1) in respect of a holding shall be paid in cash in lump within a period of one year of the date on Mich the older of the Land Tribunal under Sub-section (5) of Section 72F has become final.] [***] [(6)Where the amount of compensation is not paid on or before the expiry of the period or one year specified in Sub-section (2), such amount shall bear interest at the rate of four per cent per annum from the date of expiry of the said period of one year.] (7) Where any amount has been deducted or reserved for payment to the holders of the encumbrances or the persons entitled to the maintenance or alimony, the same shall be paid by the Land Tribunal in their order of priority to the persons entitled thereto. (8) Where a person entitled to compensation or the value of the encumbrance, maintenance or alimony dies before it is paid to him, it shall be paid to his legal representatives. [Provided that if such person has, in accordance with the rules made in this behalf, nominated any member of his family, to receive the amount, the same shall be paid to such nominee. Explanation.- for the purposes of the preceding proviso. member of family means wife or husband, sun or daughter.] (9) Where the person entitled to receive the compensation or the value of encumbrance is a private trust or endowment or minor or person suffering from some legal disability or a limited owner, the compensation or the value of encumbrance may, notwithstanding anything contained in any law, but subject to any general directions that the Government may give, be deposited for and on behalf of such person with such authority or bank as may he prescribed. (10) Whet before any court or authority, any suit or proceeding is pending which directly or indirectly affects Or is likely to affect the right of an person to receive the whole or pent of the compensation or the amount of encumbrance or maintenance or alimony payable under this Act, the court or authority may require the Land Tribunal to place at its disposal the amount so payable, and thereupon the same shall he disposed of in accordance with the orders of the court or authority.] [72I. Determination and payment of balance compensation.- (1) Every landowner or intermediary shall, as soon as may be after the determination of the compensation in respect of all holdings held by cultivating tenants under him and in respect of which the right, title and interest of the landowner and intermediaries have vested in the Government, apply to the Land Board for the determination and payment of the compensation due to him after deducting the amount referred to in Sub-section (1) of Section 72H. (2) An application under Sub-section (1) shall be in such form and shall contain such particulars as may be prescribed. (3) On receipt of an application under Sub section (1), the Land Board shall make such enquiries as may be prescribed and after giving the applicant an opportunity of being heard determine the amount of compensation due to the applicant after deducting the amount referred to in Subsection (1) of Section 72H: [Provided that where the amount of compensation mentioned in the application as due to the applicant is not more than the amount of compensation determined by the Land Board it shall not be necessary 10 give the applicant an opportunity of being heard.] (4) Subject to such rules as may be made by the Government in this behalf, the amount of compensation determined under Sub-section (3) shall be paid either in cash or in negotiable bonds redeemable after sixteen years and carrying interest at the rate of four and half percent per annum with effect from the date of such determination, or partly in cash and partly in such bonds. (5) Where the compensation is proposed to be paid in cash, it shall be payable in eight equal annual instalment with interest at the rate of four per cent per annum on the instalment in default, the first instalment being payable [before the date of expiry] of one year from the date of determination of the amount of compensation under Subsection (3).] [(5A) Notwithstanding anything contained in Sub-section (4) or Sub-section (3): (a) Where the cultivating tenant has opted to pay the purchase price payable by him under Section 72L in a lump, or (b) where the landowner or the intermediary is a small holder and the amount of compensation in respect of all holdings held by cultivating tenants under him does not exceed five thousand rupees, the amount, of compensation determined under sub-section (3) shall be paid in cash in lump within one year from the date of such determination and if not so paid shall bear interest at the rate of four percent per annum from the date Lit expiry of that period. (6) The provisions of Sub-sections (8), (9) and (10) of Section 72H shall, so far as may be, apply to the payment of the amount of compensation determined under Sub-section (3).] [72J. Payment of compensation to landowner and intermediary to be full discharge.- The payment of compensation under Section 72H and 721 shall be a full discharge of the liability of the Government for payment of such compensation, and no further claims for payment of compensation shall lie against the Government; Provided that nothing contained in this Section shall affect the liability of any person who may receive the whole or any part of the compensation or the value of encumbrances, maintenance or alimony to pay the same to the persons lawfully entitled thereto.] [72K. Issue of certificate of purchase.- (1) As soon as may be after the determination of the purchase price under Section 72F [or the passing of an order under Sub-section (3) of Section 72MM] the Land Tribunal shall issue a certificate of purchase to the cultivating tenant, and thereupon the right, title and interest of the landowner and the intermediaries, if any, in respect of the holding or part thereof to which the certificate relates, shall vest in the cultivating tenant free from all encumbrances created by the landowner or the intermediaries, if any. Explanation.- For the removal of doubts, it is hereby declared that on the issue of the certificate of purchase, the landowner or any intermediary shall have no right in the land comprised in the holding, and all his rights including rights, if any, in respect of trees reserved for his enjoyment shall stand extinguished. (2) The certificate of purchase issued under Sub-section (1) shall be conclusive proof of the assignment to the tenant of the right, title and interest of the landowner and the intermediaries, if any, over the holding or portion thereof to which the assignment relates. (3) The purchase price payable by the cultivating tenant shall be a first charge on the land comprised in the holding or part thereof to which the assignment relates and shall be-recoverable together with interest as provided in Sub-section (3) of Section 72M, under the pro-visions of the Revenue Recovery Act for the time being in force.] [72L. Purchase price payable in instalments or in lump.- The purchase price determined under Section 72F shall be payable in sixteen equal annual instalments:. Provided that it shall be open to the cultivating tenant to pay the purchase price in a lump, in which case the amount payable shall be only seventy five per cent of the purchase price: Provided further that the cultivating tenant shall exercise his option to pay the purchase price in a lump before the date or the order under Sub-section (5) of Section 72F, and such option shall be final.] [72M. Deposit of purchase price.- (1) Where the purchase price payable by the cultivating tenant determined under Section 72F, the cultivating tenant shall deposit with the Land Tribunal: (a) where the purchase price is opted to be paid in a lump, the entire amount due within nine months: or (b) where the purchase price is to be paid in instalments, the first instalment thereof within three months, from the date on which the order of the Land Tribunal under Sub-section (5) of Section 72F has become final. (2) Where the purchase price is paid instalments, the second and subsequent instalments shall be deposited with the Land Tribunal within such time and in such manner as may be prescribed. (3) Where the purchase price or any instalment thereof is not deposited on the due date, the amount in default shall bear interest at the rate of four and a half per cent per annum from that date till the date of deposit.] [72MM. Assignment by mutual agreement.- (1) Notwithstanding anything to the contrary contained in Sections 72A to 72D and Sections 72F to 72M, where the right, title and interest of the landowner and the intermediary or intermediaries, if any, in respect of a holding have vested in the Government under Section 72, the cultivating tenant, the landowner, the intermediary, or intermediaries. if any, the holders of encumbrances, if any, charged on such light, title and interest and the persons entitled to maintenance or alimony, if any, charged on such right, title and interest, may jointly apply to the Land Tribunal for an order assigning the right, title and interest of the landowner and the intermediary or intermediaries, if any, to the cultivating tenant: Provided that nothing in this Sub-section shall apply in respect of a holding, if the landowner or any intermediary of that holding is a religious, charitable or educational institution of a public nature which has opted for annuity. (2) An application under Sub-section (1) shall he in such form and shall contain such particulars as may be prescribed. (3) On receipt of an application under Sub-section (1), the Land Tribunal may, after such inquiry as may be prescribed, pass an order assigning the right, title and interest of the landowner and the intermediary or intermediaries, if any, to the cultivating tenant. (4) Before passing an order under Sub-section (3), the Land Tribunal shall, so far as may be, follow the procedure laid down in Sub-sections (1), (2), (3A), (4) and (5) of Section 72F. (5) An order of the Land Tribunal under Sub-section (3) shall be in such form and shall contain such particulars as may be prescribed. (6) Where an order has been passed by the Land Tribunal under Sub-section (3), the Government shall have no right to receive any purchase price from the cultivating tenant or liability for the payment of compensation or any other amount in respect of the holding to which the order relates. (7) Any person affected by the order of a Land Tribunal under Sub-section (3) may, within ninety days from the date of the order, apply to that Land Tribunal to set aside the order on the ground that he had no notice of the application under Sub-section (1), and the Land Tribunal may either set aside the order and proceed under Section 72F, or reject the application: Provided that no order shall be passed under this Sub-section without giving the parties interested an opportunity of being heard. (8) An appeal shall lie from any order passed by the Land Tribunal under Sub-section (7) as if such order were an order under Section 72F.] [72N. Special provisions relating to institutions which have opted for annuity instead of purchase price.- Notwithstanding anything contained in Sections 72H and 72I, where in respect of a holding the landowner or intermediary is a religious, charitable or educational institution of a public nature and; (a) an application from such institution for annuity is pending on the date notified by the Government under Subsection (1) of Section 72; or (b) the annuity payable to such institution has been determined, but no notification has been issued under Subsection (9) of Section 66, the Government shall pay to such institution the annuity that would have been payable to the institution under Section 67, from the date notified under Sub-section (1) of Section 72, and the Government shall be entitled, subject to the provisions of Section 70, to the purchase price payable by the cultivating tenant and, in the case of any holding, the right, title and interest in respect of which have not vested in the Government on the said date, also the rent to which such institution is entitled from the said date till its right, title and interest are vested in the Government: Provided that nothing contained in this Sub-section shall affect the power of the Land Board to decide whether an institution is a religious, charitable or educational institution of a public nature: Provided further that nothing contained in this Sub-section shall apply in the case of an institution which is found by the Land Board not to be a religious, charitable or educational institution of a public nature. [(1A) An application from a religious, charitable or educational institution of a public nature for annuity pending or deemed to be pending on the date notified by the Government under Sub-section (1) of Section 72 shall, on the date of publication of the Kerala Land Reforms (Amendment) Act, 1971, in the Gazette, abate, and where any such application has been made after the date of such publication, that application shall abate on the date on which it is received by the Land Board. (1B) For the removal of doubts it is hereby clarified that the annuity payable to a religious, charitable or educational institution of a public nature whose application abates under Sub-section (1A) shall be determined by the Land Tribunal under Section 72F and that Section 66 will not apply for such determination.] (2) Notwithstanding anything contained in Sections 65 to 69, a religious, charitable or educational institution of public nature which has not expressed its choice for annuity instead of purchase price before the date notified under Sub-section (1) of Section 72 shall not be entitled to express such choice, and such institution shall be entitled only to the compensation under Section 72A.] [72O. Rent paid by cultivating tenant to be adjusted towards purchase price and compensation in certain cases.- (1) Any amount paid by way of rent by the cultivating tenant in respect of his holding to the landowner or any intermediary or the Government for the period after the date of vesting of the right, title and ‘interest of the landowner and the intermediaries in respect of the holding in the Government under Section 72 shall be adjusted towards the purchase price payable by the cultivating tenant, and such amount received by the landowner or any intermediary shall be adjusted towards the compensation payable to him under Section 72H. (2) Where, consequent on the determination of the fair rent in respect of a holding, the rent payable by the cultivating tenant to the landowner or any intermediary has been reduced, the amount paid by the cultivating tenant in excess of the rent so determined-to the landowner or the intermediary for the period commencing on the beginning of the agricultural year in which the cultivating tenant filed the application for such determination and ending with the date of such determination shall be adjusted towards the purchase price payable by the cultivating tenant, and such amount received by the landowner or any intermediary shall be adjusted towards the compensation payable to him under Section 72A.] [72P. Applications under Section 54 and proceedings relating thereto to abate on the date notified under Section 72.- (1) All applications under Section 54 (other than those which have been rejected and such rejection has become final) and all proceedings in connection therewith, whether pending before the appellate authority or the High Court or the Land Board, shall, if the certificates of purchase have not been issued under Sub-section (2) of Section 59, abate with effect from the date notified under Sub-section (1) of Section 72, and no party shall be liable to pay the cost of any other party in any such proceedings. (2) Where a certificate of purchase is issued under Section 72K in respect of any holding or part thereof to which an application referred to in Sub-section (1) relates: (a) the right, title and interest of the landowner and intermediaries in respect of such holding, or part shall be deemed to have vested in the cultivating tenant from the date of such application; (b) any amount paid or deposited by the cultivating tenant by way of rent after the date of such application, shall be adjusted towards the purchase price payable by him under Section 72D. (c) any such amount received or withdrawn by the landowner or any intermediary shall be adjusted towards the compensation payable to him under Section 72H and if the amount of compensation payable under that Section is not sufficient, the balance shall be adjusted towards the compensation payable to him under Section 721; and (d) any purchase price deposited by the cultivating tenant shall be adjusted towards the purchase price payable by him under Section 72D.] [72Q. Vesting of landlord’s right not to affect right to recover arrears of rent.- The vesting of the right, title and interest of a landowner or an intermediary in respect of any holding or part of a holding in the cultivating tenant under Sub-section (2) of Section 59 or in the Government under Sub-section (9) of Section 66 or Section 72 shall not affect the right of the landowner or the intermediary to recover the arrears of rent due to him before the date of such vesting; and any such arrears may be recovered as if such vesting had not taken place, subject to the provisions of Section 73.] [72QQ. Cultivating tenant not liable to pay rent if resumption application k rejected.- Notwithstanding anything contained in any law for the time being in force, or in any contract, custom or usage, or in any judgement, decree or order of any court or Land Tribunal, in the case of a holding or part of a holding in respect of which an application, for resumption under the provisions of this Act is rejected, the cultivating tenant shall not be liable to pay any rent for such holding or part of the holding, as the case may be, with effect on and from the date notified under Sub-section (1) of Section 72] [72R. Special provisions regarding Jenmikaram under the Kanam Tenancy Act, 1955.- (1) Where the right, title and interest of a kanam tenant as defined in the Kanam Tenancy Act, 1955, in respect to any holding or part of a holding have vested in a cultivating tenant, then, notwithstanding anything contained in the said Act, such cultivating tenant shall be liable to pay the jenmikaram in respect of such holding or part- (a) where such vesting is under Sub-section (2) of Section 59 or Sub-section (2) of Section 72P, from the date on which such right, title and interest are deemed to have vested in the cultivating tenant; and (b) in other cases, from the date on which such right, title and interest have vested in the Government. [until the commencement of the Kanam Tenancy Abolition Act, 1976] and the kanam tenant shall have no liability to pay such jenmikaram. (2) Where the Government have paid any jenmikaram for or during the period commencing on the date on which the right, title and interest of the kanam tenant have vested in the Government under Section 72 and ending with the date on which the certificate of purchase has been issued to the cultivating tenant, which the cultivating tenant is liable to pay under Sub-section (1), such amount of jenmikaram may be recovered from the cultivating tenant as arrears of public revenue due on land.] [72S. Liability for assessment alter the date of vesting finder Section 72.- [(1)] Notwithstanding anything contained in the Kerala Land Tax Act, 1961, or in any other law for the time being in force, or in any contract, where the right, title and interest of the landowner and the intermediaries, if any, in respect of a holding have vested in the Government under Section 72, the cultivating tenant of that holding shall be liable to pay the basic tax payable in respect of that holding under the said Act and other taxes and cesses due in respect of that holding.] [(2) In the case of a holding or part of a holding in respect of which an application for resumption under the provisions of this Act is rejected, the cultivating tenant shall be liable to pay the basic tax and other taxes and cesses in respect of such holding or part of the holding, as the case may be, with effect on and from the date notified under Sub-section (1) of Section 72.] [73. Discharge of arrears of rent.- (1) Notwithstanding anything to the contrary contained in any other law for the time being in force, or in any contract, or in any judgement, decree or order of any court or tribunal, the landlord of a tenant specified in column (1) of the Table below shall be entitled to recover towards arrears of rent accrued due before the 1st day of May, 1968 and outstanding at the commencement of the Kerala Land Reforms (Amendment) Act, 1969, only the amount specified in the corresponding entry in column (2) of the Table: Provided that where an intermediary has collected rent from his tenant for any period prior to the 1st day of May, 1968 and has not paid the rent payable by him to his landlord for the period for which he has so collected, he shall also be liable to pay the rent payable by him for such period to his landlord: Provided further that, subject to the foregoing proviso, no intermediary shall be liable to pay to his landlord anything in excess o’ what he is entitled to receive under this Sub-section.
Table
| Class of tenant |
Amount of rent to be paid for discharge |
| (1) |
(2) |
| Tenant Possessing not more than 5 acres of land in the aggregate whether as owner, mortgagee, lessee or otherwise. |
One year’s rent or the actual amount in arrears, whichever is less. |
| Tenant possessing more than 5 acres but not more than 10 acres of land in the aggregate, |
|
| whether as owner, mortgagee, lessee or otherwise amount in arrears, whichever is less. |
Two year’s rent or the actual |
| Tenant possessing more than 10 acres of land in the aggregate, whether as owner, mortgagee, lessee or otherwise. |
Three year s rent or the actual amount in arrears, Whichever is less: |
Provided that where the tenant is in possession of more than fifteen acres of land in the aggregate, whether as owner, mortgagee. lessee or otherwise, and the landlord is a small holder, the tenant shall be liable to pay the actual amount in arrears. Explanation.- For the purposes of this Section, the rent for an year shall be deemed to be an amount equal to the rent payable for the year immediately preceding the commencement of the Kerala Land Reforms (Amendment) Act, 1969 and which has accrued due before such commencement. (2) Where any suit, appeal, revision or application which involves a claim by a landlord for arrears of rent accrued due prior to the 1st day of May, 1968, is pending before any court or Land Tribunal, such Court or Land Tribunal may, after such enquiry as it deems fit, pass an order specifying- (a) the amount to which the landlord is entitled under Sub-section (1); (b) the costs, if any. awarded to the landlord in connection with the conduct of the proceedings after the commencement of the Kerala Land Reforms (Amendment) Act, 1969; (c) the costs, if any, awarded to the tenant in connection with the conduct of the proceedings after such commencement; and (d) where such costs, are, awarded to the tenant, the amount due to the landlord after deducting such costs. (3) Where any decree or order has been passed in (avow of landlord before the commencement of the Kerala Land Reforms (Amendment) Act, 1969, by any Court or Land Tribunal for the recovery of arrears of rent accrued due prior to the 1 day of May, 1968, such decree or order shall be enforceable only to the extent of the amount due to such landlord under Sub-section (1); and to determine such amount, any of the parties to the decree or order may apply to the Court or the Land Tribunal, as the case may be, which passed the decree or order, to amend such decree or order in accordance with the provisions of Sub-section (1). (4) On receipt of an application under Sub-section (3), the Court or the Land Tribunal, as the case may be, may, after such enquiry as it deems fit, reopen the decree or order and pass an order containing the particulars specified in Sub-section (2). (5) Any landlord who has not instituted a suit or applied under Section 26 for recovery of arrears of rent accrued due prior to the 1st day of May, 1968, before the commencement of the Kerala Land Re-forms {Amendment) Act, 1969, may apply to the Land Tribunal under that Section for recovery of the amount due to him under Sub-section (1) of this Section. (6) Notwithstanding anything contained in Section 26, on receipt of an application referred to in Sub-section (5), the Land Tribunal may, after such enquiry as it deems fit, pass an order containing the particulars specified in Sub-section (2). (7) The tenant shall deposit the amount specified in an order under Sub-section (2) or Sub-section (4) or Sub-section (6) as due from him in the Court or Land Tribunal which passed the order within a period of six months from the date of the order. (8) If the tenant fails to deposit any amount as required by Sub-section (7), such amount shall, on a written requisition from the court or the Land Tribunal, as the case may be, to the District Collector, be recovered under the provisions of the Kerala Revenue Recovery Act, 1968, together with interest at the rate of six percent pee annum from the date of the order under Stab-section (2) or Sub section (4) or Sub. section (6), as the case may he. (9) Notwithstanding anything contained in this section, a tenant who has paid the amount as provided in Section 34 of the Kerala Agrarian Relations Act, 1960, or in Section 5 of the Kerala Ryotwari Tenants and Kudikidappukars Protection Act, 1962, for the discharge of arrears of rent outstanding on the 11th day of April, 1957, or the arrears of rent accrued due after that date and outstanding on the 15th day of February, 1961, on or before the date specified in those Acts for the payment of the amount, shall not be liable to pay any amount towards arrears of rent for that period. (10) The assignment by a landlord of his right to receive arrears of rent to any other person shall not affect the benefits conferred on a tenant under this Section.] 74. Prohibition of future tenancies.- (1) After the commencement of this Act, no tenancy shall be created in respect of any land. [x x x] (2) Any tenancy created in contravention of the provisions of Sub-section (1) shall be invalid. Rights and Liabilities of Kudikidappukars 75. Kudikidappukaran to have fixity.- [(1) No Kudikidappukaran shall he liable to be evicted from his kudikidappu except on the following grounds, namely:- (i) that he has alienated his right of kudikidappu to a person other than- (a) a member of his family; or (b) a person who has no other homestead or any land in possession, either as owner or as tenant, on which he could erect a homestead and whose annual in-come does not exceed two thousand rupees; (ii) that he has rented or leased out his entire kudikidappu to another person for a period of not less than two years; (iii) that he has ceased to reside in the kudikidappu continuously for a period of two years; or (iv) that he has another kudikidappu or has obtained ownership and possession of land which is fit for erecting a homestead within a distance of five kilometers from his kudikidappu; Provided that the kudikidappukaran shall not be liable to he evicted on the ground mentioned in sub-clause (iv) if the extent of the land over which he has obtained ownership and possessions is not more than three cents if it is in a city or major municipality or five cents if it is in any municipality or ten cents if it is in a panchayat area or township; Provided further that a kudikidappukaran shall be liable to be evicted, if he has obtained ownership and possession of land situate beyond a distance of five kilometers where the extent of such land is not less than twenty five cents. Explanation I.- For the purpose of this Sub-section, ‘member of family” shall mean, in the case of a joint family, any member of such family, and in other cases, wife or husband, as the case may be, and any of their lineal discendants. Explanation II.- For the purposes of this Sub-section, a kudikidappukaran shall not be deemed to have ceased to reside in a kudikidappu, notwithstanding the fact that he was not actually residing therein, if any of his near relatives who was residing with him in the kudikidappu continues to reside in the kudikidappu; and in such a case, the near relative who continues to reside in the kudikidappu shall be liable for the rent payable by the kudikidappukaran; and near relative shall mean husband or wife, children, grandchildren, father, mother, brother, sister or children of brother or sister.] (2) Notwithstanding anything contained in Sub-section (1), the person in possession of the land on which there is a homestead or hut (hereinafter in this Sub-section referred to as the landholder) in the occupation of a kudikidappukaran may, if he bona fide requires the land- [(a) for constructing a building for his own residence or for the residence of any member of his family included major sons and daughters; or] (b) for purposes in connection with a town planning scheme approved by the competent authority; or (c) for any industrial purpose, require the kudikidappukaran, to shift to a new site belonging to him, subject to the following conditions, namely: (i) the landholder shall pay to the kudikidappukaran the price of the homestead, if any, erected by the kudikidappukaran; (ii) the new site shalt be fit for erecting a homestead and shall be within a distance of one mile from the existing kudikidappu; [(iii) the extent of new site shall be the extent of the existing kudlkidappu, subject to a minimum of three cents it within the limits of a city or a major municipality, five cents if within the limits of any other mu-nicipality and ten cents if in any panchayat area or township;] (iv) the landholder shall transfer ownership and possessions of the new site to the kudikidappukaran and shall pay to him the reasonable cost of shifting the kudikidappu to the new site. Where the above conditions are compiled with, the kudikidappukaran shall be bound to shift to the new site. [(3) Notwithstanding anything contained in Sub-sections (1) and (2). where the total extent of land held by a person, either as owner or as tenant, is less than one acre and there is a kudikidappu on any land held by him, he may, if he requires the land occupied by such kudikidappu for constructing a building for his own residence: apply to the Government for the acquisition of land to which the kudikidappu may he shifted:] Provided that, after the expiry of a period of two years from the commencement of the Kerala Land Reforms (Amendment) Act, 1969, an application shall not be made under this Sub-section except with the consent of the kudikidappukaran. Explanation.- For the purposes of this Sub-section,- (a) the total extent of land held by a person shall he computed as on the 1st day of July 1969; (b) in calculating the total extent of land held by a person who is a member of.a family, the extent of land held by any member of his family or jointly by some or all of the members of such family shall also be taken into consideration. [(3A) In an application under Sub-section (3), the applicant shall offer to deposit, whenever called for, eighty seven and a halt per cent of the [amount of compensation payable for acquisition of land] equal to the extent of the existing kudikiduppu subject to a minimum of three cents if within the limits of a city or major municipality or ten cents if in any panchayat area or township. (3B) An officer authorised by the Government in this behalf may, after collecting the amount referred to in Sub-section C3A) from the applicant, acquire the necessary land under the Kerala Land Acquisition Act, 1961, give possession of the land to the kudikidappukaran and require him to shift to the said land, and thereupon the kudikidappukaran shalt be bound to shill to the new site.] [(3BB) Where the kudikidappukaran does not shift to the land acquired in pursuance of Sub-section (36) within a period of one month from the date of service on him of the requisition under that Sub-section, the officer referred to in that Sub-section shall cause him to be evicted from the existing kudikidappu.] [(3C) The kudikidappukaran shall be entitled before he shifts as required under Sub-section (38) to receive from the person in possession of the land on which his kudikidappu is situate the expenses as determined by the officer referred to in that Sub-section to be reason-ably required to shift to the new site.] [(3D) Where the kudikidappukaran shift as required under Sub-section (3W, or under Sub-section (366) he shall be entitled to the ownership and possession of the land to which he shifts or is bound to shift, as the case may be, and also to the registry of such land in his name.] [(3E) Twelve and a half per cent of the amount of compensation payable for the acquisition under Sub-section (3B) shall be met from the Kudikidappukar’s Benefit Fund constituted under Section 109.] (4) Where the person in possession of the land in which there is a kudikidappu considers that the kudikidappu is so located as to cause inconvenience to him, he may require the kudikidappukaran to shift to another part of the land which is fit for the location of the kudikidappu: Provided that the kudikidappukaran shall have the right to opt for the portion to which the kudikidappu may be shifted: Provided further that the kudikidappukaran shall not be entitled to opt for any portion which is not adjoining the boundaries of the land, except with the consent of the person in possession of the land: Provided also that if the kudikidappukaran refuses to opt, he shall be bound to shift to the portion to which he is required to shift by the person in possession of the land: Provided also that the person in possession of the land shall transfer to the kudikidappukaran his rights over the land to which the kudikidappu is to be shifted, which shall be equal to the extent of the existing kudikidappu subject to a minimum of three cents if in any city or major municipality or five cents if in any other municipality or ten cents if in any panchayat area or township and pay the price of the homestead, if any, erected by the kudikidappukaran and the cost of shifting the kudikidappu. 76. Rent payable by udikidapprikaran.- (1) All arrears of rent, if any, payable, by a kudikidappukaran on the date of the commencement of [the Kerala Land Reforms (Amendment) Act, 1969] whether the same be payable under any law, custom or contract or under a decree or order of court shall be deemed to be fully discharged if he pays one year’s rent or the actual amount in arrears, whichever is less. (2) On and after the commencement of this Act, notwithstanding any contract, decree or order of court, a kudikidappukaran shall not be required to pay more than [twenty four rupees yearly as rent in respect of his kudikidappu if it is situated within the limits of any city or major municipality or six rupees yearly as rent in respect of his kudikidappu if it is situated in any other area;] Provided that a kudikidappukaran who was not liable to pay any rent in respect of his kudikidappu immediately before the commence-ment of this Act shall not be liable to pay any rent; nor shall a kudikidappukaran be liable to pay any rent in excess of that which he was paying before the commencement of this Act. [77. Procedure to enforce shifting of kudikidappu in certain cases.- (1) If the kudikidappukaran does not comply with the requisition made under Sub-section (2) or Sub-section (4) of Section 75 by the person in possession of the land to shift to a new site, such person may apply to the Land Tribunal having jurisdiction to entertain an application under Section 80B in respect of the kudikidappu to be shifted, to enforce compliance with such requisition: Provided that no application under this Sub-section shall be made without giving the kudikidappukaran one month’s notice by registered post: Provided further that the Land Tribunal shall not entertain any application under this Sub-section in respect of a kudikidappu, it an order under Sub-section (3) of Section 80B allowing an application for the purchase of that kudikidappu has been passed and such order is in force. (2) The Land Tribunal, after such inquiry as it deems fit, and on being satisfied that the applicant has compiled with all the conditions mentioned in Sub-section (2) or Sub-section (4), as the case may be, of Section 75, may pass an order requiring the kudikidappukaran to shift the kudikidappu before such date as may be specified in the order. [***] (3) If the kudikidappukaran does not shift the kudikidappu be-fore the date specified in the order under Sub-section (2), the Land Tribunal shall cause the kudikidappukaran to be evicted from the kudikidappu.] [78. Right of kudikidappukaran to be heritable but not alienable except in certain cases.- The rights of a kudikidappukaran in his kudikidappu shall be heritable but not alienable except to any person mentioned in sub-clause (a) or sub-clause (b) of clause (i) of Subsection (1) of Section 75.] 79. Right of kudikidappukaran to maintain, repair etc., homestead or hut.- The kudikidappukaran shall have the right to maintain, repair and reconstruct with the same or different materials, but without increasing the plinth area [at the commencement of the Kerala Land Reforms (Amendment) Act,1969, by more than fifty per cent], the hut belonging to the person who permitted occupation by the kudikidappukaran, or the homestead, at his own cost. [Explanation.- In this Section and in Section 79A, “homestead” includes a dwelling house occupied by a person who is deemed to be a kudikidappukaran under Explanation IIA to clause (25) of Section 2.)] [79A. Customary and other rights of kudikidappukaran.- (1) Notwithstanding anything contained in any law, or in any contract or in any judgement, decree or order of court, the kudikidappukarn shall be entitled to all rights accrued to him by custom, usage or agreement and which he was enjoying immediately before the commencement of this Act. (2) Notwithstanding anything contained in any law, or in any judgement, decree or order of court, but without prejudice to any rights to which a kudikidappukaran may be entitled under any other law for the time being in force or under any custom, usage or contract a kudikidappukaran shall in respect of his kudikidappu have all the rights and privileges conferred on the owner of a land under the Indian Easements Act, 1882, as if the kudikidappukaran were the owner of his kudikidappu from the date on which the hut or homestead, as the case may be, was occupied or erected. (3) Notwithstanding anything contained in any law, or in any judgement, decree or order of court, or in any contract, it shall not be necessary to obtain the consent of the owner or occupier or both of the land in which a kudikidappu is situate, to lay down or place any electric supply line or other work on, over or under such land for the purpose of supply of electrical energy to the kudikidappu for domestic consumption and use. (4) Notwithstanding anything contained in any law, or in any judgement, decree or order of court, or in any contract, it shall not be necessary to obtain the consent of the owner or occupier or both of the land in which a kudikidappu is situate to lay down any pipe or to carry out any other work on, over or under such land for the purpose of supply of water to the kudikidappu for domestic consumption and use. Explanation.- For the purposes of this Section, enjoyment of any benefit or concession for a continuous period of three years immediately preceding the commencement of this Act shall be deemed to be enjoyment of a right accrued to the kudikidappukaran by custom, usage or agreement] 80. Register of kudikidappukars.- (1)The Government shall cause a register of kudikidappukars [within the limits of each local authority to be prepared and maintained.] (2) The register shall show- (a) the description of the land in which the kudikidappu is situate; (b) the location of the kudikidappu and its extent; (c) the name of the landowner and of the person in possession of the land in which the kudikidappu is situate; (d) the name and address of the kudikidappukaran; [***] [(dd) the rights referred to in Section 79A; and] (e) such other particulars as may be prescribed. [(3)Subject to such rules as may be made by the Government in this behalf, the local authority shall prepare a register of kudikidappukars within its jurisdiction. (4) The register shall be maintained by the local authority in such manner as may be prescribed. (5) Any person aggrieved by the registration of a kudikiduppu-karan under Sub-section (3) or the refusal to register a person claiming to be a kudikdappukaran may, within ninety days from the date of registration or refusal, as the case may be, appeal- (a) to the Revenue Divisional Officer having jurisdiction, where the decision appealed against is that of a municipal corporation or a municipal council: (b) to the Tahsildar having jurisdiction, in other cases. (6) On receipt of an appeal under Sub-section (5), the Revenue Divisional Officer or the Tahsildar, as the case may be, may call for the record of any proceeding which has been taken by the local authority under this Section and may make such enquiry or cause such enquiry to be made and may pass such orders thereon as he thinks fit: Provided that no order prejudicial to any person shall be passed without giving him an opportunity of being heard. (7) For the purposes of this Section, “local authority’ shall not include a cantonment board.] [80A. Right of kudikidappukaran to purchase his kudikidappi.- (1) Notwithstanding anything to the contrary contained in any law for the time being in force, a kudikidappukaran shall, subject to the provisions of this Section, have the right to purchase the kudikidappu occupied by him and lands adjoining thereto. (2) Notwithstanding anything contained in Sub-section (1), where the total extent of land held by the person in possession of the land in which the kudikidappu is situate, either as owner or as tenant is less than one acre, the kudikidappukaran shall be entitled to purchase his kudikidappu and lands adjoining thereto only incases where the person in possession of the Government under Sub-section (3) of Section 75 for the acquisition of the land to which the kudikidappu may be shifted, within a period of two years from the commencement of the Kerala Land Reforms (Amendment) Act, 1969: Provided that in a case where the person in possession has applied under Sub-section (3) of Section 75, the kudikidappukaran shall be entitled to purchase his kudikidappu and lands adjoining thereto if such application by the person in possession of the land is rejected or if such person fails to pay the expenses for shifting the kudikidappu as required by the Sub-section (3C) of Section 75. (3) The extent of land which the kudikidappukaran is entitled to purchase under this Section shall be three cents in a city or major municipality or five cents in any other municipality or ten cents in a panchayat area or township: Provided that where the land available for purchase in the land in which the kudikidappu is situate, or the land in which the kudikidappu is situate, is less than the extent specified in this Sub-section, the kudikidappukaran shall be entitled to purchase only the land available for purchase or, as the case may be, the land in which the kudikidappu is situate. (4) Notwithstanding anything contained in Sub-section (3), where in the lands held by a person, either as owner or as tenant, there are more kudikidappukars than one, the maximum extent of land which is liable to be purchased under this 5ection shall be,- (a) where such person holds less than one acre of land, three cents in a city or major municipality or five cents in any other municipality or ten cents in a panchayat area or township; (b) where such person holds one acre or more, but less than two acres, of land, six cents in a city or major municipality or ten cents in any other municipality or twenty cents in a panchayat area or township; (c) where such person holds two acres or more, but less than three acres, of land, nine cents in a city or major municipality or fifteen cents in any other municipality or thirty cents in a panchayat area or township; (d) where such person holds three acres or more, bus than four of land, twelve cents in a city or major municipality t. twenty cents in any other municipality or forty r:’ilt5 in a panchayat area or township; (e) where such person holds four acres or more, but less that five acres, of land, fifteen cents in a city or major municipality or twenty-five cents in any other municipality or silty cents in a panchayat area or township: Provided that the extent of land which a kudikidappukaran shall be entitled to purchase shall, in no case, exceed the extent specified in Sub-section(3): Provided further that if in any case falling under clause (b) or clause (c) or clause (d) or clause (e), the extent specified in that clause is not sufficient for the purchase of an extent of three cents of land by each kudikidappukaran, the extent of land which is liable to be purchased under this Section shall be the extent required for purchase of three cents by each kudikidappukaran: [Provided also that where any person in possession of ant land in which there is a kudikidappu or more than one kudikidappu, has voluntarily transferred such land on or after the 1st day of July, 1969 and before the 1st day of January, 1970 or voluntarily transfers such land on or after 1st day of January, 1970, the kudikidappukaran or each of the kudikidappukars shall be entitled to purchase such extent of land as he would have been entitled to purchase if such transfer had not taken place.] (5) Where any person holds five acres or more of land, either as owner or as tenant, and there are more kudikidappukars than one in the lands held by him, each of the kudikidappukars shall be entitled to purchase the extent of land specified in Sub-section (3). (6) No kudikidappukaran shall be entitled to purchase any land which is no in the lawful possession of the person who holds the land in which the kudikidappu is situate or which is not within the boundaries of each land. (7) The purchase price payable by a kudikidappukaran in con-sideration of the purchase allowed under this Section shall be twenty five per cent of the market value of the land purchased and the improvements thereon, other than the improvements, if any, belonging to the kudikidappukaran; Provided that where the person in possession of the land in which the kudikidappu is situate or, where he is a member of a family, such family, holds lands in excess of the ceiling area. the purchase price payable by the kudikidappukaran shall be one-half of the purchase price payable under this Sub-section. Explanation.- The provisions of Section 82 shall, so far as may be, apply to the calculation of the ceiling area for the purposes of the foregoing proviso and if no dare has been notified under Section 83, the date of the application under Sub-section (1) of Section BOB shall he deemed to be the date notified under Section 83. [(8) The purchase price payable by the kudikidappukaran shall be met from the Kudikidappukar s Benefit Fund constituted under Section 109.] [(8A) Notwithstanding anything contained in Sub-sections (7) and (8), the kudikidappukaran shall not be liable to pay his share of the purchase price incases where the person in possession of the land in which the kudikidappu is situate or, where the person in possession of the land is holding such land under a landlord or more than one landlord and the right, title and interest of such landlord or landlords have not vested in the Government under Section 72, the person in possession of such land and such landlord or landlords agrees or agree in writing that the kudikidappuka ran need not pay his share of the purchase price.] (9) Where the kudikidappukaran applies under Sub-section (1) of Section 80B for purchase of his kudikidappu. and the Land Tribunal, on application within such time as may be prescribed by the person in possession of the land in which the kudikidappu is situate, is satisfied that the portion to be purchased is so located as to cause inconvenience to him, the Land Tribunal may require the kudikidappukaran to purchase another portion of that land; Provided that the kudikidappukaran shall have the right to opt for the portion to be purchased by him: Provided further that the kudikidappukaran shall not be entitled to opt for any portion which is not adjoining the boundaries of the land, except with the consent of the person in possession of the land; Provided also that if the kudikidappukaran purchases another portion of the land, the person in possession of the land shall be liable to pay the price of the homestead, if any, erected by the kudikidappukaran and the cost of shifting the kudikidappu to such portion. (10) If any kudikidappukaran refuses to opt under Sub-section (9), his application under Sub-section (1) of Section 808 shall be dismissed. (11) Notwithstanding anything contained in Sub-sections (4) and (5), where there are more kudikidappukars than one and the extent of the land which the kudikidappukars are entitled to purchase, or the extent of the land in which the Kudikidappus are situate, is less than the multiple of the number of kudikidappukars and the extent which each kudikidappukaran is entitled to purchase under this Section, the land available for purchase, or the land in which the Kudikidappus are situate, as the case may be, shall, in the absence of any agreement among the kudikidappukars, be apportioned in equal shares, as far as practicable, for purchase by the kudikidappukars. (12) For the purposes of this Section- (a) the extent of land held by a person shall be the total extent of land held by such person, either as owner or as tenant, on the 1st day of July, 1969; (b) In calculating the extent of land held by a person who is a member of a family and the number of kudikidappukars in the lands held by such person, the extent of the land held individually by any member of his family or Jointly by some or all of the members of such family, and the number of kudikidappukars thereon shall also he taken into consideration; (c) in deciding the extent of land available for purchase by the kudikidappukaran or kudikidappukars,- (i) any voluntary transfer effected, or any boundaries put up or any building or other structures erected, after the 1st day of July, 1969, shall not he taken in to account; (ii) the sites of the buildings and other structures situate on the land shall be excluded.] [80B. Procedure for purchase by kudikidappukaran.- (1) A kudikidappukaran entitled under Section 80A to purchase the kudikidappu occupied by him and lands adjoining thereto may apply to the Land Tribunal for such purchase. (2) An application under Sub-section (I) shall be in such foam and shall contain such particulars as may be prescribed. (3) The Land Tribunal shall, after giving notice to the kudikidappukars in the land in which the kudikidappu is situate and other persons interested in the land and after such enquiry as may be prescribed, pass such orders on the application as it thinks fit: [Provided that where an application under Sub-section (1) of Section 77 in respect of the kudikidappu is pending, the Land Tribunal shall not pass any order under this Sub-section before the disposal of that application.] (4) An order under Sub-section (3) allowing an application shall specify- (i) the extent of land which the kudikidappukaran is en-titled to purchase; (ii) the purchase price payable in respect of the Land allowed to be purchased by the kudikidappukaran; (iii) the amounts due to the person in possession of the land in which the kudikidappu is situate and other persons interested in the land; (iv) the value of encumbrance subsisting or claimsior-main-tenance or alimony charged on the land allowed to be purchased by the kudikidappukaran; (v) the amount payable to the holder of the encumbrance or the person entitled to the maintenance or alimony and the order of priority in which such amount is payable; (vi) such other particulars as may he prescribed. (5) If the person in possession of the land in which the kudikidappu is situate or the landowner or the intermediary, if ariy, of the land is liable to pay any amount to the kudikidappukaran towards the price of the homestead or the cost of shifting the kudikidappu, the Land Tribunal shall in passing orders on the application for purchase set off such amount against the purchase price payable to such person. (6) Where the right, title and interest of the person in possession of the land in which the kudikidappu is situate or any other person interested in the land form part of the security for any encumbrance or charge fur maintenance or alimony, the Land Tribunal shall for the purpose of determining the value of the encumbrance or the charge for the maintenance or alimony relating to the portion in respect of which purchase is allowed, apportion the entire encumbrance or charge for the maintenance or alimony, between the land in which the kudikidappu is situate and the portion allowed to be purchased in proportion to the values of the two portions. (7) Where the person in possession of the land in which the kudikidappu is situate is a tenant, the purchase price payable in respect of the land to be purchased shall be apportioned among the landowner, the intermediaries, if any, and the tenant in possession of the land in proportion to the profits derivable by them from the holding. Explanation.- “Profits derivable from the land” shall be deemed to be equal to- (i) in the case of a landowner, the rent which he was entitled to get from the tenant holding immediately under him; (ii) in the case of an intermediary, the difference between the rent which he was entitled to get from his tenant and the rent for which he was liable to his landlord; and (iii) in the case of the tenant in possession, the difference between the net income and the rent payable by him; and the rent payable by such tenant and the intermediary for the purpose of this Explanation shall be as calculated under the provisions of this Act.] [80C. Deposit of purchase price and issue of certificate of purchase.- [(1) ***] [(2) As soon as may be after the order of the Land Tribunal under Sub-section (3) of Section 80B has become final, the Land Tribunal shall issue a certificate of purchase in such form and containing such particulars as may be prescribed, and thereupon the right, title and interest of the landowner, the intermediaries, if any, and the person in possession where he is not the landowner, in respect of the land allowed to be purchased, shall vest in the kudikidappukaran free from all encumbrances with effect from the date of such deposit or, as the case may be, the date on which the order of the Land Tribunal under the said Sub-section (3) has become final.] [(3) ***] (4) After the issue of the certificate of purchase in respect of any land under Sub-section (2), the Land Tribunal may, on application by the kudikidappukaran, put him in possession of that land, if need be by removing any person who refuses to vacate the same.] [(4A) Where the certificate of purchase issued to the kudikidappukaran is in respect of another portion of the land and the kudikidappukaran does not vacate the existing kudikidappu within a reasonable time after the issue of such certificate, the Land Tribunal shall cause him to be evicted from the existing kudikidappu.] [(5) and (6) ***] [80D. ***] [80E. Payment of purchase price, amount of encumbrance, maintenance or alimony.- (1) The purchase price payable by the kudikidappukaran shall be distributed by the Land Tribunal according to the provisions of Sub-sections (2) to (8). (2) Where the right, title and interest of the landowner and the intermediaries, if any, and the person in possession, of the land in which the kudikidappu is situate were subject to any encumbrance or charge for maintenance or alimony, the purchase price shall be paid to the person in possession of the land or apportioned among the landowner, the intermediaries, if any, and the person in possession of the land in accordance with the order of the Land Tribunal under Sub-section (3) of Section 808. (3) Where the right, title and interest of the landowner and the intermediaries, if any, or the person in possession, of the land in which the kudikidappu is situate where subject to any encumbrance or charge for maintenance or alimony, the value of such encumbrance, maintenance or alimony shall be deducted from the purchase price payable to the landowner, the intermediaries or the person in possession, as the case may be, and the balance amount shall be paid to the landowner, or the intermediaries or the person in possession, as the case may be. (4) If the total amount of such encumbrance, maintenance or alimony is equal to or more than the amount of the compensation payable to the landowner or the intermediary or the person in possession, as the case may be, the whole amount shall be reserved for payment to the holder of the encumbrance or the person entitled to the maintenance or alimony, and no amount shall be paid to the landowner or the intermediary or the person in possession, as the case may be. (5) Where any amount has been deducted or reserved for payment to the holders of encumbrances or the persons entitled to the maintenance or alimony, the same shall be paid in their order of priority to the persons entitled thereto. (6) Where a person entitled to the purchase price or the value at the encumbrance, maintenance or alimony dies before it is paid to him, it shall be paid to his legal representatives: [Provided that if such person has, in accordance with the rules made in this behalf, nominated any member of his family to receive the amount, the same shall be paid to such nominee. Explanation.- For the purpose of the preceding proviso, member of family means wife or husband, son or daughter.] (7) Where the person entitled to receive the purchase price or the value of encumbrance is a private trust or endowment or a minor or a person suffering from legal disability or a limited owner, the purchase price or the value of encumbrance may, notwithstanding anything contained in any law, but subject to any general directions that the Government may give, be deposited for and on behalf of such person with such authority, or bank as may be prescribed. (8) where before any court or authority any suit or proceeding is pending which directly or indirectly affects or is likely to affect the right of any person to receive the whole or part of the purchase price or the amount of encumbrance or maintenance or alimony payable under this Section, the court or authority may require the Land Tribunal to place at its disposal the amount so payable, and thereupon the same shall be disposed of in accordance with the orders of the court or authority.] [80F. Payment of purchase price to landowner, etc to be full dis-charge.- The payment of purchase price or the value of encumbrance, maintenance or alimony to the landowner, the intermediaries, if any, and the person in possession, of the land in which the kudikidappu is situate and other persons entitled thereto in the manner specified in Section 80E shall be a full discharge of the liability for the payment of purchase price to the landowner, the intermediaries, if any, and the person in possession, of the land in which the kudikidappu is situate, and no further claims for payment of purchase price shall lie.] 80G. Contribution towards purchase price.- (1) The amount to be met from the Kudikidappukar’s Benefit Fund under Subsection (8) of Section 80A, shall be made available to the Land Tribunal in twelve equal annual instalments for payment to the persons entitled thereto; [***] (2) The Land Tribunal shall pay the amount of each instalment made available to it under Sub-section (1) to the persons entitled thereto on such date and in such manner as may be prescribed.
CHAPTER III Restriction on Ownership and Possession of Land in Excess of Ceiling Area and Disposal of Excess Lands 81. Excemptions.- (1) The provisions of this Chapter shall not apply to- (a) lands owned or held by the Government of Kerala or the Government of any other State in India or the Government of India or a local authority [or the Cochin Port Trust] or any other authority which the Government may, in public interest, exempt, by notification in the Gazette, from the provisions of this Chapter. [Provided that the exemption under this clause shall not apply to lands owned by the Government of Kerala and held by any person under lease whether current or time expired or otherwise.] [Explanation I.- “Lands owned by the Government of Kerala” shall, for the purposes of this clause, have the same meaning as “Government Lands” under Sub-section (1) of Section 2 of the Kerala Government Land Assignment Act, 1960; [but lands escheated to the Government and held by tenants entitled to fixity of tenure under Section 13 shall not be deemed to be lands owned by the Government of Kerala.]] [Explanation II.- Lands, the right, title and interest in respect of which have vested in the Government under Sub-section (9) of Section 66 or Section 72, shall not be deemed to be “lands owned by the Government of Kerala” for the purposes of this clause;] [Explanation III.- For the purposes of this clause, “other authority”, shall include a corporation owned or controlled by the Government of Kerala or the Government of any other State in India or the Government of India;] (b) lands taken under the management of the Court of Wards: Provided that the exemption under this clause shall cease to apply at the end of three years from the commencement of this Act; (c) lands comprised in mills, factories or workshops and which are necessary for the use of such mills, factories or workshops; (d) private forests; (e) plantations; [(f) cashew estate Explanation.- For the purpose of this clause “cashew estate” shall mean dry land principally cultivated with not less than 150 cashew trees per hectare.] (g) [***] (h) lands mortgaged to the Government, or to a co-operative society (including a co-operative land mortgage bank) registered or deemed to be registered under the Co-operative Societies Act for the time being in force, or to the Kerala Financial Corporation, or to the Kerala Industrial Development Corporation or to the State Small Industries Corporation, as security for any loan advanced by the Government or by such Society or Corporation, so long as the mortgage subsists: Provided that the exemption under this clause shall cease to apply at the end of three years from the commencement of this Act; (i) lands purchased by the Kerala Co-operative Central Land Mortgage Bank or a Primary Mortgage Bank under Sec Lion 18 of the Kerala State Co-operative Land Mortgage Banks Act, 1960, or by the Kerala State Co-operative Bank Ltd., or by a primary agricultural credit co- operative society or by a scheduled bank as defined in the Reserve Bank of India Act, 1934 so long as such lands continue in the possession of the bank; (j) lands purchased by the Kerala Financial Corporation or lands the management of which has been taken over by that Corporation, under Section 32 of the State Financial Corporations Act, 1951, so long as such lands remain in the ownership, or continue under the management, as the case may be, of the said Corporation: [Provided that the exemption under this clause shall not apply in the case of lands the management of which has been taken over by the Corporation on or after the 1st day of April, 1964;] (k) lands belonging to or held by an industrial or commercial undertaking at the commencement of this Act, and set apart for use for the industrial or commercial purpose of the undertaking: Provided that the exemption under this clause shall cease to apply if such land is not actually used for the purpose for which it has been set apart, within such time as the District Collector may, by notice to the undertaking, specify in that behalf; (l) [***] [(m) house sites, that is to say, sites occupied by dwelling houses and lands, wells, tanks and other structures necessary for the convenient enjoyment of the dwelling houses.] Explanation.- For the avoidance of doubt, it is hereby declared that a compound wall shall not he deemed to he a structure necessary for the convenient enjoyment of a dwelling house, if the land on which the dwelling house is situated and enclosed by the compound waif is more than the (and necessary (or the convenient enjoyment of the dwelling house. (n) [***] (o) sites of temples, churches, mosques and cemeteries and burial and burning grounds: (p) sites of buildings including warehouses; (q) commercial sites; (r) land occupied by educational institutions including land necessary for the convenient use of the institutions and playgrounds attached to such institutions; (s) lands vested in the Bhoodan Yagna Committee; (t) lands owned or held by- (i) a University established by law; or (ii) a religious, charitable or educational institution of a public nature; or (iii) a public trust which expression shall include a wakf; Provided that- (i) the entire income of such lands is appropriated for the University, institution or trust concerned; and (ii) where the University, institution or trust comes to hold the said lands after the commencement of this Act, the Government have certified previously that such lands are bona fide required for the purposes of the University, institution or trust, as the case may be; and (u) lands granted to defence personnel for gallantry. (2) [***] [(3) The Government may if they are satisfied that it is necessary to do so in the public interest- (a) on account of any special use to which any land is put; or (b) on account of any land being bonafide required for the purpose of conversion into plantation or for the extension or preservation of an existing plantation or for any commercial, industrial, educational or charitable purpose, by notification in the Gazette, exempt such land from the provisions of this Chapter, subject to such restrictions and conditions as they may deem fit to impose: Provided that the land referred to in clause (b) shall be used for the purpose for which it is intended within such time as the Government may specify in that behalf; and, where the land is not so used within the time specified, the exemption shall cease to he in force.] [(4) Notwithstanding anything contained in this Act or in any other law for the time being in force of in any contract or other documents or in any judgement, decree or order of any Court or Tribunal or Taluk Land Board or Land Board or other authority, a person holding plantation and lands ancillary thereto or interspersed within such* plantation, [may, subject to such restrictions and conditions as may be prescribed, use] not exceeding five per cent of the extent of such holding for floriculture or for the cultivation of Vanila or medicinal plants or other [agricultural crops or for conducting dairy farms] or for establishing hotels or resorts or other tourism projects and for purposes ancillary or connected therewith.] 82. Ceiling area.- [(1) The ceiling area of land shall be, (a) in the case of an adult unmarried person or a family consisting of a sole surviving member, five standard acres, so however that the ceiling area shall riot be less than six and more than seven arid a half acre in extent; (b) in the case of a family consisting of two or more, but not more than five members, ten standard acres, so however that the ceiling area shall not be less than twelve and more than fifteen acres in extent. (c) in the case of a family consisting of more than five members, ten standard acres increased by one standard acre for each member M excess of five, so however that the ceiling area shall not he less than twelve and more than twenty acres in extent; and (d) in the case of any other person, other than a joint family, ten standard acres, so however that the ceiling are shall not be less than twelve and more than fifteen acres in extent.] (2) For the purposes of this Chapter, all the lands owned or held individually by the members of a family or jointly by some or all of the members of such family shall be deemed to be owned or held by the family. [(3) In calculating the extent of land owned or held by a family or an adult unmarried person, the shares of the members of the family or the adult unmarried person, as the case may be, in the lands owned or held. (a) by one or more of such members jointly with any person or persons other than a member or members of such family or by such adult unmarried person jointly with any other person or persons; or (b) by a co-operative society or a joint family, shall be taken into account. Explanation.- For the purposes of this Sub-section, the share of a member of a family or an adult unmarried person in the lands owned or held jointly or by a co-operative society or a joint family shall be deemed to be the extent of land which would be allotted to such member or person had such lands been divided or partitioned, as the case may be, on the date notified under Section 83. (4) Where, after the commencement of this Act, any class of land specified in Schedule It has been converted into any other class of land specified in that schedule or into a plantation, the extent of land liable to he surrendered by a person owning or holding such land shall he determined without taking into consideration such conversion.] [Provided that nothing contained in this section shall apply to the conversion of dry land into cashew estate.] (5) The lands owned or held by a private !rust or a private institution shall be deemed to be lands owned or held by the person creating the trust or establishing the institution, or, if he is not alive, by his successors-in- interest. (6) In computing the ceiling area, lands exempted under Section 81 shall be excluded. Explanation I.- For the purposes of this Section, where a person a has two or more legally wedded wives living, the husband, one of the wives named by him for the purpose and their unmarried minor children shall be deemed to be one family; and the other wife or each of the other wives and her unmarried minor children shall be deemed to be a separate family. Explanation II.- For the purposes of this Section, an adult un-married person shall include a divorced husband or divorced wife who has not remarried: Provided that if such divorced husband or divorced wife is the guardian of any unmarried minor child, he or she together with such unmarried child shall be deemed to be a family. [83. No person to hold land in excess of the ceiling area.- With effect from such dates as may be notified by the Government in the Gazette, no person shall be entitled to own or hold or to possess under a mortgage lands in the aggregate in excess of the ceiling area.] 84. Certain voluntary transfers to be null and void.- (1) Notwithstanding anything contained in any law for the time being in force. all voluntary transfers effected after the date of publication of the Kerala Reforms Bill, 1963, in the Gazette, otherwise than- (i) by way of partition; or (ii) [***] (iii) in favour of a person who was a tenant of the holding before 27th July, 1960, and continued to he so till the date of transfer; [***] (iv) [***] by a family or any member thereof or by an adult unmarried person owning or holding land in excess of the ceiling area [or otherwise than by way of gift in favour of his son or daughter or the son or daughter of his pre-deceased son or daughter by any person owning or holding land in excess of the ceiling area] shall be deemed to be transfers calculated to defeat the provisions of this Act and shall be invalid; Provided that, without prejudice to any other right of the parties to any such transfer, when any purchase price is payable under Section 56 or any compensation is payable [under Section 72H or Section 88] for any land covered by the said transfer, it shall be competent for the Land Tribunal to award to the transferee, out of the purchase price or compensation amount in respect of such land; such sum as the Land Tribunal may consider just and proper. [(1A) Notwithstanding anything contained in Sub-section (1) or in any judgement, decree or order of any court or other authority, any voluntary transfer effected by means of a gift deed executed during the period commencing on the 1st day of January. 1970 and ending with the 5th day of November, 1974, by a person owning or holding land in excess of the ceiling urea in favour of his son or daughter or the son or daughter of his predeceased son or daughter shall be not deemed to be, or ever to have been, invalid- (a) if the extent of the land comprised in the gift does not exceed the ceiling area specified in clause (a) of Sub-section (1) of Section 82; and (b) if the extent of the land comprised in the gift exceeds the ceiling area specified in the said clause, to the extent of that ceiling area: Provided that nothing contained in this Sub-section shall apply- (a) to a transfer in favour of a person who was an unmarried minor on the 1st day of January, 1970; (b) in respect of any land which has been assigned on registry under Section 96, before the commencement of the Kerala Land Re-forms (Amendment) Act, 1979.] [Explanation.- For the purposes of clause (b), a land shall be deemed to have been assigned on registry if the purchase price pay-able for the assignment of that land or the first instalment thereof has been deposited as required by the rules made under this Act.] [(2) Notwithstanding anything contained in any law for the time being in force, all voluntary transfers effected by any person (other than a family or any member thereof or by an adult unmarried person) owning or holding land in excess of the ceiling area after the 1st July, 1969, otherwise than- (i) by way of partition; or (ii) in favour of a person who was a tenant of the holding before the 27th July, 1960, and continued to be so till the date of transfer; [***] (iii) [***] shall be deemed to be transfers calculated to defeat the provision of this Act and shall be invalid: Provided that without prejudice to any other right of the parties to any such transfer, when any purchase price is payable under Section 56 or any compensation is payable under Section 72H or Section 88 for any land covered by the said transfer, it shall be competent for the Land Tribunal to award to the transferee, out of the purchase price or compensation amount in respect of such land, such sum as the Land Tribunal may consider just and proper.] [(3)For the removal of doubts, it is hereby clarified that the expression “ceiling area” in Sub-sections (1) and (2) means the ceiling area specified in Sub-section (1) of Section 82 as amended by the Kerala Land Reforms (Amendment) Act, 1969 (35 of 969).] [(4) Notwithstanding anything contained in Sub-sections (1), (1A) or (2), or in any judgement, decree, or order of any court tribunal or other authority, no acquisition of land referred to in Section 7E shall be deemed to be invalid, or ever to have been invalid, by reason only of the fact that the land so acquired was found included as, or forming part of, the land liable to be surrendered by the transferor as excess land under the provisions of this Act and no suit or other proceedings including proceedings for eviction relating to the said land shall be instituted, maintained or continued in any court or tribunal against any person who is a deemed tenant under Section’ 7E and every such suit or proceedings pending shall stand abated: Provided that ceiling cases wherein excess land has been physically taken over and distributed to landless labourers or reserved for public purposes as provided in this Act shall be reopened: Provided further that if the Taluk Land Board is satisfied that the transfer of land made by a person, in possession of excess land is calculated to defeat the ceiling provisions, it may take into account the land so transferred in determining his ceiling area, and may direct him to surrender such extent of land held or possessed by him: Provided also that no ceiling cases or proceedings in which a. ,y land has already been surrendered by, or assumed from, a person as excess land before the commencement of the Kerala Land Reforms (Second Amendment) Act, 2004, shall be reopened.] 85. Surrender of excess land.- [(1) Where a person owns or holds land excess of the ceiling area on the date notified under Section 83, such excess land shall be surrendered as hereinafter provided:] Provided that where any person bonafide believes that the ownership or possession of any land owned or [held by such person on where such person is a member of a family, by the members of such family, is liable to be purchased by the cultivating tenant or kudikidappukaran] or to be resumed by the landowner or the intermediary under the provisions of this Act, the extent of the land so liable to be purchased or to be resumed shall not be taken into account in calculating the extent of the land to be surrendered under this Sub-section. Explanation.- Where any land owned Or held by a family or adult unmarried person owning or holding land in excess of the ceiling area was transferred by such family or any member thereof or by such adult unmarried person, as the case may be, after the 18th December, 1957, and on or before the date of publication of the Kerala Land Reforms Bill, 1963, in the Gazette, otherwise than- (i) by way of partition; or (ii) on account of natural love and affection: or (iii) in favour of a person who was a tenant of holding before the 18th December, 1957, and continued to be so till the date of transfer: or (iv) in favour of a religious, charitable or educational institution of a public nature solely for the purposes of the Institution, the extent of land owned or held by such family or adult unmarried person shall be calculated for purposes of fixing the extent of land to be surrendered under this Section as if such transfer had not taken place, and such family or adult unmarried person shall be bound to surrender an extent of land which would be in excess of the ceiling area on such calculation, or where such family or person does not own or hold such extent of land, the entire land owned or held by the family or person [but nothing in this Explanation- (a) shall affect the rights of the transferee under the transfer: or (b) shall apply in the case of any transfer of land by a family or any member thereof or an adult unmarried person if the extent of land owned or held by such family or adult unmarried person, as the case may be, immediately be-fore the transfer was not in excess of ‘the ceiling area specified in the Kerala Agrarian Relations Act, 1960, and applicable to such family or adult unmarried person.] [(2) Where a person owns or holds land in excess of the ceiling area, such person shall, within a period of three months from the date notified under Section 83, file a statement before the Land Board inti-mating the location, extent and such other particulars as may be pre-scribed, of all the lands (including lands exempted under Section 81) owned or held by such person and indicating the lands proposed to be surrendered.] Explanation I.- Where lands owned or held by a family stand in the name of more than one member of the family, the identity of the land, he ownership or possession or ‘both of which is or are to be surrendered, shall be indicated as far as practicable with the concurrence of all the members in whose names they stand. Explanation II.- Where land to be surrendered is owned or held by two or more persons jointly, whether or not as members of an institution or of a joint family, the identity of the same shall be indicated as far as practicable with the concurrence of all the persons who own or hold such land. Explanation III.- Where 1[a person] owns or holds lands, including shares in the lands owned or held by a co-operative society, in excess of the ceiling area, the excess lands to be surrendered shall be lands other than shares in the lands owned or held by the co-operative society. [Explanation IV.- Where any person owns or holds land in excess of the ceiling area, including lands mortgaged to the Government or to a co-operative society or to a co-operative land mor1gaje bank registered or deemed to be registered under the Co-operative. Societies Act for the time being in force, or to the Kerala financial Corporation or to the Kerala Industrial Development Corporation or to the State Small industries Corporation, [or to a scheduled bank as defined in the Reserve Bank of India Act, 1934 [or to a corresponding new bank constituted under the Ranking Companies (Acquisition and Transfer of Undertakings) Act, 1970 or to the Stare Bank of India constituted under the State Bank of India Act, 1955 or to a subsidiary bunk as defined in the State Bank of India (Subsidiary Banks) Act, 1959]] as security for any loan advanced by the Government or by such co-operative society or bank or corporation the excess lands to he surrendered shall, as far as possible, he lands other than those so mortgaged.] [Explanation V.- Where a person owns or holds land in excess of the ceiling area including lands owned by the Government of Kerala, the excess lands to be surrendered shall, as far as possible, be the lands owned by the Government of Kerala.] [(2A) The statement under Sub-section (2) shall be filed,- (a) in the case of an adult unmarried person, by such person: (b) in the case of a minor, lunatic. idiot or a person subject to like disability, the guardian, manager or other person in charge of such person or of the property of such person; (c) in the case of a family the husband or in his absence, the wife, or in the absence of both, the guardian of the minor children; (d) in the case of any other person, any person competent to Act for such person in this behalf.] [(3) Where, after the final settlement of claims for resumption of lands held by a person as tenant, such person holds land in excess of the ceiling area, or where after the purchase of the right, title and interest of the landowner and the intermediary by the cultivating tenant in respect of lands owned by a person, such person owns land in excess of the ceiling area, such excess land shall be surrendered as hereinafter provided. (3A) The person hound to file a statement under Sub-section (2) shall, within a period of three months from the date of final settlement or purchase, file a statement before the Land Board, and the provisions of the said Sub-section shall, as far as may he, apply in regard to the particulars to be contained in such statement, the calculation of the excess land and for the procedure for the surrender of the same.] (4) Where a member of a joint family surrenders under this Section, any land belonging to the joint family and the surrender is accepted by the [Taluk Land Board] with or without modification in extent or identity of the lands surrendered, be shall be deemed to have become divided in status from the other members of the family, with effect from the date of the surrender, and the lands, the surrender of which has been accepted, shall he deemed to have been lands allotted to the share of such member on partition. (5) On receipt of the statement under Sub-section (2) or [Sub-section (3A)] [the Land Board shall transfer the statement to such Taluk Land Board as may be decided by the Land Board in accordance with such principles as may be prescribed and such Taluk Land Board shall]- (a) cause the particulars mentioned in the statement to be verified; (b) ascertain whether [the person to whom] the statement relates, owns or holds any other lands; and (c) by order, determine the extent and identity of the land to be surrendered. (6) In determining the identity of the land, the [Taluk Land Board] shall [***] accept the choice indicated under Sub-section (2) or [Sub-section (3A):] [Provided that the [Taluk Land Board] shall not be bound to accept such choice if- (A) it has reason to believe that the person whose land is indicated to be surrendered has no good title to that land; or (B) the land indicated to be surrendered is not accessible; or (C) it considers for any other reason to be recorded in writing that it is not practicable to accept the choice or to take possession of the land:] [Provided further that] where in such determination the interest of other persons are also likely to be affected, the (Taluk Land Board shall, except in cases where all the persons interested have agreed to the choice indicated, afford an opportunity to such other persons to be heard and pass suitable orders regarding the land to be surrendered. [(6A) For the removal of doubts it is hereby declared that proceedings for the determination of the extent and other particulars of any land, the ownership or possession or both of which is or are to be surrendered by an adult unmarried person or a family, shall not abate On the death of that adult unmarried person or as the case may be, the sole surviving member of that family where it consists of only one person, or the member of that family who filed the statement under this Section or under Section 85A in the case of any other family, but shall be continued against the legal representatives of such adult unmarried person or sole surviving member or the remaining member or members of such family, as the case may be, and such legal representatives or remaining member or members shall be bound to surrender the same extent of land as such adult unmarried person or sole surviving member of such family would have been liable to surrender, if such adult unmarried person or sole surviving member or the person who filed such statement, as the case may be, were alive on the date of determination of the extent and other particulars of the land.] (7) Where any person fails to file the statement specified under Sub-section (2) or [Sub-section (3A) the Land Board shall, intimate that fact to the Taluk Land Board and thereupon the Taluk Land Board shall] after necessary enquiries, by order, determine the extent and other particulars of the land, the ownership or possession or both of which is or are to be surrendered: Provided that before such determination [the Taluk Land Board] shall give an opportunity to the persons interested in the land, to be heard. (8) Where the [Taluk Land Board] determines the extent of the land to be surrendered by any person without hearing any person interested, such person may, within sixty days from the date of such determination, apply to the [Taluk Land Board] to set aside the order and, if he satisfies the [Taluk Land Board] that he was prevented by any sufficient cause from appearing before the [Taluk Land Board] it shall set aside the order and shall proceed under Sub-section (5) or Sab-section (7), as the case may be. [(9) The Taluk Board may, at any time, set aside its order under Sub-section (5) or Sub-section (7), as the case may be, and proceed afresh under that Subsection if it is satisfied that- (a) the extent of lands surrendered by, or assumed from, a person under Section 86 is less than the extent of lands which he was liable to surrender under the provisions of this Act, or (b) the lands surrendered by, or assumed from, a person are not lawfully owned or held by him; or id in a case where a person is according to such order, not liable to surrender any land. such person owns or holds lands in excess of the ceiling area:] Provided that the Taluk Land Board shall not set aside any order under this Sub-section without giving the persons affected thereby an opportunity of being heard: Provided further that the Taluk Land Board shall not initiate any proceedings under this Sub-section [after the expiry of seven years] from the date on which the order sought to be set aside has become final.] [Explanation I.- For the removal of doubts, it is hereby clarified that the references in this Sub-section to the Taluk Land Board shall, in cases in which the order under Sub-section (5) or Sub-section (7) as been passed by the Land Board, be construed as references to the Land Board.] Explanation II.- For the purposes of this Section and Section 86, “hold” with reference to land shall include “possess land under mortgage with possession”. [(9A) Power of Taluk Land Board to review its decision- Not-withstanding anything contained in this Act or in the Lamination Act, 1963 (Central Act 36 of 1963), or in any other law for the time being in force or in any judgement, decree or order of any court or other authority, the Taluk Land Board may, if it is satisfied that its decision under Sub-section (5) or Sub-section (7) or subSection (9) requires to be reviewed on the ground that such decision has been made due to the failure to produce relevant data or other particulars relating to ownership or possession before it, or by collusion or fraud or any suppression of material facts the Taluk Land Board may review such decision after giving an opportunity to the parties of being heard anti pass such orders as it may think fit: Provided that the Taluk Land Board shall not reopen any such case after the expiry of three years from the date of coming into force of the Kerala Land Reforms (Amendment) Act 1989.] [(10) Any person who, by virtue of the provisions of Sub-section (IA) of Section 84, is entitled to the restoration of the ownership or possession or both of any land may, within sixty days from the commencement of the Kerala Land Reforms (Amendment) Act, 1979, apply to the Land Board or the Taluk Land Board, as the case may be, for such restoration. (11) An application under Sub-section (10) shall be in such form, shall contain such particulars and shalt be verified in such manner as may be prescribed. (12) On receipt of an application under Sub-section (10), the Land Board or the Taluk Land Board, as the case may he, than, after giving the applicant or any other person likely to be affected, an opportunity of being heard and after such inquiry as it deems necessary, by order, restore the ownership or possession, or both, as the case may be, of the land.] [85A. Certain persons to file statements.- (1) Notwithstanding any thing contained in this Chapter, every family consisting of more than one member, owning or holding more than twelve acres in extent of land, every adult unmarried person and every family consisting of a sole surviving member, owning or holding more than six acres in ‘extent of land and every other person (other than a bank) owning or holding more than twelve acres in extent of land shall, within a period of [seventy five days] from the commencement of the Kerala Land Reforms (Amendment) Act,1972, file a statement before the Land Board intimating the location, extent and such other particulars as may be prescribed, of all lands (including lands exempted under Section 81) owned or held by such family or person. Explanation.- In this Sub-section “bank” means a scheduled bank as defined in the Reserve Bank of India Act, 1934, or a corresponding new bank constituted under the Banking Companies (Acquisition and Transfer of Undertakings) Act, 1970, or the Stale Bank of India constituted under the Stale Bank of India Act, 1955 or a Subsidiary bank as defined in the State Bank of India (Subsidiary Banks) Act, 1959. (2) The statement under Sub-section (1) shall he filled- (a) in the case of an adult unmarried person or the sole surviving member of a family, by such person; (b) in the case of a minor, lunatic, idiot or a person subject to like disability, by the guardian, manager or other person in charge of such person or of the property of such person: (c) in the case of a family, by the husband or in his absence by the wife, or, in the absence of both, by the guardian of the minor children; (d) in the case of any other person, by any person competent to act for such person in this behalf. (3) On receipt of a statement under Sub-section (1), the Land Board shall transfer the statement to such Taluk Land Board as may he decided by the Land Board in accordance with such principles as may he prescribed.] 86. Vesting of excess lands in Government.- [(1) On the determination of the extent and other particulars of the lands, the ownership or possession or both of which is or are to be surrendered under Section BS, the ownership or possession or both, as the case may be of the land shall, subject to the provisions of this Act, vest in the Government free from all encumbrances and the Taluk Land Board shall issue an order accordingly.] (2) On receipt of [the order of the Taluk Land Board under Sub-section (1)] such person shall make the surrender demanded, in such manner as may he prescribed. (3) Where any person fails to make the surrender demanded, the [Taluk Land Board] may authorise any officer to take possession or assume ownership of the land in such manner as may be prescribed. [(4) Where the ownership of any land vests in the Government under Sub-section (1), the rights of the intermediary, if any, in respect of the land shall stand extinguished, and where possession of any land which was in the possession of a cultivating tenant vests in the Government under that Sub-section, the ownership of such land shall vest in the Government and the rights of the intermediary, if any, in respect of such land shall stand extinguished.] [(5) Notwithstanding anything contained in the forgoing provisions of this Act, where any land is indicated in the statement under Sub-section (2) of Section 85 as land proposed to be surrendered, the [Taluk Land Board] may, pending determination under Sub-section (5) of Section 85 of the extent and identity of the land to be surrendered by the person who has filed the statement or on whose behalf the statement has been filed, take possession of such land if it is satisfied that such person is in possession of the land and has legal title to such possession and that the land is fit for surrender, and thereupon the provisions of Sub-section (4) shall, so far as may be, apply in respect of such land.] [(6) Nothing contained in this Chapter-shall be deemed to affect the powers of the Government or any other authority or officer, conferred by or under the provisions of the Kerala Land Conservancy Act, 1957, in respect of unauthorised occupation of lands which are the property of the Government.] 87. Excess land obtained by gift, etc., to be surrendered.- [(1) Where any person acquires any land after the date notified under Section 83 by gift, purchase, mortgage with possession, lease, surrender or any other kind of transfer inter vives or by bequest or inheritance or otherwise and in consequence thereof, the total extent of land owned or held by such person exceeds the ceiling area, such excess shall be surrendered to such authority as may be prescribed.] [Explanation I].- Where any land is exempted by or under Section 81 and such exemption is in force on the date notified under Section 83, such land shall, with effect from the date on which it ceases to be exempted, be deemed to be land acquired after the date notified under Section 83. [Explanation II.- Where, after the date notified under Section 83, any class of land specified in schedule II has been converted into any other class of land specified in that Schedule or any land exempt under Section 81 from the provisions of this Chapter is converted in to any class of land not so exempt and in consequence thereof the total extent of land owned or held by a person exceeds the ceiling area, so much extent of land as is in excess of the ceiling area, shall be deemed to be land acquired after the said date.] (1A) Any person referred to in Sub-section (1) shall file a statement containing the particulars specified in [Sub-section (1) of Section 85A within a period of three months of the date of the acquisition.] [(2)The provisions of Sections 85 and 86 shall, so far as may be, apply to the vesting in the Government of the ownership or possession or both of the lands required to be surrendered under Sub-section (1).] 88. Persons surrendering land entitled to compensation.- (1) Where ownership or possession or both of any land [***] is vested in the Government under Section 86 or Section 87, such person shall be entitled to compensation. Where the rights of an intermediary are extinguished, such intermediary shall also be entitled to compensation. [(1A) Notwithstanding anything contained in Sub-section (1), no person shall be entitled to any compensation in respect of any land owned by the Government of Kerala and held by him under lease or otherwise.] [(2) The compensation payable to an owner for the vesting in the Government] of ownership and possession of land shall be an amount calculated at the rates specified in Schedule IV, (3) The compensation payable to the landowner, intermediary or cultivating tenant for the [***] vesting in the Government or extinguishment of his rights shall be the portion of an amount calculated at the rates specified in Schedule IV that will fall to his share if such amount were apportioned among the landowner, cultivating tenant and intermediary, if any, in respect of the land according to the following provisions: (i) ninety percent of the portion of the compensation for the site of any homestead or hut in the occupation of a kudikidappukaran shall be deducted from the total amount of compensation; (ii) the balance remaining after deducting the amount referred to in clause (1) shall be apportioned among the landowner, the intermediaries and the cultivating tenant in proportion to the profits derivable by them from the land immediately before the surrender, assumption or vesting in the Government, as the case maybe. Explanation.-“Profits derivable from the land” shall be deemed to be equal to (i) in the case of a landowner; the rent which he was entitled to get immediately before the 1st day of January, 1970, from the tenant holding immediately under aim; (ii) in the case of an intermediary, the difference between the rent which he was entitled to get immediately before the 1st day of January, 1970, from his tenant and the rent for which he was liable to his landlord immediately before that day; and (iii) in the case of a cultivating Tenant, the difference between the net income and the rent which he was liable to pay immediately before the said day. (3A) Notwithstanding anything contained in Sub-sections (2) and (3), where the compensation due under those Sub-sections to an adult unmarried person, family or any other person (other than a joint family), as owner, landowner, intermediary or cultivating tenant or in any two or more of such capacities exceeds one lakh rupees, the compensation payable shall be limited to the amount specified in the Table below:
Table Scales of compensation
| Total Amount of compensation |
Rate |
| On the first Rs. 1 lakh |
100 per cent |
| On the next Rs. 50,000 |
30 per cent |
| On the balance amount |
23 per cent: |
| Provided that the compensation payable shall in no case exceed |
Rs. 2 lakhs. |
[(4) Where the rights of a mortgagee in possession are vested in the Government]- (i) Where the ownership of the land mortgaged [has vested in the Government] the mortgagee shall be treated as a holder of an encumbrance in respect of the land, and the encumbrance shall be discharged as provided in Sections 91 and 92; (ii) in other cases, the Government shall pay to the mortgagee the amount to which he would have been entitled under clause (i) if the ownership of the land mortgaged (Iliad vested in) the Government, and hold the land as mortgagee with possession with all the rights and liabilities of the mortgagee. [(5) For the removal of doubts, it is hereby declared that the compensation payable under this Section in respect of a land shall be deemed to include the compensation for growing crops and improvements, if any, thereon and that no person shall be entitled to any amount other than the compensation payable under this Section for The vesting in the Government or extinguishment of his rights (including his rights in respect of growing corps and improvements if any) in respect of the land.] 89. Payment of advance towards compensation.- Pending the determination of the amount of compensation payable to any person under Section BB, it shall be competent for the Land Board to pay such amount as it considers proper to such person as part payment of the compensation on taking proper security, in case it is found that he is entitled to such amount. The amount so paid shall be deducted from the compensation payable to such person and the Land Board shall pay to him only the balance. 90. Preparation of compensation roll.- (1) As soon as may be after the [Taluk Land Board] has determined the extent and particulars of any land the ownership or possession or both of which is or re to be surrendered, the [Taluk Land Board] shall, forwarding the necessary documents, direct the Land Tribunal to prepare and submit to the Taluk Land Board a compensation roll showing- (a) the description of the land or the interests in the land surrendered or assumed; (b) the name and address of the person surrendering the same or from whom the same was assumed; (c) the names and addresses of the landowner, intermediary and the cultivating tenant and the amount of compensation payable to each; (d) the names of the holders of the encumbrances (including mortgagees who have surrendered possession of excess lands), maintenance or alimony and the value of the encumbrances or of the claims for maintenance or alimony; and (e) such other particulars as may be prescribed [(2) On receipt of the direction under Sub-section (1), the Land Tribunal shall, after giving an opportunity to all persons interested to be heard and after making such enquiry as it considers necessary, prepare a draft compensation roll and furnish copies thereof to the persons interested, together with a notice inviting objections to the draft compensation roll within such period, not being less than thirty days from the date of the notice, as may be specified in the notice. (2A) The Land Tribunal shall also cause the draft compensation roll to be published in such manner as may be prescribed.] (3) Where any land, the ownership or possession or both of which is or are surrendered to, or assumed by,.the Government, forms part of the security for an encumbrance, maintenance or alimony, the Land ‘Tribunal shall for the purpose of discharging the same apportion the entire encumbrance, maintenance or alimony between the land surrendered to, or assumed by, the Government and the portion of the security remaining, in proportion to the values of the two portions of the security. [(4) After considering the objections, if any received within the period specified in the notice under Sub-section (2), the Land Tribunal shall prepare a final compensation roll showing the particulars mentioned in Sub-section (1) and shall also pass an order recording his reasons for each entry in the final compensation roll and for accepting or rejecting the objections, if any, received in pursuance of the notice under Sub-section (2). (5) A copy of the final compensation roll prepared under Sub-section (4) shall, after the order of the Land Tribunal under that Sub-section has become final, be forwarded to the Land Board by the Land Tribunal.] 91. Payment of compensation.- (1) On receipt of the compensation roll under Section 90, the Land Board shall pay the compensation to the persons entitled thereto, subject to the provisions of Sub-section (2). (2) Where the land or the ownership or possession of land which has vested in the Government, is subject to any encumbrance, maintenance or alimony, the value of the encumbrance, maintenance or alimony shall be deducted from the compensation amount payable to the person liable for such encumbrance, maintenance, or alimony. If the total amount of such encumbrance, maintenance or alimony is more than the amount of compensation, the compensation amount shall be distributed to the holders of the encumbrance and the persons entitled to the maintenance or alimony in the order of priority. (3) The Land Board shall also pay the mortgage amount payable to a mortgagee under clause (ii) of Sub-section (4) of Section 88. [92. Payment of compensation and amount of encumbrance.- (1) The compensation or amount of encumbrance, as the case may be, shall be paid,- (a) where the person entitled to receive the compensation or the amount of encumbrance is not a private trust or endownment or a body corporate, the compensation or the amount of encumbrance shall be paid either in cash or in negotiable bonds redeemable after the expiry or sixteen years and carrying simple interest at the rate of four and a half percent per annum with effect from the date on which the ownership or possession or both of the land has or have vested in the Government under section 86 or section 87 or partly in cash and partly in such bond, in such manner as may be prescribed; (b) where the person entitled to receive the compensation or the amount of encumbrance is a private trust or endownment or a body corporate, the compensation or the amount of encumbrance shall be paid in cash or in treasury certificate to be encashed after the expiry of sixteen years and carrying simple interest at the rate of four and a half percent per annum with effect from the date on which the ownership or possession or both of the land has or have vested in the Government under section 86 or section 87 or partly in cash and partly in such treasury certificate, in such manner as may be prescribed. (2) Where the person entitled to receive the compensation or the amount of encumbrance is a minor or a person suffering from some legal disability or a limited owner, the compensation or the amount of encumbrance, either in cash or in negotiable bond or partly in cash and partly in such bond as may be payable under sub-section (1), shall, notwithstanding anything contained in any law, but subject to any general directions that the Government may give, be deposited for and on behalf of the person with such authority or bank as may be prescribed. (3) Where a person entitled to the compensation or the amount of encumbrance under sub-section (1) dies before it is paid to him, it shall be paid to his legal representatives: Provided that if such person has, in accordance with the rules made in this behalf, nominated any member of his family to receive the amount, the same shall be paid to such nominee. Explanation.- For the purposes of the preceding proviso, “member of family” means wife or husband, son or daughter of such person. (4) Where before any court or authority any suit or proceeding is pending which directly or indirectly affects or is likely to affect the right of any person to receive the whole or part of the compensation or the amount of encumbrance, the court or authority may require the Land Board to place at its disposal the amount so payable and thereupon the same shall be disposed of in accordance with the orders of the court or authority.] 93. Payment of compensation to he full discharge.- The payment of compensation in the manner specified in Section 92 shall be i full discharge of the liability for payment of compensation, and no further claim therefore shall lie. [94. x x x] 95. Application for assignment of land.- Any person who does not possess any land or possesses only less than [one acre] of land in extent may apply to the Land Board for assignment on registry of lands to him. 96. Assignment of lands by Land Board.- [(1) The Land Board shall assign on registry subject to such conditions and restrictions as may be prescribed, the lands vested in the Government under Section 86 or Section 87, as specified below: (i) the lands in which there are kudikidappukars shall he assigned to such kudikidappukars; (ii) the remaining lands shall be assigned to- (a) landless agricultural labourers, and (b) small-holders and other landlords who are not entitled to resume any land: Provided that eighty-seven and a half per cent of the area of the lands referred to in clause (ii) available for assignment in a taluk shall be assigned to landless agricultural labourers of which one-half shall be assigned to landless agricultural labourers belonging to the [Scheduled Castes, the Scheduled Tribes and such other socially and economically backward classes of citizens as may be specified in this behalf, by the Government by notification in the Gazette.] [Explanation I.- For the purposes of this Sub-section- (a) a kudikidappukaran or the tenant of a kudiyirippu shall be deemed to be a landless agricultural labourer if he does not possess any other land: (b) kudikidappukaran shall include a person who was a kudikidappukaran to whom a certificate of purchase has been issued under Sub-section (2) of Section 80C.] (1A) Notwithstanding anything contained in Sub section (1), the Land Board may, if it considers that any land vested in the Government under Section 86 or Section 87 is required for any public purpose, reserve such land for such purpose.] (2) The and Board shall not assign to any person more than one acre in extent of land. (3) Where a person possesses any land, only so much land as will make the extent of land in his possession [one acre] shall be assigned to him 97. Payment of purchase price.- (1) The purchase price of the land assigned on registry under Section 96 shall be an amount [calculated at the rate specified in Schedule IV] and shall be payable either in lump or in sixteen equal annual instalments. The assignment shall be made on payment of the purchase price either in lump or the first instalment thereof. (2) Where the purchase price is payable in instalments, the amount outstanding after payment of each instalment shall bear interest at the rate of 4-1/2 per cent per annum. (3) All amounts due from an assignee shall he a first charge on the land assigned and shall be recoverable as arrears of land revenue under the Revenue Recovery Act for the time being in force. 98. Management of surrendered lands till assignment.- The Land Board shall, subject to such rules as may be made by the Government in this behalf, manage the lands vested in them until they are assigned under [Section 96], by making arrangements for their cultivation and protection. [98A. Interpretation.- For the purposes of this Chapter, the term “person” shall not include a co-operative society or an institution of a public nature for religious and charitable purposes established and maintained by a religious denomination or any Section thereof or the Board of Trustees for the Improvement of the City of Trivandrum constituted under Section 3 of the Trivandrum City Improvement Trust Act, 1960]. [Explanation.- If any question arises as to whether an institution is an institution of a public nature for religious and charitable purposes maintained by a religious denomination or any Section thereof, the question shall be decided by the Government and such decision shall be final.]
CHAPTER IV Miscellaneous [99. Constitution of Land Tribunal.- (1) The Government may, by notification in the Gazette, constitute one or more Land Tribunal or Land Tribunals for any area or for any class of cases specified in the notification, for the purpose of performing the functions of a Land Tribunal under this Act. (2) The Land Tribunal shall consist of a sole member who shall be a judicial officer of the rank of a Munsiff or an officer not below the rank of a Tahsildar, appointed by the Government.] [99A. Constitution of appellate authority.- (1) The Government may, by notification in the Gazette, constitute as many appellate authorities as may be necessary for the purposes of this Act. (2) The appellate authority shall consist of a sole member who shall be a judicial officer not below the rank of a Subordinate Judge [or an officer not below the rank of a Deputy Collector.] (3) Each appellate authority shall have jurisdiction over such areas [or in such class of cases] as the Government may, by notification in the Gazette, from time to time determine.] 100. Constitution of land Board.- (1) The Government shall constitute a Land Board for the whole State for performing the functions of the Land Board under this Act. The Board shall consist of a sole member, who shall be [a member of the Board of Revenue or an officer not below the rank of Secretary to Government, appointed by the Government] or of three members. (2) Where the Board consists of three members, the members shall be- [(i) a member of the Board of Revenue or an officer not below the rank of Secretary to Government, appointed by the Government, who shall be the Chairman;] (ii) a judicial officer not below the rank of a District Judge nominated by the Government in consultation with the High court; (iii) an officer of the Government nominated by the Government. (3) (a) The functions of the Board, where it consists of three members, may be exercised by a Bench consisting of all the members of the Board or by a Bench consisting of two members constituted by the Chairman or, in the event of the office of a member other than the Chairman being, vacant, by a Bench consisting of the Chairman and the other member. (b) Where any matter is heard by a Bench consisting of all the three members of the Board and the members differ in opinion on any point, the point shall be decided in accordance with the opinion of the majority. (c) Where any matter is heard by a Bench consisting of two members and the members are divided in their opinion on any point, they shall state the point upon which they differ and the matter shall then be heard upon that point only by third member and such point shall be decided according to the opinion of the third member. [100A. Constitution of Taluk Land Hoards.- (1) The Government shall, by notification in the Gazette, constitute a Taluk Land Board for each taluk in the State for performing the functions of the Taluk Land Board under this Act. (2) A Taluk Land Board shall consist of the following members, namely:- (a) an officer not below the rank of Deputy Collector appointed by the Government, who shall be the Chairman of the Board; (b) not more than six members nominated by the Government. [(2A) Notwithstanding anything contained in subSection (2), but subject to such rules as may be made by the Government in this behalf, the functions of the Taluk Land Board may be performed by the Chairman alone or by the Chairman and any one or more of the other members of the board.] [(2B) [The member or members] present at any meeting of the Taluk Land Board may deal with any evidence or memorandum taken down or made in any case during any previous meeting or meetings of the Board as if such evidence or memorandum had been taken down or made [by him or them] and may proceed with that case from the stage at which it was left at the last previous meeting in which that case was dealt with by the Board.] (3) [Subject to the provisions of Sub-sections (2A) and (2B)] the procedure to be followed by the Taluk Land Board in performance of its functions under this Act shall be such as may be prescribed. (4) A person shall be disqualified for being nominated as, or for being, a member of the Taluk Land Board if he is or has been convicted of an offence involving moral turpitude and sentenced in respect thereof to imprisonment for not less than six months unless a period of five years has elapsed from the date of expiry of the sentence. (5) The term of office of the Taluk Land Board and the manner of filling casual vacancies among the non-official members of the Board shall be such as may be prescribed. (6) Any member nominated to fill the vacancy in the office of a member shall hold office only so long as the member in whose vacancy he was nominated would have held office if the vacancy had not occurred. [(6A) Any member of the Taluk Land Board other than the Chairman shall cease to hold office if he absents himself from three consecutive meetings of the Board: Provided that no meeting from which a member absented himself shall be counted against him under this Sub-section, if due notice of that meeting was not given to him.] [(6B) The members of the Taluk Land Board other than the Chair-man shall be entitled to a sitting fee of ten rupees per day for attending the meetings of the Board: Provided that the Government may, by notification in the Gazette, and for reasons to be stated in such notification, fix such other amount as they deem fit, as sitting fee.] (7) The Government may, at any lime, for reasons to be recorded in writing, remove from office any member of the Taluk Land Board after giving him a reasonable opportunity of showing cause against the proposed removal:] [Provided that it shall not he necessary to record in writing the reasons for the removal or to give an opportunity of showing cause against the proposed removal, if the Government are of the opinion a that it is not expedient, in the public interest, to record the reasons in writing or to give such opportunity] [100B. Dissolution and reconstitution of Taluk Land Board.- (1) If the Government are of the opinion that a Taluk Land Board is not functioning satisfactorily or in accordance with the provisions of this Act, the Government may, by notification in the Gazette, dissolve the Board after giving it an opportunity of showing cause against the proposed dissolution. (2) As soon as may be after the dissolution of a Taluk Land Board under Sub-section (1), the Government shall constitute a new Taluk Land Board in accordance with the provisions of Section 100A, and until such constitution, the Land Board shall exercise the powers and perform the functions of the Taluk Land Board.] [100C. Powers of the Taluk Land Board.- For the purpose of performing its functions under this Act, the Taluk Land Board shall have all the powers of a civil court while trying a suit under the Code of Civil Procedure 1908,(Central Act 5 of 1908), in respect of the following matters, namely:- (a) summoning and enforcing the attendance of any person and examining him on oath; (b) requiring the discovery and production of any document; (c) receiving evidence on affidavit; and (d) any other matter which may be prescribed.] [100D. Constitution of Land Reforms review Board.- (1) For the purpose of reviewing the progress of implementation of this Act, the Government may. by notification in the Gazette, constitute a Board to be called the Land Reforms Review Board which shah consist of- (a) the Minister of we Slate in charge of land reforms, who shall he the Chairman; (b) the member or members, as the case may be, of the Land Board; and (c) six non official members nominated by the Government- (2) The member of the Land Board where it consists of a sole member, or the Chairman of the Land Board where it consists of three members, shall he the convenor of the Land Reforms Review Board. (3) The term of office of the non-official members of the Land Reforms Review Board shall he such as may be prescribed. (4) Any vacancy in the office of a non-official member of the Land Reforms Review Board shall be filled by the Government. (5) The procedure to be followed by the Land Reforms Review Board in the performance of its functions under this Ad shall he such as may he prescribed.] [100E. Powers of the Land Reforms Review Board.- For the purpose of performing its functions under this Act, the Land Reforms Review Board may- (a) call for returns from any authority or officer exercising any power or performing any function under this Ad or the rules made thereunder; (b) lay down such guidelines as may be necessary for the speedy and effective-implementation of this Act.] 101. Powers of the land Board and the land Tribunal.- (1) The Land Board and the Land tribunal constituted under this Act shall have all the powers of a civil court while trying a suit under the Code of Civil Procedure, 1908, in respect of the following matters, namely:- (a) summoning and enforcing the attendance of any person and examining him on oath: (b) requiring the discovery and production of any document; (c) receiving evidence on affidavit; (d) issuing commissions for the examination of witnesses or for local investigation; and (e) any other matter which may be prescribed. [(2) The Land Board shall have superintendence over all the [Land Tribunals, Appellate Authorities and the Taluk Land Boards] and the Land Board may- (a) call for returns from the [Land Tribunals, Appellate Authorities and the Taluk Land Boards] (b) make and issue general rules and prescribe forms for regulating the practice and proceedings of the [Land Tribunals, Appellate Authorities and the Taluk Land Boards] (c) prescribe forms in which books entries and accounts shall be kept by the [Land Tribunals, Appellate Authorities and the Taluk Land ;] and (d) on the application of any of the parties and after notice to the parties and after hearing such of them as desire to be heard, or of its own motion, without such notice, transfer any application, appeal or other proceeding pending before any Land Tribunal or Appellate Authority, to any other Land Tribunal or Appellate Authority, as the case may be, or re-transfer the same for trial or disposal to the Land Tribunal or the Appellate Authority, as the case may be, from which it was originally transferred.] [(e) [on its own motion or] on the application of any of the parties and after notice to the parties and after hearing such of them as desire to be heard, transfer any proceeding pending before any Taluk Land Board to any other Taluk Land Board or re-transfer the same for disposal to the Taluk Land Board from which it was originally transferred.] (3) Where in any proceeding before the Land Tribunal a question arises whether a person is a small holder or not or whether a person is or is not a tenant [or whether the right, title and interest of the landowner and the intermediaries, if any, in respect of any holding, have or have not vested in the Government under Section 72,] it shall be competent for the Land Tribunal to decide the question. [(4) If any question arises as to whether any land is exempted under Section 81, the question shall be decided by the Land Board [or the Taluk Land Board, as the case may be] in such manner and having regard to such matters as may be prescribed, and the decision [or the Land Board for the Taluk Land Board] shall be final.] (5) If any question arises as to whether any land is principally used for the purposes specified in clause (5) of Section 2, the question shall be decided by the Land Board ‘ [or the Taluk Land Board, as the case may be] after taking into account the extent of, the amount invested in, and the income from, the portion of the land so used and the remaining portion and other relevant matters, and the decision of the Land Board [or the Taluk Land Board shall be final.] [102. Appeal to Appellate Authority.- (1) The Government or any person aggrieved by any order of the Land Tribunal under Sub-section (2) of Section 12, Sub-section (3) of Section 13A, Section 22, Section 23, Sub-section (2) of Section 26 (where the amount of arrears of rent claimed exceeds five hundred rupees) Section 31, Section 47, Sub-section (3) or Sub-section (4) of Section 48 Sub-section (3) of Section 49, Sub-section (6) of Section 52, Section 57, Sub-section (5) of Section 66, Section 72F, Section 73, ‘(Sub-section (2) of Section 77], Section 80B, Sub-section (4) of Section 90, Section 106 or Section 106A may appeal against such order within such time as may be prescribed to the Appellate authority. (2) The Appellate authority may admit an appeal presented after the expiration of the period prescribed under Sub-section (1) if it is satisfied that the appellant had sufficient cause for not presenting it within that period. (3) In deciding appeals under Sub-section (1), the Appellate authority shall exercise all the powers which a court has and follow the same procedure which a court follows in deciding appeals against the decree of an original court under the Code of Civil Procedure, 1908. (4) Where there has been any modification in appeal from any decision or order of the Land Tribunal, such decision or order shall be modified accordingly.] [103. Establishment of State Land Reforms Tribunal.- The Government may, by notification in the Gazette, establish a State Land Reforms Tribunal to exercise the jurisdiction, powers and authority conferred on the State Land Reforms Tribunal by or under this Act.] [103A. Jurisdiction, powers and authority of State Land Reforms Tribunal.- (1) Save as otherwise expressly provided in this Act, the State Land Reforms Tribunal shall exercise, all the jurisdiction, powers and authority exercisable by all courts (except the Supreme Court under article 32 and article 136 of the Constitution) in relation to the matters enumerated in sub-section (2) to (6). (2) Any person aggrieved by- (i) any final order passed in an appeal against the order of the Land Tribunal; or (ii) any final order passed by the Land Board under this Act; or (iii) any final order of the Taluk Land Board under this Act; may, within such time as may be prescribed, prefer a petition to the State Land Reforms Tribunal against the order on the ground that the appellate authority or the Land Board or the Taluk Land Board, as the case may be, has either decided erroneously, or failed to decide any question of law. (3) In any petition for revision preferred under sub-section (2), the Government shall be made a party. (4) The Government may, within such time limit as may be prescribed, prefer a petition for revision to the State Land Reforms Tribunal against any final order referred to in sub-section (2) on any of the grounds mentioned in that sub-section (5) The State Land Reforms Tribunal may, after giving an opportunity to the parties to be heard, pass such orders as it deems fit and the orders of the appellate authority or the Land Board or the Taluk Land Board, as the case may be, shall wherever necessary, be modified accordingly. (6) The State Land Reforms Tribunal may, for the purpose of satisfying itself that an order made by the Land Tribunal under section 26 in case where the amount of arrears of rent claimed does not exceed five hundred rupees was according to law, call for the records and pass such order with respect thereto as it thinks fit.] [103B. Composition of the State Land Reforms Tribunal.- (1) The State Land Reforms Tribunal shall consist of a Chairman, who shall be a Judge of a High Court and two other members, of whom one shall be a person who is, or has been, or is qualified to be, a Judge of the High Court and the other shall be a person who is, or has been, an officer of the Government not below the rank of a Secretary to the State Government as the Government may think to appoint to perform the functions assigned to the State Land Reforms Tribunal by or under this Act: Provided that appointment of Chairman and other members shall be made in consultation with the Chief Justice of the High Court of Kerala. (2) Any vacancy in the office of a member of the State Land Reforms Tribunal shall be filled by the Government. (3) (a) Subject to the provisions of clause (b), the functions of the State Land Reforms Tribunal may be performed- (i) by a Bench consisting of the Chairman and any other member; or (ii) by a Bench consisting of the Chairman and two other members; or (iii) by a Bench consisting of two members other than the Chairman. (b) The powers of the State Land Reforms Tribunal under this Act may be exercised by a Bench consisting of the Chairman or a single member. (4) If any case which comes up before a Bench consisting of a single member other than the Chairman, or a Bench consisting of more than one member, of which the Chairman is not a member, involves a question of law, the Bench may, in its discretion, reserve such case for decision by the Chairman or by a Bench to be constituted under subsection (5), of which the Chairman shall be a member. (5) The Bench or Benches of the State Land Reforms Tribunal shall be constituted by the Chairman in accordance with the provisions of this Act or the rules made thereunder. (6) If the members of a Bench differ in opinion on any point, the point shall be decided according to the opinion of the majority, if there is a majority, and if the members are equally divided, they shall state the point or points on which they differ and such point or points shall be heard- (i) when the Chairman is not a member of that Bench, either by the Chairman or by the Chairman and any other member as the Chairman may direct; and (ii) when the Chairman is a member of that Bench, by any other member to whom the case is referred by the Chairman and such point or points shall be decided according to the opinion of the majority of the members of the Tribunal who have heard the case, including those who first heard the case. (7) Any member who has previously dealt with any case coming up before the State Land Reforms Tribunal, in any other capacity or is personally interested in any case coming up before the State Land Reforms Tribunal shall be disqualified to hear that case. (8) Where any case is heard by a Bench consisting of two members and the members are divided in their opinion on any point and the other member or members of the State Land Reforms Tribunal are disqualified under sub-section (7) to hear the case, the Government may appoint a person who is or has been a judge of a High Court to be an additional member of the Tribunal and the point shall be decided in accordance with the opinion of the majority of the members of the State Land Reforms Tribunal who have heard the case including those who first heard it. (9) The additional member appointed under sub-section (8) shall cease to hold office on the disposal of the case for which he was appointed. (10) The State Land Reforms Tribunal shall, with the previous sanction of the Government, make regulations consistent with the provisions of this Act and the rules made thereunder, for regulating its procedure and the disposal of its business. (11) The regulations made under sub-section (10) shall be published in the Gazette.] [103C. Term of office.- The Chairman or other member shall hold office as such or a term of three years from the date on which he enters upon his office or until he attains the age of sixty-five years.] [103D. Salaries and other terms and conditions of services of the Chairman and other members.- The salaries and allowances payable to, and the other terms and conditions of service of, the Chairman and other members shall be such as may be prescribed by the Government.] [103E. Financial and Administrative powers o f Chairman.- The Chairman shall exercise such financial and administrative powers as may be vested in him under the rules made by the Government.] [103F. Staff of the Tribunal.- (1) The Government shall determine the nature and categories of the officers and other employees required to assist the State Land Reforms Tribunal in the discharge of its functions and provide the Tribunal with such officers and other employees as it may think fit. (2) The salaries and allowances and the method of appointment and other conditions of service of the officers and other employees of the Tribunal shall be such as may be specified by rules made by the Government.] [103G. Transfer of pending cases.- Every revision petition pending before the High Court of Kerala filed under the provisions of this Act immediately before the establishment of the State Land Reforms Tribunal under this Act shall stand transferred to and will be decided by the State Land Reforms Tribunal constituted under this Act.] [103H. Proceedings before the State Land Reforms Tribunal to be judicial Proceedings.- All proceedings before the State Land Reforms Tribunal shall be deemed to be judicial proceedings within the meaning of sections 193, 219 and 228 of the Indian Penal Code.] [103I. Members and staff of the State Land Reforms Tribunal to be Public Servants.- The Chairman and other members and officers and other employees provided under section 103F to the State Land Reforms Tribunal shall be deemed to be public servants within the meaning of section 21 of the Indian Penal Code.] [103J. Exclusion of jurisdiction of Civil Courts and High Court.- On and from the date from which any jurisdiction, powers and authority becomes exercisable under this Act by the State Land Reforms Tribunal in relation to any of the matters covered by this Act, no civil court including the High Court (except the Supreme Court under article 32 and article 136 of the Constitution) shall have, or be entitled to exercise any jurisdiction to settle, decide or deal with any question or determine any matter which is by or under this Act required to be settled, decided or dealt with or to be determined by the Land Tribunal or the appellate authority or the Land Board or the Taluk Land Board or the State Land Reforms Tribunal or the Government or an officer of the Government.] 104. Proceedings by or against joint families, etc.- (1) Where, in any proceeding under this Act, a joint family is a party, it shall he sufficient to implead the manager, karanavan or yajaman and the senior must male member of such family and, in the case of a Marumakkathayam or Aliyasanthana family, also the karanavan or yajaman of each tavazhi or kavaru, but any other member of the family shall have the right to get himself impleaded as a party. (2) Where any such proceeding relates to any property or part thereof under the management of a receiver appointed by a court, it shall he sufficient to implead the receiver as party to the proceeding [and notwithstanding anything contained in any other law, it shall . not be necessary to obtain the permission of the court which appointed the receiver for so impleading him] [(3) The provisions of this Section, shall have effect notwithstanding anything to the contrary contained in any other provision of this Act.] [104A. Applications relating to holdings situate within the jurisdiction of more than one Land Tribunal.- An application to be filed before a Land Tribunal under this Act relating to a holding situate within the jurisdiction of more than one Land Tribunal may he filed before any one of such Land Tribunals, and the Land Tribunal before which the application is filed shall he competent to dispose of the application under the provisions of this Act as if the whole of the holding were situate within its jurisdiction.] 105. Authorised officer empowered to obtain information from persons.- (1) For the purpose of carrying into effect the provisions of this Act, any officer, not below the rank of a [Revenue Inspector] authorised by the Government in this behalf (hereinafter in this Section referred to as the authorised officer) may, by notice, require any person to furnish any information relating to the extent of land held by such person, the numbers of the members of the family, if any, of such person and such other particulars as may be prescribed. The person aforesaid shall furnish the information to such officer within such time as may be specified in the notice or within such further time not exceeding thirty days as the authorised officer may, in his discretion, allow. (2) (a) Where any person on whom notice under subSection (1) has been served fails to furnish the information within the time specified in that notice or within the further time allowed by the authorised officer under Sub-section (1), the authorised officer may obtain, in such manner as may he prescribed, the necessary information either by himself or through such agency as he thinks fit. (b) The authorised officer shall, as soon as may be after obtaining the information under clause (a), give to the person concerned a reasonable opportunity of making his representation and of adducing evidence, if any, in respect of such information and consider any such representation and evidence and pass such orders as he deems fit. [105A. Appointment of officers for certain purposes.- (1) The Government may appoint any officer not below the rank of a Revenue Inspector for bringing to the notice of the Land Tribunal or the Land Board or the Taluk Land Board] any fact or information required by the Land Tribunal or the Land Board, [or the Taluk Land Board] as the case may be, or for moving the Land Tribunal or the Land Board [or the Taluk Land Board] to take any action necessary for the implementation of the provisions of this Act. (2) The Land Tribunal or the Land Board [or the Taluk Land Board] may depute any officer appointed under Sub-section (1) to make local enquiry, investigation or inspection and to collect any data, and the report and the records submitted by such officer may he used without examining him as evidence in the proceedings before the Land Tribunal or the Land Board [or the Taluk Land Board.] (3) The Land Tribunal or the Land Board [or the Taluk Land Board] may, if it thinks fit, summon and examine any officer referred to in Sib-section (2).] 106. Special provisions relating to leases for Commercial or industrial purposes.- [(1) Notwithstanding anything contained in this Act, or in any other law, or in any contract, or in any order or decree of court, where on any land leased for commercial or industrial purposes, the lessee has constructed buildings for such commercial or industrial purpose before the 20th May, 1967, he shall not be liable to he evicted from-such land, but shall be liable to pay rent under the contract of tenancy, and such rent shall be liable to be varied every twelve years. Explanation.- For the purposes of this Section- (a) “lessee” includes a legal representative or an assignee of the lessee; and (b) “building” means a permanent or a temporary building and includes a shed. (1A) The lessor or the lessee may apply to such authority as may be prescribed for varying the rent referred to in Sub-section (1), and thereupon such authority may, after taking into consideration such matters us may be prescribed and after giving the lessor and the lessee an opportunity of being heard, pass such orders on the application as it deems fit.] (2) If between the 18th December, 1957 and the date of commencement of this Act, any decree or order of court has been executed and any person dispossessed by delivery, such person shall, on application before the Land Tribunal, he entitled to restoration of possession: Provided that, before restoration, such person shall be liable to pay- (i) the compensation paid by the landlord for any improvements in the land and subsisting at the time of restoration; (ii) the compensation for any improvements effected subsequent to the delivery: Provided further that he shall not be entitled to restoration if the property has passed on to the possession of a bonafide transferee for value. [(3) Nothing contained in Sub-section 01; Sub-section (1A) and Sub-section (2) shall apply to lands owned or held by the Government of Kerala or a local authority.] [Explanation.- For the purposes of this Sub-section, “local authority” includes the Cochin Port Trust and any University established by an Act of the Kerala State Legislature.] Lease for commercial or industrial purposes. [106A. Special provisions relating to buildings used by kudikidappukars for commercial or industrial purposes.- (1)Notwithstanding anything contained in this Act, or in any other law, or in any contract, or in any decree or order of court, wherein any land in which a kudikidappu is situate, the kudikidappukaran has constructed a building for any commercial or industrial purpose before the 20th May. 1967, and such kudikidappukaran was carrying on any trade, business or industry in such building without interruption from the date of construction of the building till the 1st July, 1969, he shall have the right, subject to the provisions of Sub-section (2), to carry on such trade, business or industry in such building without interference by the person in lawful possession of the land in which the building is situate:- (2) The kudikidappukaran shall he liable to pay rent as specified below for the use and occupation of the building to the person in lawful possession of the land in which the building is situate:- (a) if the kudikidappukaran was liable to pay arty rent for the use and occupation of the building before the commencement of the Kerala Land Reforms (Amendment) Act:1969, such rent: (b) in other cases, such rent as may be determined by the Land Tribunal having regard to such matters as may he prescribed. (3) Nothing contained in Sub-sections (1) and (2) shall apply to buildings constructed on lands owned or held by the Government of Kerala or a local authority. Explanation.- For the purpose of this Section, “building” means a permanent or a temporary building and includes a shed.] [106B. Special provision for issue of Certificate of title.- (1) Notwithstanding anything to the contrary contained in any other provision of this Act or in any other law for the time being in force, a person claiming to be a deemed tenant under Section 7E may apply, within such time and in such manner as may be prescribed, to the Land Tribunal having jurisdiction over the area, for a certificate of title in respect of the land held by him. (2) On receipt of an application under Sub-section (1) the Land Tribunal shall, within a period of six months from the date of application pass orders thereon after verifying the records as it may deem fit and when the application is allowed, issue a certificate of title in such manner as may be prescribed.] 107. Costs.- (1) Subject to the provisions of this Act, the costs of and incident to all proceedings before the Land Tribunal [or the Appellate authority] shall be in its discretion and it shall have full power to determine by whom or out of what property and to what extent such costs are to be paid and to give all necessary directions for the purposes aforesaid. The fact that any proceeding before the Land Tribunal [or the Appellate authority] is without jurisdictions hall he no bar to the exercise of such powers. [(2) An order passed by the Land Tribunal or the Appellate authority in exercise of the powers vested in it under Sub-section (1) may he executed by it in such manner as may he prescribed.] 108. Application of the provisions of Section 5 of the Indian limitation Act.- Unless otherwise specifically provided in this Act, the provisions of Section 5 of the Indian Limitation Act, 1908, shall apply to all proceedings under this Act. [108A. Section 11 of Code of Civil Procedure to apply to proceeding before Land Tribunal.- The provisions of Section 11 of the Code of Civil Procedure, 1908 (Central Act 5 of 1908), shall, so far as may be, apply to proceedings, before the Land Tribunal.] [109. Constitution of Agriculturist Rehabilitation Fund and Kudikidappukars Benefit Fund.- (1) A fund of not less than two hundred lakhs rupees called the Agriculturist Rehabilitation Fund and another fund of nor less than one hundred lakhs rupees called the Kudikidappukars Benefit Fund may be constituted by the Government to be administered by the Revenue Department in such manner as may he prescribed. (2) The funds referred to in Sub-section (1) shall consist of grants or loans by or from the State Government and other moneys, if any, received by the Government from any person or raised by the Government in accordance with the rules made by the Government in this behalf. (3) The Agriculturist Rehabilitation Fund shall be utilised for payment of solarium to small holders under Section 109A and for rendering help by way of loan, grant or otherwise to persons affected by this Act who are eligible for the same in accordance with the rules made by the Government. (4) The Kudikidappukars Benefit Fund shall be utilised- (a) for meeting twelve and half per cent of the [amount of compensation payable for acquisitions] as provided in Sub-section (3E) of Section 75; (b) for meeting [***] the purchase price payable by the kudikidappukars, as provided in Sub-section (8) of Section 80A; and [(c) for providing better facilities to- (i) the kudikidappukars: and (ii) persons who were kudikidappukars to whom certificates of purchase have been issued under Sub-section (2) of Section 80C. in accordance with such rules as may he made by the Government in this behalf.] Provided that a person to whom a certificate of purchase has been issued under the said Sub-section or his successor-in-interest shall not be entitled to any benefit under this clause after the expiry of a period of twenty years from the date on which the right, title and interest in respect of the land allowed to be purchased by such person have vested in him under the said Sub-section.] [109A. Solatium to small holders.- (1) The Land Board shall pay to every small holder whose right, title and interest , either as landowner or as intermediary or as both, in respect of lands held by cultivating tenants have vested in the Government under Section 72, a solatium equal to the amount of the compensation payable to him in consideration of such vesting, after deducting the value of encumbrances and claims for maintenance or alimony, if any: Provided that the solatium payable to a small holder shall, in no case, exceed [one thousand five hundred rupees:] Provided further that no small holder shad be entitled to such solatium if- (a) such compensation exceeds [five thousand rupees]; or (b) he is assessed to sales tax on a turnover which in the aggregate is not less than thirty thousand rupees in any two years within the three years immediately preceding the financial year in which the notification under Section 72 is issued, under the Kerala General Sales Tax Act, 1963 or the Central Sales Tax Act,1956 or the law of any other State relating to sales tax; or (c) he is assessed to income-tax under the Income-tax Act, 1961, in any two years within the three years referred to in clause (b) Explanation.- For the purposes of this Section, a person shall not be deemed to be a small holder if any of his predecessors-in-interest was in possession of, or had interest in, land exceeding the limits specified in clause(52) of Section 2 immediately before the 18th December, 1957, provided that nothing in this Explanation shall apply in the case of a person who would have been a small holder immediately before the 18th December, 1957, if this Act had been in force immediately before that date. (2) Any person entitled to the solatium under Sub-section (1) shall apply to the Land Board within such time as may be prescribed. (3) An application under Sub-section (2) shall be in such form and shall contain such particulars as may be prescribed. (4) On receipt of an application under Sub-section (2), the Land Board shall, after making such enquiry as may be prescribed, pay the solatium in cash. (5) Where a person entitled to the solatium dies before it is paid to him, it shall be paid to his legal representatives.] 110. Special provisions for applications of the Act.- (1) If any difficulty arises in the application of the provisions of this Act to any area on account of local variations or difference in nomenclature between the tenures prevailing in that area (by whatever name such tenures may be known) and the corresponding tenures prevailing in the remaining part, of the State, the Government may, subject to the provisions of Sub-section (2), by notification in the Gazette, direct that the said provisions shall apply to the aforesaid area subject to such adaptations, exceptions and modifications as may be specified in this behalf in such notification. (2) A draft of the notification proposed to be issued under Subsection (1) shall be laid before the Legislative Assembly for a period of ten days, and the Legislative Assembly may approve the draft with or without modification or disapprove the draft during the period in which it is so laid. On approval of the draft by the Legislative Assembly, the Government shall publish the notification as approved, in the Gazette. If the Legislative Assembly does not- (i) approve with or without modification; or (ii) disapprove; the said draft during the period aforesaid, it shall be lawful for the Government to publish the notification in the Gazette in terms of the draft. 111. Rent under certain contracts of tenancy not to be affected.- Notwithstanding anything contained in Sub-section (2) of Section 5 of the Cochin Verumpattamdars Act, VIII of 1118, the pattam payable by a verumpattamdar, to whom the provisions of the said Sub-section applied, for the period subsequent to the 1st day of Chingom, 1124, till the date of commencement of this Act, shall only be the amount payable immediately before the commencement of the said Verumpattamdars Act, whether or not such contract was renewed after such commencement. [111A. Mortgage money not to be returned in certain cases.- Notwithstanding anything contained in any law for the time being in force, or in any contract, or in any judgement, decree or order of court, where a mortgagee or any person claiming under him is entitled to fixity of tenure under any provision of this Act, the mortgagor shall not be liable to return the mortgage money or any portion thereof to such mortgagee or person.] [112. Apportionment’s of land value in cases of acquisition.- (1) Where any land is acquired under the law for the time being in force providing for the compulsory acquisition of land for public purposes, the compensation awarded under such law in respect of the land acquired shall be apportioned among the landowner, intermediaries, cultivating tenant and the kudikidappukaran in the manner specified in this Section. (2) The compensation for any building or other improvements shall be awarded to the person entitled to such building or other improvements. (3) The kudikidappukaran shall be entitled to the value of the land occupied by his homestead or hut subject to a minimum of- (a) three cents in a city or major municipality; or (b) five cents in any other municipally; or (c) ten cents in a panchayat area or township. (4) The difference between the value of three cents or five cents or ten cents, as the case may be, and the value of the extent of the land occupied by the homestead or hut shall, notwithstanding anything contained in the Kerala Land Acquisition Act, 1961, be borne by the Government or the local authority or the company or other person on whose behalf the land is acquired. (5) The balance remaining after deducting the compensation referred to in Sub-section (2) and the value of the land occupied by the homestead or hut shall he apportioned among the landowner, the intermediaries and the cultivating tenant in proportion to the profits derivable by them from the land acquired immediately before such acquisition. Explanation.- “Profits derivable from the land” shall be deemed to be equal to (i) in the case of a landowner, the rent which he was entitled to get from the tenant holding immediately under him; (ii) in the case of an intermediary, the difference between the rent which he was entitled to get from his tenant and the rent for which he was liable to his landlord; and (iii) in the case of a cultivating tenant, the difference between the net income and the rent payable by him; and the rent payable by the cultivating tenant and the intermediary for the purposes of this Explanation shall be as calculated under the provisions of this Act.] [(5A) Notwithstanding anything contained in Sub-sections (2) and (5), where there the right, title and interest of the landowner and the intermediaries in respect of the land acquired have vested in the Government under Section 72,- (a) the compensation for any building or other improvements belonging to such landowner and intermediaries shall be awarded to the Government; and (b) the balance remaining after deducting the compensation referred to in clause (a) and the value of the land occupied by the homestead or hut, if any, shall be apportioned between the cultivating tenant and the Government in proportion to the profits derivable by them from the land. Explanation.- “Profits derivable from the land” shall be deemed to be equal to- (i) in the case of the cultivating tenant, the difference between the net income immediately before the acquisition and the rent which he was liable to pay immediately before the date on which the right, title and interest of the landowner and the intermediaries have vested in the Government; and (ii) in the case of the Government, such rent.] [***] [(7) In this Section, “homestead” includes a dwelling house occupied by a person who is deemed to be a kudikidappukaran under Explanation IIA to clause (25) of Section 2.] 113. Prices published under Section 43 to be deemed to be market rates.- If, for the purposes of this Act, the price of any commodity referred to in Section 43 has to be commuted into money at the market rate for any date, such commutation shall be made at the price of that commodity published by the District Collector under the said Section for the relevant quarter. 114. Amendments to certain enactments.- (1) Sections 7 and 9 of the Devaswom Verumpattamdars (Settlement) Proclamation, XXIII of 1118, shall be omitted. [(2) In Section 113 of the Travancore-Cochin Hindu Religious Institutions Act, 1950, Sub-section (2) shall be omitted.] (3) [***] [(4) In Section 2 of the Kerala Land Relinquishment Act, 1958, in clause (d), the words, brackets and figures “as amended by the Kerala Land Reforms (Amendment) Act, 1969” shall be inserted at the end. (5) In the Kerala Prevention of Eviction Act, 1966,- (i) in clause (a) of Section 2, the words, brackets and figures “as amended by the Kerala Land Reforms (Amendment) Act, 1969” shall be inserted at the end. (ii) for Section 8 the following Section shall be substituted, namely: “8. Stay of suits or other proceedings for eviction.- Where in any suit or other proceeding for the eviction of a cultivating tenant, a holder of a kudiyirippu or a kudikidappukaran from his holding, kudiyiruppu or kudikidappu, as the case maybe, whether pending at the commencement of this Act or instituted after such commencement, the cultivating tenant or the holder of the kudiyiruppu or the kudikidappukaran makes a representation to the court or the Land Tribunal in which such suit or other proceeding is pending or instituted that no record of rights in respect of the holding or register of kudikidappukars in respect of the area in which that kudikidappu is situate, as the case may be, has been prepared, and made available to it and the court or the Land Tribunal shall not proceed with the suit or proceeding until the record of rights in respect of the holding or the land in which the kudikidappu is situate, as the case may be, is prepared, and made available to it and the court or the Land Tribunal shall also, by order, direct the Tahsildar of the Taluk in which the holding or the kudikidappu is situate to prepare a record of rights in respect of the holding or, as the case may he, the land in which the kudikidappu is situate and to file the same in the court or the Land Tribunal and the Tahsildar shall cause the same to he prepared in the manner prescribed under the Kerala Land Reforms Act, 1963: Provided that where the area in which the holding or kudikidappu is situate has been notified by the Government under Sub-section (1) of Section 3 of the Kerala Record of Rights Act, 1968, the court or the Land Tribunal shall direct the prescribed officer under that Act instead of the Tahsildar to prepare a record of rights in respect of the holding or, as the case may be, the land in which the kudikidappu is situate, in accordance with the provisions of the said Act and to file the same in the court or the Land Tribunal” (6) In Section 2 of the Kerala Record of Rights Act, 1968, for clause (a), the following clause shall be substituted, namely.- (a) the expression “kudikidappukaran” shall have the meaning assigned to it in the Kerala Land Reforms Act, 1963, as amended by the Kerala Land Reforms (Amendment) Act, 1969;] 115. Appearance before Land Tribunal in [or Appellate Authority] or Land Board [or Taluk Land Board].- (1) Any appearance, application or act in or to any Land Tribunal [or Appellate Authority] or the Land Board [or Taluk Land Board] required or authorised by law to be made or done by a party in such Land Tribunal [or Appellate Authority] or the Land Board [or Taluk Land Board] may be made or done by the party in person or by his recognised agent or by a pleader appearing, applying or acting, as the case may be, on his behalf: Provided that any such appearance shall, if the Land Tribunal [or Appellate Authority] or Land Board [or Taluk Land Board] so directs, be made by the party in person. (2) The recognised agents of parties by whom such appearance, application and act may be made or done are persons holding powers of attorney authorising them to make and do such appearance, application and act on behalf of such parties. 116. Court fees.- Notwithstanding anything contained in the Kerala Court.Fees and Suits Valuation Act, 1959, every application or appeal made under this Act [***] shall bear court fee stamp of such value as may be prescribed. 117. Members of [Land Board, [or Taluk Land Board], Appellate authority] and Land Tribunal to be deemed public servants.- The members of the[Land Board, [or Taluk Land Board], Appellate authority] and the Land Tribunal and any officer appointed under this Act shall be deemed to be public servants within the meaning of Section 21 of the Indian Penal Code. [117A. Penalty for disturbance of customary, easement, and other rights of kudikidappukars.- Any person who in any manner wilfully disturbs or interferes with the customary, easement on other rights to which a kudikidappukaran is entitled under Sub-section (1) or Sub-section (2) of Section 79A shall be punishable with imprisonment for a term which may extend to one year, or with fine which may extend to two thousand rupees, or with both.] 118. Penalty for failure to furnish return.- (1) If any person who is under an obligation to furnish a return or information under this Act refuses or wilfully fails to furnish the return or information within the time specified for the purpose, he shall be punishable with fine which may extend to two hundred rupees. (2) If any person who, after having been convicted under Sub-section (1), continues to refuse or to wilfully fail to furnish the return or information, he shall be punishable with fine which may extend to fifty rupees for each day after the previous date of conviction during which he continued so to offend. [118A. Penalty for failure to furnish statement under Section 85A.- (1) If any person bound to file a statement under Section BSA does not file the statement within the time specified in that Section, he shall he punishable with imprisonment for a term which may extend to one year, or with fine which may extend to two thousand rupees, or with both. (2) If any person who, after having been convicted under Sub-section (1), continues to fad to file the statement referred to in that Sub-section, he shall be punishable with fine which may extend to two hundred rupees for each day after the previous date of conviction during which he continued so to offend.] 119. Penalty for furnishing false returns or information.- If any person who is under an obligation to furnish any return or information furnishes any return or information which he knows or has reasons to believe to be false, he shall be punishable with fine which may extend to one thousand rupees. 120. Penalty for making false declaration.- [(1) After the commencement of the Kerala Land Reforms (Amendment) Act, 1969, no document relating to any transfer of land shall be received for registration under the Indian Registration Act, 1908, unless the transferor and the transferee make separate declarations in writing (in duplicate) in such form as may be prescribed as to the total extent of land held by him. (1A) The registering officer shall forward a copy of the declarations made under Sub-section (1) to the officer authorised by the Government in this behalf for such action as may be necessary]. (2) If any person makes any declaration before the registering officer under Sub-section (1), which he knows or has reason to believe to be false, he shall be punishable with fine not exceeding one thousand rupees. [120A. Registering officer not to register in certain cases.- Notwithstanding anything contained in the Registration Act, 1908 (Central Act 16 of 1908), where the District Collector or any other officer authorised by the Government in this behalf informs the registering officer in writing that there are reasonable grounds to believe that any document relating to transfer of land which may be presented before him for registration is intended to defeat the provisions of this Act, such registering officer shall not register such document until the District Collector or the officer so authorised, as the case may be, informs the registering officer that the transfer is not intended to defeat the provisions of this Act.] 121. Penalty for contravention of any lawful order.- If any person wilfully contravenes any lawful order passed under this Act or obstructs any person from lawfully taking possession of any land under any of the provisions of this Act, he shall be punishable with fine which may extend to five hundred rupees. [122. Penalty for cutting trees or for removing machinery, etc.- If any person cuts or causes to be cut trees on any land indicated under Sub-section (2) of Section 85, as land to be surrendered or removes or causes to be removed any building, machinery, plant or apparatus constructed, erected or fixed on any such land and used for agricultural purposes, or does or causes to be done any act likely to diminish the utility of any such land, he shall be punishable with imprisonment for a term which may extend to one year or with fine which may extend to one thousand rupees, or with both.] [122A. Offences by companies.- (1) Where an offence under this Act has been committed by a company, every person who at the time the offence was committed was in charge of, and was responsible to, the company for the conduct of the business of the company as well as the company, shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly:] Provided that nothing contained in this Sub-section shall render any such person liable to Fitly punishment, if he proves that the of-fence was committed without his knowledge or that he had exercised all due diligence to prevent the commission of such offence. (2) Notwithstanding anything contained in Sub-section (1), where any offence under this Act has been committed by company and it is proved that the offence has been committed with the consent or connivance of, or is attributable to any neglect on the part of, any director, manager, secretary or other officer of the company such director, manager, secretary or other officer shall be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly. Explanation.- For the purposes of this Section- (a) “company” means any body corporate and includes a firm or other association of individuals; and (b) “director” in relation to a firm, means a partner in the firm 123. Cognizance of offences.- (1) No court shall take cognizance of any offence punishable under this Act, except on complaint in writing made by an officer authorised by the Government in this behalf: [Provided that an offence under Section 117A shall, notwithstanding anything contained in the [Code of Criminal Procedure, 1898 (Central Act 2 of 1974)] be cognizable.] (2) No court inferior to that of [a judicial Magistrate of the first class] shall try any offence punishable under this Act. [123A. Cognizance of offences under Section 118A.- (1) Notwithstanding anything contained in Section 123, or in the Code of Criminal Procedure, 1973 (Central Act 2 of 1974), an offence punishable under Section 118A shall he tried by the Taluk Land Board of the taluk in which the person bound to file the statement under Section 85A ordinarily resides. (2) Notwithstanding anything contained in the Code of Criminal Procedure, 1973 (Central Act 2 of 1974), every member of a Taluk Land Board shall, for the purposes of Sub-section (1), be deemed to be a Judicial Magistrate of the first class. (3) object to such rules us may be made by the Government under Sub-section (5), the Taluk Land Board shall, in trying an offence punishable-under Section 118A follow the procedure prescribed by the Code of Criminal Procedure, 1973 (Central Act 2 of 1974), for the trial of summons cases by Judicial Magistrates. (4) The Taluk Land Board shall not take cognizance of any offence punishable under Section 118A, except on complaint in writing made by an officer authorised by the Government in this behalf. (5) For the trial of offences punishable under Section 118A by the Taluk Land Board, the Government may make rules in respect of the following matters, namely: (a) the constitution of benches consisting of two or more members of the Taluk Land Board; (b) the times and places of sitting; and (c) the mode of setting differences of opinion which may arise between the members of the bench so constituted. (6) For the removal of doubts it is hereby declared that, notwithstanding anything contained in Section 100A, a Taluk Land Board or any member of a Taluk Land Board shall not take cognizance of, or try, any offence punishable under Section 118A except in accordance with the provisions of this Section and the rules made thereunder.] 124. Protection of action taken under Act.- No suit, prosecution or other legal proceedings shall lie against any officer for anything in good faith done or intended to be done under this Act or the rules made thereunder. [125. Bar of jurisdiction of civil courts.- (1) No civil court shall have jurisdiction to settle, decide or deal with any question or to determine any matter which is by or under this Act required to be settled, decided or dealt with or to be determined by the Land Tribunal or the Appellate authority or the Land Board the [or Taluk Land Board] or the Government or an officer of the Government: Provided that nothing contained in this Sub-section shall apply to proceedings pending in any court at the commencement of the Kerala Land Reforms (Amendment) Act, 1969. (2) No order of the Land Tribunal or the Appellate authority or the Land Board [or the Taluk Land Board] or the Government or an officer of the Government made under this Act shall be questioned in any civil court, except as provided in this Act. (3) If in any suit or other proceedings any question regarding rights of a tenant or of a kudikidappukaran (including a question as to whether a person is a tenant or a kudikidappukaran) arises, the civil court shall stay the suit or other proceeding and refer such question to the Land Tribunal having jurisdiction over the area in which the land or part thereof is situate together with the relevant records for the decision of that question only. (4) The Land Tribunal shall decide the question referred to it under Sub-section (3) and return the records together with its decision to the civil court. (5) The civil court shall then proceed to decide the suit or other proceedings accepting the decision of the Land Tribunal on the question referred to it. (6) The decision of the Land Tribunal on the question referred to it shall, for the purposes of appeal, be deemed to be part of the finding of the civil court. (7) No civil court shall have power to grant injunction in any suit or other proceedings referred to in Sub-section (3) restraining any person from entering into or occupying or cultivating any kind or kudikidappu or to appoint a receiver for any property in respect of which a question referred to in that Sub-section has arisen, till such question is decided by the Land Tribunal., and any such injunction granted or appointment made before the commencement of the Kerala Land Reforms (Amendment) Act, 1969, or before such question has arisen, shall stand cancelled.] [(8) In this Section, “civil court” shall include a Rent Control Court as defined in the Kerala Buildings (Lease and Rent Control) Act, 1965.] 126. construction of references to acres and cents.- All references in this Act to areas of land expressed in terms of acres (but not standard acres) and cents shall be construed as references to areas ex-pressed in terms of hectares and ayes, converted thereto at the rates specified in the Schedule to the Standards of Weights and Measures (Conversion of Land Areas) Rules, 1960. 127. Act to override other laws, etc.- The provisions of this Act shall have effect notwithstanding anything in any other taw or any custom or usage or in any contract, express or implied, inconsistent with the provisions of this Act. 128. Power to remove difficulties.- If any difficulty arises in giving effect to the provisions of this Act, the Government may, as occasion may require, by order, do anything not inconsistent with the provisions of this Act, which appears to them necessary for the purpose of removing the difficulty. [128A. Delegation of powers by Land Board.- The Land Board may, with the previous approval of the Government, by general or special order in writing, delegate to any District Collector any of its powers under this Act, other than the powers under Sub-section (2) of Section 101, to be exercised in respect of such area as may be specified in the order, subject to such conditions and reservations as it may deem fit.] [128B. Wrong or excess payments recoverable under Revenue Recovery Act.- If, for any reason any amount has been paid by the Land Board or the Land Tribunal to any person not entitled to such amount under this Act or to any person in excess of the amounts due to him under this Act, such amount or, as the case may be, the amount in excess shall be recoverable from the person to whom it has been paid as arrears of public revenue due on land under the provisions of the Revenue Recovery Act for the time being in force.] 129. Power to make rules.- (1) The Government may make rules to carry out all or any of the purposes of this Act. (2) In particular, and without prejudice to the generality of the foregoing power, such rules may provide for the following matters:- [(a) the fees payable on applications, appeals and claims made under this Act and the persons by whom and the period within which such fees shall be paid;] (b) the registers to be kept and maintained by the [Land Tribunal, the Appellate authority,] [the Taluk Land Board] and the Board and the particulars to be entered therein; (c) the procedure to be followed in the preparation of compensation rolls; (d) the filing of statements before the Land Tribunal, [the Taluk Land Board] and the Land Board; (e) the procedure to be followed by the Land Tribunal, [the Taluk Land Board] and the Land Board; (f) for the joint consideration by the Land Tribunal of two or more applications involving the same question; [(ff) for the joint consideration by the Appellate authority of two or more appeals involving the sane question]; (g) the assignment of lands by the Land Board under [Section 96]; (h) the management of land before assignment under Section 98; (i) any other matter which under this Act is to he, or may be, prescribed. 130. Laying of rules and no before the Legislative Assembly.- Every rule made under this Act and every notification issued under clause (a) of Sub-section (1) or Sub-section (3) of Section 81 shall be laid as soon as may be after it is made or issued before the Legislative Assembly while it is in session for a total period of 14 days which may be comprised in one session for session or in two successive sessions, and if, before the expiry of the session in which it is so laid, or the session immediately following, the legislative Assembly makes any modification in the rule or notification or decides that the rule or notification should not be made, or issued, the rule or notification shall thereafter have effect only in such modified form or be of no effect, as the case may be; so however that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule or notification. 131. Limitation.- In computing the period of limitation for the institution of suits or proceedings under this Act, the time during which such suits or proceedings were prohibited or stayed under any of the enactments repealed by this Act, shall be excluded. 132. Repeal and Savings.- (1) (a) The Proclamation XVI of 1122 (Cochin), dated the 14th February, 1947, the Proclamation VI of 1124 (Cochin), dated the 12th January, 1949, the Kerala Roytwari Tenants and Kudikidappukars Protection Act, 1962 and the Kerala Tenants and Kudikidappukars Protection Act, 1963, are hereby repealed, and all suits, appeals, revisions, reviews and proceedings in execution of decrees stayed by the said enactments may be disposed of by the courts in which they were pending at the commencement of this Act, in accordance with the provisions of this Act. (b) The costs in respect of the suits, appeals, revisions, re-views and execution proceedings stayed by the enactments specified in clause (a) shall be in the discretion of the court. (2) The following enactments as in force in any part of the State of Kerala are hereby repealed, namely:- (i) The Cochin Verumpattamdars Act, VIII of 1118 (ii) The Travancore-Cochin Prevention of Eviction of Kudikidappukars Act, 1955. (iii) The Malabar Tenancy Act, 1929. (iv) The Madras Cultivating Tenants (Payment of Fair Rent) Act, 1956. (3) Notwithstanding the repeal of the enactments mentioned in Sub-section (2)- (a) any decree passed before the commencement of this Act for the eviction of a tenant from his holding, pursuant to which eviction has not been effected, may, on the application of the tenant or the landlord, be reopened and the matter may be disposed of in accordance with the provisions of this Act; (b) any suit for restoration filed under Section 24 or Section 26 or Sub-section (3) of Section 53 of the Malabar Tenancy Act, 1929 or any application for determination of fair rent made under Section 16 of that Act or any application for fixation of fair rent made under Section 9 of the Madras Cultivating Tenants (Payment of Fair Rent) Act, 1956, and pending disposal at the commencement of this Act shall be disposed of in accordance with the provisions of the said Acts as if those Acts had not been repealed; (c) (i) Where the decree-holder, plaintiff, appellant or petitioner, as the case may be, is a person entitled to resumption of land under this Act he shall have the right to apply to the court to allow resumption of the holding or any part thereof to which he is entitled; (ii) the application under sub-clause (i) shall be made within one year from the commencement of this Act and shall contain a statement of facts in support of the claims of the applicant and also the names and addresses of all persons who have interest in the holding either as owner, lessee or kudikidappukaran; (iii) the court shall dispose of the application as if it were an application for resumption before the Land Tribunal under this Act; (d) Notwithstanding anything contained in Section 11 of me Code of Civil Procedure, 1908, the right conferred on the decree-holder, plaintiff, appellant or petitioner, as the case may be, under sub-clause (i) of clause (c) shall not be deemed to take away or in any manner affect his right to apply for resumption under this Act. (4) (i) The Kerala Agrarian Relations Act, 1960, is hereby repealed. (ii) Notwithstanding the repeal of the Kerala Agrarian Relations Act, 1960 (hereinafter referred to as the said Act),- (a) all applications for determination of fair rent filed or purported to have been filed under the said Act, in which no order determining the fair rent had been passed by the Land Tribunal, shall be deemed to have been filed under this Act and shall be disposed of according to the provisions of this Act; (b) where the Land Tribunal constituted or purported to have been constituted under the said Act had passed an order determining the fair rent in respect of a holding, but an appeal or application for revision in respect of such order was pending before the Appellate or revising authority at the time when the said Act was declared unconstitutional by the Supreme Court or the High Court, or the proceedings under the said Act were stayed under the Kerala Tenants and Kudikidappukars Protection Ordinance, 1962, as the case may be, in its or their application to the land comprised in the holding, such Appellate or revising authority shall reopen the matter and dispose of it in accordance with the provisions of this Act, and, for that purpose, shall have all the powers of the Appellate or revising authority, as the case may be, under this Act; (c) Where the Land Tribunal constituted or purported to have been constituted under the said Act had passed an order determining the fair rent in respect of a holding, but the time for preferring appeal or revision in respect of such order had not expired at the time when the said Act was declared unconstitutional by the Supreme Court or the High Court, or the proceedings under the said Act were stayed under the Kerala Tenants and Kudikidappukars Protection Ordinance, 1962, as the case may be, in its or their application to the land comprised in the holding, any party aggrieved by the order of the Land Tribunal may, within three months from the commencement of this Act, prefer an appeal or an application for revision against such order before the Appellate or revising authority under this Act, and thereupon such authority shall re-open the matter and dispose of it in accordance with the provisions of this Act; (d) in cases where orders determining fair rent have been passed or purported to have been passed under the said Act and such order had become final, such orders shall be deemed to have been passed under this Act for purposes of payment of fair rent; (e) notwithstanding anything contained in this Act, the fair rent referred to in sub-clause (d) shall be the rent payable by the cultivating tenant, but such fair rent shall not be taken as the basis for the determination of the purchase price under Section 55, and the fair rent for the determination of such purchase price shall be the fair rent determined under this Act. (iii) Subject to the provisions of clause (ii), the said Act or the rules, notifications or orders made or issued thereunder, shall not be deemed to have conferred any right or imposed any liability on any person, as if the said Act had not been enacted.
Schedule I [See section 2 (27) Kuttanad Area Alleppey District
|
Taluk |
|
Village |
| 1. |
Ambalapuzha |
1. |
Prakkad |
|
|
2. |
Ambalapuzha |
|
|
3. |
Alleppey |
| 2. |
Kuttanad |
4. |
Aryad South |
|
|
5. |
Punnapra |
|
|
6. |
Pulincunno |
|
|
7. |
Chennamkari |
|
|
8. |
Kainakari |
|
|
9. |
Champakulam |
|
|
10. |
Nedumudy |
|
|
11. |
Thakazhy |
|
|
12. |
Kozhimukku |
|
|
13. |
Thalavady |
|
|
14. |
Neelamperoor |
|
|
15. |
Veliyanad |
|
|
16. |
Muttar |
|
|
17. |
Ramankari |
| 3. |
Sherthallai |
18. |
Panavaili |
|
|
19. |
Vayalar West |
|
|
20. |
Vayalar East |
|
|
21. |
Thuravoor South |
|
|
22. |
Thuravoor North |
|
|
23. |
Aroor |
|
|
24. |
Thycattussery |
| 4. |
Karthigappally |
25. |
Pathiyoor |
|
|
26. |
Cheppad |
|
|
27. |
Pallipad |
|
|
28. |
Haripad |
|
|
29. |
Veeyapuram |
|
|
30. |
Cheruthana |
|
|
31. |
Karuvatta |
| 5. |
Mavelikara |
32. |
Thamarakuiam |
|
|
33. |
Kannamangalam |
|
|
34. |
Thripoorunthura |
|
|
35. |
Chennithala |
|
|
36. |
Mavelikara |
|
|
37. |
Chunakara |
|
|
38. |
Thazhakara |
|
|
39. |
Noomad |
|
|
40. |
Palamel |
|
|
41. |
Pandalam South |
|
|
42. |
Thonaloor |
| 6. |
Thiruvalla |
43. |
Kizhakkumbhagom |
|
|
44. |
Kadapra |
|
|
45. |
Peringara |
|
|
46. |
Kavumbhagom |
|
|
47. |
Thiruvalla |
| 7. |
Chenp,annoor |
48. |
Cheriyanad |
|
|
49. |
Venmony |
|
|
50. |
Mannar |
|
|
51. |
Kurattisseri |
|
|
52. |
Puliyoor |
| Kottayam District |
| 8. |
Kottayam |
53. |
Thiruvarppu |
|
|
54. |
Kottayam |
|
|
55. |
Nattakam |
|
|
56. |
Panachikkad |
|
|
57. |
Vij ayapuram |
|
|
58. |
Aymanam |
|
|
59. |
Kumarakom |
|
|
60. |
Kaipuzha |
|
|
61. |
Onamthuruthu |
|
|
62. |
Puthuppally |
| 9. |
Changanacherry |
63. |
Kuruchi |
|
|
64. |
Vazhappally West |
|
|
65. |
Vazhappally East |
|
|
66. |
Changanacherry |
|
|
67. |
Madappally |
|
|
68. |
Thrikodithanam |
|
|
69. |
Vakathanam |
| 10. |
Vaikom |
70. |
Naduvile |
|
|
71. |
Thaiayazham |
|
|
72. |
Kallara |
|
|
73. |
Vechoor |
|
|
74. |
Manjoor |
|
|
75. |
Vadayar |
|
|
76. |
Kaduthuruthy |
[Schedule II] [See Section 2 (55)] Lands other than nilam Trivandrum District
|
Class of land |
Standard acres |
| 1. |
Garden land: |
|
|
(i) Land used principally for growing coconut trees |
1.00 |
|
(ii) Land used principally for growing arecanut trees |
0.50 |
|
(iii) Land used principally for growing peppervines |
1.50 |
| 2. |
Dry land principally cultivated with cashew |
2.00 |
| 3. |
Other dry land |
2.50 |
| 4. |
Palliyal Land |
3.00 |
| Quilon District |
| 1. |
Garden land: |
|
|
(i) Land used principally for growing coconut trees |
1.00 |
|
(ii) Land used principally for growing arecanut trees |
0.50 |
|
(iii) Land used principally for growing peppervines |
1.50 |
| 2. |
Dry land principally cultivated with cashew |
2.00 |
| 3. |
Other dry land |
2.50 |
| 4. |
Palliyal Land |
3.00 |
| Alleppey District |
| 1. |
Garden land: |
|
|
(i) Land used principally for growing coconut trees |
1.00 |
|
(ii) Land used principally for growing arecanut trees |
0.50 |
|
(iii) Land used principally for growing peppervines |
2.00 |
| 2. |
Dry land principally cultivated with cashew |
2.00 |
| 3. |
Other dry land |
2.50 |
| 4. |
Palliyal Land |
:4.00 |
| Kottayam District |
| 1. |
Garden land: |
|
|
(i) Land used principally for growing coconut trees |
1.00 |
|
(ii) Land used principally for growing arecanut trees : |
0.50 |
|
(iii) Land used principally for growing peppervines |
1.50 |
| 2. |
Dry land principally cultivated with cashew |
2.00 |
| 3. |
Other dry land |
2.00 |
| 4. |
Palliyal land |
3.00 |
| Palghat District |
| 1. |
Garden land: |
|
|
(i) Land used principaliy for growing coconut trees : |
1.25 |
|
(ii) land used principally for growing arecanut trees : |
0.50 |
|
(iii) land used principary for growing peppervines |
3.00 |
| 2. |
Dry land principally cultivated with cashew |
2.00 |
| 3. |
Oliter dry land |
2.50 |
| 4. |
Palliyal Land |
4.00 |
| Malappuram District |
| 1. |
Garden lard: |
|
|
(i) Land used principally for growing coconut trees |
1.00 |
|
(ii) Land used principally for growing arecanut trees : |
0.50 |
|
(iii) Land used principally for growing peppervines |
3.00 |
| 2. |
Dry land principally cultivated with cashew |
2.00 |
| 3. |
Other dry land |
2.50 |
| 4. |
Palliyal Land |
3.00 |
| Kozhikode District |
| 1. |
Garden land: |
|
|
(i) Land used principally for growing coconut trees : |
1.00 |
|
(ii) Land used principally for growing arecanut trees : |
0.50 |
|
(iii) land wed principally for growing peppervines |
3.00 |
| 2. |
Dry land principally cultivated with cashew |
2.00 |
| 3. |
Other dry land |
2.50 |
| 4. |
Palliyal land |
3.00 |
| Cannanore District |
| 1. |
Garden land: |
|
|
(i) Land used principally for growing coconut trees : |
1 25 |
|
(ii) Land used principally for growing arecanut trees : |
0.50 |
|
(iii) Land used principally for growing peppervines |
3.00 |
| 2. |
Dry land principally cultivated with cashew |
2.00 |
| 3. |
Other dry land |
2.50 |
| 4. |
Palliyal Land |
3.00 |
Part II Standard acres of nilam
| Sl No. |
Taluk |
Double crop nilam (acre) |
Single crop nilam (acre) |
| (1) |
(2) |
(3) |
(4) |
| 1. |
Nevvattinkara |
|
|
|
Trivandrum |
1.00 |
2.00 |
|
Nedumangad |
|
|
|
Chirayinkil |
|
|
| 2. |
Quilon |
|
|
|
Kottarakkara |
|
|
|
Kunnathur |
1.00 |
2.00 |
|
Pathanapuram |
|
|
|
Pathanamthitta |
|
|
| 3. |
Karunagappally |
|
|
|
Karthikappally |
1.00 |
2.00 |
|
Mavelikara |
|
|
| 4. |
Chengannur |
|
|
|
Thiruvalla |
1.00 |
1.75 |
|
Kuttanad |
|
|
| 5. |
Arnbalapuzha |
|
|
|
Sherthalai |
1.50 |
2.50 |
| 6. |
Changanacherry |
|
|
|
Kanjirappally |
|
|
|
Peermade |
|
|
|
Kottayam |
1.00 |
2.00 |
|
Vaikom |
|
|
|
Meenachil |
|
|
|
Devikolam |
|
|
|
Udurnbanchola |
|
|
| 7. |
Thoduptrzha |
|
|
|
Moovattupuzha |
1.00 |
2.00 |
|
Cochin |
|
|
|
Kanavannur |
|
|
| 8. |
Kunnarhunad |
|
|
|
Parur |
1.25 |
2.25 |
|
Alwaye |
|
|
| 9. |
Crangannur |
|
|
|
Mukundapuram |
1.25 |
2.00 |
|
Trichur |
|
|
|
Talappally |
|
|
| 10. |
Chittur |
|
|
|
Alathur |
0.75 |
1.50 |
|
Palghat |
|
|
| 11. |
Ottappalam |
|
|
|
Perinthalmanna |
1.00 |
2.00 |
|
Mannarghat |
|
|
|
Ernad |
|
|
| 12. |
Chowghat |
|
|
|
Ponnani |
1.25 |
2.25 |
|
Tirur |
|
|
| 13. |
Kozhikode |
|
|
|
Quilandy |
1.50 |
3.00 |
|
Badagara |
|
|
| 14. |
South Wynad |
|
|
|
North Wynad |
1.25 |
2.25 |
| 15. |
Tellicherry |
|
|
|
Cannanore |
|
|
|
Taliparamba |
1.25 |
2.25] |
|
Hosdrug |
|
|
|
Kasargod |
|
|
Schedule III
| Sl No. |
Class of land |
|
Rate of fair rent |
| (1) |
(2) |
|
(3) |
| 1. |
Nilam |
|
|
|
(i) Land converted into nilam by tenant’s lahour not falling under items (v), (vi) and (vii) |
|
1/8th of the gross paddy produce |
|
(ii) Other nilam not failing under iterms (v), (vi) and (vii) |
|
1/4th of the gross paddy produce |
|
(iii) Kole land |
|
1/6th of the gross paddy produce |
|
(iv) Land not being Karinilam cultivated on the Kalpad system |
|
1/6th of the gross paddy produce For the districts of Cannanore, Ernakulam, Alleppey and Kottayam No such land in other district |
|
(v) Karinilam: |
|
|
|
(a) Converted into wet by tenant’s labour |
|
1/9th of the gross paddy produce [***] |
|
(b) Other Karinilam |
|
1/5th of the gross paddy produce |
|
(vi) Nilam in the North Wynad and South Wynad taluks: |
|
|
|
(a) Converted by tenant’s labour |
|
1/20th of the gross paddy produce |
|
(b) other nilam |
|
1/12th of the gross paddy produce |
|
(vii) Nilam in the Devicolam, Peermade and Udumbanchola taluks and the Attappady valley. |
|
|
|
(a) Converted by tenant’s labour |
|
1/6th of the gross paddy produce |
|
(b) Other wet land |
|
1/8th of the gross paddy produce |
|
(vii) Nilam where fishing is carried on for part of the year by a varamdar |
|
Aggregate of rent fixed as for nilam and 1/8th of the gross annual income derived from fishing [determined in such manner as may be prescribed] |
|
(ix) Nilam not used for paddy cultivation (hut not cultivated with sugarcane) |
|
Rent that would have been pay-able had the land been used for cultivation of paddy |
| 2. |
Garden |
|
|
|
(i) Coconut frees in respect of which the landlord is hound to pay compensation under the Kerala Compensation for Tenant’s improvements Act, 1958 |
|
[1/6th]of the gross paddy produce |
|
(ii) Coconut trees in respect of which the landlord is not bound In pay compensation under the Kerala, Compensation for ‘tenant’s s Improvements Act, 1958 |
|
1/4th of the gross coconut produce |
|
(iii) Arecanut trees in respect of which the landlord is bound to pay compensation under the Kerala, Compensation for Tenant’s Improvemems Act 1958 |
|
[1/16th]of the gross arecanul produce |
|
(iv) Arecanut trees in respect of which the landlord is bound to pay compensation under the Kerala, Compensation for Tenant’s Improvements Act 1958 |
|
1/4th of the gross arecanut produce |
|
(v) Pepper-vines in respect of which the landlord is bound to pay compensation under the Kerala, Compensation for Tenant’s Improvements Act, 19581 |
|
[1/20th]of the gross pepper produce |
|
(vi) Pepper-vines in respect of which the landlord is not hound to pay compensation under the Kerala: Compensation for Tenant’s Improvements Act,1958 |
|
[1/16th]of the gross pepper produce |
| 3. |
Dry Land- |
|
|
|
(a) Cultivated with groundnut or other crops notified by the Government |
|
[1/10th]of the gross produce |
|
(b) in other cases |
|
Rs. 4 per acre |
| 4. |
Palliyal land 1/8th of the gross produce of the land or Rs. 4 per acre, whichever is higher |
|
|
| 5. |
Land under Punam or Kumari cultivation |
|
Rs. 3 per acre |
| 6. |
Land under sugarcane cultivation |
|
1/4th of the gross sugarcane produce |
| 7. |
Land not falling under any of the above items |
|
Contract rent |
[Schedule IV] Rates Of Compensation Part I Land other than nilam
|
Class of land |
Rate per acre Rs. |
|
Trivandrum, Quilon, Alleppey, Kottayam, Ernakulam and Trichur Districts |
|
| 1. |
Garden land: |
|
|
(i) Land used principally for growing coconut trees |
2,000 |
|
(ii) Land used principally for growing arecanut trees |
2,000 |
|
(iii) Land used principally for growing peppervines |
1,300 |
| 2. |
Dry land principally cultivated with cashew |
750 |
| 3. |
Palliyal Land |
500 |
| 4. |
Waste land (with or without scattered trees) |
400 |
| [4A. |
Land not yet cultivated and which cannot be put to cultivation without incurring heavy expenditure |
100] |
| 5. |
Land not falling under any of the above classes Palghat, tvtalappuram, Kozhikode and Cannanore Districts |
500 |
| 1. |
Garden land: |
|
|
(i) Land used principally for growing coconut trees |
1,600 |
|
(ii) Land used principally for growing arecanut trees |
3,000 |
|
Land used principally for growing peppenrines |
700 |
| 2. |
Dry land principally cultivated with cashew |
500 |
| 3. |
Palliyal Land |
400 |
| 4. |
Waste land (with or without scattered trees) |
200 |
| [4A. |
Land riot yet cultivated and which cannot be put to cultivation without incurring heavy expenditure |
100] |
| 5. |
Land not falling under any of the above classes |
300 |
Part II Nilams
| Sl No. |
Talak |
Rate per acre of
double crop nilam |
Rate per acre of single crop nilam |
| (1) |
(2) |
(3) |
(4) |
| 1. |
Neyyattinkara |
|
|
|
Trivandrum |
|
|
|
Nedumangad |
2,000 |
1,000 |
|
Chirayinkil |
|
|
| 2. |
Quilon |
|
|
|
Kottarakkara |
|
|
|
Kunnathur |
|
|
|
Pathanapuram |
2,000 |
1,000 |
|
Pathanamthitta |
|
|
| 3. |
Karunagappally |
|
|
|
Karthikappally |
2.000 |
1,000 |
|
Mavelikara |
|
|
| 4. |
Chengannur |
|
|
|
Thiruvalla |
2.000 |
1,200 |
|
Kuttanad |
|
|
| 5. |
Ambalapuzha |
|
|
|
Sherlhallai |
1.300 |
800 |
| 6. |
Changanacherry |
|
|
|
Kanjirappally |
|
|
|
Peermade |
|
|
|
Kottayam |
|
|
|
Vaikom |
2,000 |
1.000 |
|
Meenachil |
|
|
|
Devicolam |
|
|
|
Udurnbanchola |
|
|
| 7. |
Thodupuzha |
2,000 |
1,000 |
|
Moovanupuzha |
|
|
|
Cochin |
|
|
|
Kanayannur |
|
|
| 8. |
Kunnachunad |
|
|
|
Yarur |
1,600 |
900 |
|
Alwaye |
|
|
| 9. |
Crangannur |
|
|
|
Mukundapuram |
1.600 |
1,000 |
|
Trichur |
|
|
|
Talappally |
|
|
| 10. |
Chittur |
|
|
|
Alathur |
2,000 |
1,300 |
|
Palghat |
|
|
| 11. |
Ottappalarn |
|
|
|
Yerinthalmantre |
2,000 |
1,000 |
|
Mannarghat |
|
|
|
Ernad |
|
|
| 12. |
Chowghat |
|
|
|
Ponnani |
1,600 |
900 |
|
Tirur |
|
|
| 13. |
Kozhikode |
|
|
|
Quilandy |
1,300 |
700 |
|
Badagara |
|
|
| 14. |
South Wynad |
|
|
|
North Wynad |
1,600 |
900 |
| 15. |
Tellicher |
|
|
|
Cannanor |
|
|
|
Taliparamba |
1,600 |
900] |
|
Hosdrug |
|
|
|
Kasargod |
|
|
UNCITRAL Arbitration Rules 2010
Resolution adopted by the General Assembly
[on the report of the Sixth Committee (A/65/465)]
65/22. UNCITRAL Arbitration Rules as revised in 2010
The General Assembly,
Recalling its resolution 2205 (XXI) of 17 December 1966, which established the United Nations Commission on International Trade Law with the purpose of furthering the progressive harmonization and unification of the law of international trade in the interests of all peoples, in particular those of developing countries,
Also recalling its resolution 31/98 of 15 December 1976 recommending the use of the Arbitration Rules of the United Nations Commission on International Trade Law,1
Recognizing the value of arbitration as a method of settling disputes that may arise in the context of international commer- cial relations,
Noting that the Arbitration Rules are recognized as a very successful text and are used in a wide variety of circumstances covering a broad range of disputes, including disputes between private commercial parties, investor-State disputes, State-to- State disputes and commercial disputes administered by arbitral institutions, in all parts of the world,
Recognizing the need for revising the Arbitration Rules to conform to current practices in international trade and to meet changes that have taken place over the last thirty years in arbitral practice, Believing that the Arbitration Rules as revised in 2010 to reflect current practices will significantly enhance the efficiency of arbitration under the Rules,
Convinced that the revision of the Arbitration Rules in a manner that is acceptable to countries with different legal, social and economic systems can significantly contribute to the development of harmonious international economic relations and to the continuous strengthening of the rule of law,
Noting that the preparation of the Arbitration Rules as revised in 2010 was the subject of due deliberation and extensive consultations with Governments and interested circles and that the revised text can be expected to contribute significantly to the establishment of a harmonized legal framework for the fair and efficient settlement of international commercial disputes, Also noting that the Arbitration Rules as revised in 2010 were adopted by the United Nations Commission on International Trade Law at its forty-third session after due deliberation,2
1. Expresses its appreciation to the United Nations Com- mission on International Trade Law for having formulated and adopted the revised provisions of the Arbitration Rules, the text of which is contained in an annex to the report of the United Nations Commission on International Trade Law on the work of its forty-third session;3
2. Recommends the use of the Arbitration Rules as revised in 2010 in the settlement of disputes arising in the context of international commercial relations;
3. Requests the Secretary-General to make all efforts to ensure that the Arbitration Rules as revised in 2010 become generally known and available.
57th plenary meeting
6 December 2010
UNCITRAL Arbitration Rules
(as revised in 2010)
Section I. Introductory rules
Scope of application*
Article 1
1. Where parties have agreed that disputes between them in respect of a defined legal relationship, whether contractual or not, shall be referred to arbitration under the UNCITRAL Arbitration Rules, then such disputes shall be settled in accordance with these Rules subject to such modification as the parties may agree.
2. The parties to an arbitration agreement concluded after 15 August 2010 shall be presumed to have referred to the Rules in effect on the date of commencement of the arbitration, unless the parties have agreed to apply a particular version of the Rules. That presumption does not apply where the arbitration agree- ment has been concluded by accepting after 15 August 2010 an offer made before that date.
3. These Rules shall govern the arbitration except that where any of these Rules is in conflict with a provision of the law applicable to the arbitration from which the parties cannot derogate, that provision shall prevail.
Notice and calculation of periods of time
Article 2
1. A notice, including a notification, communication or proposal, may be transmitted by any means of communication that provides or allows for a record of its transmission.
2. If an address has been designated by a party specifically for this purpose or authorized by the arbitral tribunal, any notice shall be delivered to that party at that address, and if so delivered shall
*A model arbitration clause for contracts can be found in the annex to the Rules.
be deemed to have been received. Delivery by electronic means such as facsimile or e-mail may only be made to an address so designated or authorized.
3. In the absence of such designation or authorization, a notice is:
(a) Received if it is physically delivered to the addressee; or
(b) Deemed to have been received if it is delivered at the place of business, habitual residence or mailing address of the addressee.
4. If, after reasonable efforts, delivery cannot be effected in accordance with paragraphs 2 or 3, a notice is deemed to have been received if it is sent to the addressee’s last-known place of business, habitual residence or mailing address by registered letter or any other means that provides a record of delivery or of attempted delivery.
5. A notice shall be deemed to have been received on the day it is delivered in accordance with paragraphs 2, 3 or 4, or attempted to be delivered in accordance with paragraph 4. A notice transmitted by electronic means is deemed to have been received on the day it is sent, except that a notice of arbitration so transmitted is only deemed to have been received on the day when it reaches the addressee’s electronic address.
6. For the purpose of calculating a period of time under these Rules, such period shall begin to run on the day following the day when a notice is received. If the last day of such period is an official holiday or a non-business day at the residence or place of business of the addressee, the period is extended until the first business day which follows. Official holidays or non- business days occurring during the running of the period of time are included in calculating the period.
Notice of arbitration
Article 3
1. The party or parties initiating recourse to arbitration (hereinafter called the “claimant”) shall communicate to the other party or parties (hereinafter called the “respondent”) a notice of arbitration.
2. Arbitral proceedings shall be deemed to commence on the date on which the notice of arbitration is received by the respondent.
3. The notice of arbitration shall include the following:
(a) A demand that the dispute be referred to arbitration;
(b) The names and contact details of the parties;
(c) Identification of the arbitration agreement that is invoked;
(d) Identification of any contract or other legal instrument out of or in relation to which the dispute arises or, in the absence of such contract or instrument, a brief description of the relevant relationship;
(e) A brief description of the claim and an indication of the amount involved, if any;
(f) The relief or remedy sought;
(g) A proposal as to the number of arbitrators, language and place of arbitration, if the parties have not previously agreed thereon.
4. The notice of arbitration may also include:
(a) A proposal for the designation of an appointing authority referred to in article 6, paragraph 1;
(b) A proposal for the appointment of a sole arbitrator referred to in article 8, paragraph 1;
(c) Notification of the appointment of an arbitrator referred to in article 9 or 10.
5. The constitution of the arbitral tribunal shall not be hindered by any controversy with respect to the sufficiency of the notice of arbitration, which shall be finally resolved by the arbitral tribunal.
Response to the notice of arbitration
Article 4
1. Within 30 days of the receipt of the notice of arbitration, the respondent shall communicate to the claimant a response to the notice of arbitration, which shall include:
(a) The name and contact details of each respondent;
(b) A response to the information set forth in the notice of arbitration, pursuant to article 3, paragraphs 3 (c) to (g).
2. The response to the notice of arbitration may also include:
(a) Any plea that an arbitral tribunal to be constituted under these Rules lacks jurisdiction;
(b) A proposal for the designation of an appointing authority referred to in article 6, paragraph 1;
(c) A proposal for the appointment of a sole arbitrator referred to in article 8, paragraph 1;
(d) Notification of the appointment of an arbitrator referred to in article 9 or 10;
(e) A brief description of counterclaims or claims for the purpose of a set-off, if any, including where relevant, an indication of the amounts involved, and the relief or remedy sought;
(f) A notice of arbitration in accordance with article 3 in case the respondent formulates a claim against a party to the arbitration agreement other than the claimant.
3. The constitution of the arbitral tribunal shall not be hindered by any controversy with respect to the respondent’s failure to communicate a response to the notice of arbitration, or an incomplete or late response to the notice of arbitration, which shall be finally resolved by the arbitral tribunal.
Representation and assistance
Article 5
Each party may be represented or assisted by persons chosen by it. The names and addresses of such persons must be communicated to all parties and to the arbitral tribunal. Such communication must specify whether the appointment is being made for purposes of representation or assistance. Where a person is to act as a representative of a party, the arbitral tribunal, on its own initiative or at the request of any party, may at any time require proof of authority granted to the representative in such a form as the arbitral tribunal may determine.
Designating and appointing authorities
Article 6
1. Unless the parties have already agreed on the choice of an appointing authority, a party may at any time propose the name or names of one or more institutions or persons, including the Secretary-General of the Permanent Court of Arbitration at The Hague (hereinafter called the “PCA”), one of whom would serve as appointing authority.
2. If all parties have not agreed on the choice of an appointing authority within 30 days after a proposal made in accordance
with paragraph 1 has been received by all other parties, any party may request the Secretary-General of the PCA to designate the appointing authority.
3. Where these Rules provide for a period of time within which a party must refer a matter to an appointing authority and no appointing authority has been agreed on or designated, the period is suspended from the date on which a party initiates the procedure for agreeing on or designating an appointing authority until the date of such agreement or designation.
4. Except as referred to in article 41, paragraph 4, if the appointing authority refuses to act, or if it fails to appoint an arbitrator within 30 days after it receives a party’s request to do so, fails to act within any other period provided by these Rules, or fails to decide on a challenge to an arbitrator within a reasonable time after receiving a party’s request to do so, any party may request the Secretary- General of the PCA to designate a substitute appointing authority.
5. In exercising their functions under these Rules, the appointing authority and the Secretary-General of the PCA may require from any party and the arbitrators the information they deem necessary and they shall give the parties and, where appropriate, the arbitrators, an opportunity to present their views in any manner they consider appropriate. All such communications to and from the appointing authority and the Secretary-General of the PCA shall also be provided by the sender to all other parties.
6. When the appointing authority is requested to appoint an arbitrator pursuant to articles 8, 9, 10 or 14, the party making the request shall send to the appointing authority copies of the notice of arbitration and, if it exists, any response to the notice of arbitration.
7. The appointing authority shall have regard to such considerations as are likely to secure the appointment of an independent and impartial arbitrator and shall take into account the advisability of appointing an arbitrator of a nationality other than the nationalities of the parties.
Section II. Composition of the arbitral tribunal
Number of arbitrators
Article 7
1. If the parties have not previously agreed on the number of arbitrators, and if within 30 days after the receipt by the respondent of the notice of arbitration the parties have not agreed that there shall be only one arbitrator, three arbitrators shall be appointed.
2. Notwithstanding paragraph 1, if no other parties have responded to a party’s proposal to appoint a sole arbitrator within the time limit provided for in paragraph 1 and the party or parties concerned have failed to appoint a second arbitrator in accordance with article 9 or 10, the appointing authority may, at the request of a party, appoint a sole arbitrator pursuant to the procedure provided for in article 8, paragraph 2, if it determines that, in view of the circumstances of the case, this is more appropriate.
Appointment of arbitrators (articles 8 to 10)
Article 8
1. If the parties have agreed that a sole arbitrator is to be appointed and if within 30 days after receipt by all other parties of a proposal for the appointment of a sole arbitrator the parties have not reached agreement thereon, a sole arbitrator shall, at the request of a party, be appointed by the appointing authority.
2. The appointing authority shall appoint the sole arbitrator as promptly as possible. In making the appointment, the appointing authority shall use the following list-procedure, unless the parties agree that the list-procedure should not be used or unless the appointing authority determines in its discretion that the use of the list-procedure is not appropriate for the case:
(a) The appointing authority shall communicate to each of the parties an identical list containing at least three names;
(b) Within 15 days after the receipt of this list, each party may return the list to the appointing authority after having deleted the name or names to which it objects and numbered the remaining names on the list in the order of its preference;
(c) After the expiration of the above period of time the appointing authority shall appoint the sole arbitrator from among the names approved on the lists returned to it and in accordance with the order of preference indicated by the parties;
(d) If for any reason the appointment cannot be made according to this procedure, the appointing authority may exercise its discretion in appointing the sole arbitrator.
Article 9
1. If three arbitrators are to be appointed, each party shall appoint one arbitrator. The two arbitrators thus appointed shall choose the third arbitrator who will act as the presiding arbitrator of the arbitral tribunal.
2. If within 30 days after the receipt of a party’s notification of the appointment of an arbitrator the other party has not notified the first party of the arbitrator it has appointed, the first party may request the appointing authority to appoint the second arbitrator.
3. If within 30 days after the appointment of the second arbitrator the two arbitrators have not agreed on the choice of the presiding arbitrator, the presiding arbitrator shall be appointed by the appointing authority in the same way as a sole arbitrator would be appointed under article 8.
Article 10
1. For the purposes of article 9, paragraph 1, where three arbitrators are to be appointed and there are multiple parties as claimant or as respondent, unless the parties have agreed to another method of appointment of arbitrators, the multiple parties jointly, whether as claimant or as respondent, shall appoint an arbitrator.
2. If the parties have agreed that the arbitral tribunal is to be composed of a number of arbitrators other than one or three, the arbitrators shall be appointed according to the method agreed upon by the parties.
3. In the event of any failure to constitute the arbitral tribunal under these Rules, the appointing authority shall, at the request of any party, constitute the arbitral tribunal and, in doing so,
may revoke any appointment already made and appoint or reappoint each of the arbitrators and designate one of them as the presiding arbitrator.
Disclosures by and challenge of arbitrators** (articles 11 to 13)
Article 11
When a person is approached in connection with his or her possible appointment as an arbitrator, he or she shall disclose any circumstances likely to give rise to justifiable doubts as to his or her impartiality or independence. An arbitrator, from the time of his or her appointment and throughout the arbitral proceedings, shall without delay disclose any such circumstances to the parties and the other arbitrators unless they have already been informed by him or her of these circumstances.
Article 12
1. Any arbitrator may be challenged if circumstances exist that give rise to justifiable doubts as to the arbitrator’s impartiality or independence.
2. A party may challenge the arbitrator appointed by it only for reasons of which it becomes aware after the appointment has been made.
3. In the event that an arbitrator fails to act or in the event of the de jure or de facto impossibility of his or her performing his or her functions, the procedure in respect of the challenge of an arbitrator as provided in article 13 shall apply.
Article 13
1. A party that intends to challenge an arbitrator shall send notice of its challenge within 15 days after it has been notified of the appointment of the challenged arbitrator, or within 15 days after the circumstances mentioned in articles 11 and 12 became known to that party.
** Model statements of independence pursuant to article 11 can be found in the annex to the Rules.
2. The notice of challenge shall be communicated to all other parties, to the arbitrator who is challenged and to the other arbitrators. The notice of challenge shall state the reasons for the challenge.
3. When an arbitrator has been challenged by a party, all parties may agree to the challenge. The arbitrator may also, after the challenge, withdraw from his or her office. In neither case does this imply acceptance of the validity of the grounds for the challenge.
4. If, within 15 days from the date of the notice of challenge, all parties do not agree to the challenge or the challenged arbitrator does not withdraw, the party making the challenge may elect to pursue it. In that case, within 30 days from the date of the notice of challenge, it shall seek a decision on the challenge by the appointing authority.
Replacement of an arbitrator
Article 14
1. Subject to paragraph 2, in any event where an arbitrator has to be replaced during the course of the arbitral proceedings, a substitute arbitrator shall be appointed or chosen pursuant to the procedure provided for in articles 8 to 11 that was applicable to the appointment or choice of the arbitrator being replaced. This procedure shall apply even if during the process of appointing the arbitrator to be replaced, a party had failed to exercise its right to appoint or to participate in the appointment.
2. If, at the request of a party, the appointing authority determines that, in view of the exceptional circumstances of the case, it would be justified for a party to be deprived of its right to appoint a substitute arbitrator, the appointing authority may, after giving an opportunity to the parties and the remaining arbitrators to express their views: (a) appoint the substitute arbitrator; or (b) after the closure of the hearings, authorize the other arbitrators to proceed with the arbitration and make any decision or award.
Repetition of hearings in the event of the replacement of an arbitrator
Article 15
If an arbitrator is replaced, the proceedings shall resume at the stage where the arbitrator who was replaced ceased to perform his or her functions, unless the arbitral tribunal decides otherwise.
Exclusion of liability
Article 16
Save for intentional wrongdoing, the parties waive, to the fullest extent permitted under the applicable law, any claim against the arbitrators, the appointing authority and any person appointed by the arbitral tribunal based on any act or omission in connection with the arbitration.
Section III. Arbitral proceedings General provisions
Article 17
1. Subject to these Rules, the arbitral tribunal may conduct the arbitration in such manner as it considers appropriate, provided that the parties are treated with equality and that at an appropriate stage of the proceedings each party is given a reasonable opportunity of presenting its case. The arbitral tribunal, in exercising its discretion, shall conduct the proceedings so as to avoid unnecessary delay and expense and to provide a fair and efficient process for resolving the parties’ dispute.
2. As soon as practicable after its constitution and after inviting the parties to express their views, the arbitral tribunal shall establish the provisional timetable of the arbitration. The arbitral tribunal may, at any time, after inviting the parties to express their views, extend or abridge any period of time prescribed under these Rules or agreed by the parties.
3. If at an appropriate stage of the proceedings any party so requests, the arbitral tribunal shall hold hearings for the presentation of evidence by witnesses, including expert witnesses, or for oral argument. In the absence of such a request, the arbitral tribunal shall decide whether to hold such hearings or whether the proceedings shall be conducted on the basis of documents and other materials.
4. All communications to the arbitral tribunal by one party shall be communicated by that party to all other parties. Such communications shall be made at the same time, except as otherwise permitted by the arbitral tribunal if it may do so under applicable law.
5. The arbitral tribunal may, at the request of any party, allow one or more third persons to be joined in the arbitration as a party provided such person is a party to the arbitration agreement, unless the arbitral tribunal finds, after giving all parties, including the person or persons to be joined, the opportunity to be heard, that joinder should not be permitted because of prejudice to any of those parties. The arbitral tribunal may make a single award or several awards in respect of all parties so involved in the arbitration.
Place of arbitration
Article 18
1. If the parties have not previously agreed on the place of arbitration, the place of arbitration shall be determined by the arbitral tribunal having regard to the circumstances of the case. The award shall be deemed to have been made at the place of arbitration.
2. The arbitral tribunal may meet at any location it considers appropriate for deliberations. Unless otherwise agreed by the parties, the arbitral tribunal may also meet at any location it considers appropriate for any other purpose, including hearings.
Language
Article 19
1. Subject to an agreement by the parties, the arbitral tribunal shall, promptly after its appointment, determine the language or languages to be used in the proceedings. This determination shall apply to the statement of claim, the statement of defence, and any further written statements and, if oral hearings take place, to the language or languages to be used in such hearings.
2. The arbitral tribunal may order that any documents annexed to the statement of claim or statement of defence, and any supplementary documents or exhibits submitted in the course of the proceedings, delivered in their original language, shall be accompanied by a translation into the language or languages agreed upon by the parties or determined by the arbitral tribunal.
Statement of claim
Article 20
1. The claimant shall communicate its statement of claim in writing to the respondent and to each of the arbitrators within a period of time to be determined by the arbitral tribunal. The claimant may elect to treat its notice of arbitration referred to in article 3 as a statement of claim, provided that the notice of arbitration also complies with the requirements of paragraphs 2 to 4 of this article.
2. The statement of claim shall include the following particulars:
(a) The names and contact details of the parties;
(b) A statement of the facts supporting the claim;
(c) The points at issue;
(d) The relief or remedy sought;
(e) The legal grounds or arguments supporting the claim.
3. A copy of any contract or other legal instrument out of or in relation to which the dispute arises and of the arbitration agreement shall be annexed to the statement of claim.
4. The statement of claim should, as far as possible, be accompanied by all documents and other evidence relied upon by the claimant, or contain references to them.
Statement of defence
Article 21
1. The respondent shall communicate its statement of defence in writing to the claimant and to each of the arbitrators within a period of time to be determined by the arbitral tribunal. The respondent may elect to treat its response to the notice of arbitration referred to in article 4 as a statement of defence, provided that the response to the notice of arbitration also complies with the requirements of paragraph 2 of this article.
2. The statement of defence shall reply to the particulars (b) to (e) of the statement of claim (art. 20, para. 2). The statement of defence should, as far as possible, be accompanied by all documents and other evidence relied upon by the respondent, or contain references to them.
3. In its statement of defence, or at a later stage in the arbitral proceedings if the arbitral tribunal decides that the delay was justified under the circumstances, the respondent may make a counterclaim or rely on a claim for the purpose of a set-off provided that the arbitral tribunal has jurisdiction over it.
4. The provisions of article 20, paragraphs 2 to 4, shall apply to a counterclaim, a claim under article 4, paragraph 2 (f), and a claim relied on for the purpose of a set-off.
Amendments to the claim or defence
Article 22
During the course of the arbitral proceedings, a party may amend or supplement its claim or defence, including a counterclaim or a claim for the purpose of a set-off, unless the arbitral tribunal considers it inappropriate to allow such amendment or supplement having regard to the delay in making it or prejudice to other parties or any other circumstances. However, a claim or defence, including a counterclaim or a claim for the purpose of a set-off, may not be amended or supplemented in such a manner that the amended or supplemented claim or defence falls outside the jurisdiction of the arbitral tribunal.
Pleas as to the jurisdiction of the arbitral tribunal
Article 23
1. The arbitral tribunal shall have the power to rule on its own jurisdiction, including any objections with respect to the existence or validity of the arbitration agreement. For that purpose, an arbitration clause that forms part of a contract shall be treated as an agreement independent of the other terms of the contract. A decision by the arbitral tribunal that the contract is null shall not entail automatically the invalidity of the arbitration clause.
2. A plea that the arbitral tribunal does not have jurisdiction shall be raised no later than in the statement of defence or, with respect to a counterclaim or a claim for the purpose of a set-off, in the reply to the counterclaim or to the claim for the purpose of a set-off. A party is not precluded from raising such a plea by the fact that it has appointed, or participated in the appointment of, an arbitrator. A plea that the arbitral tribunal is exceeding the scope of its authority shall be raised as soon as the matter alleged to be beyond the scope of its authority is raised during the arbitral proceedings. The arbitral tribunal may, in either case, admit a later plea if it considers the delay justified.
3. The arbitral tribunal may rule on a plea referred to in paragraph 2 either as a preliminary question or in an award on the merits. The arbitral tribunal may continue the arbitral proceedings and make an award, notwithstanding any pending challenge to its jurisdiction before a court.
Further written statements
Article 24
The arbitral tribunal shall decide which further written statements, in addition to the statement of claim and the statement of defence, shall be required from the parties or may be presented by them and shall fix the periods of time for communicating such statements.
Periods of time
Article 25
The periods of time fixed by the arbitral tribunal for the communication of written statements (including the statement of claim and statement of defence) should not exceed 45 days. However, the arbitral tribunal may extend the time limits if it concludes that an extension is justified.
Interim measures
Article 26
1. The arbitral tribunal may, at the request of a party, grant interim measures.
2. An interim measure is any temporary measure by which, at any time prior to the issuance of the award by which the dispute is finally decided, the arbitral tribunal orders a party, for example and without limitation, to:
(a) Maintain or restore the status quo pending determination of the dispute;
(b) Take action that would prevent, or refrain from taking action that is likely to cause, (i) current or imminent harm or (ii) prejudice to the arbitral process itself;
(c) Provide a means of preserving assets out of which a subsequent award may be satisfied; or
(d) Preserve evidence that may be relevant and material to the resolution of the dispute.
3. The party requesting an interim measure under paragraphs 2 (a) to (c) shall satisfy the arbitral tribunal that:
(a) Harm not adequately reparable by an award of damages is likely to result if the measure is not ordered, and such harm substantially outweighs the harm that is likely to result to the party against whom the measure is directed if the measure is granted; and
(b) There is a reasonable possibility that the requesting party will succeed on the merits of the claim. The determination on this possibility shall not affect the discretion of the arbitral tribunal in making any subsequent determination.
4. With regard to a request for an interim measure under paragraph 2 (d), the requirements in paragraphs 3 (a) and (b) shall apply only to the extent the arbitral tribunal considers appropriate.
5. The arbitral tribunal may modify, suspend or terminate an interim measure it has granted, upon application of any party or, in exceptional circumstances and upon prior notice to the parties, on the arbitral tribunal’s own initiative.
6. The arbitral tribunal may require the party requesting an interim measure to provide appropriate security in connection with the measure.
7. The arbitral tribunal may require any party promptly to disclose any material change in the circumstances on the basis of which the interim measure was requested or granted.
8. The party requesting an interim measure may be liable for any costs and damages caused by the measure to any party if the arbitral tribunal later determines that, in the circumstances then prevailing, the measure should not have been granted. The arbitral tribunal may award such costs and damages at any point during the proceedings.
9. A request for interim measures addressed by any party to a judicial authority shall not be deemed incompatible with the agreement to arbitrate, or as a waiver of that agreement.
Evidence
Article 27
1. Each party shall have the burden of proving the facts relied on to support its claim or defence.
2. Witnesses, including expert witnesses, who are presented by the parties to testify to the arbitral tribunal on any issue of fact or expertise may be any individual, notwithstanding that
the individual is a party to the arbitration or in any way related to a party. Unless otherwise directed by the arbitral tribunal, statements by witnesses, including expert witnesses, may be presented in writing and signed by them.
3. At any time during the arbitral proceedings the arbitral tribunal may require the parties to produce documents, exhibits or other evidence within such a period of time as the arbitral tribunal shall determine.
4. The arbitral tribunal shall determine the admissibility, relevance, materiality and weight of the evidence offered.
Hearings
Article 28
1. In the event of an oral hearing, the arbitral tribunal shall give the parties adequate advance notice of the date, time and place thereof.
2. Witnesses, including expert witnesses, may be heard under the conditions and examined in the manner set by the arbitral tribunal.
3. Hearings shall be held in camera unless the parties agree otherwise. The arbitral tribunal may require the retirement of any witness or witnesses, including expert witnesses, during the testimony of such other witnesses, except that a witness, including an expert witness, who is a party to the arbitration shall not, in principle, be asked to retire.
4. The arbitral tribunal may direct that witnesses, including expert witnesses, be examined through means of telecommunication that do not require their physical presence at the hearing (such as videoconference).
Experts appointed by the arbitral tribunal
Article 29
1. After consultation with the parties, the arbitral tribunal may appoint one or more independent experts to report to it, in writing, on specific issues to be determined by the arbitral tribunal. A copy of the expert’s terms of reference, established by the arbitral tribunal, shall be communicated to the parties.
2. The expert shall, in principle before accepting appointment, submit to the arbitral tribunal and to the parties a description of his or her qualifications and a statement of his or her impartiality and independence. Within the time ordered by the arbitral tribunal, the parties shall inform the arbitral tribunal whether they have any objections as to the expert’s qualifications, impartiality or independence. The arbitral tribunal shall decide promptly whether to accept any such objections. After an expert’s appointment, a party may object to the expert’s qualifications, impartiality or independence only if the objection is for reasons of which the party becomes aware after the appointment has been made. The arbitral tribunal shall decide promptly what, if any, action to take.
3. The parties shall give the expert any relevant information or produce for his or her inspection any relevant documents or goods that he or she may require of them. Any dispute between a party and such expert as to the relevance of the required information or production shall be referred to the arbitral tribunal for decision.
4. Upon receipt of the expert’s report, the arbitral tribunal shall communicate a copy of the report to the parties, which shall be given the opportunity to express, in writing, their opinion on the report. A party shall be entitled to examine any document on which the expert has relied in his or her report.
5. At the request of any party, the expert, after delivery of the report, may be heard at a hearing where the parties shall have the opportunity to be present and to interrogate the expert. At this hearing, any party may present expert witnesses in order to testify on the points at issue. The provisions of article 28 shall be applicable to such proceedings.
Default
Article 30
1. If, within the period of time fixed by these Rules or the arbitral tribunal, without showing sufficient cause:
(a) The claimant has failed to communicate its statement of claim, the arbitral tribunal shall issue an order for the termination of the arbitral proceedings, unless there are remaining matters that may need to be decided and the arbitral tribunal considers it appropriate to do so;
(b) The respondent has failed to communicate its response to the notice of arbitration or its statement of defence, the arbitral tribunal shall order that the proceedings continue, without treating such failure in itself as an admission of the claimant’s allegations; the provisions of this subparagraph also apply to a claimant’s failure to submit a defence to a counterclaim or to a claim for the purpose of a set-off.
2. If a party, duly notified under these Rules, fails to appear at a hearing, without showing sufficient cause for such failure, the arbitral tribunal may proceed with the arbitration.
3. If a party, duly invited by the arbitral tribunal to produce documents, exhibits or other evidence, fails to do so within the established period of time, without showing sufficient cause for such failure, the arbitral tribunal may make the award on the evidence before it.
Closure of hearings
Article 31
1. The arbitral tribunal may inquire of the parties if they have any further proof to offer or witnesses to be heard or submissions to make and, if there are none, it may declare the hearings closed.
2. The arbitral tribunal may, if it considers it necessary owing to exceptional circumstances, decide, on its own initiative or upon application of a party, to reopen the hearings at any time before the award is made.
Waiver of right to object
Article 32
A failure by any party to object promptly to any non-compliance with these Rules or with any requirement of the arbitration agreement shall be deemed to be a waiver of the right of such party to make such an objection, unless such party can show that, under the circumstances, its failure to object was justified.
Section IV. The award Decisions
Article 33
1. When there is more than one arbitrator, any award or other decision of the arbitral tribunal shall be made by a majority of the arbitrators.
2. In the case of questions of procedure, when there is no majority or when the arbitral tribunal so authorizes, the presiding arbitrator may decide alone, subject to revision, if any, by the arbitral tribunal.
Form and effect of the award
Article 34
1. The arbitral tribunal may make separate awards on different issues at different times.
2. All awards shall be made in writing and shall be final and binding on the parties. The parties shall carry out all awards without delay.
3. The arbitral tribunal shall state the reasons upon which the award is based, unless the parties have agreed that no reasons are to be given.
4. An award shall be signed by the arbitrators and it shall contain the date on which the award was made and indicate the place of arbitration. Where there is more than one arbitrator and any of them fails to sign, the award shall state the reason for the absence of the signature.
5. An award may be made public with the consent of all parties or where and to the extent disclosure is required of a party by legal duty, to protect or pursue a legal right or in relation to legal proceedings before a court or other competent authority.
6. Copies of the award signed by the arbitrators shall be communicated to the parties by the arbitral tribunal.
Applicable law, amiable compositeur
Article 35
1. The arbitral tribunal shall apply the rules of law designated by the parties as applicable to the substance of the dispute. Failing such designation by the parties, the arbitral tribunal shall apply the law which it determines to be appropriate.
2. The arbitral tribunal shall decide as amiable compositeur or ex aequo et bono only if the parties have expressly authorized the arbitral tribunal to do so.
3. In all cases, the arbitral tribunal shall decide in accordance with the terms of the contract, if any, and shall take into account any usage of trade applicable to the transaction.
Settlement or other grounds for termination
Article 36
1. If, before the award is made, the parties agree on a settlement of the dispute, the arbitral tribunal shall either issue an order for the termination of the arbitral proceedings or, if requested by the parties and accepted by the arbitral tribunal, record the settlement in the form of an arbitral award on agreed terms. The arbitral tribunal is not obliged to give reasons for such an award.
2. If, before the award is made, the continuation of the arbitral proceedings becomes unnecessary or impossible for any reason not mentioned in paragraph 1, the arbitral tribunal shall inform the parties of its intention to issue an order for the termination of the proceedings. The arbitral tribunal shall have the power to issue such an order unless there are remaining matters that may need to be decided and the arbitral tribunal considers it appropriate to do so.
3. Copies of the order for termination of the arbitral proceedings or of the arbitral award on agreed terms, signed by the arbitrators, shall be communicated by the arbitral tribunal to the parties. Where an arbitral award on agreed terms is made, the provisions of article 34, paragraphs 2, 4 and 5, shall apply.
Interpretation of the award
Article 37
1. Within 30 days after the receipt of the award, a party, with notice to the other parties, may request that the arbitral tribunal give an interpretation of the award.
2. The interpretation shall be given in writing within 45 days after the receipt of the request. The interpretation shall form part of the award and the provisions of article 34, paragraphs 2 to 6, shall apply.
Correction of the award
Article 38
1. Within 30 days after the receipt of the award, a party, with notice to the other parties, may request the arbitral tribunal to correct in the award any error in computation, any clerical or typographical error, or any error or omission of a similar nature. If the arbitral tribunal considers that the request is justified, it shall make the correction within 45 days of receipt of the request.
2. The arbitral tribunal may within 30 days after the communication of the award make such corrections on its own initiative.
3. Such corrections shall be in writing and shall form part of the award. The provisions of article 34, paragraphs 2 to 6, shall apply.
Additional award
Article 39
1. Within 30 days after the receipt of the termination order or the award, a party, with notice to the other parties, may request the arbitral tribunal to make an award or an additional award as to claims presented in the arbitral proceedings but not decided by the arbitral tribunal.
2. If the arbitral tribunal considers the request for an award or additional award to be justified, it shall render or complete its award within 60 days after the receipt of the request. The arbitral tribunal may extend, if necessary, the period of time within which it shall make the award.
3. When such an award or additional award is made, the provisions of article 34, paragraphs 2 to 6, shall apply.
Definition of costs
Article 40
1. The arbitral tribunal shall fix the costs of arbitration in the final award and, if it deems appropriate, in another decision.
2. The term “costs” includes only:
(a) The fees of the arbitral tribunal to be stated separately as to each arbitrator and to be fixed by the tribunal itself in accordance with article 41;
(b) The reasonable travel and other expenses incurred by the arbitrators;
(c) The reasonable costs of expert advice and of other assistance required by the arbitral tribunal;
(d) The reasonable travel and other expenses of witnesses to the extent such expenses are approved by the arbitral tribunal;
(e) The legal and other costs incurred by the parties in relation to the arbitration to the extent that the arbitral tribunal determines that the amount of such costs is reasonable;
(f) Any fees and expenses of the appointing authority as well as the fees and expenses of the Secretary-General of the PCA.
3. In relation to interpretation, correction or completion of any award under articles 37 to 39, the arbitral tribunal may charge the costs referred to in paragraphs 2 (b) to (f), but no additional fees.
Fees and expenses of arbitrators
Article 41
1. The fees and expenses of the arbitrators shall be reasonable in amount, taking into account the amount in dispute, the complexity of the subject matter, the time spent by the arbitrators and any other relevant circumstances of the case.
2. If there is an appointing authority and it applies or has stated that it will apply a schedule or particular method for determining the fees for arbitrators in international cases, the arbitral tribunal in fixing its fees shall take that schedule or method into account to the extent that it considers appropriate in the circumstances of the case.
3. Promptly after its constitution, the arbitral tribunal shall inform the parties as to how it proposes to determine its fees and expenses, including any rates it intends to apply. Within 15 days of receiving that proposal, any party may refer the proposal to the appointing authority for review. If, within 45 days of receipt of such a referral, the appointing authority finds that the proposal of the arbitral tribunal is inconsistent with paragraph 1, it shall make any necessary adjustments thereto, which shall be binding upon the arbitral tribunal.
4. (a) When informing the parties of the arbitrators’ fees and expenses that have been fixed pursuant to article 40, paragraphs 2 (a) and (b), the arbitral tribunal shall also explain the manner in which the corresponding amounts have been calculated;
(b) Within 15 days of receiving the arbitral tribunal’s determination of fees and expenses, any party may refer for review such determination to the appointing authority. If no appointing authority has been agreed upon or designated, or if the appointing authority fails to act within the time specified in these Rules, then the review shall be made by the Secretary-General of the PCA;
(c) If the appointing authority or the Secretary-General of the PCA finds that the arbitral tribunal’s determination is inconsistent with the arbitral tribunal’s proposal (and any adjustment thereto) under paragraph 3 or is otherwise manifestly excessive, it shall, within 45 days of receiving such a referral, make any adjustments to the arbitral tribunal’s determination that are necessary to satisfy the criteria in paragraph 1. Any such adjustments shall be binding upon the arbitral tribunal;
(d) Any such adjustments shall either be included by the arbitral tribunal in its award or, if the award has already been issued, be implemented in a correction to the award, to which the procedure of article 38, paragraph 3, shall apply.
5. Throughout the procedure under paragraphs 3 and 4, the arbitral tribunal shall proceed with the arbitration, in accordance with article 17, paragraph 1.
6. A referral under paragraph 4 shall not affect any determination in the award other than the arbitral tribunal’s fees and expenses;
nor shall it delay the recognition and enforcement of all parts of the award other than those relating to the determination of the arbitral tribunal’s fees and expenses.
Allocation of costs
Article 42
1. The costs of the arbitration shall in principle be borne by the unsuccessful party or parties. However, the arbitral tribunal may apportion each of such costs between the parties if it determines that apportionment is reasonable, taking into account the circumstances of the case.
2. The arbitral tribunal shall in the final award or, if it deems appropriate, in any other award, determine any amount that a party may have to pay to another party as a result of the decision on allocation of costs.
Deposit of costs
Article 43
1. The arbitral tribunal, on its establishment, may request the parties to deposit an equal amount as an advance for the costs referred to in article 40, paragraphs 2 (a) to (c).
2. During the course of the arbitral proceedings the arbitral tribunal may request supplementary deposits from the parties.
3. If an appointing authority has been agreed upon or designated, and when a party so requests and the appointing authority consents to perform the function, the arbitral tribunal shall fix the amounts of any deposits or supplementary deposits only after consultation with the appointing authority, which may make any comments to the arbitral tribunal that it deems appropriate concerning the amount of such deposits and supplementary deposits.
4. If the required deposits are not paid in full within 30 days after the receipt of the request, the arbitral tribunal shall so inform the parties in order that one or more of them may make the required payment. If such payment is not made, the arbitral tribunal may order the suspension or termination of the arbitral proceedings.
5. After a termination order or final award has been made, the arbitral tribunal shall render an accounting to the parties of the deposits received and return any unexpended balance to the parties.
ANNEX
Model arbitration clause for contracts
Any dispute, controversy or claim arising out of or relating to this contract, or the breach, termination or invalidity thereof, shall be settled by arbitration in accordance with the UNCITRAL Arbitration Rules.
Note. Parties should consider adding:
(a) The appointing authority shall be … [name of institution or person];
(b) The number of arbitrators shall be … [one or three];
(c) The place of arbitration shall be … [town and country];
(d) The language to be used in the arbitral proceedings shall be … .
Possible waiver statement
Note. If the parties wish to exclude recourse against the arbitral award that may be available under the applicable law, they may consider adding a provision to that effect as suggested below, considering, however, that the effectiveness and conditions of such an exclusion depend on the applicable law.
Waiver
The parties hereby waive their right to any form of recourse against an award to any court or other competent authority, insofar as such waiver can validly be made under the applicable law.
Model statements of independence pursuant to article 11 of the Rules
No circumstances to disclose
I am impartial and independent of each of the parties and intend to remain so. To the best of my knowledge, there are no circumstances, past or present, likely to give rise to justifiable doubts as to my impartiality or independence. I shall promptly notify the parties and the other arbitrators of any such circumstances that may subsequently come to my attention during this arbitration.
Circumstances to disclose
I am impartial and independent of each of the parties and intend to remain so. Attached is a statement made pursuant to article 11 of the UNCITRAL Arbitration Rules of (a) my past and present professional, business and other relationships with the parties and (b) any other relevant circumstances. [Include statement.] I confirm that those circumstances do not affect my independence and impartiality. I shall promptly notify the parties and the other arbitrators of any such further relationships or circumstances that may subsequently come to my attention during this arbitration.
Note. Any party may consider requesting from the arbitrator the following addition to the statement of independence:
I confirm, on the basis of the information presently available to me, that I can devote the time necessary to conduct this arbitration diligently, efficiently and in accordance with the time limits in the Rules.
Printed in Austria
V.11-80167—April 2011—1,500
FOOTNOTE
1 Official Records of the General Assembly, Thirty-first Session, Supplement No. 17 (A/31/17), chap. V, sect. C.
2 Ibid., Sixty-fifth Session, Supplement No. 17 (A/65/17), chap. III.
3 Ibid., annex I.
The Hindu Succession (Amendment) Act, 2005
NO. 39 OF 2005
[5th September, 2005.]
An Act further to amend the Hindu Succession Act, 1956.
BE it enacted by Parliament in the Fifty-sixth Year of the Republic of India as follows:-
1. Short title and commencement.- (1) This Act may be called the Hindu Succession (Amendment) Act, 2005.
(2) It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint.
2. Amendment of section 4.- In section 4 of the Hindu Succession Act, 1956 (hereinafter referred to as the principal Act), sub-section (2) shall be omitted.
3. Substitution of new section for section 6.- For section 6 of the principal Act, the following section shall be substituted, namely:-
‘6. Devolution of interest in coparcenary property.- (1) On and from the commencement of the Hindu Succession (Amendment) Act, 2005, in a Joint Hindu family governed by the Mitakshara law, the daughter of a coparcener shall,-
(a) by birth become a coparcener in her own right in the same manner as the son;
(b) have the same rights in the coparcenary property as she would have had if she had been a son;
(c) be subject to the same liabilities in respect of the said coparcenary property as that of a son,
and any reference to a Hindu Mitakshara coparcener shall be deemed to include a reference to a daughter of a coparcener:
Provided that nothing contained in this sub-section shall affect or invalidate any disposition or alienation including any partition or testamentary disposition of property which had taken place before the 20th day of December, 2004.
(2) Any property to which a female Hindu becomes entitled by virtue of sub-section (1) shall be held by her with the incidents of coparcenary ownership and shall be regarded, notwithstanding anything contained in this Act, or any other law for the time being in force, as property capable of being disposed of by her by testamentary disposition.
(3) Where a Hindu dies after the commencement of the Hindu Succession (Amendment) Act, 2005, his interest in the property of a Joint Hindu family governed by the Mitakshara law, shall devolve by testamentary or intestate succession, as the case may be, under this Act and not by survivorship, and the coparcenary property shall be deemed to have been divided as if a partition had taken place and,-
(a) the daughter is allotted the same share as is allotted to a son;
(b) the share of the pre-deceased son or a pre-deceased daughter, as they would have got had they been alive at the time of partition, shall be allotted to the surviving child of such predeceased son or of such pre-deceased daughter; and
(c) the share of the pre-deceased child of a pre-deceased son or of a pre-deceased daughter, as such child would have got had he or she been alive at the time of the partition, shall be allotted to the child of such pre-deceased child of the pre-deceased son or a pre-deceased daughter, as the case may be.
Explanation.- For the purposes of this sub-section, the interest of a Hindu Mitakshara coparcener shall be deemed to be the share in the property that would have been allotted to him if a partition of the property had taken place immediately before his death, irrespective of whether he was entitled to claim partition or not.
(4) After the commencement of the Hindu Succession (Amendment) Act, 2005, no court shall recognise any right to proceed against a son, grandson or great-grandson for the recovery of any debt due from his father, grandfather or great-grandfather solely on the ground of the pious obligation under the Hindu law, of such son, grandson or great-grandson to discharge any such debt:
Provided that in the case of any debt contracted before the commencement of the Hindu Succession (Amendment) Act, 2005, nothing contained in this sub-section shall affect-
(a) the right of any creditor to proceed against the son, grandson or great-grandson, as the case may be; or
(b) any alienation made in respect of or in satisfaction of, any such debt, and any such right or alienation shall be enforceable under the rule of pious obligation in the same manner and to the same extent as it would have been enforceable as if the Hindu Succession (Amendment) Act, 2005 had not been enacted.
Explanation.- For the purposes of clause (a), the expression “son”, “grandson” or “great-grandson”shall be deemed to refer to the son, grandson or great-grandson, as the case may be, who was born or adopted prior to the commencement of the Hindu Succession (Amendment) Act, 2005.
(5) Nothing contained in this section shall apply to a partition, which has been effected before the 20th day of December, 2004.
Explanation.- For the purposes of this section “partition” means any partition made by execution of a deed of partition duly registered under the Registration Act, 1908 (16 of 1908) or partition effected by a decree of a court.’.
4. Omission of section 23.- Section 23 of the principal Act shall be omitted.
5. Omission of section 24.- Section 24 of the principal Act shall be omitted.
6. Amendment of section 30.- In section 30 of the principal Act, for the words “disposed of by him”, the words “disposed of by him or by her” shall be substituted.
7. Amendment of Schedule.- In the Schedule to the principal Act, under the sub-heading “Class 1”, after the words “widow of a pre-deceased son of a pre-deceased son”, the words “son of a pre-deceased daughter of a pre-deceased daughter; daughter of a pre-deceased daughter of a pre-deceased daughter; daughter of a pre-deceased son of a pre-deceased daughter; daughter of a pre-deceased daughter of a pre-deceased son” shall be added.
T. K. VISWANATHAN,
Secy. to the Govt. of India.
Criminal Tribes Act 1871
(Act No. 27 of 1871)
[Dated 12th October, 1871]
Received the assent of the Governor General on the 12th October 1871.
Passed by the [President] of India in Council.
An Act for the Registration of Criminal Tribes and Eunuchs.
Preamble.- Whereas it is expedient to provide for the registration, surveillance and control of certain criminal tribes and eunuchs; It is hereby enacted as follows:-
1. Short title commencement.- This Act may be called “The Criminal Tribes’ Act, 1871”, [Repealed].
Local extent.- This section and section twenty extend to the whole of British India: the rest of this Act extends only to the territories under the governments of the Lieutenant-Governors of the North-Western Provinces and the Panjab, respectively, and under the administration of the Chief Commissioner of Oudh.
Part I.
Criminal Tribes.
2. Local Government to report what tribes should be declared criminal.- If the Local Government has reason to believe that any tribe, gang or class of persons is addicted to the systematic commission of non-bailable offences, it may report the case to the [President] in Council, and may request his permission to declare such tribe, gang or class to be a criminal tribe.
3. Report to contain certain particulars.- The report shall state the reasons why such tribe, gang or class is considered to be addicted to the systematic commission of non-bailable offences, and, as far as possible, the nature and the circumstances of the offences in which the members of the tribe are supposed to have been concerned; and shall describe the manner in which it is proposed that such tribe, gang or class shall earn its living when the provisions hereinafter contained have been applied to it.
4. Occupation of wandering tribe to be stated and also proposed residence and means of livelihood.- If such tribe, gang or class has no fixed place of residence, the report shall state whether such tribe, gang or class follows any lawful occupation, and whether such occupation is, in the opinion of the Local Government, the real occupation of such tribe, gang or class, or a pretence for the purpose of facilitating the commission of crimes, and shall set forth the grounds on which such opinion is based; and the report shall also specify the place of residence in which such wandering tribe, gang or class is to be settled under the provisions hereinafter contained, and the arrangements which are proposed to be made for enabling it to earn its living therein.
5. Notification declaring tribe to be criminal.- If, upon the consideration of any such report, the [President] in Council is satisfied that the tribe, gang or class to which it relates ought to be declared criminal, and that the means by which it is proposed that such tribe, gang or class shall earn its living are adequate, he may authorize the Local Government to publish in the Local Gazette a notification declaring that such tribe, gang or class is a criminal tribe, and thereupon the provisions of this Act shall become applicable to such tribe, gang or class.
6. Bar of jurisdiction of Courts in questions relating to notification.- No Court of Justice shall question the validity of any such notification on the ground that the provisions hereinbefore contained, or any of them, have not been complied with, or entertain in any form whatever the question whether they have been complied with; but every such notification shall be conclusive proof that the provisions of this Act are applicable to the tribe, gang or class specified therein.
7. Register of members of such tribes.- When the notification mentioned in section five has been published, the Local Government may direct the Magistrate of any district in which such tribe, gang or class, or any part thereof, is at the time resident, to make a register of the members of such tribe, gang or class, or of any part thereof. The declaration of the Local Government that any such tribe, gang or class, or any part of it, is resident in any district, shall be conclusive proof of such residence.
8. Procedure in making register.- Upon receiving such direction, the said Magistrate shall publish a notice in the place where the register is to be made, calling upon all the members of such tribe, gang or class, or of such portion thereof as is directed to be registered, to appear, at a time and place therein specified, before such persons as he appoints, and to give those persons such information as may be necessary to enable them to make the register.
9. Penalties for failing to appear, refusing or giving false information.- Any member of any such tribe, gang or class who, without lawful excuse, the burthen of proving which shall lie upon him.
shall fail to appear according to such notice.
or who shall intentionally omit to furnish such information.
or who shall furnish, as true, information on the subject which he knows or has reason to believe to be false.
shall be deemed guilty of an offence under the first parts of section one hundred and seventy-four, or one hundred and seventy-six, or one hundred and seventy-seven of the Indian Penal Code, respectively, as the case may be.
10. Charge of register and Reporting desirable alterations.- The register, when made, shall be kept by the District Superintendent of Police, who shall, from time to time, report to the said Magistrate any alterations which ought to be made therein, either by way of addition or erasure.
11. By whom alterations to be made.- No alteration shall be made in such register except by or by order of the said Magistrate, and he shall write his initials against every such alteration.
Notice to persons affected.- Notice shall be given of any such intended alteration, and of the time when, and place where, it is to be made, to every person affected thereby.
12. Complains of entres in register.- Any person deeming himself aggrieved by any entry made, or proposed to be made, in such register, either when the register is first made or subsequently, may complain to the said Magistrate against such entry, and the Magistrate shall retain such person’s name on the register, or enter it therein, or erase it therefrom, as he may see fit.
Every order for the erasure of any such person’s name shall state the grounds on which such person’s name is erased.
The Commissioner shall have power to review any order of entry, retention or erasure, passed by the said Magistrate on any such complaint, either on appeal by the person registered or proposed to be registered, or otherwise.
13. Settlement of tribe in place prescribed by Local Government.- Any tribe, gang or class, which has been declared to be criminal, and which has no fixed place of residence, may be settled in a place of residence prescribed by the Local Government.
14. Removal to other place.- Any tribe, gang or class which has been declared to be criminal, or any part thereof, may, by order of the Local Government, be removed to any other place of residence.
15. Arrangements to be made prior to settlement or removal.- No tribe, gang or class, shall be settled or removed under the provisions of this Act until such arrangements as the Local Government shall, with the concurrence of the [President] in Council, consider suitable, have been made for enabling such tribe, gang or class, or such part thereof as is to be so settled or removed, to earn a living in the place in or to which it is to be settled or removed.
16. Transfer of register of persons ordered to be removed.- When the removal of any persons has been ordered under this Act, the register of such persons’ names shall be transferred to the District Superintendent of Police of the district to which such persons are removed, and the Magistrate of the said district and the Commissioner of the division in which it is situated, shall thereupon be empowered to exercise respectively the powers provided in sections eleven and twelve.
17. Power to place tribe in reformatory settlement.- The Local Government may, with the sanction of the [President] in Council, place any tribe, gang or class, which has been declared to be criminal, or any part thereof, in a reformatory settlement.
18. Power to make rules.- The Local Government may, with the previous consent of the [President] in Council, make rules to prescribe-
(1) the form in which the register shall be made by the said Magistrate;
(2) the mode in which the said Magistrate shall publish the notice prescribed in section eight, and the means by which the persons whom it concerns, and the Headmen, Village-Watchmen and landowners or occupiers of the village, in which such persons reside, shall be informed of its publication;
(3) the mode in which the notice prescribed in section eleven shall be given;
(4) the limits within which persons whose names are on the register shall reside;
(5) conditions as to holding passes, under which such persons may be permitted to leave the said limits;
(6) conditions to be inserted in any such pass as to
(a) the places where the holder of the pass may go or reside;
(b) the officers before whom, from time to time, he shall be hound to present himself;
(c) and the time during which he may absent himself;
(7) conditions as to answering at roll-call or otherwise, in order to satisfy the said Magistrate or persons authorized by him, that the persons whose names are on the register are actually present at given times within the said limits;
(8) the inspection of the residences and villages of any such tribe, gang or class, and the prevention or removal of contrivances for enabling the residents therein to conceal stolen property, or to leave their place of residence without leave;
(9) the terms upon which registered persons may be discharged from the operation of this Act;
(10) the mode in which criminal tribes shall be-settled and removed;
(11) the control and supervision of reformatory settlements;
(12) the works on which, and the hours during which, persons placed in a reformatory settlement shall be employed, the rates at which they shall be paid, and the disposal, for the benefit of such persons, of the surplus proceeds of their labour after defraying the whole or such part of the expenses of then: supervision and control as to the Local Government shall seem fit;
(13) the discipline to which persons endeavouring to escape from any such settlement, or otherwise offending against the rules for the time being in force, shall be submitted; the periodical visitation of such settlement, and the removal from it of such persons as it shall seem expedient to remove;
(14) and generally to carry out the purposes of this Act.
19. Penalties for breach of rules.- Any person violating any of the rules made under section eighteen shall be punished with rigorous imprisonment for a term which may extend to six months, or with fine, or with whipping, or with all or any two of those punishments; and, on any second conviction for a breach of any of the said rules, with rigorous imprisonment which may extend to one year, or with fine, or with whipping to be inflicted in the manner prescribed by any law in force for the time being in relation to whipping, or with all or any two of those punishments.
20. Arrest of registered person found beyond prescribed limits.- Any person registered under the provisions of this Act, who is found in any part of British India, beyond the limits so prescribed for his residence, without such pass as may be required by the said rules, or in a place or at a time not permitted by the conditions of his pass, or who escapes from a reformatory settlement, may be arrested without warrant by any police-officer or village-watchman, and taken before a Magistrate, who, on proof of the facts, shall order him to be removed to the district in which he ought to have resided, or to the reformatory settlement from which he has escaped (as the case may be), there to be dealt with according to the rules under this Act for the time being in force.
The rules for the time being in force for the transmission of prisoners shall apply to all persons removed under this section: Provided that an order from the Local Government or from the Inspector General of Prisons shall not be necessary, for the removal of such persons.
21. Duties of Village-Heaclmeu, Village-Watchmen, &c.- It shall be the duty of every Village-Headman and Village-Watchman in a village in which any persons belonging to a tribe, class or gang which has been declared criminal reside, and of every owner or occupier of land on which any such persons reside, to give the earliest information in his power at the nearest police station of
(1) the failure of any such person to appear and give information, as directed in section eight;
(2) the departure of any such person from such Tillage or from such land (as the case may be).
And it shall be the duty of every Village-Headman and Village-Watchman in a village, and of every owner or occupier of land, to give the earliest information in his power at the nearest police station of the arrival at such village or on such land (as the case may be) of any persons who may reasonably be suspected of belonging to any such tribe, class or gang.
22. Penalty for breach of such duties.- Any Village-Headman, Village-Watchman, owner or occupier of land, who shall fail to comply with the requirements of section twenty-one, shall be deemed to have committed an offence under the first part of section one hundred and seventy-six of the Indian Penal Code.
23. Indemnity for past registrations and detentions.- All Magistrates and other persons are hereby indemnified for anything heretofore done under the circular order 18 of 1856 of the Judicial Commissioner of the Panjab, or under any orders of the Local Governments of the North-Western Provinces or Oudh, relating to the registration or detention of tribes regarded by such Local Governments as criminal tribes; and no suit or other proceeding shall be maintained against any such Magistrate or other person in respect of anything so done.
Part II.
Eunuchs.
24. Registers of eunuchs and their property.- The Local Government shall cause the following registers to be made and kept up by such officer as, from time to time, it appoints in this behalf:-
(a) a register of the names and residences of all eunuchs residing in any town or place to which the Local Government specially extends this Part of this Act, who are reasonably suspected of kidnapping or castrating children, or of committing offences under section three hundred and seventy-seven of the Indian Penal Code, or of abetting the commission of any of the said offences; and
(b) a register of the property of such of the said eunuchs as, under the provisions hereinafter contained, are required to furnish information as to their property.
`Eunuch’ defined.- The term `eunuch’ shall, for the purposes of this Act, be deemed to include all persons of the male sex who admit themselves, or on medical inspection clearly appear, to be impotent.
25. Complaints of entries in register.- Any person deeming himself aggrieved by any entry made or proposed to be made in such register, either when the register is first made or subsequently, may complain to the said officer, who shall enter such person’s name, or erase it, or re kin it, as he sees fit.
Every order for erasure of such person’s name shall state the grounds on which such person’s name is erased.
The Commissioner shall have power to review any order passed by such officer on such complaint, either on appeal by the complainant or otherwise.
26. Penalty on registered eunuch appearing in female clothes.- Any eunuch so registered who appears, dressed or ornamented like a woman, in a public street or place, or in any other place, with the intention of being seen from a public street or place.
or dancing in public, or for hire.- or who dances or plays music, or takes part in any public exhibition, in a public street or place or for hire in a private house, may be arrested without warrant, and shall be punished with imprisonment of either description for a term which may extend to two years, or with fine, or with both.
27. Penalty on registered eunuch keeping boy under sixteen.- Any eunuch so registered who has in his charge, or keeps in the house in which he resides, or under his control, any boy who has not completed the age of sixteen years, shall be punished with imprisonment for a term which may extend to two years, or with fine, or with both.
28. Maintenance and education of boys whose parents cannot be found.- The Magistrate may direct that any such boy shall be returned to his parents or guardians, if they can be discovered. If they cannot be discovered, the Magistrate may make such arrangements as lie thinks necessary for the maintenance and education of such boy, and may direct that the whole or any part of a fine inflicted under section twenty-seven may be employed in defraying the cost of such arrangements.
The Local Government may direct out of what local or municipal fund so much of the cost of such arrangements as is not met by the fine imposed, shall be defrayed.
29. Disabilities of registered eunuchs.- No eunuch so registered shall be capable-
(a) of being or acting as guardian to any minor,
(b) of making a gift,
(c) of making a will, or
(d) of adopting a son.
30. Power to require information as to registered eunuch’s properly.- Any officer authorized by the Local Government in this behalf may, from time to time, require any eunuch so registered to furnish information as to all property, whether movable or immovable, of or to which he is possessed or entitled, or which is held in trust for him.
Penalty for refusing such information.- Any such eunuch intentionally omitting to furnish such information, or furnishing, as true, information on the subject which he knows, or has reason to believe, to be false, shall be deemed to have committed an offence under section one hundred and seventy-six or one hundred and seventy-seven of the Indian Penal Code, as the case may be.
31. Rules for making and keeping up registers of eunuchs.- The Local Government may, with the previous sanction of the [President] in Council, make rules for the making and keeping up and charge of registers made under this Part of the Act.
The Transgender Persons (Protection of Rights) Act, 2019
NO. 40 OF 2019
[5th December, 2019.]
An Act to provide for protection of rights of transgender persons and their welfare and for matters connected therewith and incidental thereto.
BE it enacted by Parliament in the Seventieth Year of the Republic of India as follows:—
CHAPTER I PRELIMINARY
1. Short title, extent and commencement. (1) This Act may be called the Transgender Persons (Protection of Rights) Act, 2019.
(2) It extends to the whole of India.
(3) It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint.
2. Definitions.- In this Act, unless the context otherwise requires,—
(a) “appropriate Government” means,—
(i) in relation to the Central Government or any establishment, wholly or substantially financed by that Government, the Central Government;
(ii) in relation to a State Government or any establishment, wholly or substantially financed by that Government, or any local authority, the State Government;
(b) “establishment” means—
(i) any body or authority established by or under a Central Act or a State Act or an authority or a body owned or controlled or aided by the Government or a local authority, or a Government company as defined in section 2 of the Companies Act, 2013, and includes a Department of the Government; or
(ii) any company or body corporate or association or body of individuals, firm, cooperative or other society, association, trust, agency, institution;
(c) “family” means a group of people related by blood or marriage or by adoption made in accordance with law;
(d) “inclusive education” means a system of education wherein transgender students learn together with other students without fear of discrimination, neglect, harassment or intimidation and the system of teaching and learning is suitably adapted to meet the learning needs of such students;
(e) “institution” means an institution, whether public or private, for the reception, care, protection, education, training or any other service of transgender persons;
(f) “local authority” means the municipal corporation or Municipality or Panchayat or any other local body constituted under any law for the time being in force for providing municipal services or basic services, as the case may be, in respect of areas under its jurisdiction;
(g) “National Council” means the National Council for Transgender Persons established under section 16;
(h) “notification” means a notification published in the Official Gazette;
(i) “person with intersex variations” means a person who at birth shows variation in his or her primary sexual characteristics, external genitalia, chromosomes or hormones from normative standard of male or female body;
(j) “prescribed” means prescribed by rules made by the appropriate Government under this Act; and
(k) “transgender person” means a person whose gender does not match with the gender assigned to that person at birth and includes trans-man or trans-woman (whether or not such person has undergone Sex Reassignment Surgery or hormone therapy or laser therapy or such other therapy), person with intersex variations, genderqueer and person having such socio-cultural identities as kinner, hijra, aravani and jogta.
CHAPTER II
PROHIBITION AGAINST DISCRIMINATION
3. Prohibition against discrimination.- No person or establishment shall discriminate against a transgender person on any of the following grounds, namely:—
(a) the denial, or discontinuation of, or unfair treatment in, educational establishments and services thereof;
(b) the unfair treatment in, or in relation to, employment or occupation;
(c) the denial of, or termination from, employment or occupation;
(d) the denial or discontinuation of, or unfair treatment in, healthcare services;
(e) the denial or discontinuation of, or unfair treatment with regard to, access to, or provision or enjoyment or use of any goods, accommodation, service, facility, benefit, privilege or opportunity dedicated to the use of the general public or customarily available to the public;
(f) the denial or discontinuation of, or unfair treatment with regard to the right of movement;
(g) the denial or discontinuation of, or unfair treatment with regard to the right to reside, purchase, rent, or otherwise occupy any property;
(h) the denial or discontinuation of, or unfair treatment in, the opportunity to stand for or hold public or private office; and
(i) the denial of access to, removal from, or unfair treatment in, Government or private establishment in whose care or custody a transgender person may be.
CHAPTER III
RECOGNITION OF IDENTITY OF TRANSGENDER PERSONS
4. Recognition of identity of transgender person.- (1) A transgender person shall have a right to be recognised as such, in accordance with the provisions of this Act.
(2) A person recognised as transgender under sub-section (1) shall have a right to self-perceived gender identity.
5. Application for certificate of identity.- A transgender person may make an application to the District Magistrate for issuing a certificate of identity as a transgender person, in such form and manner, and accompanied with such documents, as may be prescribed:
Provided that in the case of a minor child, such application shall be made by a parent or guardian of such child.
6. Issue of certificate of identity.- (1) The District Magistrate shall issue to the applicant under section 5, a certificate of identity as transgender person after following such procedure and in such form and manner, within such time, as may be prescribed indicating the gender of such person as transgender.
(2) The gender of transgender person shall be recorded in all official documents in accordance with certificate issued under sub-section (1).
(3) A certificate issued to a person under sub-section (1) shall confer rights and be a proof of recognition of his identity as a transgender person.
7. Change in gender.- (1) After the issue of a certificate under sub-section (1) of section 6, if a transgender person undergoes surgery to change gender either as a male or female, such person may make an application, along with a certificate issued to that effect by the Medical Superintendent or Chief Medical Officer of the medical institution in which that person has undergone surgery, to the District Magistrate for revised certificate, in such form and manner as may be prescribed.
(2) The District Magistrate shall, on receipt of an application along with the certificate issued by the Medical Superintendent or Chief Medical Officer, and on being satisfied with the correctness of such certificate, issue a certificate indicating change in gender in such form and manner and within such time, as may be prescribed.
(3) The person who has been issued a certificate of identity under section 6 or a revised certificate under sub-section (2) shall be entitled to change the first name in the birth certificate and all other official documents relating to the identity of such person:
Provided that such change in gender and the issue of revised certificate under sub-section (2) shall not affect the rights and entitlements of such person under this Act.
CHAPTER IV
WELFARE MEASURES BY GOVERNMENT
8. Obligation of appropriate Government.- (1) The appropriate Government shall take steps to secure full and effective participation of transgender persons and their inclusion in society.
(2) The appropriate Government shall take such welfare measures as may be prescribed to protect the rights and interests of transgender persons, and facilitate their access to welfare schemes framed by that Government.
(3) The appropriate Government shall formulate welfare schemes and programmes which are transgender sensitive, non-stigmatising and non-discriminatory.
(4) The appropriate Government shall take steps for the rescue, protection and rehabilitation of transgender persons to address the needs of such persons.
(5) The appropriate Government shall take appropriate measures to promote and protect the right of transgender persons to participate in cultural and recreational activities.
CHAPTER V
OBLIGATION OF ESTABLISHMENTS AND OTHER PERSONS
9. Non- discrimination in employment.- No establishment shall discriminate against any transgender person in any matter relating to employment including, but not limited to, recruitment, promotion and other related issues.
10. Obligations of establishments.- Every establishment shall ensure compliance with the provisions of this Act and provide such facilities to transgender persons as may be prescribed.
11. Grievance redressal mechanism.- Every establishment shall designate a person to be a complaint officer to deal with the complaints relating to violation of the provisions of this Act.
12. Right of residence.- (1) No child shall be separated from parents or immediate family on the ground of being a transgender, except on an order of a competent court, in the interest of such child.
(2) Every transgender person shall have—
(a) a right to reside in the household where parent or immediate family members reside;
(b) a right not to be excluded from such household or any part thereof; and
(c) a right to enjoy and use the facilities of such household in a non-discriminatory manner.
(3) Where any parent or a member of his immediate family is unable to take care of a transgender, the competent court shall by an order direct such person to be placed in rehabilitation centre.
CHAPTER VI
EDUCATION, SOCIAL SECURITY AND HEALTH OF TRANSGENDER PERSONS
13. Obligation of educational institutions to provide inclusive education to transgender persons.- Every educational institution funded or recognised by the appropriate Government shall provide inclusive education and opportunities for sports, recreation and leisure activities to transgender persons without discrimination on an equal basis with others.
14. Vocational training and self-employment.- The appropriate Government shall formulate welfare schemes and programmes to facilitate and support livelihood for transgender persons including their vocational training and self-employment.
15. Healthcare facilities.- The appropriate Government shall take the following measures in relation to transgender persons, namely:—
(a) to set up separate human immunodeficiency virus Sero-surveillance Centres to conduct sero-surveillance for such persons in accordance with the guidelines issued by the National AIDS Control Organisation in this behalf;
(b) to provide for medical care facility including sex reassignment surgery and hormonal therapy;
(c) before and after sex reassignment surgery and hormonal therapy counselling;
(d) bring out a Health Manual related to sex reassignment surgery in accordance with the World Profession Association for Transgender Health guidelines;
(e) review of medical curriculum and research for doctors to address their specific health issues;
(f) to facilitate access to transgender persons in hospitals and other healthcare institutions and centres;
(g) provision for coverage of medical expenses by a comprehensive insurance scheme for Sex Reassignment Surgery, hormonal therapy, laser therapy or any other health issues of transgender persons.
CHAPTER VII
NATIONAL COUNCIL FOR TRANSGENDER PERSONS
16. National Council for Transgender Persons.- (1) The Central Government shall by notification constitute a National Council for Transgender Persons to exercise the powers conferred on, and to perform the functions assigned to it, under this Act.
(2) The National Council shall consist of—
(a) the Union Minister in-charge of the Ministry of Social Justice and Empowerment, Chairperson, ex officio;
(b) the Minister of State, in-charge of the Ministry of Social Justice and Empowerment in the Government, Vice-Chairperson, ex officio;
(c) Secretary to the Government of India in-charge of the Ministry of Social Justice and Empowerment, Member, ex officio;
(d) one representative each from the Ministries of Health and Family Welfare, Home Affairs, Housing and Urban Affairs, Minority Affairs, Human Resources Development, Rural Development, Labour and Employment and Departments of Legal Affairs, Pensions and Pensioners Welfare and National Institute for Transforming India Aayog, not below the rank of Joint Secretaries to the Government of India, Members, ex officio;
(e) one representative each from the National Human Rights Commission and National Commission for Women, not below the rank of Joint Secretaries to the Government of India, Members, ex officio;
(f) representatives of the State Governments and Union territories by rotation, one each from the North, South, East, West and North-East regions, to be nominated by the Central Government, Members, ex officio;
(g) five representatives of transgender community, by rotation, from the State Governments and Union territories, one each from the North, South, East, West and North-East regions, to be nominated by the Central Government, Members;
(h) five experts, to represent non-governmental organisations or associations, working for the welfare of transgender persons, to be nominated by the Central Government, Members; and
(i) Joint Secretary to the Government of India in the Ministry of Social Justice and Empowerment dealing with the welfare of the transgender persons, Member Secretary, ex officio.
(3) A Member of National Council, other than ex officio member, shall hold office for a term of three years from the date of his nomination.
17. Functions of Council.- The National Council shall perform the following functions, namely:—
(a) to advise the Central Government on the formulation of policies, programmes, legislation and projects with respect to transgender persons;
(b) to monitor and evaluate the impact of policies and programmes designed for achieving equality and full participation of transgender persons;
(c) to review and coordinate the activities of all the departments of Government and other Governmental and non-Governmental Organisations which are dealing with matters relating to transgender persons;
(d) to redress the grievances of transgender persons; and
(e) to perform such other functions as may be prescribed by the Central Government.
CHAPTER VIII
OFFENCES AND PENALTIES
18. Offences and penalties.- Whoever,—
(a) compels or entices a transgender person to indulge in the act of forced or bonded labour other than any compulsory service for public purposes imposed by Government;
(b) denies a transgender person the right of passage to a public place or obstructs such person from using or having access to a public place to which other members have access to or a right to use;
(c) forces or causes a transgender person to leave household, village or other place of residence; and
(d) harms or injures or endangers the life, safety, health or well-being, whether mental or physical, of a transgender person or tends to do acts including causing physical abuse, sexual abuse, verbal and emotional abuse and economic abuse, shall be punishable with imprisonment for a term which shall not be less than six months but which may extend to two years and with fine.
CHAPTER IX
MISCELLANEOUS
19. Grants by Central Government.- The Central Government shall, from time to time, after due appropriation made by Parliament by law in this behalf, credit such sums to the National Council as may be necessary for carrying out the purposes of this Act.
20. Act not in derogation of any other law.- The provisions of this Act shall be in addition to, and not in derogation of, any other law for the time being in force.
21. Protection of action taken in good faith.- No suit, prosecution or other legal proceeding shall lie against the appropriate Government or any local authority or any officer of the Government in respect of anything which is in good faith done or intended to be done in pursuance of the provisions of this Act and any rules made thereunder.
22. Power of appropriate Government to make rules.- (1) The appropriate Government may, subject to the condition of previous publication, by notification, make rules for carrying out the provisions of this Act.
(2) In particular, and without prejudice to the generality of the foregoing power, such rules may provide for all or any of the following matters, namely:—
(a) the form and manner in which an application shall be made under section 5;
(b) the procedure, form and manner and the period within which a certificate of identity is issued under sub-section (1) of section 6;
(c) the form and manner in which an application shall be made under sub-section (1) of section 7;
(d) the form, period and manner for issuing revised certificate under sub-section (2) of section 7;
(e) welfare measures to be provided under sub-section (2) of section 8;
(f) facilities to be provided under section 10;
(g) other functions of the National Council under clause (e) of section 17; and
(h) any other matter which is required to be or may be prescribed.
(3) Every rule made by the Central Government under sub-section (1), shall be laid, as soon as may be after it is made, before each House of Parliament, while it is in session, for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rule or both Houses agree that the rule should not be made, the rule shall thereafter have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule.
(4) Every rule made by the State Government under sub-section (1), shall be laid, as soon as may be after it is made, before each House of the State Legislature where it consists of two Houses, or where such legislature consists of one House, before that House.
23. Power to remove difficulties.- (1) If any difficulty arises in giving effect to the provisions of this Act, the Central Government may, by order published in the Official Gazette, make such provisions, not inconsistent with the provisions of this Act as appear to it to be necessary or expedient for removing the difficulty:
Provided that no such order shall be made after the expiry of the period of two years from the date of commencement of this Act.
(2) Every order made under this section shall, as soon as may be after it is made, be laid before each House of Parliament.
————
DR. G. NARAYANA RAJU,
Secretary to the Govt. of India.
The State Bank of India Act, 1955
ACT NO. 23 OF 19551
[8th May, 1955.]
An Act to constitute a State Bank for India, to transfer to it the undertaking of the Imperial Bank of India and to provide for other matters connected therewith or incidental thereto.
WHEAEAS for the extension of banking facilities on a large scale, more particularly in the rural and semi-urban areas, and for diverse other public purposes it is expedient to constitute a State Bank for India, and to transfer to it the undertaking of the Imperial Bank of India and to provide for other matters connected therewith or incidental thereto;
BE it enacted by Parliament in the Sixth Year of the Republic of India as follows:—
CHAPTER I PRELIMINARY
1. Short title and commencement.— (1) This Act may be called the State Bank of India Act, 1955.
(2) It shall come into force on such date2 as the Central Government may, by notification in the Official Gazette, appoint.
2. Definitions.— In this Act, unless the context otherwise requires,—
(a) “appointed day” means the date on which this Act comes into force;
(b) “Central Board” means the Central Board of Directors of the State Bank;
3[(bb) “chairman” means the chairman of the Central Board;]
(c) “goods” includes bullion, wares and merchandise;
(d) “Imperial Bank” means the Imperial Bank of India constituted under the Imperial Bank of India Act, 1920 (47 of 1920);
3[(dd) “Local Board” means a Local Board constituted under section 21;]
(e) “prescribed” means prescribed by regulations made under this Act;
(f) “Reserve Bank” means the Reserve Bank of India constituted under the Reserve Bank of India Act, 1934 (2 of 1934);
(g) “State Bank” means the State Bank of India constituted under this Act;
4* * * * *
5* * * * *
6[(j) “workman” has the meaning assigned to it in the Industrial Disputes Act, 1947 (14 of 1947).]
1. The Act has been extended to Dadra and Nagar Haveli by Reg. 6 of 1963, s. 2 and the first Schedule (w.e.f. 1-7-1965); Pondicherry by Reg. 7 of 1963, s. 3 and first Schedule (w.e.f. 1-10-1963); and Goa, Daman and Diu by Reg. 11 of 1963, s. 3 and Schedule.
2. 1st July, 1955, vide notification No. S.R.O. 1077, dated 14th May, 1955, see Gazette of India, Part II, sec. 3(ii).
3. Ins. by Act 35 of 1964, s. 2 (w.e.f. 1-12-1964).
4. Clause (h) omitted by Act 19 of 2018, s. 3 (w.e.f. 1-4-2017).
5. Omitted by Act 27 of 2010, s. 2 (w.e.f. 15-9-2010).
6. Ins. by Act 48 of 1973, s. 2 (w.e.f. 1-7-1974).
CHAPTER II
INCORPORATION AND SHARE CAPITAL OF STATE BANK
3. Establishment of the State Bank.—(1) A Bank to be called the State Bank of India shall be constituted to carry on the business of banking and other business in accordance with the provisions of this Act and for the purpose of taking over the undertaking of the Imperial Bank.
(2) The 1[Central Government], together with such other persons as may from time to time become shareholders in the State Bank in accordance with the provisions of this Act, shall, so long as they are shareholders in the State Bank, constitute a body corporate with perpetual succession and a common seal under the name of the State Bank of India, and shall sue and be sued in that name.
(3) The State Bank shall have power to acquire and hold property, whether movable or immovable, for the purposes for which it is constituted and to dispose of the same.
2[4. Authorised capital.— Subject to the provisions of this Act, the authorised capital of the State Bank shall be five thousand crores of rupees divided into five hundred crores of fully paid-up shares often rupees each:
Provided that the Central Board may reduce the nominal or face value of the shares, and divide the authorised capital into such denomination as it may decide with the approval of the Reserve Bank:
Provided further that the Central Government may, in consultation with the Reserve Bank, increase or reduce the authorised capital so however that the shares in all cases shall be fully paid-up shares.]
5. Issued capital.— (1) The issued capital of the State Bank shall, on the appointed day, be five crores, sixty-two lakhs and fifty thousand rupees divided into five lakhs, sixty-two thousand and five hundred shares, all of which shall, on the appointed day, stand allotted to the Reserve Bank in lieu of the shares of the Imperial Bank 3[transferred to and vested in it under section 6].
4[(2) The issued capital of the State Bank shall consist of equity shares or equity and preference shares:
Provided that the issue of preference shares shall be in accordance with the guidelines framed by the Reserve Bank specifying the class of preference shares, the extent of issue of each class of such preference shares (whether perpetual or irredeemable or redeemable) and the terms and conditions subject to which, each class of preference shares may be issued:
Provided further that the Central Board may from time to time increase, with the previous approval of the Reserve Bank and the Central Government, whether by public issue or rights issue or preferential allotment or private placement, in accordance with the procedure as may be prescribed, the issued capital by the issue of equity or preference shares:
Provided also that the Central Government shall, at all times, hold not less than fifty-one per cent. of the issued capital consisting of equity shares of the State Bank.]
(3) No increase in the issued capital beyond twelve crores and fifty lakhs of rupees shall be made under sub-section (2) without the previous sanction of the Central Government.
5[(4) Subject to the provisions contained in sub-section (2), the Central Board may increase from time to time, by way of issuing bonus shares to existing equity shareholders, the issued capital in such manner as the Central Government may, after consultation with the Reserve Bank, direct.
(5) The State Bank may, accept the money in respect of shares issued towards increase in the issued capital in instalments, make calls, forfeit unpaid shares and re-issue them, in such manner as may be prescribed.]
1. Subs. by Act 32 of 2007, s. 2, for “Reserve Bank” (w.e.f. 29-6-2007).
2. Subs. by Act 27 of 2010, s. 3, for section 4 (w.e.f. 15-9-2010).
3. Subs. by Act 33 of 1955, s. 2, for “transferred to it by paragraph 2 of the First Schedule” (w.e.f. 21-9-1955)
4. Subs. by Act 27 of 2010, s. 4, for sub-section (2) (w.e.f. 15-9-2010).
5. Ins. by s. 4, ibid. (w.e.f. 15-9-2010).
CHAPTER III
TRANSFER OF UNDERTAKING OF THE IMPERIAL BANK TO STATE BANK
6. Transfer of assets and liabilities of the Imperial Bank to the State Bank.— (1) Subject to the other provisions contained in this Act, on the appointed day,
(a) all shares in the capital of the Imperial Bank shall be transferred to, and shall vest in, the Reserve Bank, free of all trusts, liabilities and encumbrances, and
(b) the undertaking of the Imperial Bank shall be transferred to, and shall vest in, the State Bank.
(2) The undertaking of the Imperial Bank shall be deemed to include all rights, powers, authorities and privileges, and all property, movable and immovable, including cash balances, reserve funds, investments and all other interests and rights in, or arising out of, such property as may be in the possession of that bank immediately before the appointed day, and all books, accounts, and documents relating thereto, and shall also be deemed to include all debts, liabilities and obligations of whatever kind then existing of that bank.
1[(3) Unless otherwise expressly provided by or under this Act, all contracts, deeds, bonds, agreements, powers of attorney, grants of legal representation and other instruments of whatever nature subsisting or having effect immediately before the appointed day and to which the Imperial Bank is a party or which are in favour of the Imperial Bank shall be of as full force and effect against or in favour of the State Bank, as the case may be, and may be enforced or acted upon as fully and effectually as if instead of the Imperial Bank the State Bank had been a party thereto or as if they had been issued in favour of the State Bank].
(4) If on the appointed day any suit, appeal or other legal proceeding of whatever nature, is pending by or against the Imperial Bank, the same shall not abate, be discontinued or be in any way prejudicially affected by reason of the transfer to the State Bank of the undertaking of the Imperial Bank or of anything contained in this Act, but the suit, appeal or other proceeding may be continued, prosecuted and enforced by or against the State Bank.
7. Transfer of service of existing officers and employees of the Imperial Bank to the State Bank.— (1) Every officer or other employee of the Imperial Bank (excepting the managing director, the deputy managing director and other directors) in the employment of the Imperial Bank immediately before the appointed day shall, on and from the appointed day, become an officer or other employee, as the case may be, of the State Bank, and shall hold his office or service therein by the same tenure, at the same remuneration and upon the same terms and conditions and with the same rights and privileges as to pension, gratuity and other matters as he would have held the same on the appointed day if the undertaking of the Imperial Bank had not vested in the State Bank, and shall continue to do so unless and until his employment in the State Bank is terminated or until his remuneration, terms or conditions are duly altered by the State Bank.
(2) Any person who, on the appointed day, is entitled to or is in receipt of, a pension or other superannuation or compassionate allowance or benefit from the Imperial Bank or any provident, pension or other fund or any authority administering such fund shall be entitled to be paid by, and to receive from, the State Bank or any provident, pension or other fund or any authority administering such fund the same pension, allowance or benefit so long as he observes the conditions on which the pension, allowance or benefit was granted, and if any question arises whether he has so observed such conditions, the question shall be determined by the Central Government and the decision of the Central Government thereon shall be final.
(3) Notwithstanding anything contained in sub-section (1) or sub-section (2), no appointment made or promotion, increment in salary, pension, allowance or any other benefit granted to any person after the 19th day of December, 1954, and before the appointed day which would not ordinarily have been made or granted or which would not ordinarily have been admissible under the rules or authorisations of the Imperial Bank or of any provident, pension or other fund in force prior to the 19th day of December, 1954, shall have effect or be payable or claimable from the State Bank or from any provident, pension or other fund or from any authority administering the fund, unless the Central Government has, by general or special order, confirmed the appointment, promotion or increment or has directed the continued grant of the pension allowance or other benefit as the case may be.
1. Subs. by Act 33 of 1955, s. 3, for sub-section (3) (w.e.f. 21-9-1955).
(4) Notwithstanding anything contained in the Industrial Disputes Act, 1947 (14 of 1947), or in any other law for the time being in force, the transfer of the services of any officer or other employes of the Imperial Bank from that Bank to the State Bank shall not entitle such officer or other employees to any compensation under that Act or other law, and no such claim shall be entertained by any Court, Tribunal or other authority.
(5) Any person holding office as managing director, deputy managing director, director or member of any Local Board of the Imperial Bank immediately before the appointed day shall be deemed to have vacated his office as such on the appointed day, and notwithstanding anything contained in this Act or in any other law for the time being in force or in any agreement or contract, he shall not be entitled to any compensation from the Imperial Bank or the State Bank for the loss of office or for the premature termination of any agreement or contract relating to his employment, except such pension, compensation or other benefit which the State Bank may grant to him, having regard to what that person would have received as an officer of the Imperial Bank if this Act had not been passed and if he had retired from his employment in the ordinary course.
(6) Where any managing director, deputy managing director, director, officer or other employee of the Imperial Bank has, after the 19th day of December, 1954, and before the appointed day, been paid any sum by way of compensation or gratuity, the State Bank shall be entitled to claim refund of any sum so paid if the payment is not confirmed by the Central Government by general or special order.
8. Existing provident and other funds of the Imperial Bank.— For the persons who immediately before the appointed day are the trustees of the following funds, that is to say,—
(a) the Imperial Bank of India Employees Provident Fund;
(b) the Imperial Bank of India Employees Pension and Guarantee Fund;
(c) the Bank of Bombay Officers Pension and Guarantee Fund;
(d) the Bank of Madras Pension and Gratuity Fund; and
(e) the Bank of Madras Officers Provident and Mutual Guarantee Fund;
there shall be substituted as trustees such persons as the Central Government may, by general or special order, specify.
9. Compensation to be given to shareholders of Imperial Bank.— (1) Every person who immediately before the appointed day is registered as a holder of shares in the Imperial Bank shall be entitled to compensation in accordance with the provisions contained in the First Schedule.
(2) Nothing contained in sub-section (1) shall affect the rights inter se between the holder of any share in the Imperial Bank and any other person who may have an interest in such share, and such other person shall be entitled to enforce his interest against the compensation awarded to the holder of such share, but not against the Reserve Bank.
CHAPTER IV SHARES
10. Transferability of shares.— (1) Save as otherwise provided in sub-section (2), the shares of the State Bank shall be freely transferable.
(2) Nothing contained in sub-section (1) shall entitle the 1[Central Government] to transfer any shares held by it in the State Bank if such transfer will result in reducing the shares held by it to less than 2[fifty-one per cent. of the issued capital consisting of equity shares,] of the State Bank.
1. Subs. by Act 32 of 2007, s. 4, for “Reserve Bank” (w.e.f. 29-6-2007).
2. Subs. by 27 of 2010, s. 5, for “fifty-five per cent. of the issued capital” (w.e.f. 15-9-2010).
1[10A. Right of registered shareholders to nominate.— (1) Every individual registered shareholder may, at any time, nominate, in the prescribed manner, an individual to whom all his rights in the shares shall vest in the event of his death.
(2) Where the shares are registered in the name of more than one individual jointly, the joint holders may together nominate in the prescribed manner, an individual to whom all their rights in the shares shall vest in the event of the death of all the joint holders.
(3) Notwithstanding anything contained in any other law for the time being in force or in any disposition, whether testamentary or otherwise, where a nomination in respect of shares is made in the prescribed manner and which purports to confer on the nominee the right to vest the shares, the nominee shall, on the death of the shareholder or, as the case may be, on the death of all the joint holders, become entitled to all the rights of the shareholder or, as the case may be, of all the joint holders, in relation to such shares and all other persons shall be excluded unless the nomination is varied or cancelled in the prescribed manner.
(4) Where the nominee is a minor, it shall be lawful for the individual registered holder of the shares to make nomination to appoint, in the prescribed manner, any person to become entitled to the shares in the event of his death during the minority of the nominee.]
2[11. Restrictions on voting rights.— No shareholder, other than the 3[Central Government], shall be entitled to exercise voting rights in respect of any shares held by him in excess of ten per cent. of the issued capital:
Provided that such shareholder shall be entitled to exercise voting rights at such higher percentage as the Central Government may, after consultation with the 3[Central Government], specify.]
4[Provided further that the shareholder holding any preference share capital in the State Bank shall, in respect of such capital, have a right to vote only on resolutions placed before the State Bank which directly affect the rights attached to his preference shares:
Provided also that no preference shareholder, other than the Central Government, shall be entitled to exercise voting rights in respect of preference shares held by him in excess of ten per cent, of total voting rights of all the shareholders holding preference share capital only.]
12. Shares to be approved securities.— Notwithstanding anything contained in the Acts hereinafter mentioned in this section, the shares of the State Bank shall be deemed to be included among the securities enumerated in section 20 of the Indian Trusts Act, 1882 (2 of 1882), and also to be approved securities for the purposes of the Insurance Act, 1938 (4 of 1938), and the 5[Banking Regulations Act, 1949 (10 of 1949)].
6[13. Register of shareholders.— (1) The State Bank shall keep at its Central Office, a register, in one or more books of the shareholders, and shall enter therein the following particulars so far as they may be available:—
(i) the names, addresses and occupations, if any, of the shareholders and a statement of the shares held by each shareholder, distinguishing each share by its denoting number;
(ii) the date on which each person is so entered as a shareholder;
(iii) the date on which any person ceases to be a shareholder; and
(iv) such other particulars as may be prescribed.
7[Provided that nothing in this sub-section shall apply to the shares held with a depository.]
1. Ins. by Act 27 of 2010, s. 6 (w.e.f. 15-9-2010).
2. Subs. by Act 3 of 1994, s. 3, for section 11 (15-10-1993).
3. Subs. by Act 32 of 2007, s. 5, for “Reserve Bank” (w.e.f. 29-6-2007).
4. Ins. by Act 27 of 2010, s. 7 (w.e.f. 15-9-2010).
5. Subs. by Act 3 of 1994, s. 4, for “Banking Companies, 1949” (w.e.f. 15-10-1993).
6. Subs. by s. 13, ibid., for section 13 (w.e.f. 15-10-1993).
7. Ins. by Act 8 of 1997, s. 3 (w.e.f. 15-1-1997).
(2) Notwithstanding anything contained in sub-section (1), it shall be lawful for the State Bank to keep the register of shareholders 1[in computer floppies or diskettes or any other electronic form] subject to such safeguards as may be prescribed.
(3) Notwithstanding anything contained in the Indian Evidence Act, 1872 (1 of 1872), a copy of, or extract from, the register of shareholders, certified to be a true copy under the hand of an officer of the State Bank authorised in this behalf, shall, in all legal proceedings, be admissible in evidence.]
2[13A. Register of beneficial owners.— The register of beneficial owners maintained by a depository under section 11 of the Depositories Act, 1996 (22 of 1996), shall be deemed to be a register of shareholders for the purposes of this Act.]
14. [Branch registers.]Omitted by the State Bank of India (Amendment) Act, 1993 (3 of 1994), s. 6 (w.e.f. 15-10-1993).
3[15. Trusts not to be entered on the register of shareholders.— No notice of any trust, express, implied or constructive, shall be entered on the register of shareholders or be receivable by the State Bank.]
4[Provided that nothing in this section shall apply to a depository in respect of shares held by it as a registered owner on behalf of the beneficial owners.
Explanation.—For the purposes of section 13, section 13A and this section, the expressions “beneficial owner”, “depository” and “registered owner” shall have the meanings respectively assigned to them in clauses (a), (e) and (j) of sub-section (1) of section 2 of the Depositories Act, 1996 (22 of 1996).]
CHAPTER V MANAGEMENT
16. Offices, branches and agencies.— (1) Unless otherwise provided by the Central Government, by notification in the Official Gazette, the Central Office of the State Bank shall be at 5[Mumbai, and shall also be known as Corporate Centre].
(2) The State Bank shall have local head offices in 6[Mumbai, Kolkata and Chennai] and at such other places in India as the Central Government, in consultation with the Central Board, may determine.
(3) The State Bank shall maintain as its branches or agencies, all branches or agencies of the Imperial Bank which were in existence 7[in India] immediately before the appointed day, and no such branch may be closed without the previous approval of the Reserve Bank.
(4) The State Bank may establish branches or agencies at any place in or outside India in addition to the branches or agencies referred to in sub-section (3).
(5) Notwithstanding anything contained in sub-section (4), the State Bank shall establish not less than four hundred branches in addition to the branches referred to in sub-section (3) within five years of the appointed day or such extended period as the Central Government may specify in this behalf, and the places where such additional branches are to be established shall be determined in accordance with any such programme as may be drawn up by the Central Government from time to time in consultation with the Reserve Bank and the State Bank, and no branch so established shall be closed without the previous approval of the Reserve Bank.
17. Management.— (1) The general superintendence and direction of the affairs and business of the State Bank shall be entrusted to the Central Board which may exercise all powers and do all such acts and things as may be exercised or done by the State Bank and are not by this Act expressly directed or required to be done by the State Bank in general meeting.
1. Subs. by Act 27 of 2010, s. 8, for “in computer floppies or diskettes” (w.e.f. 15-9-2010).
2. Ins. by Act 8 of 1997, s. 4 (w.e.f. 15-1-1997).
3. Subs. by Act 3 of 1993, s. 7, for section 15 (w.e.f. 15-10-1993).
4. The proviso and Explanation ins. by Act 8 of 1997, s. 5 (w.e.f. 15-1-1997).
5. Subs. by Act 27 of 2010, s. 9, for “Bombay” (w.e.f. 15-9-2010).
6. Subs. by s. 9, ibid., for “Bombay, Calcutta and Madras” (w.e.f. 15-9-2010).
7. Ins. by Act 33 of 1955, s. 4 (w.e.f. 21-9-1955).
(2) The Central Board in discharging its functions shall act on business principles, regard being had to public interest.
18. Central Board to be guided by directions of Central Government.— (1) In the discharge of its functions 1*** the State Bank shall be guided by such directions in matters of policy involving public interest as the Central Government may, in consultation with the Governor of the Reserve Bank and the chairman of the State Bank, give to it.
(2) 2[All directions shall be given by the Central Government] and, if any question arises whether a direction relates to a matter of policy involving public interest, the decision of the Central Government thereon shall be final.
19. Composition of the Central Board.— 3*** The Central Board shall consist of the following, namely:
(a) a chairman 4*** to be appointed by the Central Government in consultation with the Reserve Bank 5***.
6[(b) such number of managing directors not exceeding four, as may be appointed by the Central Government in consultation with the Reserve Bank;]
7* * * * *
(c) if the total amount of the holdings of the shareholders, other than the 8[Central Government], whose names are on the 9[register of shareholders] three months before the date fixed for election of directors is—
(i) not more than ten per cent. of the total issued capital, two directors,
(ii) more than ten per cent. but not more than twenty-five per cent. of such capital three directors, and
(iii) more than twenty-five per cent. of such capital, four directors, to be elected in the prescribed manner by such shareholders;
10[(ca) one director, from among the employees of the State Bank, who are workmen, to be appointed by the Central Government in the manner provided in the rules made under this Act;
(cb) one director, from among such of the employees of the State Bank, as are not workmen, to be appointed by the Central Government in the manner provided in the rules made under this Act];
(d) not less than two and not more than six directors to be nominated by the Central Government 11***, from among persons having special knowledge of the working of co-operative institutions and of rural economy or experience in commerce, industry, banking or finance;]
(e) one director to be nominated by the Central Government; and
12[(f) one director, possessing necessary expertise and experience in matters relating to regulation or supervision of commercial banks to be nominated by the Central Government on the recommendation of the Reserve Bank.]
1. The words “including those relating to a subsidiary bank” omitted by Act 19 of 2018, s. 4 (w.e.f. 1-4-2017).
2. Subs. by Act 32 of 2007, s. 6, for “All directions given by the Central Government shall be given through the Reserve Bank” (w.e.f. 29-6-2007).
3. The brackets and figure “(1)” omitted by Act 3 of 1994, s. 8 (w.e.f. 15-10-1993).
4. Certain words omitted by Act 73 of 1976, s. 4 (w.e.f. 11-6-1976).
5. The words “and a vice-chairman” omitted by Act 27 of 2010, s. 10 (w.e.f. 15-9-2010).
6. Subs. by s. 10, ibid., for clause (b) (w.e.f. 15-9-2010). 7. Omitted by s. 10, ibid. (w.e.f. 15-9-2010).
8. Subs. by Act 32 of 2007, s. 7, for “Reserve Bank” (w.e.f. 29-6-2007).
9. Subs. by Act 3 of 1994, s. 8, for “Principal register” (w.e.f. 15-10-1993).
10. Ins. by Act 48 of 1973, s. 3 (w.e.f. 1-7-1974).
11. The words “in consultation with the Reserve Bank” omitted by Act 27 of 2010, s. 10 (w.e.f. 15-9-2010).
12. Subs. by s. 10, ibid., for clause (f) (w.e.f. 15-9-2010).
1* * * * *
2[19A. Qualifications for election of directors elected by shareholders.—(1) The directors elected under clause (c) of section 19 shall—
(a) have special knowledge or experience in respect of one or more of the following areas, namely:—
(i) agriculture and rural economy,
(ii) banking,
(iii) co-operation,
(iv) economics,
(v) finance,
(vi) law,
(vii) small-scale industry,
(viii) any other area the special knowledge of, and experience in, which in the opinion of the Reserve Bank shall be useful to the State Bank;
(b) represent the interests of depositors; or
(c) represent the interests of farmers, workers and artisans.
(2) Without prejudice to the provisions of sub-section (1) and notwithstanding anything to the contrary contained in this Act or in any other law for the time being in force, no person shall be eligible to be elected as director under clause (c) of section 19 unless he is a person having fit and proper status based upon track record, integrity and such other criteria as the Reserve Bank may notify from time to time in this regard and the Reserve Bank may specify in the notification issued under this sub-section, the authority to determine the fit and proper status, the manner of such determination, the procedure to be followed for such determinations and such other matters as may be considered necessary or incidental thereto.
(3) Where the Reserve Bank is of the opinion that any director of the State Bank elected under clause (c) of section 19 does not fulfil the requirements of sub-sections (1) and (2), it may, after giving to such director and the State Bank a reasonable opportunity of being heard, by order, remove such director.
(4) On the removal of a director under sub-section (3), the Central Board shall co-opt any other person fulfilling the requirements of sub-sections (1) and (2), as a director in place of the person so removed, till a director is duly elected by the shareholders of the State Bank in the next annual general meeting; and the person so co-opted shall be deemed to have been duly elected by the shareholders of the State Bank as a director.
19B. Power of Reserve Bank to appoint additional directors.— (1) If the Reserve Bank is of the opinion that in the interest of banking policy or in the public interest or in the interests of the State Bank or its depositors, it is necessary so to do, it may, from time to time and by order in writing appoint, with effect from such date as may be specified in the order, one or more persons as additional directors of the State Bank.
(2) Any person appointed as additional director under sub-section (1) shall,—
(a) hold office during the pleasure of the Reserve Bank and subject thereto for a period not exceeding three years or such further periods not exceeding three years at a time as the Reserve Bank may, by order, specify;
1. Sub-section (2) and (3) omitted by Act 35 of 1964, s. 3 (w.e.f. 1-12-1964).
2. Ins. by Act 27 of 2010, s. 11 (w.e.f. 15-9-2010).
(b) not incur any obligation or liability by reason only of his being an additional director or for anything done or omitted to be done in good faith in the execution of the duties of his office or in relation thereto; and
(c) not be required to hold qualification shares in the State Bank.
(3) For the purpose of reckoning any proportion of the total number of directors of the State Bank any additional director appointed under this section shall not be taken into account.]
20. Term of office of chairman, managing director, etc.— (1) 1[The chairman, 2*** and each managing director] shall hold office for such term not exceeding five years, as the Central Government may fix when appointing them and shall be eligible for reappointment.
3[(1A) Notwithstanding anything contained in sub-section (1), the Central Government shall have the right to terminate the terms of office of the chairman, 2*** or a managing director, as the case may be, at any time before the expiry of the term fixed under sub-section (1) by giving him notice of not less than three months in writing or three months’ salary and allowances in lieu of such notice; and the chairman, 2*** or a managing director, as the case may be, shall also have the right to relinquish his office at any time before the expiry of the term so fixed by giving to the Central Government notice of not less than three months in writing.]
4* * * * *
(3) Subject to the provisions contained in section 19 and 5*** a director elected under clause (c) 6*** of 7 [that section] shall hold office for 8 [three years] and 9*** 10 *** and shall be eligible for re- election 11***:
12[Provided that no such director shall hold office continuously for a period exceeding six years.]
13[(3A) 14[subject to the provisions contained in sub-section (4), a director] appointed under clause (ca) or clause (cb) 15[of section 19 or nominated under clause (d) of that section] shall hold office for such term, not exceeding three years, as the Central Government may specify 16*** and shall be eligible 17[for re appointment or re-nomination, as the case may be:]]
12[Provided that no such director shall hold office continuously for a period exceeding six years.]
18[(4) A director appointed under clause (ca) or clause (cb) 19[of section 19 or nominated under clause (d) or clause (e) or clause (f) of that section] shall hold office during the pleasure of the authority appointing or nominating him, as the case may be.]
1. Subs. by Act 73 of 1976, s. 4, for “The chairman and the vice-chairman” (w.e.f. 11-6-1976).
2. The words “, vice-chairman” omitted by Act 27 of 2010, s. 12 (w.e.f. 15-6-2010).
3. Ins. by Act 73 of 1976, s. 4 (w.e.f. 11-6-1976).
4. Omitted by s. 4, ibid. (w.e.f. 11-6-1976).
5. The words, brackets and figures “and in sub-section (5)” omitted by Act 66 of 1988, s.12 (w.e.f. 8-7-1992).
6. The words, brackets and figures “of sub-section (1)” omitted by Act 3 of 1994, s. 9 (w.e.f. 15-10-1993).
7. Subs. by Act 66 of 1988, s. 12, for certain words (w.e.f. 8-7-1992).
8. Subs. by s. 12, ibid., for “four years” (w.e.f. 8-7-1992).
9. The words “and thereafter until his successor shall have been duly elected” omitted by Act 45 of 2006, s. 14 (w.e.f. 16-10-2006).
10. The words “or nominated” omitted by Act 66 of 1988, s. 12 (w.e.f. 8-7-1992).
11. The words “or re nomination” omitted by s. 12, ibid. (w.e.f. 8-7-1992). 12. Ins. by s. 12, ibid. (w.e.f. 8-7-1992).
13. Ins. by Act 48 of 1973, s. 4 (w.e.f. 1-7-1974).
14. Subs. by Act 66 of 1988, s. 12, for “A director” (w.e.f. 8-7-1992).
15. Subs. by Act 3 of 1994, s. 9, for certain words (w.e.f. 15-10-1993).
16. The words “and thereafter until his successor shall have been duly appointed or nominated” omitted by Act 27 of 2010, s. 12 (w.e.f. 15-9-2010).
17. Subs. by Act 66 of 1988, s. 12, for certain words (w.e.f. 8-7-1992).
18. Subs. by s. 12, ibid., for sub-section (4) (w.e.f. 8-7-1992).
19. Subs. by Act 3 of 1994, s. 9, for certain words (w.e.f. 15-10-1993).
1* * * * *
2[21. Local Boards.— (1) There shall be constituted at each place where the State Bank has a local head office, a Local Board which shall consist of the following members, namely:—
3[(a) the chairman, ex officio or the managing director nominated by the chairman;]
4[(b) all such directors elected or nominated to the Central Board under clause (c) or clause (d) of section 19 as are ordinarily resident in the area falling within the jurisdiction of the local head office;]
(c) six members to be nominated by the Central Government 5***;
6* * * * *
(e) 7[the Chief General Manager] of the local head office, appointed by the State Bank, ex officio.
8[(2) Where as a result of the establishment of any local head office (hereinafter referred to as the new local head office) for any area which is already falling within the jurisdiction of another local head office (hereinafter referred to as the existing local head office) a Local Board (hereinafter referred to as the new Local Board) is constituted for the new local head office, any person who is, at the time of such Constitution, holding office as a member of a Local Board (hereinafter referred to as the existing Local Board) for an existing local head office under clause (c) of sub-section (1) and is ordinarily resident in the area falling within the jurisdiction of the new local head office, shall cease to hold office as member of the existing Local Board and shall become a member of the new Local Board and shall on becoming such member be deemed to have been nominated to the new Local Board and shall hold office as such member for the unexpired portion of his term of office as a member of the existing Local Board.]
(3) Any vacancy caused in the existing Local Board as a result of any member thereof becoming a member of the new Local Board under sub-section (2) shall be deemed to be a casual vacancy and be filled in accordance with the provisions of section 25.
9* * * * *
10[(5) The 11[Central Government] shall, in consultation with the chairman, appoint—
(a) a member of a Local Board nominated under clause (c) of sub-section (1) to be the president thereof; and
(b) a member of a Local Board holding office under clause (b) or nominated under clause (c) of that sub-section to be the vice-president thereof.]
12[21A. Term of office of members of Local Board.— 13[(1) Subject to the provisions contained in this section and in sub-section (2) of section 21, a member of a Local Board—
(a) nominated under clause (c) of sub-section (1) of section 21 shall hold office for such term, not exceeding three years, as the Central Government may specify in this behalf 14***;
1. Omitted by Act 66 of 1988, s. 12 (w.e.f. 8-7-1992).
2. Subs. by Act 35 of 1964, s. 5, for section 21 (w.e.f. 1-12-1974).
3. Subs. by Act 27 of 2010, s. 13, for clause (a) (w.e.f. 15-9-2010).
4. Subs. by Act 3 of 1994, s. 10, for clause (b) (w.e.f. 15-10-1993).
5. The words “in consultation with the Reserve Bank” omitted by Act 27 of 2010, s. 13 (w.e.f. 15-9-2010).
6. Omitted by Act 3 of 1994, s. 10(w.e.f. 15-10-1993).
7. Subs. by Act 48 of 1973, s. 5, for “the Secretary and Treasurer” (w.e.f. 1-7-1974).
8. Subs. by Act 3 of 1994, s. 10, for sub-section (2) (w.e.f. 15-10-1993).
9. Omitted by s. 10, ibid. (w.e.f. 15-10-1993).
10. Subs. by s. 10, ibid., for sub-section (5) (w.e.f. 15-10-1993).
11. Subs. by Act 27of 2010, s. 13, for “Governor of the Reserve Bank” (w.e.f. 15-9-2010).
12. Ins. by Act 35 of 1964, s. 6 (w.e.f. 1-12-1964).
13. Subs. by Act 66 of 1988, s. 13, for sub-section (1) (w.e.f. 15-10-1993).
14. The words “and thereafter until his successor has been duly nominated” omitted by Act 45 of 2006, s. 15 (w.e.f. 16-10-2006).
(b) elected under clause (d) of sub-section (1) of section 21 shall hold office for three years and 1***, and shall be eligible for re-nomination or re-election, as the case may be:
Provided that no such director shall hold office continuously for a period exceeding six years.]
2* * * * *
(3) A director of the Central Board becoming a member of a Local Board by virtue of the provisions of clause (b) of sub-section (1) of section 21 shall cease to hold office as such member on his ceasing to be a director or on his ceasing to be ordinarily resident in the relevant area.
(4) The president and the vice-president of a Local Board shall each hold office for two years or the remaining period of his office as a member of the Local Board, whichever is shorter, and shall be eligible for re-appointment so long as he is a member of the Local Board.
3[(5) A member of a Local Board nominated under clause (c) of sub-section (1) of section 21 shall hold office during the pleasure of the Central Government.]
4[21B. Powers of Local Board.— In respect of the area falling within the jurisdiction of the local head office for which the Local Board has been constituted, a Local Board shall, subject to such general or special direction as the Central Board may give from time to time, exercise such powers and perform such duties and functions as may be entrusted or delegated to it by the Central Board.]
21C. Local Committees.—5[(1) A Local Committee may be constituted by the Central Board for any area and shall consist of such number of members as may be prescribed.
6[(2) The chairman or the managing director nominated by him shall be an ex officio member of every such Local Committee.]
(3) A Local Committee shall exercise such powers and perform such functions and duties as the Central Board may confer on or assign to it.]
22. Disqualifications for directorship of Central Board or membership of Local Boards or Committees.— (1) No person shall be qualified to be a director of the Central Board or a member of a Local Board or of a Local Committee if—
(a) he holds the office of director, provisional director, promoter, agent or manager of any banking company already established or advertised as about to be established; or
(b) he is a salaried officer of Government not specially authorised by the Central Government to be a director or member; or
(c) he has been removed or dismissed from the service of Government on a charge of corruption or bribery; or
(d) he holds any office of profit under the State Bank other than the office of chairman, 7*** 8[managing director] or 9[ 10[Chief General Manager or legal or technical adviser]]; or
1. The words “and thereafter until his successor has been duly nominated” omitted by Act 45 of 2006, s. 15 (w.e.f. 16-10-2006).
2. Omitted by Act 3 of 1994, s. 11 (w.e.f. 15-10-1993).
3. Ins. by Act 66 of 1988, s. 13 (w.e.f. 8-7-1992).
4. Subs. by Act 27 of 2010, s. 14, for section 21B (w.e.f. 15-9-2010).
5. Ins. by Act 35 of 1964, s.6 (w.e.f. 1-12-1964).
6. Subs. by Act 27 of 2010, s. 15, for sub-section (2) (w.e.f. 15-9-2010).
7. The word “vice-chairman” omitted by s. 16, ibid. (w.e.f 15-9-2010).
8. Subs. by Act 26 of 1959, s. 2, for “or managing director” (w.e.f. 11-6-1976).
9. Ins. by Act 35 of 1964, s. 7 (w.e.f. 1-12-1964).
10. Subs. by Act 48 of 1973, s. 7, for “secretary and treasurer” (w.e.f. 26-6-1974).
1[(da) in the case of a director appointed under clause (ca) or clause (cb) 2*** of section 19,—
(i) he is not serving in the State Bank or has not been serving in it for a continuous period of at least five years; and
(ii) he is of such age that there is a likelihood of his attaining the age of superannuation during his term of office as a director; or]
(e) he is or at any time has been adjudicated an insolvent or has suspended payment of his debts or has compounded with his creditors; or
(f) he is declared lunatic or becomes of unsound mind; or
(g) he is or has been convicted of any offence involving moral turpitude; or
3[(h) in the case of an elected director, he is not registered as a holder in his own right of unencumbered shares in the State Bank, either as sole holder or as first named holder when jointly held, of a nominal value of at least five thousand rupees.]
(2) No two persons who are partners of the same firm or are directors of the same private company or one of whom is an agent of the other or holds a power of attorney from a firm of which the other is a partner may be directors of the Central Board or members of the same Local Board or Local Committee at the same time.
(3) The appointment, nomination or election as director or member of a Local Board or of a Local Committee of any person who is a member of Parliament or the Legislature, of any State shall be void unless within two months of the date of his appointment, nomination or election he ceases to be a member of Parliament or the State Legislature, and if any director or member of a Local Board or of a Local Committee is elected or nominated as a member of Parliament or any State Legislature, he shall cease to be a director or member of the Local Board or of Local Committee as from the date of such election or nomination, as the case may be.
4[(4) In this section,—
(a) “banking company” has the same meaning as in the 5 [Banking Regulation Act, 1949 (10 of 1949)];
(b) “manager” means the chief executive officer, by whatever name called, of a Banking company;
(c) “private company” has the same meaning as in the Companies Act, 1956 (1 of 1956)].
23 .Vacation of office of directors, etc.—If a director of the Central Board or a member of a Local Board or a Local Committee—
(a) becomes subject to any of the disqualifications mentioned in section 22; or
(b) resigns his office by giving notice in writing under his hand, in the case of the 6[chairman 7*** and amanaging director] to the Central Government and in the case of other directors or members of Local Boards or Committees, to the Central Board, and the resignation is accepted; or
(c) is absent without leave of the Central Board, the Local Board or the Local Committee of which he is a director or member, as the case may be, for more than three consecutive meetings thereof;
his seat shall thereupon become vacant.
1. Ins. by Act 48 of 1973, s. 7 (w.e.f. 26-6-1974).
2. The words, brackets and figure “of sub-section (1)” omitted by Act 3 of 1994, s. 13 (w.e.f. 15-10-1993).
3. Subs. by Act 27 of 2010, s. 16, for clause (h) (w.e.f. 15-9-2010).
4. Ins. by Act 26 of 1959, s. 2 (w.e.f. 28-8-1959).
5. Subs. by Act 3 of 1994, s. 13, for “Banking Companies Act, 1949” (w.e.f. 15-10-1993).
6. Subs. by Act 73 of 1976, s. 4, for “the chairman and vice-chairman” (w.e.f. 11-6-1976).
7. The word “, vice-chairman” omitted by Act 27 of 2010, s. 17 (w.e.f. 15-9-2010).
1[Provided that nothing in clause (c) shall apply to the chairman in relation to his membership of a Local Board or of a Local Committee.]
24. Removal from office of directors, etc.— (1) The Central Government may, after consulting the Reserve Bank, remove from office 2[the chairman 3*** or a managing director.]
4* * * * *
(3) The Central Government, 5*** may remove from office any director6[appointed under clause (ca) or clause (cb) or nominated under clause(d) 7[of section 19] 8[or any member of a Local Board nominated under clause (c) of sub-section (1) of section 21] and 9[appoint or nominate, as the case may be], in his stead another person to fill the vacancy.
(4) The shareholders, other than the 10[Central Government], may, by a resolution passed by majority, of the votes of such shareholders holding in the aggregate not less than one-half of the share capital held by all such shareholders, remove any director elected under clause (c) 11***of section 19 and elect in his stead another person to fill the vacancy.
12* * * * *
(6) No person shall be removed from his office under sub-section (1) 13*** or sub-section (3) unless he has been given an opportunity of showing cause against his removal.
14[24A. Supersession of Central Board in certain cases.— (1) Where the Central Government, on the recommendation of the Reserve Bank is satisfied that in the public interest or for preventing the affairs of the State Bank being conducted in a manner detrimental to the interest of the depositors or the State Bank or for securing the proper management of the State Bank, it is necessary so to do, the Central Government may, for reasons to be recorded in writing, by order, supersede the Central Board for a period not exceeding six months as may be specified in the order:
Provided that the period of supersession of the Central Board may be extended from time to time, so, however, that the total period shall not exceed twelve months.
(2) On supersession of the Central Board under sub-section (1), the Central Government may, in consultation with the Reserve Bank, appoint an Administrator (not being an officer of the Central Government or a State Government) who has experience in law, finance, banking, economics or accountancy, for such period as it may determine.
(3) The Central Government may issue such directions to the Administrator as it may consider necessary and the Administrator shall be bound to follow such directions.
(4) Notwithstanding anything contained in this Act, upon making the order of supersession of the Central Board—
(a) the chairman, managing director and other directors shall, as from the date of supersession, vacate their offices as such;
(b) all the powers, functions and duties which may, by or under the provisions of this Act or any other law for the time being in force, be exercised and discharged by or on behalf of the Central Board, or by a resolution passed in the general meeting of the State Bank, shall, until the Central
1. The proviso added by Act 21 of 1957, s. 3 (w.e.f. 11-6-1976).
2. Subs. by Act 73 of 1976, s. 4, for “the chairman or the vice-chaiman” ( w.e.f. 11-6-1976).
3. The word “, vice-chairman” omitted by Act 27 of 2010, s. 18 (w.e.f. 15-9-2010).
4. Omitted by Act 73 of 1976, s. 4 (w.e.f. 11-6-1976).
5. The words “after consulting the Reserve Bank,” omitted by Act 27 of 2010, s. 18 (w.e.f. 15-9-2010).
6. Subs. by Act 48 of 1973, s. 8, for “nominated under clause (d)” (w.e.f. 1-7-1974).
7. Subs. by Act 3 of 1994, s. 14, for “sub-section (1) of section 19” (w.e.f. 15-10-1993).
8. Ins. by Act 35 of 1964, s. 8 (w.e.f. 1-12-1964).
9. Subs. by Act 48 of 1973, s. 8 for “nominate” (w.e.f. 1-7-1974).
10. Subs. by Act 32 of 2007, s. 8, for “Reserve Bank” (w.e.f. 29-6-2007).
11. Certain words omitted by Act 3 of 1994, s. 14 (w.e.f. 15-10-1993).
12. Omitted by s. 14, ibid. (w.e.f. 15-10-1993).
13. The words, bracket and figure “or sub-section (2)” omitted by Act 73 of 1976, s. 4 (w.e.f. 11-6-1976).
14. Ins. by Act 27 of 2010, s. 19 (w.e.f. 15-9-2010).
Board is reconstituted, be exercised and discharged by the Administrator appointed under sub-section (2):
Provided that the powers exercised by the Administrator shall be valid notwithstanding that such power is also exercisable by a resolution passed in the general meeting of the State Bank.
(5) The Central Government may, in consultation with the Reserve Bank, constitute a committee of three or more persons who have experience in law, finance, banking, economics or accountancy to assist the Administrator in the discharge of his duties.
(6) The committee shall meet at such times and places and observe such rules of procedure as may be specified by the rules made under this Act.
(7) The salary and allowances of the Administrator and the members of the committee shall be such as may be specified by the rules made under this Act and be payable by the State Bank.
(8) On and before the expiration of two months before the expiry of the period of supersession of the Central Board, the Administrator of the State Bank shall call the general meeting of the State Bank to elect new directors and re-constitute the said Board.
(9) Notwithstanding anything contained in any other law for the time being in force or in any contract, no person shall be entitled to claim any compensation for the loss or termination of his office on supersession of the Central Board.
(10) The Administrator appointed under sub-section (2) shall vacate office immediately after the re-constitution of the Central Board.]
25. Casual vacancies.— 1[(1) If the chairman, 2*** or a managing director is rendered incapable of discharging his duties by reason of infirmity or otherwise or is absent on leave or otherwise in circumstances not involving the vacation of his office, the Central Government may, in consultation with the Reserve Bank, appoint another person to officiate in the vacancy.]
3[(2) Where any vacancy occurs before the expiry of the term of office of a director, other than the Chairman, 2*** or a managing director or 4[a director appointed under clause (ca) or 5[clause (cb) of section 19 or of a member of a Local Board other than the Chief General Manager] the vacancy shall be filled—
(a) in the case of an elected director, by election; and
(b) in the case of a director nominated under clause (d) of section 19 or a member of a Local Board nominated under clause (c) of sub-section (1) of section 21, by nomination 6***:
Provided that where the duration of the vacancy in the office of an elected director is likely to be less than six months, the vacancy may be filled by the remaining directors] by co-opting a person not disqualified under section 22.]
(3) A person elected or nominated or co-opted, as the case may be, 7[under sub-section (2)] shall hold office for the unexpired portion of the term of his predecessor.
8[(4) Where any vacancy occurs before the expiry of the term of office of a director appointed under clause (ca) or clause (cb) 9*** of section 19, such vacancy shall be filled in accordance with the said clause (ca) or as the case may be, clause (cb), and the director so appointed shall hold office for the period specified under sub-section (3A) of section 20.]
1. Subs. by Act 73 of 1976, s. 4, for sub-section (1) w.e.f. 11-6-1976).
2. The word “, vice-chairman” omitted by Act 27 of 2010, s. 20 (w.e.f. 15-9-2010).
3. Subs. by Act 35 of 1964, s. 9, for sub-section (2) (w.e.f. 1-12-1964).
4. Subs. by Act 48 of 1973, s. 9, for certain words (w.e.f. 1-7-1974).
5. Subs. by Act 3 of 1994, s. 15, for certain words, brackets, letters and figure (w.e.f. 15-10-1993).
6. The words “in consultation with the Reserve Bank” omitted by Act 27 of 2010, s. 20 (w.e.f. 15-9-2010).
7. Subs. by Act 48 of 1973, s. 9, for “under this section” (w.e.f. 1-7-1974).
8. Ins. by s. 9, ibid. (w.e.f. 1-7-1974).
9. The words, brackets and figure “by sub-section (1)” omitted by Act 3 of 1994, s. 15 (w.e.f. 15-10-1993).
26. Remuneration of directors.— (1) Without prejudice to the provisions contained in sections 27, 28 and 29, the directors shall be paid such fees and allowances for attending the meetings of the Central Board or of any of its Committees and for attending to any other work of the State Bank as may be prescribed.
(2) Notwithstanding anything contained in sub-section (1), no fees shall be payable to a managing director or any other director who is an officer of the Central Government or the Reserve Bank.
27. Powers and remuneration of chairman.— (1) The Chairman shall preside at all meetings of the Central Board and subject to such general or special directions as the Central Board may give, exercise all such powers and do all such acts and things as may be exercised or done by the State Bank.
(2) The chairman shall receive such salary, fees, allowances and perquisites1[as may be determined by the Central Government].
2* * * * *
28. [Powers and remuneration of vice-chairman.] Omitted by the State Bank of India (Amendment) Act, 2010 (27 of 2010), s. 21 (w.e.f. 15-9-2010).
29. Powers and remuneration of managing director.—(1) A managing director—
(a) shall be a whole-time officer of the State Bank; 3***
(b) subject to the general control of the chairman 4***, shall exercise such powers and perform such duties as may be entrusted or delegated to him by the Central Board 5[; and]
5[(c) when authorised by the chairman, shall preside at the meetings of the Central Board in his absence.]
(2) A managing director shall receive such salary and allowances6[as may be determined by the Central Government].
7* * * * *
30. Executive and other committees of the Central Board.— The Central Board may constitute such and so many committees, including an executive committee, of itself as it deems fit to exercise such powers and perform such duties as may, subject to such conditions, if any, as the Central Board may impose, be delegated to them by the Central Board.
31. Meetings of the Central Board.— 8[(1) The Central Board shall meet at such time and place and shall observe such rules of procedure in regard to the transaction of business at its meetings as may be prescribed; and the meeting of the Central Board may be held by participation of the directors of the Central Board through videoconferencing or such other electronic means, as may be prescribed, which are capable of recording and recognising the participation of the directors and the proceedings of such meetings are capable of being recorded and stored:
Provided that the Central Government may in consultation with the Reserve Bank, by notification in the Official Gazette, specify the matters which shall not be discussed in a meeting of the Central Board held through videoconferencing or such other electronic means.
(2) All questions at the meeting shall be decided by a majority of the votes of the directors present in the meeting or through videoconferencing or such other electronic means and in the case of equality of votes the chairman or, in his absence, the managing director authorised by the chairman shall have a second or casting vote.]
1. Subs. by Act 73 of 1976, s. 4, for certain words (w.e.f. 11-6-1976).
2. The proviso omitted by s. 4, ibid. (w.e.f. 11-6-1976).
3. The word “and” omitted by Act 27 of 2010, s. 22 (w.e.f. 15-9-2010).
4. The words “and the vice-chairman” omitted by s. 22, ibid. (w.e.f. 15-9-2010). 5. Ins. by s. 22, ibid. (w.e.f. 15-9-2010).
6. Subs. by Act 73 of 1976, s. 4, for certain words (w.e.f. 11-6-1976).
7. The proviso omitted by s. 4, ibid. (w.e.f. 11-6-1976).
8. Subs. by Act 27 of 2010, s. 23, for sub-section (1) and (2) (w.e.f. 15-9-2010).
(3) A director who is directly or indirectly concerned or interested in any contract, loan, arrangement or proposal entered into or proposed to be entered into by or on behalf of the State Bank shall at the earliest possible opportunity disclose the nature of his interest to the Central Board and shall not be present at any meeting of the Central Board when any such contract, loan, arrangement or proposal is discussed unless his presence is required by the other directors for the purpose of eliciting information, and no director so required to be present shall vote on any such contract, loan, arrangement or proposal.
1[Provided that nothing contained in this sub-section shall apply to such director by reason only of his being—
(i) a shareholder (other than a director) holding not more than two per cent. of the paid-up capital in any public company as defined in the Companies Act, 1956 (1 of 1956) or any corporation established by or under any law for the time being in force in India or any co-operative society with which or to which the State Bank has entered into or made, or proposes to enter into or make, a contract, loan, arrangement or proposal; or
(ii) a director ex officio of the State Bank 2***,3[or]]
4[(iii) an officer or other employee of the State Bank, if he is a director appointed under clause(ca) or clause (cb) 5*** of section 19.]
(4) If for any reason neither the chairman nor the vice-chairman is able to be present at a meeting of the Central Board, any director, 6***authorised by the chairman in writing in this behalf, and in the absence of such authorisation, 7[any director] elected by the directors present from amongst themselves, shall preside at the meeting and, in the event of equality of votes, shall have a second or casting vote.
8[31A. Meetings of Local Boards.— (1) A Local Board shall meet at such time and place and shall observe such rules of procedure in regard to the transaction of business at its meetings as may be prescribed.
(2) All questions at the meeting shall be decided by a majority of the votes of the members present and in the case of equality of votes, the person presiding at the meeting shall have a second or casting vote.
(3) A member who is directly or indirectly concerned or interested in any contract, loan, arrangement or proposal entered into or proposed to be entered into by or on behalf of the State Bank, shall, at the earliest possible opportunity, disclose the nature of his interest to the Local Board and shall not be present at any meeting of the Local Board when any such contract, loan, arrangement or proposal is discussed unless his presence is required by the other members for the purpose of eliciting information, and no member so required to be present shall vote on any such contract, loan, arrangement or proposal:
Provided that nothing contained in this sub-section shall apply to such member by reason only of his being—
(i) a shareholder (other than a director) holding not more than two per cent. of the paid-up capital in any public company as defined in the Companies Act, 1956 (1 of 1956), or any corporation established by or under any law for the time being in force in India or any co-operative society, with which or to which the State Bank has entered into or made or proposes to enter into or make, a contract, loan, arrangement or proposal; or
(ii) a director ex officio of the State Bank 9***.
1. Ins. by Act 56 of 1962, s. 2 (w.e.f. 1-1-1963).
2. The words “or a director of a subsidiary bank” omitted by Act 19 of 2018, s. 5 (w.e.f. 1-4-2017). 3. Added by Act 48 of 1973, s. 10 (w.e.f. 1-7-1974).
4. Ins. by s. 10, ibid. (w.e.f. 26-6-1976).
5. The words, brackets and figure “of sub-section (1)” omitted by Act 3 of 1994, s. 16 (w.e.f. 15-10-1993).
6. The words “, other than a managing director” omitted by Act 48 of 1973, s. 10 (w.e.f. 1-7-1974).
7. Subs. by s. 10, ibid., for “any such director” (w.e.f. 1-7-1974). 8. Ins. by Act 35 of 1964, s. 10 (w.e.f. 1-2-1964).
9. The words “or a director of a subsidiary bank” omitted by Act 19 of 2018, s. 6 (w.e.f. 1-4-2017).
(4) If for any reason neither the president nor the vice-president is able to be present at a meeting of the Local Board, any member,1[other than the Chief General Manager] elected by the members present from amongst themselves, shall preside at the meeting.
(5) Notwithstanding anything contained in this section, the chairman shall preside at any meeting of a Local Board at which he is present and in the absence of the chairman, 2[the managing director authorised by the chairman], shall, whenever he is present, preside at such meetings.]
CHAPTER VI BUSINESS OF THE STATE BANK
32. State Bank to act as agent of the Reserve Bank.— (1) The State Bank shall, if so required, by the Reserve Bank, act as agent of the Reserve Bank at all places in India where it has a branch 3*** and where there is no branch of the banking department of the Reserve Bank, for—
(a) paying, receiving, collecting and remitting money, bullion and securities on behalf of any Government in India; and
(b) undertaking and transacting any other business which the Reserve Bank may from time to time entrust to it.
(2) The terms and conditions on which any such agency business shall be carried on by the State Bank on behalf of the Reserve Bank shall be such as may be agreed upon.
(3) If no agreement can be reached on any matter referred to in sub-section (2) or if a dispute arises between the State Bank and the Reserve Bank as to the interpretation of any agreement between them, the matter shall be referred to the Central Government and the decision of the Central Government thereon shall be final.
(4) The State Bank may transact any business or perform any functions entrusted to it under sub-section (1) 4[by itself 5***] or through an agent approved by the Reserve Bank.
6 [33. Other business which the State Bank may transact.— Subject to the other provisions contained in this Act, the State Bank may carry on and transact the business of banking as defined in clause (b) of section 5 of the Banking Regulation Act, 1949 (10 of 1949), and may engage in one or more of the other forms of business specified in sub-section (1) of section 6 of that Act.]
34. Business which the State Bank may not transact.— 7***.
(6) Save as otherwise provided in 8[this Act] the State Bank shall not own or, acquire any 9*** immovable property except for the purpose of providing buildings or other accomodation in which to carry on the business of the State Bank or for providing residences for its officers and other employees:
Provided that if any such building or other accommodation is not immediately required for any of the purposes of the State Bank, the State Bank may utilise it to the best advantage by letting it out or in any other manner.
35. State Bank may acquire the business of other Banks.— (1) The State Bank may, with the sanction of the Central Government, and shall, if so directed by the Central Government in consultation with the Reserve Bank, enter into negotiations for acquiring the business, including the assets and liabilities, of any banking institution.
1. Subs. by Act 48 of 1973, s. 11, for certain words (w.e.f. 1-7-1974).
2. Subs. by Act 27 of 2010, s. 24, for “the vice-chairman, if he is a member of the Local Board” (w.e.f. 15-9-2010).
3. The words “or where there is a branch of a subsidiary bank” omitted by Act 19 of 2018, s. 7 (w.e.f. 1-4-2017).
4. Subs. by Act 38 of 1954, s. 64 and the Third Schedule, for “either by itself” (w.e.f. 10-9-1959).
5. The words “or through a subsidiary bank” omitted by Act 19 of 2018, s. 7 (w.e.f. 1-4-2017). 6. Subs. by Act 48 of 1973, s. 12, for section 33 (w.e.f. 1-3-1977).
7. Sub-sections (1), (2), (3) or (5) omitted by s. 13, ibid. (w.e.f. 1-3-1977).Earlier sub-section (3) was substituted for sub-sections (3) or (4) by Act 29 of 1959, s. 5 (w.e.f. 1-3-1977).
8. Subs. by Act 56 of 1962, s.2, for “section 33” (w.e.f. 1-1-1963).
9. The words “interest in” omitted by s. 2, ibid. (w.e.f. 1-1-1963).
1[(2) The terms and conditions relating to such acquisition, if agreed upon by the Central Board of the State Bank and the directorate or management of the banking institution concerned and approved by the Reserve Bank, shall be submitted to the Central Government for its sanction and that Government may by order in writing (hereafter in this section referred to as the order of sanction) accord its sanction thereto.
(3) Notwithstanding anything contained in this Act or any other law for the time being in force or any instrument regulating the constitution of the banking institution concerned, the terms and conditions as sanctioned by the Central Government shall come into effect on the date specified by the Central Government in this behalf in the order of sanction and be binding upon the State Bank and the banking institution concerned as well as upon the shareholders (or, as the case may be, proprietors) and creditors of that banking institution.
(4) If for any reason the terms and conditions cannot come into effect on the date specified in the order of sanction, the Central Government may fix another suitable date for that purpose.
(5) On the date on which the terms and conditions as aforesaid come into effect the business and the assets and liabilities of the banking institution concerned as covered by the acquisition shall, by virtue, and in accordance with the provisions, of the order of sanction stand transferred to, and become respectively the business and the assets and liabilities of, the State Bank.
(6) The consideration for the acquisition of the business and the assets and liabilities of any banking institution under this section may, if so agreed upon, be paid either in cash or by allotment of shares in the capital of the State Bank or partly in cash and partly by allotment of shares, and the State Bank may, for the purpose of any such allotment, increase, subject to the other provisions contained in this Act relating to the increase of capital, the capital of the State Bank by the issue of such number of shares as may be determined by the State Bank.
(7) Any business acquired under this section shall thereafter be carried on by the State Bank in accordance with the provisions of this Act, subject to such exemptions or modifications as the Central Government may, by notification in the Official Gazette, make in this behalf in consultation with the Reserve Bank:
Provided that no such exemption or modification shall be made so as to have effect for a period of more than seven years from the date of acquisition.
(8) Notwithstanding anything contained in the Industrial Disputes Act, 1947 (14 of 1947), or in any other law or in any agreement for the time being in force, on the acquisition of the business and the assets and liabilities of any banking institution under this section, no officer or other employee of that banking institution shall be entitled to any compensation to which he may be entitled under that Act or that other law or that agreement and no claim in respect of such compensation shall be entertained by any Court, Tribunal or other authority, if on his having accepted in writing an offer of employment by the State Bank on the terms and conditions proposed by it he has been employed in accordance with such terms and conditions.
(9) The Central Government may, if it considers necessary or expedient in the case of any banking institution in relation to which an order of sanction has been made under this section, appoint whether before or after the coming into effect of the terms and conditions relating to the acquisition of the business and the assets and liabilities of that banking institution, a suitable person to take over the management of that banking institution for the purposes of winding up its affairs and distributing its assets, and the expenditure incurred in connection with such management (including the remuneration for the person so appointed and his staff, if any) shall be paid out of the assets of the banking institution or by the State Bank as the Central Government may direct.
(10) Simultaneously with the appointment of a suitable person to take over the management of any banking institution under sub-section (9) or immediately thereafter, the Central Government shall issue directions to be followed by that person in the management of that banking institution for the purposes aforesaid and thereupon—
1. Subs. by Act 26 of 1959, s. 6, for sub-sections (2), (3) and (4) (w.e.f. 28-8-1959).
(a) the provisions of the Companies Act, 1956 (1 of 1956), or the 1[Banking Regulation Act, 1949 (10 of 1949),] or any other law for the time being in force or any instrument having effect by virtue of any such Act or law, in so far as they are inconsistent with such directions, shall cease to apply to or in relation to that banking institution;
(b) all persons in charge of the management, including any person holding office as manager or director of the banking institution immediately before the issue of such directions, shall be deemed to have vacated their offices as such; and
(c) the persons appointed to take over the management of the banking institution shall in accordance with those directions take all such steps as may be necessary to facilitate the winding up of its affairs and distribution of its assets.
(11) The Central Government, when satisfied that nothing further remains to be done in order to wind up the affairs of any such banking institution, may by another order in writing direct that as from such date as may be specified therein the banking institution shall stand dissolved and thereupon any such direction shall have effect notwithstanding anything to the contrary contained in any other law.
(12) No action under this section shall be questioned on the ground merely of any defect in the constitution of any banking institution in relation to which such action has been taken or in the constitution of its Board of Directors or in the appointment of any person entrusted with the management of its affairs.
(13) In this section “banking institution” includes any individual or any association of individuals (whether incorporated or not, or whether a department of Government or a separate institution), carrying on the business of banking.]
2[35A. Arrangement with the State Bank on appointment of directors to prevail.— (1) Where any arrangement entered into by the State Bank with a company provides for the appointment by the State Bank of one or more directors of such company, such provisions and any appointment of directors made in pursuance thereof shall be valid and effective notwithstanding anything to the contrary contained in the Companies Act, 1956 (1 of 1956), or in any other law for the time being in force or in the memorandum, articles of association or any other instrument relating to the company, and any provision regarding share qualification, age limit, number of directorships, removal from office of directors and such like conditions contained in any such law or instrument aforesaid, shall not apply to any director appointed by the State Bank in pursuance of the arrangement as aforesaid.
(2) Any director appointed as aforesaid shall—
(a) hold office during the pleasure of the State Bank and may be removed or substituted by any person by order in writing of the State Bank;
(b) not incur any obligation or liability by reason only of his being a director or for anything done or omitted to be done in good faith in the discharge of his duties as a director or anything in relation thereto;
(c) not be liable to retirement by rotation and shall not be taken into account for computing the number of directors liable to such retirement.]
CHAPTER VII FUNDS, ACCOUNTS AND AUDIT
36. Integration and Development Fund.— (1) The State Bank shall maintain a special fund to be known as the Integration and Development Fund into which shall be paid—
1. Subs. by Act 3 of 1994, s. 17, for “Banking Companies Act, 1949” (w.e.f. 15-10-1993).
2. Ins. by Act 1 of 1984, s. 43 (w.e.f. 15-2-1984).
(a) the dividends payable to the 1[Central Government] on such shares of the State Bank held by it as do not exceed fifty-five per cent. of the total issued capital; and
(b) such contributions as the 2*** the Central Government may make from time to time.
3[Provided that if the balance in the Integration and Development Fund on the date of declaration of any dividends by the State Bank is rupees five crores or more, no amount shall be paid into that Fund under clause (a) and the dividends payable to the 1[Central Government] shall be 4 [paid to that Government], and if such balance on such date is less than rupees five crores, only so much of dividends then payable as will bring such balance to rupees five crores shall be paid into that Fund and the balance of such dividends shall be paid to the 1[Central Government].]
(2) The amount in the said Fund shall be applied exclusively for meeting—
(a) losses in excess of such yearly sum as may be agreed upon between the 1[Central Government] and the State Bank and attributable to the branches established in pursuance of sub-section (5) of section 16;
5***
6* * * * * *
(b) such other losses or expenditure as may be approved by the Central Government in consultation with the Reserve Bank.
(3) Subject to the provisions of sub-section (2), the said Fund shall be the property, of the 1[Central Government] and no shareholder of the State Bank or any other person shall have any claim to the amount held in the said Fund.
7[(4) No amount applied for any of the purposes specified in sub-section (2) shall, for the purposes of the 8[Income-tax Act, 1961 (43 of 1961)], be treated as income, profits or gains of the State Bank.]
37. Reserve Fund.— The State Bank shall establish a Reserve Fund which shall consist of—
(a) the amount held in the Reserve Fund of the Imperial Bank transferred to the State Bank on the appointed day; and
(b) such further sums as may be transferred to it by the State Bank out of its annual net profits before declaring a dividend.
38. Disposal of profits.— (1) After making provision for bad and doubtful debts, depreciation in assets, equalisation of dividends, contribution to staff and superannuation funds and for all other matters for which provisions is necessary by or under this Act or which are usually provided for by banking companies, the State Bank may, out of its net profits, declare a dividend.
(2) Subject to the provisions of paragraph 6 of the First Schedule, the rate of dividend shall be determined by the Central Board.
9[38A. Transfer of unpaid or unclaimed dividend.— (1) Where, after the commencement of the State Bank of India (Amendment) Act, 2010 (27 of 2010), a dividend has been declared by the State Bank but which has not been paid to a shareholder or claimed by any shareholder entitled to it, within thirty days from the date of declaration, the State Bank shall, within seven days from the date of expiry of the said period of thirty days, transfer the total amount of dividend which remains unpaid, or unclaimed, to a special account to be named, the “unpaid dividend account” maintained by it.
1. Subs. by Act 32 of 2007, s. 9, for “Reserve Bank” (w.e.f. 29-6-2007).
2. The words “the Reserve Bank or” omitted by s. 9, ibid. (w.e.f. 29-6-2007).
3. The proviso added by Act 35 of 1964, s. 12 (w.e.f. 1-12-1964).
4. Subs. by Act 32 of 2007, s. 9, for “paid to that Bank” (w.e.f. 29-6-2007).
5. The word “and” omitted by Act 38 of 1959, s. 64 and the Third Schedule (w.e.f. 10-9-1959).
6. Clause (aa) omitted by Act 19 of 2018, s. 8 (w.e.f. 1-4-2017).
7. Ins. by Act 26 of 1959, s. 7 (w.e.f. 28-8-1959).
8. Subs. by Act 3 of 1994, s. 18, for “Indian Income-tax Act, 1922 (11 of 1922)” (w.e.f. 15-10-1993).
9. Ins. by Act 27 of 2010, s. 25 (w.e.f. 15-9-2010).
Explanation.— In this sub-section, the expression “dividend which remains unpaid” means any dividend the warrant in respect thereof has not been encashed or which has otherwise not been paid or claimed.
(2) Where the whole or any part of any dividend, declared by the State Bank before the commencement of the State Bank of India (Amendment) Act, 2010 (27 of 2010), remains unpaid at such commencement, the State Bank shall, within a period of six months from such commencement, transfer such unpaid amount to the account referred to in sub-section (1).
(3) Any money transferred to the unpaid dividend account of the State Bank, in pursuance of this section which remains unpaid or unclaimed for a period of seven years from the date of such transfer shall be transferred by the State Bank to the Investor Education and Protection Fund established under sub- section (1) of section 205C of the Companies Act, 1956 (1 of 1956) for being utilised for the purpose and in the manner specified in that section.]
39. Books to be balanced each year.— The Central Board shall cause the books of the State Bank to be closed, and balanced 1[as] on the 31st day of 2[March] 3[or such other date in each year as the Central Government may, by notification in the Official Gazette, specify:]
4[Provided that with a view to facilitating the transition from one period of accounting to another period of accounting under this section, the Central Government may, by order published in the Official Gazette, make such provisions as it considers necessary or expedient for the closing and balancing of, or for other matters relating to, the books in respect of the concerned years.]
40. Returns.—(1) The State Bank shall furnish to the Central Government and to the Reserve Bank 5[within three months from the 31st day of 6[March] 7[or the date specified under section 39, as the case may be] as on which its books are closed and balanced]; its balance sheet, together with the profit and loss account and the 8[auditor’s report and a report by the Central Board on the working and activities of the State Bank] during the period covered by the accounts:
9[Provided that the Central Government may, after consultation with the Reserve Bank, extend the said period of three months by such further period, not exceeding three months, as it may think fit.]
10[(2) The balance sheet and the profit and loss account shall be signed by the chairman, managing directors and at least three other directors of the Central Board.]
(3) The State Bank shall also, within two months from the date on which its accounts are closed and balanced, transmit to the Central Government and the Reserve Bank a statement showing, as far as may be available, the name, address and occupation of, and the number of shares held by, each shareholder of the State Bank as on the said date.
11[(4) The Central Government shall cause the auditors’ report and the report by the Central Board on the working and activities of the State Bank to be laid, as soon as may be after they are received, before each House of Parliament 12***.
1. Ins. by Act 48 of 1973, s. 14 (w.e.f. 31-12-1973).
2. Subs. by Act 27 of 2010, s. 26, for “December” (w.e.f. 15-9-2010).
3. Subs. by Act 66 of 1988, s. 14, for “in each year” (w.e.f. 30-12-1988).
4. The proviso ins. by s. 14, ibid. (w.e.f. 30-12-1988).
5. Subs. by Act 48 of 1973, s. 15, for certain words (w.e.f. 31-12-1973).
6. Subs. by Act 27 of 2010, s. 27, for “December” (w.e.f. 15-9-2010).
7. Ins. by Act 66 of 1988, s. 15 (w.e.f. 30-12-1988).
8. Subs. by Act 1 of 1984, s. 44, for certain words (w.e.f. 15-2-1984).
9. The proviso added by Act 48 of 1973, s. 15 (w.e.f. 31-12-1973).
10. Subs. by Act 27 of 2010, s. 27, for sub-section (2) (w.e.f. 15-9-2010).
11. Ins. by Act 1 of 1984, s. 44 (w.e.f. 15-2-1984).
12. Certain words omitted by Act 81 of 1985, s. 3 (w.e.f. 1-5-1986).
41. Audit.— (1) The affairs of the State Bank shall be 1[audited by two or more auditors] duly qualified to act as auditors of companies under 2[section 226 of the Companies Act, 1956 (1 of 1956)], who shall be appointed by 3[the State Bank with the previous approval of the Reserve Bank].
(2) The auditors shall receive such remuneration as the Reserve Bank may fix in consultation with the Central Government.
(3) An auditor may be a shareholder but not director or member of a Local Board or of a Local Committee or an officer of the State Bank shall be eligible to be an auditor during his continuance in office as such director, member or officer.
(4) An auditor shall on relinquishing office, be eligible for reappointment.
(5) The auditors shall severally be, and continue to act as, auditors until the 4[annual] general meeting after their respective appointment, and if any vacancy arises before the expiry of the term of office of an auditor, the vacancy may be filled by 3[the State Bank with the previous approval of the Reserve Bank].
(6) Every auditor shall be supplied with a copy of the annual balance sheet and profit and loss account, and a list of all books kept by the State Bank, and it shall be the duty of the auditor to examine the balance sheet and profit and loss account with the accounts and vouchers relating thereto, and in the performance of his duties, the auditor—
(a) shall have, at all reasonable times, access to the books, accounts and other documents of the State Bank;
(b) may, at the expense of the State Bank, or if he is appointed by the Central Government, at the expense of the Central Government, employ accountants or other persons to assist him in investigating such accounts; and
(c) may, in relation to such accounts, examine any director or any member of a Local Board or of a Local Committee or any officer of the State Bank.
(7) The auditors shall make a report to the Central Government upon the annual balance sheet and accounts, and in every such report they shall state—
(a) whether, in their opinion, the balance sheet is a full and fair balance sheet containing all the necessary particulars and properly drawn up so as to exhibit 5[a true and fair view] of the affairs of the State Bank, and in case they have called for any explanation or information, whether it has been given and whether it is satisfactory;
(b) whether or not the transactions of the State Bank which have come to their notice have been within the powers of the State Bank;
(c) whether or not the returns received from the offices and branches of the State Bank have been found adequate for the purpose of their audit;
(d) whether the profit and loss account shows a true balance of 6[profit or loss] for the period covered by such account; and
(e) any other matter which they consider should be brought to the notice of the shareholders or the Central Government, as the case may be.
7[Explanation 1.—For the purposes of this Act,—
(a) the balance sheet shall not be treated as not disclosing a true and fair view of the affairs of the State Bank, and
1. Subs. by Act 48 of 1973, s. 16, for “audited by two auditors” (w.e.f. 31-12-1973).
2. Subs. by Act 26 of 1959, s. 8, for “sub-section (1) of section 144 of the Indian Companies Act, 1913 (7 of 1913)” (w.e.f. 28-8-1959).
3. Subs. by Act 27 of 2010, s. 28, for “the Reserve Bank in consultation with the Central Government” (w.e.f. 15-9-2010).
4. Subs. by Act 26 of 1959, s. 8, for “first” (w.e.f. 28-8-1959).
5. Subs. by Act 35 of 1964, s. 13, for “a true and correct view” (w.e.f. 1-12-1964).
6. Subs. by Act 26 of 1959, s. 8, for “profit and loss” (w.e.f. 28-8-1959). 7. Ins. by Act 48 of 1973, s. 16 (w.e.f. 31-12-1973).
(b) the profit and loss account shall not be treated as not showing a true balance of profit or loss of the period covered by such account,
merely, by reason of the fact that the balance sheet or, as the case may be, the profit and loss account, does not disclose any matters which are, by the provisions of the Banking Regulation Act, 1949 (10 of 1949) read with the relevant provisions of this Act, not required to be disclosed.
Explanation 2.— For the purposes of this Act, the accounts of the State Bank shall not be deemed as having not been properly drawn up on the ground merely that they do not disclose certain matters if—
(i) those matters are such as the State Bank is, by virtue of any provision contained in the Banking Regulation Act, 1949 (10 of 1949), read with the relevant provisions of this Act, or any other Act, not required to disclose; and
(ii) the provisions referred to in clause (i) are specified in the balance sheet and profit and loss account of the State Bank or in the auditors’ report].
(8) The auditors shall also forward a copy of the audit report to the State Bank.
(9) Without prejudice to anything contained in the foregoing provisions, the Central Government may appoint at any time such auditors as it thinks fit to examine and report on the accounts of the State Bank.
1[42. Balance sheet, etc., of State Bank may be discussed at general meeting.— (1) An annual general meeting shall be held in each financial year at the Corporate Centre or at such other place in Mumbai other than the Corporate Centre or at such other place in India and at such time, as shall from time to time be specified by the Central Board and a general meeting other than an annual general meeting may be convened by the State Bank at any other time and at such place in India as shall from time to time be specified by the Central Board:
Provided that such annual general meeting shall be held before the expiry of six weeks from the date on which the balance sheet together with the profit and loss account and auditors’ report, under sub- section (1) of section 40, is forwarded to the Central Government or to the Reserve Bank, whichever date is earlier.
(2) The shareholders present at an annual general meeting shall be entitled to discuss and adopt the balance sheet and the profit and loss account of the State Bank made up to the previous 31st day of March or the date specified under section 39, as the case may be, the report of the Central Board on the working and activities of the State Bank for the period covered by the accounts and the auditors’ report on the balance sheet and accounts.]
CHAPTER VIII
MISCELLANEOUS
43. State Bank may appoint officers and other employees.— 2[(1)] The State Bank may appoint such number of officers, advisers and employees as it considers necessary or desirable for the efficient performance of its functions, and determine the terms and conditions of their appointment and service.
3[(2) The officers, advisers and employees of the State Bank shall individually or jointly or with other officers, advisers and employees in a Local Committee exercise such powers and perform such duties as may by general or special order, be entrusted or delegated to them by the Central Board or its executive committee.]
4 [43A. Bonus.— (1) No officer, adviser or other employee [other than an employee within the meaning of clause (13) of section 2 of the Payment of Bonus Act, 1965 (21 of 1965)] of the State Bank shall be entitled to be paid any bonus.
1. Subs. by Act 27 of 2010, s. 29, for section 42 (w.e.f. 15-9-2010).
2. Section 43 renumbered as sub-section (1) thereof by Act 35 of 1964, s. 14 (w.e.f. 1-12-1964).
3. Subs. by Act 27 of 2010, s. 30, for sub-section (2) (w.e.f. 15-9-2010).
4. Ins. by Act 64 of 1984, s. 2 (w.e.f. 11-9-1984).
(2) No employee of the State Bank, being an employee within the meaning of clause (13) of section 2 of the Payment of Bonus Act, 1965 (21 of 1965), shall be entitled to be paid any bonus except in accordance with the provisions of that Act.
(3) The provisions of this section shall have effect notwithstanding any judgment, decree or order of any Court, tribunal or other authority and notwithstanding anything contained in any other provision of this Act or in the Industrial Disputes Act, 1947 (14 of 1947), or any other law for the time being in force or any practice, usage or custom or any contract, agreement, settlement, award or other instrument.]
44. Obligation as to fidelity and secrecy.— (1) The State Bank shall observe, except as otherwise required by law, the practices and usages customary among bankers, and, in particular, it shall not divulge any information relating to or to the affairs of its constituents except in circumstances in which it is, in accordance with the law or practice and usage customary among bankers, necessary or appropriate for the State Bank to divulge such information.
(2) Every director, member of a Local Board or of a Local Committee, auditor, adviser, officer or other employee of the State Bank shall, before entering upon his duties, make a declaration of fidelity and secrecy as in the form set out in the Second Schedule.
1[(3) Nothing contained in this section shall apply to the credit information disclosed under the Credit Information Companies (Regulation) Act, 2005 (30 of 2005).]
45. Bar to liquidation of State Bank.— No provision of law relating to the winding up of companies shall apply to the State Bank, and the State Bank shall not be placed in liquidation save by order of the Central Government and in such manner as it may direct.
46. Indemnity of directors and members of Local Boards and Local Committees, etc.— (1) Every director and every member of a Local Board or a Local Committee shall be indemnified by the State Bank against all losses and expenses incurred by him in or in relation to the discharge of his duties except such as are caused by his own wilful act or default.
(2) Neither a director nor a member of a Local Board or a Local Committee shall be responsible for any loss or expense caused to the State Bank by the insufficiency or deficiency of the value of or title to any property or security acquired or taken on behalf of the State Bank or by the insolvency or wrongful act of any customer or debtor or by anything done in or in relation to the execution of the duties of his office or otherwise than for his wilful act or default.
47. Defects in appointment or constitution not to invalidate acts or proceedings.—(1) No act or proceeding of the Central Board or of a Local Board or a Local Committee shall be questioned on the ground merely of the existence of any vacancy or defect in the constitution of the Board or Committee, as the case may be.
(2) All acts done by any person acting in good faith as a director or as a member of a Local Board or of a Local Committee shall, notwithstanding that there was some defect in his appointment or qualifications, be as valid as if he was a director of the Central Board or a member of the Local Board or the Local Committee, as the case may be.
48. [Power to remove difficulties] Omitted by the State Bank of India (Amendment) Act, 1964 (35 of 1964), s.15 (w.e.f. 1-12-1964).
49. Power of Central Government to make rules.— (1) The Central Government, in consultation with the Reserve Bank, may, by notification in the Official Gazette, 2[make rules to provide for all matters for which provision is necessary or expedient for the purpose of giving effect to the provisions of this Act].
(2) In particular, and without prejudice to the generality of the foregoing power, such rules may provide for—
(a) the procedure for the payment of compensation under this Act;
1. Ins. by Act 30 of 2005, s. 34 and the Schedule (w.e.f. 14-12-2006).
2. Subs. by Act 48 of 1973, s. 18, for certain words (w.e.f. 31-12-1973).
(b) the determination of persons to whom the said compensation shall be payable in all cases, including cases where shares in the Imperial Bank have been held by more than one person, or where they have been transferred before the appointed day but the transfer has not been registered or where the shareholder is dead;
1[(c) the manner of appointment of a director under clause (ca) or clause (cb) 2*** of section 19, and all other matters connected therewith or incidental thereto;]
3[(d) the time and place of meeting of the Committee and the rules of procedure to be observed by it under sub-section (6) of section 24A;
(e) the salary and allowances of the Administrator and the members of the committee under sub-section (7) of section 24A.]
4[(3) Every rule made by the Central Government under this Act shall be laid, as soon as may be after it is made, before each House of Parliament while it is in session, for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rule or both Houses agree that the rule should not be made, the rule shall thereafter have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule.]
50. Power of Central Board to make regulations.—(1) The Central Board may, after consultation with the Reserve Bank and with the previous sanction of the Central Government 5[by notification in the Official Gazette] make regulations, not inconsistent with this Act and the rules made thereunder to provide for all matters for which provision is expedient for the purpose of giving effect to the provisions of this Act.
(2) In particular, and without prejudice to the generality of the foregoing power, such regulations may provide for—
(a) the nature of shares of the State Bank, the manner in which and the conditions subject to which shares may be held and transferred and generally all matters relating to the rights and duties of shareholders;
6[(aa) the procedure for increasing issued capital by the issue of equity or preference shares under sub-section (2) and the manner of accepting money for issued capital, forfeiture and re-issue of shares under sub-section (5) , of section 5;
(ab) the manner of nominating an individual by one individual under sub-section (1) , the manner of nominating an individual by the joint holders under sub-section (2), the manner of varying or cancellation of nomination under sub-section (3), and the manner of nominating a minor under sub-section (4) , of section 10A;]
7[(b) the maintenance of register of shareholders, and the particulars to be entered in such register in addition to those specified in section 13, the safeguards to be observed in the maintenance of register of shareholders on computer 8[floppies or diskettes or any other electronic form], the inspection and closure of the register of shareholders and all other matters connected therewith;]
(c) the holding and conduct of elections under this Act, including the allocation of elected directors to the various areas 9[falling within the jurisdiction of each local head office], and the final determination of doubts or disputes regarding the qualifications of candidates for election or regarding the validity of elections;
1. Ins. by Act 48 of 1973, s. 18 (w.e.f. 31-12-1973).
2. The words, brackets and figure “of sub-section (1)” omitted by Act 3 of 1994, s. 19 (w.e.f. 15-10-1993). 3. Ins. by Act 27 of 2010, s. 31 (w.e.f. 15-9-2010).
4. Ins. by Act 1 of 1984, s. 47 (w.e.f. 15-2-1984).
5. Ins. by Act 66 of 1988, s. 17 (w.e.f. 30-12-1988).
6. Ins. by Act 27 of 2010, s. 32 (w.e.f. 15-9-2010).
7. Subs. by Act 3 of 1994, s. 20, for clause (b) (w.e.f. 15-10-1993).
8. Subs. by Act 27 of 2010, s. 32,for “floppies or diskettes” (w.e.f. 15-9-2010).
9. Subs. by Act 3 of 1994, s. 20, for certain words (w.e.f. 15-10-1993).
1[(ca) the determination of areas falling within the jurisdiction of each local head office;]
2[(d) the powers, functions and duties of Local Boards and the restrictions, conditions or limitations, if any, subject to which they may be exercised or performed, the formation and constitution of Local Committees (including the number of members of any such Committee) and of Committees of Local Boards, the powers, functions and duties of such Committees, the holding of meetings of Local Committees and Committees of Local Boards and the conduct of business thereat;]
(e) the fees and allowances which may be paid to directors, or members of Local Boards or Local Committees for attending any meetings of the Central Board or of its committees or of the Local Boards or Local Committees, as the case may be, or for attending to any other work of the State Bank;
(f) the manner in which the business of the Central Board 3 [or of Local Boards] shall be transacted and the procedure to be followed at the meetings thereof;
(g) the formation of committees of the Central Board and the delegation of powers and functions of the Central Board to such committees and the conduct of business in such committees;
4* * * * *
(i) the manner in which general meetings shall be convened, the procedure to be followed thereat and the manner in which voting rights may be exercised;
(j) the holding of meetings of shareholders 5*** and the business to be transacted thereat;
(k) the manner in which notices may be served on behalf of the State Bank upon shareholders or other persons;
(l) the provision of seals for the State Bank and the manner and effect of their use;
(m) the conduct and defence of legal proceedings and the manner of signing pleadings;
(n) the duties and conduct of officers, other employees, advisers and agents of the State Bank;
6[(o) the establishment and maintenance of superannuation pension, provident or other funds for the benefit of the employees of the State Bank or of the dependants of such employees or for the purposes of the State Bank, and the granting of superannuation allowances, annuities and pensions payable out of any such fund;]
(p) the form and manner in which contracts binding on the State Bank may be executed;
7[(q) the terms, conditions, stipulations, restrictions and limitations, if any, in the transaction by the State Bank of its businesses in regard to the advancing or lending of money or the discounting or purchase of any instrument, negotiable or otherwise, with or without reference to any security, purpose, amount, period or otherwise;]
(r) the conditions subject to which alone, advances may be made to directors, members of Local Boards or of Local Committees or officers of the State Bank, or the relatives of such directors, members or officers or to companies, firms or individuals with which or with whom such directors, members, officers, or relatives, are connected as partners, directors, managers, servants, shareholders or otherwise;
(s) the statements, returns, and forms that are required for the purposes of this Act;
1. Ins. by Act 3 of 1994, s. 20 (w.e.f. 15-10-1993).
2. Subs. by Act 35 of 1964, s. 16, for clause (d) (w.e.f. 1-12-1964).
3. Ins. by s. 16, ibid. (w.e.f. 1-12-1964).
4. Omitted by s. 16, ibid. (w.e.f. 1-12-1964).
5. The words “on branch registers” omitted by Act 3 of 1994, s. 20 (w.e.f. 15-10-1993). 6. Subs. by Act 26 of 1959, s. 10, for clause (o) (w.e.f. 28-8-1959).
7. Subs. by Act 48 of 1973, s. 19, for clause (q) (w.e.f. 31-12-1973).
(t) the payment of dividends, including interim dividends;
(u) generally for the conduct of the business of the State Bank.
1[(2A) All regulations made under this section shall have effect from such earlier or later date as may be specified in the regulations.]
(3) Notwithstanding anything contained in this section, the first regulations shall be made by the Reserve Bank with the previous sanction of the Central Government, and thereupon shall be deemed to be the regulations made by the Central Board under this section and shall have force accordingly until they are amended or repealed.
2[(4) Every regulation shall, as soon as may be after it is made under this Act by the Central Board, be forwarded to the Central Government and that Government shall cause a copy of the same to be laid before each House of Parliament, while it is in session, for a total period of thirty days, which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the regulation or both Houses agree that the regulation should not be made, the regulation shall thereafter have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that regulation.]
3[51. Requirements of foreign law to be complied within certain cases.—If, according to the laws of any country outside India, the provisions of this Act by themselves are not effective to transfer to and vest in the State Bank any asset or liability which forms part of the undertaking of the Imperial Bank and which is situate in that country, the Imperial Bank shall take all such steps as may be required by the laws of that country for the purpose of effecting or perfecting such transfer and vesting, and in connection therewith the Imperial Bank may realise any asset and discharge any liability and transfer the net proceeds thereof to the State Bank.]
52. [Amendment of Act 2 of 1934.] Rep. by the Repealing and Amending Act, 1960 (58 of 1960), s. 2
and the First Schedule (w.e.f. 26-12-1960).
53. [Amendment of Act 10 of 1949.] Rep. by s. 2 and the First Schedule, ibid.(w.e.f. 26-12-1960)
4[54. [Amendment of Act 47 of 1920.] Rep. by s. 2 and the First Schedule, ibid. (w.e.f. 26-12-1960).]
55. No proceeding to lie in India against Imperial Bank after appointed day.—On and from the appointed day, no person shall make any claim or demand or take any proceeding in India against the Imperial Bank or a director, officer or other employee thereof in his capacity as such director, officer or employee except in so far as may be necessary for enforcing the provisions of this Act or except in so far as it relates to any offence committed by any such director, officer or employee.
56. References to the Imperial Bank, the Bank of Bengal, etc., in other laws.—On and from the appointed day, any reference to the Imperial Bank or to the Bank of Bengal, the Bank of Madras or the Bank of Bombay in any law (other than this Act or the Imperial Bank of India Act, 1920 (47 of 1920) or in any contract or other instrument shall, except as otherwise provided in any general or special order made by the Central Government, be deemed to be a reference to the State Bank.
57. Dissolution of Imperial Bank, etc.—(1) On such day as the Central Government may, by notification in the Official Gazette, specify in this behalf the Imperial Bank shall stand dissolved, and the Imperial Bank of India Act, 1920 (47 of 1920), shall stand repealed.
(2) On the day specified in the notification under sub-section (1), the State Bank shall pay to the Reserve Bank a sum of ten lakhs of rupees.
1. Ins. by Act 48 of 1973, s. 19 (w.e.f. 31-12-1973).
2. Ins. by Act 1 of 1984, s. 48 (w.e.f. 15-2-1984).
3. Subs. by Act 33 of 1955, s. 5, for section 51 (w.e.f. 1-4-1957).
4. Ins. by s. 6, ibid. (w.e.f. 1-4-1957).
(3) If, on the day specified in the notification under sub-section (1), the Imperial Bank has in its possession or custody any assets created on or after the appointed day, such assets shall be disposed of in accordance with directions issued by the Central Government in this behalf.]
THE FIRST SCHEDULE
(See section 9)
COMPENSATION FOR THE TRANSFER OF SHARES OF THE IMPERIAL BANK TO THE RESERVE BANK
1. In this Schedule, “shareholder” means any person who immediately before the appointed day is registered as the holder of a share in the Imperial Bank.
2. As compensation for the shares in the capital of the Imperial Bank which, by reason of this Act, are transferred to and vested in the Reserve Bank, the Reserve Bank shall pay to every shareholder, in the manner set out hereinafter, an amount calculated at the rate of one thousand seven hundred and sixty-five rupees and ten annas per share in the case of a fully paid-up share and four hundred and thirty-one rupees, twelve annas and four pies per share in the case of a partly paid-up share.
3. Notwithstanding the transfer of the shares in the capital of the Imperial Bank to the Reserve Bank, any shareholder who immediately before the appointed day is entitled to payment of dividend on the shares of the Imperial Bank held by him shall be entitled to receive from the State Bank—
(a) all dividends accruing due on his shares in respect of any half year which ended before the appointed day and remaining unpaid;
(b) dividends calculated at a rate to be specified by the Central Government in respect of any period immediately preceding the appointed day for which the Imperial Bank has not declared any dividend.
4. (1) The compensation provided for in this Schedule shall be given in Central Government securities and the form of such securities and the value thereof, computed with reference to their market value, shall be such as the Central Government may, by notification in the Official Gazette, specify in this behalf:
Provided that where the amount of such compensation is not an exact multiple of the value of the Government security as so notified, the amount in excess of the nearest lower multiple of such value shall be paid by cheque drawn on the Reserve Bank.
(2) Notwithstanding anything contained in sub-paragraph (1), any person who is registered as the holder of a share in the Imperial Bank on the 19th day of December, 1954, and continues to be so until the appointed day shall, if he applies in writing in this behalf to the Reserve Bank before the expiry of three months from the appointed day, be entitled to be paid, by cheque drawn on the Reserve Bank, any compensation payable to him upto the first ten thousand rupees.
5. (1) Any shareholder to whom compensation is payable under this Schedule may apply to the Reserve Bank before the expiry of three months from the appointed day for the transfer to him of shares in the State Bank in lieu of such compensation, and for the purposes of such transfer the value of each share of the State Bank shall be such as may be determined by the Reserve Bank in this behalf.
(2) If on receipt of an application under sub-paragraph (1), the Reserve Bank, in its discretion, decides to transfer any shares to the applicant, it shall issue to the State Bank a warrant in the prescribed form directing it to transfer in favour of the person specified in the warrant such number of shares as may be specified therein out of the shares standing allotted to it under sub-section (1) of section 5, and the State Bank shall be bound to comply with such warrant.
(3) A warrant issued by the Reserve Bank under this paragraph shall not be liable to duty under the Indian Stamp Act, 1899 (2 of 1899).
6. (1) The Reserve Bank may, if it decides to transfer, in pursuance of paragraph 5, more than two lakhs, fifty-three thousand and one hundred and twenty-five shares, require the State Bank to issue to it such further shares as may be necessary to secure that it holds not less than fifty-five per cent. of the issued capital of the State Bank, and the State Bank shall, without prejudice to the provisions contained in sub-section (3) of section 5, comply with such requirement on the Reserve Bank subscribing one hundred rupees for each share.
(2) No share issued to the Reserve Bank at par under this paragraph shall carry dividend at a rate higher than four per cent. per annum.
THE SECOND SCHEDULE
(See section 44)
DECLARATION OF FIDELITY AND SECRECY
I……………………………………………..do hereby declare that I will faithfully, truly and to the best of my skill and ability execute and perform the duties required of me as director, member of Local Board, member of Local Committee, auditor, adviser, officer or other employee (as the case may be) of the State Bank and which properly relate to the office or position in the said State Bank held by me.
I further declare that I will not communicate or allow to be communicated to any person not legally entitled thereto any information relating to the affairs of the State Bank or to the affairs of any person having any dealing with the State Bank; nor will I allow any such person to inspect or have access to any books or documents belonging to or in the possession of the State Bank and relating to the business of the State Bank or to the business of any person having any dealing with the State Bank.
THE THIRD SCHEDULE.— [Amendments to the Reserve Bank of India Act, 1934.] Rep. by the Repealing and Amending Act, 1960 (58 of 1960), s. 2, and the First Schedule (w.e.f. 26-12-1960).
THE FOURTH SCHEDULE.— [Amendments to the Banking Companies Act, 1949.] Rep. by s. 2 and the First Schedule, ibid. (w.e.f. 26-12-1960).
THE FIFTH SCHEDULE.— [Amendment to the Imperial Bank of India Act, 1920.] Added by the State Bank of India (Amendment) Act, 1955 (33 of 1955), by s. 7 (with retrospective effect).
Reserve Bank of India Act, 1934
[Act No. 2 of 1934]1
[6th March 1934]
PREAMBLE
An Act to constitute a Reserve Bank of India.
Whereas it is expedient to constitute a Reserve Bank for India to regulate the issue of Bank notes and the keeping of reserves with a view to securing monetary stability in 2[India] and generally to operate the currency any credit system of the country to its advantage;
And whereas in the present disorganisation of the monetary systems of the world it is not possible to determine what will be suitable as a permanent basis for the Indian monetary system;
But whereas it is expedient to make temporary provision on the basis of the existing monetary system, and to leave the question of the monetary standard best suited to India to be considered when the international monetary position has become sufficiently clear and stable to make it possible to frame permanent measures;
It is hereby enacted as follows: –
CHAPTER I PRELIMINARY
1. Short title, extent and commencement.
(1) This Act may be called the Reserve Bank of India Act, 1934.
1 1. For Statement of Objects and Reasons, see Gazette of India, 1933, Pt. V, p. 160; and for Report of Select Committee, see ibid., pp. 197-207.
For the functioning of the Reserve Bank in or in relation to Burma, after the separation of that country from India. see the M. O. 1937.
This Act was extended to Berar by Act 4 of 1941; to Goa, Daman and Diu by Reg. 6 of 1962; to Dadra and Nagar Haveli by Reg. 6 of 1963, s.2 and Sch. I (w.e.f.1-7-1965) and to the whole of the union territory of Lakshadweep by Reg. 8 of 1965, s.3 and Sch. to the State of Sikkim: vide Notification No. S. D. 208(E), dated 16-5-1975. Extraordinary, pt II Sec 3 (ii) P1213 and come into force in Sikkim (w.e.f. 14-8-1976); vide Notification No. S. O. 547 (E) dated 13.8.1976.
This Act has been supplemented by Act 28 of 1964.
2 Substituted by the A.O. 1948 for “British India”.
1[(2) It extends to the whole of India 2[* * *].
(3) This section shall come into force at once, and the remaining provisions of this Act shall come into force on such date or dates3 as the 4[Central Government] may, by notification in the Gazette of India, appoint.
2. Definitions.
In this Act, unless there is anything repugnant in the subject or context, –
5[* * * * *
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6[(aii)] “the Bank” means the Reserve Bank of India constituted by this Act;
7[(aiii) “Bank for International Settlements” means the body corporate established with the said name under the law of Switzerland in pursuance of an agreement dated the 20th January, 1930, signed at the Hague;]
(b) “the Central Board” means the Central Board of Directors of the Bank;
8[* * * * *
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9[1[(bvi)] “Deposit Insurance Corporation” means the Deposit Insurance Corporation established under section 3 of the Deposit Insurance Corporation Act, 1961;]
1 Subs. by the A. O. 1950, for sub-section (2).
2 The words “except the State of Jammu and Kashmir” omitted by Act 62 of 1956, s.2 and Sch. (w.e.f. 1- 11-1956).
3 Ss. 2 to 19, 47, 50 to 52, 55 to 58 and 61 were brought into force on 1st January, 1935, see Gazette of India, 1934, Pt. I.P. 1369; and the other sections on 1st April, 1935, see ibid., 1935, Pt. I. P. 538.
4 Subs. by the M. O. 1937, for “G. G. in C”.
5 Cls. (a) and (ai) omitted by Act 61 of 1981, s.61 and Sch. II (w.e.f. 12-7-1982).
6 Cls (a) and (aa) re-lettered as cls. (a-i) and (a-ii) respectively by Act 23 of 1965, s.2 (w.e.f. 1-3-1966).
7 Ins. by Act 51 of 1974, s.2.
8 Cls. (bi), (bii), (biii), (biv), (bv) and (bviii) omitted by Act 61 of 1981, s.61 and Sch.II (w.e.f. 12-7- 1982).
9 Ins. by Act 47 of 1961, s.51 and Sch.II (w.e.f. 1-1-1962).
2[*****]
3[*****]
4[(bviiia) “Exim Bank” means the Export-Import Bank of India established under the Export-Import Bank of India Act, 1981;]
5[(bix) “foreign currency” and “foreign exchange” have the meanings respectively assigned to them in the Foreign Exchange Regulation Act, 1973;
(c) “Industrial Finance Corporation” means the Industrial Finance Corporation of India established under the Industrial Finance Corporation Act, 1948;]
6[(ca) “International Development Association” means the “Association” referred to in the International Development Association (Status, Immunities and Privileges) Act, 1960;
(cb) “International Finance Corporation” means the “Corporation” referred to in the International Finance Corporation (Status, Immunities and Privileges) Act, 1958;
(cc) “International Monetary Fund” and “International Bank for Reconstruction and Development” mean respectively the “International Fund” and the “International Bank”, referred to in the International Monetary Fund and Bank Act, 1945;]
7[(ccc) “National Bank” means the National Bank for Agriculture and Rural Development established under section 3 of the National Bank for Agriculture and Rural Development Act, 1981;]
8(cccc) “National Housing Bank” means the National Housing Bank established under section 3 of the National Housing Bank Act, 1987;
1 Cls (bbb) and (bbbb) re-lettered as cls. (bvi) and (bvii) respectively by Act 23 of 1965, s.2 (w.e.f. 1-3- 1966).
2 Clause (bvii) omitted by the Industrial Development Bank (Transfer of Undertaking and Repeal) Act, 2003 (Act No.53 of 2003 ), Sec. 1.
3 Cls. (bi), (bii), (biii), (biv), (bv) and (bviii) omitted by Act 61 of 1981, s.61 and Sch.2 (w.e.f. 12-7- 1982).
4 Ins. by Act 28 of 1981, s.40 and Sch.II, (w.e.f. 1-1-1982).
5 Subs. by Act 24 of 1978, s.3, for cl. (c) w.e.f. 21-7-1978).
6 Ins. by Act 51 of 1974, s.2.
7 Ins. by Act 61 of 1981, s.61 and Sch.II (w.e.f. 12-7-1982).
8 Ins. by Act 53 of 1987 (w.e.f. 9-7-1988).
1[* * * * *
* * * * *
* * * * *
* * * * *
* * * * *]
2[(cv) “Reconstruction Bank” means the Industrial Reconstruction Bank of India established under section 3 of the Industrial Reconstruction Bank of India, Act, 1984;]
(d) “rupee coin” means 3[* * *] rupees which are legal tender 4[in 5[India]] under the provisions of the Indian Coinage Act, 1906; 6[* * *]
(e) “scheduled bank” means a bank included in the Second Schedule;
7[(ea) “Sponsor Bank” means a Sponsor Bank as defined in the Regional Rural Banks Act, 1976;]
8[9[(eb)] “State Bank” means the State Bank of India constituted under the State Bank of India Act, 1955;]
10[(el) “Small Industries Bank” means the Small Industries Development Bank of India established under Section 3 of the Small Industries Development Bank of India Act, 1989”.]
11[* * * * *]
12[(fi) “State Financial Corporation” means any State Financial Corporation established under the State Financial Corporations Act 1951;]
1 Cls. (ci), (cia), (cii), (ciii), (civ) and (f) omitted by s.61 and Sch.II, Act 61 of 1981 (w.e.f. 12-7-1982).
2 Ins. by Act 62 of 1984, s. 71 and Sch.III (w.e.f. 20-3-1985).
3 The word “silver” omitted by Act 62 of 1948, s.7 and Sch. (w.e.f. 1-1-1949).
4 Ins. by the M. O. 1937.
5 Subs. by Act 32 of 1951, s.2, for “the States” (w.e.f. 1-11-1951).
6 The word “and” omitted by the M. O. 1937.
7 Ins. by Act 21 of 1976, s.33 (w.e.f. 26-9-1975).
8 Ins. by Act 23 of 1955, s.52 and Sch.III (w.e.f. 1-7-1955). formerly cl. (ee) ins. by the A. O. 1950 was omitted by Act 32 of 1951, s.4 (w.e.f. 1-11-1951).
9 Cl. (ei) re-lettered as cl. (eb) by Act 21 of 1976 s.33 (w.e.f. 26-9-1975).
10 Ins. by Act. 39 of 1989.
11 Cls. (ci), (cia), (cii), (ciii), (civ) and (f) omitted by s.61 and Sch.II, of Act 61 of 1981 (w.e.f. 12-7- 1982).
12 Ins. by Act 24 of 1978, s.3 (w.e.f. 21-7-1978).
1[* * * * *]
2[(g) “Unit Trust” means the Unit Trust of India established under section 3 of the Unit Trust of India Act, 1963;]
3[(h) “agricultural operations”, “central co-operative bank”, “co-operative society”, “crops”, “marketing of crops”, “pisciculture”, “regional rural bank” and “State co-operative bank” shall have the meanings respectively assigned to them in the National Bank for Agriculture and Rural Development Act, 1981;
(i) “co-operative bank”, “co-operative credit society”, “director”, “primary agricultural credit society”, “primary co-operative bank” and “primary credit society” shall have the meanings respectively assigned to them in Part V of the Banking Regulation Act, 1949;]
CHAPTER II
INCORPORATION, 4[CAPITAL], MANAGEMENT AND BUSINESS
3. Establishment and incorporation of Reserve Bank.
(1) A bank to be called the Reserve Bank of India shall be constituted for the purposes of taking over the management of the currency from the 5[Central Government] and of carrying on the business of banking in accordance with the provisions of this Act.
(2) The Bank shall be a body corporate by the name of the Reserve Bank of India, having perpetual succession and a common seal, and shall by the said name sue and be sued.
6[4. Capital of the Bank.
The capital of the Bank shall be five crores of rupees.]
5. [Increase and reduction of share capital.].
[Rep. by Act 62 of 1948, s.7 and Sch. (w.e.f. 1-1-1949)].
1 Cls. (f) to (k) ins. by the M. O. 1937, omitted by Act 11 of 1947, s.2 (w.e.f. 1-4-1947) and cl. (g) ins. by Act 32 of 1951, s.4 (w.e.f. 1-11-1951) omitted by Act 62 of 1956, s.2 and Sch. (w.e.f. 1-11-1956).
2 Ins. by Act 52 of 1963, s.44 and Sch.II (w.e.f. 1-2-1964).
3 Ins. by Act 61 of 1981, s.61 and Sch.II (w.e.f. 12-7-1982).
4 Subs. by Act. 62 of 1948, s.7 and Sch., for “SHARE CAPITAL” (w.e.f. 1-1-1949).
5 Subs. by the M. O. 1937, for “G. G. in C.”.
6 Subs. by Act 62 of 1948, s.7 and Sch., for the original section (w.e.f. 1-1-1949).
6. Offices, branches and agencies.
The Bank shall, as soon as may be, establish offices in Bombay, Calcutta, 1[Delhi and Madras] 2[* * *] and may establish branches or agencies in any other place in India 3[* * *] or, with the previous sanction of the 4[Central Government], elsewhere.
5[7. Management.
(1) The Central Government may from time to time give such directions to the Bank as it may, after consultation with the Governor of the Bank, consider necessary in the public interest.
(2) Subject to any such directions, the general superintendence and direction of the affairs and business of the Bank shall be entrusted to a Central Board of Directors which may exercise all powers and do all acts and things which may be exercised or done by the Bank.
6[(3) Save as otherwise provided in regulations made by the Central Board, the Governor and in his absence the Deputy Governor nominated by him in this behalf, shall also have powers of general superintendence and direction of the affairs and the business of the Bank, and may exercise all powers and do all acts and things which may be exercised or done by the Bank.]
8. Composition of the Central Board, and term of office of Directors.
7[(1) The Central Board shall consist of the following Directors, namely:-
(a) a Governor and 8[not more than four] Deputy Governors to be appointed by the Central Government;
(b) four Directors to be nominated by the Central Government, one from each of the four Local Boards as constituted by section 9;
(c) 9[ten] Directors to be nominated by the Central Government; and
1 Subs. by Act 11 of 1947, s.5, for “Delhi, Madras and Rangoon” (w.e.f. 1-4-1947).
2 The words “and a branch in London” omitted by Act 24 of 1955, s.3.
3 The words “or Burma” ins. by the M. O. 1937, omitted by Act 11 of 1947, s.5 (w.e.f. 1-4-1947).
4 Subs. by the M. O. 1937, for “G. G. in C.”.
5 Subs. by Act 62 of 1948, s.7 and Sch., for the original section (w.e.f. 1-1-1949).
6 Subs. by Act 32 of 1951, s.5, for the former sub-section (w.e.f. 1-1-1949).
7 Subs. by Act 62 of 1948, s.7 and Sch., for the former Sub-section (w.e.f. 1-1-1949).
8 Subs. by Act 18 of 1964, s.38 and Sch.II, for “three” (w.e.f. 1-7-1964).
9 Subs. by s.38 and Sch.II, Act 18 of 1964, for “six” (w.e.f. 1-7-1964).
(d) one Government official to be nominated by the Central Government;]
(2) The Governor and Deputy Governors shall devote their whole time to the affairs of the Bank, and shall receive such salaries and allowances as may be determined by the Central Board, with the approval of the 1[Central Government]:
2[Provided that the Central Board may, if in its opinion it is necessary in the public interest so to do, permit the Governor or a Deputy Governor to undertake, at the request of the Central Government or any State Government, such part-time honorary work, whether related to the purposes of this Act or not, as is not likely to interfere with his duties as Governor or Deputy Governor, as the case may be:]
3[Provided further that the Central Government may, in consultation with the Bank, appoint a Deputy Governor as the Chairman of the National Bank, on such terms and conditions as that Government may specify.]
(3) A Deputy Governor and the Director nominated under clause (d) of sub- section (1) may attend any meeting of the Central Board and take part in its deliberations but shall not be entitled to vote:
4[Provided that when the Governor is, for any reason, unable to attend any such meeting, a Deputy Governor authorised by him in this behalf in writing may vote for him at that meeting.]
(4) The Governor and a Deputy Governor shall hold office for such term not exceeding five years as the 5[Central Government] may fix when appointing them, and shall be eligible for re-appointment.
6[A Director nominated under clause (c) of sub-section (1) shall 7[* * *] hold office for a period of four years 8[and thereafter until his successor shall have been nominated].]
A Director nominated under clause (d) of sub-section (1) shall hold office during the pleasure of the 9[Central Government].
(5) No act or proceeding of the Board shall be questioned on the ground merely of the existence of any vacancy in, or any defect in the constitution of, the Board.
1 Subs. by the M.O. 1937, for “G. G. in C.”.
2 Ins. by Act 35 of 1962, s.2.
3 Ins. by Act. 61 of 1981, s.61 and Sch.II (w.e.f. 12-7-1982).
4 Subs. by Act 54 of 1953, s.2, for the proviso.
5 Subs. by M. O. 1937 for “G. G. in C.”.
6 Subs. by Act 62 of 1948, s.7 and Sch., for the second paragraph (w.e.f. 1-1-1949).
7 The words, brackets and figure “subject to the provisions of sub-section (6)” omitted by Act 18 of 1964, s.38 and Sch.II (w.e.f. 1-7-1964).
8 Ins. by Act 51 of 1974, s.4.
9 Subs. by M. O. 1937 for “G. G. in C.”.
1[2* * * * *]
(7) A retiring Director shall be eligible for re-nomination.]
3[9. Local Boards, their constitution and functions.
(1) A Local Board shall be constituted for each of the four areas specified in the First Schedule and shall consist of five members to be appointed by the Central Government to represent, as far as possible, territorial and economic interests and the interests of co-operative and indigenous banks.
(2) The members of the Local Board shall elect from amongst themselves one person to be the chairman of the Board.
4[(3) Every member of a Local Board shall hold office for a term of four years and thereafter until his successor shall have been appointed and shall be eligible for re-appointment.]
(4) A Local Board shall advise the Central Board on such matters as may be generally or specifically referred to it and shall perform such duties as the Central Board may delegate to it.]
10. Disqualifications of Directors and members of Local Boards.
(1) No person may be a Director or a member of a Local Board who –
(a) is a salaried Government official 5[* * *] 6[* * *], or
(b) is, or at any time has been, adjudicated an insolvent, or has suspended payment or has compounded with his creditors, or
(c) is found lunatic or becomes of unsound mind, or
(d) is an officer or employee of any bank, or
7[(e) is a Director of a banking company within the meaning of clause (c) of section 5 of the 8[Banking Regulation Act, 1949], or of a co- operative bank.]
1 Ins. by Act 62 of 1948, s.7 and Sch. (w.e.f. 1-1-1949).
2 Sub-section (6) omitted by Act 18 of 1964, s.38 and Sch.II (w.e.f. 1-7-1964).
3 Subs. by Act 62 of 1948, s.7 and Sch., for s.9 (w.e.f. 1-1-1949).
4 Subs. by Act 51 of 1974, s.5, for sub-section (3).
5 The words “or a salaried official of a State in India” omitted by the A. O. 1950.
6 The words “or Burma” ins. by the M. O. 1937, omitted by Act 11 of 1947, s.8 (w.e.f. 1-4-1947).
7 Subs. by Act 23 of 1965, s.3 for the original cl. (e) (w.e.f. 1-3-1966).
8 Subs. by Act 51 of 1974, s.3 for “Banking Companies Act, 1949”.
(2) No two persons who are partners of the same mercantile firm, or are Directors of the same private company, or one of whom is the general agent of or holds a power of procuration from the other, or from a mercantile firm of which the other is a partner, may be Directors or members of the same Local Board at the same time.
(3) Nothing in clause (a), clause (d) or clause (e) of sub-section (1) shall apply to the Governor, or to a Deputy Governor, or to the Director nominated under clause (d) of sub-section (1) of section 8.
11. Removal from and vacation of office.
(1) The 1[Central Government] may remove from office the Governor, or a Deputy Governor or 2[any other Director or any member of a Local Board].
3[*****]
4[(2) A Director nominated under clause (b) or clause (c) of sub-section (1) of section 8 shall cease to hold office if without leave from the Central Board he absents himself from three consecutive meetings of the Board convened under sub-section (1) of section 13.]
(3) The 5[Central Government] shall remove from office any Director and the Central Board shall remove from office any member of a Local Board, if such Director or member becomes subject to any of the disqualifications specified in sub-section (1) or sub-section (2) of section 10.
(4) A Director or member of a Local Board removed or ceasing to hold office, under the foregoing sub-sections shall not be eligible for re-appointment either as Director or as member of a Local Board until the expiry of the term for which his appointment was made.
(5) The 6[* * *] nomination 7[* * *] as Director or member of a Local Board of any person who is a member of 8[Parliament or the Legislature 9[of any State]] shall be void, unless, within two months of the date of his 10[* * *]
1 Subs. by the M. O. 1937, for “G. G. in C.”.
2 Subs. by Act 32 of 1951, s.6, for “any other Director” (w.e.f. 1-11-1951).
3 The proviso omitted by Act 62 of 1948, s.7 and Sch. (w.e.f. 1-1-1949).
4 Subs. by s.7 and Sch., Act 62 of 1948, for the former sub-section (2) (w.e.f. 1-1-1949).
5 Subs. by the M. O. 1937, for “G. G. in C.”.
6 The word “appointment” omitted by Act 62 of 1948, s.7 and Sch. (w.e.f. 1-1-1949).
7 The words “or election” omitted by s.7 and Sch., Act 62 of 1948 (w.e.f. 1-1-1949).
8 Subs. by the A. O. 1950, for certain words.
9 Subs. by Act 32 of 1951, s.6, for “of a Part A State or a Part C State” (w.e.f. 1-11-1951).
10 The word “appointment” omitted by Act 62 of 1948, s.7 and Sch. (w.e.f. 1-1-1949).
nomination 1[* * *], he ceases to be such member, and, if any Director or member of a Local Board is elected or nominated as a member of 2[Parliament or any such Legislature], he shall cease to be a Director or member of the Local Board as from the date of such election or nomination, as the case may be.
(6) A Director may resign his office to the 3[Central Government], and a member of a Local Board may resign his office to the Central Board, and on the acceptance of the resignation the office shall become vacant.
12. Casual Vacancies and absences
(1) If the Governor or a Deputy Governor by infirmity or otherwise is rendered incapable of executing his duties or is absent on leave or otherwise in circumstances not involving the vacation of his appointment, the 4[Central Government] may, after consideration of the recommendations made by the Central Board in this behalf, appoint another person to officiate for him, and such person may, notwithstanding anything contained in clause (d) of sub- section (1) of section 10, be an officer of the Bank.
5[* * * * *]
(3) Where any casual vacancy in the office of any member of a Local Board occurs 6[* * *], the Central Board may nominate thereto any 7[* * *] person recommended by the 8[other] members of the Local Board.
(4) Where any casual vacancy occurs in the office of a Director other than the vacancies provided for in sub-section (1), the vacancy shall be filled 9[by the Central Government].
(5) A person nominated 10[* * *] under this section to fill a casual vacancy shall 11[* * *] hold office for the unexpired portion of the term of his predecessor.
1 The words “or election” omitted by s.7 and Sch., Act 62 of 1948 (w.e.f. 1-1-1949).
2 Subs. by the A.O. 1950, for “any such Legislature or Council”.
3 Subs. by the M. O. 1937, for “G. G. in C.”.
4 Subs. by the M. O. 1937, for “G. G. in C.”.
5 Sub-section (2) omitted by Act 62 of 1948, s.7 and Sch. (w.e.f. 1-1-1949).
6 The words “otherwise than by the occurrence of a vacancy in the office of a Director, elected by the Local Board” omitted by s.7 and Sch., Act 62 of 1948, (w.e.f. 1-1-1949).
7 The word “qualified” omitted by s.7 and Sch., Act 62 of 1948 (w.e.f. 1-1-1949).
8 Subs. by s.7 and Sch., Act 62 of 1948, for “elected” (w.e.f. 1-1-1949).
9 Subs. by s.7 and Sch., Act 62 of 1948, for certain words (w.e.f. 1-1-1949).
10 The words “or elected” omitted by s.7 and Sch., Act 62 of 1948, (w.e.f. 1-1-1949).
11 The words “subject to the proviso contained in sub-section (4)” omitted by s.7 and Sch., Act 62 of 1948 (w.e.f. 1-1-1949).
13. Meetings of the Central Board.
(1) Meetings of the Central Board shall be convened by the Governor at least six times in each year and at least once in each quarter.
(2) Any 1[four Directors] may require the Governor to convene a meeting of the Central Board at any time and the Governor shall forthwith convene a meeting accordingly.
(3) The Governor, or 2[if for any reason, he is unable to attend,] the Deputy Governor authorized by the Governor under the proviso to subsection (3) of section 8 to vote for him, shall preside at meetings of the Central Board, and, in the event of an equality of votes, shall have a second or casting vote.
14. to 16. [General meetings. First constitution of the Central Board. First constitution of Local Board.]
[Rep. by the Act 62 of 1948, s.7 and Sch. (w.e.f. 1-1-1949).]
17. Business which the Bank may transact.
The Bank shall be authorized to carry on and transact the several kinds of business hereinafter specified, namely:-
(1) the accepting of money on deposit without interest from and the collection of money for, 3[* * *] the 4[Central Government], 5[6[* * *] the 7[State] Governments 8[* * *] 9[* * *] local authorities, banks and any other persons;
(2) (a) the purchase, sale and rediscount of bills of exchange and promissory notes, 10[drawn on 11[and payable in India]] and arising out of bona fide
1 Subs. by Act 18 of 1964, s.38 and Sch.II, for “three Directors” (w.e.f. 1-7-1964).
2 Subs. by Act 24 of 1955, s.5, for “in his absence”.
3 The words “the Secretary of State” omitted by the A. O. 1948.
4 Subs. by the M. O. 1937, for “G. G. in C”.
5 Subs. by the M. O. 1937, for “L. G.’s”.
6 The words “the Federal Railway Authority” omitted by the A. O. 1948.
7 Subs. by the A. O. 1950, for “provincial”.
8 The words “the Government of Burma, the Burma Railway Board” omitted by Act 11 of 1947, s.11 (w.e.f. 1-4-1947).
9 The words and letter “Part B States” omitted by Act 32 of 1951, s.7 (w.e.f. 1-11-1951).
10 Subs. by the M. O. 1937, for “drawn on and payable in India”.
11 Subs. by Act 11 of 1947, s.11, for “India or Burma and payable in India or Burma” (w.e.f. 1-4-1947).
commercial or trade transactions bearing two or more good signatures, one of which shall be that of a scheduled bank 1[or a State co-operative bank] 2[or any financial institution, which is predominantly engaged in the acceptance or discounting of bills of exchange and promissory notes and which is approved by the Bank in this behalf] 3[* * *] and 4[maturing,–
(i) in the case of bills of exchange and promissory notes arising out of any such transaction relating to the export of goods from India, within one hundred and eighty days, and
(ii) in any other case, within ninety days, from the date of such purchase or rediscount exclusive of days of grace;]
(b) the purchase, sale and rediscount of bills of exchange and promissory notes, 5[drawn 6[and payable in India]] and bearing two or more good signatures, one of which shall be that of a scheduled bank 7[or a 8[State] co- operative bank 9[or any financial institution, which is predominantly engaged in the acceptance or discounting of bills of exchange and promissory notes and which is approved by the Bank in this behalf] and drawn or issued for the purpose of 10[financing agricultural operations] or the marketing of crops, and maturing within 11[fifteen months] from the date of such purchase or rediscount, exclusive of days of grace;
12[* * * * *]
13[(bb) the purchase, sale and rediscount of bills of exchange and promissory notes drawn and payable in India and bearing two or more good signatures, one of which shall be that of a State Co-operative bank] or a State financial corporation 14[or any financial institution, which is predominantly engaged in
1 Ins. by Act 32 of 1951, s.7 (w.e.f. 1-11-1951).
2 Ins. by Act 51 of 1974. s.6.
3 The words “or a Burma scheduled bank” ins. by the M. O. 1937, omitted by Act 11 of 1947, s.11 (w.e.f. 1-4-1947).
4 Subs. by Act 35 of 1962, s.3, for certain words.
5 Subs. by the M. O. 1937, for “drawn on and payable in India”.
6 Subs. by Act 11 of 1947, s.11, for “India or Burma and payable in India or Burma” (w.e.f. 1-4-1947).
7 Subs. by Act 11 of 1947, S.11 for certain words (w.e.f. 1.4.1947).
8 Subs. by the A. O. 1950, for “Provincial”.
9 Ins. by Act 51 of 1974, s.6.
10 Subs. by Act 51 of 1974, s.6 for “financing seasonal agricultural operations”.
11 Subs. by the Act 32 of 1951, s.7, for “nine months” (w.e.f. 1-11-1951).
12 Explanation added by Act 54 of 1953, s.3 omitted by Act 23 of 1965, s.4 (w.e.f. 1-3-1966).
13 Ins. by Act 54 of 1953, s.3.
14 Ins. by Act 51 of 1974, s.6.
the acceptance or discounting of bills of exchange and promissory notes and which is approved by the Bank in this behalf, and drawn or issued for the purpose of financing the production or marketing activities of cottage and small scale industries approved by the Bank and maturing within twelve months from the date of such purchase or rediscount, exclusive of days of grace, provided that the payment of the principal and interest of such bills of exchange or promissory notes is fully guaranteed by the State Government;]
(c) the purchase, sale and rediscount of bills of exchange and promissory notes 1[drawn 2[and payable in India]] and bearing the signature of a scheduled bank, 3[* * *] and issued or drawn for the purpose of holding or trading in securities of 4[the Central Government 5[or a 6[State] Government]] 7[* * *] and maturing within ninety days from the date of such purchase or rediscount, exclusive of days of grace;
(3) (a) the purchase from and sale to scheduled banks 8[* * *] of 9[foreign exchange] 10[* * *].
11[(b) the purchase, sale and rediscount of bills of exchange (including treasury bills) drawn in or on any place in any country outside India which is a member of the International Monetary Fund and maturing,–
(i) in the case of bills of exchange arising out of any bona fide transaction relating to the export of goods from India, within one hundred and eighty days, and
(ii) in any other case, within ninety days, from the date of such purchase or rediscount:
Provided that no such purchase, sale or rediscount shall be made in India except with a scheduled bank or a State co-operative bank;]
1 Subs. by the M. O. 1937, for “drawn and payable in India”.
2 Subs. by the Act 11 of 1947, s.11, for certain words (w.e.f. 1-4-1947).
3 The words “or a Burma scheduled bank” omitted by s.11 Act 11 of 1947. (w.e.f. 1-4-1947).
4 Subs. by the M. O. 1937, for “the Government of India or a L. G.”
5 Subs. by the Act 11 of 1947, s.11, for certain words (w.e.f. 1-4-1947).
6 Subs. by the A. O. 1950, for “Provinicial”.
7 The words “or such securities of Part B States as may be specified in this behalf by the Central Government on the recommendation of Central Board” omitted by Act 32 of 1951, s.7 (w.e.f. 1-11-1951).
8 The words “and Burma scheduled banks”, ins. by the M. O. 1937, omitted by Act 11 of 1947, s.11 (w.e.f. 1-4-1947).
9 Subs. by Act 62 of 1948, s.7 and Sch., for “sterling” (w.e.f. 1-1-1949).
10 Certain words omitted by Act 24 of 1978, s.4 (w.e.f. 21-7-1978).
11 Subs. by Act 35 of 1962 s.3 for Sub-clause (b).
1[* * * * *]
2[(3A) the making to any scheduled bank or State co-operative bank, of loans and advances, against promissory notes of such bank, repayable on demand or on the expiry of fixed periods not exceeding one hundred and eighty days;
Provided that the borrowing bank furnishes a declaration in writing, to the effect that –
(i) it holds bills of exchange arising out of any transaction relating to the export of goods from India, of a value not less than the amount of such loans or advances, –
(a) drawn in India and on any place in any country outside India which is a member of the International Monetary Fund or in any other country notified in this behalf by the Bank in the Gazette of India, and
3[(b) maturing not later than one hundred and eighty days from the date of the loan or advance, and it will, so long as any part of such loans and advances remains unpaid, continue to hold such bills of exchange of a value not less than the amount of such loans or advances outstanding for the time being; or]
4[(ii) it has granted a pre-shipment loan or advance to an exporter or any other person in India in order to enable him to export goods from India, the amount of the loan or advance drawn and outstanding at any time being not less than the outstanding amount of the loan or advance obtained by the borrowing bank from the Bank;]]
5[(3B) the making to any scheduled bank or State co-operative bank of loans and advances repayable on demand or on the expiry of fixed periods not exceeding one hundred and eighty days against promissory notes of such bank;
Provided that the borrowing bank furnishes a declaration in writing to the effect that it has made loans and advances for bona fide commercial or trade transactions or for financing agricultural operations or the marketing of crops or for other agricultural purposes as set out in the declaration and the said declaration includes such other particulars as may be required by the Bank:]
(4) the making to 6[* * *] local authorities, scheduled banks 7[1[* * *]
2[State] co-operative banks 3[and State Financial Corporations 4[* * *]] of
1 Sub-clause (c) omitted by Act 62 of 1948 s.7 and Sch. (w.e.f. 1-1-1949).
2 Ins. by Act 35 of 1962 s.3.
3 Subs. by Act 58 of 1968, s.24, for sub-clause (b) (w.e.f. 1-2-1969).
4 Subs. by s.24, of Act 58 of 1968 for cl. (ii) (w.e.f. 1-2-1969).
5 Ins. by Act 51 of 1974, s.6.
6 The words and letter “Part B States” omitted by Act 32 of 1951, s.7 (w.e.f. 1-11-1951).
7 Subs. by the M. O. 1937, for “and Provincial co-operative banks”.
loans and advances, repayable on demand or on the expiry of fixed periods not exceeding ninety days, against the security of –
(a) stocks, funds and securities (other than immovable property) in which a trustee is authorized to invest trust money by any Act of Parliament 5[of the United Kingdom] or by any law for the time being in force in 6[India]7[* * *];
(b) gold or silver or documents of title to the same;
(c) such bills of exchange and promissory notes as are eligible for purchase or rediscount by the Bank 8[or as are fully guaranteed as to the repayment of the principal and payment of interest by a State Government];
(d) promissory notes of any scheduled bank 9[ 10[or 11[State]] Co- operative bank], supported by documents of title to goods 12[such documents having been transferred], assigned, or pledged to any such bank as security for 13[a loan or advance made] for bona fide commercial or trade transactions, or for the purpose of 14[financing agricultural operations] or the marketing of crops:
15[Provided that loans and advances made against the security of bills of exchange and promissory notes arising out of any transaction relating to the export of goods from India shall be repayable on demand or on the expiry of fixed periods not exceeding one hundred and eighty days];
1 The words “Burma scheduled banks” omitted by Act 11 of 1947, s.11 (w.e.f. 1-4-1947).
2 Subs. by the A. O. 1950, for “Provincial”.
3 Subs. by Act 19 of 1957, s.2, for “State Financial Corporations established under the State Financial Corporations Act, 1951), (63 of 1951), and the principal currency authority of Ceylon”.
4 Certain words omitted by Act 24 of 1978, s.4 (w.e.f. 21-7-1978).
5 Ins. by the A. O. 1950.
6 Subs. by Act 32 of 1951, s.2, for “the States” (w.e.f. 1-11-1951).
7 The words “or Burma” ins. by the M. O. 1937, omitted by Act 11 of 1947, s.11 (w.e.f. 1-4-1947).
8 Ins. by Act 24 of 1955, s.6.
9 Subs. by the M. O. 1937, for “or a Provincial co-operative bank”.
10 Subs. by Act 11 of 1947, s.11, for certain words (w.e.f. 1-4-1947).
11 Subs. by A. O. 1950, for “Provisional”.
12 Subs. by Act 32 of 1951, s.7 for “which have been transferred” (w.e.f. 1-11-1951).
13 Subs. by Act 24 of 1955, s.6, for “a cash credit or overdraft granted”.
14 Subs. by Act 51 of 1974, s.6, for “financing seasonal agricultural operations”.
15 Ins. by Act 35 of 1962, s.3.
1[(4A) the making to any State Financial Corporation 2[* * *], of loans and advances repayable on the expiry of fixed periods not exceeding eighteen months from the date of such loan or advance, against securities of the Central Government or of any State Government, of any maturity, or against bonds and debentures issued by that Corporation and guaranteed by the State Government concerned and maturing within a period not exceeding eighteen months from the date of such loan or advance:
3[Provided that the previous approval of the State Government shall be obtained for the borrowing by the State Financial Corporation and the amount of loans and advances granted to that Corporation under this clause shall not, at any time, exceed in the aggregate 4[twice the paid up share capital] thereof];
5[(4AA) the making of annual contributions to the National Rural Credit (Long Term Operations) Fund and the National Rural Credit] (Stabilisation) Fund established under sections 42 and 43, respectively, of the National Bank for Agriculture and Rural Development Act, 1981;]
6[(4B) the making to the Industrial Finance Corporation of India 7[* * *] of loans and advances, –
(a) repayable on demand or on the expiry of fixed periods not exceeding ninety days from the date of such loan or advance, against securities of the Central Government or of any State Government; or
(b) repayable on the expiry of fixed periods not exceeding eighteen months from the date of such loan or advance, against securities of the Central Government of any maturity or against bonds and debentures issued by the said Corporation and guaranteed by the Central Government and maturing within a period not exceeding eighteen months from the date of such loan or advance:
8[* * * * *]
9[(4BB) the making to any financial institution notified by the Central Government in this behalf, of loans and advances, –
1 Ins. by Act 14 of 1960. s.2.
2 Certain words omitted by Act 24 of 1978, s.4 (w.e.f. 21-7-1978).
3 Subs. by Act 51 of 1974, s.6, for the former proviso.
4 Subs. by Act No.81 of 1985, s.2 for certain words (w.e.f. 1-5-1986).
5 Subs. by Act 61 of 1981, s.61 and Sch.II, for cl. (4AA) (w.e.f. 12-7-1982).
6 Ins. by Act 54 of 1953, s.3.
7 Certain words omitted by Act 24 of 1978, s.4 (w.e.f. 21-7-1978).
8 Proviso omitted by Act No.66 of 1988, s.5 (w.e.f. 30-12-88).
9 Subs. by Act 14 of 1960, s.2 for cl.(4BB) which was ins. by Act 19 of 1957, S.2.
(a) repayable on demand or on the expiry of fixed periods not exceeding ninety days from the date of such loan or advance, against the securities of the Central Government or of any State Government, or
(b) repayable on the expiry of fixed periods not exceeding eighteen months from the date of such loan or advance, against securities of the Central Government or of any State Government, of any maturity, or against bonds and debentures issued by that financial institution and guaranteed by the Central Government or any State Government, and maturing within a period not exceeding eighteen months from the date of such loan or advance:
Provided that the amount of loans and advances granted to a financial institution under sub-clause (b) shall not, at any time, exceed in the aggregate sixty per cent, of the paid-up share capital thereof];
1[(4BBB) the making to the Unit Trust of loans and advances –
(i) repayable on demand or on the expiry of a fixed period not exceeding ninety days from the date of such loan or advance against the security of stocks, funds and securities (other than immovable property) in which a trustee is authorised to invest trust money by any law for the time being in force in India;
2[* * *]
(ii) repayable on demand or within a period of eighteen months from the date of such loan or advance against the security of the bonds of the Unit Trust issued with the approval of and guaranteed by the Central Government];
3[(iii) for the purpose of any scheme other than the first unit scheme under the Unit Trust of India Act, 1963 on such terms and conditions and against the security of such other property of the Unit Trust as may be specified in this behalf by the Bank]];
4[(4C) the making to a Warehousing Corporation established under the Agricultural Produce (Development and Warehousing) Corporations Act, 1956, of loans and advances, –
(a) repayable on demand or on the expiry of fixed periods not exceeding ninety days, from the date of such loan or advance, against securities of the Central Government or of any State Government, or
(b) repayable on the expiry of fixed periods not exceeding eighteen months from the date of such loan or advance, against securities of the Central Government or of any State Government, of any maturity, or
1 Ins. by Act 52 of 1963, s.44 and Sch.II (w.e.f. 1-2-1964).
2 The word “or” omitted by Act 17 of 1966, s.11 (w.e.f. 10-6-1966).
3 Ins. by s.11, Act 17 of 1966. (w.e.f. 10-6-1966).
4 Ins. by Act 28 of 1956, s.55 (w.e.f. 1-8-1956).
against bonds and debentures issued by the Corporation to which the loan or advance is made, and guaranteed by the Central or a State Government, and maturing within a period not exceeding eighteen months from the date of such loan or advance:
Provided that the amount of loans and advances granted under clause
(b) shall not at any time exceed, in the aggregate, three crores of rupees in the case of the Central Warehousing Corporation and fifty lakhs of rupees in the case of a State Warehousing Corporation];
1[(4D) the making to the Deposit Insurance Corporation of loans and advances; and generally assisting the Corporation in such manner and on such terms as may be determined by the Central Board];
2[(4DD) the making to the National Housing Bank of loans and advances and generally assisting the National Housing Bank in such manner and on such terms as may be determined by the Central Board];
3[(4E) the making to the National Bank of loans and advances repayable on demand or on the expiry of fixed period not exceeding eighteen months from the date of making of the loan or advance, either-
(i) against the security of stocks, funds and securities (other than immovable property) in which a trustee is authorised to invest trust money by any law for the time being in force in India; or
(ii) on such other terms and conditions as the Bank may specify];
4[(4F) contributing to the initial capital of the Unit Trust];
5[(4G) the making of loans and advances to, and the purchasing of bonds and debentures of, 6[****] 7[the Exim Bank] 8[or the Reconstruction Bank] 9[or the Small Industries Bank] out of the National Industrial Credit (Long Term Operations) Fund established under section 46C;
1 Ins. by Act 47 of 1961, s.51 and Sch.II (w.e.f. 1-1-1962).
2 Ins. by Act 53 of 1987, s.56 and Second Schedule (w.e.f. 9-7-1988).
3 Subs. by Act 61 of 1981, s.61 and Sch.II, for cl. (4E) (w.e.f. 12-7-1982).
4 Ins. by Act 52 of 1963. s.44 and Sch.II (w.e.f. 1-2-1664).
5 Ins. by Act 18 of 1964, s.38 and Sch.II (w.e.f. 1-7-1964).
6 The words “the Development Bank or” omitted by the Industrial Development Bank (Transfer of Undertaking and Repeal) Act, 2003 (Act No.53 of 2003), Sec. 2(a).
7 Ins. by Act 28 of 1981, s.40 and Sch.II (w.e.f. 1-1-1982).
8 Ins. by Act 62 of 1984, s.71 and Sch.III (w.e.f. 20-3-1985).
9 Ins. by Act 39 of 1989.
1[(4GG) the making of loans and advances to, and the purchasing of bonds and debentures of, the National Housing Bank out of the National Housing Credit (Long Term Operations) Fund established under section 46D];
(4H) the making to 2[*****] 3[the Small Industries Bank] of loans and advances –
(a) repayable on demand or on the expiry of fixed periods not exceeding ninety days, from the date of such loan or advance against the security of stocks, funds and securities (other than immovable property) in which a trustee is authorised to invest trust money by any law for the time being in force in India; or
(b) against the security of bills of exchange or promissory notes, arising out of bona fide commercial or trade transactions bearing two or more good signatures and maturing within five years from the date of such loan or advance];
4[(4-I) the making to scheduled banks, 5[****] 6[the Exim Bank] 7[or the Reconstruction Bank or the Small Industries Bank], the Industrial Finance Corporation and any other financial institution as may, on the recommendation of the Bank, be approved in this behalf by the Central Government of loans and advances repayable on demand or otherwise and against such security and on such other terms and conditions as may be approved in this behalf by the Central Board for the purpose of enabling such banks, or financial institution, as the case may be, to purchase foreign exchange from the Bank for the purpose of financing the import of capital goods or for such other purposes as may be approved by the Central Government];
8[(4J) the making to the Exim Bank of loans and advances –
(a) repayable on demand or on the expiry of a fixed period not exceeding ninety days, from the date of such loan or advance against the security of stocks, funds and securities (other than immovable property) in which a trustee is authorised to invest trust money by any law for the time being in force in India; or
1 Ins. by Act 53 of 1987, s.56 and the Second Schedule (w.e.f. 9-7-1988).
2 The words “the Development Bank or” omitted by the Industrial Development Bank (Transfer of Undertaking and Repeal) Act, 2003 (Act No.53 of 2003), Sec. 2(a).
3 Ins. by Act 39 of 1989.
4 Ins. by Act 24 of 1978, s.4 (w.e.f. 21-7-1978).
5 The words “the Development Bank” omitted by the Industrial Development Bank (Transfer of Undertaking and Repeal) Act, 2003 (Act No.53 of 2003), Sec. 2(b).
6 Ins. by Act 28 of 1981, s.40 and Sch.II (w.e.f. 1-1-1982).
7 Ins. by Act 39 of 1989.
8 Ins. by Act. 28 of 1981, s.40 and Sch.II (w.e.f. 1-1-1982).
(b) against the security of bills of exchange or promissory notes, arising out of bona fide commercial or trade transactions bearing two or more good signatures and maturing within five years from the date of such loan or advance;]
1[(4K) the making to the Reconstruction Bank of loans and advances –
(a) repayable on demand or on the expiry of a fixed period not exceeding ninety days, from the date of such loan or advance against the security of stocks, funds and securities (other than immovable property) in which a trustee is authorised to invest trust money by any law for the time being in force in India; or
(b) against the security of bills of exchange or promissory notes, arising out of bona fide commercial or trade transactions bearing two or more good signatures and maturing within five years from the date of such loan or advance];
(5) the making to the 2[Central Government] 3[4[* * *] 5[and 6[State Governments]] of advances repayable in each case not later than three months from the date of the making of the advance;
7[(6) the issue of demand drafts, telegraphic transfers and other kinds of remittances made payable at its own offices or agencies, the purchase of telegraphic transfers, and the making, issue and circulation of bank post bills];
8[(6A) dealing in derivatives, and, with the approval of the Central Board, in any other financial instrument.
Explanation.– For the purposes of this clause, “derivative” means an instrument, to be settled at a future date, whose value is derived from change in one or a combination of more than one of the following underlyings, namely:–
(a) interest rate,
(b) price of securities of the Central Government or a State Government or of such securities of a local authority as may be specified in this behalf by the Central Government,
1 Ins. by Act. 62 of 1984, s.71 and Sch.III (w.e.f. 20-3-1985).
2 Subs. by the M.O. 1937, for “G. G. in C”.
3 Subs., M.O. 1937, for certain words.
4 The words “the Federal Railway Authority” omitted by the A. O. 1948.
5 Subs. by Act 11 of 1947, s.11, for certain words (w.e.f. 1-4-1947).
6 Subs. by the A. O. 1950, for “Provincial”.
7 Subs. by Act 32 of 1951, s.7, for cl. (6) (w.e.f. 1-11-1951).
8 Ins. by sec. 2 of the RBI (Amendment) Act, 2006 (Act No. 26 of 2006) (w.e.f. 9.1.2007).
(c) price of foreign securities,
(d) foreign exchange rate,
(e) index of rates or prices,
(f) credit rating or credit index,
(g) price of gold or silver coins, or gold or silver bullion, or
(h) any other variable of similar nature.]
1[* * * * * * *]
(8) the Purchase and sale of securities 2[of the Central 3[Government or a 4[State] Government]] of any maturity or of such securities of a local authority 5[* * *] as may be specified in this behalf by the 6[Central Government] on the recommendation of the Central Board:
Provided that securities fully guaranteed as to principal and interest by 7[any such Government 8[or authority]] shall be deemed for the purposes of this clause to be securities of such government 9[or authority];
10[* * * * * * *]
11[(8A) the purchase and sale of shares in, or the capital of 12[the 13[National Bank] 14[the Deposit Insurance Corporation], 15[*****], the State Bank 1[or
1 Cl. (7) rep. by Act 2 of 1948, s.2 and Sch.
2 Subs. by the M. O. 1937, for “of the G. of I or of a L. G.”.
3 Subs. by Act, 11 of 1947 s.11 for certain words (w.e.f. 1-4-1947).
4 Subs. by the A. O. 1950, for “Provincial”.
5 The words and letter “or such Part B States” omitted by Act 32 of 1951, s.7 (w.e.f. 1-11-1951).
6 Subs. by the M. O. 1937 for “G. G. in C.”.
7 Subs. by the M. O. 1937 for certain words.
8 Subs. by s.7, M. O. 1937, for “authority or State” (w.e.f. 1-11-1951).
9 Subs. by s.7, M. O. 1937, for “authority or State” (w.e.f. 1-11-1951).
10 Second proviso omitted by Act 32 of 1951, s.7 (w.e.f. 1-11-1951).
11 Ins. by Act 23 of 1955, s.52 and Sch.III (w.e.f. 1-7-1955).
12 Ins. By Act 10 of 1963, s. 47 and Sch. II (w.e.f. 1-5-1963)
13 Sub. By Act 61 of 1981, s. 61 and Sch. II, for “Agricultural Refinance and Development Corporation” (w.e.f. 12-7-1982)
14 Ins. by Act 47 of 1961, s.51 and Sch. II (w.e.f. 1-1-1962).
15 The words “the Development Bank” omitted by the Industrial Development Bank (Transfer of Undertaking and Repeal) Act, 2003 (Act No.53 of 2003), Sec. 2(b).
any other bank 2[or financial institution] notified by the Central Government in this behalf]];
3[(8AA) the promoting, establishing, supporting or aiding in the promotion, establishment and support of any financial institution, whether as its subsidiary or otherwise;]
4[(8B) the keeping of deposits with the State Bank for such specific purposes as may be approved by the Central Government in this behalf];
(9) the custody of monies, securities and other articles of value, and the collection of the proceeds, whether principal, interest or dividends, of any such securities;
(10) the sale and realisation of all property, whether movable or immovable, which may in any way come into the possession of the Bank in satisfaction, or part satisfaction, of any of its claims;
(11) the acting as agent for 5[* * *] the 6[Central Government] 7[or any 8[State] Government 9[* * *] or any local authority 10[* * *] 11[or the Industrial Finance Corporation of India 12[* * *] 13[or any other body corporate which is established or constituted by or under any other law] 14[or the Government of any such country outside India or 15[any such person or authority] as may be approved in this behalf by the Central Government] in the transaction of any of the following kinds of business, namely; –
(a) the purchase and sale of gold or silver 16[or foreign exchange];
1 Subs. by Act 79 of 1956, s.43 and Sch.II for “or any of its subsidiary banks” (w.e.f. 22-10-1956).
2 Ins. by Act 18 of 1957, s.2.
3 Ins. by Act 53 of 1987 (w.e.f. 9-7-1988).
4 Ins. by Act 38 of 1959, s.64 and Sch. III (w.e.f. 10-9-1959).
5 The words “the Secretary of State” omitted by the A. O. 1948.
6 Subs. by the M. O. 1937, for “G. G. in C”.
7 Subs. M. O. 1937, for certain words.
8 Subs. by the A. O. 1950, for “Provincial”.
9 The words “or the Government of Burma; omitted by Act 11 of 1947, s.11 (w.e.f. 1-4-1947).
10 The words and letter “or any Part B State” omitted by Act 32 of 1951, s.7 (w.e.f. 1-11-1951).
11 Ins. by Act 44 of 1959, s.2.
12 Certain words omitted by Act 24 of 1978, s.4 (w.e.f. 21-7-1978).
13 Ins. by Act 51 of 1974, s.6.
14 Ins. by Act 32 of 1951, s.7 (w.e.f. 1-11-1951).
15 Subs. by Act 51 of 1974, s.6 for “any such person”.
16 Ins. by Act 23 of 1947, s.3.
(b) the purchase, sale, transfer and custody of bills of exchange, securities or shares in any company;
(c) the collection of the proceeds, whether principal, interest or dividends, of any securities or shares:
(d) the remittance of such proceeds, at the risk of the principal, by bills of exchange payable either in India or elsewhere;
(e) the management of public debt;
1[(f)2[* * *] the issue and management of 3[* * *] bonds and debentures];
4[(11A) the acting as agent for the Central Government, –
5[(a) in guaranteeing the due performance by any small scale industrial concern, approved by the Central Government, of its obligations to any bank or other financial institution in respect of loans and advances made, or other credit facilities provided, to it by such bank or other financial institution and the making as such agent of payments in connection with such guarantee, and
(b) in administering any scheme for subsidising the rate of interest or other charges in relation to any loans or advances made, or other credit facilities provided, by banks or other financial institutions for the purpose of financing or facilitating any export from India and the making as such agent of payments on behalf of the Central Government;]
6[(12) the purchase and sale of gold or silver coins and gold and silver bullion and foreign exchange and the opening of a gold account with the principal currency authority of any foreign country or the Bank for International Settlements or any international or regional bank or financial institution formed by such principal currency authority or authorities or by the Government of any foreign country;]
7[(12A) the purchase and sale of securities issued by the Government of any country outside India or by any institution or body corporate established outside India and expressed to be payable in a foreign currency or any
1 Ins. by Act 44 of 1949, s.2.
2 The words “in respect of the aforesaid Corporation” omitted by Act 51 of 1974, s.6.
3 The word “its” omitted by s.6, Act 51 of 1974.
4 Subs. by Act 58 of 1968, s.24, for cl. (11A) (w.e.f. 1-2-1969). Original cl. (11A) was ins. by Act 14 of 1960, s.2.
5 Sub-clause (a) of clause (11A) shall stand omitted by Act 21 of 1978, s.9.
6 Subs. by Act 24 of 1978, s.4, for cl, (12) (w.e.f. 21-7-1978).
7 Subs. by Act 24 of 1978, s.4, for cl. 12A (w.e.f. 21-7-1978).
international or composite currency unit, being in the case of purchase by the Bank securities maturing within a period of ten years from the date of purchase:
Provided that in the case of securities of an institution or body corporate, the repayment of principal and payment of interest in respect of such securities shall be guaranteed by the Government of the country concerned];
1[(12AA) lending or borrowing of securities of the Central Government or a State Government or of such securities of a local authority as may be specified in this behalf by the Central Government or foreign securities;
(12AB) dealing in repo or reverse repo:
Provided that lending or borrowing of funds by way of repo or reverse repo shall not be subject to any limitation contained in this section.
Explanation.– For the purposes of this clause,–
(a) “repo” means an instrument for borrowing funds by selling securities of the Central Government or a State Government or of such securities of a local authority as may be specified in this behalf by the Central Government or foreign securities, with an agreement to repurchase the said securities on a mutually agreed future date at an agreed price which includes interest for the funds borrowed;
(b) “reverse repo” means an instrument for lending funds by purchasing securities of the Central Government or a State Government or of such securities of a local authority as may be specified in this behalf by the Central Government or foreign securities, with an agreement to resell the said securities on a mutually agreed future date at an agreed price which includes interest for the funds lent.]
2[(12B) the making of loans and advances in foreign currencies to scheduled banks, 3[****] 4[the Exim Bank], 5[the Reconstruction Bank or the Small Industries Bank], the Industrial Finance Corporation, any State Financial Corporation and any other financial institution as may, on the recommendation of the Bank, be approved by the Central Government and on such terms and conditions as may be specified by the Central Board in this behalf, against promissory notes of such bank or financial institution, as the case may be:
1 Ins. by sec. 2 of the RBI (Amendment) Act, 2006 (Act No. 26 of 2006) (w.e.f. 9.1.2007).
2 Ins. by s.4, Act 24 of 1978 (w.e.f. 21-7-1978).
3 The words “the Development Bank” omitted by the Industrial Development Bank (Transfer of Undertaking and Repeal) Act, 2003 (Act No.53 of 2003), Sec. 2(b).
4 Ins. by Act 28 of 1981, s.40 and Sch.II (w.e.f. 1-1-1982).
5 Ins. by Act 39 of 1989.
Provided that the borrowing bank or financial institution, as the case may be, furnishes a declaration in writing to the effect that –
(a) it has made loans and advances in foreign currencies for financing international trade or for the import of capital goods or for such other purposes as may be approved by the Central Government; and
(b) that the amount of loans or advances so made and outstanding at any time will not be less than the outstanding amount of the loans or advances obtained by it from the Bank;]
1[(13) the opening of an account with an office outside India of any bank, including a bank incorporated in India or the making of an agency agreement with, and the acting as an agent or correspondent of, any bank incorporated outside India, or the principal currency authority of any country under the law for the time being in force in that country or any international or regional bank or financial institution formed by such principal currency authorities or foreign governments, and the investing of the funds of the Bank in the shares and securities of any such international or regional bank or financial institution or of any other foreign institution as may be approved by the Central Board in this behalf];
2[(13A) participation in any arrangement for the clearing and settlement of any amounts due from, or to, any person or authority on account of the external trade of India with any other country or group of countries or of any remittances to, or from, that country or group of countries, including the advancing, or receiving, of any amount in any currency in connection therewith, and, for that purpose, becoming, with the approval of the Central Government, a member of any international or regional clearing union of central banks, monetary or other authorities, or being associated with any such clearing arrangements, or becoming a member of any body or association formed by central banks, monetary or other similar authorities, or being associated with the same in any manner];
(14) the borrowing of money for a period not exceeding one month for the purposes of the business of the Bank, and the giving of security for money so borrowed:
Provided that no money shall be borrowed under this clause from any person in India 3[* * *] other than a scheduled bank 4[* * *] or from any person outside India 5[* * *] other than a bank which is the principal currency authority of any country under the law for the time being in force in that country:
1 Subs. by Act 24 of 1978, s.4 for cl. (13) (w.e.f. 21-7-1978).
2 Ins. by Act 44 of 1973, s.2 (retrospectively).
3 The words “or Burma” ins. by the M. O. 1937, omitted by Act 11 of 1947, s.11, (w.e.f. 1-4-1947).
4 The words “or a Burma Scheduled Bank” ins. by the M. O. 1937, omitted by s.11, Act 11 of 1947 (w.e.f. 1-4-1947).
5 The words “and Burma” ins. by the M. O. 1937, omitted by s.11, Act 11 of 1947 (w.e.f. 1-4-1947).
Provided further that the total amount of such borrowing from persons in India 1[* * *] shall not at any time exceed the amount of the 1[capital] of the Bank:
2[* * * * *]
(15) the making and issue of bank notes subject to the provisions of this Act
3[* * *];
4[* * *]
5[(15A) the exercise of powers and functions and the performance of duties entrusted to the Bank under this act or under any other law for the time being in force;]
6[(15B) the providing of facilities for training in banking and for the promotion of research, where, in the opinion of the Bank, such provision may facilitate the exercise by the Bank of its powers and functions, or the discharge of its duties;]
(16) generally, the doing of all such matters and things as may be incidental to or consequential upon the exercise of its powers or the discharge of its duties under this Act 7[* * *].
18. Power of direct discount.
8[* * *] When, in the opinion of the 9[Bank] 10[* * *], a special occasion has arisen making it necessary or expedient that action should be taken 11[under this section] for the purpose of regulating credit in the interests of Indian 12[* * *] trade, commerce, industry and agriculture, the Bank may, notwithstanding any limitation contained in 13[* * *] section 17, –
1 Subs. by Act 32 of 1951, s.7, for “share capital” (w.e.f. 1-11-1951).
2 Cl. (14A) Ins. by Act 79 of 1956, s.43 and Sch.II (w.e.f. 22-10-1956), omitted by Act 38 of 1959, s.64 and Sch.III (w.e.f. 1-10-1959).
3 The words “and the making and issue of Burma notes in accordance with the law of Burma” ins. by the M. O. 1937, omitted by Act 11 of 1947, s.11 (w.e.f. 1-4-1947).
4 The word “and” omitted by ordinance 47 of 1945, s.6.
5 Subs. by Act 23 of 1955, s.52 and Sch.III for cl. (15A) (w.e.f. 1-7-1955).
6 Ins. by Act 58 of 1968, s.24 (w.e.f. 1-2-1969).
7 The words “and the law of Burma” ins. by the M. O. 1937, omitted by Act 11 of 1947, s.11 (w.e.f. 1-4- 1947).
8 The brackets and figure “(1)” omitted by Act 51 of 1974, s.7.
9 Subs. by Act 32 of 1951, s.8 for “Central Board” (w.e.f. 1-1-1949).
10 Certain words omitted by Act 62 of 1948, s.7 and Sch. (w.e.f. 1-1-1949).
11 Subs. by Act 51 of 1974, s.7, for “under this sub-section”.
12 The words “or Burma” ins. by the M. O. 1937, omitted by Act 11 of 1947, s.12 (w.e.f. 1-4-1947).
13 Certain words omitted by Act 51 of 1974, s.7.
1[(1) purchase, sell or discount any bill of exchange or promissory note though such bill or promissory note is not eligible for purchase or discount by the Bank under that section; or]
2[* * * * *]
3[(3) make loans or advances to –
(a) a State co-operative bank, or
(b) on the recommendation of a State co-operative bank, to a co- operative society registered within the area in which the State co- operative bank operates, or
(c) any other person, repayable on demand or on the expiry of fixed periods, not exceeding ninety days, on such terms and conditions as the Bank may consider to be sufficient.]
4[* * * * * * *]
5[* * * * * * *]
6[18A. Validity of loan or advance not to be questioned.
Notwithstanding anything to the contrary contained in any other law for the time being in force, –
(a) the validity of any loan or advance granted by the Bank in pursuance of the provisions of this Act shall not be called in question merely on the ground of non-compliance with the requirements of such other law as aforesaid or of any resolution, contract, memorandum, articles of association or other instrument:
Provided, that nothing in this clause shall render valid any loan or advance obtained by any company or co-operative society where such company or co-operative society is not empowered by its memorandum to obtain loans or advances;
(b) where a loan or advance has been granted under clause (3A) or under clause (3B) of section 17 or a loan or advance granted under clause (3) of section 18 by the Bank to any person has been applied by such person,
1 Subs. by s.7, Act 51 of 1974, for the former clause.
2 Cl. 2 omitted by Act 24 of 1978, s.5 (w.e.f. 21-7-1978).
3 Subs. by s.7, Act 51 of 1974, for the former clause.
4 The proviso omitted by Act 62 of 1948, s.7 and Sch. (w.e.f. 1-1-1949).
5 Sub-section (2) omitted by Act 51 of 1974, s.7.
6 Ins. by s. 8, Act 51 of 1974.
wholly or in part, in making a loan or advance to any borrowers, any sum received –
(i) by the borrowing bank on account of bills of exchange in respect of which the declaration under clause (i) of the proviso to clause (3A) of section 17 has been furnished or in repayment or realisation of the outstanding loans and advances referred to in clause (ii) of the said proviso or in the proviso to clause (3B) of the said section, or
(ii) by the borrowing bank or any other person in repayment or realisation of loans and advances granted to a borrower out of funds obtained by it or by him from the Bank under section 18, shall be utilised only for the repayment by the borrowing bank or other person, as the case may be, of the amounts due to be repaid by it or by him to the Bank, and shall be held by it or by him in trust for the Bank, until such time as the amounts are so repaid.]
19. Business which the Bank may not transact.
Save as otherwise provided in sections 17, 18, 1[42] and 45, the Bank may not –
(1) engage in trade or otherwise have a direct interest in any commercial, industrial, or other undertaking except such interest as it may in any way acquire in the course of the satisfaction of any of its claims:
Provided that all such interests shall be disposed of at the earliest possible moment;
2[(2) purchase the shares of any banking company or of any other company, or grant loans upon the security of any such shares;]
(3) advance money on mortgage of, or otherwise on the security of, immovable property or documents of title relating thereto, or become the owner of immovable property, except so far as is necessary for its own business premises and residences for its officers and servants;
(4) make loans or advances;
(5) draw or accept bills payable otherwise than on demand;
(6) allow interest on deposits or current accounts.
1 Ins. by Act 38 of 1956, s.2 (w.e.f. 6-10-1956).
2 Subs. by Act 32 of 1951, s.9, for cl. (2) (w.e.f. 1-11-1951).
CHAPTER III
CENTRAL BANKING FUNCTIONS
20. Obligation of the Bank to transact Government business.
The Bank shall undertake to accept monies for account of 1[* * *] the Central Government 2[* * *] and to make payments up to the amount standing to the credit of 3[its account], and to carry out 4[its exchange], remittance and other banking operations, including the management of the public debt 5[of the Union].
6[* * * *]
21. Bank to have the right to transact Government business in India.
(1) The 7[Central Government] 8[* * *] shall entrust the Bank, on such conditions as may be agreed upon, with all 9[its] money, remittance, exchange and banking transactions in India, and, in particular, shall deposit free of interest all 10[its] cash balances with the Bank:
Provided that nothing in this sub-section shall prevent the 11[Central Government] 12[* * *] from carrying on money transactions at places where the Bank has no branches or agencies, and the 13[Central Government] 14[***] may hold at such places such balances as 15[it] may require.
1 Subs. by the M.O. 1937 for certain words.
2 The words and letter “and the Governments of Part A States” omitted by Act 37 of 1956, s. 104 (w.e.f. 1-11-1956).
3 Subs. by s. 104, Act 37 of 1956, for “their accounts respectively” (w.e.f. 1-11-1956).
4 Subs. by s. 104, Act 37 of 1956, for “their exchange” (w.e.f. 1-11-1956).
5 Ins. by s. 104, Act 37 of 1956, (w.e.f. 1-11-1956).
6 S. 20A Transaction of business for British Military Administration, Burma) which was temporarily inserted by Ordinance 19 of 1945 has now been omitted owing to the repeal of the Ordinance by Act 11 of 1947.
7 Subs. by the M.O. 1937, for “G.G. in C.”
8 The words “and the State Governments” omitted by Act 37 of 1956, s. 104 (w.e.f. 1-11-1956).
9 Subs. by s. 104, Act 37 of 1956, for “their” (w.e.f. 1-11-1956).
10 Subs. by s. 104, Act 37 of 1956, for “their” (w.e.f. 1-11-1956).
11 Subs. by the M.O. 1937, for “G.G. in C.”
12 The words “or any State Government” omitted by s. 104, Act 37 of 1956, (w.e.f. 1-11-1956).
13 Subs. by the M.O. 1937, for “G.G. in C.”
14 The words “and the State Governments” omitted by Act 37 of 1956, s. 104 (w.e.f. 1-11-1956).
15 Subs. by s. 104, Act 37 of 1956, for “their” (w.e.f. 1-11-1956).
(2) The 1[Central Government] 2[***] shall entrust the Bank, on such conditions as may be agreed upon, with the management of the public debt and with the issue of any new loans.
(3) In the event of any failure to reach agreement on the conditions referred to in this section the 3[Central Government] shall decide what the conditions shall be.
4[(4) Any agreement made under this section shall be laid, as soon as may be after it is made, before Parliament.]
5[* * * *]
6[21A. Bank to transact Government business of States on agreement.
(1) The Bank may by agreement with the Government of any 7[***] State 8[* * *] undertake–
(a) all its money, remittance, exchange and banking transactions in India, including in particular, the deposit, free of interest, of all its cash balances with the Bank; and
(b) the management of the public debt of, and the issue of any new loans by, that State.
(2) Any agreement made under this section shall be laid, as soon as may be after it is made, before Parliament.]
9[21B. Effect of agreements made between the Bank and certain States before the 1st November, 1956.
(1) Any agreement made under section 21 or section 21A between the Bank and the Government of a State specified in the Explanation below and in force immediately before the 1st day of November, 1956, shall, as from that day have effect as if it were an agreement made on that day under section 21A between the Bank and the Government of the corresponding State subject to
1 Subs. by the M.O. 1937, for “G.G. in C.”
2 The words “and each State Government” omitted by s. 104, Act 37 of 1956, (w.e.f. 1-11-1956).
3 Subs. by the M.O. 1937, for “G.G. in C.”
4 Subs. by s. 104 Act 37 of 1956, for sub-section (4) (w.e.f. 1-11-1956).
5 Sub-section (5) ins. by Act. 32 of 1951, s. 11 (w.e.f. 1-11-1951), omitted by Act 37 of 1956, s. 104 (w.e.f. 1-11-1956).
6 Ins. by Act 32 of 1951, s. 12 (w.e.f. 1-11-1951).
7 The word and letter “Part B” omitted by Act 37 of 1956, s. 104 (w.e.f. 1-11-1956).
8 The brackets and words “(including the autonomous State of Meghalaya)” ins. by Act 55 of 1969, s. 75 were omitted by Act 81 of 1971, s. 72 (w.e.f. 21-1-1972).
9 Ins. by Act 37 of 1956, s. 104 (w.e.f. 1-11-1956).
such modifications, if any, being of a character not affecting the general operation of the agreement, as may be agreed upon between the Bank and the Government of the corresponding State, or in default of such agreement, as may be made therein by order of the Central Government.
Explanation.– In this sub-section ‘‘corresponding State’’ means,–
(a) in relation to the agreement between the Bank and the State of Andhra, the State of Andhra Pradesh;
(b) in relation to the agreement between the Bank and any other Part- A State as it existed before the 1st day of November, 1956, the State with the same name, and
(c) in relation to the agreement between the Bank and the Part B State of Mysore or Travancore-Cochin as it existed before the 1st day of November, 1956, the State of Mysore or Kerala respectively.
(2) Any agreement made under section 21A between the Bank and the Government of the Part B State of Hyderabad, Madhya Bharat or Saurashtra shall be deemed to have terminated on the 31st day of October, 1956.]
22. Right to issue bank notes.
(1) The Bank shall have the sole right to issue bank notes in 1[India], and may, for a period which shall be fixed by the 2[Central Government] on the recommendation of the Central Board, issue currency notes of the Government of India supplied to it by the 3[Central Government], and the provisions of this Act applicable to bank notes shall, unless a contrary intention appears, apply to all currency notes of the Government of India issued either by the 4[Central Government] or by the Bank in like manner as if such currency notes were bank notes, and references in this Act to bank notes shall be construed accordingly.
(2) On and from the date on which this Chapter comes into force the 5[Central Government] shall not issue any currency notes.
23. Issue Department.
(1) The issue of bank notes shall be conducted by the Bank in an Issue Department which shall be separated and kept wholly distinct from the Banking Department, and the assets of the Issue Department shall not be subject to any liability other than the liabilities of the Issue Department as hereinafter defined in section 34.
1 Subs. by Act 32 of 1951, s. 2, for “the States” (w.e.f. 1-11-1951).
2 Subs. by the M.O. 1937, for “G.G. in C”.
3 Subs. by the M.O. 1937, for “G.G. in C”.
4 Subs. by the M.O. 1937, for “G.G. in C”.
5 Subs. by the M.O. 1937, for “G.G. in C”.
(2) The Issue Department shall not issue bank notes to the Banking Department or to any other person except in exchange for other bank notes or for such coin, bullion or securities as are permitted by this Act to form part of the Reserve.
1[* * * * *]
2[24. Denominations of notes.
(1) Subject to the provisions of sub-section (2), bank notes shall be of the denominational values of two rupees, five rupees, ten rupees, twenty rupees, fifty rupees, one hundred rupees, five hundred rupees, one thousand rupees, five thousand rupees and ten thousand rupees or of such other denominational values, not exceeding ten thousand rupees, as the Central Government may, on the recommendation of the Central Board, specify in this behalf.
(2) The Central Government may, on the recommendation of the Central Board, direct the non-issue or the discontinuance of issue of bank notes of such denominational values as it may specify in this behalf.]
25. Form of bank notes.
The design, form and material of bank notes shall be such as may be approved by the 3[Central Government] after consideration of the recommendations made by Central Board.
26. Legal tender character of notes.
(1) Subject to the provisions of sub-section (2), every bank note shall be legal tender at any place in 4[India] in payment or on account for the amount expressed therein, and shall be guaranteed by the 5[Central Government].
(2) On recommendation of the Central Board the 6[Central Government] may, by notification in the Gazette of India, declare that, with effect from such date as may be specified in the notification, any series of bank notes of any denomination shall cease to be legal tender 7[save at such office or agency of the Bank and to such extent as may be specified in the notification].
1 Sub-section (3) ins. by the M.O. 1937, omitted by Act 11 of 1947, s. 13 (w.e.f. 1-4-1947).
2 Subs. by Act 58 of 1968, s. 25, for s. 24 (w.e.f. 1-2-1969).
3 Subs. by the M.O. 1937, for “G.G. in C.”.
4 Subs. by Act 32 of 1951, s. 2, for “the States” (w.e.f. 1-11-1951).
5 Subs. by the M.O. 1937, for “G.G. in C.”.
6 Subs. by the M.O. 1937, for “G.G. in C.”.
7 Subs. by Act 32 of 1951, s. 13, for “save at an office or agency of the Bank” (w.e.f. 1-11-1951).
1[* * * * *]
2[26A. Certain bank notes to cease to be legal tender.
Notwithstanding anything contained in section 26, no bank note of the denominational value of five hundred rupees, one thousand rupees or ten thousand rupees issued before the 13th day of January, 1946, shall be legal tender in payment or on account for the amount expressed therein.]
27. Re-issue of notes.
The Bank shall not re-issue bank notes which are torn, defaced or excessively soiled.
28. Recovery of notes lost, stolen, mutilated or imperfect.
3[* * *] Notwithstanding anything contained in any enactment or rule of law to the contrary, no person shall of right be entitled to recover from the 4[Central Government] or the Bank, the value of any lost, stolen, mutilated or imperfect currency note of the Government of India or bank note:
Provided that the Bank may, with the previous sanction of the 5[Central Government], prescribe the circumstances in and the conditions and limitations subject to which the value of such currency notes or bank notes may be refunded as of grace and the rules made under this proviso shall be laid on the table 6[* * *] of 7[Parliament].
8[* * * * *]
9[28A. Issue of special bank notes and special one rupee notes in certain cases.
1 Sub-section (3) ins. by the M.O. 1937, omitted by Act 11 of 1947, s. 14 (w.e.f. 1-4-1947).
2 Ins. by Act 62 of 1956, s. 2 and Sch. (w.e.f. 1-11-1956).
3 The brackets and figure “(1)” and sub-section (2) ins. by the M.O. 1937, omitted by Act 11 of 1947, s. 15 (w.e.f. 1-4-1947).
4 Subs. by the M.O. 1937, for “G.G. in C.”.
5 Subs. by M.O. 1937 for “G. G. in C”.
6 The words “of both Houses” omitted by the A.O. 1948.
7 Subs. by the A. O. 1950. for “the Central Legislature”.
8 The brackets and figure (I) and sub. section (2) ins. by the M.O. 1937, omitted by Act 11 of 1947, s. 15 (w.e.f. 1-4-1947).
9 Ins. by Act 14 of 1959, s. 2.
(1) For the purpose of controlling the circulation of bank notes without India, the Bank may, notwithstanding anything contained in any other provision of this Act, issue bank notes of such design, form and material as may be approved under sub-section (3) (hereinafter in this section referred to as special bank notes) of the denominational values of five rupees, ten rupees and one hundred rupees.
(2) For the purpose of controlling the circulation of Government of India one rupee notes without India, the Central Government may, notwithstanding anything contained in any other provision of this Act or in the Currency Ordinance, 1940, issue Government of India notes of the denominational value of one rupee of such design, form and material as may be adopted under sub-section (3) (hereinafter in this section referred to as special one rupees notes).
(3) The design, form and material of the special bank notes shall be such as may be approved by the Central Government after consideration of the recommendations made by the Governor and of the special one rupee notes shall be such as the Central Government may think fit to adopt.
(4) Neither the special bank notes nor the special one rupee notes shall be legal tender in India.
(5) The special one rupee note shall be deemed to be included in the expression ‘‘rupee coin’’ for all the purposes of this Act except section 39, but shall be deemed not to be a currency note for any of the purposes of this Act.
(6) Where a special bank note is on its face expressed to be payable at a specified office or branch of the Bank, the obligation imposed by section 39 shall be only on the specified office or branch and, further, shall be subject to such regulations as may be made under this section.
(7) The Bank may, with the previous sanction of the Central Government, make regulations to provide for all matters for which provision is necessary or convenient for the purpose of giving effect to the provisions of this section, and, in particular, the manner in which, and the conditions or limitations subject to which–
(i) bank notes and one rupee notes in circulation in any country outside India may be replaced by special notes issued under this section;
(ii) any such special notes may be exchanged for any other bank notes or one rupee notes].
29. Bank exempt from stamp duty on bank notes.
The Bank shall not be liable to the payment of any stamp duty under the Indian Stamp Act, 1899, in respect of bank notes 1[* * *] issued by it.
30. Powers of Central Government to supersede Central Board.
1 The words “or Burma notes” ins. by the M.O. 1937, omitted by Act 11 of 1947, s. 16 (w.e.f. 1-4-1947).
(1) If in the opinion of the 1[Central Government] the Bank fails to carry out any of the obligations imposed on it by or under this Act 2[* * *] 3[the Central Government] may, by notification in the Gazette of India, declare the Central Board to be superseded, and thereafter the general superintendence and direction of the affairs of the Bank shall be entrusted to such agency as the 4[Central Government] may determine, and such agency may exercise the powers and do all acts and things which may be exercised or done by the Central Board under this Act.
(2) When action is taken under this section the 5[Central Government] shall cause a full report of the circumstances leading to such action and of the action taken to be laid before 6[Parliament] at the earliest possible opportunity and in any case within three months from the issue of the notification superseding the Board.
31. Issue of demand bills and notes.
7[(1)] No person in 8[India] other than the Bank or, as expressly authorized by this Act, the 9[Central Government] shall draw, accept, make or issue any bill of exchange, hundi, promissory note or engagement for the payment of money payable to bearer on demand, or borrow, owe or take up any sum or sums of money on the bills, hundis or notes payable to bearer on demand of any such person:
Provided that cheques or drafts, including hundis, payable to bearer on demand or otherwise may be drawn on a person’s account with a banker, shroff or agent.
10[(2) notwithstanding anything contained in the Negotiable Instruments Act, 1881, no person in 11[India] other than the Bank or, as expressly authorised by this Act, the Central Government shall make or issue any promissory note expressed to be payable to the bearer of the instrument.]
32. [Penalty.]
1 Subs. by the M.O. 1937, for “G.G. in C”.
2 The words “or by or under the law of Burma” ins. by the M.O. 1937, omitted by Act 11 of 1947, s. 17 (w.e.f. 1-4-1947).
3 Subs. by the M.O. 1937, for “he”.
4 Subs. by the M.O. 1937, for “G.G. in C”.
5 Subs. by the M.O. 1937, for “G.G. in C”.
6 Subs. by the A.O. 1950, for “the Central Legislature”.
7 S. 31 re-numbered as sub-section (1) of that section by Act 23 of 1946, s. 2.
8 Subs. by Act. 32 of 1951, S. 2. for “the states” (w.e.f. 1-11-1951).
9 Subs. by the M.O. 1937, for “G.G. in C”.
10 Ins. by Act 23 of 1946, s. 2.
11 Subs. by Act 32 of 1951, s. 2, for “the States” (w.e.f. 1-11-1951).
[Rep. by the Reserve Bank of India [Amendment] Act, 1974 (51 of 1974), S. 9.]
33. Assets of the Issue Department.
(1) The assets of the Issue Department shall consist of gold coin, gold bullion, 1[foreign securities], rupee coin and rupee securities to such aggregate amount as is not less than the total of the liabilities of the Issue Department as hereinafter defined.
2[(2) The aggregate value of the gold coin, gold bullion and foreign securities held as assets and the aggregate value of the gold coin and gold bullion so held shall not at any time be less than two hundred crores of rupees and one hundred and fifteen crores of rupees, respectively.]
3[(3) The remainder of the assets shall be held in rupee coin, Government of India rupee securities of any maturity, promissory notes drawn by the National Bank for any loans or advances under clause (4E) of section 17 and such bills of exchange and promissory notes payable in India as are eligible for purchase by the Bank under sub-clause (a) or sub-clause (b) or sub- clause (bb) of clause (2) of section 17 or under clause (1) of section 18.]
(4) For the purposes of this section, gold coin and gold bullion shall be valued at 4[a price not exceeding the international market price for the time being obtaining], rupee coin shall be valued at its face value, and securities shall be valued 5[at rates not exceeding the market rates] for the time being obtaining.
(5) Of the gold coin and gold bullion held as assets, not less than seventeen- twentieths shall be held in 6[India], and all gold coin and gold bullion held as assets shall be held in the custody of the Bank or its agencies;
Provided that gold belonging to the Bank which is in any other bank or in any mint or treasury or in transit may be reckoned as part of the assets.
7[(6) For the purposes of this section, the foreign securities which may be held as part of the assets shall be –
(i) securities of the following kinds payable in the currency of any foreign country which is a member of the International Monetary Fund, namely:–
(a) balances with the bank which is the principal currency authority of that foreign country and any other balances or securities in foreign
1 Subs. by Act 62 of 1948, s. 7, and Sch., for “sterling securities” (w.e.f. 1-1-1949).
2 Subs. by Act 48 of 1957, s. 2, (w.e.f. 31-10-1957).
3 Subs. by Act 61 of 1981, s. 61 and Sch. II, for sub-section (3) (w.e.f. 12-7-1982).
4 Subs. by Act 8 of 1991, s. 2, for “0.118489 grammes of fine gold per rupee” (w.e.f. 15-10-1990).
5 Subs. by Act 58 of 1968, s. 26, for “at the market rate” (w.e.f. 1-2-1969).
6 Subs. by Act 32 of 1951, s. 2, for “the States” (w.e.f. 1-11-1951).
7 Subs. by Act 51 of 1974, s. 10 for sub-section (6).
currency maintained with or issued by the International Monetary Fund, the International Bank for Reconstruction and Development, the International Development Association or the International Finance Corporation 1[or Asian Development Bank] or the Bank for International Settlements or 2[any banking or financial institution 3[approved] by the Central Government] in this behalf, provided that they are repayable within a 4[period of ten years];
(b) bills of exchange bearing two or more good signatures and drawn on and payable at any place in that foreign country and having a maturity not exceeding ninety days; and
(c) Government securities of that foreign country maturing 5[within ten years];
(ii) any drawing rights representing a liability of the International Monetary Fund.]
34. Liabilities of the Issue Department.
(1) The liabilities of the Issue Department shall be an amount equal to the total of the amount of the currency notes of the Government of India and bank notes for the time being in circulation.
6[* * * * *]
7[* * * * *]
35. [Initial assets and liabilities.]
[Rep. by Act 62 of 1948. s. 7 and Sch.(w.e.f. 1-1-1949).]
36. [Method of dealing with fluctuations in rupee coin assets.]
[Rep. by Act 55 of 1963, s. 3 (w.e.f. 1-2-1964).]
8[37. Suspension of assets requirements as to foreign securities.
1 Ins. by Act 24 of 1978, s. 6 (w.e.f. 21-7-1978).
2 Subs. by s. 6, 24 of 1978, for certain words (w.e.f. 21-7-1978).
3 Subs. by Act 1 of 1984, s. 4, for “notified” (w.e.f. 15-2-1984).
4 Subs. by Act 24 of 1978, s. 6, for “period of five years” (w.e.f. 21-7-1978).
5 Subs. by s. 6, Act 24 of 1978, for “within five years” (w.e.f. 21-7-1978).
6 Sub-section (2) omitted by Act 55 of 1963, s. 2 (w.e.f. 1-2-1964).
7 Sub-section (3) ins. by the M.O. 1937, omitted by Act 11 of 1947, s. 19 (w.e.f. 1-4-1947).
8 Subs. by Act 38 of 1956, s. 4, for s. 37 (w.e.f. 6-10-1656).
Notwithstanding anything contained in the foregoing provisions, the Bank may, with the previous sanction of the Central Government, for periods not exceeding six months in the first instance, which may, with the like sanction, be extended from time to time by periods not exceeding three months at a time, hold as assets foreign securities of less amount in value than that required by sub-section (2) of section 33.
1[* * * * *]
38. Obligations of Government and the Bank in respect of rupee coin.
The 2[Central Government] shall undertake not 3[* * *] to put into circulation any rupees, except through the Bank 4[* * *]; and the Bank shall undertake not to dispose of rupee coin otherwise than for the purposes of circulation 5[* * *].
39. Obligation to supply different forms of currency.
(1) The Bank shall issue rupee coin on demand in exchange for bank notes and currency notes of the Government of India, and shall issue currency notes or bank notes on demand in exchange for coin which is legal tender under the Indian Coinage Act, 1906.
(2) The Bank shall, in exchange for currency notes or bank notes of 6[two] rupees or upwards, supply currency notes or bank notes of lower value or other coins which are legal tender under the Indian Coinage Act, 1906, in such quantities as may, in the opinion of the Bank, be required for circulation; and the 7[Central Government] shall supply such coins to the Bank on demand. If the 8[Central Government] at any time fails to supply such coins, the Bank shall be released from its obligations to supply them to the public.
9[40. Transactions in foreign exchange.
The Bank shall sell to or buy from any authorised person who makes a demand in that behalf at its office in Bombay, Calcutta, Delhi or Madras 10[or at such of its branches as the Central Government may, by order, determine],
1 Proviso omitted by Act 48 of 1957, s. 3 (w.e.f. 31-10-1957).
2 Subs. by the M.O. 1937, for “G.G. in C.”.
3 Certain words omitted by Act 55 of 1963, s. 4 (w.e.f. 1-2-1964).
4 The words “and as provided in that section” omitted by Ordinance 4 of 1940, s. 3.
5 Certain words omitted by Act 55 of 1963, s. 4 (w.e.f. 1-2-1964).
6 Subs. by Act 62 of 1948, s. 7 and Sch., for “five” (w.e.f. 1-1-1949).
7 Subs. by the M.O. 1937, for “G.G. in C.”.
8 Subs. by the M.O. 1937, for “G.G. in C.”.
9 Subs. by Act 23 of 1947, s.4, for ss. 40 and 41.
10 Ins. by Act 54 of 1953, s. 5.
foreign exchange at such rates of exchange and on such conditions as the Central Government may from time to time by general or special order determine, having regard so far as rates of exchange are concerned to its obligations to the International Monetary Fund:
Provided that no person shall be entitled to demand to buy or sell foreign exchange of a value less than two lakhs of rupees.
Explanation.– In this section ‘‘authorised person’’ means a person who is entitled by or under the 1[Foreign Exchange Regulation Act, 1973], to buy, or as the case may be, sell, the foreign exchange to which his demand relates.]
41. [Obligation to buy sterling]
[Rep. by Act 23 of 1947, s. 4 (w.e.f. 18-4-1947).
2[41A. [Obligation to provide remittance between India and Burma.]
[Rep. by Act 11 of 1947, s. 22 (w.e.f. 1-4-1947).
42. Cash reserves of scheduled banks to be kept with the Bank.
3[(1) Every bank included in the Second Schedule shall maintain with the Bank an average daily balance the amount of which shall not be less than 4[such per cent. of the total of the demand and time liabilities in India of such bank as shown in the return referred to in sub-section (2), as the Bank may from time to time, having regard to the needs of securing the monetary stability in the country, notify in the Gazette of India]:
5[Provided that the Bank may, by notification in the Gazette of India, increase the said rate to such higher rate as may be specified in the notification so however that the rate shall not be more than 6[twenty per cent] of the total of the demand and time liabilities.]
Explanation.– For the purposes of this section,–
(a) ‘‘average daily balance’’ shall mean the average of the balances held at the close of business on each day 7[of a fortnight];
1 Subs. by Act 1 of 1984, s. 5, for “Foreign Exchange Act, 1947” (w.e.f. 15-2-1984).
2 Ins. by the M.O. 1937.
3 Subs. by Act 38 of 1956, s. 5, for sub-section (1) (w.e.f. 6-10-1956).
4 Subs. by sec. 3 of the RBI (Amendment) Act, 2006 (Act No. 26 of 2006) (w.e.f.1.4.2007) for the words “three per cent. of the total of the demand and time liabilities in India of such bank as shown in the return referred to in sub-section (2)”.
5 Subs. by s. 4, Act 35 of 1962, for the proviso.
6 Subs. by Act 9 of 1991, s. 2, for words “fifteen per cent”.
7 Subs. by Act 1 of 1984, s. 6, for “of a week” (w.e.f. 29-3-1985).
1[(b) ‘‘fortnight’’ shall mean the period from Saturday to the second following Friday, both days inclusive;]
2[(c) ‘‘liabilities’’ shall not include –
(i) the paid-up capital or the reserves or any credit balance in the profit and loss account of the bank;
(ii) the amount of any loan taken from the Bank 3[****] 4[or from the Exim Bank] 5[or from the Reconstruction Bank] 6[or from the National Housing Bank] or from the 7[National Bank] 8[* * *] or 9[from the Small Industries Bank].
(iii) in the case of a State co-operative bank, also any loan taken by such bank from a State Government 10[or from the National Co- operative Development Corporation established under the National Co- operative Development Corporation Act, 1962] and any deposit of money with such bank representing the reserve fund or any part thereof 11[* * *] maintained with it by any co-operative society within its area of operation;]
12[(iv) in the case of a State co-operative bank, which has granted an advance against any balance maintained with it, such balance to the extent of the amount outstanding in respect of such advance;]
13[(v) in the case of a Regional Rural Bank, also any loan taken by such bank from its Sponsor Bank;]
14[(d) the aggregate of the ‘‘liabilities’’ of a scheduled bank which is not a State co-operative bank, to,–
1 Subs. by s. 6, Act 1 of 1984, for cl. (b) (w.e.f. 29-3-1985).
2 Subs. by Act 23 of 1965, s. 6, for cl. (c) (w.e.f. 1-3-1966).
3 The words “or from the Development Bank” omitted by the Industrial Development Bank (Transfer of Undertaking and Repeal) Act, 2003 (Act No.53 of 2003), Sec. 3.
4 Ins. by Act 28 of 1981, s. 40 and Sch. II (w.e.f. 1-1-1982).
5 Ins. by Act 62 of 1984, s. 71 and Sch. III (w.e.f. 20-3-1985).
6 Ins. by Act 53 of 1987 s. 56 and the Second Schedule (w.e.f. 9-7-1988).
7 Subs. by Act 61 of 1981, s. 61 and Sch. II, for “Agricultural Refinance and Development Corporation” (w.e.f. 12-7-1982).
8 Certain words omitted by Act 51 of 1974, s. 11.
9 Ins. by Act 39 of 1989.
10 Ins. by Act I of 1984, s. 6 (w.e.f. 29-3-1985).
11 Certain words omitted by Act 51 of 1974, s. 11.
12 Ins. by Act 51 of 1974, s. 11.
13 Ins. by Act I of 1984, s. 6 (w.e.f. 29-3-1985).
14 Ins. by Act 51 of 1974, s. 11.
(i) the State Bank;
(ii) a subsidiary bank as defined in section 2 of the State Bank of India (Subsidiary Banks) Act, 1959;
(iii) a corresponding new bank constituted by section 3 of the Banking Companies (Acquisition and Transfer of Undertakings) Act, 1970:
1[(iiia) a corresponding new bank constituted by section 3 of the Banking Companies (Acquisition and Transfer of Undertakings) Act, 1980;]
(iv) a banking company as defined in clause (c) of section 5 of the Banking Regulation Act, 1949;
(v) a co-operative bank; or
(vi) any other financial institution notified by the Central Government in this behalf, shall be reduced by the aggregate of the liabilities of all such banks and institutions to the scheduled bank;
(e) the aggregate of the ‘‘liabilities’’ of a scheduled bank which is a State co-operative bank, to, –
(i) the State Bank;
(ii) a subsidiary bank as defined in section 2 of the State Bank of India (Subsidiary Banks) Act, 1959;
(iii) a corresponding new bank constituted by section 3 of the Banking Companies (Acquisition and Transfer of Undertakings) Act, 1970;
2[(iiia) a corresponding new bank constituted by section 3 of the Banking Companies (Acquisition and Transfer of Undertakings) Act, 1980:]
(iv) a banking company as defined in clause (c) of section 5 of the Banking Regulation Act, 1949; or
(v) any other financial institution notified by the Central Government in this behalf, shall be reduced by the aggregate of the liabilities of all such banks and institutions to the State Co-operative bank.]
(1A) Notwithstanding anything contained in sub-section (1), the Bank may, by notification in the Gazette of India, direct that every scheduled bank shall, with effect from such date as may be specified in the notification, maintain with the Bank, in addition to the balance prescribed by or under sub-section (1), an additional average daily balance the amount of which shall not be less
1 Ins. by Act I of 1984, s. 6 (w.e.f. 29-3-1985).
2 Ins. by Act 1 of 1984, s. 6 (w.e.f. 29-3-1985).
than the 1[rate specified in the notification, such additional balance being calculated with reference to the excess of the total of the demand and time liabilities of the bank as shown in the return referred to in sub-section (2) over the total of its demand and time liabilities] at the close of business on the date specified in the notification as shown by such return so however, that the additional balance shall, in no case, be more than such excess:
2[Provided that the Bank may, by a separate notification in the Gazette of India, specify different dates in respect of a bank subsequently, included in the Second Schedule.]
3[****]
4[(1C) The Bank may, for the purposes of this section, specify from time to time with reference to any transaction or class of transactions that such transaction or transactions shall be regarded as liability in India of a scheduled bank, and if any question arises as to whether any transaction or class of transactions shall be regarded, for the purposes of this section, as liability in India of a schedule bank, the decision of the Bank thereon shall be final.]
5[(2) Every scheduled bank shall send to the Bank a return signed by two responsible officers of such bank showing–
(a) the amount of its demand and time liabilities and the amount of its borrowings from banks in India 1[classifying them into demand and time liabilities],
1 Subs. by Act 35 of 1962, s. 4, for certain words.
2 Ins. by Act 1 of 1984, s. 6 (w.e.f. 29-3-1985). Prior to this, the proviso was omitted by Act 35 of 1962, s. 4, (w.e.f. 15-9-1962)
3 Sub-sections(1AA) and (1B) omitted by Act 26 of 2006, s. 3. Before omission, sub-setions (1AA) and (1B) stood as under:
[(1AA) Notwithstanding anything contained in sub-section (1) or subsection (1A), it shall not be necessary for any scheduled bank to maintain with the Bank any balance which shall be more than 3[twenty per cent] of the total of its demand and time liabilities as shown in the return referred to in sub-section (2).]
(1B) Where any scheduled bank maintains, in pursuance of a notification issued under the proviso to sub-section (1) or under sub-section (1A), any balance with the Bank the amount of which is not less than that required to be maintained by such notification, the Bank may pay to the scheduled bank interest at such rate or rates as may be determined by the Bank from time to time on the amount by which such balance actually maintained is in excess of the balance which the scheduled bank would have to maintain, if no such notification was issued:
Provided that no interest shall be payable on any such amount actually maintained as is in excess of the balance required to be maintained by or under sub-section (1) or under sub-section (1A).]
Provided further that where the Bank does not, under sub-section (5), demand the payment of the penalty imposed by sub-section (3), it may pay interest at such rate or rates as may be determined by the Bank from time to time on the amount actually maintained with it by the scheduled bank, notwithstanding that such amount is less than the balance required to be maintained in pursuance of a notification issued under the proviso to sub-section (1) or under sub-section (1A).]
4 Ins. by Act 1 of 1984, s. 6 (w.e.f. 29-3-1985).
5 Subs. by Act 32 of 1951, s. 16, for sub-section (2) (w.e.f. 1-11-1951).
2[* * * * *]
(b) the total amount of legal tender notes and coins held by it in India,
(c) the balance held by it at the Bank in India,
(d) the balances held by it at other banks in current account and the money at call and short notice in India.,
(e) the investments (at book value) in Central and State Government securities including treasury bills and treasury deposit receipts,
(f) the amount of advances in India,
(g) the inland bills purchased and discounted in India 3[and foreign bills purchased and discounted], 4[at the close of business on each alternate Friday, and every such return shall be sent not later than seven days after the date to which it relates]:
5[Provided that the Bank may, by notification in the Gazette of India, delete or modify or add to any of the particulars specified in the foregoing clauses:
Provided further that where 6[such alternate] Friday is a public holiday under the Negotiable Instruments Act, 1881, for one or more offices of a scheduled bank, the return shall give the preceding working day’s figures in respect of such office or offices, but shall nevertheless be deemed to relate to that Friday:
7[Provided also that where the Bank is satisfied that the furnishing of a fortnightly return under this sub-section is impracticable in the case of any scheduled bank by reason of the geographical position of the bank and its branches, the Bank may allow such bank –
(i) to furnish a provisional return for the fortnight within the period aforesaid to be followed by a final return not later than twenty days after the date to which it relates, or
(ii) to furnish in lieu of a fortnightly return a monthly return to be sent not later than twenty days after the end of the month to
1 Subs. by Act 51 of 1974, s. 11, for certain words.
2 Cl. (aa) omitted by s. 11, Act 51 of 1974.
3 Ins. by Act 54 of 1953, s. 6.
4 Subs. by Act 1 of 1984, s. 6 for certain words (w.e.f. 29-3-1985).
5 Subs. by Act 51 of 1974, s. 11, for “Provided that”.
6 Ins. by Act 1 of 1984, s. 6 (w.e.f. 29-3-1985).
7 Subs by Act 1 of 1984 s. 6, for the third proviso (w.e.f. 29-3-1985).
which it relates giving the details specified in this sub-section in respect of such bank at the close of business for the month.]]
1[(2A) Where the last Friday of a month is not an alternate Friday for the purpose of sub-section (2), every scheduled bank shall send to the Bank, a special return giving the details specified in sub-section (2) as at the close of business on such last Friday or where such last Friday is a public holiday under the Negotiable Instruments Act, 1881 as at the close of business on the preceding working day and such return shall be sent not later than seven days after the date to which it relates.]
2[(3) If the average daily balance held at the Bank by a scheduled bank during any 3[fortnight] is below the minimum prescribed by or under sub- section (1) or sub-section (1A), such Scheduled bank shall be liable to pay to the Bank in respect of that 4[fortnight] penal interest at a rate of three per cent, above the bank rate on the amount by which such balance with the Bank falls short of the prescribed minimum, and if during the next succeeding 5[fortnight], such average daily balance is still below the prescribed minimum the rates of penal interest shall be increased to a rate of five per cent, above the bank rate in respect of that 6[fortnight) and each subsequent 7[fortnight) during which the default continues on the amount by which such balance at the Bank falls short of the prescribed minimum.]
8[(3A) When under the provisions of sub-section (3) penal interest at the increased rate of five per cent, above the bank rate has become payable by a scheduled bank, 9[if thereafter the average daily balance held at the Bank during the next succeeding 10[fortnight] is still below the prescribed minimum.
(a) every director, manager or secretary of the scheduled bank, who is knowingly and wilfully a party to the default, shall be punishable with fine which may extend to five hundred rupees and with a further fine which may extend to five hundred rupees for each subsequent 11[fortnight] during which the default continues, and
1 . Ins. by Act 1 of 1984, s. 6 (w.e.f. 29-3-1985).
2 Subs. by Act 38 of 1956, s. 5, for sub-section (3) (w.e.f. 6-10-1956).
3 Subs. by Act 1 of 1984, s. 6, for “week” (w.e.f. 29-3-1985).
4 Subs. by Act 1 of 1984, s. 6, for “week” (w.e.f. 29-3-1985).
5 Subs. by Act 1 of 1984, s. 6, for “week” (w.e.f. 29-3-1985).
6 Subs. by Act 1 of 1984, s. 6, for “week” (w.e.f. 29-3-1985).
7 Subs. by Act 1 of 1984, s. 6, for “week” (w.e.f. 29-3-1985).
8 Ins. by Act 38 of 1940, s. 2.
9 Subs. by Act 38 of 1956, s. 5, for certain words (w.e.f. 6-10-1956).
10 Subs. by Act 1 of 1984, s. 6, for “week” (w.e.f. 29-3-1985).
11 Subs. by Act 1 of 1984, s. 6, for “week” (w.e.f. 29-3-1985).
(b) the Bank may prohibit the scheduled bank from receiving after the said 1[fortnight] any fresh deposit,]
and, if default is made by the scheduled bank in complying with the prohibition referred to in clause (b), every director and officer of the scheduled bank who is knowingly and wilfully a party to such default or who through negligence or otherwise contributes to such default shall in respect of each such default be punishable with fine which may extend to five hundred rupees and with a further fine which may extend to five hundred rupees for each day after the first on which a deposit received in contravention of such prohibition is retained by the scheduled bank.
Explanation.– In this sub-section ‘‘officer’’ includes a 2[* * *] manager, secretary, branch manager, and branch secretary.]
(4) Any scheduled bank failing to comply with the provisions of subsection (2) 3[shall be liable to pay to the Bank] a penalty of one hundred rupees for each day during which the failure continues.
4[(5) (a) The penalties imposed by sub-sections (3) and (4) shall be payable within a period of fourteen days from the date on which a notice issued by the Bank demanding the payment of the same is served on the scheduled bank, and in the event of a failure of the scheduled bank to pay the same within such period, may be levied by a direction of the principal civil court having jurisdiction in the area where an office of the defaulting bank is situated, such direction to be made only upon an application made in this behalf to the court by the Bank;
(b) when the court makes a direction under clause (a), it shall issue a certificate specifying the sum payable by the scheduled bank and every such certificate shall be enforceable in the same manner as if it were a decree made by the court in a suit;
(c) notwithstanding anything contained in this section, if the Bank is satisfied that the defaulting bank had sufficient cause for its failure to comply with the provisions of sub-sections (1), (1A) or (2), it may not demand the payment of the penal interest or the penalty, as the case may be.]
5[(6) The Bank shall, save as hereinafter provided, by notification in the Gazette of India,–
1 Subs. by Act 1 of 1984, s. 6 for “Week” (w.e.f. 29-3-1985).
2 The words “managing agent,” omitted by Act 32 of 1951, s. 16 (w.e.f. 1-11-1951).
3 Subs. by s. 16, Act 32 of 1951., for certain words (w.e.f. 1-11-1951).
4 Subs. by Act 35 of 1962, s. 4, for sub-section (5).
5 Subs. by Act 10 of 1949, s. 55 and Sch. I, for sub-section (6) (w.e.f. 16-3-1949).
(a) direct the inclusion in the Second Schedule of any bank not already so included which carries on the business of banking 1[in India] and which–
(i) has a paid-up capital and reserves of an aggregate value of not less than five lakhs of rupees, and
(ii) satisfies the Bank that its affairs are not being conducted in a manner detrimental to the interests of its depositors, and
(iii) 2[is a State co-operative bank or a company] as defined in 3[section 3 of the Companies Act, 1956, or an institution notified by the Central Government in this behalf] or a corporation or a company incorporated by or under any law in force in any place 4[outside India];
(b) direct the exclusion from that Schedule of any scheduled bank.–
(i) the aggregate value of whose paid-up capital and reserves becomes at any time less than five lakhs of rupees, or
(ii) which is, in the opinion of the Bank after making an inspection under section 35 of the 5[Banking Regulation Act, 1949], conducting its affairs to the detriment of the interests of its depositors, or
(iii) which goes into liquidation or otherwise ceases to carry on banking business:
Provided that the Bank may, on application of the scheduled bank concerned and subject to such conditions, if any, as it may impose, defer the making of a direction under sub-clause (i) or sub-clause (ii) of clause (b) for such period as the Bank considers reasonable to give the scheduled bank an opportunity of increasing the aggregate value of its paid-up capital and reserves to not less than five lakhs of rupees or, as the case may be, of removing the defects in the conduct of its affairs:
(c) alter the description in that Schedule whenever any scheduled bank changes its name.
Explanation.– In this sub-section the expression ‘‘value’’ means the real or exchangeable value and not the nominal value which may be shown in the books of the bank concerned; and if any dispute arises in computing the aggregate value of the paid-up capital and reserves of a
1 Subs. by Act 32 of 1951, s. 16 for “in any state of India” (w.e.f. 1-11-1951).
2 Subs. by Act 23 of 1965, s. 6, for “is a company” (w.e.f. 1-3-1966).
3 Subs. by Act 19 of 1957, s. 4, for “clause (2) of section 2 of the Indian Companies Act, 1913 (7 of 1913)”.
4 Subs. by Act 32 of 1951, s. 16, for “outside the States of India” (w.e.f. 1-11-1951).
5 Subs. by Act 51 of 1974, s. 3, for certain words.
bank, a determination thereof by the Bank shall be final for the purposes of this sub-section.]
1[(6A) In considering whether a State co-operative bank or a regional rural bank should be included in or excluded from the Second Schedule, it shall be competent for the Bank to act on a certificate from the National Bank on the question whether or not a State co-operative bank or a regional rural bank, as the case may be, satisfies the requirements as to paid-up capital and reserves or whether its affairs are not being conducted in a manner detrimental to the interests of its depositors.]
2[(7) The Bank may, for such period and subject to such conditions as may be specified, grant to any scheduled bank such exemptions from the provisions of this section as it thinks fit with reference to all or any of its offices or with reference to the whole or any part of its assets and liabilities.]
3[43. Publication of consolidated statement by the Bank.
The Bank shall cause to be published each 4[fortnight] a consolidated statement showing the aggregate liabilities and assets of all the scheduled banks together, based on the returns and information received under this Act or any other law for the time being in force.]
5[43A. Protection of action taken in good faith.
(1) No suit or other legal proceeding shall lie against the Bank or any of its officers for anything which is in good faith done or intended to be done in pursuance of section 42 or section 43 6[or in pursuance of the provisions of Chapter IIIA].
(2) No suit or other legal proceeding shall lie against the Bank or any of its officers for any damage caused or likely to be caused by anything which is in good faith done or intended to be done in pursuance of section 42 or section 43 7[or in pursuance of the provisions of Chapter IIIA].]
44. [Power to require returns from co-operative banks.]
[Rep. by the Banking Laws (Application to Co-operative Societies) Act, 1965 (23 of 1965), s. 7 (w.e.f. 1-3-1966).]
1 Ins. by Act 61 of 1981, s. 61 and Sch. II (w.e.f. 12-7-1982).
2 Ins. by Act 32 of 1951, s. 16 (w.e.f. 1-11-1951).
3 Subs. by Act 51 of 1974, s. 12, for s. 43.
4 Subs. by Act 1 of 1984, s. 7, for “week” (w.e.f. 29-3-1985).
5 Ins. by Act 54 of 1953, s. 7.
6 Ins. by Act 35 of 1962, s. 5.
7 Ins. by Act 35 of 1962, s. 5.
1[45. Appointment of Agents.
(1) Unless otherwise directed by the Central Government with reference to any place, the Bank may, having regard to public interest, convenience of banking, banking development and such other factors which in its opinion are relevant in this regard, appoint the National Bank, or the State Bank or a corresponding new bank constituted under section 3 of the Banking Companies (Acquisition and Transfer of Undertakings) Act, 1970, or a corresponding new bank constituted under section 3 of the Banking Companies (Acquisition and Transfer of Undertakings) Act, 1980, or any subsidiary bank as defined in the State Bank of India (Subsidiary Banks) Act, 1959, as its agent at all places, or at any place in India for such purposes as the Bank may specify.
(2) When any bank is appointed by the Bank as its agent under subsection (1) to receive on behalf of the Bank any payment required to be made into the Bank, or any bill, hundies or other securities required to be delivered into the Bank, under any law or rule, regulations or other instructions having the force of law, the same may be paid or delivered into the bank so appointed as the agent of the Bank.]
2[CHAPTER IIIA
COLLECTION AND FURNISHING OF CREDIT INFORMATION
45A. Definitions.
In this Chapter, unless the context otherwise requires,–
(a) ‘‘banking company’’ means a banking company as defined in section 5 of the 3[Banking Regulation Act, 1949], and includes the State Bank of India, 4[any subsidiary bank as defined in the State Bank of India (Subsidiary Banks) Act, 1959, any corresponding new bank constituted by section 3 of the Banking Companies (Acquisition and Transfer of Undertakings) Act, 1970, and any other financial institution notified by the Central Government in this behalf];
(b) ‘‘borrower’’ means any person to whom any credit limit has been sanctioned by any banking company, whether availed of or not, and includes–
(i) in the case of a company or corporation, its subsidiaries;
1 Subs. by Act 61 of 1981, s. 61 and Sch. II, for s. 45 (w.e.f. 12-7-1982).
2 Ins. by Act 35 of 1962, s. 6.
3 Subs. by Act 51 of 1974, s. 3, for “Banking Companies Act, 1949”.
4 Subs. by s. 13, ibid., for certain words.
(ii) in the case of a Hindu Undivided Family, any member thereof or any firm in which such member is a partner;
(iii) in the case of a firm, any partner thereof of any other firm in which such partner is a partner; and
(iv) in the case of an individual, any firm in which such individual is a partner;
(c) ‘‘credit information’’ means any information relating to–
(i) the amounts and the nature of loans or advances and other credit facilities granted by a banking company to any borrower or class of borrowers;
(ii) the nature of security taken from any borrower 1[or class of borrowers] for credit facilities 2[granted to him or to such class];
(iii) the guarantee furnished by a banking company for any of its customers 3[or any class of its customers];
4[(iv) the means, antecedents, history of financial transactions and the credit worthiness of any borrower or class of borrowers;
(v) any other information which the Bank may consider to be relevant for the more orderly regulation of credit or credit policy.]
45B. Power of Bank to collect credit information.
The Bank may–
(a) collect, in such manner as it may think fit, credit information from banking companies; and
(b) furnish such information to any banking company in accordance with the provisions of section 45D.
45C. Power to call for returns containing credit information.
(1) For the purpose of enabling the Bank to discharge its functions under this Chapter, it may at any time direct any banking company to submit to it such statements relating to such credit information and in such form and within such time as may be specified by the Bank from time to time.
1 Ins. by Act 51 of 1974, s. 13.
2 Subs. by s. 13, ibid., for certain words.
3 Ins. by Act 51 of 1974, s. 13.
4 Ins. by Act 51 of 1974, s. 13.
(2) A banking company shall, notwithstanding anything to the contrary contained in any law for the time being in force or in any instrument regulating the constitution thereof or in any agreement executed by it, relating to the secrecy of its dealings with its constituents, be bound to comply with any direction issued under sub-section (1).
45D. Procedure for furnishing credit information to banking companies.
(1) A banking company may, in connection with any financial arrangement entered into or proposed to be entered into by it, with any person, make an application to the Bank in such form as the Bank may specify requesting it to furnish the applicant with such credit information as may be specified in the application.
(2) On receipt of an application under sub-section (1), the Bank shall, as soon as may be, furnish the applicant with such credit information relating to the matters specified in the application, as may be in its possession:
Provided that the information so furnished shall not disclose the names of the banking companies which have submitted such information to the Bank.
(3) The Bank may in respect of each application levy such fees, not exceeding twenty-five rupees, as it may deem fit for furnishing credit information.
45E. Disclosure of information prohibited.
(1) Any credit information contained in any statement submitted by a banking company under section 45C or furnished by the Bank to any banking company under section 45D, shall be treated as confidential and shall not, except for the purposes of this Chapter, be published or otherwise disclosed.
(2) Nothing in this section shall apply to –
(a) the disclosure by any banking company, with the previous permission of the Bank, of any information furnished to the Bank under section 45C:
(b) the publication by the Bank, if it considers necessary in the public interest so to do, of any information collected by it under section 45C, in such consolidated form as it may think fit without disclosing the name of any banking company or its borrowers:
1[(c) the disclosure or publication by the banking company or by the Bank of any credit information to any other banking company or in accordance with the practice and usage customary among bankers or as permitted or required under any other law:
Provided that any credit information received by a banking company under this clause shall not be published except in accordance with the
1 Ins. by Act 51 of 1974, s. 14.
practice and usage customary among bankers or as permitted or required under any other law.]
1[(d) the disclosures of any credit information under the Credit Information Companies (Regulation) Act, 2005.]
(3) Notwithstanding anything contained in any law for the time being in force, no court, tribunal or other authority shall compel the Bank or any banking company to produce or to give inspection of any statement submitted by that banking company under section 45C or to disclose any credit information furnished by the Bank to that banking company under section 45D.
45F. Certain claims for compensation barred.
No person shall have any right, whether in contract or otherwise, to any compensation for any loss incurred by reason of the operation of any of the provisions of this Chapter.
45G. [Penalties.]
[Rep. by the Reserve Bank of India (Amendment) Act,1974 (51 of 1974), s. 15.]
2[CHAPTER IIIB
PROVISIONS RELATING TO NON-BANKING INSTITUTIONS RECEIVING DEPOSITS AND FINANCIAL INSTITUTIONS
45H. Chapter IIIB not to apply in certain cases.
The provisions of this Chapter shall not apply to the State Bank or a banking company as defined in section 5 of the 3[Banking Regulation Act, 1949] or 4[a corresponding new bank as defined in clause (da) of section 5 of that Act or a subsidiary bank as defined in the State Bank of India (Subsidiary Banks) Act, 1959] or 5[a Regional Rural Bank or a co-operative bank] or a primary agricultural credit society or a primary credit society]:
Provided that for the purposes of this Chapter, the 6[Tamil Nadu Industrial Investment Corporation Limited] shall not be deemed to be a banking company.
1 Added by the Credit Information Companies (Regulation) Act, 2005 (Act No. 30 of 2005), Sch., Pt. I.
2 Ins. by Act 55 of 1963, s.5. (w.e.f. 1-2-1964).
3 Subs. by Act 51 of 1974, s.3, for “Banking Companies Act, 1949.
4 Subs. by Act 1 of 1984, s.8, for certain words (w.e.f. 15-2-1984).
5 Subs. by Act 21 of 1976, s.33, for the words “a co-operative bank” (w.e.f. 26.9.1975).
6 Subs. by Act 51 of 1974, s. 16, for “Madras Industrial Investment Corporation Limited”.
45I. Definitions.
In this Chapter, unless the context otherwise requires,–
1[(a) ‘‘business of a non-banking financial institution’’ means carrying on of the business of a financial institution referred to in clause (c) and includes business of a non-banking financial company referred to in clause (f);]
2[(aa)] ‘‘company’’ means a company as defined in section 3 of the Companies Act, 1956 and includes a foreign company within the meaning of section 591 of that Act:
(b) ‘‘corporation’’ means a corporation incorporated by an Act of any legislature;
3[(bb) ‘‘deposit’’ includes and shall be deemed always to have included any receipt of money by way of deposit or loan or in any other form, but does not include,–
(i) amounts raised by way of share capital;
(ii) amounts contributed as capital by partners of a firm;
(iii) amounts received from a scheduled bank or a co-operative bank or any other banking company as defined in clause (c) of section 5 of the Banking Regulation Act, 1949;
(iv) any amount received from,–
4[*****]
(b) a State Financial Corporation,
(c) any financial institution specified in or under section 6A of the Industrial Development Bank of India Act, 1964, or
(d) any other institution that may be specified by the Bank in this behalf:
(v) amounts received in the ordinary course of business, by way of–
(a) security deposit,
1 Ins. by Act 23 of 1997 s. 2 (w.e.f. 9-1-1997).
2 Cl. (a) renumbered as (aa) by Act 23 of 1997 s.2 (w.e.f. 9-1-1997).
3 Subs. by Act 1 of 1984 s.9, for cl. (bb) w.e.f. 15-2-1984).
4 Item (a) – containing the words “the Development Bank” – omitted by the Industrial Development Bank (Transfer of Undertaking and Repeal) Act, 2003 (Act No.53 of 2003), Sec. 4.
(b) dealership deposit,
(c) earnest money,
(d) advance against orders for goods, properties or services,
(vi) any amount received from an individual or a firm or an association of individuals not being a body corporate, registered under any enactment relating to money lending which is for the time being in force in any State; and
(vii) any amount received by way of subscriptions in respect of a chit.
Explanation I.– ‘‘Chit’’ has the meaning assigned to it in clause (b) of section 2 of the Chit Funds Act, 1982.
Explanation II.– Any credit given by a seller to a buyer on the sale of any property (whether movable or immovable) shall not be deemed to be deposit for the purposes of this clause;]
1[(c) ‘‘financial institution’’ means any non-banking institution which carries on as its business or part of its business any of the following activities, namely:–
(i) the financing, whether by way of making loans or advances or otherwise, of any activity other than its own:
(ii) the acquisition of shares, stock, bonds, debentures or securities issued by a Government or local authority or other marketable securities of a like nature:
(iii) letting or delivering of any goods to a hirer under a hire-purchase agreement as defined in clause (c) of section 2 of the Hire-Purchase Act, 1972:
(iv) the carrying on of any class of insurance business;
(v) managing, conducting or supervising, as foreman, agent or in any other capacity, of chits or kuries as defined in any law which is for the time being in force in any State, or any business, which is similar thereto;
(vi) collecting, for any purpose or under any scheme or arrangement by whatever name called, monies in lumpsum or otherwise, by way of subscriptions or by sale of units, or other instruments or in any other manner and awarding prizes or gifts, whether in cash or kind, or disbursing monies in any other way, to persons from whom monies are
1 Subs. by Act 51 of 1974, s.17, for cl. (c)
collected or to any other person, 1[but does not include any institution, which carries on as its principal business,–
(a) agricultural operations; or (aa) industrial activity; or]
(b) the purchase or sale of any goods (other than securities) or the providing of any services; or
(c) the purchase, construction or sale of immovable property, so however, that no portion of the income of the institution is derived from the financing of purchases, constructions or sales of immovable property by other persons;]
2[Explanation.– For the purposes of this clause, ‘‘industrial activity’’ means any activity specified in sub-clauses (i) to
(xviii) of clause (c) of section 2 of the Industrial Development Bank of India Act, 1964;]
(d) ‘‘firm’’ means a firm as defined in the Indian Partnership Act, 1932 3[* * *];
(e) ‘‘non-banking institution’’ means a company, corporation 4[or cooperative society].
5[(f) ‘‘non-banking financial company’’ means–
(i) a financial institution which is a company;
(ii) a non-banking institution which is a company and which has as its principal business the receiving of deposits, under any scheme or arrangement or in any other manner, or lending in any manner;
(iii) such other non-banking institution or class of such institutions, as the Bank may, with the previous approval of the Central Government and by notification in the Official Gazette, specify;]
6[45-IA. Requirement of registration and net owned fund.
1 Subs. by Act 23 of 1997, s. 2 (w.e.f. 9-1-1997).
2 Ins. by Act 23 of 1997, s.2 (w.e.f. 9-1-1997).
3 Certain words omitted by Act 1 of 1984, s. 9, (w.e.f. 15-2-1984).
4 Subs. by s.9 ibid., for certain words (w.e.f. 15-2-1984).
5 Ins. by Act 23 of 1997, s.2, (w.e.f. 9-1-1997).
6 Ins. by Act 23 of 1997, s.3, (w.e.f. 9-1-1997).
(1) Notwithstanding anything contained in this Chapter or in any other law for the time being in force, no non-banking financial company shall commence or carry on the business of a non-banking financial institution without–
(a) obtaining a certificate of registration issued under this Chapter; and
(b) having the net owned fund of twenty-five lakh rupees or such other amount, not exceeding two hundred lakh rupees, as the Bank may, by notification in the Official Gazette, specify.
(2) Every non-banking financial company shall make an application for registration to the Bank in such form as the Bank may specify:
Provided that a non-banking financial company in existence on the commencement of the Reserve Bank of India (Amendment) Act, 1997 shall make an application for registration to the Bank before the expiry of six months from such commencement and notwithstanding anything contained in sub-section (1) may continue to carry on the business of a non-banking financial institution until a certificate of registration is issued to it or rejection of application for registration is communicated to it.
(3) Notwithstanding anything contained in sub-section (1), a non-banking financial company in existence on the commencement of the Reserve Bank of India (Amendment) Act, 1997 and having a net owned fund of less than twenty-five lakh rupees may, for the purpose of enabling such company to fulfil the requirement of the net owned fund, continue to carry on the business of a non-banking financial institution–
(i) for a period of three years from such commencement; or
(ii) for such further period as the Bank may, after recording the reasons in writing for so doing, extend, subject to the condition that such company shall, within three months of fulfilling the requirement of the net owned fund, inform the Bank about such fulfilment:
Provided that the period allowed to continue business under this subsection shall in no case exceed six years in the aggregate.
(4) The Bank may, for the purpose of considering the application for registration, require to be satisfied by an inspection of the books of the non- banking financial company or otherwise that the following conditions are fulfilled:–
(a) that the non-banking financial company is or shall be in a position to pay its present or future depositors in full as and when their claims accrue;
(b) that the affairs of the non-banking financial company are not being or are not likely to be conducted in a manner detrimental to the interest of its present or future depositors;
(c) that the general character of the management or the proposed management of the non-banking financial company shall not be prejudicial to the public interest or the interest of its depositors;
(d) that the non-banking financial company has adequate capital structure and earning prospects;
(e) that the public interest shall be served by the grant of certificate of registration to the non-banking financial company to commence or to carry on the business in India;
(f) that the grant of certificate of registration shall not be prejudicial to the operation and consolidation of the financial sector consistent with monetary stability, economic growth and considering such other relevant factors which the Bank may, by notification in the Official Gazette, specify; and
(g) any other condition, fulfilment of which in the opinion of the Bank, shall be necessary to ensure that the commencement of or carrying on of the business in India by a non-banking financial company shall not be prejudicial to the public interest or in the interest of the depositors.
(5) The Bank may, after being satisfied that the conditions specified in sub- section (4) are fulfilled, grant a certificate of registration subject to such conditions which it may consider fit to impose.
(6) The Bank may cancel a certificate of registration granted to a non-banking financial company under this section if such company–
(i) ceases to carry on the business of a non-banking financial institution in India; or
(ii) has failed to comply with any condition subject to which the certificate of registration had been issued to it; or
(iii) at any time fails to fulfil any of the conditions referred to in clauses (a) to (g) of sub-section (4); or
(iv) fails–
(a) to comply with any direction issued by the Bank under the provisions of this chapter; or
(b) to maintain accounts in accordance with the requirements of any law or any direction or order issued by the Bank under the provisions of this Chapter; or
(c) to submit or offer for inspection its books of account and other relevant documents when so demanded by an inspecting authority of the Bank; or
(v) has been prohibited from accepting deposit by an order made by the Bank under the provisions of this Chapter and such order has been in force for a period of not less than three months:
Provided that before cancelling a certificate of registration on the ground that the non-banking financial company has failed to comply with the provisions of clause (ii) or has failed to fulfil any of the conditions referred to in clause (iii) the Bank, unless it is of the opinion that the delay in cancelling the certificate of registration shall be prejudicial to public interest or the interest of the depositors or the non-banking financial company, shall give an opportunity to such company on such terms as the Bank may specify for taking necessary steps to comply with such provision or fulfillment of such condition;
Provided further that before making any order of cancellation of certificate of registration, such company shall be given a reasonable opportunity of being heard.
(7) A company aggrieved by the order of rejection of application for registration or cancellation of certificate of registration may prefer an appeal, within a period of thirty days from the date on which such order of rejection or cancellation is communicated to it, to the Central Government and the decision of the Central Government where an appeal has been preferred to it, or of the Bank where no appeal has been preferred, shall be final:
Provided that before making any order of rejection of appeal, such company shall be given a reasonable opportunity of being heard.
Explanation.– For the purposes of this section,–
(I) “net owned fund” means–
(a) the aggregate of the paid-up equity capital and free reserves as disclosed in the latest balance-sheet of the company after deducting therefrom–
(i) accumulated balance of loss;
(ii) deferred revenue expenditure; and
(iii) other intangible assets; and
(b) further reduced by the amounts representing–
(1) investments of such company in shares of–
(i) its subsidiaries;
(ii) companies in the same group;
(iii) all other non-banking financial companies; and
(2) the book value of debentures, bonds, outstanding loans and advances (including hire-purchase and lease finance) made to, and deposits with,–
(i) subsidiaries of such company; and
(ii) companies in the same group, to the extent such amount exceeds ten per cent of (a) above.
(II) “subsidiaries” and “companies in the same group” shall have the same meanings assigned to them in the Companies Act, 1956.
45- IB. Maintenance of percentage of assets.
(1) Every non-banking financial company shall invest and continue to invest in India in unencumbered approved securities, valued at a price not exceeding the current market price of such securities, an amount which, at the close of business on any day, shall not be less than five per cent, or such higher percentage not exceeding twenty-five per cent, as the Bank may, from time to time and by notification in the Official Gazette, specify, of the deposits outstanding at the close of business on the last working day of the second preceding quarter:
Provided that the Bank may specify different percentages of investment in respect of different classes of non-banking financial companies.
(2) For the purpose of ensuring compliance with the provisions of this section, the Bank may require every non-banking financial company to furnish a return to it in such form, in such manner and for such period as may be specified by the Bank.
(3) If the amount invested by a non-banking financial company at the close of business on any day falls below the rate specified under subsection (1), such company shall be liable to pay to the Bank, in respect of such shortfall, a penal interest at a rate of three per cent per annum above the bank rate on such amount by which the amount actually invested falls short of the specified percentage, and where the shortfall continues in the subsequent quarters, the rate of penal interest shall be five per cent per annum above the bank rate on such shortfall for each subsequent quarter.
(4) (a) The penal interest payable under sub-section (3) shall be payable within a period of fourteen days from the date on which a notice issued by the Bank demanding payment of the same is served on the non-banking financial company and, in the event of a failure of the non-banking financial company to pay the same within such period, penalty may be levied by a direction of the principal civil court having jurisdiction in the area where an office of the defaulting non-banking financial company is situated and such direction shall be made only upon an application made in this behalf to the court by the Bank; and
(b) When the court makes a direction under clause (a), it shall issue a certificate specifying the sum payable by the non-banking financial company and every such certificate shall be enforceable in the same manner as if it were a decree made by the court in a suit.
(5) Notwithstanding anything contained in this section, if the Bank is satisfied that the defaulting non-banking financial company had sufficient cause for its failure to comply with the provisions of sub-section (1), it may not demand the payment of the penal interest.
Explanation,– For the purposes of this section,–
(i) “approved securities” means securities of any State Government or of the Central Government and such bonds, both the principal whereof and the interest whereon shall have been fully and unconditionally guaranteed
by any such Government;
(ii) “unencumbered approved securities” includes the approved securities lodged by the non-banking financial company with another institution for an advance or any other arrangement to the extent to which such securities have not been drawn against or availed of or encumbered in any manner;
(iii) “quarter” means the period of three months ending on the last day of March, June, September or December.
45- IC. Reserve fund.
(1) Every non-banking financial company shall create a reserve fund and transfer therein a sum not less than twenty per cent of its net profit every year as disclosed in the profit and loss account and before any dividend is declared.
(2) No appropriation of any sum from the reserve fund shall be made by the non-banking financial company except for the purpose as may be specified by the Bank from time to time and every such appropriation shall be reported to the Bank within twenty-one days from the date of such withdrawal:
Provided that the Bank may, in any particular case and for sufficient cause being shown, extend the period of twenty-one days by such further period as it thinks fit or condone any delay in making such report.
(3) Notwithstanding anything contained in sub-section (1), the Central Government may, on the recommendation of the Bank and having regard to the adequacy of the paid-up capital and reserves of a non-banking financial company in relation to its deposit liabilities, declare by order in writing that the provisions of sub-section (1) shall not be applicable to the non-banking financial company for such period as may be specified in the order:
Provided that no such order shall be made unless the amount in the reserve fund under sub-section (1) together with the amount in the share
premium account is not less than the paid-up capital of the non-banking financial company.]
45J. Bank to regulate or prohibit issue of prospectus or advertisement soliciting deposits of money.
The Bank may, if it considers necessary in the public interest so to do, by general or special order,–
(a) regulate or prohibit the issue by any non-banking institution of any prospectus or advertisement soliciting deposits of money from the public; and
(b) specify the conditions subject to which any such prospectus or advertisement, if not prohibited, may be issued.
1[45JA. Power of Bank to determine policy and issue directions.
(1) If the Bank is satisfied that, in the public interest or to regulate the financial system of the country to its advantage or to prevent the affairs of any non-banking financial company being conducted in a manner detrimental to the interest of the depositors or in a manner prejudicial to the interest of the non-banking financial company, it is necessary or expedient so to do, it may determine the policy and give directions to all or any of the non-banking financial companies relating to income recognition, accounting standards, making of proper provision for bad and doubtful debts, capital adequacy based on risk weights for assets and credit conversion factors for off-balance- sheet items and also relating to deployment of funds by a non-banking financial company or a class of non-banking financial companies or non- banking financial companies generally, as the case may be, and such non- banking financial companies shall be bound to follow the policy so determined and the directions so issued.
(2) Without prejudice to the generality of the powers vested under sub- section (1), the Bank may give directions to non-banking financial companies generally or to a class of non-banking financial companies or to any non- banking financial company in particular as to–,
(a) the purpose for which advances or other fund based or non-fund based accommodation may not be made; and
(b) the maximum amount of advances or other financial accommodation or investment in shares and other securities which, having regard to the paid-up capital, reserves and deposits of the non-banking financial company and other relevant considerations, may be made by that non- banking financial company to any person or a company or to a group of companies].
1 Ins. by Act 23 of 1997 s. 4 (w.e.f. 9-1-1997).
45K. Power of Bank to collect information from non-banking institutions as to deposits and to give directions.
(1) The Bank may at any time direct that every non-banking institution shall furnish to the Bank, in such form, at such intervals and within such time, such statements, information or particulars relating to or connected with deposits received by the non-banking institution, as may be specified by the Bank by general or special order.
(2) Without prejudice to the generality of the power vested in the Bank under sub-section (1), the statements, information or particulars to be furnished under sub-section (1) may relate to all or any of the following matters, namely, the amount of the deposits, the purposes and periods for which, and the rates of interest and other terms and conditions on which, they are received.
(3) The Bank may, if it considers necessary in the public interest so to do, give directions to non-banking institutions either generally or to any non- banking institution or group of non-banking institutions in particular, in respect of any matters relating to or connected with the receipt of deposits, including the rates of interest payable on such deposits, and the periods for which deposits may be received.
(4) If any non-banking institution fails to comply with any direction given by the Bank under sub-section (3), the Bank may prohibit the acceptance of deposits by that non-banking institution.
1[* * * * *]
(6) Every non-banking institution receiving deposits shall, if so required by the Bank and within such time as the Bank may specify, cause to be sent at the cost of the non-banking institution a copy of its annual balance sheet and profit and loss account or other annual accounts to every person from whom the non-banking institution holds, as on the last day of the year to which the accounts relate, deposits higher than such sum as may be specified by the Bank.
45L. Power of Bank to call for information from financial institutions and to give directions.
(1) If the Bank is satisfied that for the purpose of enabling it to regulate the credit system of the country to its advantage it is necessary so to do; it may–
(a) require financial institutions either generally or any group of financial institutions or financial institution in particular, to furnish to the Bank in such form, at such intervals and within such time, such statements, information or particulars relating to the business of such financial institutions or institution, as may be specified by the Bank by general or special order.
1 Sub-section (5) omitted by Act 51 of 1974, s. 18.
(b) give to such institutions either generally or to any such institution in particular, directions relating to the conduct of business by them or by it as financial institutions or institution.
(2) Without prejudice to the generality of the power vested in the Bank under clause (a) of sub-section (1), the statements, information or particulars to be furnished by a financial institution may relate to all or any of the following matters, namely, the paid-up capital, reserves or other liabilities, the investments whether in Government securities or otherwise, the persons to whom, and the purposes and periods for which, finance is provided and the terms and conditions, including the rates of interest, on which it is provided.
(3) In issuing directions to any financial institution under clause (b) of sub- section (1), the Bank shall have due regard to the conditions in which, and the objects for which, the institution has been established, its statutory responsibilities, if any, and the effect the business of such financial institution is likely to have on trends in the money and capital markets.
45M. Duty of non-banking institutions to furnish statements, etc., required by Bank.
It shall be the duty of every non-banking institution to furnish the statements, information or particulars called for, and to comply with any direction given to it, under the provisions of this Chapter.
1[45MA. Powers and duties of auditors.
(1) It shall be the duty of an auditor of a non-banking institution to inquire whether or not the non-banking institution has furnished to the Bank such statements, information or particulars relating to or connected with deposits received by it, as are required to be furnished under this Chapter, and the auditor shall, except where he is satisfied on such inquiry that the non- banking institution has furnished such statements, information or particulars, make a report to the Bank giving the aggregate amount of such deposits held by the non-banking institution;
2[(1A) The Bank may, on being satisfied that it is necessary so to do, in the public interest or in the interest of the depositors or for the purpose of proper assessment of the books of account, issue directions to any non-banking financial company or any class of non-banking financial companies or non- banking financial companies generally or to the auditors of such non-banking financial company or companies relating to balance-sheet, profit and loss account, disclosure of liabilities in the books of account or any matter relating thereto;]
1 Ins. by s. 19 of Act 51 of 1974.
2 Ins. by s. 5 of Act 23 of 1997 (w.e.f. 9-1-1997).
(2) Where, in the case of 1[a non-banking financial company] the auditor has made, or intends to make, a report to the Bank under sub-section (1), he shall include in his report under sub-section (2) of section 227 of the Companies Act, 1956, the contents of the report which he has made, or intends to make to the Bank.]
2[(3) Where the Bank is of the opinion that it is necessary so to do in the public interest or in the interest of the non-banking financial company or in the interest of the depositors of such company, it may at any time by order direct that a special audit of the accounts of the non-banking financial company in relation to any such transaction or class of transactions or for such period or periods, as may be specified in the order, shall be conducted and the Bank may appoint an auditor or auditors to conduct such special audit and direct the auditor or the auditors to submit the report to it.
(4) The remuneration of the auditors as may be fixed by the Bank, having regard to the nature and volume of work involved in the audit and the expenses of or incidental to the audit, shall be borne by the non-banking financial company so audited.]
3[45MB. Power of Bank to prohibit acceptance of deposit and alienation of assets.
(1) If any non-banking financial company violates the provisions of any section or fails to comply with any direction or order given by the Bank under any of the provisions of this Chapter, the Bank may prohibit the non-banking financial company from accepting any deposit.
(2) Notwithstanding anything to the contrary contained in any agreement or instrument or any law for the time being in force, the Bank, on being satisfied that it is necessary so to do in the public interest or in the interest of the depositors, may direct, the non-banking financial company against which an order prohibiting from accepting deposit has been issued, not to sell, transfer, create charge or mortgage or deal in any manner with its property and assets without prior written permission of the Bank for such period not exceeding six months from the date of the order.
45MC. Power of Bank to file winding up petition.
(1) The Bank, on being satisfied that a non-banking financial company,–
(a) is unable to pay its debt; or
(b) has by virtue of the provisions of section 45-IA become disqualified to carry on the business of a non-banking financial institution; or
1 Subs. by Act 23 of 1997 s. 5 for words “a non-banking institution, being a company” (w.e.f. 9-1-1997).
2 Ins. by Act 23 of 1997 s.5 (w.e.f. 9-1-1997)
3 Ins. by Act 23 of 1997 s.6 (w.e.f. 9-1-1997)
(c) has been prohibited by the Bank from receiving deposit by an order and such order has been in force for a period of not less than three months; or
(d) the continuance of the non-banking financial company is detrimental to the public interest or to the interest of the depositors of the company, may file an application for winding up of such non-banking financial company under the Companies Act, 1956.
(2) A non-banking financial company shall be deemed to be unable to pay its debt if it has refused or has failed to meet within five working days any lawful demand made at any of its offices or branches and the Bank certifies in writing that such company is unable to pay its debt.
(3) A copy of every application made by the Bank under sub-section (1) shall be sent to the Registrar of Companies.
(4) All the provisions of the Companies Act, 1956 relating to winding up of a company shall apply to a winding up proceeding initiated on the application made by the Bank under this provision.]
45N. Inspection.
1[(1) The Bank may, at any time, cause an inspection to be made by one or more of its officers or employees or other persons (hereafter in this section referred to as the inspecting authority)-
(i) of any non-banking institution, including a financial institution, for the purpose of verifying the correctness or completeness of any statement, information or particulars furnished to the Bank or for the purpose of obtaining any information or particulars which the non-banking institution has failed to furnish on being called upon to do so; or
(ii) of any non-banking institution being a financial institution, if the Bank considers it necessary or expedient to inspect that institution.]
(2) It shall be the duty of every director or member of any committee or other body for the time being vested with the management of the affairs of the non-banking institution or other officer or employee thereof to produce to the inspecting authority all such books, accounts and other documents in his custody or power and to furnish that authority with any statements and information relating to the business of the institution as that authority may require of him, within such time as may be specified by that authority.
(3) The inspecting authority may examine on oath any director or member of any committee or body for the time being vested with the management of the affairs of the non-banking institution or other officer or employee thereof, in relation to its business and may administer an oath accordingly.
1 Subs. by Act 51 of 1974, s.20, for sub-section (1).
1[CHAPTER IIIC
PROHIBITION OF ACCEPTANCE OF DEPOSITS BY UNINCORPORATED BODIES
45R. Interpretation.
The words and expressions used in this Chapter and defined in Chapter IIIB shall have the meanings respectively assigned to them therein.]
2[45S. Deposits not to be accepted in certain cases.
(1) No person, being an individual or a firm or an unincorporated association of individuals shall, accept any deposit–
(i) If his or its business wholly or partly includes any of the activities specified in clause (c) of section 45-I; or
(ii) if his or its principal business is that of receiving of deposits under any scheme or arrangement or in any other manner, or lending in any manner;
Provided that nothing contained in this sub-section shall apply to the receipt of money by an individual by way of loan from any of his relatives or to the receipt of money by a firm by way of loan from the relative or relatives of any of the partners.
(2) Where any person referred to in sub-section (1) holds any deposit on the 1st day of April, 1997 which is not in accordance with sub-section (1), such deposit shall be repaid by that person immediately after such deposit becomes due for repayment or within three years from the date of such commencement, whichever is earlier;
Provided that if the Bank is satisfied on an application made by any person to the Bank that such person is unable to repay a part of the deposits for reasons beyond his control or such repayment shall cause extreme hardship to him, it may, by an order in writing, extend such period by a period not exceeding one year subject to such conditions as may be specified in the order.
(3) On and from the 1st day of April, 1997, no person referred to in sub- section (1) shall issue or cause to be issued any advertisement in any form for soliciting deposit.
Explanation.– For the purposes of this section, a person shall be deemed to be a relative of another if, and only if,–
1 Ins. by Act 1 of 1984, s. 10 (w.e.f. 15-2-1984)
2 Subs. by Act 23 of 1997 s.9 (w.e.f. 1-4-1997)
(i) they are members of a Hindu undivided family; or
(ii) they are husband and wife; or
(iii) the one is related to the other in the manner indicated in the List of Relatives below:–
List of relatives–
1. Father, 2. Mother (including step-mother), 3. Son (including stepson), 4. Son’s wife, 5. Daughter (including step-daughter), 6. Father’s father, 7. Father’s mother, 8. Mother’s mother, 9. Mother’s father, 10. Son’s son, 11. Son’s son’s wife, 12. Son’s daughter, 13. Son’s daughter’s husband, 14. Daughter’s husband, 15. Daughter’s son, 16. Daughter’s son’s wife, 17. Daughter’s daughter, 18. Daughter’s daughter’s husband, 19. Brother (including stepbrother),
20. Brother’s wife, 21. Sister (including step-sister), 22. Sister’s husband.]
45T. Power to issue search warrants.
(1) Any court having jurisdiction to issue a search warrant under the Code of Criminal Procedure, 1973 may, on an application by an officer of the Bank or of the State Government authorised in this behalf stating his belief that certain documents relating to acceptance of deposits in contravention of the provisions of section 45S are secreted in any place within the local limits of the jurisdiction of such court, issue a warrant to search for such documents.
(2) A warrant issued under sub-section (1) shall be executed in the same manner and shall have the same effect as a search warrant issued under the Code of Criminal Procedure, 1973.]
1[CHAPTER IIID
REGULATION OF TRANSACTIONS IN DERIVATIVES, MONEY MARKET INSTRUMENTS, SECURITIES, ETC.
45U. Definitions.
For the purposes of this Chapter,–.
(a) “derivative” means an instrument, to be settled at a future date, whose value is derived from change in interest rate, foreign exchange rate, credit rating or credit index, price of securities (also called “underlying”), or a combination of more than one of them and includes interest rate swaps, forward rate agreements, foreign currency swaps,
1 Ins. by sec. 4 of the RBI (Amendment) Act, 2006 (Act No. 26 of 2006) (w.e.f. 9.1.2007).
foreign currency-rupee swaps, foreign currency options, foreign currency- rupee options or such other instruments as may be specified by the Bank from time to time;
(b) “money market instruments” include call or notice money, term money, repo, reverse repo, certificate of deposit, commercial usance bill, commercial paper and such other debt instrument of original or initial maturity up to one year as the Bank may specify from time to time;
(c) “repo” means an instrument for borrowing funds by selling securities with an agreement to repurchase the securities on a mutually agreed future date at an agreed price which includes interest for the funds borrowed;
(d) “reverse repo” means an instrument for lending funds by purchasing securities with an agreement to resell the securities on a mutually agreed future date at an agreed price which includes interest for the funds lent;
(e) “securities” means securities of the Central Government or a State Government or such securities of a local authority as may be specified in this behalf by the Central Government and, for the purposes of “repo” or “reverse repo”, include corporate bonds and debentures.
45V. Transactions in derivatives.
(1) Notwithstanding anything contained in the Securities Contracts (Regulation) Act, 1956 (42 of 1956) or any other law for the time being in force, transactions in such derivatives, as may be specified by the Bank from time to time, shall be valid, if at least one of the parties to the transaction is the Bank, a scheduled bank, or such other agency falling under the regulatory purview of the Bank under the Act, the Banking Regulation Act, 1949 (10 of 1949), the Foreign Exchange Management Act, 1999 (42 of 1999), or any other Act or instrument having the force of law, as may be specified by the Bank from time to time.
(2) Transactions in such derivatives, as had been specified by the Bank from time to time, shall be deemed always to have been valid, as if the provisions of sub-section (1) were in force at all material times.
45W. Power to regulate transactions in derivatives, money market instruments, etc.
(1) The Bank may, in public interest, or to regulate the financial system of the country to its advantage, determine the policy relating to interest rates or interest rate products and give directions in that behalf to all agencies or any of them, dealing in securities, money market instruments, foreign exchange, derivatives, or other instruments of like nature as the Bank may specify from time to time:
Provided that the directions issued under this sub-section shall not relate to the procedure for execution or settlement of the trades in respect of the transactions mentioned therein, on the Stock Exchanges recognised under section 4 of the Securities Contracts (Regulation) Act, 1956(42 of 1956).
(2) The Bank may, for the purpose of enabling it to regulate agencies referred to in sub-section (1), call for any information, statement or other particulars from them, or cause an inspection of such agencies to be made.
45X. Duty to comply with directions and furnish information.
It shall be the duty of every director or member or other body for the time being vested with the management of the affairs of the agencies referred to in section 45W to comply with the directions given by the Bank and to submit the information or statement or particulars called for under that section.]
CHAPTER IV GENERAL PROVISIONS
46. Contribution by Central Government to the Reserve Fund.
The 1[Central Government] shall transfer to the Bank rupee securities of the value of five crores of rupees to be allocated by the Bank to the Reserve Fund.
2[46A. Contribution to National Rural Credit (Long Term Operations) Fund and National Rural Credit (Stabilisation) Fund.
The Bank shall contribute every year such sums of money as it may consider necessary and feasible to do so, to the National Rural Credit (Long Term Operations) Fund and the National Rural Credit (Stablisation) Fund established and maintained by the National Bank under sections 42 and 43, respectively, of the National Bank for Agriculture and Rural Development Act, 1981.]
3[46B. * * * *]
[Section 46-B omitted by National Bank for Agriculture & Rural Development Act, 1981 [61 of 1981] (w.e.f. 12-7-1982).]
4[46C. National Industrial Credit (Long Term Operations) Fund.
(1) The Bank shall establish and maintain a Fund to be known as the National Industrial Credit (Long Term Operations) Fund to which shall be credited –
(a) an initial sum of ten crores of rupees by the Bank;
1 Subs. by M. O. 1937, for “G.G. in C.”.
2 Subs. by Act 61 of 1981, s. 61 and Sch. II for ss. 46A and 46B (w.e.f. 12-7-1982).
3 Section 46-B omitted by National Bank for Agriculture & Rural Development Act, 1981 [61 of 1981] (w.e.f. 12-7-1982).
4 Ins. by Act 18 of 1964, s. 38 and sch. II (w.e.f. 1-7-1964).
(b) such further sums of money as the Bank may contribute every year:
Provided that the annual contribution during each of the five years commencing with the year ending on the 30th day of June, 1965 shall not be less than five crores of rupees:
Provided further that the Central Government may, if the circumstances so require, authorise the Bank to reduce the said sum of five crores of rupees in any year.
(2) The amount in the said Fund shall be applied by the Bank only to the following objects, namely:-
1[*****]
2[(c) the making to the Exim Bank 3[or the Reconstruction Bank 4[or the Small Industries Bank as the case may be,] of loans and advances for the purposes of any business of the Exim Bank 5[or the Reconstruction Bank, or 6[the Small Industries Bank] as the case may be]];
(d) the purchasing of bonds and debentures issued by the Exim Bank 7[or the Reconstruction Bank, 8[or the Small Industries Bank] as the case may be]].
9[46D. National Housing Credit (Long Term Operations) Fund.
(1) The Bank shall establish and maintain a Fund to be known as the National Housing Credit (Long Term Operations) Fund to which shall be credited every year such sums of money as it may consider necessary.
1 Clauses (a) and (b) omitted by the Industrial Development Bank (Transfer of Undertaking and Repeal) Act, 2003 (Act No.53 of 2003), Sec.5. Prior to the deletion, the clauses read as under:-
“(a) the making to the Development Bank of loans and advances for the purpose of the purchase of, or subscription to, stocks, shares, bonds or debentures issued by the Industrial Finance Corporation of India, a State Financial Corporation, or any other financial institution which may be notified by the Central Government in this behalf, or for the purposes of any other business of the Development Bank;
(b) the purchasing of bonds and debentures issued by the Development Bank;”
2 Ins. by Act 28 of 1981, s. 40 and Sch. II (w.e.f. 1-1-1982).
3 Ins. by Act 62 of 1984, s. 71 and Sch. III (w.e.f. 20-3-1985).
4 Ins. by Act 39 of 1989.
5 Ins. by Act 62 of 1984, s. 71 and Sch. III (w.e.f. 20-3-1985).
6 Ins. by Act 39 of 1989.
7 Ins. by Act 62 of 1984, s. 71 and Sch. III (w.e.f. 20-3-1985).
8 Ins. by Act 39 of 1989.
9 Ins. by Act 53 of 1987 (w.e.f. 9-7-1988).
(2) The amount in the said Fund shall be applied by the Bank only to the following objects, namely:
(a) the making to the National Housing Bank of loans and advances for the purpose of any business of the National Housing Bank;
(b) the purchasing of bonds and debentures issued by the National Housing Bank.
1[47. Allocation of surplus profits.
After making provision for bad and doubtful debts, depreciation in assets, contributions to staff and superannuation funds 2[and for all other matters for which provision is to be made by or under this Act or which] are usually provided for by bankers, the balance of the profits shall be paid to the Central Government.]
48. Exemption of Bank from income-tax and super-tax.
(1) Notwithstanding anything contained in 3[the Income-Tax Act, 1961], or any other enactment for the time being in force relating to income-tax or super-tax, the Bank shall not be liable to pay income-tax or super-tax on any of its income, profits or gains.
4[* * * * * *]
49. Publication of bank rate.
The Bank shall make public from time to time the standard rate at which it is prepared to buy or re-discount bills of exchange or other commercial paper eligible for purchase under this Act.
5[50. Auditors.
(1) Not less than two auditors shall be appointed, and their remuneration fixed, by the Central Government.
(2) The auditors shall hold office for such term not exceeding one year as the Central Government may fix while appointing them, and shall be eligible for re-ppointment.]
51. Appointment of special auditors by Government.
1 Subs. by Act 62 of 1948, s. 7 and Sch. for s. 47 (w.e.f. 1-1-1949).
2 Subs. by Act 24 of 1955, s. 8, for “and such other contingencies as”.
3 Subs. by Act 24 of 1978, s. 8, for “Indian Income-tax Act, 1922” (w.e.f. 21-7-1978).
4 The proviso and sub-section (2) omitted by Act 62 of 1948, s. 7 and Sch. (w.e.f. 1-1-1949).
5 Subs. by s. 7 and Sch., ibid., for s. 50 (w.e.f. 1-1-1949).
Without prejudice to anything contained in section 50, the 1[Central Government] may at any time appoint the 2[Comptroller and Auditor- General]3[* * *] to examine and report upon the accounts of the Bank.
52. Powers and duties of auditors.
(1) Every auditor shall be supplied with a copy of the annual balance-sheet, and it shall be his duty to examine the same, together with the accounts and vouchers, relating thereto; and every auditor shall have a list delivered to him of all books kept by the Bank, and shall at all reasonable times have access to the books, accounts and other documents of the Bank, and may, at the expense of the Bank, 4[* * *] employ accountants or other persons to assist him in investigating such accounts, and may, in relation to such accounts, examine any Director or officer of the Bank.
(2) The auditors shall make a report 5[* * *] to the 6[Central Government] 7[* * *] upon the annual balance-sheet and accounts, and in every such report they shall state whether, in their opinion, the balance-sheet is a full and fair balance-sheet containing all necessary particulars and properly drawn up so as to exhibit a true and correct view of the state of the Bank’s affairs, and, in case they have called for any explanation or information from the Central Board, whether it has been given and whether it is satisfactory. 8[* * *]
53. Returns.
(1) The Bank shall prepare and transmit to the 9[Central Government] a weekly account of the Issue Department and of the Banking Department in 10[such] from as the 11[Central] Government] may, by notification in the Gazette of India, prescribe. The 12[Central Government] shall cause these
1 Subs. by the M. O. 1937, for “G. G. in C.”.
2 Subs. by Act 32 of 1951, s. 18, for “Auditor-General” (w.e.f. 1-11-1951).
3 The words “or such auditors as it thinks fit” omitted by Act 62 of 1948, s. 7 and Sch. (w.e.f. 1-1-1949).
4 Certain words omitted by Act 24 of 1955, s. 9.
5 The words “to the shareholders or” omitted by Act 62 1948, s. 7 and Sch. (w.e.f. 1-1-1949).
6 Subs. by the M. O. 1937, for “G. G. in C.”.
7 The words “as the case may be” omitted by s. 7 and Sch., ibid. (w.e.f. 1-1-1949).
8 The words “Any such report made to the shareholders shall be read, together with the report of the Central Board, at the annual general meeting”. omitted by Act 62 of 1948, s. 7 and Sch. (w.e.f. 1-1- 1949).
9 Subs. by the M. O. 1937, for “G. G. in C.”.
10 Subs. by the M.O. 1937, for certain words.
11 Subs. by the M. O. 1937, for “G. G. in C.”.
12 Subs. by the M. O. 1937, for “G. G. in C.”.
accounts to be 1[published in the Gazette of India at such intervals and in such modified form as it may deem fit].
(2) The Bank shall also, within two months from the date on which the annual accounts of the Bank are closed, transmit to the 2[Central Government] a copy of the annual accounts signed by the Governor, the Deputy Governors and the Chief Accounting Officer of the Bank, and certified by the auditors, together with a report by the Central Board on the working of the Bank throughout the year, and the 3[Central Government] shall cause such accounts and report to be published in the Gazette of India.
4[* * * * * *]
5[54. Rural Credit and Development.
The Bank may maintain expert staff to study various aspects of rural credit and development and in particular it may:-
(a) tender expert guidance and assistance to the National Bank;
(b) conduct special studies in such areas as it may consider necessary to do so for promoting integrated rural development.]
6[54A. Delegation of powers.
(1) The Governor may, by general or special order, delegate to a Deputy Governor, subject to such conditions and limitations, if any, as may be specified in the order, such of the powers and functions exercisable by him 7[* * *] under this Act or under any other law for the time being in force as he may deem necessary for the efficient administration of the functions of the Bank.
(2) The fact that a Deputy Governor exercises any power or does any act or thing in pursuance of this Act shall be conclusive proof of his authority to do so.]
8[54AA. Power of Bank to depute its employees to other institutions.
1 Subs. by Act 24 of 1978, s. 9, for certain words (w.e.f. 21-7-1978).
2 Subs. by the M. O. 1937, for “G. G. in C.”.
3 Subs. by the M. O. 1937, for “G. G. in C.”.
4 Sub-section (3) omitted by Act 62 of 1948, s. 7 and Sch. (w.e.f. 1-1-1949).
5 Subs. by Act 61 of 1981, s. 61 and Sch. II. for S. 54 (w.e.f. 12-7-1982).
6 Ins. by Act 24 of 1955, s. 10.
7 The words “by or” omitted by Act 58 of 1960, s. 3 and Sch. II.
8 Ins. by Act 58 of 1968, s. 28 (w.e.f. 1-2-1969).
1[(1) The Bank may, notwithstanding anything contained in any law, or in any agreement, for the time being in force, depute any member of its staff for such period as it may think fit, –
(a) to any institution which is wholly or substantially owned by the Bank;
(b) to the Development Bank, so, however, that no such deputation shall continue after the expiration of thirty months from the commencement of section 5 of the Public Financial Institutions Laws (Amendment) Act, 1975;
(c) to the Unit Trust, so, however, that no such deputation shall continue after the expiration of thirty months from the date notified by the Central Government under sub-section (1) of section 4A of the Unit Trust of India Act, 1963, and thereupon the person so deputed shall, during the period of his deputation, render such service to the institution to which he is so deputed as that institution may require.]
(2) Where a person has been deputed to an institution under subsection (1), he shall not be entitled to claim any salary, emoluments and other terms and conditions of service which he would not have been entitled to claim if he had not been so deputed.
(3) Nothing contained in this section shall empower the Bank to depute any member of its staff to any institution on any salary, emoluments or other terms and conditions which is or are less favourable to him than that or those to which he is entitled immediately before such deputation.
(4) For the purposes of this section, an institution shall be deemed to be substantially owned by the Bank if in the capital of the institution the Bank has not less than forty per cent, share.
Explanation. – The word “capital” means, in relation to the Unit Trust, the initial capital of that Trust.]
55 and 56. [Reports by the Bank. Power to require declaration as to ownership of registered shares.]
[Rep. by Act 62 of 1948, s. 7 and Sch.(w.e.f. 1-1-1949).]
57. Liquidation of the Bank.
(1) Nothing in the 2[Companies Act, 1956], shall apply to the Bank, and the Bank shall not be placed in liquidation save by order of the 3[Central Government] and in such manner as 4[it may direct].
1 Subs. by Act 52 of 1975, s. 20, for sub-section (1) (w.e.f. 16-2-1976).
2 Subs. by Act 19 of 1957, s. 5, for “Indian Companies Act, 1913 (7 of 1913)”.
3 Subs. by the M.O. 1937, for “G. G. in C.”.
4 Subs. Ibid., for “he may direct”.
1[* * * * * *]
58. Power of the Central Board to make regulations.
(1) The Central Board may, with the previous sanction of the 2[Central Government] 3[by notification in the official Gazette] make regulations consistent with this Act to provide for all matters for which provision is necessary or convenient for the purpose of giving effect to the provisions of this Act.
(2) In particular and without prejudice to the generality of the foregoing provision, such regulations may provide for all or any of the following matters, namely:-
4[* * * * *]
(f) the manner in which the business of the Central Board shall be transacted, and the procedure to be followed at meetings thereof;
(g) the conduct of business of Local Boards and the delegation to such Boards of powers and functions;
(h) the delegation of powers and functions of the Central Board 5[* * *] to Deputy Governors, Directors or officers of the Bank;
(i) the formation of Committees of the Central Board, the delegation of powers and functions of the Central Board to such Committees, and the conduct of business in such Committees;
(j) the constitution and management of staff and superannuation funds for the officers and servants of the Bank;
(k) the manner and form in which contracts binding on the Bank may be executed;
(l) the provisions of an official seal of the Bank and the manner and effect of its use;
(m) the manner and form in which the balance-sheet of the Bank shall be drawn up, and in which the accounts shall be maintained;
(n) the remuneration of Directors of the Bank;
1 Sub-section (2) omitted by Act 62 of 1948, s. 7 and Sch., (w.e.f. 1-1-1949).
2 Subs. by the M.O. 1937, for “G. G. in C.”.
3 Ins. by Act 66 of 1988 (w.e.f. 30-12-88)
4 Cls. (a) to (e) omitted by Act 62 of 1948, s. 7 and Sch., (w.e.f. 1-1-1949).
5 The words “to the Governor, or “omitted by Act 54 of 1953, S. 8.
(o) the relations of the scheduled banks with the Bank and the returns to be submitted by the scheduled banks to the Bank;
(p) the regulation of clearing-houses for the banks 1(including post office savings banks).
2[(pp) the regulation of fund transfer through electronic means between the banks or between the banks and other financial institutions referred to in clause (c) of section 45-I, including the laying down of the conditions subject to which banks and other financial institutions shall participate in such fund transfers, the manner of such fund transfers and the rights and obligations of the participants in such fund transfers.]
(q) the circumstances in which, and the conditions and limitations subject to which, the value of any lost, stolen, mutilated or imperfect currency note of the Government of India or bank note may be refunded; and
(r) generally, for the efficient conduct of the business of the Bank.
3[(3) Any regulation made under this section shall have effect from such earlier or later date as may be specified in the regulation.
(4) Every regulation shall, as soon as may be after it is made by the Central Board, be forwarded to the Central Government and that Government shall cause a copy of the same to be laid before each House of Parliament, while it is in session, for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the
regulation, or both Houses agree that the regulation should not be made, the regulation shall, thereafter, have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that regulation.]
4[(5)] Copies of all regulations made under this section shall be available to the public on payment.
5[58A. Protection of action taken in good faith.
(1) No suit, prosecution or other legal proceeding shall lie against the Central Government or the Bank or any other person in respect of anything which is
1 Subs. by Act 66 of 1988 (w.e.f. 30-12-1988).
2 Ins. vide The Information Technology Act, 2000 (w.e.f. 17-10-2000).
3 Ins. by Act 51 of 1947 s. 24.
4 Sub. Section (3) re-numbered as “(5)” by s. 24, Act 51 of 1974.
5 Ins. by s. 25, Act 51 of 1974.
in good faith done or intended to be done under this Act or in pursuance of any order, regulation or direction made or given thereunder.
(2) No suit or other legal proceeding shall lie against the Central Government or the Bank for any damage caused or likely to be caused by anything which is in good faith done or intended to be done under this Act or in pursuance of any order, regulation or direction made or given thereunder.]
1[CHAPTER V
PENALTIES
58B. Penalties.
(1) Whoever in any application, declaration, return, statement, information or particulars made, required or furnished by or under or for the purposes of any provisions of this Act, or any order, regulation or direction made or given thereunder or in any prospectus or advertisement issued for or in connection with the invitation by any person, of deposits of money from the public wilfully makes a statement which is false in any material particular knowing it to be false or wilfully omits to make a material statement shall be punishable with imprisonment for a term which may extend to three years and shall also be liable to fine.
(2) If any person fails to produce any book, account or other document or to furnish any statement, information or particulars which, under this Act or any order, regulation or direction made or given thereunder, it is his duty to produce or furnish or to answer any question put to him in pursuance of the provisions of this Act or of any order, regulation or direction made or given thereunder, he shall be punishable with fine which may extend to two thousand rupees in respect of each offence and if he persists in such failure or refusal, with further fine which may extend to one hundred rupees for every day, after the first during which the offence continues.
(3) If any person contravenes the provisions of section 31, he shall be punishable with fine, which may extend to the amount of the bill of exchange, hundi, promissory note or engagement for payment of money in respect whereof the offence is committed.
(4) If any person discloses any credit information, the disclosure of which is prohibited under section 45E, he shall be punishable with imprisonment for a term, which may extend to six months, or with fine, which may extend to one thousand rupees, or with both.
1[(4A) If any person contravenes the provisions of sub-section (1) of section 45-IA, he shall be punishable with imprisonment for a term which shall not be
1 Ins. by Act 51 of 1974, s. 26.
less than one year but which may extend to five years and with fine which shall not be less than one lakh rupees but which may extend to five lakh rupees.
(4AA) If any auditor fails to comply with any direction given or order made by the Bank under section 45MA, he shall be punishable with fine, which may extend to five thousand rupees.
(4AAA) Whoever fails to comply with any order made by the Company Law Board under sub-section (2) of section 45QA, shall be punishable with imprisonment for a term which may extend to three years and shall also be liable to a fine of not less than rupees fifty for every day during which such non-compliance continues.]
(5) If any person, 2[other than an auditor]-
(a) receives any deposit in contravention of any direction given or order made under Chapter IIIB; or
3[(aa) fails to comply with any direction given or order made by the Bank under any of the provisions of Chapter IIIB; or]
(b) issues any prospectus or advertisement otherwise than in accordance with section 45NA or any order made under section 45J, as the case may be, he shall be punishable with imprisonment for a term which may extend to three years and shall also be liable to fine which may extend, –
(i) in the case of a contravention falling under clause (a), to twice the amount of the deposit received; and
(ii) in the case of a contravention falling under clause (b), to twice the amount of the deposit called for by the prospectus or advertisement.
4[(5A) If any person contravenes any provision of section 45S, he shall be punishable with imprisonment for a term which may extend to two years, or with fine which may extend to twice the amount of deposit received by such person in contravention of that section, or two thousand rupees, whichever is more, or with both:
Provided that in the absence of special and adequate reasons to the contrary to be mentioned in the judgement of the court, the imprisonment shall not be less than one year and the fine shall not be less than one thousand rupees.
1 Ins. by s. 10 of Act 23 of 1997 (w.e.f. 9-1-1997).
2 Ins. by s. 10 of Act 23 of 1997 (w.e.f. 9-1-1997).
3 Ins. by s. 10 of Act 23 of 1997 (w.e.f. 9-1-1997).
4 Ins. by Act 1 of 1984 s. 11 (w.e.f. 15-2-1984).
(5B) Notwithstanding anything contained in section 29 of the Code of Criminal Procedure, 1973, it shall be lawful for a Metropolitan Magistrate or a Judicial Magistrate of the first class to impose a sentence of fine in excess of the limit specified in that section on any person convicted under subsection (5A).]
(6) If any other provision of this Act is contravened or if any default is made in complying with any other requirement of this Act or of any order, regulation or direction made or given or condition imposed thereunder, any person guilty of such contravention or default shall be punishable with fine which may extend to two thousand rupees and where a contravention or default is a continuing one, with further fine which may extend to one hundred rupees for every day after the first, during which the contravention or default continues.
58C. Offences by companies.
(1) Where a person committing a contravention or default referred to in section 58B is a company, every person who, at the time the contravention or default was committed, was in charge of, and was responsible to, the company for the conduct of the business of the company, as well as the company, shall be deemed to be gulity of the contravention or default and shall be liable to be proceeded against and punished accordingly:
Provided that nothing contained in this sub-section shall render any such person liable to punishment if he proves that the contravention or default was committed without his knowledge or that he had exercised all due diligence to prevent the contravention or default.
(2) Notwithstanding anything contained in sub-section (1), where an offence under this Act has been committed by a company and it is proved that the same was committed with the consent or connivance of or is attributable to any neglect on the part of, any director, manager, secretary, or other officer or employee of the company, such director, manager, secretary, other officer or employee shall also be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly.
Explanation 1. – Any offence punishable under this Act shall be deemed to have been committed at the place where the registered office or the principal place of business, as the case may be, in India, of the company is situated.
Explanation 2. – For the purpose of this section, –
(a) “a company” means any body corporate and includes a corporation, a non-banking institution, a firm, a co-operative society or other association of individuals;
(b) “director”, in relation to a firm, means a partner in the firm.
58D. Application of section 58B barred.
Nothing contained in section 58B shall apply to, or in respect of, any matter dealt with in section 42.
58E. Cognizance of offences.
(1) No court shall take cognizance of any offence punishable under this Act except upon a complaint in writing made by an officer of the Bank, generally or specially authorized in writing in this behalf by the Bank, and no court other than that of a Metropolitan Magistrate or a Judicial Magistrate of the first class or a court superior thereto shall try any such offence:
1[Provided that in respect of any offence punishable under sub-section (5A) of section 58B, a complaint in writing may also be made by an officer of the State Government, generally or specially authorised in writing in this behalf by that Government.]
(2) Notwithstanding anything contained in the Code of Criminal Procedure, 1973 a Magistrate may, if he sees reason so to do, dispense with the personal attendance of the officer of the Bank filing the complaint, but the Magistrate may in his discretion, at any stage of the proceedings, direct the personal attendance of the complainant.
58F. Application of fine.
A court imposing any fine under this Act may direct that the whole or any part thereof shall be applied in, or towards payment of, the costs of the proceedings.]
2[58G. Power of Bank to impose fine.
(1) Notwithstanding anything contained in section 58B, if the contravention or default of the nature referred to in section 58B is committed by a non- banking financial company, the Bank may impose on such non-banking financial company –
(a) a penalty not exceeding five thousand rupees; or
(b) where the contravention or default is under sub-section (4A) or clause
(a) or clause (aa) of sub-section (5) of section 58B, a penalty not exceeding five lakh rupees or twice the amount involved in such contravention or default, where the amount is quantifiable, whichever is more; and where such contravention or default is a continuing one, further penalty which may extend to twenty-five thousand rupees for every day, after the first, during which the contravention or default continues.
(2) For the purpose of imposing penalty under sub-section (1), the Bank shall serve a notice on the non-banking financial company requiring it to show
1 Ins. by Act 1 of 1984 s. 12 (w.e.f. 15-2-1984).
2 Ins. by s. 11 of Act 23 of 1997 (w.e.f. 9-1-1997).
cause why the amount specified in the notice should not be imposed as a penalty and a reasonable opportunity of being heard shall also be given to such non-banking financial company.
(3) Any penalty imposed by the Bank under this section shall be payable within a period of thirty days from the date on which notice issued by the Bank demanding payment of the sum is served on the non-banking financial company and, in the event of failure of the non-banking financial company to pay the sum within such period, may be levied on a direction made by the principal civil court having jurisdiction in the area where the registered office or the head office of the non-banking financial company is situated;
Provided that no such direction shall be made, except on an application made by an officer of the Bank authorised in this behalf, to by the principal civil court.
(4) The court, which makes a direction under sub-section (3), shall issue a certificate specifying the sum payable by the non-banking financial company and every such certificate shall be enforceable in the same manner as if it were a decree made by the court in a civil suit.
(5) No complaint shall be filed against any non-banking financial company in any court of law pertaining to any contravention or default in respect of which any penalty has been imposed by the Bank under this section.
(6) Where any complaint has been filed against a non-banking financial company in a court in respect of contravention or default of the nature referred to in section 58B, no proceedings for imposition of penalty against that non-banking financial company shall be taken under this section.]
59 to 61. [Amendment of Act 3 of 1906. Repeals, Amendment of section 11,Act 7 of 1913.]
Rep. by Act 20 of 1937, s. 3 Sch. II.
1[THE FIRST SCHEDULE
(See section 9)
2[1. The Western Area shall consist of the States of Goa, Gujarat, Madhya Pradesh and Maharashtra and the Union Territories of Dadra and Nagar Haveli and Daman and Diu.
1 Subs. by the Adaptation of Laws (No. 3) Order 1956, for the former First Schedule.
2 Subs. by Act 23 of 1997 s.12 for the former items No. 1 & 2 of the First Schedule (w.e.f. 9.1.1997).
2. The Eastern Area shall consist of the States of Arunachal Pradesh, Assam, Bihar, Manipur, Meghalaya, Mizoram, Nagaland, Orissa, Sikkim, Tripura and West Bengal and the Union Territories of Andaman and Nicobar Islands.]
3. The Northern Area shall consist of the States of Jammu & Kashmir, 1[Punjab, Haryana,] 2[Himachal Pradesh], Rajasthan and Uttar Pradesh and Union Territories of 3[Chandigarh,] 4[and Delhi].
4. The Southern Area shall consist of the States of Andhra Pradesh, 5[Karnataka], 6[Tamil Nadu] and Kerala and the 7[Union Territories of Pondicherry and 8[Lakshadweep]]. ]
9[THE SECOND SCHEDULE
[See section 42 and section 2(e)]
10[SCHEDULED BANKS
A B Bank Ltd.
Abhyudaya Co-operative Bank Ltd. ABN Amro Bank N.V.
Abu Dhabi Commercial Bank Ltd.
1 Subs. by the Punjab Reorganisation and Delhi High Court (Adaptation of Laws on Union Subjects) Order, 1968. for “Punjab” (w.e.f. 1.11.1966).
2 Ins. by the State of Himachal Pradesh (Adaptation of Laws in Union Subjects) Order, 1973 (w.e.f. 25.1.1971).
3 Ins. by the Punjab Reorganisation and Delhi High Court (Adaptation of Laws on Union Subjects) Order, 1968 (w.e.f. 1.11.1966).
4 Subs. by the State of Himachal Pradesh (Adaptation of Laws on Union Subjects) Order, 1973, for “Himachal Pradesh and Delhi” (w.e.f. 25.1.1971).
5 Subs. by the Mysore State (Alternation of Name) (Adaptation of Laws on Union Subjects) Order, 1974, for “Mysore” (w.e.f. 1.11.1973).
6 Subs. by the Madras State (Alteration of Name) (Adaptation of Laws on Union Subjects) Order, 1970, for “Madras” (w.e.f. 14.1.1969).
7 Subs. by Reg. 7 of 1963 s. 8 for “Union territory of Laccadive, Minicoy and Aminidivi Islands.”
8 Subs. by the Laccadive, Minicoy and Aminidivi Islands (Alteration of Name) Adaption of Laws Order, 1974 for “Laccadive, Minicoy and Aminidivi Islands” (w.e.f. 1.11.1973).
9 This Schedule as amended by the M. O. 1937, Acts 23 of 1955, 79 of 1956 and 38 of 1959 and by notifications issued under section 42(6) of this Act from time to time is reproduced here.
10 List as on February 28, 2009.
Ahmedabad Mercantile Co-Op Bank Ltd. Akola Gramin Bank, Akola (Maharashtra)
The Akola Janata Commercial Co-operative Bank Ltd., Akola. The Akola Urban Co-operative Bank Ltd., Akola.
Allahabad Bank
Allahabad Kshetriya Gramin Bank, Allahabad (Uttar Pradesh) Amanath Co-operative Bank Ltd. Bangalore
American Express Banking Corporation Andhra Bank
Andhra Pradesh Grameena Vikas Bank, Warangal (Andhra Pradesh) Andhra Pradesh Mahesh Co-Op Urban Bank Ltd.
Andhra Pradesh State Co-operative Bank Ltd., Hyderabad Andhra Pragathi Grameena Bank, Kapada ( Andhara Pradesh) Antwerp Diamond Bank N.V.
Aravali Kshetriya Gramin Bank, Sawai Madhopur (Rajasthan) Arunachal Pradesh Rural Bank, Pasighat (Arunachal Pradesh) Aryavart Gramin Bank, Lucknow (Uttar Pradesh)
Aurangabad Jalna Kshetriya Gramin Bank, Aurangabad (Maharashtra) Axis Bank Ltd.
Baitarani Gramya Bank, Baripada (Orissa) Balasore Gramya Bank, Balasore (Orissa)
Ballia Kshetriya Gramin Bank, Ballia (Uttar Pradesh) Bank Internasional Indonesia
Bank of America N.A.
Bank of Bahrain & Kuwait B.S.C. Bank of Baroda
Bank of Ceylon Bank of India
Bank of Maharashtra Bank of Nova Scotia
The Bank of Rajasthan Ltd.
Bank of Tokyo – Mitsubishi UFJ Ltd. Barclays Bank
Bardhaman Gramin Bank, Burdwan (West Bengal) Bareilly Kshetriya Gramin Bank, Bareilly (Uttar Pradesh)
Baroda Gujarat Gramin Bank, Bharuch (Gujarat) Bassein Catholic Co-operative Bank Ltd.
Bastar Kshetriya Gramin Bank, Jagdalpur (Chhattisgarh) Basti Gramin Bank, Basti (Uttar Pradesh)
Begusarai Kshetriya Gramin Bank, Begusarai (Bihar) Bhagalpur-Banka Kshetriya Gramin Bank, Bhagalpur (Bihar) Bhandara Gramin Bank, Bhandara (Maharashtra)
Bharat Co-operative Bank (Mumbai) Ltd. Bharati Sahakari Bank Limited.
Bhilwara Ajmer Kshetriya Gramin Bank, Bhilwara (Rajasthan) Bihar State Co-operative Bank Ltd., Patna
Bikaner Kshetriya Gramin Bank, Bikaner (Rajasthan)
Bilaspur Raipur Kshetriya Gramin Bank, Bilaspur (Chhattisgarh) BNP Paribas
Bolangir Anchalik Gramya Bank, Bolangir (Orissa) Bombay Mercantile Co-operative Bank Limited Buldhana Gramin Bank, Buldhana (Maharashtra
Bundi-Chittorgarh Kshetriya Gramin Bank, Bundi (Rajasthan) Cachar Gramin Bank, Silchar (Assam)
Calyon Bank Canara Bank
The Catholic Syrian Bank Ltd.
Cauvery Kalpatharu Grameena Bank, Mysore (Karnataka) Central Bank of India
Chaitanya Godavari Grameena Bank, Guntur (Andhra Pradesh) Chambal Kshetriya Gramin Bank, Morena (Madhya Pradesh) Champaran Kshetriya Gramin Bank, Motihari (Bihar) Chandrapur Gadchiroli Gramin Bank, Chandrapur (Maharashtra) Charminar Co-op.Urban Bank Ltd.
Chhindwara Seoni Kshetriya Gramin Bank, Chhindwara (M.P.) Chikmagalur-Kodagu Grameena Bank, Chikmagalur (Karnataka) China Trust Commercial Bank
Citi Bank N.A.
Citizen Credit Co-operative Bank Ltd., Dadar.] City Union Bank Ltd.
Corporation Bank
Cosmos Co-operative Urban Bank Ltd. Cuttack Gramya Bank, Cuttack (Orissa) DBS Bank Ltd.
Deccan Grameena Bank, Rangareddy (Andhra Pradesh) Dena Bank
Dena Gujarat Gramin Bank, Gandhinagar (Gujarat) Deutsche Bank A.G.
Development Credit Bank Ltd.
Devipatan Kshetriya Gramin Bank, Gonda (Uttar Pradesh) The Dhanalakshmi Bank Ltd.
Dhenkanal Gramya Bank, Dhenkanal (Orissa) Dombivli Nagari Sahakari Bank Ltd.
Dungarpur-Banswara Kshetriya Gramin Bank, Dungarpur (Rajasthan) Durg-Rajanandgaon Gramin Bank, Rajanandgaon (Chhatisgarh) Ellaquai Dehati Bank, Srinagar (Jammu & Kashmir)
Etawah Kshetriya Gramin Bank, Etawah (Uttar Pradesh) Faizabad Kshetriya Gramin Bank, Faizabad (Uttar Pradesh) Fatehpur Kshetriya Gramin Bank, Fatehpur (Uttar Pradesh) The Federal Bank Ltd.
Gaur Gramin Bank, Malda (West Bengal)
Giridih Kshetriya Gramin Bank, Giridih (Jharkhand) Goa State Co-operative Bank Ltd., Panaji
Goa Urban Co-operative Bank Limited.
Gopalganj Kshetriya Gramin Bank, Gopalganj (Bihar) Gorakhpur Kshetriya Gramin Bank, Gorakhpur (Uttar Pradesh) Greater Bombay Co-operative Bank Limited
Gujarat State Co-operative Bank Ltd., Ahmedabad Gurgaon Gramin Bank, Gurgaon (Haryana)
Gwalior Datia Kshetriya Gramin Bank, Datia (Madhya Pradesh) Hadoti Kshetriya Gramin Bank, Kota (Rajasthan)
Haryana Gramin Bank, Rohtak (Haryana) Haryana State Co-operative Bank Ltd., Chandigarh
Hazaribagh Kshetriya Gramin Bank, Hazaribagh (Jharkhand) HDFC Bank Ltd.
Himachal Gramin Bank, Mandi (Himachal Pradesh) Hindon Gramin Bank, Ghaziabad (Uttar Pradesh) The Hongkong and Shanghai Banking Corpn. Ltd. Howrah Gramin Bank, Howrah (West Bengal) ICICI Bank Ltd.
IDBI Bank Ltd.
Indian Bank
Indian Mercantile Co-operative Bank Ltd.,Lucknow Indian Overseas Bank
IndusInd Bank Ltd. ING Vysya Bank Ltd. J.P.Morgan Chase Bank
Jaipur Thar Gramin Bank, Jaipur (Rajasthan) Jalgaon Janata Sahakari Bank Ltd.
The Jammu & Kashmir Bank Ltd.
Jammu Rural Bank, Jammu (Jammu & Kashmir) Janakalyan Sahakari Bank Ltd., Bombay Janalaxmi Co-operative Bank Ltd.
Janata Sahakari Bank Ltd., Pune.
Jhabua-Dhar Kshetriya Gramin Bank, Jhabua (Madhya Pradesh) JSC VTB Bank
Kalahandi Anchalika Gramya Bank, Bhawanipatna, (Orissa) Kallappanna Awade Ichalkaranji Janata Sahakari Bank Ltd., Ichalkaranji Kalupur Commercial Co-op.Bank Ltd.
Kalyan Janata Sahakari Bank Ltd., Kalyan Kamraz Rural Bank, Sopore (Jammu & Kashmir)
Kanpur Kshetriya Gramin Bank, Kanpur (Uttar Pradesh) Kapole Co-operative Bank Ltd., Bombay
Karad Urban Co-operative Bank Ltd. The Karnataka Bank Ltd.
Karnataka State Co-operative Bank Ltd., Bangalore Karnataka Vikas Grameena Bank, Dharwad (Karnataka) The Karur Vysya Bank Ltd.
Kashi Gomti Samyut Gramin Bank, Varanasi (Uttar Pradesh) Kerala State Co-operative Bank Ltd., Thiruvananthapuram
The Khamgaon Urban Co-operative Bank Ltd., Khamgaon. Kisan Gramin Bank, Budaun (Uttar Pradesh)
Koraput Panchabati Gramya Bank, Jeypore (Orissa) Kosi Kshetriya Gramin Bank, Pumea (Bhiar)
Kotak Mahindra Bank Ltd.
Krishna Grameena Bank, Gulbarga (Karnataka) Krung Thai Bank Public Company Ltd.
Kshetriya Gamin Bank, Hoshangabad (Madhya Pradesh) Kshetriya Kisan Gramin Bank, Mainpuri (Uttar Pradesh) Lakhimi Gaonlia Bank, Golaghat (Assam)
The Lakshmi Vilas Bank Ltd.
Langpi Dehangi Rural Bank, Diphu (Assam)
Lucknow Kshetriya Gramin Bank, Sitapur (Uttar Pradesh) Madhavpura Mercantile Co-Op Bank Ltd.
Madhubani Kshetriya Gramin Bank, Madhubani (Bihar) Madhya Bharath Gramin Bank, Sagar (Madhya Pradesh) Madhya Bihar Gramin Bank, Patna (Bihar)
Madhya Pradesh Rajya Sahakari Bank Maryadit., Bhopal Mahakaushal Kshetriya Gramin Bank, Narsinghpur (Madhya Pradesh) Mahanagar Co-operative Bank Ltd., Mumbai
Maharashtra State Co-operative Bank Ltd., Mumbai Mallabhum Gramin Bank, Bankura (West Bengal) Malwa Gramin Bank, Sangrur (Punjab)
Mandla Balaghat Kshetriya Gramin Bank, Mandla (Madhya Pradesh) Manipur Rural Bank, Imphal (Manipur)
Mapusa Urban Co-operative Bank of Goa Ltd., Mapusa Marathwada Gramin Bank, Nanded (Maharashtra) Marudhar Kshetriya Gramin Bank, Churu (Rajasthan) Marwar Gramin Bank, Pali (Rajasthan)
Mashreq Bank p.s.c.
Mayurakshi Gramin Bank, Suri (West Bengal) Meghalaya Rural Bank, Shillong (Meghalaya) Mehsana Urban Co-Op Bank Ltd.
Mewar-Aanchalik Gramin Bank, Udaipur (Rajasthan) Mithila Kshetriya Gramin Bank, Darbhanga (Bihar)
Mizoram Rural Bank, Aizawal (Mizoram) Mizuho Corporate Bank
Monghyr Kshetriya Gramin Bank, Monghyr (Bihar) Murshidabad Gramin Bank, Berhampore (West Bengal)
Muzaffarnagar Kshetriya Gramin Bank, Muzaffarnagar (Uttar Pradesh) Nadia Gramin Bank, Krishnanagar (West Bengal)
Nagaland Rural Bank, Kohima (Nagaland)
Nagar Urban Co-operative Bank Ltd., Ahmednagar Nagpur Nagrik Sahakari Bank Ltd.
Nainital Almora Kshetriya Gramin Bank, Nainital (Uttaranchal) The Nainital Bank Ltd.
Narmada Malwa Gramin Bank, Indore (Madhya Pradesh) Nasik Merchant’s Co-operative Bank Ltd.
New India Co-operative Bank Ltd., Bombay NKGSB Co-operative Bank Ltd.
North Malabar Gramin Bank, Kannur (Kerala) Nutan Nagarik Sahakari Bank Ltd., Ahmedabad Oman International Bank S.A.O.G.
Oriental Bank of Commerce
Orissa State Co-operative Bank Ltd., Bhubaneswar Palamau Kshetriya Gramin Bank, Daltonganj (Jharkhand) Pallavan Grama Bank, Salem (Tamil Nadu)
Pandyan Grama Bank, Virudhunagar (Tamil Nadu) Parsik Janata Sahakari Bank Ltd., Thane
Parvatiya Gramin Bank, Chamba (Himachal Pradesh) Pondicherry State Co-operative Bank Ltd., Pondichery Pragathi Gramin Bank, Bellary (Karnataka) Pragjyotish Gaonlia Bank, Nalbari (Assam)
Pratapgarh Kshetriya Gramin Bank, Pratapgarh (Uttar Pradesh) Prathama Bank, Moradabad (Uttar Pradesh)
Pravara Sahakari Bank Ltd.
Puduvai Bharathiar Grama Bank (Puducherry) Punjab & Maharashtra Co-operative Bank Ltd. Punjab & Sind Bank
Punjab Gramin Bank, Kapurthala (Punjab)
Punjab National Bank
Punjab State Co-operative Bank Ltd., Chandigarh Puri Gramya Bank, Pipli (Orissa)
Rae Bareli Kshetriya Gramin, Rae Bareli (Uttar Pradesh) Raigarh Kshetriya Gramin Bank, Raigarh (Chhattisgarh) Rajasthan Gramin Bank, Alwar (Rajasthan)
Rajasthan State Co-operative Bank Ltd., Jaipur Rajkot Nagrik Sahakari Bank Ltd.
Ranchi Kshetriya Gramin Bank, Ranchi (Jharkhand)
Rani Laxmi Bai Kshetriya Gramin Bank, Jhansi (Uttar Pradesh)
Ratlam Mandasaur Kshetriya Gramin Bank, Mandsaur (Madhya Pradesh) Ratnagiri Sindhudurg Gramin Bank, Ratnagiri (Maharashtra)
The Ratnakar Bank Ltd
Rewa Sidhi Gramin Bank, Rewa (Madhya Pradesh) Rupee Co-operative Bank Ltd.
Rushikulya Gramya Bank, Berhampur (Orissa) Sagar Gramin Bank, Amtala (West Bengal)
Samastipur Kshetriya Gramin Bank, Samastipur (Bihar) Sangli Urban Co-operative Bank Ltd.
Santhal Parganas Gramin Bank, Dumka (Jharkhand) Saptagiri Grameena Bank, Chitoor (Andhra Pradesh) Saran Kshetriya Gramin Bank, Chapra (Bihar) Saraswat
Co-operative Bank Ltd., Bombay
Sardar Bhiladwala Pardi Peoples Coop Bank Ltd. Saurashtra Gramin Bank, Rajkot (Gujarat)
SBI Commercial & International Bank Ltd.
Shahadol Kshetriya Gramin Bank, Shahadol (Madhya Pradesh) Shahjahanpur Kshetriya Gramin Bank, Shahjahanpur (Uttar Pradesh) Shamrao Vithal Co-operative Bank Ltd.
Sharda Gramin Bank, Satna (Madhya Pradesh) Shikshak Sahakari Bank Ltd., Nagpur.
Shinhan Bank
Shreyas Gramin Bank, Aligarh (Uttar Pradesh) Singhbhum Kshetriya Gramin Bank, Chaibasa (Jharkhand) Siwan Kshetriya Gramin Bank, Siwan (Bihar)
Societe Generale
Solapur Gramin Bank, Solapur (Maharashtra) Solapur Janata Sahakari Bank Ltd.
Sonali Bank Ltd.
The South Indian Bank Ltd.
South Malabar Gramin Bank, Malappuram (Kerala)
Sriganganagar Kshetriya Gramin Bank, Sriganganagar (Rajasthan) Standard Chartered Bank
State Bank of Bikaner & Jaipur State Bank of Hyderabad State Bank of India
State Bank of Indore
State Bank of Mauritius Ltd. State Bank of Mysore
State Bank of Patiala State Bank of Travancore
Subansiri Gaonlia Bank, North Lakhimpur (Assam)
Sultanpur Kshetriya Gramin Bank, Sultanpur (Uttar Pradesh) Surat Peoples Co-op Bank Ltd.
Surguja Kshetriya Gramin Bank, Ambikapur (Chhattisgarh) Sutluj Gramin Bank, Bhatinda (Punjab)
Syndicate Bank
Tamil Nadu State Apex Co-operative Bank Ltd., Chennai Tamilnad Mercantile Bank Ltd.
Thane Bharat Sahakari Bank Ltd.
Thane Gramin Bank, Thane (Maharashtra) Thane Janata Sahakari Bank Ltd.
Tripura Gramin Bank, Agartala (Tripura)
Triveni Kshetriya Gramin Bank, Orai (Uttar Pradesh) UBS AG
UCO Bank
Union Bank of India United Bank of India
Uttar Banga Kshetriya Gramin Bank, Cooch Behar (West Bengal) Uttar Pradesh State Co-operative Bank Ltd., Lucknow
Uttaranchal Gramin Bank, Dehradun (Uttaranchal) Vaishali Kshetriya Gramin Bank, Muzaffarpur (Bihar) Vasavi Coop Urban Bank LImited.
Vidisha-Bhopal Kshetriya Gramin Bank, Vidisha (Madhya Pradesh) Vidur Gramin Bank, Bijnor (Uttar Pradesh)
Vijaya Bank
Visveshwaraya Grameena Bank, Mandya (Karnataka) West Bengal State Co-operative Bank Ltd., Kolkata Yavatmal Gramin Bank, Yavatmal (Maharashtra)
Yes Bank Ltd.
Zoroastrian Co-operative Bank Ltd., Bombay
THE THIRD SCHEDULE
[Repealed by Act 23 of 1955, s. 52 and Sch. III (w.e.f. 1-7-1955)
THE FOURTH SCHEDULE
[Repealed by Act 62 of 1948, s. 7 and Sch. (w.e.f. 1-1-1949)
THE FIFTH SCHEDULE
[Repealed by the M.O. 1937]
*************
The Drugs and Cosmetics Rules 1945
(As amended up to the 31st December, 2016)
[21st December 1945]
Notificaiton: No. F. 28-10/45-H (1). _In exercise of the powers conferred by 1[sections 6(2), 12, 33 and 33N] of the Drugs and Cosmetics Act, 1940 (XXIII of 1940), the Central Government is pleased to make the following Rules:-
PART I
PRELIMINARY
1. Short title, extent and commencement. (1) These Rules may be called the Drugs 9[and Cosmetics] Rules, 1945.
(2) They extend to the whole of India.
2[***]
10[***]
2. Definitions. In these Rules, unless there is anything repugnant in the subject or context
(a) “the Act” means the Drugs and Cosmetics Act, 1940 (XXIII of 1940) as amended from time to time;
3[(b) “Central Licence Approving Authority” means the Drugs Controller, India, or the Joint Drugs Controller (India) or the Deputy Drugs Controller (India) appointed by the Central Government;]
(c) “Director” means the Director of the Central Drugs Laboratory;
(d) “Form” means a form set forth in Schedule A;
4[(dd) Homoeopathic medicines include any drug which is recorded in Homoeopathic provings or therapeutic efficacy of which has been established through long clinical experience as recorded in authoritative Homoeopathic literature of India and abroad and which is prepared according to the techniques of Homoeopathic pharmacy and covers combination of ingredients of such Homoeopathic medicines but does not include a medicine which is administered by parenteral route;]
(e) “Laboratory” means the Central Drugs Laboratory;
5[(ea) “registered Homoeopathic medical practitioner” means a person who is registered in the Central Register or State Register of Homoeopathy;]
8[(eb)”Phytopharmaceutical drug” includes purified and standardised fraction with defined minimum four bio-active or phyto-chemical compounds (qualitatively and quantitatively assessed) of an extract of a medicinal plant or its part, for internal or external use of human beings or animals for diagnosis, treatment, mitigation or prevention of any disease or disorder but does not include administration by parenteral route.]
6[(ee) “Registered medical practitioner” means a person
(i) holding a qualification granted by an authority specified or notified under section 3 of the Indian Medical Degrees Act, 1916 (7 of 1916), or specified in the Schedules to the Indian Medical Council Act, 1956 (102 of 1956); or
(ii) registered or eligible for registration in a medical register of a State meant for the registration of persons practising the modern scientific system of medicine 7[excluding the Homoeopathic system of medicine]; or
1. Subs. by G.S.R. 370(E), dt. 7-4-1994. 2. Omitted by G.S.R. 358, dt. 15-3-1975.
3. Sub. by GSR. 579(E), dt. 20-9-2006, earlier Ins. by G.S.R. 923(E), dt. 14-12-1992.
4. Ins. by Notfn. No. F. 1-59 / 68-D, dt. 19-11-1969.
5. Ins. by G.S.R 680 (E), dt. 5-12-1980. 6. Ins. by Notfn. F. 1-22 / 59-D, dt. 9-4-1960.
7. Ins. by S.O. 2139, dt. 15-6-1972. 8. Ins. By G.S.R 918(E), dt. 30-11-2015.
9. Ins. by GSR 1183(E), dt 17-8-1964. 10. Sub-rule (3) omitted by GSR 19, dt. 15-12-1977.
(iii) registered in a medical register, 1[other than a register for the registration of Homoeopathic practitioner], of a State, who although not falling within sub-clause (i) or sub-clause (ii) is declared by a general or special order made by the State Government in this behalf as a person practising the modern scientific system of medicine for the purposes of this Act; or
(iv) registered or eligible for registration in the register of dentists for a State under the Dentists Act, 1948 (16 of 1948); or
(v) who is engaged in the practice of veterinary medicine and who possesses qualifications approved by the State Government;]
2[(f) “retail sale” means a sale 3[whether to a hospital, or dispensary, or a medical, educational or research institute or to any other person] other than a sale by way of wholesale dealing];
4[(g) “sale by way of wholesale dealing” means sale to a person for the purpose of selling again and includes sale to a hospital, dispensary, medical, educational or research institution;]
5[(h) “Schedule” means a Schedule to these Rules;]
6[(i) State Government in relation to a Union Territory means the Administrator thereof;
9[***]
PART II
THE CENTRAL DRUGS LABORATORY
3. Functions. It shall be the function of the Laboratory
(i) to analyse or test such samples of drugs as may be sent to it under sub- section (2) of section 11, or under sub-section (4) of section 25 of the Act;
7[* * * * *]
(iii) to carry out such other duties as may be entrusted to it by the Central Government or, with the permission of the Central Government, by a State Government after consultation with the Drugs Technical Advisory Board.
8[3A. (1)The functions of the Laboratory in respect of the following drugs or classes of drugs shall be carried out at the Central Research Institute, Kasauli, and the functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the Director of the said Institute :
(1) Sera.
(2) Solution of serum proteins intended for injection.
(3) Vaccines.
(4) Toxins.
(5) Antigens.
1. Ins. by S.O. 2139, dt. 5-6-1972.
2 Subs. by Notfn. No. F. 1-3/51-DS., dt. 15-11-1954.
3. Ins. by G.S.R 681 (E), dt. 6-6-1988.
4. Subs. by Notfn. F-1-16/57, dt. 15.6.1957.
5. Subs. by Notfn. No. F. 28-10/45-H (1), dt. 31-3-1957.
6. Subs. by Notfn. No. F-1-16/57-D, dt. 15-6-1957.
7. Cl. (ii) omitted, by Notfn. No. F-1-16/57-D, dt. 15-6-1957. 8 Ins. by Notfn. No. F. 4-1 / 60-D, dt. 15-5-1961.
9. Cl. (j) omitted by GSR 592(E), dt. 13-08-2008
(6) Anti-toxins.
(7) Sterilized surgical ligature and sterilised surgical suture.
(8) Bacteriophages:
1[Provided that the functions of the Director in respect of Oral Polio Vaccine shall be exercised by the Deputy Director and Head of the Polio Vaccine Testing Laboratory in case of Central Research Institute, Kasauli only.]
2[(1A) The functions of the Laboratory in respect of Oral Polio Vaccine shall be carried out by the following Institutes and the functions of the Director in respect of the said drugs shall be exercised by the Director of the respective Institutes :-
(a) Pasteur Institute of India, Coonoor.
(b) Enterovirus Research Centre (Indian Council of Medical Research), Haffkin Institute Compound, Parel, Bombay-400012.]
3[(c) The National Institute of Biologicals, NOIDA.]
4[(2) The functions of the Laboratory in respect of the following drugs or classes of drugs shall be carried out at the Indian Veterinary Research Institute, Izatnagar or Mukteshwar and the functions of the Director in respect of the said drugs or classes of drugs shall be exercised by the Director of either of the said institutes.
(1) Anti-sera for veterinary use.
(2) Vaccines for veterinary use.
(3) Toxoids for veterinary use.
(4) Diagnostic Antigens for veterinary use.]
5[(3) The functions of the laboratory in respect of testing of condoms shall be carried out at the Central Drugs Testing Laboratory, Chennai, and the functions of the Director in respect of the said products shall be exercised by the Director of the said Laboratory.]
6[(4)] The functions of the Laboratory in respect of the following drug shall be carried out at the Laboratory of the Serologist and Chemical Examiner to the Government of India, Calcutta and the functions of the Director in respect of the said drug shall be performed by the Serologist and Chemical Examiner of the said Laboratory :
VDRL Antigen.
7[(5) The function of the Laboratory in respect of Intra-Utrine Devices and Falope Rings shall be carried out at the Central Drugs Testing Laboratory, Thane, Maharashtra and the functions of the Director in respect of the said devices shall be exercised by the Director of the said Laboratory.]
1. Subs. by G.S.R.445(E), dt. 30-4-1992. Earlier Ins. by G.S.R.62(E), dt. 15-2-1982.
2. Ins. by G.S.R. 445(E), dt. 30-4-1992.
3. Ins. by G.S.R.249(E), dt. 4-4-2002.
4. Ins. by Notfn. No. F.-1-6/62-D, dt. 2-7-1969.
5. Sub. By G.S.R. 651(E), dt. 9-9-2009, earlier Ins. by S. O. No. 2139, dt. 12-8-1972.
6. Sub-rule (4) omitted and sub-rule (5) renumbered as sub-rule (4) by Notfn. No. G.S.R. 62(E), dt. 15-2-1982.
7. Subs. by G.S.R 242(E), dt. 18-3-1998. Earlier Ins. by G.S.R. No. 865 (E), dt. 25-10-1990.
1[(6) The functions of the Laboratory in respect of human blood and human blood products including components, to test for freedom of HIV antibodies, shall be carried out by the following Institutes/Hospitals and the functions of the Director in respect of the above mentioned products shall be exercised by the head of the respective Institute, namely:-
(a) National Institute for Communicable Disease, Department of Microbiology, Delhi.
(b) National Institute of Virology, Pune
(c) Centre of Advanced Research in Virology, Christian Medical College, Vellore.]
2[(7) The functions of the Laboratory in respect of Homoeopathic medicines shall be carried out at the Homoeopathy Pharmacopoeia Laboratory, Ghaziabad and the functions of the Director in respect of the Homoeopathic medicines shall be exercised by the Director of the laboratory.]
3[(8) (a) The functions of the Laboratory in respect of the following kits or class of drugs shall be carried out at the National Institute of Biologicals, Noida and the functions of the Director in respect of the said drugs or class of drugs shall be exercised by the Director of the said institute.
(b) The kits or class of drugs referred to in clause (a) are-
(1) Blood grouping reagents.
(2) Diagnostic kits for human immunodeficiency virus, Hepatitis B Surface Antigen and Hepatitis C Virus.
(3) Blood products-
(a) Human Albumin;
(b) Human Normal Immunoglobulin (intramuscular and intravenous);
(c) Human Coagulation Factor VIII;
(d) Human Coagulation Factor IX;
(e) Plasma Protein Fractionation;
(f) Fibrin Sealant Kit;
(g) Anti Inhibitor Coagulation complex.
(4) Recombinant products such as-
(a) Recombinant insulin and insulin analogue;
(b) r-erythropoietin (EPO);
(c) r-Granulocyte Colony stimulating Factor (G-CSF).
(5) Biochemical kits-
(a) Glucose Test Strips;
(b) Fully Automated analyzer based glucose reagents.]
4. Despatch of samples for test or analysis.- (1) Samples for test or analysis under sub-section (4) of section 25 of the Act shall be sent by registered post in a sealed packet, enclosed, together with a memorandum in Form 1, in an outer cover addressed to the Director.
(2) The packet as well as the outer cover, shall be marked with a distinguishing number.
(3) A copy of the memorandum in Form 1 and a specimen impression of the seal used to seal the packet shall be sent separately by registered post to the Director.
5. Recording of condition of seals. On receipt of the packet, it shall be opened by an officer authorised in writing in that behalf by the Director who shall record the condition of the seal on the packet.
1. Ins. by G.S.R 16(E), dt. 10-1-1990.
2. Ins. by G.S.R 246(E), dt. 1-5-1991.
3. Sub. by G.S.R. No. 908(E), dt. 4-4-2014. Earlier Ins. by G.S.R. No. 249 (E), dt. 4-4-2002.
6. Report of result of test or analysis. After test or analysis the result of the test or analysis, together with full protocols of the tests applied, shall be supplied forthwith to the sender in Form 2.
7. Fees. The fees for test and analysis shall be those specified in Schedule B.
8. Signature of certificates. Certificates issued under these Rules by the Laboratory shall be signed by the Director or by an officer authorised by the Central Government by Notification in the Official Gazette to sign such certificates.
1[PART III
[RULES 9 to 20- omitted by SRO. 2136 dated 15-06-1957]
PART IV
2[IMPORT AND REGISTRATION]
21. In this Part.–
3[(a) “import licence” means either a licence in Form 10 to import drugs 4[* * *]; excluding those specified in Schedule X, or a licence in Form 10-A to import drugs specified in Schedule X;]
(b) “licensing authority” means the authority appointed by the Central Government to perform the duties of the licensing authority under these Rules and includes any person to whom the powers of a licensing authority may be delegated under Rule 22;
(c) “licence for examination, test or analysis” means a licence in Form 11 to import small quantities of drugs the import of which is otherwise prohibited, for the purpose of examination, test or analysis;
5[(d) “manufacturer” includes a manufacturer of drugs, who may be a Company or a unit or a body corporate or any other establishment in a country other than India, having its drugs manufacturing facilities duly approved by the National Regulatory Authority of that country, and who also has a free sale approval of the drugs approved by the said authority in the concerned country, and/or in other major countries;
(e) “Registration Certificate” means a certificate issued under Rule 27A by the licensing authority in Form 41 for registration of the premises and the drugs manufactured by the manufacturer meant for import into and use in India.]
22. The licensing authority may with the approval of the Central Government by an order in writing delegate the 2[power to sign licences and Registration Certificate and] such other powers as may be specified in the order to any other person under his control.
1. Part III (Rules 9 to 20) omitted by Notfn. No. F. 1-16/57-D (SRO 2136), dt. 15-6-1957.
2. Sub. by G.S.R 604 (E), dt. 24-8-2001.
3. Subs. by G.S.R 462 (E),dt. 22-6-1982.
4. Omitted by G.S.R 604 (E), dt. 24-8-2001.
5. Ins. by G.S.R 604 (E), dt. 24-8-2001.
1[23. Import licences.– An import licence in Form 10 shall be required for 2 [import of drugs], excluding those specified in Schedule X, and an import licence in Form 10- A shall be required for the import of drugs specified in Schedule X.]
2[24. Form and manner of application for import licence.– (1) An application for an import licence shall be made to the licensing authority in Form 8 for drugs excluding those specified in Schedule X, and in Form 8A for drugs specified in Schedule X, either by the manufacturer himself having a valid wholesale licence for sale or distribution of drugs under these Rules, or by the manufacturer‘s agent in India either having a valid licence under the Rules to manufacture for sale of a drug or having a valid wholesale licence for sale or distribution of drugs under these Rules, and shall be accompanied by a licence fee of one thousand rupees for a single drug and an additional fee at the rate of one hundred rupees for each additional drug and by an undertaking in Form 9 duly signed by or on behalf of the manufacturer:
Provided that in the case of any subsequent application made by the same importer for import licence for drugs manufactured by the same manufacturer, the fee to accompany each such application shall be one hundred rupees for each drug:
(2) Any application for import licence in Form 8 or Form 8-A, as the case may be, shall be accompanied by a copy of Registration Certificate issued in Form 41 under Rule 27A:
Provided that in case of emergencies the licensing authority may, with the approval of the Central Government, issue an import licence in Form 10 or 10A, as the case may be, without the issuance of Registration Certificate under Rule 27A, for reasons to be recorded in writing.
3[Provided further that Registration certificate shall not be required to be accompanied with an application for an import licence under the Rules for the import of in-vitro diagnostic kits and regents, except for the diagnostic kits notified from time to time under sub-clause (iv) of clause (b) of section 3.]
(3) A fee of two hundred and fifty rupees shall be paid for a duplicate copy of the licence issued under this Rule, if the original is defaced, damaged or lost.]
4[24A. Form and manner of application for Registration Certificate.— (1) An application for issue of a Registration Certificate shall be made to the licensing authority in Form 40, either by the manufacturer himself, having a valid wholesale licence for sale or distribution of drugs under these rules, or by his authorised agent in India, either having a valid licence under the rules to manufacture for sale of a drug or having a valid wholesale licence for sale or distribution of drugs under these rules, and shall be accompanied by the fee specified in sub-rule (3) and the informations and undertakings specified in Schedules D-I and D-II duly signed by or on behalf of the manufacturer.
1. Subs. by G.S.R. 462 (E), dt. 22-6-1982.
2. Subs. by G.S.R 604 (E), dt. 24-8-2001.
3. Ins. by G.S.R. 35(E), dt. 20.1.2005.
4. Ins. by G.S.R 604 (E), dt. 24-08-2001.
(2) The authorisation by a manufacturer to his agent in India shall be documented by a power of attorney executed and authenticated either in India before a First Class Magistrate, or in the country of origin before such an equivalent authority, the certificate of which is attested by the Indian Embassy of the said country, and the original of the same shall be furnished along with the application for Registration Certificate.
(3) (i) A fee of one thousand and five hundred US dollars 1[or its equivalent in Indian rupees] shall be paid along with the application in Form 40 as registration fee for his premises meant for manufacturing of drugs intended for import into and use in India
(ii) A fee of one thousand US dollars 1[or its equivalent in Indian rupees] shall be paid along with the application in Form 40 for the registration of a single drug meant for import into and use in India and an additional fee at the rate of one thousand US dollars for each additional drug:
Provided that in the case of any subsequent application for registration of additional drugs by the same manufacturer, the fee to accompany shall be one thousand US dollars 1[or its equivalent in Indian rupees] for each drug.
(4) The fees shall be paid through a Challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account “0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines”:
Provided that in the case of any direct payment of fees by a manufacturer in the country of origin, the fees shall be paid through Electronic Clearance System (ECS) from any bank in the country of origin to the Bank of Baroda, Kasturba Gandhi Marg, New Delhi, through the Electronic Code of the bank in the Head of Account “0210- Medical and Public Health, 04- Public Health, 104-Fee and Fines”, and the original receipt of the said transfer shall be treated as an equivalent to the bank challan, subject to the approval by the Bank of Baroda that they have received the payment.
(5) The applicant shall be liable for the payment of a fee of five thousand US dollars 1[or its equivalent in Indian rupees] for expenditure as may be required for inspection or visit of the manufacturing premises or drugs, by the licensing authority or by any other persons to whom powers have been delegated in this behalf by the licensing authority under Rule 22.
(6) The applicant shall be liable for the payment of testing fees directly to a testing laboratory approved by the Central Government in India or abroad, as may be required for examination, tests and analysis of drug.
(7) A fee of three hundred US dollars 1[or its equivalent in Indian rupees] shall be paid for a duplicate copy of the Registration Certificate, if the original is defaced, damaged or lost.
(8) No Registration Certificate shall be required under these Rules in respect of an inactive bulk substance to be used for a drug formulation, with or without pharmacopoeial conformity.]
1. Ins. by G.S.R. 35(E), dt. 20.1.2005.
25. Licences for import of drugs manufactured by one manufacturer.– (1) A single application may be made, and a single licence may be issued, in respect of the import of more than one drug or class of drugs manufactured by the same manufacturer:
1[Provided that the drugs or classes of drugs are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit:
Provided further that if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs a separate licence shall be required in respect of the drugs manufactured by each such factory.]
2[* * * * *]
3[25A. Condition to be satisfied before a licence in Form 10 or Form 10-A is granted. (1) A licence in Form 10 or in Form 10-A shall be granted by the licensing authority having regard to–
(i) the premises, where the imported substances will be stocked, are equipped with proper storage accommodation for preserving the properties of the drugs to which the licence applies; and
(ii) the occupation, trade or business ordinarily carried out by the applicant:
Provided that the licensing authority may refuse to grant a licence in Form 10-A in respect of any applicant where he is satisfied,–
(a) that the applicant has not complied with the provisions of the Act or these rules; or
(b) that by reasons of—
4[(i) his conviction under the Act or these Rules or the Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985) or the rules made thereunder;]
(ii) previous suspension or cancellation of the licence granted to him; he is not a fit person to whom licence shall be granted.
(2) Any person who is aggrieved by the order passed by the licensing authority under this Rule may, within thirty days of the receipt of the order, appeal to the Central Government and the Central Government may after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for making a representation in the matter, make such orders in relation thereto as it thinks fit.]
1. Ins. by Notfn. No. F. 1-19/48-D, dt. 27-10-1949.
2. Omitted Notfn. No.F. 1-16/57-D, dt. 15-6-1957.
3. Subs. by G.S.R 462(E), dt. 22-6-1982. Earlier Ins. by Notfn. No. F. 1-9/52-D. dt. 3-11-1958.
4. Subs. by G.S.R 604 (E), dt. 24-8-2001.
1[25B. Registration Certificate for import of drugs manufactured by one manufacturer.–(1) A single application may be made, and a single Registration Certificate in Form 41 may be issued in respect of the import of more than one drug or class of drugs, manufactured by the same manufacturer:
Provided that the drug or classes of drugs, are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit:
Provided further that if a single manufacturer has two or more factories situated in different places manufacturing the same or different drugs, separate Registration Certificates shall be required in respect of the drugs manufactured by each such factory.]
26. Conditions of import licence. An import licence shall be subject to the following conditions:
(i) the manufacturer shall at all times observe the undertaking given by him or on his behalf in Form 9;
(ii) the licensee shall allow any Inspector authorised by the licensing authority in that behalf to enter with or without notice any premises where the imported substance is stocked, to inspect the means, if any, employed for testing the substance and to take samples;
(iii) the licensee shall on request furnish to the licensing authority from every batch of each substance or from such batch or batches as the licensing authority may from time to time specify a sample of such amount as the licensing authority may consider adequate for any examination required to be made, and the licensee shall, if so required, furnish full protocols of the tests, if any, which have been applied;
(iv) if the licensing authority so directs the licensee shall not sell or offer for sale any batch in respect of which a sample is or protocols are furnished under the last preceding sub-rule until a certificate authorising the sale of the batch has been issued to him by or on behalf of the licensing authority;
(v) the licensee shall, on being informed by the licensing authority that any part of any batch of the substance has been found by the licensing authority not to conform with the standards of strength, quality and purity prescribed by Chapter III of the Act, or the rules thereunder and on being directed so to do, withdraw the remainder of that batch from sale and, so far as may in the particular circumstances of the case be practicable, recall the issues already made from that batch;
(vi) the licensee shall maintain a record of all sales by him of substances for the import of which a licence is required, showing particulars of the substance and of the person to whom sold and such further particulars, if any, as the licensing authority may specify and such record shall be open to the inspection of any Inspector authorised in that behalf by the licensing authority:
1. Ins. by G.S.R. No. 604(E), dt. 24-8-2001.
1[Provided that in respect of the sale or distribution of drugs specified in Schedule X, the licensee shall maintain a separate record or register showing the following particulars, namely:
1. Name of the Drug,
2. Batch number,
3. Name and address of the manufacturer,
4. Date of transaction,
5. Opening stock on the business day,
6. Quantity of drug received, if any, and the source from which received,
7. Name of the purchaser, his address and licence number,
8. Balance quantity of drug at the end of the business day,
9. Signature of the person under whose supervision the drugs have been supplied.]
(vii) the licensee shall comply with such further requirements, if any, applicable to the holders of import licenses, as may be specified in any rules, subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than four months‘ notice.
27. Grant of import licence. On receipt of an application for an import licence in the form and manner prescribed in Rule 24, the licensing authority shall, on being satisfied that, if granted, the conditions of the licence will be observed, issue an import licence in Form 10 1[or From 10A, as the case may be].
2[27A Grant of Registration Certificate. (1) On receipt of an application for Registration Certificate in the Form and manner specified in Rule 24A, the licensing authority shall, on being satisfied, that, if granted, the conditions of the Registration Certificate will be observed, issue a Registration Certificate in Form 41:
Provided further that if the application is complete in all respects and informations specified in Schedules D-I and D-II are in order, the licensing authority shall, within nine months from the date of receipt of an application, issue such Registration Certificate, and in exceptional circumstances and for reasons to be recorded in writing, the Registration Certificate may be issued within such extended period, not exceeding three months, as the licensing authority may deem fit.
(2) If the applicant does not receive the Registration Certificate within the period as specified in the proviso to sub-rule (1), he may appeal to the Central Government and the Central Government may after such enquiry into the matter, as it considers necessary, may pass such orders in relation thereto as it thinks fit.]
1. Ins. by G.S.R 462 (E), dt. 22-6-1982.
2. Ins. by G.S.R 604 (E), dt. 24-8-2001.
1[28. Duration of import licence. A licence unless, it is sooner suspended or cancelled, shall be 2[valid for a period of three years from the date of its issue:]
Provided that if application for a fresh licence is made three months before the expiry of the existing licence the current licence shall be deemed to continue in force until orders are passed on the application.]
3[28A. Duration of Registration Certificate.— A Registration Certificate, unless, it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue:
Provided that if the application for a fresh Registration Certificate is made nine months before the expiry of the existing certificate, the current Registration Certificate shall be deemed to continue in force until orders are passed on the application.]
4[29. Suspension and cancellation of import licence. If the manufacturer or licensee fails to comply with any of the conditions of an import licence, the licensing authority may after giving the manufacturer or licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel it for such period as it thinks fit, either wholly or in respect of some of the substances to which it relates:
Provided that a person, who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter, pass such orders in relation thereto as it thinks fit.]
3[29A. Suspension and cancellation of Registration Certificate.— If the manufacturer fails to comply with any of the conditions of the Registration Certificate, the licensing authority may after giving him an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel the Registration Certificate for such period as it thinks fit either wholly or in respect of some of the substances to which it relates:
Provided that a person, who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter, pass such orders in relation thereto as it thinks fit.]
1. Amended by Notfn. No. F. 1-10/62-D, dt. 19-4-1964.
2. Subs. by G.S.R 604 (E), dt. 24-8-2001.
3. Ins. by G.S.R 604 (E), dt. 24-8-2001.
4. Subs. by G.S.R 604 (E), dt. 24-8-2001.
30. Prohibition of import after expiry of potency.— No biological or other special product specified in Schedule C or C (I) shall be imported after the date shown on the label, wrapper or container of the drug as the date up to which the drug may be expected to retain a potency not less than, or not to acquire a toxicity greater than, that required, or as the case may be, permitted by the prescribed test.
1[* * * * *]
2[30AA. Import of new Homoeopathic medicine.— (1) No new Homoeopathic medicine shall be imported except under and in accordance with the permission in writing of the Licensing Authority.
(2) The importer of a New Homoeopathic medicine when applying for permission shall produce before the Licensing Authority such documentary and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it.]
3[Explanation.— For the purpose of this rule, ‘New Homoeopathic Medicine‘ means—
(i) a Homoeopathic medicine which is not specified in the Homoeopathic Pharmacopoeia of India or United States of America or of the United Kingdom or the German Homoeopathic Pharmacopoeia; or
(ii) which is not recognized in authoritative Homoeopathic literature as efficacious under the conditions recommended; or
(iii) a combination of Homoeopathic medicines containing one or more medicines which are not specified in any of the Pharmacopoeias referred to in clause (i) as Homoeopathic medicines and also not recognized in authoritative Homoeopathic literature as efficacious under the conditions recommended.]
4[30B. Prohibition of import of certain drugs. No drug, the manufacture, sale or distribution of which is prohibited in the country of origin, shall be imported under the same name or under any other name except for the purpose of examination, test or analysis.]
5[31. Standard for certain imported drugs.— No drug shall be imported unless it complies with the standard of strength, quality and purity, if any, and the test prescribed in the Rules shall be applicable for determining whether any such imported drug complies with the said standard:
Provided that the drugs intended for veterinary use, the standards of strength, quality and purity, if any, shall be those that are specified in Schedule F(1) and the test prescribed in that Schedule shall be applicable for determining whether any such imported drug complies with the said standards and where no standards are specified in Schedule F(1) for any veterinary drug, the standards for such drug shall be those specified in the current edition, for the time being in force, of the British Pharmacopoeia Veterinary:
1. Rule 30A omitted by G.S.R.944 (E), dt. 21-9-1988. Earlier rules 30A and 30AA ins. by Notfn. F. 1- 30/48-G, Dt. 14.4.1952.
2. Ins. by notification No. F 1-30/48, dt. 14-01-1952.
3. Subs. G.S.R. 680 (E) ,dt. 5-12-1980.
4. Ins. by Notfn. No. F. 1-45 4-1-1951.
5. Subs. G.S.R. 604 (E), dt. 24-8-2001.
Provided further that the licensing authority shall not allow the import of any drug having less than sixty per cent residual shelf-life period as on the date of import:
Provided also that in exceptional cases the licensing authority may, for reasons to be recorded in writing, may allow, the import of any drug having lesser shelf-life period, but before the date of expiry as declared on the container of the drug.]
1[32. Packing and labelling of imported drugs. No drug shall be imported unless it is packed and labelled in conformity with the Rules in Parts IX and X 2[* * *] and further conform to the standards laid down in Part XII provided that in the case of drugs intended for veterinary use, the packing and labelling shall conform to the rules in Parts IX and X and Schedule F(1)].
3[32A Packing and Labelling of Homoeopathic medicine. No Homoeopathic medicine shall be imported unless it is packed and labelled in conformity with the rules in Part IX-A.]
33. Import of drugs for examination, test or analysis Small quantities of drugs the import of which is otherwise prohibited under section 10 of the Act may be imported for the purpose of examination, test or analysis subject to the following conditions:
(a) No drug shall be imported for such purpose except under a licence in Form 11;
(b) the licensee shall use the substances imported under the licence exclusively for purposes of examination, test or analysis and shall carry on such examination, test or analysis in the place specified in the licence, or in such other places as the licensing authority may from time to time authorise;
(c) the licensee shall allow any Inspector authorized by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances are kept, and to inspect the premises, and investigate the manner in which the substances are being used and to take samples thereof;
(d) the licensee shall keep a record of, and shall report to the licensing authority, the substances imported under the licence, together with the quantities imported, the date of importation and the name of the manufacturer;
(e) the licensee shall comply with such further requirements, if any, applicable to the holders of licences for examination, test or analysis as may be specified in any rules subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month‘s notice.
1. Subs. by Notfn. No. F. 1-6/62-D (SO 2889), dt. 2-7-1969.
2. Certain words omitted by G.S.R. 661(E), dt. 3-7-1992.
3. Ins. by S. O. No. 2139, dt. 5-6-1972.
1[33A Import of drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients.— Small quantities of new drug, as defined in Rule 122-E, the import of which is otherwise prohibited under section 10 of the Act, may be imported for treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such disease requiring therapies for unmet medical needs, by a Medical Officer of a Government Hospital or an Autonomous Medical Institution providing tertiary care, duly certified by the Medical Superintendent of the Government Hospital, or Head of the Autonomous Medical Institution, subject to the following conditions, namely:-
(a) no new drug shall be imported for the said purpose except under a licence in Form 11-A, and the said drug has been approved for marketing in the country of origin;
(b) the licensee shall use the substances or drugs imported under the licence exclusively for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, under the supervision of its own Medical Officers at the place, specified in the licence or at such other places, as the licensing authority, may from time to time authorise;
(c) the licensee shall allow an Inspector authorised by the licensing authority in this behalf to enter, with or without prior notice, the premises where the substances or drugs are stocked, and to inspect the premises and relevant records and investigate the manner in which the substances or drugs are being used and to take, if necessary, samples thereof ;
(d) the licensee shall keep a record of, and shall submit the said report half yearly to the licensing authority, the substances or drugs imported under the licence, together with the quantities imported and issued to the patients, the date of importation, the name of the manufacturer, the name and address of the patient for whom the drug is prescribed and the name of disease;
(e) the licensee shall comply with such other requirements, if any, applicable to the holders of import licences for import of new drugs for treatment of patients by Government Hospitals, as may be specified from time to time in any rule subsequently made under Chapter III of the Act and of which the licensing authority has given to him not less than one month‘s notice;
(f) the drug shall be stocked under proper storage conditions and shall be dispensed under the supervision of a registered pharmacist;
(g) the quantity of any single drug so imported shall not exceed 100 average dosages per patient:
Provided that the licensing authority may, in exceptional circumstances, sanction the import of drug of a larger quantity.]
34. Application for licence for examination, test or analysis. (1) An application for a licence for examination, test or analysis shall be made in Form 12 and shall be made or countersigned by the head of the institution in which, or by a proprietor or director of the company or firm by which the examination, test or analysis will be conducted.
1. Ins. by G.S.R 604 (E), dt. 24-8-2001.
(2) The licensing authority may require such further particulars to be supplied as he may consider necessary.
1[(3) Every application in Form 12 shall be accompanied by a fee of one hundred rupees for a single drug and an additional fee of fifty rupees for each additional drug.
(4) The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other Bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account 0210-Medical and Public Health, 04- Public Health, 104- Fees and Fines.]
2[34A. Application for licence to import small quantities of new drugs by a Government Hospital or Autonomous Medical Institution for the treatment of patients. (1) An application for an import licence for small quantities of a new drug, as defined in Rule 122-E for the purpose of treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, shall be made in Form 12-AA, by a Medical Officer of the Government Hospital or Autonomous Medical Institution, which shall be certified by the Medical Superintendent of the Government Hospital or Head of the Autonomous Medical Institution, as the case may be.
(2) The licensing authority may require such further particulars to be supplied, as he may consider necessary.
(3) Every application in Form 12-AA shall be accompanied by a fee of one hundred rupees for a single drug and an additional fee of fifty rupees for each additional drug.
(4) The fees shall be paid through a challan in the Bank of Baroda, Kasturba Gandhi Marg, New Delhi-110001 or any other branch or branches of Bank of Baroda, or any other Bank, as notified, from time to time, by the Central Government, to be credited under the Head of Account 0210- Medical and Public Health, 04- Public Health, 104- Fees and Fine.]
35. Cancellation of licence for examination, test or analysis. (1) A licence for examination, test or analysis may be cancelled by the licensing authority for breach of any of the conditions subject to which the licence was issued.
(2) A licensee whose licence has been cancelled may appeal to the Central Government within three months of the date of the order.
1. Subs. by G.S.R 604 (E), dt. 24-8-2001.
2. Ins. by G.S.R 604 (E), dt. 24-8-2001.
1[35A. Cancellation of licence for import of small quantities of new drugs. (1) A licence for import of small quantities of a new drug, defined in Rule122E, for the purpose of the treatment of patients suffering from life threatening diseases, or diseases causing serious permanent disability, or such diseases requiring therapies for unmet medical needs, by a Government Hospital or an Autonomous Medical Institution may be cancelled by the licensing authority for breach of any of the conditions subject to which the licence was issued or for contravention of any of the provisions of the Act and rules made thereunder.
(2) A licensee whose licence has been cancelled may appeal to the Central Government within three months from the date of the receipt of the order, and the Central Government may after such enquiry into the matter, as it considers necessary and after giving the appellant an opportunity for representing his views, may pass such orders in relation thereto, as it thinks fit.]
36. Import of drugs for personal use. Small quantities of drugs, the import of which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to the following conditions:
(i) the drugs shall form part of a passenger‘s bona fide baggage and shall be the property of, and be intended for, the exclusive personal use of the passenger;
(ii) the drugs shall be declared to the Customs authorities if they so direct;
(iii) the quantity of any single drug so imported shall not exceed one hundred average doses :
Provided that the licensing authority may in an exceptional case in any individual case sanction the import of a larger quantity:
2[Provided further that any drug, imported for personal use but not forming part of bona fide personal baggage, may be allowed to be imported subject to the following conditions, namely:
(i) the licensing authority, on an application made to it in Form 12A is satisfied that the drug is for bona fide personal use;
(ii) the quantity to be imported is reasonable in the opinion of the licensing authority and is covered by prescription from a registered medical practitioner ; and
(iii) the licensing authority grants a permit in respect of the said drug in Form 12B.]
3[37. Packing of patent or proprietary medicine.— Patent or proprietary medicines shall be imported in containers intended for retail sale:
4[Provided that such medicines may be imported in bulk containers by any person who holds a licence to manufacture, if such person has obtained permission in writing to import such medicines from the licensing authority at least three months prior to the date of import and the imports are made within a period of twelve months from the date of issue of such permission].]
38. Statement to accompany imported drugs. All consignments of drugs sought to be imported shall be accompanied by an invoice or other statement showing the name and address of the manufacturer and the name and quantities of the drugs.
39. Documents to be supplied to the Customs Collector. Before drugs for the import of which a licence is not required are imported a declaration signed by or on behalf of the manufacturer or by or on behalf of the importer that the drugs comply with the provisions of Chapter III of the Drugs and Cosmetics Act, 1940 and the Rules thereunder shall be supplied to the Customs Collector.
1. Ins. by G.S.R 604 (E), dt. 24-8-2001.
2. Ins. by Notfn. No.F-1-36/54-D.S., (SRO 560), dt. 3-3-1955.
3. Ins. by Notfn. No.F-1-3/51-D.S., (SRO 3262), dt. 15-10-1954.
4. Ins. by Notfn. No.F-1-45/58-D, (SO 115), dt. 4-1-1961.
1[40. Procedure for the import of drugs. (1) If the Customs Collector has reason to doubt whether any drugs comply with the provisions of Chapter III of the Act and Rules thereunder he may, and if requested by an officer appointed for this purpose by the Central Government shall, take samples of any drugs in the consignment and forward them to the Director of the laboratory appointed for this purpose by the Central Government and may detain the drugs in the consignment of which samples have been taken until the report of the Director of the said laboratory or any other officer empowered by him on this behalf, subject to the approval of the Central Government, on such samples is received:
Provided that if the importer gives an undertaking in writing not to dispose of the drugs without the consent of the Customs Collector and to return the consignment or such portion thereof as may be required, the Customs Collector shall make over the consignment to the importer.
(2) If an importer who has given an undertaking under the proviso to sub-rule (1) is required by the Customs Collector to return the consignment or any portion thereof he shall return the consignment or portion thereof within ten days of receipt of the notice.]
2[41. (1) If the Director of the laboratory appointed for the purpose by the Central Government or any other officer empowered by him on this behalf, subject to the approval of the Central Government, reports to the Customs Collector that the samples of any drug in a consignment are not of standard quality, or that the drug contravenes in any other respect the provisions of Chapter III of the Act or the Rules thereunder and that the contravention is such that it cannot be remedied by the importer, the Customs Collector shall communicate the report forthwith to the importer who shall, within two months of his receiving the communication either export all the drugs of that description in the consignment, to the country in which they were manufactured or forfeit them to the Central Government which shall cause them to be destroyed :
Provided that the importer may within fifteen days of receipt of the report make a representation against the report to the Customs Collector, and the Customs Collector shall forward the representation with a further sample to the licensing authority, who after obtaining, if necessary, the report of the Director of the Central Drugs Laboratory, shall pass orders thereon which shall be final.
3[(2) If the Director of the laboratory appointed for the purpose by the Central Government or any other officer empowered by him on this behalf, subject to the approval of the Central Government reports to the Customs Collector that the samples of any drug contravene in any respect the provisions of Chapter III of the Act or the Rules thereunder and that the contravention is such that it can be remedied by the importer, the Customs Collector shall communicate the report forthwith to the importer and permit him to import the drug on his giving an undertaking in writing not to dispose of the drug without the permission of the officer authorised in this behalf by the Central Government.]]
4[* * * * *]
1. Subs. by Notifn. 1-99/52-D.S., dated 3-11-1953. 2. Subs. by Notfn. No. F. 7-7/47-D, dt. 5-1-1954.
3. Ins. by Notfn. No. 7-11/47-D, dt. 5-10-1951.
4. Rule 42 omitted by Notfn. No. F. 1-9/52-DS., dt. 3-11-1953.
43. The drugs specified in Schedule D shall be exempt from the provisions of Chapter III of the Act and of the Rules made thereunder to the extent, and subject to the conditions specified in that Schedule.
1[43A. No drug shall be imported into India except through one of the following places, namely:
Freozepore Cantonment and Amritsar Railway Stations:
In respect of drugs imported by rail across the frontier with Pakistan.
Ranaghat, Bongaon and Mohiassan Railways Stations:
In respect of drugs imported by rail across the frontier with Bangladesh.
5[Petrapole Road in West Bengal, Sutarkandi in Assam, Old Raghna Bazar and Agartala in Tripura :
In respect of drugs imported by Road from Bangladesh;]
2[Raxaul:
In respect of drugs imported by road and railway lines connecting Raxaul in India and Birganj in Nepal;]
4[Chennai, Kolkata, Mumbai, Cochin, Nhava Sheva, Kandla and Inland Container Depots at Tuglakabad and Patparganj in Delhi and Tuticorin in Tamil Nadu and Marmugao port in Goa and Visakhapatnam in Andhra Pradesh:
In respect of drugs imported by sea into India;
Chennai, Kolkata, Mumbai, Delhi,Ahmedabad, Hyderabad, Goa, Bengaluru and Visakhapatnam:
in respect of drugs imported by air into India.]
4[43-B. Drugs, consignments of which are in transit through India to foreign countries and which shall not be sold or distributed in India shall be exempted from the requirements of Chapter III of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the Rules made thereunder:
Provided that if the Government of the countries to which the drugs are consigned regulate their import by the grant of import licences, the importer shall at the time of import into India, produce such import licences.]
1. Subs. by G.S.R 478 (E), dt. 6-8-1981. Earlier Ins. by Notfn No. F.7/7/47-D. dt. 5-1-1954.
2. Ins. by G.S.R 120 (E), dt. 5-3-1998.
3. Sub. by G.S.R 532 (E), dt. 18-05-2016. Earlier sub. by G.S.R 575 (E), dt. 17-11-2012, G.S.R 101 (E), dt. 18-2-2011, G.S.R 45 (E), dt. 21-1-2010, G.S.R 504 (E), dt. 18-7-2002, G.S.R 647 (E), dt. 28-10-1998.
4. Added by Notfn. No. E. 1-60/D, (SO 1056) dt. 19-3-1964.
5. Ins. by G.S.R. 116 (E), 24-01-2009.
PART V
1[GOVERNMENT ANALYSTS, INSPECTORS, LICENSING AUTHORITIES AND CONTROLLING AUTHORITIES]
2[44. Qualifications of Government Analyst. A person appointed as a Government Analyst under the Act shall be a person who
(a) is a graduate in medicine or science or pharmacy or Pharmaceutical Chemistry of a 3[University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] and has had not less than five years‘ post-graduate experience in the testing of drugs in a laboratory under control of (i) a Government Analyst appointed under the Act, or (ii) the head of an Institution or testing laboratory approved for the purpose by the appointing authority, 4[or has completed two years‘ training on testing of drugs, including items stated in Schedule C, in Central Drugs Laboratory], or
(b) possesses a post-graduate degree in medicine or science or pharmacy or Pharmaceutical chemistry of a 3[University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] or possesses the Associateship Diploma of the Institution of Chemists (India) obtained by passing the said examination with ‘Analysis of Drugs and Pharmaceuticals‘ as one of the subjects and has had after obtaining the said post-graduate degree or diploma not less than three years‘ experience in the testing of drugs in a laboratory under the control of (i) a Government Analyst appointed under the Act, or (ii) the head of an Institution or testing laboratory approved for the purpose by the appointing authority 4[or has completed training on testing of drugs, including items stated in Schedule C, in Central Drugs Laboratory]:
Provided that-
4[(i) for purpose of examination of items in Schedule C,-
(ia) the persons appointed under clause (a) or (b) and having degree in Medicine, Physiology, Pharmacology, Microbiology, Pharmacy should have experience or training in testing of said items in an institution or laboratory approved by the appointing authority for a period of not less than six months;
(ib) the person appointed under clause(a) or (b) but not having degree in the above subjects should have experience or training in testing of said Schedule C drugs for a period of not less than three years in an institution or laboratory approved by the appointing authority or have completed two years training on testing of drugs including items stated in Schedule C in Central Drugs Laboratory;]
1. Subs. by G.S.R 443 (E), dt. 12-4-1989.
2. Subs. by G.S.R. No. 1427, dt. 22-10-1977.
3. Subs. by G.S.R. 71(E), dt 30.1.1987.
4. Ins. by G.S.R 697(E) dt. 26-10-1995.
(ii) for a period of four years from the date on which Chapter IV of the Act takes effect in the States, persons whose training and experience are regarded by the appointing authority as affording, subject to such further training, if any, as may be considered necessary, a reasonable guarantee of adequate knowledge and competence, may be appointed as Government Analysts. The persons so appointed may, if the appointing authority so desires, continue in service after the expiry of the said period of four years;
(iii) no person who is engaged directly or indirectly in any trade or business connected with the manufacture of drugs shall be appointed as a Government Analyst for any area:
Provided further that for the purpose of examination of Anti-sera, Toxoid and Vaccines and Diagnostic Antigens for Veterinary use, the person appointed shall be a person who is a graduate in Veterinary Science, or general science, or medicine or pharmacy and has had not less than five years‘ experience in the standardization of biological products or person holding a post-graduate degree in Veterinary Science, or general science, or medicine or pharmacy or pharmaceutical chemistry with an experience of not less than three years in the standardization of biological products :
Provided also that persons, already appointed as Government Analysts may continue to remain in service, if the appointing authority so desires, notwithstanding the fact that they do not fulfil the qualifications as laid down in clause (a), clause (b) or the preceding proviso.
45. Duties of Government Analysts.− (1) The Government Analyst shall cause to be analysed or tested such samples or drugs 1[and cosmetics] as may be sent to him by Inspectors or other persons under the provisions of Chapter IV of the Act and shall furnish reports of the results of test or analysis in accordance with these Rules.
(2) A Government Analyst shall from time to time forward to the Government reports giving the result of analytical work and research with a view to their publication at the discretion of Government.
46. Procedure on receipt of sample.− On receipt of a package from an Inspector containing a sample for test or analysis, the Government Analyst shall compare the seals on the packet 2[or on portion of sample or container] with the specimen impression received separately and shall note the condition of the seals on the 3[packet or on portion of sample or container]. After the test or analysis has been completed, he shall forthwith supply to the Inspector a report in triplicate in Form 13 of the result of the test or analysis, together with full protocols of the tests or analysis applied:
1. Ins. by S.O. 2139 dt. 5-6-1972.
2. Ins. by G.S.R. 59(E), dt. 7-2-1995.
3. Subs.by G.S.R. 59(E),dt. 7-2-1995.
1[Explanation.- It shall be deemed to be full and sufficient compliance with the requirement of the rule in respect of the supply of “protocols of the tests or analysis applied”, if
(1) for pharmacopoeial drug, where the tests or methods of analysis prescribed in the official pharmacopoeia are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report;
(2) for patent or proprietary medicines for which the tests and methods prescribed in any of the official pharmacopoeias are applicable and are followed, references to the specific tests or analysis in the pharmacopoeias are given in the report;
(3 )for patent or proprietary medicines containing pharmacopoeial drugs for which the official tests or analysis or methods of assays are modified and applied, a description of the actual tests or, as the case may be, analysis or methods of assays so applied is given in the report;
(4) for patent or proprietary medicines for which no pharmacopoeial tests or methods of analysis are available or can be applied but for which tests or methods of analysis given in standard books or journals are followed, a description of such tests or methods of analysis applied together with the reference to the relevant books or journals from which the tests or methods of analysis have been adopted, is given in the report;
(5) for those drugs for which methods of test are not available and have been evolved by the Government Analyst, a description of tests applied is given in the report.]
47. Report of result of test or analysis.- An application from a purchaser for test or analysis of a drug under section 26 of the Act shall be made in Form 14 A and the report of test or analysis of the drug made on such application shall be supplied to the applicant in Form 14B.
48. Fees.- The fees to be paid by a person submitting to the Government Analyst under section 26 of the Act for test or analysis of a drug 3[or cosmetic] purchased by him shall be those specified in Schedule B.
2[49. Qualifications of Inspectors.— A person who is appointed an Inspector under the Act shall be a person who has a degree in Pharmacy or Pharmaceutical Sciences or Medicine with specialisation in Clinical Pharmacology or Microbiology from a University established in India by law:
Provided that only those Inspectors: ⎯
1. Ins. by No. F. 1-60/61-D, dt. 12-7-1962 (G.S.R 984 (E), dt. 12-7-1962).
2. Subs. by No. G.S.R 658 (E), dt. 19-10-1993.
3. Ins. by No. G.S.R 1140 (E), dt. 26-8-1978.
(i) Who have not less than 18 months‘ experience in the manufacture of at least one of the substances specified in Schedule C, or
(ii) Who have not less than 18 months‘ experience in testing of at least one of the substances in Schedule C in a laboratory approved for this purpose by the licensing authority, or
(iii) Who have gained experiences of not less than three years in the inspection of firms manufacturing any of the substances specified in Schedule C during the tenure of their services as Drugs Inspectors;
shall be authorised to inspect the manufacture of the substances mentioned in Schedule C:]
1[Provided further that the requirement as to the academic qualification shall not apply to persons appointed as Inspectors on or before the 18th day of October, 1993.]
2[49A. Qualification of a Licensing Authority.— No person shall be qualified to be a Licensing Authority under the Act unless:-
(i) he is a graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in clinical pharmacology or microbiology from a University established in India by law; and
(ii) he has experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years:
3[ Provided that the requirements as to the academic qualification shall not apply to those inspectors and the Government Analysts who were holding those positions on the 12th day of April,1989.]]
4[50. Controlling authority. (1) All Inspectors appointed by the Central Government shall be under the control of an officer appointed in this behalf by the Central Government.
(2) All Inspectors appointed by the State Government shall be under the control of an officer appointed in this behalf by the State Government.
(3) For the purposes of these rules an officer appointed by the Central Government under sub-rule (1), or as the case may be, an officer appointed by the State Government under sub-rule (2), shall be a controlling authority.]
1. Ins. by G.S.R 552 (E), dt. 4-12-1996.
2. Ins. by G.S.R 443 (E), dt. 12-4-1989.
3. Subs. by G.S.R. 532 (E), dt. 14.8.1991.
4. Subs. by S.O. 2139, dt. 5-6-1972.
1[50A. Qualification of a Controlling Authority. (1) No person shall be qualified to be a Controlling Authority under the Act unless
(i) he is a graduate in Pharmacy or Pharmaceutical Chemistry or in Medicine with specialization in Clinical Pharmacology or Microbiology from a University established in India by law; and
(ii) he has experience in the manufacture or testing of drugs or enforcement of the provisions of the Act for a minimum period of five years:
2[Provided that the requirements as to the academic qualifications shall not apply to those Inspectors and the Government Analysts who were holding those positions on the 12th day of April, 1989.]
51. Duties of Inspectors of premises licensed for sale.- Subject to the instructions of the controlling authority, it shall be duty of an Inspector authorized to inspect premises licensed for the sale of drugs
(1) to inspect 3[not less than once a year] all establishments licensed for the sale of drugs within the area assigned to him;
(2) to satisfy himself that the conditions of the licences are being observed;
(3) to procure and send for test or analysis, if necessary, imported packages which he has reason to suspect contain drugs being sold or stocked or exhibited for sale in contravention of the provisions of the Act or Rules thereunder;
(4) to investigate any complaint in writing which may be made to him;
(5) to institute prosecutions in respect of breaches of the Act and Rules thereunder;
(6) to maintain a record of all inspections made and action taken by him in the performance of his duties, including the taking of samples and the seizure of stocks, and to submit copies of such record to the controlling authority;
(7) to make such enquiries and inspections as may be necessary to detect the sale of drugs in contravention of the Act;
1. Ins. by G.S.R 443 (E), dt. 12-04-1989.
2. Subs. by G.S.R 532 (E), dt. 14-8-1991.
3. Subs. by G.S.R. 700 (E), dt. 28-9-2001.
(8) when so authorized by the State Government, to detain imported packages which he has reason to suspect contain drugs, the import of which is prohibited.
52. Duties of Inspectors specially authorized to inspect the manufacture of 1[drugs or cosmetics].- Subject to the instructions of the controlling authority it shall be the duty of an Inspector authorized to inspect the manufacture of drugs
(1) to inspect 2[not less than once a year], all premises licensed for manufacture of 1[drugs or cosmetics] within the area allotted to him to satisfy himself that the conditions of the licence and provisions of the Act and Rules thereunder are being observed;
(2) in the case of establishments licensed to manufacture products specified in Schedules C and C(1) to inspect the plant and the process of manufacture, the means employed for standardizing and testing the 2[drugs or cosmetics], the methods and place of storage, the technical qualifications of the staff employed and all details of location, construction and administration of the establishment likely to affect the potency or purity of the product;
(3) to send forthwith to the controlling authority after each inspection a detailed report indicating the conditions of the licence and provisions of the Act and rules thereunder which are being observed and the conditions and provisions, if any, which are not being observed;
(4) to take samples of the 1[drugs or cosmetics] manufactured on the premises and send them for test or analysis in accordance with these Rules;
(5) to institute prosecutions in respect of breaches of the Act and Rules thereunder.
53. Prohibition of disclosure of information. Except for the purposes of official business or when required by a Court of Law, an Inspector shall not, without the sanction in writing of his official superior, disclose to any person any information acquired by him in the course of his official duties.
54. Form of order not to dispose of stock. An order in writing by an Inspector under clause (c) of section 22 of the Act requiring a person not to dispose of any stock in his possession shall be in Form 15.
1. Subs. by G.S.R 504 (E), dt. 18-7-2002.
2. Subs. by G.S.R 700 (E), dt. 28-9-2001.
1[54A. Prohibition of sale.- No person in possession of a drug 2[or cosmetic] in respect of which an Inspector has made an order under clause (c) of sub-section (1) of section 22 of the Act shall in contravention of that order sell or otherwise dispose of any stock of such drug 2[or cosmetic].
3[55. Forms of receipts for seized drug, cosmetic, record register, document or any other material object.– A receipt by an Inspector for the stock of any drug or cosmetic or for any record, register, document or any other material object seized by him under clause (c) or clause (cc) of sub-section (1) of section 22 of the Act shall be in Form 16.]
4[55A. Manner of certifying copies of seized documents.— The Drugs Inspector shall return the documents , seized by him under clause (cc) or produced before him under clause (cca), of sub-section (1) of section 22 of the Act, within a period of twenty days of the date of such seizure or production, to the person from whom they have seized or, as the case may be, the person who produced them, after copies thereof of extracts therefrom have been signed by the concerned Drug Inspector and the person from whom they have seized , or, as the case may be , who produced such records.]
56. Form of intimation of purpose of taking samples.- When an Inspector takes a sample of a drug for the purpose of test or analysis, he shall intimate such purpose in writing in Form 17 to the person from whom he takes it.
5[56A. Form or receipt for samples of drugs where fair price tendered is refused.— Where the fair price, for the samples of drugs taken for the purpose of test or analysis, tendered under sub-section (1) of section 23 has been refused, the Inspector shall tender a receipt therefor to the person from whom the said samples have been taken as specified in Form 17A.]
57. Procedure for despatch of sample to Government Analyst. (1) The portion of sample or the container sent by an Inspector to the Government Analyst for test or analysis under sub-section (4) of section 23 of the Act shall be sent by registered post or by hand in a sealed packet, enclosed together with a memorandum in Form 18, in an outer cover addressed to the Government Analyst.
(2) A copy of the memorandum and a specimen impression of the seal used to seal the packet shall be sent to the Government Analyst separately by registered post or by hand.
1. Ins. by No. F. 1-19/59-D, dt. 13-6-1961.
2. Ins. by G.S.R 850(E), dt. 07-12-1994.
3. Subs. by G.S.R. No. 926 dt. 16-7-1977.
4. Ins. by G.S.R 89 (E), dt. 16-2-1985.
5. Ins. by G.S.R 292 (E), dt. 29-5-1997.
1[58. Confiscation of drugs, implements, machinery etc. (1) Where any person has been convicted for contravening any of the provisions of Chapter IV of the Act or any Rule made thereunder, the stock of the drug in respect of which the contravention has been made shall be liable to confiscation.
(2) Where any person has been convicted for the manufacture of any drug deemed to be misbranded under clause (a), clause (b), clause (c), clause (d), clause (f) or clause (g) of section 17 of the Act, or adulterated drug under section 17B of the Act, or for manufacture for sale, or stocking or exhibiting for sale or distribution of any drug without a valid licence as required under clause (c) of section 18 of the Act, any implements or machinery used in such manufacture, sale or distribution and any receptacle, packages, or coverings in which such drug is contained and the animals, vehicles, vessels or other conveyances used in carrying such drug shall also be liable to confiscation.]
2[58A. Procedure for disposal of confiscated drugs. (1) The Court shall refer the confiscated drugs to the Inspector concerned for report as to whether they are of standard quality or contravene the provisions of the Act or the Rules in any respect.
(2) If the Inspector, on the basis of Government Analyst‘s report finds the confiscated drugs to be not of standard quality or to contravene any of the provisions of the Act or the Rules made thereunder, he shall report to the Court accordingly. The Court shall thereupon order the destruction of the drugs. The destruction shall take place under the supervision of the Inspector in the presence of such authority, if any, as may be specified by the Court.
(3) If the Inspector finds that the confiscated drugs are of standard quality and do not contravene the provisions of the Act or the Rules made thereunder, he shall report to the Court accordingly. 3[The Court may then order the Inspector to give the stocks of confiscated drugs to hospital or dispensary maintained or supported by the Government or by Charitable Institutions].]
1. Subs. by S. O. 289, dt. 3-2-1973.
2. Ins. by No. F. 1-9/62-D (GSR 6), dt. 2-12-1964.
3. Subs. by G.S.R 59 (E), dt. 7-2-1995.
PART VI
SALE OF DRUGS OTHER THAN HOMOEOPATHIC MEDICINES
59. (1) The State Government shall appoint Licensing Authorities for the purpose of this Part for such areas as may be specified.
1[(2) Applications for the grant or renewal of a licence 2[to sell, stock, exhibit or offer for sale or distribute] drugs, other than those included in Schedule X, 3[shall be made in Form 19 accompanied by a fee of rupees one thousand and five hundred or Form 19A accompanied by a fee of rupees five hundred, as the case may be, or in the case of drugs included in Schedule X shall be made in Form 19C accompanied by a fee of rupees five hundred, to the licensing authority:]
Provided that in the case of an itinerant vendor or an applicant who desires to establish a shop in a village or town having population of 5,000 or less, the application in Form 19-A shall be accompanied by a fee of rupees ten.
(3) 3[A fee of rupees one hundred and fifty] shall be paid for a duplicate copy of a licence 2[to sell, stock, exhibit or offer for sale or distribute] drugs, other than those included in Schedule X, or for a licence 2[to sell, stock, exhibit or offer for sale or distribute] drugs, included in Schedule X, if the original is defaced, damaged or lost:
Provided that in the case of itinerant vendor or an applicant who desires to establish a shop in a village or town having a population of 5,000 or less, the fee for a duplicate copy of a licence if the original is defaced, damaged or lost, shall be rupees two.
(4) Application for renewal of a licence 2[to sell, stock, exhibit or offer for sale or distribute] drugs, after its expiry but within six months of such expiry 3[shall be accompanied by a fee of rupees one thousand and five hundred plus an additional fee at the rate of rupees five hundred per month or part thereof in Form 19, rupees five hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part thereof in Form 19-A and rupees five hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part thereof in Form 19C:]
Provided that in the case of an itinerant vendor or an applicant desiring to open a shop in a village or town having a population of 5,000 or less the application for such renewal shall be accompanied by a fee of rupees ten, plus an additional fee at the rate of rupees eight per month or part thereof.]
1. Subs. by G.S.R 462 (E), dt. 22-6-1982.
2. Subs. by G.S.R 788 (E), dt. 10-10-1985.
3. Subs. by G.S.R 601 (E), dt. 24-08-2001.
1[60. A licensing authority may with the approval of the State Government by an order in writing delegate the power to sign licences and such other powers as may be specified in the order to any other person under his control.]
2[61. Forms of licences to sell drugs. (1) a licence 3[ to sell, stock, exhibit or offer for sale or distribute] drugs other than those specified in Schedules C, C (1) and X and by retail on restricted licence or by wholesale, shall be issued in Form 20, Form 20A or Form 20B, as the case may be:
Provided that a licence in Form 20A shall be valid for only such drugs as are specified in the licence.
(2) A licence 3[to sell, stock, exhibit or offer for sale or distribute] drugs specified in Schedule C and C (1) excluding those specified in Schedule X, by retail on restricted licence or by wholesale shall be issued in Form 21, Form 21A or Form 21B, as the case may be:
4[Provided that a licence in Form 21A shall not be granted for drugs specified in Schedules C and shall be valid for only such Schedule C (1) drugs as are specified in the licence.]
(3 )A licence 3[to sell, stock, exhibit or offer for sale or distribute] drugs specified in Schedule X by retail or by wholesale shall be issued in Form 20F or Form 20G as the case may be.]
62. Sale at more than one place. If drugs are sold or stocked for sale at more than one place, separate application shall be made, and a separate licence shall be issued, in respect of each such place:
5[Provided that this shall not apply to itinerant vendors who have no specified place of business and who will be licensed to conduct business in a particular area within the jurisdiction of the licensing authority.]
1. Amended by F. 1-16/57-D, dt. 15-6-1957.
2. Subs. by G.S.R 462 (E), dt. 22-6-1982.
3. Subs. by G.S.R 788 (E), dt. 10-10-1985.
4. Subs. by G.S.R 487 (E), dt. 2-7-1984.
5. Added by Notfn. No. F. 10-21/49-D, dt. 10-3-1953.
1[62A. Restricted licences in Forms 20A and 21A. (a) Restricted licences in Forms 20A and 21A shall be issued subject to the discretion of the Licensing Authority, to dealers or persons in respect of drugs whose sale does not require the supervision of a qualified person.
(b) Licences to itinerant vendors shall be issued only in exceptional circumstances for bona fide travelling agents of firms dealing in drugs or for a vendor who purchases drugs from a licensed dealer for distribution in sparsely populated rural areas where other channels of distribution of drugs are not available.
(c) The licensing authority may issue a licence in Form 21A to a travelling agent of a firm but to no other class of itinerant vendors for the specific purpose of distribution to medical practitioners or dealers, samples of biological and other special products specified in Schedule C:
Provided that travelling agents of licensed manufacturers, agents, of such manufacturers and importers of drugs shall be exempted from taking out licence for the free distribution of samples of medicines among members of the medical profession, hospitals, dispensaries and the medical institution or research institutions.
1[62-B. Conditions to be satisfied before a licence in Form 20A or Form 21A is granted. (1) A licence in Form 20A or Form 21A shall not be granted to any person, unless the authority empowered to grant the licence is satisfied that the premises in respect of which the licence is to be granted are adequate and equipped with proper storage accommodation for preserving the properties of drugs to which the licence applies:
Provided that this condition shall not apply in the case of licence granted to itinerant vendors.
(2) In granting a licence under Rule 62A the authority empowered to grant it shall have regard to:
(i) the number of licences granted in the locality during one year immediately preceding; and
(ii) the occupation, trade or business carried on by such applicant :
1. Ins. by Notfn. No. F. 1-9/60-D, dt. 3-7-1961.
Provided that the licensing authority may refuse to grant or renew a licence to any applicant or licensee in respect of whom it is satisfied that by reason of his conviction of an offence under the Act or these Rules or the previous cancellation or suspension of any licence granted thereunder, he is not a fit person to whom a licence should be granted under this rule.
(3) Any person who is aggrieved by the order passed by the licensing authority in sub-rule (1) may, within 30 days from the date of the receipt of such order appeal to the State Government and the State Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter make such order in relation thereto as it thinks fit.]
1[62C. Application for licence to sell drugs by wholesale or to distribute the same from a motor vehicle. (1) Application for the grant or renewal of a licence to sell by wholesale or to distribute from a motor vehicle shall be made to the Licensing Authority in Form 19AA and shall be accompanied by 2[a fee of rupees five hundred]:
Provided that if the applicant applies for the renewal of a licence after its expiry but within six months of such expiry , the fee payable for renewal of such licence shall be 2[rupees five hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part thereof].
(2) A fee of 2[rupees one hundred and fifty] shall be paid for a duplicate copy of a licence issued under this rule, if the original is defaced, damaged or lost.]
3[62D. Form of licences to sell drugs by wholesale or distribute drugs from a motor vehicle. A licence shall be issued for sale by wholesale or for distribution from a motor vehicle of drugs other than those specified in Schedule and Schedule C(1) in Form 20BB and of drugs specified in Schedule C and Schedule C(1) in Form 21BB :
Provided that such a licence shall not be required in a case where a public carrier or a hired vehicle is used for transportation or distribution of drug.]
3[63. Duration of licence. An original licence or a renewed licence to sell drugs, unless sooner suspended or cancelled, shall be 2[valid for a period of five years on and from the date on which] it is granted or renewed:
1. Ins. by Notfn. No. 1-9/60-D dt. 3-7-1961.
2. Subs. by Notfn. No. G.S.R 601 (E), dt. 24-8-2001.
3. Amended by Notfn. No. F. 1-10/62-D, dt. 10-4-1964.
1[Provided that if the application for renewal of licence in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired if application for its renewal is not made within six months after its expiry].]
2[63A. Certificate of renewal of a sale licence. The certificate of renewal of a sale licence in Forms 20, 20A, 20B,3[20F, 20G], 21, 21A and 21B shall be issued in Form 21C.]
4[63B. Certificate of renewal of licence. A certificate of renewal of a licence in Form 20BB or Form 21BB shall be issued in Form 21CC.]
5[64. Conditions to be satisfied before a licence in Form 8[20, 20B, 20F,20G, 21 or 21B] is granted . (1)A licence in Form 3[20, 20B, 20F, 20G, 21 or 21B]
6[to sell, stock, exhibit or offer for sale or distribute] drugs shall not be granted 7[or renewed] to any person unless the authority empowered to grant the licence is satisfied that the premises in respect of which the licence is to be granted 7[or renewed] are adequate, equipped with proper storage accommodation for preserving the properties of the drugs to which the licence applies and are in charge of a person competent in the opinion of the licensing authority to supervise and control the sale, distribution and preservation of drugs :
Provided that in the case of a pharmacy a licence in Form 20 or 21 shall not be granted 7[or renewed] unless the licensing authority is satisfied that the requirements prescribed for a pharmacy in Schedule N have been complied with:
3[Provided further that licence in Form 20F shall be granted 7[or renewed] only to a pharmacy and in areas where a pharmacy is not operating, such licence may be 7[granted or renewed] to a chemist and druggist.]
Explanation. For the purpose of this rule the term ‘Pharmacy‘ shall be held to mean to include every store or shop or other place : (1) where drugs are dispensed, that is, measured or weighed or made up and supplied ; or (2) where prescriptions are compounded; or (3) where drugs are prepared; or (4) which has upon it or displayed within it, or affixed to or used in connection with it, a sign bearing the word or words
“Pharmacy”, “Pharmacist”, “Dispensing Chemist” or “Pharmaceutical Chemist”; or
(5) which, by sign, symbol or indication within or upon it gives the impression that the operations mentioned at (1), (2) and (3) are carried out in the premises; or (6) which is advertised in terms referred to in (4) above.
1. Amended by S. O. No. 2139, dt. 12-8-1972.
2. Ins. by Notfn. No. F. 1-10/62-D, dt. 10-4-1964.
3. Ins. by G.S.R 462 (E), dt. 22-6-1982.
4. Ins. by Notfn. No. F.1-10/62-D,dt. 10-4-1964.
5. Subs. by Notfn. No.F.1-16/57-D,dt. 15-6-1957 and No. F. 1-19/59-D, dt. 13-6-1961.
6. Subs. by G.S.R 788 (E), dt. 10-10-1985.
7. Subs. by No. G.S.R 681(E), dt. 6-6-1988.
8. Subs. by G.S.R 462 (E), dt. 22-6-1982.
(2) In granting 1[or renewing] a licence under sub-rule (1) the authority empowered to grant it shall have regard
2[(i) to the average number of licences granted 1[or renewed] during the period of 3 years immediately preceding, and]
(ii) to the occupation, trade or business ordinarily carried on by such applicant during the period aforesaid:
Provided that the licensing authority may refuse to grant or renew a licence to any applicant or licensee in respect of whom it is satisfied that by reason of his conviction of an offence under the Act or these rules, or the previous cancellation or suspension of any licence granted 1[or renewed] thereunder, he is not a fit person to whom a licence should be granted 1[or renewed] under this rule. Every such order shall be communicated to the licensee as soon as possible:
3[Provided further that in respect of an application for the grant of a licence in Form 20B or Form 21B or both, the licensing authority shall satisfy himself that the premises in respect of which a wholesale licence is to be granted 1[or renewed] are:-
(i) of an area of not less than ten square meters; and]
4[(ii) in the charge of a competent person, who—
(a) is a Registered Pharmacist, or
(b) has passed the matriculation examination or its equivalent examination from a recognised Board with four years‘ experience in dealing with sale of drugs, or
(c) holds a degree of a recognised University with one year‘s experience in dealing with drugs:]
5[Provided also that,-
(i) in respect of an application for the grant of a licence in Form 20 or Form 21 or both, the licensing authority shall satisfy itself that the premises are of an area] of not less than 10 square meters, and
(ii) in respect of an application for the grant of a licence
(A) In Form 20 or Form 21 or both, and
(B) In Form 20 B or Form 21B or both, the licensing authority shall satisfy itself that the premises are of an area not less than 15 square meters:
1. Ins. by G.S.R 681(E), dt. 6.6.1988.
2. Subs. by Notfn. No. F. 1-19/59-D, dt. 13-6-1961.
3. Ins. by G.S.R 681(E), dt. 6.6.1980.
4. Substituted. G.S.R 351(E), dt. 26-4-2000. 5. Ins. by G.S.R 91(E), dt. 25-2-1997.
Provided also that the provisions of the preceding proviso shall not apply to the premises for which licences have been issued by the licensing authority before the commencement of the Drugs and Cosmetics (1st Amendment) Rules, 1997.]
1[(3) Any person who is aggrieved by the order passed by the licensing authority in sub-Rule (1) may, within 30 days from the date of receipt of such order, appeal to the State Government and the State Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his views in the matter, make such an order in relation thereto as it thinks fit.]
65. Condition of licences. Licences in 2[Forms 20, 20-A, 20-B, 20-F, 20-G, 21 and 21-B] shall be subject to the conditions stated therein and to the following general conditions
2[(1) Any drug shall, if compounded or made on the licensee‘s premises be compounded or made by or under the direct and personal supervision of a 3[registered Pharmacist].]
(2) The supply, otherwise than by way of wholesale dealing, 4[* * *] of any drug supplied on the prescription of a Registered Medical Practitioner shall be effected only by or under the personal supervision of a 3[registered Pharmacist].
5[(3) (1) The supply of any drug 6[other than those specified in Schedule X] on a prescription of a Registered Medical Practitioner shall be recorded at the time of supply in a prescription register specially maintained for the purpose and the serial number of the entry in the register shall be entered on the prescription. The following particulars shall be entered in the register:_
(a) serial number of the entry,
(b) the date of supply,
(c) the name and address of the prescriber,
7[(d) the name and address of the patient, or the name and address of the owner of the animal if the drug supplied is for veterinary use,
(e) the name of the drug or preparation and the quantity or in the case of a medicine made up by the licensee, the ingredients and quantities thereof,
(f) in the case of a drug specified in 2[Schedule C or 8[Schedule H and Schedule H1]] the name of the manufacturer of the drug, its batch number and the date of expiry of potency, if any,
(g) the signature of the 3[registered Pharmacist] by or under whose supervision the medicine was made up or supplied:
1. Amended by F.1-9/60-D dt. 3-7-1961.
2. Subs. by G.S.R 462 (E), dt. 22-6-1982.
3. Subs. by G.S.R 676 (E), dt. 6-9-1994.
4. Omitted by No. G.S.R 462(E), dt. 22-6-1982.
5. Subs. by S. O. 2139, dt. 5-6-1972.
6. Ins. by G.S.R. 462(E), dt. 22-6-1982.
7. Subs. by G.S.R. 926 dt. 16-7-1977.
8. Subs. by G.S.R 588 (E), dt. 30-08-2013.
Provided that in the case of drugs which are not compounded in the premises and which are supplied from or in the original containers, the particulars specified in items (a) to (g) above may be entered in a cash or credit memo book, serially numbered and specially maintained for this purpose:
Provided further that if the medicine is supplied on a prescription on which the medicine has been supplied on a previous occasion and entries made in the prescription register, it shall be sufficient if the new entry in the register includes a serial number, the date of supply, the quantity supplied and a sufficient reference to an entry in the register recording the dispensing of the medicine on the previous occasion:
Provided also that it shall not be necessary to record the above details in the register or in the cash or credit memo particulars in respect of−
(i) any drugs supplied against prescription under the Employees State Insurance Scheme if all the above particulars are given in that prescription, and
(ii) any drug other than that specified in 1[Schedule C or 4[Schedule H and Schedule H1]] if it is supplied in the original unopened container of the manufacturer and if the prescription is duly stamped at the time of supply with the name of the supplier and the date on which the supply was made and on condition that the provisions of sub-rule (4)(3) of this rule are complied with.
5[(h) the supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection.]
(2) The option to maintain a prescription register or a cash or credit memo book in respect of drugs and medicines which are supplied from or in the original container, shall be made in writing to the Licensing Authority at the time of application for the grant or renewal of the licence to sell by retail:
Provided that the Licensing Authority may require records to be maintained only in prescription register if it is satisfied that the entries in the carbon copy of the cash or credit memo book are not legible.]
2[(4) (1) The supply by retail, otherwise than on a prescription of a drug specified in Schedule C 3[* * *] shall be recorded at the time of supply either−
1. Subs. by G.S.R 462 (E), dt. 22-6-1982.
2. Ins. by Notfn. No. 1-63/61-D, dt. 17-7-1963.
3. Omitted by G.S.R 462 (E), dt. 22-6-1982.
4. Subs. by G.S.R 588 (E), dt. 30-08-2013.
5. Ins. by G.S.R 588 (E), dt. 30-08-2013.
(i) in a register specially maintained for the purpose in which the following particulars shall be entered :
(a) serial number of the entry,
(b) the date of supply,
(c) the name and address of the purchaser,
(d) the name of the drug and the quantity thereof,
(e) in the case of a drug specified in Schedule C, the name of the manufacturer, the batch number and the date of expiry of potency,
(f) the signature of the person under whose supervision the sale was effected, or
(ii) in a cash or credit memo book, serially numbered containing all the particulars specified in items (b) to (f) of sub-clause (i) above.
NOTE: The entries in the carbon copy of the cash or credit memo which is retained by the licensee shall be maintained in a legible manner.
(2) The option to maintain a register or a cash or credit memo book shall be made in writing to the Licensing Authority at the time of application for the grant or renewal of a licence to sell by retail:
Provided that the Licensing Authority may require records to be maintained in a register if it is satisfied that the entries in the carbon copy of the cash/credit memo book are not legible.
(3)(i) The supply by retail of any drug shall be made against a cash/credit memo which shall contain the following particulars :
(a) Name, address and sale licence number of the dealer, 1[(b) Serial number of the cash/credit memo,
(c) the name and quantity of the drug supplied.]
(ii) Carbon copies of cash/credit memos shall be maintained by the licensee as record.
1. Ins. by G. S. R. No. 245, dt. 21-2-1976.
1[(4)(i) Records of purchase of a drug intended for sale or sold by retail shall be maintained by the licensee and such records shall show the following particulars, namely:
(a) the date of purchase,
(b) the name and address of the person from whom purchased and the number of the relevant licence held by him,
(c) the name of the drug, the quantity and the batch number, and
(d) the name of the manufacturer of the drug.
(ii) Purchase bills including cash or credit memo shall be serially numbered by the licensee and maintained by him in a chronological order.]
2[(5)(1) Subject to the other provisions of these Rules the supply of a drug by wholesale shall be made against a cash or credit memo bearing the name and address of the licensee and his licence number under the Drugs and Cosmetics Act in which the following particulars shall be entered
(a) the date of sale,
(b) the name, address of the licensee to whom sold and his sale licence number. In case of sale to an authority purchasing on behalf of Government, or to a hospital, medical, educational or research institution or to a Registered Medical Practitioner for the purpose of supply to his patients the name and address of the authority, institution or the Registered Medical Practitioner as the case may be,
(c) the name of the drug, the quantity and the batch number,
(d) the name of the manufacturer,
3[(e) the signature of the competent person under whose supervision the sale was effected.]
(2) Carbon copies of cash or credit memos specified in clause (1) shall be preserved as records for a period of three years from the date of the sale of the drug.
1. Subs. by G.S.R 1242 (E), dt. 17-9-1979.
2. Amended by F. 1-63/62-D, dt. 17-7-1963.
3. Ins. by G.S.R 496 (E), dt. 9-6-1995.
1[(3) (i) Records of purchase of a drug intended for resale or sold by wholesale shall be maintained by the licensee and such records shall show the following particulars, namely:-
(a) the date of purchase,
(b) the name, address and the number of the relevant licence held by the person from whom purchased,
(c) the name of the drug, the quantity and the batch number, and
(d) the name of the manufacturer of the drug.
(ii) Purchase bills including cash or credit memos shall be serially numbered by the licensee and maintained by him in a chronological order.]
(6) The licensee shall produce for inspection by an Inspector appointed under the Act on demand all registers and records maintained under these Rules, and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and Rules thereunder have been observed.
(7) Except where otherwise provided in these Rules, all registers and records maintained under these Rules shall be preserved for a period of not less than two years from the date of the last entry therein.
(8) Notwithstanding anything contained in this Rule it shall not be necessary to record particulars in a register specially maintained for the purpose if the particulars are recorded in any other register specially maintained under any other law for the time being in force.
2[(9) (a) Substances specified in 3[Schedule H and Schedule H1] or Schedule X shall not be sold by retail except on and in accordance with the prescription of a Registered Medical Practitioner and in the case of substances specified in Schedule X, the prescriptions shall be in duplicate, one copy of which shall be retained by the licensee for a period of two years.
(b) The supply of drugs specified in 3[Schedule H and Schedule H1] or Schedule X to Registered Medical Practitioners, Hospitals, Dispensaries and Nursing Homes shall be made only against the signed order in writing which shall be preserved by the licensee for a period of two years.]
_
1. Subs. by G.S.R 1242(E), dt. 17-9-1979.
2. Subs. by G.S.R 462(E), dt. 22-6-1982.
3. Subs. by G.S.R 588(E), dt. 30-8-2013.
_
(10) For the purposes of clause (9) a prescription shall
(a) be in writing and be signed by the person giving it with his usual signature and be dated by him;
1[(b) specify the name and address of the person for whose treatment it is given, or the name and address of the owner of the animal if the drug is meant for veterinary use;]
(c) indicate the total amount of the medicine to be supplied and the dose to be taken.
(11) The person dispensing a prescription containing a drug specified in 5[Schedule H and Schedule H1] 2[and Schedule X] shall comply with the following requirements in addition to other requirement of these rules.
(a) the prescription must not be dispensed more than once unless the prescriber has stated thereon that it may be dispensed more than once;
(b) if the prescription contains a direction that it may be dispensed a stated number of times or at stated intervals it must not be dispensed otherwise than in accordance with the directions;
(c) at the time of dispensing there must be noted on the prescription above the signature of the prescriber the name and address of the seller and the date on which the prescription is dispensed.
4[(11-A) No person dispensing a prescription containing substances specified in 3[5[Schedule H and Schedule H1] or X], may supply any other preparation, whether containing the same substance or not, in lieu thereof.
3[(12) Substances specified in Schedule X kept in retail shop or premises used in connection therewith shall be stored—
(a) under lock and key in cupboard or drawer reserved solely for the storage of these substances; or
(b) in a part of the premises separated from the remainder of the premises and to which only responsible persons have access;]
1. Subs. by G. S. R. No. 926, dt. 24-6-1977.
2. Ins. by G.S.R 462 (E), dt. 22-6-1982.
3. Subs., by G.S.R 462 (E), dt. 22-6-1982.
4. Ins. by SO 2139, dt. 5-6-1972.
5. Subs. by G.S.R 588(E), dt. 30-8-2013.
1 [* * * * *]
2[(15)(a) The description “Drugstore” shall be displayed by such licensees who do not require the services of a 3[Registered Pharmacist].
(b) The description “Chemists and Druggists” shall be displayed by such licensees who employ the services of a 3[Registered Pharmacist] but who do not maintain a “Pharmacy” for compounding against prescriptions.
(c) The description “Pharmacy”, “Pharmacist”, “Dispensing Chemist” or “Pharmaceutical Chemist” shall be displayed by such licensees who employ the services of a 3[Registered Pharmacist] and maintain a “Pharmacy” for compounding against prescriptions:
3[Explanation:- For the purpose of this rule,-
(i) “Registered Pharmacist” means a person who is a registered Pharmacist as defined in clause (i) of section (2) of the Pharmacy Act, 1948 (Act No. 8 of 1948):
Provided that the provisions of sub-clause (i) shall not apply to those persons who are already approved as “qualified person” by the licensing authority on or before 31st December, 1969:
(ii) “Date of Expiry of potency” means the date that is recorded on the container, label or wrapper as the date up to which the substance may be expected to retain a potency not less than or not to acquire a toxicity greater than that required or permitted by the prescribed test].]
4[(16) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.]
1. Sub-Rules (13) and (14) omitted by G.S.R 462 (E), dt. 22-6-1982.
2. Subs. by Notfn. No. F. 1-16/57-D, dt. 15-6-1957.
3. Subs. by G.S.R 676 (E), dt. 6-9-1994.
4. Subs. by Notfn. No. F. 1-14/68-D dt. 26-10-1968.
1[(17) No drug shall be sold or stocked by the licensee after the date of expiration of potency recorded on its container, label or wrapper, or in violation of any statement or direction recorded on such container, label or wrapper:
Provided that any such drugs in respect of which the licensee has taken steps with the manufacturer or his representative for the withdrawal, reimbursement or disposal of the same, may be stocked after the date of expiration of potency pending such withdrawal, reimbursement or disposal, as the case may be, subject to the condition that the same shall be stored separately from the trade stocks 2[and all such drugs shall be kept in packages or cartons, the top of which shall display prominently, the words “Not for sale”].]
3[(18) No drug intended for distribution to the medical profession as free sample which bears a label on the container as specified in clause 4[(ix)] of sub-rule (1) of rule 96, and no drug meant for consumption by the Employees‘ State Insurance Corporation, the Central Government Health Scheme, the Government Medical Stores Depots, the Armed Forces Medical Stores or other Government institutions, which bears a distinguishing mark or any inscription on the drug or on the label affixed to the container thereof indicating this purpose shall be sold or stocked by the licensee on his premises:]
5[Provided that this sub-rule shall not be applicable to licensees who have been appointed as approved chemists, by the State Government in writing, under the employees‘ State Insurance Scheme, or have been appointed as authorised agent or distributor, by the manufacturer in writing, for drugs meant for consumption under the Central Government Health Scheme, the Government Medical Stores Depots, the Armed Forces Medical Stores or other Government Institutions for drugs meant for consumption under those schemes 6[or have been appointed as authorised Depots or Carrying and Forwarding agent by the manufacturer in writing, for storing free samples meant for distribution to medical profession] subject to the conditions that the stock shall be stored separately from the trade stocks and shall maintain separate records of the stocks received and distributed by them.]
1. Ins. by Notfn. No. F. 1-55/61-D, dt. 22-8-1964.
2. Ins. by S. O. No. 903, dt. 28-2-1976.
3. Ins. by Notfn. No. 1-113/69-D, dt. 23-12-1969.
4. Subs. by G.S.R. 676(E) dt. 6-9-1994.
5. Subs. by G.S.R. 496(E) dt. 9-6-1995.
6. Ins. by G.S.R 352(E), dt. 26-4-2000.
1[(19) The supply by retail of any drug in a container other than the one in which the manufacturer has marketed the drug, shall be made only by dealers who employ the services of a 2[Registered Pharmacist] and such supply shall be made under the direct supervision of the 2[Registered Pharmacist] in an envelope or other suitable wrapper or container showing the following particulars on the label:
(a) name of the drug,
(b) the quantity supplied,
(c) the name and address of the dealer.]
3[(20) The medicines for treatment of animals kept in a retail shop or premises shall be labelled with the words ‘Not for human use and shall be stored for treatment of animals only‘
(a) in a cupboard or drawer reserved solely for the storage of veterinary drugs, or
(b) in a part of the premises separated from the remainder of the premises to which customers are not permitted to have access.]
4[(21) (a) The supply of drugs specified in Schedule X shall be recorded at the time of supply in a register (bound and serially page numbered) specially maintained for the purpose and separate pages shall be allotted for each drug.
(b) The following particulars shall be entered in the said register, namely:–
(i) Date of transaction;
(ii) Quantity received, if any, the name and address of the supplier and the number of the relevant licence held by the supplier;
(iii) Name of the drug;
(iv) Quantity supplied;
(v) Manufacturer‘s name;
(vi) Batch No. or Lot No;
(vii) Name and address of the patient/purchaser;
(viii) Reference Number of the prescription against which supplies were made;
(ix) Bill No and date in respect of purchases and supplies made by him;
(x) Signature of the person under whose supervision the drugs have been supplied.]
1. Ins. by G. S. R. 444 dt. 28-4-1973.
2. Subs. by G.S.R 676 (E), dt. 6-9-1994.
3. Added by G. S. R. No. 926 dt. 16-7-1977.
4. Ins. by G.S.R 462 (E), dt. 22-6-1982.
1[65A. Additional information to be furnished by an applicant for liscence or a licensee to the Licensing Authority. The applicant for the grant of a licence or any person granted a licence under this Part shall, on demand, furnish to the licensing authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership of occupation or rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm, or any other relevant matter which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.]
66. Cancellation and suspension of licences. (1) The Licensing Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or Rules thereunder:
1[Provided that, where such failure or contravention is the consequence of an act or omission on the part of an agent or employee, the licence shall not be cancelled or suspended if the licensee proves to the satisfaction of the licensing authority−
(a) that the act or omission was not instigated or connived at by him or, if the licensee is a firm or company, by a partner of the firm or a director of the company, or
(b) that he or his agent or employee had not been guilty of any similar act or omission within twelve months before the date on which the act or omission in question took place, or where his agent or employee had been guilty of any such act or omission the licensee had not or could not reasonably have had, knowledge of that previous act or omission, or
(c) if the act or omission was a continuing act or omission, he had not or could not reasonably have had knowledge of that previous act or omission, or
(d) that he had used due diligence to ensure that the conditions of the licence or the provisions of the Act or the Rules thereunder were observed.]
2[(2) A licensee whose licence has been suspended or cancelled may, within three months of the date of order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.]
3[66A. Procedure for disposal of drugs in the event of cancellation of licence.—
(1) In case a licensee, whose licence has been cancelled, desires to dispose of the drugs he has in his possession in the premises in respect of which the licence has been cancelled, he shall apply in writing to the licensing authority for this purpose, giving the following particulars, namely:—
1. Ins. by S. O. 2139, dt. 12-8-1972.
2. Subs. by G. S. R. 926 dt. 16-7-1977.
3. Ins. by G.S.R 1242 (E), dt. 17-9-1979.
(a) the name and address of the person to whom the drugs are proposed to be sold or supplied together with the number of the licence for sale or manufacture, as the case may be, held by him,
(b) the names of drugs together with their quantities, batch numbers, the names and addresses of their manufacturers and the dates of their expiry, if any, proposed to be sold to the person mentioned in clause (a).
(2) The licensing authority may, after examination of the particulars referred to in sub-rule (1) and, if necessary, after inspection by an Inspector of the premises where the drugs are stocked, grant the necessary permission for their disposal.]
6[****]
1[PART VIA
SALE OF HOMOEOPATHIC MEDICINES
67A. (1) The State Government shall appoint Licensing Authorities for the purpose of this Part for such areas as may be specified.
(2) Application for the grant or renewal of a licence 2[to sell, stock or exhibit or offer for sale or distribute] Homoeopathic medicines shall be made in Form 19-B to the Licensing Authority and shall be accompanied by a 3[fee of rupees two hundred and fifty]:
4[Provided that if the applicant applies for renewal of licence after its expiry but within six months of such expiry the fee payable for renewal of such licence shall be 3[rupees two hundred and fifty plus an additional fee at the rate of rupees fifty or part thereof].
5[(3) If the original licence is either defaced, damaged or lost, a duplicate copy thereof may be issued on payment of a 3[fee of rupees fifty].]
67B. A Licensing Authority may, with the approval of the State Government, by an order in writing, delegate the power to sign licences and such other powers, as may be specified, to any other person under his control.
67C. Forms of licences to sell drugs. (1) A licence 2[to sell, stock or exhibit or offer for sale or distribute] Homoeopathic medicines by retail or by wholesale shall be issued in Form 20C or 20D as the case may be.
1. Added by Notfn. No. F. 1-35/64-D, dt. 18-8-1964. 2. Subs. by G.S.R 788(E) dt. 10-10-1985.
3. Subs. by G.S.R 601 (E), dt. 24-8-2001.
4. Amended by S. O. 2139 dt. 12-8-1972.
5. Added by G. S. R. 665, dt. 28-5-77.
6. Rule 67 omitted by SO 289 (E), dt. 20-12-1972.
67D. Sale at more than one place. If drugs are sold or stocked for sale at more than one place, a separate application shall be made and a separate licence shall be obtained in respect of each place.
67E. Duration of licences. An original licence or a renewed licence unless it is sooner suspended or cancelled shall be 1[valid for a period of five years on and from the date on which] it is granted or renewed :
2[Provided that if the application for renewal of a licence in force is made before its expiry or if the application is made within six month of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if application for its renewal is not made within six months after its expiry.]
3[67EE. Certificate of renewal. The certificate of renewal of a sale licence in Forms 20C and 20D shall be issued in Form 20E.]
67F. Condition to be satisfied before a licence in Form 20C or Form 20D is granted.- (1) A licence in Form 20C or Form 20D to 4[to sell, stock or exhibit or offer for sale or distribute] Homoeopathic medicines shall not be granted to any person unless the authority empowered to grant the licence is satisfied that the premises in respect of which the licence is to be granted are clean and in the case of a licence in Form 20C the sale premises is in charge of a person who is or has been dealing in Homoeopathic medicines and who is in the opinion of the Licensing Authority competent to deal in Homoeopathic medicines:
5[Provided that no registered Homoeopathic medical practitioner who is practising Homoeopathy in the premises where Homoeopathic medicines are sold shall deal in Homoeopathic medicines.]
(2) Any person who is aggrieved by the order passed by the Licensing Authority under sub-rule (1) may within 30 days from the date of the receipt of such order appeal to the State Government and the State Government may, after such enquiry into the matter as it considers necessary and after giving the appellant an opportunity for representing his case, make such order in relation thereto as it thinks fit.
1. Subs. by G.S.R 601 (E), dt. 24-8-2001.
2. Subs. by S. O. 2139 dt. 5-6-1972.
3. Added by Notfn. No. F. 1-14/67-D, dt. the 3-2-1969.
4. Subs. by G.S.R 788 (E), dt. 10-10-1985.
5. Ins. by Notfn. No. G.S.R 680 (E), dt. 5-12-1980.
67G. Conditions of licence. Licence in Form 20C or 20D shall be subject to the conditions stated therein and to the following further conditions, namely:
(1) The premises where the Homoeopathic medicines are stocked for sale or sold are maintained in a clean condition.
(2) The sale of Homoeopathic medicines shall be conducted under the supervision of a person, competent to deal in Homoeopathic medicines.
(3) The licensee shall permit an Inspector to inspect the premises and furnish such information as he may require for ascertaining whether the provisions of the Act and the Rules made thereunder have been observed.
(4) The licensee in Form 20D shall maintain records of purchase and sale of Homoeopathic medicines containing alcohol together with names and addresses of parties to whom sold.
1[(5) The licensee in Form 20C shall maintain records of purchase and sale of Homoeopathic medicines containing alcohol. No records of sale in respect of Homoeopathic potentised preparation in containers of 30 ml. or lower capacity and in respect of mother tinctures made up in quantities up to 60 ml. need be maintained.]
2[(6) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.]
3[67GG. Additional information to be furnished by an applicant for licence or a licensee to the Licensing Authority. The applicant for the grant of a licence or any person granted a licence under this Part shall, on demand furnish to the Licensing Authority, before the grant of the licence or during the period the licence is in force as the case may be, documentary evidence in respect of the ownership or occupation or rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm, or any other relevant matter, which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.]
1. Ins. by Notfn. No. F. 1-59/68-D, dt. the 19-11-1969.
2. Ins. by G.S.R 331 (E), dt. 8-5-1984.
3. Ins. by S. O. 2139 dt. 5-6-1972.
67-H. Cancellation and suspension of licences. (1) The Licensing Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or Rules made thereunder:
1[Provided that, where such failure or contravention is the consequence of an act or omission on the part of an agent or employee, the licence shall not be cancelled or suspended if the licensee proves to the satisfaction of the Licensing Authority−
(a) that the act or omission was not instigated or connived at by him or, if the licensee is a firm or company, by a partner of the firm or a director of the company, or
(b) that he or his agent or employee had not been guilty of any similar act or omission within twelve months before the date on which the act or omission in question took place, or where his agent or employee had been guilty of any such act or omission, the licensee had not or could not reasonably have had, knowledge of that previous act or omission, or
(c) if the act or omission was a continuing act or omission that he had not or could not reasonably have had knowledge of that previous act or omission, or
(d) that he had used due diligence to ensure that the conditions of the licence or the provisions of the Act or the Rules thereunder were observed.]
2[(2) A licensee whose licence has been suspended or cancelled may, within three months of the date of the order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.]
1. Ins. by S. O. 2139 dt. 5-6-1972.
2. Amended by G.S.R. 926 dt. 16-7-1977.
PART VII
1[MANUFACTURE FOR SALE OR FOR DISTRIBUTION] OF DRUGS OTHER THAN HOMOEOPATHIC MEDICINES
68. Manufacture on more than one set of premises. If drugs are manufactured on more than one set of premises a separate application shall be made and a separate licence shall be issued in respect of each such set of premises.
2[68-A. Grant or Renewal of Licences by the Central Licence Approving Authority.— (1) Notwithstanding anything contained in this Part, on and from the commencement of the Drugs and Cosmetics (Amendment) Rules,1992, a licence for the manufacture for sale or distribution of drugs as specified from time to time by the Central Government by notification in the Official Gazette, for the purpose of this rule, shall be granted or renewed, as the case may be, by the Central Licence Approving Authority (appointed by the Central Government):]
Provided that the application for the grant or renewal of such licence shall be made to the Licensing Authority.
(2) On receipt of the application for grant or renewal of a licence, the licensing authority shall,-
(i) verify the statement made in the application form;
(ii) cause the manufacturing and testing establishment to be inspected in accordance with the provisions of rule 79; and
(iii) in case the application is for the renewal of licence, call for the information(s) of the past performance of the licensee.
(3) If the licensing authority is satisfied that the applicant is in a position to fulfil the requirements laid down as in these Rules, he shall prepare a report to that effect and forward it along with the application 3[and the licence (in triplicate) to be granted and renewed, duly completed] to the Central Licence Approving Authority:
Provided that if the licensing authority is of the opinion that the applicant is not in a position to fulfil the requirements laid down in these Rules, he may, by order, for reasons to be recorded in writing, refuse to grant or renew the licence, as the case may be.
(4) If on receipt of the application and the report of the licensing authority referred to in sub-rule (3) and after taking such measures including inspection of the premises by the Inspector, appointed by the Central Government under section 21 of the Act, with or without an expert in the concerned field if deemed necessary, the Central Licence Approving Authority, is satisfied that the applicant is in a position to fulfil the requirements laid down in these Rules, he may grant or renew the licence, as the case may be:
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1. Subs. by G.S.R 788 (E), dt. 10-10-1985.
2. Ins. by G.S.R 923 (E), dt. 14-12-1992.
3. Subs. by G.S.R 89 (E), dt. 14-2-1996.
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Provided that if the Central Licence Approving Authority is of the opinion that the applicant is not in a position to fulfil the requirements laid down in these rules, he may, notwithstanding the report of the licensing authority, by order, for reasons to be recorded in writing, reject the application for grant or renewal of licence, as the case may be.]
1[68B. Delegation of Powers by the Central Licence Approving Authority.— The Central Licence Approving Authority may with the approval of the Central Government, by notification delegate his powers of signing licences and any other powers under the rules to any person under his control having same qualifications as prescribed for controlling authority under Rule 50A for such areas and for such periods as may be specified.]
2[69. Application for licence to manufacture drugs other than those specified in Schedules C and C(I) to the Drugs and Cosmetics Rules. 3[(1) Application for grant or renewal of 4[licence to manufacture for sale or for distribution] of drugs, other than those specified in Schedules C and C(I) shall be made to the licensing authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the licensing authority) and shall be made
(a) in the case of repacking of drugs excluding those specified in Schedule X for sale or distribution in, Form 24B;
(b) in the case of manufacture of drugs included in Schedule X, in Form 24F;
(c) in any other case, in Form 24.]
5[(2)(a) Every application in Form 24B shall be made up to ten items for each category of drugs categorised in Schedule M and shall be accompanied by a licence fee of rupees five hundred plus and an inspection fee of rupees two hundred for every inspection or for the purpose of renewal of the licence.
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1. Ins. by G.S.R 89 (E), dt. 14-02-1996.
2. Amended by Notfn. F. 1-22/59-D, dt. 9-4-1960.
3. Subs. by G.S.R 462 (E), dt. 22-06-1982.
4 Subs. by G.S.R.788 (E), dt. 10-10-1985.
5. Subs. by G.S.R 601(E), dt. 21-8-2001.
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(b) Every application in Form 24F shall be made up to ten items for each category of drugs categorised in Schedule M and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every subsequent inspection or for the purpose of renewal of licence.
(c) Every application in Form 24 shall be made up to ten items for each category of drugs 3[referred to in Schedule M relating to pharmaceuticals products and Schedule MIII relating to medical devices and in-vitro diagnostics] and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of one thousand and five hundred for every inspection or for the purpose of renewal of the licence.]
1[(3) If a person applies for the renewal of a licence after the expiry thereof but within six months of such expiry the fee payable for the renewal of such licence shall be−]
2[(i) in the case of Form 24B a licence fee of rupees five hundred plus an additional fee at the rate of rupees two hundred and fifty per month or part thereof in addition to an inspection fee of rupees two hundred;
(ii) in the case of Form 24F a licence fee of rupees six thousand plus an additional fee at the rate of rupees one thousand per month or part thereof in addition to an inspection fee of rupees one thousand;
(iii) in the case of Form 24 a licence fee of rupees six thousand plus an additional fee at the rate of rupees one thousand per month or part thereof in addition to an inspection fee of rupees one thousand and five hundred.]
1[(4) A fee 2[rupees one thousand shall be paid] for a duplicate copy of the licence issued under clause (a), clause (b) or clause (c) of sub-Rule (1) if the original is defaced, damaged or lost.]
2[(5) Applications for manufacture of more than ten items of each category of drugs as categorized under Schedule M and M-III or for manufacture of additional items of drugs by licensees in Form 24 or Form 24F shall be accompanied by an additional fee at the rate of rupees three hundred for each additional item of drug. Applications in Form 24B for licence to manufacture for sale and distribution for repacking for more than 10 items of each category or for manufacture of additional item of drug shall be accompanied by additional fee of rupees one hundred for each additional item of drugs as cetegorized in Schedule M and M-III].
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1. Subs. by G.S.R 462 (E), dt. 22-6-1982.
2. Subs. by G.S.R 26 (E), dt. 19-1-2006.
3. Subs. by G.S.R 640 (E), dt. 29-6-2016.
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1[(6) Where an application under this Rule is for the manufacture of drug formulations falling under the purview of new drug as defined in rule 122E, such application shall also be accompanied with approval, in writing in favour of the applicant, from the licensing authority as defined in clause (b) of rule 21.]
2[69A. Loan Licences.⎯ 3[(1) Application for the grant or renewal of loan licences to manufacture for sale or for distribution of drugs other than those specified in Schedule C, Schedule C (1) and Schedule X shall be made up to ten items for each category of drugs 5[referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics] and shall be made in Form 24A accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred to the licensing authority:
Provided that if the applicant applies for the renewal of a licence after its expiry but within six months of such expiry, the fee payable for renewal of such licence shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred plus an additional fee at the rate of rupees one thousand per month or part thereof.]
4[Explanation.- For the purpose of this rule a loan licence means a licence which the Licensing Authority may issue to an applicant who does not have his own arrangements for manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in Form 25.]
(2) The Licensing Authority shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture, and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan licence.
3[(3) Subject to the provisions of sub-rule (2), application for manufacture of more than ten items for each category of drug on a loan licence shall be accompanied by an additional fee of rupees three hundred per additional item specified 5[referred to in Schedule M relating to pharmaceuticals products and Schedule MIII relating to medical devices and in-vitro diagnostics].
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1. Ins. by G.S.R 311 (E), dt. 1-5-2002.
2. Amended by Notfn. No. F. 1-16/57-D, dt. 15-6- 1957.
3. Subs. by G.S.R 601(E) dt. 24-8-2001.
4. Subs. by G.S.R 724(E) dt. 07-11-2013.
5. Subs. by G.S.R 640 (E), dt. 29-6-2016.
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1[(4) If the Licensing Authority is satisfied that a loan licence is defaced, damaged or lost or otherwise rendered useless, he may, on payment of a 2[fee of rupees one thousand] issue a duplicate licence.]
3[* * * * *]
4[70. Form of licence to repack or manufacture drugs other than those specified in Schedules C and C(1).- Licences for repacking of drugs against application in Form 24-B shall be granted in Form 25-B, licences for manufacture of drugs included in Schedule X and against application in Form 24-F shall be granted in Form 25-F and licences for manufacture of drugs against application in Form 24 shall be granted in Form 25.]
5[70A. Form of loan 6[licence to manufacture for sale or for distribution] of drugs other than those 7[specified in Schedules C, C(1) and X].⎯ 6 A loan [licence to manufacture for sale or for distribution] or drugs other than those 7[specified in Schedules C, C(1) and X] shall be issued in Form 25A.]
8[71. Conditions for the grant or renewal of a licence in Form 25 9[or Form 25F].⎯
Before a licence in Form 25 9[or Form 25F] is granted or renewed, the following conditions shall be complied with by the applicant.-
(1) The manufacture shall be conducted under the active direction and personal supervision of competent technical staff consisting at least of one person who is a whole-time employee and who is
(a) a graduate in Pharmacy or Pharmaceutical Chemistry of 10[a University established in India by law or has an equivalent qualification recognised and notified by the Central Government for such purpose] and has had at least eighteen months practical experience after the graduation in the manufacture of drugs. This period of experience may, however, be reduced by six months if the person has undergone training in manufacture of drugs for a period of six months during his University course; or
(b) a graduate in Science of 10[a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] who for the purpose of his degree has studied Chemistry as a principal subject and has had at least three years practical experience in the manufacture of drugs after his graduation; or
_
1. Ins. by Notfn. No. F.1-20/64-D, dt. 26.10.1968.
2. Subs. by Notfn. No. G.S.R. 601 (E), dt. 24.8.2001.
3. Rule 69 omitted by G.S.R. 944 (E), dt. 21-9-1988. 4. Subs. by Notfn. No. G.S.R. 462 (E), dt. 22.6.1982.
5. Ins. by Notfn. No. F.1-16/57 D, 15-6-1957 & No. F.1/22/59-D, dt. 9.4.1960.
6. Subs. by Notfn. No. G.S.R. 788 (E), dt. 10-10-1985.
7. Subs. by Notfn. No. G.S.R. 462 (E), dt. 22-6-1982.
8. Subs. by Notfn. No. F.1-16/57-D, dt. 15-6-1957.
9. Ins. by G.S.R. 462(E), dt. 22-6-1982.
10. Subs. by Notfn. No. G.S.R. 71 (E), dt. 30-1-1987.
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(c) a graduate in Chemical Engineering or Chemical Technology or Medicine of 1[a University established in India by law or has an equivalent qualification recognised and notified by the Central Government for such purpose] with general training and practical experience, extending over a period of not less than three years in the manufacture of drugs, after his graduation; or
2[(d) holding any foreign qualification the quality and content of training of which are comparable with those prescribed in clause (a), clause (b) or clause
(c) and is permitted to work as competent technical staff under this Rule by the Central Government:]
Provided that any person who was immediately before the 29th June, 1957, actively directing and personally supervising the manufacture of drugs and whose name was accordingly entered in any licence granted in Form 25 3[or Form 25F] as it existed before the date shall be deemed to be qualified for the purposes of this rule:
4[Provided further that for drugs other than those specified in Schedules C, C(1) and X and meant for veterinary use, the whole-time employee under whose supervision the manufacture is conducted shall be a graduate in Veterinary Science or Pharmacy or General Science or Medicine of a University recognized by the Central Government and who has had at least three years practical experience in the manufacture of drugs excluding graduate in Pharmacy who shall have at least eighteen months practical experience in the manufacture of drugs:]
5[Provided 6[also] that the Licensing Authority may, in the matter of manufacture of disinfectant fluids, insecticides, liquid paraffin, medicinal gases, non-chemical contraceptives, plaster of Paris and surgical dressings, for the manufacture of which the knowledge of Pharmaceutical Chemistry or Pharmacy is not essential, permit the manufacture of the substance under the active direction and personal supervision of the competent technical staff, who, although not having any of the qualifications included in clause (a), (b) or (c) of this rule, has, in the opinion of the Licensing Authority, adequate experience in the manufacture of such substance.]
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1. Subs. by G.S.R. 71(E), dt. 30-1-1987.
2. Added by Notfn. NO. F. 1-19/59-D, dt. 13-6-1961.
3. Ins. by. G.S.R. 462 (E), dt. 22-6-1982.
4. Ins. by. G.S.R. 93 (E), dt. 24-2-1999.
5. Added Notfn. No. F. 1-14/68-D, dt. the 26-10-1968. 6. Sub. by. G.S.R. 93 (E), dt. 24-2-1999.
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(2) The factory premises shall comply with the conditions prescribed in Schedule M.
(3) The applicant shall provide adequate space, plant and equipment for the manufacturing operations; the space, plant and equipment recommended for various operations are given in Schedule M.
1[(4) The applicant shall provide and maintain adequate staff, premises and laboratory equipment for carrying out tests of the strength, quality and purity of the substances at a testing unit, which shall be separate from the manufacturing unit and the head of the testing unit shall be independent of the head of the manufacturing unit :
Provided that the manufacturing units, which, before the commencement of the Drugs and Cosmetics (Amendment) Rules, 1977, were making arrangements with institutions approved by the Licensing Authority for such tests to be carried out on their behalf may continue such arrangements up to the 30th June, 1977 :
Provided further that for tests requiring sophisticated instrumentation techniques or biological or microbiological methods other than sterility the Licensing Authority may permit such tests to be conducted by institutions approved by it 4 [ under Part XV(A) of these rules] for this purpose.]
2[(4A) The head of the testing unit referred to in condition (4) shall possess a degree in Medicine or Science or Pharmacy or Pharmaceutical Chemistry of a University recognized for this purpose and shall have experience in the testing of drugs, which in the opinion of the licensing authority is considered adequate.]
(5) The applicant shall make adequate arrangements for the storage of drugs manufactured by him.
3[(6) The applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and data justifying that the patent or proprietary medicines
(i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful;
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1. Subs. by G.S.R. 926 dt. 16-7-1977.
2. Ins. by G.S.R. 681(E), dt. 5-12-1980.
3. Ins. by G.S.R. 515 dt. 10-4-1976.
4. Ins. by G.S.R. 1172 dt. 23-8-1977.
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(ii) are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulation and under the conditions in which the formulation for administration and use are recommended;
(iii) are stable under the conditions of storage recommended;
(iv) contain such ingredients and in such quantities for which there is therapeutic justification; and]
1[(v) have the approval, in writing, in favour of the applicant to manufacture drugs formulations falling under the purview of new drug as defined in Rule
122-E, from the Licensing Authority as defined in clause (b) of rule 21.]
2[(7) The licensee shall comply with the requirements of Good Manufacturing Practices as laid down in Schedule M.]
6[(8) The applicant shall make application for grant of licence for a drug formulation containing single active ingredient only in proper name.]
3[71A. Conditions for the grant or renewal of a licence in Form 25B. Before a licence in Form 25B is granted or renewed the following conditions shall be complied with by the applicant :-
(1) the repacking operation shall be carried out under hygienic conditions and under the supervision of a competent person;
4[(2) the factory premises shall comply with the conditions prescribed in Schedule M; and]
5[(3) the applicant shall have adequate arrangements in his own premises for carrying out tests for the strength, quality and purity of the drugs at a testing unit which shall be separate from the repacking unit:]
6[(4) The application for grant of licence for a drug formulation containing single active ingredient shall be made only in proper name:]
Provided that the repacking units, which before the commencement of the Drugs and Cosmetics (Second Amendment) Rules, 1977, were making arrangements with institutions approved by the licensing authority for such tests to be carried out on their behalf, may continue such arrangements up to the 31st July, 1977:
_
1. Ins. by G.S.R. 311 (E), dt. 1-5-2002.
2. Ins. by G.S.R. 735 (E), dt. 24-6-1988.
3. Ins. by No. F.1-22/59-D, dt. 9-4-1960.
4. Amended by S.O. 2139 dt. 12-8-1972.
5. Amended by G.S.R. 926 dt. 16-7-1977.
6. Ins. by G.S.R. 570 (E), dt. 7-8-2014.
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Provided further that for tests requiring sophisticated instrumentation techniques or biological or microbiological methods the licensing authority may permit such test to be conducted by institutions approved by it under Part XV(A) of these Rules for this purpose.]
Explanation.− A person who satisfies the following minimum qualifications shall be deemed to be a “competent person” for the purposes of rule 71A or 74A of these rules, namely: −
(a) a person who holds the Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948 (VIII of 1948) or a person who is
registered under the said Act, or
(b) a person who has passed the Intermediate examination with Chemistry as one of the principal subjects or an examination equivalent to it or an examination recognized by the Licensing Authority as equivalent to it; or
(c) a person who has passed the Matriculation examination or an examination recognized by the Licensing Authority as equivalent to it and has had not less than four years‘ practical experience in the manufacture, dispensing or repacking of drugs.]
1[71B. Conditions for the grant of renewal of a licence in Form 25A.− Before a licence in Form 25A is granted or renewed, the applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and data justifying that the patent or proprietary medicines:-
(i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful;
(ii) are safe for use in the context of the vehicles, recipients, additives and pharmaceutical aids used in the formulations and under conditions in which the formulations for administration and use are recommended;
(iii) are stable under the conditions of storage recommended; and
(iv) contain such ingredients and in such quantities for which there is therapeutic justification.
2[Provided that the application for grant of a licence for a drug formulation containing single active ingredient shall be made only in proper name.]
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1. Ins. by G.S.R. 515 (E), dt. 24-3-1976.
2. Ins. by G.S.R. 570 (E), dt. 7-8-2014.
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1[72. Duration of licence.– An original licence or a renewed licence in Form 25, 2[Form 25B or Form 25F] unless sooner suspended or cancelled shall be 3[valid for a period of five years on and from the date on which] it is granted or renewed:
4[Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]
2[73. Certificate of renewal.– The certificate of renewal of a licence in Form 25 or Form 25F shall be issued in Form 26 or Form 26E respectively].
5[73A. A certificate of renewal of loan licence.- The certificate of renewal of a loan licence in Form 25A shall be issued in Form 26A.]
5[73AA. Duration of loan licence.– An original loan licence in Form 25A or a renewed loan licence in Form 26A, unless sooner suspended or cancelled, shall be 3[valid for a period of five years on and from the date on which] it is granted or renewed:]
6[Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]
7[73B. Certificate of renewal of licence in Form 25B.– The certificate of renewal of a licence in Form 25B shall be issued in Form 26B.]
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1. Subs. by Notfn. No. F.1-10/62-D, dt. 10-4-1964.
2. Subs. by G.S.R. 462 (E), dt. 22-6-1982.
3. Subs. by G.S.R. 601 (E), dt. 24-8-2001.
4. Amended by S.O. 2139 dt. 12-8-1972.
5. Amended by Notfn. No. F.1-10/62-D, dt. 10-4-1964.
6. Amended by S.O. 2139 dt. 12-8-1972.
7. Ins. by S.O. 1196, dt. 6-5-1960.
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1[74. Conditions of licence in Form 25.− A licence in 2[Form 25 and Form 25F] shall be subject to the conditions stated therein and to the following further conditions, namely :
(a) the licensee shall provide and maintain staff, premises and the equipment as specified in rule 71;
(b) the licensee shall comply with the provisions of the Act and of these rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV of the Act; provided that where such further requirements are specified in the Rules, these would come into force, four months after publication in the Official Gazette;
(c) the licensee shall either in his own laboratory or in any other laboratory approved by the Licensing Authority 4 [ under Part XV (A) of these rules] test each batch or lot of the raw material used by him for the manufacture of his products and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained for a period of 5 years from the date of manufacture;
(d) the licensee shall keep records of the details of manufacture as per particulars given in Schedule U of each batch of the drugs manufactured by him and such records shall be retained for a period of five years;
(e) the licensee shall allow an 3[ Inspector appointed under the Act], to enter, with or without prior notice, any premises and to inspect the plant and the process of manufacture and the means employed in standardizing and testing the drugs;
(f) the licensee shall allow an 3[ Inspector appointed under the Act] to inspect all registers and records maintained under these rules and to take samples of the manufactured drugs and shall supply to such Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the rules thereunder have been observed;
(g) the licensee shall, from time to time, report to the Licensing Authority any changes in the expert staff responsible for the manufacture or testing of the drugs and any material alterations in the premises or plant used for the purpose which have been made since the date of the last inspection made on behalf of the licensing authority;
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1. Subs. by Notfn. No. F. 1-20/64-D (S.O. 3868), dt. 26-10-1968.
2. Subs. by G.S.R. 462 (E), dt. 22-6-1982.
3. Amended by G.S.R. 444 dt. 28-4-1973.
4. Ins. by G.S.R. 1172 (E), dt. 23-8-1977.
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1[ (h) the licensee shall, on request, furnish to the Licensing Authority, the Controlling Authority or to such authorities as the Licensing Authority or the Controlling Authority may direct from every batch, or batches of drugs as the Licensing Authority or the Controlling Authority may from time to time specify, a sample of such quantity as may be considered adequate by such authority for any examination and, if so required, also furnish full protocols of tests which have been applied;]
(i) if the Licensing Authority 2[or the Controlling Authority] so directs and if requested by the licensee who had also furnished prima facie reasons for such directions, the licensee shall not sell or offer for sale any batch in respect of which a sample is or protocols are furnished under clause (h) until a certificate authorizing the sale of the batch has been issued to him by or on behalf of the Licensing Authority 2[or the Controlling Authority;
(j) the licensee shall on being informed by the Licensing Authority 2[or the Controlling Authority] that any part of any batch of the drug has been found by the Licensing Authority 2[or the Controlling Authority]not to conform with the standards of strength, quality or purity specified in these rules and on being directed so to do, withdraw the remainder of the batch from sale, and, so far as may in the particular circumstances of the case be practicable, recall all issues already made from that batch;
(k) the licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed;
1[(l) the licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label, the reference samples shall be maintained for a period of three months beyond the date of expiry or potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture;]
2[(m) the licensee, who has been granted a licence in Form 25F, shall-
(i) forward to the licensing authority of the concerned States of manufacture and supply of the drug a statement of the sales effected to manufacturers, wholesalers, retailers, hospitals, dispensaries and nursing homes and Registered Medical Practitioners every three months;
(ii) maintain accounts of all transactions giving details as indicated below in a register bound and serially page numbered and such records shall be retained for a period of five years or one year after the expiry of potency, whichever is later:-
_
1. Subs. by G.S.R. No. 444 dt. 31-3-1973.
2. Ins. by G.S.R. No. 444 dt. 31-3-1973.
3. Ins. by G.S.R. 462 (E), dt. 22-6-1982.
_
A. Accounts of the drugs specified in Schedule X used for the manufacture:
1. Date of issue.
2. Name of the drug.
3. Opening balance of stock on the production day.
4. Quantity received, if any, and source from where received.
5. Quantity used in manufacture.
6. Balance quantity on hand at the end of the production day.
7. Signature of the person in charge.
B. Accounts of production:
1. Date of manufacture.
2. Name of the drug.
3. Batch Number.
4. Quantity of raw material used in manufacture.
5. Anticipated yield.
6. Actual yield,
7 Wastage,
8. Quantity of the manufactured goods transferred.
C. Accounts of the manufactured drugs:
1. Date of manufacture.
2. Name of the drug.
3. Batch Number.
4. Opening Balance.
5. Quantity manufactured.
6. Quantity sold.
7. Name of the purchaser and his address.
8. Balance quantity at the end of the day.
9. Signature of the person in charge.
(n) the licensee shall store drugs specified in Schedule X in bulk form and when any of such drug is required for manufacture in a place other than its place of storage it shall be kept in a separate place under the direct custody of a responsible person;]
1[(o) the licensee shall comply with the requirements of 2[Good Laboratory Practices as laid down in Schedule L-I and] ‘Good Manufacturing Practices‘ as laid down in Schedule M.]
3[(p) No advertisement of the drugs specified in Schedule H, Schedule H1 and Schedule X shall be made except with the previous sanction of the Central Government.]
_
1. Ins. by G.S.R. 735 (E), dt. 24-6-1988.
2. Ins by G.S.R. 780 (E), dt. 10-11-2008.
3. Ins by G.S.R. 289 (E), dt. 15-04-2015.
_
74A. Conditions for licence in Form 25B._ A licence in Form 25B shall be subject to the conditions stated therein and to the following conditions:_
(a) the repacking of drugs shall at all times be conducted under the personal supervision of at least one person who is approved as a competent person by the Licensing Authority;
(b) the licensee shall either provide and maintain adequate arrangements in his own premises for carrying out tests of the strength, quality and purity of the drugs repacked or make arrangements with some institution approved by the Licensing Authority 3[under Part XV (A) of these rules] for such tests to be regularly carried out on his behalf by the institution;
(c) the licensee shall make adequate arrangements for the storage of drugs;
2[(d) the licensee shall comply with the provisions of the Act and of these rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV of the Act:
Provided that where such further requirements are specified in the Rules, these would come into force four months after publication in the Official Gazette.]
(e) the licensee shall allow any 4[Inspector appointed under the Act] to enter with or without notice, any premises where the packing of drugs in respect of which the licence is issued is carried on, to inspect the premises and to take samples of repacked drugs;
2[(f) the licensee shall, either in his own laboratory or, in any other laboratory approved by the Licensing Authority, test each batch or lot of raw material used by him for repacking and also each batch of the product thus repacked and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained for a period of five years from the date of repacking. The licensee shall allow the Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and these rules have been observed;]
_
1. Ins. by G.S.R. 735 (E), dt. 24-6-1988.
2. Subs. by Notfn. No. F.1-20/64-D, dt. 26-10-1968.
3. Ins. by G.S.R. 1172 (E), dt. 23-8-1977.
4. Subs. by G.S.R. 444 (E), dt. 31-3-1973.
_
1[(g) the licensee shall maintain an Inspection Book, in Form 35, to enable an Inspector to record his impressions and the defects noticed;]
2[(h) the licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label, the reference sample shall be maintained for a period of three months beyond the date of expiry of potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture.
4[(i) No advertisement of the drugs specified in Schedule H, Schedule H1 or Schedule X shall be made except with the previous sanction of the Central Government.]
3[74B. Conditions of licence in Form 25A. (1) The licence in Form 25A shall be deemed to be cancelled or suspended, if the licence owned by the licensee in Form 25, whose manufacturing facilities have been availed of by the licensee, is cancelled or suspended, as the case may be, under these rules.
(2) The licensee shall comply with the provisions of the Act and of these rules and with such further requirements if any, as may be specified in any rules subsequently made under Chapter IV of the Act; provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette.
(3) The licensee shall test each batch or lot of the raw material used by him for the manufacture of his products and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained for a period of five years from the date of manufacture. The licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and these rules have been observed.
_
1. Ins. by Notfn. No. 1-14/68-D, dt. 26-10-1968.
2. Ins. by G.S.R. 444 (E) dt. 31-3-1973 .
3. Subs. by Notfn. No. F. 1-14/68-D, dt. the 26-10-1968.
4. Ins. by G.S.R. 289 (E) dt. 15-4-2015.
_
(4) The licensee shall either-
(i) provide and maintain to the satisfaction of the Licensing Authority adequate staff and adequate laboratory facilities for carrying out test of the strength, quality and purity of the substances manufactured by him, or
(ii) make arrangements with some institution approved by the Licensing Authority 7[under Part XV (A) of these rules] for such tests to be regularly carried out on his behalf by the institution.
1[(5) The licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label the reference samples shall be maintained for a period of three months beyond the date of expiry of potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture.]
2[(6) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.]
8[(7) No advertisement of the drugs specified in Schedule H, Schedule H1 or Schedule X shall be made except with the previous sanction of the Central Government.]
3[75. Form of application for licence to manufacture for sale or distribution of drugs specified in Schedules C and C(1) and X 4[excluding those specified in Part XB and Schedule X]._(1) Applications for the grant or renewal of licence to manufacture for sale or distribution of drugs specified in Schedules C and C(1) 4[excluding those specified in Part X-B and Schedule X], shall be made to the Licensing Authority in Form 27 and 5[shall be made up to ten items for each category of drugs 6[referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics] and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection or for the purpose of renewal of licences:]
Provided that if the applicant applies for renewal of licence after its expiry but within six months of such expiry, the fee payable for renewal of the licence shall be 5[a licence fee of rupees six thousand plus an additional fee of rupees one thousand per month or a part thereof in addition to an inspection fee of rupees one thousand and five hundred.]
(2) Application for grant or renewal of licence to manufacture for sale or distribution of drugs specified in Schedules C, C(1) and X shall be made to the licensing authority in Form 27-B, and 5[shall be made up to ten items for each category of drugs 6[referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics] and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand five hundred for every inspection or for the purpose of renewal of licences]:
_
1. Ins. by G.S.R.. No. 444, dt. 28-4-1973.
2. Ins. by G.S.R. 331 (E), dt. 8-5-1984.
3. Subs. by G.S.R. 462 (E), dt. 22-6-1982.
4. Subs. by G.S.R. 28(E), dt. 22-1-1993.
5. Subs. by G.S.R. 601(E), dt. 24-8-2001.
6. Subs. by G.S.R. 640(E), dt. 29-6-2016.
7. Subs. by G.S.R. 1172(E), dt. 23-8-1977.
8. Ins. by G.S.R. 289(E), dt. 15-4-2015.
_
Provided that the applicant shall possess a licence in Form 28 to manufacture such drugs:
Provided further that if the application for renewal of a licence is made after its expiry but within six months of such expiry, the fee payable for renewal of the licence shall be 1[rupees six thousand plus an additional fee of rupees one thousand per month or part thereof in addition to an inspection fee of rupees one thousand five hundred.]
2[(3) The application for grant or renewal of licence to manufacture for sale or for distribution of drugs in 4[Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs] shall be made to the licensing authority appointed under this Part in Form 27D and 1[shall be made up to ten items for each category of drugs categorized in Schedule M and shall be accompanied by a licence fee of rupees six thousand and an inspection fee of rupees one thousand five hundred for every inspection or for the purposes of renewal of licences:]
Provided that if the application for renewal of a licence is made after its expiry but within six months of such expiry, the fee payable for renewal of the licence 1[shall be rupees six thousand plus an additional fee of rupees one thousand per month or a part thereof in addition to the inspection fee of rupees one thousand and five hundred.]
1[(4) A fee of rupees one thousand shall be paid for duplicate copy of the licence issued under sub-rule (1), sub-rule (2) or sub-rule (3), as the case may be, if the original licence is defaced, damaged or lost.
(5) If the licensee applies for manufacture of more than ten items of each category of drugs, the application shall be accompanied by an additional fee at the rate of rupees three hundred for each additional item of drugs 5[referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics].]
3[(6) Where an application under this Rule is for the manufacture of drug formulations falling under the purview of new drugs as defined in Rule 122-E, such application shall also be accompanied with approval, in writing, in favour of the applicant, from the licensing authority as defined in clause (b) of Rule 21.]]
_
1. Subs. by G.S.R. 601 (E), dt. 24-8-2001.
2. Ins. by G.S.R. 119 (E), dt. 11-3-1996.
3. Ins. by G.S.R. 311 (E), dt. 1-5-2002.
4. Subs. by G.S.R. 26 (E), dt. 19-1-2006.
5. Subs. by G.S.R. 640 (E), dt. 29-6-2016.
_
1[75A. Loan licences.− (1) Applications for the grant or renewal of loan 2[licences for the manufacture for sale or for distribution] of drugs specified in Schedules C and C(1) 3[excluding those specified in Part X-B and Schedule X] shall be made in Form 27-A to the licensing authority and 4[shall be made upto ten items for each category of drugs 14[referred to in Schedule M relating to pharmaceuticals products and Schedule M-III relating to medical devices and in-vitro diagnostics] and shall be accompanied by a fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection or for the purpose of renewal of licences:]
5[Provided that if the applicant applies for the renewal of a licence after its expiry but within six months of such expiry the fee payable for renewal of the licence shall be 4[rupees six thousand and an inspection of fee of rupees one thousand five hundred plus an additional fee at the rate of rupees one thousand] per month or a part thereof.]
11[Explanation. − For the purpose of this rule a loan licence means a licence which a licensing authority may issue to an applicant who intends to avail the manufacturing facilities owned by a licensee in Form 28.]
12[(1A) The application for grant or renewal of loan license to manufacture for sale or distribution of drugs in ‘Large Volume Parenterals‘, ‘Sera and Vaccine‘ and ‘Recombinant DNA (r-DNA) derived drugs‘ shall be made to the licensing authority appointed under this Part, in Form 27DA and be made upto ten items for each category of drugs categorized in Schedule M and accompanied by a license fee of six thousand rupees and an inspection fee of one thousand five hundred rupees for every inspection or for the purpose of renewal of licenses:
Provided that if the application for renewal of a license is made after its expiry but within six months of such expiry, the fee payable for renewal of the license shall be six thousand rupees plus an additional fee of one thousand rupees per month or a part thereof in addition to the inspection fee of one thousand and five hundred rupees;]
(2) The licensing authority, shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities for testing to undertake the manufacture on behalf of the applicant for a loan licence.
13[***]
4[(3) Subject to the provisions of sub-rule (2), the application for manufacture of more than ten items of each category of drugs on a loan license, shall be accompanied by an additional fee at the rate of rupees three hundred for each additional item of drugs.
(4) If the licensing authority is satisfied that a loan licence is defaced, damaged or lost, he may, on payment of a fee of rupees one thousand, issue a duplicate copy of loan licence.]
6[* * * * *]
7[76. 8[Forms of licence to manufacture drugs specified in Schedules C and C(1), 9[excluding those specified in Part XB and Schedule X], or drugs specified in Schedules C, C(1) and X and the conditions for the grant or renewal of such licences.- 10[A licence to manufacture for sale or for distribution of drugs specified in
_
1. Ins. by F.1-16/57-D, dt. 15-6-1957.
2. Subs. by G.S.R 788 (E), dt. 10-10-1985.
3. Subs. by G.S.R 28 (E), dt. 22-1-1993.
4. Subs. by G.S.R 601 (E), dt. 24-8-2001.
5. Amended by S.O.2139 dt. 13-8-1972.
6. Rule 75B omitted by G.S.R. 944 (E), dt. 21-9-1988.
7. Amended by F- 1- /57-D, dt. 15-6-1969.
8. Subs. by G.S.R. 462 (E), dt. 22-6-1982.
9. Subs. by G.S.R. 28 (E) , dt. 22.1.1993.
10. Subs. by G.S.R. 119 (E), dt. 11-3-1996.
11. Subs. by G.S.R. 724 (E), dt. 7-11-2013.
12. Ins. by G.S.R. 574 (E) , dt. 17.7.2012.
13. Proviso omitted by G.S.R. 574 (E) , dt. 17.7.2012.
14. Subs. by G.S.R. 640 (E), dt. 29-06-2016.
_
Schedules C and C(1) other than 4[Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs] specified in Part X B and Schedule X shall be issued in Form 28 and a licence to manufacture for sale or distribution of drugs specified under Schedules C and C(1) (other than 4[Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs] specified in Part X-B) and Schedule X shall be issued in Form 28B. A licence to manufacture for sale or for distribution of 4[Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs] shall be issued in Form 28-D. Before a licence in Form 28 or Form 28B or Form 28D is granted or renewed, the following conditions shall be complied with by the applicant:-
(1) The manufacture will be conducted under the active direction and personal supervision of competent technical staff consisting at least of one person who is a whole time employee and who is
(a) a graduate in Pharmacy or Pharmaceutical Chemistry of 1[a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] and has had at least eighteen months‘ practical experience after the graduation in the manufacture of drugs to which this licence applies; this period of experience may however be reduced by six months if the person has undergone training in manufacture of drugs to which the licence applies for a period of six months during his University course; or
(b) a graduate in Science of 1[a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] who for the purpose of his degree has studied Chemistry 3[or Microbiology] as a principal subject and has had at least three years‘ practical experience in the manufacture of drugs to which this licence applies after his graduation; or
(c) a graduate in Medicine of 1[a University established in India by law or has an equivalent qualification recognized and notified by the Central Government for such purpose] with at least three years‘ experience in the manufacture and pharmacological testing of biological products after his graduation; or
2[(d) a graduate in Chemical Engineering of a University recognised by the Central Government with at least three years‘ practical experience in the manufacture of drugs to which this licence applies after his graduation; or
(e) holding any foreign qualification the quality and content of training of which are comparable with those prescribed in clause (a), clause (b), clause (c) or clause (d) and is permitted to work as competent technical staff under this Rule by the Central Government.]
_
1. Subs. by G.S.R. 71(E), dt. 30-1-1987.
2. Ins. by F.1-19/59-D, dt. 13-6-1967.
3. Ins. by G.S.R. 245(E), dt. 3-2-1976.
4. Subs. by G.S.R. 26 (E), dt. 19-1-2006.
_
Provided that any person who was approved by the licensing authority as an expert responsible for the manufacture of drugs for the purpose of rule 76 read with Rule 78 as these Rules were in force immediately before the 29th June, 1957, shall be deemed to be qualified for the purposes of this rule:
1[Provided that for the drugs specified in Schedules C and C(1) meant for veterinary use, the whole time employee under whose supervision the manufacture is conducted may be a graduate in Veterinary Science or general science or medicine or pharmacy of a University, recognized by the Central Government and who has had at least three years‘ experience in the manufacture of biological products:
5[Provided also that for medical devices, the whole time employee under whose supervision the manufacture or testing is conducted shall be—
(i) a graduate in Pharmacy or Engineering (in appropriate branch) from a University recognised by the Central Government for such purposes and has had at least eighteen months practical experience in the manufacturing or testing of devices to which this licence applies after his graduation; or
(ii) a graduate in science, from a University recognised by the Central Government for such purposes, with Physics or Chemistry or Microbiology as one of the subject and has had at least three years practical experience in the manufacturing or testing of devices to which this licence applies after his graduation; or
(iii) a diploma in Pharmacy or Engineering (in appropriate branch) from a Board or Institute recognised by the Central Government or the State Government, as the case may be, for such purposes and has had at least four years practical experience in the manufacturing or testing of devices to which this licence applies after his diploma; or
(iv) having a foreign qualification, the quality and content of training of which are comparable with those specified in clause (i), clause (ii) and clause (iii) and is permitted to work as competent technical staff under this rule by the Central Government.]
6[(2) The applicant proposing to manufacture pharmaceutical products shall comply with the provisions referred to in Schedule M.
(2A) The applicant proposing to manufacture medical devices and in-vitro diagnostics shall comply with the quality management system as referred to in Schedule M-III.
(3) The applicant shall provide adequate space, plant and equipment for pharmaceutical products as referred to in Schedule M and for Medical devices and in- vitro diagnostics as referred to in Schedule M-III.]
3[(4) The applicant shall provide and maintain adequate staff, premises and laboratory equipment for carrying out such tests of the strength, quality and purity of the substances as may be required to be carried out by him under the provisions of Part X of these rules including proper housing for animals used for the purposes of such tests, the testing unit being separate from the manufacturing unit and the head of the testing unit being independent of the head of the manufacturing unit:
Provided that the manufacturing units which before the commencement of the Drugs and Cosmetics (Amendment) Rules, 19774, were making arrangements with institutions approved by the Licensing Authority for such tests to be carried out on their behalf may continue such arrangements upto the 30th June, 1977 :
Provided further that for tests requiring sophisticated instrumentation techniques or biological or microbiological methods other than sterility the Licensing Authority may permit such tests to be conducted by institutions approved by it 2[under Part XV (A) of these rules] for this purpose.
_
1. Ins. by F.1-6/62-D (SO 2889), dt. 2-7-1969.
2. Ins. by G.S.R 1172 (E), dt. 23-8-1977.
3. Sub. by G.S.R 926 (E), dt. 24-6-1977.
4. These rules came in to force on 28th May, 1977 vide G.S.R 665 (E), dt. 6-5-1977.
5. Sub. by G.S.R 690 (E), dt. 25-9-2014. Earlier Ins. by G.S.R 109 (E), dt. 22-2-1994.
6. Sub. by G.S.R 640 (E), dt. 29-6-2016.
_
1[(4A) The head of the testing unit referred to in condition (4) shall possess a degree in Medicine or Science or Pharmacy or Pharmaceutical Chemistry of a University recognized for this purpose and shall have experience in the testing of drugs, which in the opinion of the Licensing authority is considered adequate.]
(5) The applicant shall make adequate arrangements for the storage of drugs manufactured by him.
2[(6) The applicant shall furnish to the Licensing Authority, if required to do so, data on the stability of drugs which are likely to deteriorate for fixing the date of expiry which shall be printed on the labels of such drugs on the basis of the data so furnished.]
3[(7) The applicant shall, while applying for licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and data justifying that the patent or proprietary medicines−
(i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful;
(ii) are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulations and under the conditions in which the formulations for administration and use are recommended;
(iii) are stable under the conditions of storage recommended;
(iv) contain such ingredients and in such quantities for which there is therapeutic justification.;] and
4[(v) have the approval, in writing, in favour of the applicant to manufacture drug formulations falling under the purview of new drug as defined in Rule 122E, from the licensing authority as defined in clause (b) of rule 21.]
5[(8) The licensee of pharmaceutical products shall comply with the requirements of ‘Good Manufacturing Practices‘ as laid down in Schedule M and the licensee of Medical Devices and in-vitro diagnostics shall comply with the requirements of “Quality Management System” as laid down in Schedule M-III..]
_
1. Ins. by G.S.R 681 (E), dt. 5-12-1980.
2. Ins. by G.S.R 444 dt. 31-3-1973.
3. Ins. by G.S.R 515 dt. 24-3-1976.
4. Ins. by G.S.R 311 (E), dt. 1-5-2002.
5. Subs. by G.S.R 640 (E), dt. 29-06-2016. Previously Ins. by G.S.R 735 (E), dt. 24-6-1988.
_
1[Explanation:- For the purpose of this rule, 6[“Large Volume Parenterals” sera and vaccines and recombinant DNA (r-DNA) derived drugs,] shall mean the sterile solutions intended for parenteral administration with a volume of 100 ml. or more (and shall include anti-coagulant solutions) in one container of the finished dosage form intended for single use.]
7[(9) The applicant shall make application for grant of licence for a drug formulation containing single active ingredient only in proper name.]
2[76A. Forms of loan licenses to manufacture for sale or for distribution drugs specified in Schedule C and C(1) excluding drugs specified in Schedule X or of Large Volume Parenterals, Sera and Vaccine and recombinant DNA (r-DNA) derived drugs, and conditions for the grant or renewal of such license.— A loan license to manufacture for sale or for distribution of drugs specified in Schedules C and C(1), excluding drugs specified in Schedule X, and Large Volume Parenterals, Sera and Vaccine and Recombinant DNA(r- DNA) derived drugs specified in Part XB shall be issued in Form 28A and a loan license to manufacture for sale or for distribution of Large Volume Parenterals, Sera and Vaccine and Recombinant DNA (r-DNA) derived drugs shall be issued in Form 28DA, and the applicant shall, while applying for a licence to manufacture patent or proprietary medicines, furnish to the Licensing Authority evidence and data justifying that the patent or proprietary medicines-
(i) contain the constituent ingredients in therapeutic/prophylactic quantities as determined in relation to the claims or conditions for which the medicines are recommended for use or claimed to be useful;
(ii) are safe for use in the context of the vehicles, excipients, additives and pharmaceutical aids used in the formulations, and under the conditions in which the formulations for administration and use are recommended;
(iii) are stable under the conditions of storage recommended; and
(iv) contain such ingredients and in such quantities for which there is therapeutic justification.]
7[Provided that the application for grant of a licence for a drug formulation containing single active ingredient shall be made only in proper name.]
3[77. Duration of licence. An original licence in 4[Form 28, Form 28B and Form 28D or renewed licence in Forms 26, 26F, and Form 26H], unless sooner suspended or cancelled shall be 5[valid for a period of five years on and from the date on which] it is granted or renewed:
_
1. Ins. by G.S.R. 119 (E), dt. 11-3-1996.
2. Subs. by G.S.R. 574 (E), dt. 17-7-2012.Earlier Subs. by G.S.R. 788 (E), dt. 10-10-1985 and Subs. by G.S.R. 462 (E), dt. 22-6-1982.
3. Amended by No. G.1-10/62-D, dt. 10-4-1964.
4. Subs. by G.S.R. 119 (E), dt. 11-3-1996.
5. Subs. by G.S.R. 601 (E), dt. 24-8-2001.
6. Subs. by G.S.R. 26 (E), dt. 19-1-2006.
7. Ins. by G.S.R. 570 (E) dt. 7-8-2014.
_
1[Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]]
2[78. Conditions of licence.− A licence in 3[Form 28, Form 28B or Form 28D] shall be subject to the special conditions, if any, set out in Schedule F or ScheduleF(1), as the case may be, which relate to the substance in respect of which the licence is granted and to the following general conditions:−
(a) (i) The licensee shall provide and maintain an adequate staff and adequate premises and plant for the proper manufacture and storage of the substances in respect of which the licence is issued;
(ii) Without prejudice to the generality of the foregoing requirement, every holder of a licence who for any purpose engaged in the culture or manipulation of pathogenic spore-bearing micro-organisms shall provide to the satisfaction of the Licensing Authority separate laboratories and utensils and apparatus required for the culture or manipulation of such micro-organisms, the laboratories, utensils and apparatus so provided not being used for the manufacture of any other substance;
4[(b) The licensee shall provide and maintain staff, premises and equipment as specified in Rule 76;]
5[(c)(i) The licensee shall maintain records of manufacture as per particulars given in Schedule U;
(ii) The licensee shall either in his own laboratory or in any laboratory approved by the Licensing Authority 6 [ under Part XV (A) of these rules] test each batch or lot of the raw material used by him for the manufacture of his product and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. The records or registers shall be retained in the case of a substance for which a potency date is fixed for a period of two years from the expiry of such date, and in the case of other substances for a period of five years from the date of manufacture;]
(d) The licensee shall allow an 7[Inspector appointed under the Act] to enter, with or without prior notice, any premises where the manufacture is carried on and to inspect the premises, and in the case of substances specified in Schedules C and C(1), to inspect the plant and the process of manufacture and the means employed for standardizing and testing the substance;]
_
1. Amended by S.O. 2139 dt. 12-8-1972.
2. Amended by F.1-6/62-B, dt. 2-6-1969.
3. Subs. by G.S.R. 119 (E), dt. 11-3-1996.
4. Amended by F.1-16/57-D (SO 2136), dt. 15-6-1957.
5. Amended by F.1-20/64-D (SO 3868), dt. 26-10-1968.
6. Ins. by G.S.R. 1172 (E), dt. 23-8-1977.
7. Subs. by G.S.R. 444 (E), dt. 31-3-1973.
_
(e) The licensee shall allow an 1[Inspector appointed under the Act] to inspect all registers and records maintained under these Rules and to take samples of the manufactured product and shall supply to such Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and Rules thereunder have been observed;]
(f) The licensee shall from time to time report to the Licensing Authority any changes in the expert staff responsible for the manufacture or testing of the substance and any material alterations in the premises or plant used for that purpose which have been made since the date of the last inspection made on behalf of the Licensing Authority before the issue of the licence;
1[(g) The licensee shall on request furnish to the Licensing Authority, Controlling Authority or to such authorities as the Licensing Authority or the Controlling Authority may direct, from every batch of drug as the Licensing Authority or the Controlling Authority may from time to time specify, a sample of such quantity as may be considered adequate by such Authority for any examination and, if so required, also furnish, full protocols of the tests which have been applied;]
2[(h) If the Licensing Authority or the Controlling Authority so directs, the licensee shall not sell or offer for sale any batch in respect of which a sample is, or protocols are furnished under the last preceding sub-paragraph until a certificate authorising the sale of the batch has been issued to him by or on behalf of the Licensing Authority or the Controlling Authority;]
1[(i) The licensee shall on being informed by the Licensing Authority or the Controlling Authority that any part of any batch of the substance has been found by the Licensing Authority or the Controlling Authority not to conform with the standards of strength, quality or purity specified in these rules and on being directed so to do, withdraw the remainder of that batch from sale and so far as may in the particular circumstances of the case be practicable recall all issues already made from that batch;]
(j) No drug manufactured under the licence shall be sold unless the precautions necessary for preserving its properties have been observed throughout the period after manufacture;
3[(k) The licensee shall comply with the provisions of the Act and of these rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV of the Act, provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette;]
_
1. Subs. by G.S.R 444, dt. 28-4-1973.
2. Amended by F.1-16/57-D, dt. 15-6-1957.
3. Amended by F.1-14/68-B (SO 3868), dt. 26-10-1968.
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1[(l) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impression and defects noticed.]
2[(m) The licensee shall maintain reference samples from each batch of the drugs manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the label, the reference samples shall be maintained for a period of three months beyond the date of expiry of potency. In case of drugs where no date of expiry is specified on the label the reference samples shall be maintained for a period of three years from the date of manufacture.]
3[(n) The licensee, who has been granted a license in Form 28B shall−
(i) forward to the licensing authority of the concerned States of manufacture and supply of the drug a statement of the sales effected to manufacturers, wholesalers, retailers, hospitals, dispensaries and Nursing Homes and Registered Medical Practitioners every three months;
(ii) maintain accounts of all transactions giving details as indicated below in a register bound and serially page numbered and such records shall be retained for a period of five years or one year after the expiry of potency, whichever is later.
A. Accounts of the drugs specified in Schedule X used for the manufacture:-
1. Date of issue.
2. Name of the drug.
3. Opening balance of stock on the production day.
4. Quantity received, if any, and source from where received.
5. Quantity used in manufacture.
6. Balance quantity on hand at the end of the production day.
7. Signature of the person in charge.
_
1. Subs. by F.1-14/68-B (SO3868), dt. 26-10-1968.
2. Ins. by G.S.R. 444, dt. 28-4-1973.
3. Ins. by G.S.R. 462 (E), dt. 22-6-1982.
_
B. Accounts of Production:
1. Date of manufacture.
2. Name of the drug.
3. Batch Number.
4. Quantity of raw material used in manufacture.
5. Anticipated yield.
6. Actual yield.
7 Wastage.
8. Quantity of the manufactured goods transferred.
C. Accounts of the manufactured drugs:
1. Date of manufacture.
2. Name of the drug.
3. Batch Number.
4. Opening Balance.
5. Quantity manufactured.
6. Quantity sold.
7. Name of the purchaser and his address.
8. Balance quantity at the end of the day.
(o) The licensee shall store drugs specified in Schedule X in bulk form and when any of such drug is required for manufacture in a place other than its place of storage it shall be kept in a separate place under the direct custody of a responsible person.]
1[(p) The licensee shall comply with the requirements of 3[‘Good Manufacturing Practices‘ as laid down in Schedule L-1 and Good Manufacturing Practices‘ as laid down in Schedule M.]
4[(q) No advertisement of the drugs specified in Schedule H, Schedule H1 or Schedule X shall be made except with the previous sanction of the Central Government.]
2[78A. Conditions of license in 5[Form 28A or Form 28DA]- (1) The license in 5[Form 28A of Form 28DA] shall be deemed to be cancelled or suspended, if the licence owned by the licensee in 6[5[Form 28 or Form 28D] whose manufacturing facilities have been availed of by the licensee is cancelled or suspended, as the case may be, under these rules.
_
1. Ins. by G.S.R. 735 (E), dt. 24-6-1998.
2. Amended by F.1-14/68-D (S.O. 3868), dt. 26-10-1968.
3. Ins. by G.S.R. 780 (E), dt. 10-9-2008.
4. Ins. by G.S.R. 289 (E), dt. 15-4-2015.
5. Subs. by G.S.R. 574 (E), dt. 17-7-2012.
6. Subs. by G.S.R. 592 (E), dt. 13-8-2008.
_
(2) The licensee shall comply with the provisions of the Act, and of these rules and with such further requirements if any, as may be specified in any rules subsequently made under Chapter IV of the Act, provided that where such further requirements are specified in the rules, those would come into force four months after publication in the Official Gazette.
(3) The licensee shall test each batch or lot of the raw material used by him for the manufacture of his products and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests as specified in Schedule U. Records or registers shall be retained, in the case of a substance for which a potency date is fixed, for a period of two years from the expiry of such date and in the case of other substances, for a period of five years from the date of manufacture. The licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and these rules have been observed.
(4) The licensee shall either (i) provide and maintain to the satisfaction of the Licensing Authority adequate staff and adequate laboratory facilities for carrying out tests of the strength, quality and purity of the substances manufactured by him, or (ii) make arrangements with some institution approved by the Licensing Authority for such tests to be regularly carried out on his behalf by the institution.]
1[(5) The licensee shall furnish to the Licensing Authority, if required to do so, data on the stability of drugs which are likely to deteriorate for fixing the date of expiry which would be printed on the labels of such drugs on the basis of the data so furnished.]
2[(6) The licensee shall maintain reference samples from each batch of the drug manufactured by him in a quantity which is at least twice the quantity of the drug required to conduct all the tests performed on the batch. In case of drugs bearing an expiry date on the labels, the reference samples shall be maintained for a period of three months beyond the date of expiry of potency. In case of drugs where no date of expiry of potency is specified on the label, the reference samples shall be maintained for a period of three years from the date of manufacture.]
3[(7) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.]
4[(8) No advertisement of the drugs specified in Schedule H, Schedule H1 or Schedule X shall be made except with the previous sanction of the Central Government.
5[79. Inspection before grant or renewal of licence.− Before a licence under this Part is granted or renewed the Licensing Authority or Central Licence Approving Authority, as the case may be, shall cause the establishment in which the manufacture is proposed to be conducted or being conducted to be inspected by one or more Inspectors appointed under this Act with or without an expert in the concerned field. The Inspector or Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for standardizing and testing the drugs to be manufactured or being manufactured and enquire into the professional qualifications of the technical staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plants, testing equipments and the ‘Requirements of Good Manufacturing Practices‘ and the ‘Requirements of Plant and Equipment‘ as laid down in Schedule M read with the Requirements of Maintenance of Records as laid down in Schedule U.]
_
1. Ins. by G.S.R. 444, dt. 28-4-1973.
2. Subs. by G.S.R. 574 (E), dt. 17-7-2012.
3. Ins. by G.S.R. 331 (E), dt. 8-5-1984.
4. Ins. by G.S.R. 289 (E), dt. 15-4-2015.
5. Subs. by G.S.R. 923 (E), dt. 14-12-1992.
_
1[80. Report by Inspector.− The Inspector shall forward a detailed descriptive report giving his findings on each aspect of inspection along with his recommendations after completion of his inspection in accordance with the provisions of Rule 79, to the Licensing Authority or Central Licence Approving Authority, as the case may be.]
81. Procedure of Licensing Authority.− (1) If the Licensing Authority 5[or Central Licence Approving Authority, as the case may be,] after such further enquiry, if any, as he may consider necessary, is satisfied that the requirements of the Rules under the Act have been complied with and that the conditions of the licence and the Rules under the Act will be observed, he 2[shall issue a licence under this Part].
(2) If the Licensing Authority 5[or Central Licence Approving Authority, as the case may be,] is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence can be granted and shall supply the applicant with a copy of the inspection report.
3[82. Further application after rejection.− If within a period of six months from the rejection of an application for a licence the applicant informs the Licensing Authority 5[or Central Licence Approving Authority, as the case may be,] that the conditions laid down have been satisfied and deposits an inspection 4[fee of rupees two hundred and fifty] the Licensing Authority 5[or Central Licence Approving Authority, as the case may be,] may, if after causing a further inspection to be made, he is satisfied that the conditions for the grant of a licence have been complied with, 5[in respect of drugs notified under Rule 68-A] issue a licence in Form 28 2[or Form 28-B].
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1. Subs. by G.S.R. 923 (E), dt. 14-12-1992.
2. Ins. by G.S.R. 462 (E), dt. 22-6-1982.
3. Ins. by F.1-16/57-D, dt. 15-6-1957.
4. Subs. by G.S.R. 601 (E), dt. 24-8-2001.
5. Ins. by G.S.R. 923 (E), dt. 14-12-1992.
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83. Renewal.− On application being made for renewal, the licensing authority may cause an inspection to be made and, if satisfied that the condition of the licence and the Rules under the Act are, and will continue to be observed, 1[he shall prepare a report to that effect in respect of those drugs which have been notified by the Central Government under Rule 68-A and forward it along with the application to the Central Licence Approving Authority], and shall issue a certificate of renewal 3[under this Part].
3[83-A. Certificate of renewal of a loan licence.− The certificate of renewal of a loan licence in 8[Form 28A or Form 28DA] shall be issued in Form 26A or Form 26J respectively.]
4[83-AA. Duration of loan licence.− An original loan licence in 8[Form 28A or Form 28DA] or a renewed loan licence in 8 [ Form 26A or Form J], unless sooner suspended or cancelled, shall be 5[valid for a period of five years on and from the date on which] it is granted or renewed:
6[Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry, after payment of the additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry].]
84. The provisions of this Part shall apply to the manufacture of drugs for sale notwithstanding that such drugs are manufactured for sale outside India.
7[6[84-A. Provision for appeal to the State Government or Central Government by party whose licence has not been granted or renewed.−
Any person who is aggrieved by the order passed by the Licensing Authority or the Central Licence Approving Authority, as the case may be, refusing to 2[grant or renew a licence under this Part], may within thirty days from the date of receipt of such order, appeal to the State Government or Central Government, as the case may be, and the State Government or the Central Government may, after such enquiry into the matter,] as is considered necessary and after giving the said person an opportunity for representing his views, may pass such order in relation thereto as it thinks fit.]
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1. Ins. by G.S.R. 923 (E), dt. 14-12-1992.
2. Subs. by G.S.R. 119 (E), dt. 11-3-1996..
3. Ins. by F1-16/57-B, dt. 15-6-1957.
4. Ins. by Notfn. No. F. 1-10/62-D, dt. 10-4-1964.
5. Subs. by G.S.R. 601 (E), dt. 24-8-2001.
6. Subs. by S.O. 2139, dt. 12-8-1972.
7. Subs. by G.S.R. 923 (E), dt. 14-12-1992 as corrected by G.S.R. 373 (E), dt. 13-4-1993.
8. Subs. by G.S.R. 574 (E), dt. 17-5-2012.
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6[84AA. Additional information to be furnished by an applicant for licence or a licensee to the licensing authority. The applicant for the grant of a licence or any person granted a licence under this Part shall, on demand, furnish to the Licensing Authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership or occupation on rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm or any other relevant matter which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.]
1[84B. Prohibition for the manufacture for sale of cyclamates and preparations containing cyclamates. No person shall manufacture for sale cyclamates and preparations containing cyclamates.]
2[85. Cancellation and suspension of licences. (1) The Central Licence Approving Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part, or suspend it for such period as he thinks fit either wholly or in respect of any of the drugs to which it relates 3[or direct the licensee to stop manufacture, sale or distribution of the said drugs and 4[thereupon order the destruction of drugs and] the stock thereof in the presence of an Inspector], if in his opinion, the licensee has failed to comply with any of the conditions of the licencee or with any provisions of the Act or rules made thereunder.
(2) The Licensing Authority may, for such licences granted or renewed by him, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates, 3[or direct the licensee to stop manufacture, sale or distribution of the said drugs and 4[thereupon order the destruction of drugs and] the stock thereof in the presence of an Inspector] if, in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or rules made thereunder.]
5[(3) A licensee whose licence has been suspended or cancelled by the Central Licence Approving Authority or Licensing Authority under sub-rule (1) or sub-rule (2), as the case may be, may within ninety days of the receipt of a copy of the order by him prefer an appeal to the Central Government or the State Government, as the case may be, and the Central Government or the State Government may after giving the licensee an opportunity of being heard, confirm, reverse or modify such order.]
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1. Ins. by S.O.2358, dt. 26-8-1972.
2. Subs. by G.S.R. 923 (E), dt. 14-12-1992 as corrected by G.S.R. 373 (E), dt. 13-4-1993.
3. Ins. by G.S.R. 20 (E), dt. 11-1-1996.
4. Ins. by (Corrigenda) G.S.R. 514 (E), dated 5.11.1996.
5. Ins. by 615 (E), dt. 9-8-1994 as corrected by G.S.R. 55 (E), dt. 7-2-1995.
6. Ins. by S.O. 2139, dt. 5-6-1972.
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1[PART VIIA
2[MANUFACTURE FOR SALE OR FOR DISTRIBUTION] OF HOMOEOPATHIC MEDICINES
85A. Manufacture on more than one set of premises. If Homoeopathic medicines are manufactured in more than one set of premises a separate application shall be made and a separate licence shall be obtained in respect of each such set of premises.
85B. Application for licence to manufacture Homoeopathic medicines. (1) Application for grant or renewal of 2[licence to manufacture for sale or for distribution] of Homoeopathic medicines shall be made to the Licensing Authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the Licensing Authority) and shall be made in Form 24-C.
3[(2) The application in Form 24-C shall be accompanied–
(a) by a fee of 4[rupees two hundred] for the manufacture of Homoeopathic mother tinctures and potentised preparations and an inspection fee of 4[rupees one hundred] for the first inspection or 4[rupees fifty] in case of inspection for renewal of licence;
(b) by a fee of 4[rupees two hundred] for the manufacture of Homoeopathic potentised preparations only, and an inspection fee of 4[rupees one hundred] for the first inspection or 4[rupees fifty] in case of inspection for renewal of licence;
(c) by a fee of 4[rupees two hundred] for the manufacture of potentised preparations from back potencies by pharmacies which are already licensed to sell Homoeopathic medicines by retail and an inspection fee of 4[rupees one hundred] for the first inspection or 4[rupees fifty] in case of inspection for renewal of licence.
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1. Ins. under G.S.R. 1185 (E), dt. 18-8-1964.
2. Sub. by G.S.R. 788 (E), dt. 10-10-1985.
3. Sub. by G.S.R. 245, dt. 11-2-1976.
4. Subs. by G.S.R. 601 (E), dt. 24-8-2001.
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1[(3) If a person applies for renewal of a licence after its expiry but within six months of such expiry, the fee payable for the renewal of such a licence shall be_
(a) 2[rupees two hundred] plus an additional fee at the rate of 2[rupees one hundred] per month or part thereof and an inspection fee of 2[rupees fifty] for the manufacture of Homoeopathic mother tinctures and potentised preparations;
4[(b)2[rupees two hundred] plus an additional fee at the rate of 2[rupees one hundred] per month or part thereof and an inspection fee of 2[rupees fifty] for the manufacture of Homoeopathic potentised preparations only;]
(c) 2[rupees two hundred] plus an additional fee at the rate of 2[rupees one hundred] per month or part thereof and an inspection fee of 2[rupees fifty] for the manufacture of Homoeopathic mother tinctures and potentised preparations from back potencies by pharmacies who are already licensed to sell Homoeopathic medicines by retail.]
(4) A fee of 2[rupees fifty] shall be paid for a duplicate copy of the licence for the manufacture of Homoeopathic mother tinctures and potentised preparations issued under sub-rule (1) if the original is defaced, damaged or lost, while the fee to be paid for such a duplicate copy of the licence for the manufacture of Homoeopathic potentised preparations only shall be 2[rupees fifty].
3[(5) Applications by licensee to manufacture additional items of Homoeopathic medicines shall be made to the Licensing Authority and such applications shall be accompanied by a fee of 2[rupees fifty] for each additional item.]
85C. Application to manufacture ‘New Homoeopathic medicines.‘Subject to the other provisions of these Rules
(1) no ‘New Homoeopathic medicine‘ shall be manufactured unless it is previously approved by the Licensing Authority mentioned in Rule 21;
(2) the manufacturer of ‘New Homoeopathic medicine‘, when applying to the Licensing Authority mentioned in sub-rule (1) shall produce such documentary and other evidence as may be required by the Licensing Authority for assessing the therapeutic efficacy of the medicine including the minimum provings carried out with it.
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1. Subs. by G.S.R. 245, dt. 3-2-1976.
2. Subs. by G.S.R. 601 (E), dt. 24-8-2001.
3. Ins. by G.S.R. 13 (E), dt. 7-1-1983.
4. Subs. by G.S.R. 779 (E), dt. 18-7-1980.
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(3) While applying for a licence to manufacture a ‘New Homoeopathic medicine‘ an applicant shall produce along with his application evidence that the
‘New Homoeopathic medicine‘ for the manufacture of which application is made has already been approved.
Explanation.− The term ‘New Homoeopathic medicine‘ in this rule shall have the same meaning as in rule 30AA.
1[85D. Form of licence to manufacture Homoeopathic medicines.— Licence for manufacture of Homoeopathic medicines is a licence to manufacture potentised preparations from back potencies by Pharmacies who are already licensed to sell Homoeopathic medicines by retail and shall be granted in Form 25C.]
85E. Conditions for the grant or renewal of a licence in Form 25C−Before a ence in Form 25C is granted or renewed the follow ng conditions sha l be complied
with by the applicant:—
(1) The manufacture of Homoeopathic medicines shall be conducted under the direction and supervision of competent technical staff consisting at least of one person who is a whole time employee 2[and who is—
(a) a graduate in Science with Chemistry as one of the subjects with three years‘ experience in manufacture of Homoeopathic Medicines; or
(b) a graduate in Pharmacy with 18 months of experience in the manufacture of Homoeopathic medicines; or
(c) holds qualification as defined under sub-clause (g) of clause (1) of section 2 of Homoeopathy Central Council Act, 1973 (59 of 1973) with 18 months of experience in the manufacture of Homoeopathic medicines:
Provided that the persons who are already in employment with five years‘ experience in the manufacture of Homoeopathic medicines and whose name was accordingly entered in any licence granted in Form 25C for manufacture of different classes of Homoeopathic medicines included in them shall be deemed to be qualified for the purpose of this rule.]
3[(2) The factory premises shall comply with the requirements and conditions specified in Schedule M-I:
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1. Amended by F.1-59/68-D (SO 4816), dt. 19-11-1969.
2. Subs. by G.S.R. 812 (E), dt. 14-11-1994 as corrected by G.S.R. 517 (E), dt. 26-6-1995.
3. Subs. by G.S.R. 570 (E), dt. 12-6-1987.
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Provided that where the Licensing Authority considers it necessary or expedient so to do, it may having regard to the nature and extent of manufacturing operations, relax or suitably alter the said requirements or conditions in any particular case for reasons to be recorded in writing.]
(3) The applicant for manufacture of Homoeopathic mother tinctures shall either (i) provide and maintain adequate staff, premises and laboratory equipment for identifying the raw materials and for testing the mother tinctures wherever possible, or (ii) make arrangements with some institution approved by the Licensing Authority 2[under Part XV(A) of these rules] for such tests, wherever possible, to be regularly carried out on his behalf by that institution.
(4) The premises where Homoeopathic medicines are manufactured shall be distinct and separate from the premises used for residential purposes.
(5) Homoeopathic medicines shall not be manufactured simultaneously with drugs pertaining to other systems of medicine.
(6) The applicant shall make arrangements for proper storage of Homoeopathic medicines manufactured by him:
1[Provided that in case potentised preparations are made in a Pharmacy holding licence in Form 20-C, the conditions (2) and (3) shall not apply. The licensee shall ensure to the satisfaction of the Licensing Authority that the products manufactured by it, conform to the claims made on the label.]
3[85-EA. Inspection before grant or renewal of licence.- Before a licence under this Part is granted or renewed in Form 25C or Form 26C, the Licensing Authority shall cause the establishment, in which the manufacture is proposed, to be conducted or being conducted, to be inspected by one or more Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for standardizing and testing the substances to be manufactured and inquire into the professional qualifications of the technical staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plants, testing equipments and the requirements of plant and equipment as laid down in Part I of Schedule M read with the requirements of maintenance of records as laid down in Schedule U.
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1. Amended by F.1-59/68-D (SO 4816), dt. 19-11-1969.
2. Ins. by G.S.R. 1172 (E), dt. 23-8-1977.
3. Ins. by G.S.R. 493 (E), dt. 9-6-1995.
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85EB. Report by Inspector.– The Inspector or Inspectors shall forward a detailed descriptive report giving his or their findings on each aspect of inspection along with his or their recommendations after completion of his or their inspection to the Licensing Authority.
85EC. Grant or refusal of licence.– (1) If the Licensing Authority after such further enquiry, if any, as he may consider necessary is satisfied that the requirements of the rules under the Act have been complied with and that conditions of the licence and the rules under the Act shall be observed, he shall grant or renew a licence in Form 25C or Form 26C.
(2) If the Licensing Authority is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence can be granted or renewed and shall supply the applicant with a copy of inspection report.]
85ED. Further application after rejection.– If within a period of six months from the rejection of an application for a licence, the applicant informs the Licensing Authority that the conditions laid down have been fulfilled and deposits an inspection fee of 1[rupees two hundred and fifty], the Licensing Authority may, if, after causing further inspection to be made, he is satisfied that the conditions for the grant of licence have been complied with, issue a licence in Form 25C or Form 26C.
85EE. Appeal to the State Government.– Any person who is aggrieved by the order passed by the Licensing Authority refusing to grant or renew a licence under this Part may within ninety days from the date of receipt of such order, appeal to the State Government and the State Government may, after such enquiry into the matter as is considered necessary and after giving the said person an opportunity for representing the case, pass such order as it thinks fit.]
85F. Duration of licence.– An original licence or a renewed licence unless it is sooner suspended or cancelled shall be 1[valid for a period of five years on and from the date on which] it is granted or renewed:
2[Provided that if the application for renewal of a licence in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired if application for its renewal is not made within six months of its expiry.]
85G. Certificate of renewal.– The certificate of renewal of a licence in Form 25-C shall be issued in Form 26-C.
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1. Subs. by G.S.R. 601 (E), dt. 24-8-2001.
2. Subs. by S.O. 2139, dt. 12-8-1972.
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85H. Conditions of licence.– A licence in Form 25-C shall be subject to the conditions stated therein and to the following further conditions, namely :
(a) the licensee shall provide and maintain staff and premises as specified in Rule 85-E;
(b) the licensee shall allow an 1[Inspector appointed under the Act] to enter, with or without prior notice, any premises where the manufacture of a Homoeopathic medicine in respect of which the licence is issued is carried on, to inspect the premises and to take samples of the manufactured Homoeopathic medicines;
(c) the licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the rules made thereunder have been observed;
2[(d) the licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and defects noticed;]
(e) the licensee shall comply with the following conditions in respect of mother tinctures manufactured by him_
(i) the crude drug used in the manufacture of the mother tincture shall be identified and records of such identification shall be kept 3[for a period of five years];
(ii) the total solids in the mother tincture shall be determined and records of such tests shall be kept 3[for a period of five years];
(iii) the alcohol content in the mother tincture shall be determined and records of the same shall be maintained 3[for a period of five years];
(iv) the containers of mother tinctures shall preferably be of glass and shall be clean and free from any sort of impurities or adhering matter. The glass shall be neutral as far as possible;
(v) in the process of manufacture of mother tinctures hygienic conditions shall be scrupulously observed by the licensee. Storage and handling conditions shall also be properly observed by the licensee according to Homoeopathic principles;
___
1. Amended by G. S. R. 444, dt. 28-4-1973.
2. Amended by F-1-14/ 68-D, dt. 26-10-1968.
3. Ins. by G.S.R. 13(E), dt. 7-1-1983.
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1[(ea) no colour shall be added to any Homoeopathic medicines :
Provided that caramel may be added to combination of Homoeopathic preparations with syrup base;]
(f) records shall be maintained of Homoeopathic medicines containing alcohol and the quantities sold together with names and addresses of parties to whom sold.2 [Such records shall be maintained for a period of five years.]
3[85HH. Additional information to be furnished by an applicant for the licence or a licensee to the Licensing Authority.– The applicant for the grant of licence or any other person granted a licence under this Part shall, on demand, furnish to the Licensing Authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership or occupation in rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm or any other relevant matters which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.]
85-I. Cancellation and suspension of licences.– (1) The Licensing Autority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates if, in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or Rules made thereunder.
4[(2) A licensee whose licence has been suspended or cancelled may, within three months of the date of the order under sub-rule (1), prefer an appeal against that order to the State Government, which shall decide the same.]
PART VIII
MANUFACTURE FOR EXAMINATION, TEST OR ANALYSIS
86. Conditions relating to manufacture for examination, test or analysis.– The provisions of Section 18 of the Act shall not apply to the manufacture of any drug in small quantities for the purpose of examination, test or analysis if the conditions prescribed in this Part are fulfilled.
87. Labelling.– Any drug manufactured for the purpose of examination, test or analysis shall be kept in containers bearing labels indicating the purpose for which it has been manufactured.
88. Labelling of drugs supplied to other persons.– If any drug manufactured for the purpose of examination, test or analysis is supplied by the manufacturer to any other person, the container shall bear a label on which shall be stated the name and address of the manufacturer, the accepted scientific name of the substance if known, or if not known a reference which will enable the substance to be identified and the purpose for which it has been manufactured.
___
1. Ins. by G.S.R. 680 (E), dt. 5-12-1980.
2. Ins. by G.S.R. 13 (E), dt. 7-1-1983.
3. Ins. by S. O. 2139, dt. 12-8-1972.
4. Subs. G.S.R. 926, dt. 16-7-1977.
___
89. Licence.– If the person proposing to manufacture a drug for the purpose of examination, test or analysis does not hold a licence in Form 25 or Form 28 in respect of such drugs he shall, before commencing such manufacture, obtain a licence in Form 29:
1[Provided that in the case of a drug the composition of which is such that the drug is not generally recognized among experts qualified by scientific training and experience to evaluate the safety of drugs as safe for use, no licence in Form 29 shall be granted unless the applicant produces a certificate from the “Licensing Authority” mentioned in Rule 21, to the effect that there would be no objection to such licence being granted.
90. Form of application.– 2[(1)] An application for a licence in Form 29 shall be made to the Licensing Authority appointed by the State Government for the purpose of this Part (hereafter in this Part referred to as the Licensing Authority) in Form 30 and shall be made by or countersigned by the head of the institution in which, or a director of the firm or company by which, the substance will be manufactured.
4[(2) Every application in Form 29 shall be accompanied by a fee of 3[rupees two hundred fifty].
91. Duration of licence.– A licence in Form 29 shall, unless sooner cancelled, be in force for a period of one year from the date of issue, and may thereafter be renewed for periods of one year at a time.
92. Conditions of licence.− A licence in Form 29 shall be subject to the following conditions
(a) the licensee shall use the drugs manufactured under the licence exclusively for purpose of examination, test or analysis, and shall carry on the manufacture and examination, test or analysis at the place specified in the licence;
(b) the licensee shall allow any 3[inspector appointed under the Act] to enter, with or without notice, the premises where the drugs are manufactured and to satisfy himself that only examination, test or analysis work is being conducted;
(c) the licensee shall keep a record of the quantity of drugs manufactured for examination, test or analysis and of any person or persons to whom the drugs have been supplied;
(d) the licensee shall comply with such further requirements, if any, applicable to the holders of licences in Form 29 as may be specified in any rules subsequently made under the Act and of which the Licensing Authority has given him not less than one month‘s notice;
(e) the licensee shall maintain an Inspection Book to enable an Inspector to record his impressions and defects noticed.
93. Cancellation of licences.-
(1) The Licensing Authority may after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part, either wholly or in respect of some of the substances to which it relates, if, in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provision of the Act or Rules thereunder
___
1. Ins. under F. 1-19/59-D (SO 1449), dt. 13-6-1961.
2. Re-numbered by S.O. 903, dt. 28-2-1976.
3. Subs. by G.S.R. by 444, dt. 31.3.1973.
4. Ins. by S.O 903, dt. 28-2-1976.
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1[(2) A licensee whose licence has been suspended or cancelled may appeal to the State Government within three months of the date of the order.]
PART IX
LABELLING AND PACKING OF DRUGS OTHER THAN HOMOEOPATHIC MEDICINES
94. Exemption of certain drugs from certain provisions of this Part.— (1) Labels on packages or containers of drugs for export shall be adapted to meet the specific requirements of the law of the country to which the drug is to be exported but the following particulars shall appear in a conspicuous position on the innermost container in which the drug is packed and every other covering in which that container is packed:
(a) name of the drug;
(b) the name, address of the manufacturer and the number of the licence under which the drug has been manufactured;
(c) batch or lot number;
(d) date of expiry, if any:
2[Provided that where a drug, not classified under Schedule F, Schedule F(1) and Schedule X, 5[or blood products defined under rule 122EA] is required by the
consignee to be not labelled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the Licensing Authority mentioned in Rule 21.]
4[Provided further that where a drug classified as Narcotic Drug or Psychotropic Substance is to be exported under a code number, the same may be permitted by the said licensing authority on the following conditions, namely:-
(i) Each consignment of export shall be accompanied with requisite import license from the importing country;
(ii) The applicant shall obtain a no objection certificate from the Drugs Controller, India for manufacture of such formulations to be exported with code number against each export order along with certificate from the regulatory authority of the importing country controlling Narotic Drugs and Psychotropic Substances that they do not have any objection for the import of the drug with code number;
(iii) The State Licensing Authority shall issue the manufacturing license for these formulations on each export order on the basis of a No Objection Certificate from Drugs Controller, India;
(iv) A no objection certificate shall be obtained from the drugs Controller, India for export of each consignment; and
(v) A no objection certificate shall be obtained from the Narcotic Commissioner of India, Gwalior for export of each consignment of the drug.]
3[(2) The provisions of Rules 96 to 101 inclusive, shall not apply to a medicine made up ready for treatment, whether after or without dilution, which is supplied on the prescription of a registered practitioner provided that:
(i) the medicine is labelled with the following particulars : –
(a) the name and address of the supplier;
(b) the name of the patient and the quantity of the medicine;
(c) the number representing serial number of the entry in the prescription register;
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1. Subs. by F.1-10/68-D (S.O 2482), dt. 17-6-1969.
2. Ins. by G.S.R. 676 (E), dt. 2-6-1988.
3. Subs. by F.1-19/59-D, dt. 13-6-1961.
4. Ins. by G.S.R. 592 (E), dt. 13-8-2008.
5. Subs. by 592 (E), dt. 13-8-2008.
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(d) the dose, if the medicine is for internal use;
1[(e) the words “FOR EXTERNEL USE ONLY” shall be printed on the label if the medicine is for external application].
(ii) Condition (3) of the conditions in Rule 65 is satisfied.]
95. Prohibition of sale or distribution unless labelled.— Subject to the other provisions of these Rules, no person shall sell or distribute any drug (including a patent or proprietary medicine) unless it is labelled in accordance with these Rules.
2[96. Manner of Labelling.— (1) Subject to the other provisions of these Rules, the following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any drug and on every other covering in which the container is packed, namely :—
(i) the name of the drug−
3[(A) for this purpose, the proper name of the drug shall be printed or written in a more conspicuous manner than the trade name, if any, which shall be shown immediately after or under the proper name and shall be]—
(a) for drugs included in the Schedule F or Schedule F (1), the name given therein;
(b) for drugs included in the Indian Pharmacopoeia or the official pharmacopoeias and official compendia of drug standards prescribed in Rule 124, the name or synonym specified in the respective official pharmacopoeias and official compendia of drug standards followed by the letters ‘I.P., or, as the case may be, by the recognized abbreviations of the respective official pharmacopoeias and official compendia of drug standards;
(c) for drugs included in the National Formulary of India, the name or synonym specified therein followed by the letters ‘N.F.I.‘;
(d) for other drugs, the international non-proprietary name, if any, published by the World Health Organisation or where an international non-proprietary name is not published, the name descriptive of the true nature or origin of the substance;
4[* * * * *]
(ii) A correct statement of the net content in terms of weight, measure, volume, number of units of contents, number of units of activity, as the case may be, and the weight, measure and volume shall be expressed in Metric system.
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1. Subs. by G.S.R. 462 (E), dt. 22-6-1982.
2 Amended under G.S.R.19, dt. 15-12-1977.
3. Subs. by G.S.R. 27(E), dt. 17-1-1981.
4. Sub-clause (B) omitted by G.S.R. 94 (E), dt. 8-2-2000. Earlier ins. by G.S.R. 27 (F), dt.-1-1981.
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(iii) The content of active ingredients− This shall be expressed−
(a) for oral liquid preparations in terms of the content per single dose, being indicated in 5 millilitres 1[** *]:
Provided that where the dose is below 5 millilitres the contents of active ingredients may be expressed in terms of 1 millilitre; 2[or fraction thereof:]
3[Provided further that where the single dose is more than 5 millilitres, the content of active ingredients shall be expressed in terms of minimum single dose as approved by the licensing authority;]
(b) for liquid parenteral preparations ready for administration in terms of 1 millilitre or percentage by volume or per dose in the case of single dose container :
Provided that if the preparation is contained in an ampoule it will be enough if the composition is shown on the label or wrapper affixed to any package in which such ampoule is issued for sale;
(c) for drugs in solid form intended for parenteral administration, in terms of units or weight per milligram or gram;
(d) for tablets, capsules, pills and the like, in terms of the content in each tablet, capsule, pill or other unit, as the case may be;
(e) for other preparations, in terms of percentage by weight or volume or in terms of unitage per gram or millilitre, as the case may be:
Provided that clause (iii) shall not apply to the pharmacopoeial preparations where the composition of such preparation is specified in the respective pharmacopoeia and to a preparation included in the National Formulary of India.
(iv) 4[The name of the manufacturer and the address of the premises of the manufacturer where the drug has been manufactured:]
Provided that if the drug is contained in an ampoule or a similar small container, it shall be enough if only the name of the manufacturer and his principal place of 5[manufacture] is shown.
(v) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figure representing the batch number being preceded by the words ‘Batch No.‘ or ‘B. No.‘ or ‘Batch‘ or ‘Lot No.‘ or ‘Lot‘.
NOTES
(1) In the case of drugs manufactured by a continuous process, like manufacture of magnesium sulphate, pharmaceutical chemicals etc., the production resulting in one homogenous mix of the finished products shall be considered as one “Batch”.
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1. Omitted by G.S.R. 285 (E), dt. 16-7-1996.
2. Ins. by G.S.R. 681(E), dt. 5-12-1980.
3. Ins. by G.S.R. 285 (E), dt. 16-7-1996.
4. Subs. by G.S.R. 491 (E), dt. 25-7-1991.
5. Subs. by G.S.R. 17 (E), dt. 7-1-1986.
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(2) In the case of powders, liquid orals, ointments etc., one “Batch Number” shall be assigned to all the containers filled from one homogenous bulk.
(3) In the case of tablets, capsules, lozenges, troches, etc., one “Batch Number” shall be assigned to the products manufactured from one homogenous mix ready for compression or filling.
(4) In the case of parenteral preparations sterilized by steam under pressure, one “Batch Number” shall be assigned to all containers filled from one homogenous bulk solution and sterilized in one sterilizer load.
(5) In the case of containers of parenteral preparations filled from one homogenous bulk solution and sterilized in more than one sterilizer load, the
“Batch Number” assigned to the containers in the different sterilizer loads shall be the same “Batch Number” as is assigned to the homogenous bulk solution, provided the samples taken from all the sterilizer loads pass the sterility test, and are kept separate from one another until the report of the sterility test is available.
Explanation.— For the purpose of chemical and other tests, representative samples from all containers filled from the homogenous bulk solution should be taken.
(6) In the case of parenteral and other sterile products filled aseptically, a “Batch Number” shall be assigned to all containers filled from one homogenous mix during one filling operation, the filling operation being completed in a period of not more than a day and during which no schedule change in the filling assembly is made.
When containers are filled from one homogenous mix, in a number of filling operations, the “Batch Number” assigned to the containers filled in individual filling operations shall be the same “Batch Number” as is assigned to the homogenous mix, provided the samples taken from all the different filling operations pass the sterility tests, and are kept separate from one another until the report of the sterility test is available.
Explanation.- For the purpose of chemical and other tests, representative samples from all containers filled from the homogenous mix should be taken.
(7) In the case of medicinal gases produced by a continuous process of operation a week‘s production from one tank load shall be considered as a Batch.
(vi) Every drug manufactured in India shall bear on its label the number of the licence under which the drug is manufactured, the figure representing the manufacturing licence number being preceded by the words “Manufcaturing Licence Number” or “Mfg. Lic. No.” or “M.L.”.
(vii) Drugs specified in Schedule P and their preparations including combinations with other drugs shall bear on their labels the date of manufacture, and the date of expiry of potency, and the period between the date of manufacture and the date of expiry shall not exceed that laid down in the said Schedule 1[under the conditions of storage specified therein. 2[Drugs and their preparations not included in Schedule P], shall bear on their labels the date of their manufacture and also the date of their expiry which shall not exceed sixty months from the date of manufacture:]
Provided that this period may be extended by the Licensing Authority specified in clause (b) of Rule 21 in respect of any specified drug if satisfactory evidence is produced by the manufacturer to justify such an extension.
7[(viii) Drugs specified in Schedule C(I) and their preparations including combinations in other drugs shall bear on their labels (a) the date of manufacture, and (b) date of expiry of potency fixed by the manufacturer:
3[4[Provided that drugs in bulk form included in Schedule C(I) which are not ready for use and not included in Schedule P need not bear on the label the date of expiry of potency:]
Provided further that no reference shall be made to any other licence number granted by any authority outside India on any label or container or in any covering in which the container is packed or in any other matter or advertisement enclosed therewith].
(ix) Every drug intended for distribution to the medical profession as a free sample shall, while complying with the labelling provisions under clauses (i) to (viii), further bear on the label of the container the words ‘Physician‘s Sample—Not to be sold‘ which shall be overprinted.
5[(x) If any preparation contains not less than 3 per cent by volume of alcohol the quantity of alcohol shall be stated in terms of the average percentage by volume of absolute alcohol in the finished products.]
6[(xi) In addition to the other particulars which are required to be printed or written under these Rules, the label of innermost container of the following categories of drugs and every other covering in which the container is packed shall bear a conspicuous red vertical line on the left side running throughout the body of the label which should not be less than 1mm in width and without disturbing the other conditions printed on the label under these rules, namely: —
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1. Subs. by G.S.R. 17 (E), dt. 7-1-1986.
2. Subs. by G.S.R. 285 (E), dt. 16-7-1996.
3. Subs. by G.S.R. 487(E), dt. 2-7-1984.
4. Subs. by G.S.R. 813 (E), dt. 27-7-1988.
5. Ins. by G.S.R. 462 (E), dt. 22-6-1982.
6. Ins. by G.S.R. 597 (E), dt. 17-6-1992.
7. Subs. by G.S.R. 592 (E), dt. 13-8-2008.
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Narcotic analgestics, hypnotics, sedatives, tranquillisers, corticosteroids, hormones, hypoglycemics, antimicrobials, antiepileptics, antidepressants, anticoagulants, anti-cancer drugs and all other drugs falling under Schedules ‘G‘, ‘H‘, and ‘X‘ whether covered or not in the above list:
Provided that the provisions of this clause shall not apply to: −
(a) preparations intended for animal treatment;
(b) preparations intended for external use;
(c) ophthalmic preparations and ear drops; and
(d) sterile preparations such as sutures, surgical dressings and preparations intended for parenteral use.]
1[(xii) Drugs and their preparations including combinations with other drugs imported into the country shall also bear on the label, the license number under which the drug is imported, preceded by the words “Import License” and the name and address of the importer.]
(2)(i) The particulars to be printed or written on the label of a mechanical contraceptive shall be as specified in Schedule R.
(ii) The following particulars, in addition to those specified under sub-rule (1) shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container and on every other covering in which the container of a contraceptive, other than a mechanical contraceptive, is packed, namely : −
(a) the date of manufacture;
(b) the date upto which the contraceptive is expected to retain its properties;
(c) the storage conditions necessary for preserving the properties of the contraceptive upto the date indicated in sub-clause (b) :
Provided that for oral contraceptives it shall be sufficient to display on the label of the container the date of manufacture only.
(3)(i) The particulars prescribed in sub-rule (1) shall be printed or written in indelible ink either on the label borne by a container of vaccine lymph or on a label or wrapper affixed to any package in which the container is issued for sale. The said particulars shall be indelibly marked on the sealed container of surgical ligature or suture or printed or written in indelible ink on a label enclosed therein.
(ii) Nothing in these rules shall be deemed to require the labelling of any transparent cover or of any wrapper, case or other covering used solely for the purpose of packing, transport or delivery.
(4) Where by any provision of these rules any particulars are required to be displayed on a label on the container, such particulars may, instead of being displayed on a label, be etched, painted or otherwise indelibly marked on the container:
___
1. Ins. by G.S.R. 592 (E), dt. 13-08-2008.
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Provided that, except where otherwise provided in these rules, the name of the drug or any distinctive letters intended to refer to the drug shall not be etched, painted or otherwise indelibly marked on any glass container other than ampoules.
Explanation.— For the purpose of this rule, the date of expiry shall be in terms of month and year and it shall mean that the drug is recommended till the last day of the month. The date of expiry shall be preceded by the words ‘Expiry date‘.]
97. Labelling of medicines.— 1[(1) The container of a medicine for internal use shall—
(a) if it contains a substance specified in Schedule G, be labelled with the words “Caution: it is dangerous to take this preparation except under medical supervision” – conspicuously printed and surrounded by a line within which there shall be no other words;
(b) if it contains a substance specified in Schedule H, be labelled with the symbol Rx and conspicuously displayed on the left top corner of the label and be also labelled with the following words:
‘Schedule H drug- Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only‘,
(c) if it contains a substance specified in Schedule H, and comes within the purview of the 2[Narcotic Drugs and Psychotropic Substances Act, 1985 (61 of 1985)] be labelled with the symbol NRx which shall be in red and conspicuously displayed on the left top corner of the label, and be also labelled with the following words:
‘Schedule H drug -Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only‘;
(d) If it contains a substance specified in Schedule X, be labelled with the symbol XRx which shall be in red conspicuously displayed on the left top corner of the label and be also labelled with the following words :-
‘Schedule X drug -Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only‘.
4[(e) if it contains a drug substance specified in Schedule H1, the drug formulation shall be labeled with the symbol Rx which shall be in red conspicuously displsyed on the left top corner of the label, and shall also be labelled with the following words in a box with a red border:
(2) The container of an embrocation, liniment, lotion, 3[ointment, antiseptic cream,] liquid antiseptic or other liquid medicine for external application shall be labelled with the words:
“FOR EXTERNAL USE ONLY”.
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1. Subs. by G.S.R. 462 (E), dt. 22-6-1982.
2. Subs. By G.S.R. 282(E), dt. 16.7.1996. As corrected by G.S.R. 241(E), dt. 15.4.1998.
3. Ins. by G.S.R. 850 (E), dt. 7-12-1994.
4. Subs. by G.S.R. 588 (E), dt. 30-8-2013.
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1[(3) The container of a medicine made up ready only for treatment of an animal shall be labelled conspicuously with the words ‘Not for human use; for animal treatment only‘ and shall bear a symbol depicting the head of a domestic animal.]
2[* * * * *]
10[(3A) The container of a medicine for treatment of food producing animals shall be labeled with the withdrawal period of the drug for the species on which it is intended to be used:
Provided that if the specific withdrawal period has not been validated, the withdrawal period shall not be less than seven days for eggs or milk, twenty eight days for meat from poultry and mammals including fat and offal, five hundred degree days for fish meat.
Explanation:- For the purpose of this Rule, the withdrawal period is the period of interval between the last administration of a veterinary medicine to animals under the normal conditions of use and the production of food stuff from such animals to ensure that food stuffs do not contain residues in quantities in excess of the maximum residue limits laid down.]
3[(4)] The container of a medicine prepared for treatment of human ailments shall if the medicine contains industrial methylated spirit, indicate this fact on the label and be labelled with the words :
“For External Use only”.
4[(5) Substances specified in Schedule X in bulk form shall bear a label wherein the symbol as specified in sub-Rule (1) shall be given conspicuously in red letters.]
5[* * * * *]
6[102. Non-Sterile Surgical Ligature and Suture.- Every container of, and wrapper enclosing surgical ligature or suture other than a ligature or suture offered or intended to be offered for sale as sterile, shall bear a label on which are printed or written in a conspicuous manner in indelible red ink the words “Non-sterile surgical ligature (suture) – not to be used for operations upon the human body unless efficiently sterilized”.]
103. 7[* * * * *]
(2) The name and address of the manufacturer shall be printed on the label of the container of a patent or proprietary medicine.
8[(3) The true formula or list of the ingredients shall be printed or written in indelible ink on the outer label of every package containing patent or proprietary medicine.]
9[104 Use of letter I.P. etc.– The letters ‘I.P‘. and recognized abbreviations of pharmacopoeias and official compendia of drug standards prescribed under these Rules shall be entered on the label of the drug only for the purpose of indicating that the drug is in accordance with standards set out in the Indian Pharmacopoeia or in any such pharmacopoeia or official compendium of drug standards recognized under the Rules.]
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1. Subs. by notification No. F.1-6/62-D(S.O.2889),, dt. 2.7.1969.
2. Subs. (4) omitted by G.S.R. 462 (E), dt. 22-1-1982.
3. Sub-rule (5) re-numbered as sub-Rule (4), by G.S.R. 462 (E), dt. 22-6-1982.
4. Ins. by G.S.R. 462 (E), dt. 22-6-1982.
5. Rules 98, 99,100 and 101 omitted, by G.S.R. 462 (E), dt. 22-6-1982.
6. Sub. by F. No. F1-3/51-DS, dt. 15.10.1954.
7. Sub-rule (1) omitted by S.O. 2136, dt. 15.6.1957.
8. Sub. by S.O. 2136, dt. 15.6.1957.
9. Sub. by G.S.R. 19, dt. 15.12.1977.
10. Ins. by G.S.R. 128 (E), dt. 17.1.2012.
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1[104A. Prohibition against altering inscriptions on containers, labels or wrappers of drug.– No person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any drug:
Provided that nothing in this rule shall apply to any alteration, any inscription or mark made on the container, label or wrapper of any drug at the instance or direction or with the permission of the Licensing Authority.]
2[105. Packing of drugs.–(1) The pack sizes of drugs meant for retail sale shall be as prescribed in Schedule P1 to these rules.
(2) The pack sizes of drugs not covered by Schedule P-1 shall be as given below: –
Unless specified otherwise in Schedule P-1,
(i) The pack sizes for Tablets/Capsules shall be–
Where the number of Tablets (coated or uncoated)/Capsules (hard or soft gelatin) is less than 10, such packing shall be made by the integral number. For numbers above 10, the pack size of Tablets/Capsules shall contain multiples of 5.
(ii) The pack sizes for liquid Oral preparations shall be 30 ml (paediatric only)/60 ml/100 ml/200 ml/450 ml.
(iii) The pack sizes for Paediatric Oral Drops shall be 5 ml/10 ml/15 ml.
(iv) The pack sizes for Eye/Ear/Nasal drops shall be 3 ml/5 ml/10 ml.
(v) The pack size for Eye Ointment shall be 3 gm/5 gm/ 10 gm:
Provided that the provisions of the pack sizes covered under this rule shall not apply to: –
1. Pack sizes or dosage forms not covered by the foregoing provisions of this rule.
2. The imported formulations in finished form.
3. Preparations intended for Veterinary use.
4 Preparations intended for Export.
5. Vitamins/Tonics/Cough Preparations/Antacids/Laxatives in Liquid Oral forms, Unit dose (including applicaps).
6. Pack sizes of dosage forms meant for retail sale to Hospitals, Registered Medical Practitioners, Nursing Homes.
7. Physician‘s Samples.
8. Pack sizes of large volume Intravenous Fluids:
4[Provided further that] pack sizes of any of the new drug as and when approved by the Licensing Authority appointed under Rule 21 and if not covered under this rule, shall be examined for the purpose of approval with specific justification by the said Licensing Authority:
3[4[Provided also that] Oxytocin injection meant for sale shall be in single unit blister pack only:]
5[Provided also that Diclofenac injection for human use shall be in single unit dose pack only.]
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1. Ins. by G.S.R. 1242 (E), dt. 17-9-1979.
2. Ins. by G.S.R. 796 (E), dt. 1-10-1992.
3. Sub. by G.S.R. 242 (E), dt. 3-4-2001.
4. Sub. by G.S.R. 558 (E), dt. 17-7-2015.
5. Ins. by G.S.R. 558 (E), dt. 17-7-2015.
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1[105A. Packings of drugs specified in Schedule X.- The drugs specified in Schedule X shall be marketed in packings not exceeding-
(i) 100 unit doses in the case of tablets/capsules;
(ii) 300 ml in the case of oral liquid preparations; and
(iii) 5 ml in the case of injections:
Provided that nothing in this rule shall apply to packing meant for use of a hospital or a dispensary subject to the conditions that–
(i) such supplies are made by the manufacturers or distributors direct to the hospital/dispensaries; and
(ii) hospital packs shall not be supplied to a retail dealer or to a Registered Medical Practitioner.]
2[106. Diseases which a drug may not purport to prevent or cure.— (1) No drug may purport or claim to prevent or cure or may convey to the intending user thereof any idea that it may prevent or cure one or more of the diseases or ailments specified in Schedule J.
(2) No drug may purport or claim to procure or assist to procure, or may convey to the intending user thereof any idea that it may procure or assist to procure, miscarriage in women.
3[* * * *]
4[PART IXA
LABELLING AND PACKINGOF HOMOEOPATHIC MEDICINES
106-A. Manner of labelling of Homoeopathic medicines.— (A) The following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any Homoeopathic medicine and on every other covering in which the container is packed—
(i) The words ‘Homoeopathic medicine‘,
(ii) The name of the medicine—
5[(a) For drugs specified in the Homoeopathic Pharmacopoeias of India or the United States of America or the United Kingdom, or the German Homoeopathic Pharmacopoeia, the name specified in that Pharmacopoeia.]
(b) For other drugs, the name descriptive of the true nature of the drugs.
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1. Ins. by G.S.R. 462 (E), dt. 22-6-1982.
2. Sub. by notification F. 1-16/52-DC (SO 2122), dt. 22-6-1954.
3. Omitted by G.S.R. 462(E), dt. 22.6.1982.
4. Ins. by G.S.R. 1185 (E), dt. 18.8.1964.
5. Subs. by G.S.R. 680 (E), dt. 5-12-1980.
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(iii) The potency of the Homoeopathic medicine—For this purpose the potency shall be expressed either in decimal, centesimal or millisimal systems.
1[(iiiA) In case of Homoeopathic medicine containing two or more ingredients the name of each ingredient together with its potency and proportion expressed in metric system shall be stated on the label.]
2[(iv) Name and address of the manufacturer when sold in original containers of the manufacturer. In case a Homoeopathic medicine is sold in a container other than that of the manufacturer—the name and address of the seller:]
5[Provided that where such medicines are imported, the name and address of the importer shall also be mentioned on the label.]
(v) In case the Homoeopathic medicine contains alcohol, the alcohol content in percentage by volume in terms of ethyl alcohol shall be stated on the label:
3[Provided that in case the total quantity of the pharmacopoeial homoeopathic medicine in the container is 30 millilitres or less, it will not be necessary to state the content of alcohol on the label.]
(B) In addition to the above particulars the label of a Homoeopathic mother tincture shall display the following particulars: −
(i) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figures representing the batch number being preceded by the words “Batch No.” or “Batch” or “Lot Number” or “Lot No.” or “Lot” or any distinguishing prefix.
(ii) Manufacturing licence number, the number being preceded by the words “Manufacturing Licence Number” or “Mfg. Lic. No.” or “M.L.”.
4[Explanation.− This clause shall not apply to a Homoeopathic mother tincture manufactured outside India.
(C) No Homoeopathic medicine containing a single ingredient shall bear a proprietary name on its label.]
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1. Subs. by G.S.R. 466 (E), dt. 17-5-1994.
2. Sub. by notification F.1-59/68-D, dt. 19-11-1969.
3. Subs. by G.S.R. 108 (E), dt. 22-2-1994.
4. Ins. by S.O. 2139, dt. 12-8-1972.
5. Ins. by G.S.R. 263 (E), dt. 20-4-2009.
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1[106-B. Prohibition of quantity and percentage.– No Homoeopathic medicine containing more than 12% alcohol v/v (Ethyl alcohol) shall be packed and sold in packing or bottles of more than 30 millilitres, except that it may be sold to hospitals/dispensaries in packings or bottles of not more than 100 millilitres.]
PART X
SPECIAL PROVISIONS RELATING TOBIOLOGICAL AND OTHER SPECIAL PRODUCTS
2[107. Name of substance.— If any substance specified in Schedule C is advertised or sold as a proprietary medicine or is contained in a medicine so advertised or sold, the proper name of the substance shall appear on the label in the manner prescribed in this Part.
3[Explanation.− For the purpose of this rule the expression “proper name” means the proper name stated in Schedule F or if no such name is stated, the name descriptive of the true nature and origin of the substance:
Provided that in the case of veterinary biological product the expression “proper name” means the proper name stated in Schedule F (1) or if no such name is stated, the name or synonym given in the current edition for the time being of the 4[British Pharmacopoea (Veterinary)] , or, if no such name is stated either in Schedule F (1) or the 4[British Pharmacopoea (Veterinary)], the name descriptive of the true nature and origin of the substance approved by the Licensing Authority.
108. Container.— 5[(1) No substance specified in Schedule C shall be sold or offered for sale unless it has been sealed in a previously sterilized container made of glass or any other suitable material approved for the purpose by the Licensing Authority appointed under rule 21, in such manner as may, in the opinion of the Licensing Authority, suffice to preclude the access of bacteria:
Provided that it shall not be necessary to use a previously sterilized container if the filled and sealed container is to be sterilized after the sealing and such sterilizing procedure would render the product sterile. However, the Licensing Authority may, for any special reasons, direct the licensee to pre-sterile such containers.]
(2) When any such substance is issued in liquid form in containers which are sealed in such a manner that portions of the contents can be withdrawn for use on different occasions, the liquid shall contain a sufficient proportion of some antiseptic to prevent the growth of any organism which may be accidentally introduced in the process of removing a portion of the contents of the container:
6[Provided that nothing in this sub-rule shall apply to a penicillin suspension in oil and wax.]
___
1. Ins. by G.S.R. 108 (E), dt. 22-2-1994.
2. Subs. by F. 1-5/47-D (SRO 2889), dt. 25-11-1949.
3. Subs. by F. 1-6/62-D, dt. 2-7-1969.
4. Subs. by G.S.R.647 (E), dt. 28-10-1998.
5. Subs. by G.S.R. 245, dt. 21-2-1976.
6. Ins. by SO 115, dt. 04-1-1961.
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1[(3) The container shall comply with such further requirements, if any, as are specified in Schedule F or Schedule F (1) as the case may be, in that behalf.
(4) The Licensing Authority may in the case of any particular preparation of any such substance dispense with any of the requirements of this Rule or Schedule F or Schedule F (1) as the case may be, and may make such additional requirements, as having regard to the nature of the preparation, they may deem necessary.]
2[109. Labelling.– (1) The following particulars and such further particulars, if any, as are specified in Schedule F or Schedule F (1), as the case may be, shall be printed or written in indelible ink on the label of every phial, ampoule or other container of a substance specified in Schedule C and on every other covering in which such phial, ampoule or container is packed—
(a) where a drug is imported, the number of licence under which it is imported, preceded by the words ‘Import Licence‘:
Provided that no reference shall be made to any other import licence number granted by any authority outside India on any label or container or in any covering in which the container is packed or in any other matter of advertisement enclosed therein;
(b) where a test for potency in units is required by these rules, a statement of the potency in units defined in terms of relation to the standard preparation specified in Schedule F or F (1), as the case may be :
Provided that this clause shall not apply in the case of vaccine lymph;
(c) where a test for potency or maximum toxicity is required the date upto which the substance if kept under suitable conditions may be expected to retain a potency not less than stated on the label of the container or not to acquire a toxicity greater than that permitted by the test, as the case may be. The date of expiry shall be in terms of month and year and it shall mean that the drug is recommended for use till the last day of the month. The date of expiry shall be preceded by the words ‘Expiry date‘ :
Provided that nothing in these rules shall be deemed to require the labelling of any transparent cover or any wrapper, case or other covering used solely for the purpose of packing, transport or delivery.
(2) The particulars prescribed in clause (a) of the preceding sub-rule shall be printed or written in indelible ink either on the label borne by a container of vaccine lymph or on a label or wrapper affixed to any package in which the container is issued for sale. The said particulars shall be indelibly marked on the sealed container of surgical ligature or suture or printed or written in indelible ink on a label enclosed therein.
___
1. Subs. by F.1-6/62-D (SO 2889), dt. 2-7-1969.
2. Subs. by G.S.R.19, dt. 15-12-1977.
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(3) The following particulars, and such further particulars, if any, as are specified in Schedule F or Schedule F (1), as the case may be, shall be printed or written in indelible ink either on the label borne by the container of any substance specified in Schedule C or on a label or wrapper affixed to any package in which any such container is issued for sale, namely:–
(a) the date on which the manufacture of the particular batch from which the substance in the container is taken was completed as defined in Schedule F or Schedule F(1), or if there is no definition in Schedule F or Schedule F(1) as hereafter defined in this rule and in the case of vaccine prepared from concentrates, the date of completion of the final products and the bottling for issue;
(b) where an antiseptic substance has been added, the nature and the percentage proportion introduced;
(c) the precaution necessary for preserving the properties of the contents up to the date indicated in clause (c) of sub-rule (1).
(4) For the purpose of clause (a) of sub-rule (3), the date on which the manufacture of a batch is completed shall be—
(a) in cases where a test for potency or toxicity is required by these rules or not being so required, is accepted by the Licensing Authority as sufficient for the purpose of fixing the date of completion of manufacture, the date on which the substance was removed from cold storage after having been kept at a temperature not exceeding 5° C continuously for a period not exceeding two years from the time when the last test was completed,
(b) in cases where no such test is required or accepted−
(i) if the substance is a serum obtained from a living animal, the earliest date on which any material contributing to the batch was removed from the animal;
(ii) if the substance was obtained by the growth of organisms or artificial media, the earliest date on which growth was terminated in any of the material contributing to the batch:
Provided that if a batch of the substance (including all material contributing to this batch) has for a period of not more than three years been kept in cold storage at a temperature not exceeding 5°C continuously from the earliest practicable date after that on which growth was terminated in the material as the case may be, the date of removal from cold storage shall be treated as the date on which the manufacture of the batch is completed;
(c) in all other cases, the date on which the substance is filled in the container.
1[109-A. Labelling of Medical Devices.– Subject to the other provisions of these rules, the following particulars shall be printed in indelible ink on the label or sticker on the shelf pack of the medical device or on the outer cover of such medical device and on every outer covering in which the medical device is packed, namely:––
(a) proper name of the medical device;
(b) the details necessary for the user to identify the device and its use;
(c) the name of the manufacturer and address of the manufacturing premises where the device has been manufactured;
(d) the correct statement of the net quantity in terms of weight, measure, volume, number of units, as the case may be, and the number of the devices contained in the package shall be expressed in metric system; and
(e) the date of manufacture and date of expiry; alternately the label shall bear the shelf life of the product:
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1. Sub. by G.S.R. 690 (E), dt. 25-9-2014. Earlier Ins. by G.S.R. 109 (E), dt. 22-2-1994.
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Provided that in the case of sterile devices the date of sterilisation may be given as date of the manufacture of the device:
Provided further that the device is made up of stable materials such as stainless steel or titanium, and supplied non-sterile, date of expiry may not be necessary;
(f) to provide, wherever required, an indication that the device contains medicinal or biological substance;
(g) to provide, a distinctive batch number or lot number preceded by the word “Lot No.” or “Lot” or “Batch No.” or “B. No.”;
(h) to indicate, wherever required, any special storage or handling conditions applicable to the device;
(i) to indicate, if the device is supplied as a sterile product, its sterile state and the sterilisation method;
(j) to give, if considered relevant, warnings or precautions for the attention of the user of the medical device;
(k) to label the device, if the device is intended for single use;
(l) to overprint on the label of the container, the words “FOR CLINICAL INVESTIGATION ONLY”, if the device is intended for clinical investigation;
(m) to overprint on the label of the device, the words “Physician‘s Sample—Not to be sold”, if a medical device is intended for distribution to the medical professional as a free sample;
(n) to provide, except for imported devices, the manufacturing licence number by preceding the words “Manufacturing Licence Number” or “Mfg. Lic. No.” or “M. L”;
(o) Devices or In-vitro diagnostics which are not sold to customer or patient directly and are sold for use by hospitals or diagnostic labs shall provide the information affixing additional label or sticker on outer shelf pack;
(p) to provide on the label, in case of imported devices, with the approval of the licensing authority mentioned in rule 21, the import licence number, name and address of the importer and address of the actual manufacturing premises, date of manufacture, (if not already printed at the time of import):
Provided that the label may bear symbols recognised by the Bureau of Indian Standards or International Organisation for Standardisation (ISO) in lieu of text and the device safety is not compromised by a lack of understanding on the part of the user in case the meaning of the symbol is not obvious to the device user.]
1[109B. Exemption of certain labelling requirements for medical devices for export from India.–– The labels on packages or container of devices for export shall be adopted to meet specific requirements of the law of the country to which the device is to be exported, but the following particulars shall appear in conspicuous manner on the label of the shelf pack of the medical device in which the device is packed and every other outer covering in which the container is packed-
(a) name of the Device;
(b) the distinctive batch number or lot number preceded by the word “Lot No.” or “Lot” or “Batch No.” or “B.No.”;
(c) the date of expiry, if any;
(d) the name and address of the manufacturer and address of actual premises where the device has been manufactured;
(e) the manufacturing Licence No. preceded by the letters “M.L. No” or “Manufacturing Licence No”;
(f) the internationally recognised symbols in lieu of text, wherever required:
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1. Ins. by G.S.R. 690 (E), dt. 25-9-2014.
___
Provided that where a device is required by the consignee not to be labeled with the name and address of the manufacturer, the label on the packages or container shall bear a code number as approved by the licensing authority and the code number shall bear the name of the State or Union territory, in abbreviation, followed by the word “Device” and “manufacturing licence number:
Provided further that where a device is required by the consignee not to be labeled with the code number also, the label on the packages or container shall bear a special code number, as requested by the consignee, and approved by the licensing authority under rule 21.]
1[109C. Shelf life of the medical devices.–– The shelf life of the medical devices shall not exceed sixty months from the date of manufacture:
Provided that this period may be extended by the licensing authority, in respect of any specified medical device, if satisfactory evidence is produced by the manufacturer to justify such an extension.]
110. Prohibition of sale of substance after prescribed date.– No person shall sell, or exhibit for sale any substance specified in Schedule C after the date recorded on the container, label or wrapper as the date upto which the substance may be expected to retain a potency not less than, or not to acquire a toxicity greater than that required or permitted by the prescribed test as the case may be.
2 [* * * * *]
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1. Ins. by G.S.R. 109 (E), dt. 22-2-1994.
2. Rule 110A omitted by G.S.R. 1242(E), dt. 17.9.1979.
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1[111. Standards.– Every substance specified in Schedules C and C (1) intended for sale shall conform with the standards of strength, quality and purity specified in these Rules and in Schedule F or F(1), as the case may be, and the tests for determining such conformity shall be applied to samples taken from the final product after every manufacturing process has been completed.]
2[112. Tests for strength and quality.– The tests, if any, required for determining the strength and quality of each of the substances specified in Schedules C and C (1) shall be those set out in Schedule F or Schedule F (1) 4[or as specified, as the case may be].]
3[* * * * *]
115. Application of tests for sterility.– The tests shall be applied−
(a) to samples taken from each batch of the substance before the operation of filling and sealing the containers in which it is to be issued has commenced except preparations, which after being sealed in the containers are to be sterilized by heat, in a manner satisfactory to the Licensing Authority; and
(b) to the contents of sample containers when ready for issue.
4[ * * * * *]
119.− (1) If at this examination no growth of micro-organisms is found in any tube, the sample may be treated as having passed the test.
(2) If at the examination a growth of micro-organisms is visible, further samples may be taken and the tests may be repeated on the further samples taken; but no container the contents of which form part of the batch shall be issued until such further samples have passed the test. The process of taking samples from the batch for a test may be repeated twice:
Provided that if the same organism is visible in more than one test the batch shall be treated as not sterile and the material contained in the batch shall not be issued or used as part of a further batch unless and until it has been re-sterilized and has passed the tests.
120. −Notwithstanding anything contained in the last preceding rule, in any case where—
(a) a substance is required in an emergency by a registered medical practitioner, but the licensee has no filled containers in stock; or
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1. Amended by F.1-6/62-D (SO 2889), dt. 2-7-1969.
2 Subs. by G.S.R. 663(E), dt. 3.7.1992.
3. Rules 113 and 114 omitted by G.S.R. 663(E),dt. 3.7.1992.
4. Rules 116, 117 and 118 omitted by G.S.R. 663 (E), dt. 3-7-1992.
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(b) a substance which in the opinion of the Licensing Authority is so unstable in solution that the delay occasioned by the completing of the sterility test on filled containers would render its issue in active form impossible, the licensee may issue the substance from a batch which has already passed the tests for sterility and freedom from abnormal toxicity, without completing the sterility test on the filled containers, provided that he complies with the following conditions—
(i) the licensee shall before the issue take samples in the required proportion from the containers into which the batch is filled, and after the required inoculation shall examine the tube every day for five days;
(ii) if at any examination any growth is visible in any of the tubes, he shall immediately notify the Licensing Authority;
(iii) he shall keep available for inspection a record of all issues made under this Rule containing such particulars of the circumstances in which the issue is made as the Licensing Authority may require.
1[121. Test for freedom from abnormal toxicity.– The test for freedom from abnormal toxicity shall be carried out as per the current edition of Indian Pharmacopoeia in the case of each batch of the serum tested by the licensee or by an institution approved by the Licensing Authority for the purpose of carrying out the test on its behalf.]
2[121A. Test for pyrogens– Solution of substances intended for parenteral administration in large volumes (10 ml or more at a time) shall be pyrogen-free and tested for pyrogens. If water or any other aqueous solvent is supplied along with the substances for preparing such solutions, it shall also be pyrogen-free and tested for pyrogens.]
122. Substances specified in Schedule C(1).– The following provisions shall apply in the case of a substance specified in Schedule C (1): –
3[(a) The container shall comply with the requirements, if any, specified in Schedule F or Schedule F (1) 4[or as specified], as the case may be.]
5 [* * * * *]
(c) The substance shall conform to the standards of strength, quality and purity specified in Schedule F or Schedule F (1) 4[or as specified], as the case may be and the tests for determining the strength, quality and purity of the substance shall be those specified in Schedule F or Schedule F (1) 4[or as specified,] as the case may be.
(d) The tests for determining the strength, quality and purity of a substance specified in Schedule F or Schedule F (1) 3[or as specified] as the case may be shall be applied to samples taken from the final product after each manufacturing process has been completed.
(e) The substance should be stored in a cool place and away from light.
___
1. Subs. by G.S.R. 834 (E), dt. 29-12-1999.
2. Subs. by SO 1449, dt. 13-06-1961. Earlier Ins. by F.1-27/56-D, dt. 18-12-1956
3. Subs. by F.1-6/62-D, dt. 2-7-1969
4. Subs. by G.S.R. 663 (E), dt. 3-7-1992
5. Omitted by G.S.R. 19, dt. 15.12.1977.
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1[PART X A.
IMPORT OF MANUFACTURE OFNEW DRUG FOR CLINICAL TRIALS OR MARKETING
122-A. Application for permission to import new drug.- 2[(1) (a) No new drug shall be imported, except under, and in accordance with, the permission granted by the Licensing Authority as defined in clause (b) of rule 21.
(b) An application for the grant of permission to import a new drug shall be made in Form 44 to the Licensing Authority, accompanied by a fee of fifty thousand rupees:
Provided that where a subsequent application by the same applicant for that drug, whether in modified dosage form or with new claims, is made, the fee to accompany such application shall be fifteen thousand rupees.
Provided further that any application received after one year of the grant of approval for the import and sale of new drug, shall be accompanied by a fee of fifteen thousand rupees and such information and data as required by 3[Appendix I or Appendix IA or Appendix IB] of Schedule Y, as the case may be].
(2) The importer of a new drug when applying for permission under sub-rule (1), shall submit data as given in 3[Appendix I or Appendix IA or Appendix IB] to Schedule Y including the results of local clinical trials carried out in accordance with the guidelines specified in that Schedule and submit the report of such clinical trials in the format given in appendix II to the said Schedule:
Provided that the requirement of submitting the results of local clinical trials may not be necessary if the drug is of such a nature that the Licensing Authority may, in public interest, decide to grant such permission on the basis of data available from other countries:
Provided further that the submission of requirements relating to Animal Toxicology, Reproduction studies, Teratogenic studies, Perinatal studies, Mutagenicity and Carcinogenicity may be modified or relaxed in case of new drugs approved and marketed for several years in other countries if he is satisfied that there is adequate published evidence regarding the safety of the drug, subject to the other provisions of these rules.
2[(3) The Licensing Authority, after being satisfied that the drug if permitted to be imported as raw material (bulk drug substance) or as finished formulation shall be effective and safe for use in the country, may issue an import permission in Form 45 and/or Form 45- A, subject to the conditions stated therein:
Provided that the Licensing Authority shall, where the data provided or generated on the drug is inadequate, intimate the applicant in writing, and the conditions, which shall be satisfied before permission could be considered.]
122-B. Application for approval to manufacture new drug 4[***].- 2[(1)(a) No new drug shall be manufactured for sale unless it is approved by the Licensing Authority as defined in clause (b) of rule 21.
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1. Ins. by G.S.R. 944 (E), dt. 21-9-1988.
2. Subs. by G.S.R. 900 (E), dt. 12.12.2001.
3. Subs. by G.S.R. 918 (E), dt. 30.11.2005.
4. Omitted by G.S.R. 26 (E), dt. 19.01.2006.
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(b) An application for the grant of approval to manufacture the new drug and its formulations shall be made in Form 44 to the Licensing Authority as defined in clause (b) of Rule 21 and shall be accompanied by a fee of fifty thousand rupees:
Provided that where the application is for permission to import a new drug (bulk drug substance) and grant of approval to manufacture its formulation/s, the fee to accompany such application shall be fifty thousand rupees only.
Provided further that where a subsequent application by the same applicant for that drug, whether in modified dosage form or with the new claims, is made, the fee to accompany such subsequent application shall be fifteen thousand rupees:
Provided also that any application received after one year of the grant of approval for the manufacture for sale of the new drug, shall be accompanied by a fee of fifteen thousand rupees and such information and data as required by 4[Appendix 1 or Appendix 1A or Appendix IB] of Schedule Y, as the case may be.]
(2) The manufacturer of a new drug under sub-rule (1) when applying for approval to the Licensing Authority mentioned in the said sub-rule, shall submit data as given in 4[Appendix 1 or Appendix 1A or Appendix IB] to Schedule Y including the results of clinical trials carried out in the country in accordance with the guideline specified in Schedule Y and submit the report of such clinical trials in the same format given in Appendix II to the said Schedule.
1[(2A) The Licensing authority as defined in clause (b) of rule 21 after being satisfied that the drug if approved to be manufactured as raw material (bulk drug substance) or as finished formulation shall be effective and safe for use in the country, shall issue approval in Form 46 and/or Form 46A, as the case may be, subject to the conditions stated therein:
Provided that the Licensing Authority shall, where the data provided or generated on the drug is inadequate, intimate the applicant in writing, and the conditions, which shall be satisfied before permission could be considered.]
(3) When applying for approval to manufacture a new drug under sub-rule (1) or its preparations, to the State Licensing Authority, an applicant shall produce along with his application, evidence that the drug for the manufacture of which application is made has already been approved 5[in the name of the applicant] by the Licensing Authority mentioned in Rule 21:
Provided that the requirement of submitting the results of local clinical trials may not be necessary if the drug is of such nature that the 6[Licensing Authority in Rule 21] may, in public interest, decide to grant such permission on the basis of data available from other countries:
Provided further that the submission of requirements relating to Animal Toxicology, Reproduction studies, Teratogenic studies, Perinatal studies, Mutagenicity and Carnicogenicity may be modified or relaxed in case of new drugs approved and marketed for several years in other countries if he is satisfied that there is adequate published evidence regarding the safety of the drug, subject to the other provisions of these rules.
2 [* * * * *]
3[122D. Permission to import or manufacture fixed dose combination.- (1) An application for permission to import or manufacture fixed dose combination of two or more drugs as defined in clause (c) of rule 122-E shall be made to the Licensing Authority as defined in clause (b) of Rule 21 in Form 44, accompanied by a fee of fifteen thousand rupees and shall be accompanied by such information and data as is required in Appendix VI of Schedule Y.
___
1. Ins. by G.S.R. 900(E), dt. 12-12-2001.
2. Rules 122-C omitted, by G.S.R. 900(E), dt. 12-12-2001. 3. Subs. by G.S.R. 900(E), dt. 12-12-2001.
4. Subs. by G.S.R. 918(E), dt. 30-11-2015.
5. Ins. by G.S.R. 26 (E), dt. 19-01-2006.
6. Subs. by G.S.R. 26 (E), dt. 19-01-2006.
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(2) The Licensing Authority after being satisfied that the fixed dose combination if approved to be imported or manufactured as finished formulation shall be effective and safe for use in the country, shall issue permission in Form 45 or Form 46, as the case may be, subject to the conditions stated therein:
Provided that the Licensing Authority shall, where the data provided or generated on the fixed dose combination is inadequate, intimate the applicant in writing, and the conditions which shall be satisfied before grant of approval/permission could be considered.
122DA. Application for permission to conduct clinical trials for New Drug/Investigational New Drug.− (1) No clinical trial for a new drug, whether for clinical investigation or any clinical experiment by any institution, shall be conducted except under, and in accordance with, the permission, in writing, of the Licensing Authority defined in clause (b) of Rule 21.
(2) An application for grant of permission to conduct−
(a) human clinical trials (Phase-I) on a new drug shall be made to the Licensing Authority in Form 44 accompanied by a fee of fifty thousand rupees and such information and data as required under Schedule Y.
(b) exploratory clinical trials (Phase-II) on a new drug shall be made on the basis of data emerging from Phase-I trial, accompanied by a fee of twenty-five thousand rupees;
(c) confirmatory clinical trials (Phase-III) on a new drug shall be made on the basis of the data emerging from Phase-II and where necessary, data emerging from Phase-I also, and shall be accompanied by a fee of twenty-five thousand rupees:
Provided that no separate fee shall be required to be paid along with application for import/manufacture of a new drug based on successful completion of phases clinical trials by the applicant:
Provided further that no fee shall be required to be paid along with the application by Central Government or State Government Institutes involved in clinical research for conducting trials for academic or research purposes.
(3) The Licensing Authority after being satisfied with the clinical trials, shall grant permission in Form 45 or Form 45-A or Form 46 or Form 46-A, as the case may be, subject to the conditions stated therein:
Provided that the Licensing Authority shall, where the data provided on the clinical trials is inadequate, intimate the applicant in writing, within six months from the date of such intimation or such extended period, not exceeding a further period of six months, as the Licensing Authority may, for reasons to be recorded in writing, permit, intimating the conditions which shall be satisfied before permission could be considered.
1[(4) No permission for conduct of clinical trial intended for academic purposes in respect of approved drug formulation shall be required for any new indication or new route of administration or new dose or new dosage form where,-
(a) the trial is approved by the Ethics Committee; and
(b) subject to the provisions of sub-rule 5, the data generated is not intended for submission to licensing authority.
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1. Ins. by G.S.R. 313(E), dt. 16-03-2016.
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(5) The Ethics Committee shall however inform the licensing authority about the cases approved by it and also about cases where there could be an overlap between the clinical trial for academic and regulatory purposes and where the said authority does not convey its comments to the Ethics Committee within a period of thirty days from the date of receipt of communication from the Ethics Committee, it shall be presumed that no permission from the licensing authority is required.]
1[Explanation:- For the purposes of these rules,—
(a) “Clinical Trial” means a systematic study of any new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic), and/or adverse effects with the objective of determining safety and/or efficacy of the new drug;
(b) “Global Clinical Trial” means any clinical trial which is conducted as part of multi- national clinical development of a drug;
(c) “Investigational New Drug” means a new chemical entity or a product having therapeutic indication but which has never been tested earlier on human being;
(d) “New Chemical Entity” means an active substances in developmental stage which may be specified as a drug under the Act, after undergoing any clinical trial.]
2[****]
3[122-DAB- Compensation in case of injury or death during clinical trial.-
4[(1) In case of an injury occurring to the subject during the clinical trial, free medical management shall be given as long as required or till such time it is established that the injury is not related to the clinical trial, whichever is earlier.]
(2) In case, the injury occurring to the trial subject is related to the clinical trial, such subject shall also be entitled for financial compensation as per order of the Licensing Authority defined under clause (b) of Rule 21, and the financial compensation will be over and above any expenses incurred on the medical management of the subject.
5[(2A) In case, there is no permanent injury, the quantum of compensation shall be commensurate with the nature of the non-permanent injury and loss of wages of the subject.]
(3) In the case of clinical trial related death of the subject, his / her nominee(s) would be entitled for financial compensation, as per the order of the Licensing Authority defined under clause (b) of Rule 21 and the financial compensation will be over and above any expenses incurred on the medical management of such subject.
(4) The expenses on medical management and financial compensation in the case of clinical trial injury or death of the trial subject shall be borne by the sponsor of the clinical trial.
(5) Any injury or death of the subject occurring in clinical trial due to following reasons shall be considered as clinical trial related injury or death and the subject or his/her nominees(s), as the case may be, are entitled for financial compensation for such injury or death:
(a) Adverse effect of investigational product(s);
(b) Violation of the approved protocol, scientific misconduct or negligence by the sponsor or his representative or the investigator;
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1. Subs. by G.S.R. 826 (E), dt. 30-10-2015 with following explanation.
“Explanation.−For the purpose of these rules Investigational New Drug means a new chemical entity or a product having therapeutic indication but which have never been earlier tested on human beings.”
2. Omitted rule 122DAA by G.S.R. 826 (E), dt. 30-10-2015, before omission it stood as under:
“122DAA. Definition of Clinical trial.–For the purpose of this Part, “Clinical trial” means a systematic study of new drug(s) in human subject(s) to generate data for discovering and/or verifying the clinical, pharmacological (including pharmacodynamic and pharmacokinetic) and/or adverse effects with the objective of determining safety and / or efficacy of the new drug.”
3. Ins. by G.S.R. 53 (E), dt. 30-01-2013.
4. Subs. by G.S.R. 889 (E), dt. 12-12-2014.
5. Ins. by G.S.R. 889 (E), dt. 12-12-2014.
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(c) Failure of investigational product to provide intended therapeutic effect, where, the standard care, though available, was not provided to the subject as per the clinical trial protocol;
(d) Use of placebo in a placebo-controlled trial where, the standard care, though available, was not provided to the subject as per the clinical trial protocol;
(e) Adverse effects due to concomitant medication excluding standard care, necessitated as part of approved protocol;
(f) For injury to a child in-utero because of the participation of parent in clinical trail;
(g) Any clinical trial procedures involved in the study.
(6) The sponsor, whether a pharmaceutical company or an institution shall give an undertaking along with the application for clinical trail permission to the Licensing Authority defined in clause (b) of Rule 21, to provide compensation in the case of clinical trial related injury or death for which subjects are entitled to compensation.
(7) In case, the sponsor fails to provide medical management for the injury to the subject and / or financial compensation to the trial subject for clinical trial related injury or financial compensation to the subject‘s nominee(s) in case of clinical trial related death of the subject, the Licensing Authority may after giving an opportunity to show cause why such an order should not be passed, by an order in writing, stating the reasons thereof, suspend or cancel the clinical trial and / or restrict Sponsor including his representative(s) to conduct any further clinical trials in the country or take any other action deemed fit under the rules.]
1[122 DAC. Permission to conduct clinical trial:- (1) The Licensing Authority as defined in clause (b) of Rule 21, on being satisfied that the data submitted along with the application in support of the proposed clinical trial is adequate in all respects, issue permission for conduct of clinical trial, subject to the following conditions, namely:-
(a) Clinical trial shall be conducted in compliance with the approved protocols, requirements of Schedule Y annexed to these rules, Good Clinical Practice Guidelines for conduct of clinical trials in India and other applicable regulations;
(b) Approval of the Ethics Committee shall be obtained before initiation of the study;
(c) Clinical trial shall be registered at Clinical Trials Registry of India before enrolling the first patient for the study;
(d) Annual status report of each clinical trial, as to whether it is ongoing, completed or terminated, shall be submitted to the Licensing Authority and in case of termination of any clinical trial the detailed reasons for the same shall be communicated to the said Licensing Authority;
(e) Any report of serious adverse event occurring during clinical trial to the subject, after due analysis, shall be forwarded within ten days of its occurrence as per Appendix XI and in compliance with the procedures prescribed in Schedule Y;
(f) In case of an injury or death during the clinical trial to the subject of the clinical trial the applicant shall provide complete medical management and compensation in the case of trial related injury or death in accordance with Rule 122 DAB and the procedures prescribed under Schedule Y, and the details of compensation provided in such cases shall be intimated to the Licensing Authority within thirty days of the receipt of the order of the said authority;
(g) The premises of Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical trial sites shall be open to inspection by the officers authorized by the Central Drugs Standard Control Organization, who may be accompanied by an officer of the State Drug Control Authority concerned, to verify compliance to the requirements of Schedule Y, Good Clinical Practices guidelines for conduct of clinical trials in India and other applicable regulations;
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1. Ins. by G.S.R. 63 (E), dt. 01-02-2013.
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(h) The Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical trial sites and the investigator shall allow officers authorized by the Central Drug Standard Control Organization, who may be accompanied by an officer of the State Drug Control Authority concerned, to enter with or without prior notice, any premises of sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical trial sites to inspect, search and seize any record, data, document, books, investigational drugs etc. related to clinical trials and provide adequate replies to any queries raised by the inspecting authority in relation to the conduct of clinical trial;
(2) Notwithstanding the conditions specified in sub-Rule (1), the Licensing Authority, on being satisfied that the data submitted along with the application in support of the proposed clinical trial is adequate in all respect, may also impose such additional conditions for issuance of permission in respect of specific clinical trials, if considered necessary, regarding the objective, design, subject population, subject eligibility, assessments, conduct and treatment of such clinical trial.
(3) If any Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors, Investigators conducting clinical trial and clinical trial sites fail to comply with any of the above conditions, the Licensing Authority, may, after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons thereof,-
(a) Issue warning letter giving details of deficiency found during the inspection, which might affect the right or well-being of the clinical trial subject or the validity of the study conducted at that site;
(b) Recommend that study may be rejected or discontinued;
(c) Suspend or cancel the clinical trial permission;
(d) Debar the Investigator(s), Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors to conduct any clinical trial in future.
(4) The Sponsor including their employees, subsidiaries and branches, their agents, contractors and sub-contractors and clinical trial Investigators, against whom action as mentioned in sub- Rule (3) has been taken by the Licensing Authority, may, within ninety days of the receipt of the copy of the order of the Licensing Authority prefer an appeal to the Central Government, and the Central Government may, after giving such appellant an opportunity of being heard, confirm, reverse or modify such order.]
122DB. Suspension or cancellation of Permission/Approval.- If the importer or manufacturer under this Part fails to comply with any of the conditions of the permission or approval, the Licensing Authority may, after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel it.
122DC. Appeal.- Any person aggrieved by an order passed by the Licensing Authority under this Part, may within sixty days from the date of such order, appeal to the Central Government, and the Central Government may, after such enquiry into the matter as is considered necessary, pass such order in relation thereto as it thinks fit.
1[122 DD. Registration of Ethics Committee:- (1) No Ethics Committee shall review and accord its approval to a clinical trial protocol without prior registration with the Licensing Authority as defined in clause (b) of Rule21:
Provided that any Ethics Committee, existing on the date of commencement of the Drugs and Cosmetics (Third Amendment) Rules, 2013, who has already reviewed and accorded approval to clinical trial protocol, shall obtain registration within a period of forty- five days from the date of commencement of Drugs and Cosmetics (Third Amendment) Rules, 2013.
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1. Ins. by G.S.R. 72 (E), dt. 08-02-2013.
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(2) An application for registration of Ethics Committee shall be made to the Licensing Authority in accordance with the requirements as specified in the Appendix VIII of Schedule Y.
(3) The Licensing Authority after being satisfied that the requirements have been complied with, may grant registration to the Ethics Committee subject to such conditions as may be stated therein.
(4) The Ethics Committee shall review and accord its approval to a clinical trial and also carry ongoing review of the trial at appropriate intervals, as specified in Schedule Y, and the Good Clinical Practice Guidelines for Clinical Trials in India and other applicable regulatory requirements for safeguarding the rights, safety and well-being of the trial subjects.
(5) In the case of any serious adverse event occurring to the clinical trial subjects during the clinical trial, the Ethics Committee shall analyze and forward its opinion as per procedure specified under APPENDIX XII of Schedule Y.
(6) The Ethics Committee shall allow inspectors or officials authorized by the Central Drugs Standard Control Organization to enter its premises to inspect any record, data or any document related to clinical trial and provide adequate replies to any query raised by such inspectors or officials, as the case may be in relation to the conduct of clinical trial.
(7) The registration, unless it is suspended or cancelled, shall be valid for a period of three years from the date of issue:
Provided that if the application for re-registration is received by the Licensing Authority within three months before the expiry, the registration shall continue to be in force until orders are passed by the said authority:
Provided further that the Licensing Authority shall be informed in writing in case of any change in the membership or the constitution of the Ethics Committee takes place.
(8) If the Licensing Authority is not satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and the conditions which must be satisfied before the registration can be granted.
(9) If the Ethics Committee fails to comply with any of the conditions of registration, the Licensing Authority may, after giving an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, suspend or cancel the registration of the Ethics Committee for such period as considered necessary.
(10) The Ethics Committee whose registration has been suspended or cancelled by the Licensing Authority, may, within ninety days of the receipt of the copy of the order, prefer an appeal to the Central Government and the Central Government may after giving an opportunity of being heard, confirm, reverse or modify such order.
Explanation:- For the purpose of this Rule an Ethics Committee is a committee comprising of medical, scientific, non-medical and nonscientific members, whose responsibility is to ensure the protection of the rights, safety and will-being of human subjects involved in a clinical trial and it shall be responsible for reviewing and approving the protocol, the suitability of the investigators, facilities, methods and adequacy of information to be used for obtaining and documenting informed consent of the study subjects and adequacy of confidentiality safeguards.]
122E. Definition of new drug.- For the purpose of this Part, new drug shall mean and include-
1[(a) A drug, as defined in the Act including bulk drug substance 2[or phytopharmaceutical drug] which has not been used in the country to any significant extent under the conditions prescribed, recommended or suggested in the labelling thereof and has not been recognized as effective and safe by the licensing authority mentioned under rule 21 for the proposed claims:
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1. Ins. by G.S.R. 591 (E), dt. 17-8-1999.
2. Ins. by G.S.R. 918 (E), dt. 30-11-2015.
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Provided that the limited use, if any, has been with the permission of the licensing authority.]
(b) A drug already approved by the Licensing Authority mentioned in Rule 21 for certain claims, which is now proposed to be marketed with modified or new claims, namely, indications, dosage, dosage form (including sustained release dosage form) and route of administration.
(c) A fixed dose combination of two or more drugs, individually approved earlier for certain claims, which are now proposed to be combined for the first time in a fixed ratio, or if the ratio of ingredients in an already marketed combination is proposed to be changed, with certain claims, viz. indications, dosage, dosage form (including sustained release dosage form) and route of administration. (See items (b) and (c) of Appendix VI to Schedule Y.)
Explanation.- For the purpose of this rule−
1[(i) all vaccines and Recombinant DNA (r-DNA) derived drugs shall be new drugs unless certified otherwise by the Licensing Authority under Rule 21;]
(ii) a new drug shall continue to be considered as new drug for a period of four years from the date of its first approval 2[***].]
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1. Ins. by G.S.R. 45(E), dt. 24.01.2011.
2. Omitted by G.S.R. 724(E), dt. 7.11.2013, the following words,-
“or its inclusion in the Indian Pharmacopoeia Whichever is earlier”.
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1[PART XB
REQUIREMENTS FOR THE COLLECTION, STORAGE, PROCESSING AND DISTRIBUTION OF WHOLE HUMAN BLOOD, HUMAN BLOOD COMPONENTS BY BLOOD BANKS ANDMANUFACTURE OF BLOOD PRODUCTS
2[122EA. Definitions.- (1) In this Part and in the Forms contained in Schedule A and in Part XII-B, 3[Part XII-C and Part XIID] of Schedule F, unless there is anything repugnant in the subject or context−
(a) “apheresis” means the process by which blood drawn from a donor, after separating plasma or platelets, or leucocytes, is re-transfused simultaneously into the said donor;
(b) “autologous blood” means the blood drawn from the patient for re-transfusion unto himself later on;
(c) “blood” means and includes whole human blood, drawn from a donor and mixed with an anti-coagulant;
(d) “blood bank” means a place or organization or unit or institution or other arrangements made by such organization, unit or institution for carrying out all or any of the operations for collection, apheresis, storage, processing and distribution of blood drawn from donors and/or for preparation, storage and distribution of blood components;
(e) “blood component” means a drug prepared, obtained, derived or separated from a unit of blood drawn from a donor;
(f) “blood product” means a drug manufactured or obtained from pooled plasma of blood by fractionation, drawn from donors;
4[(fa) “cord blood bank” means a place or organization or unit for carrying out and responsible for operations of collection, processing, testing, banking, selection and release of cord blood units;]
(g) “donor” means a person who voluntarily donates blood after he has been declared fit after a medical examination, for donating blood, on fulfilling the criteria given hereinafter, without accepting in return any consideration in cash or in kind from any source but does not include a professional or a paid donor.
Explanation.- For the purposes of this clause, benefits or incentives like pins, plaques, badges, medals, commendation certificates, time-off from work, membership of blood assurance programme, gifts of little or intrinsic monetary value shall not be construed as consideration;
(h) “leucapheresis” means the process by which the blood drawn from a donor, after leucocyte concentrates have been separarated is re-transfused simultaneously into the said donor;
(i) “plasmapheresis” means the process by which the blood drawn from a donor, after plasma has been separated, is re-transfused during the same sitting into the said donor;
(j) “plateletpheresis” means the process by which the blood drawn from a donor, after platelet concentrates have been separated, is re-transfused simultaneously into the said donor;
(k) “professional donor” means a person who donates blood for a valuable consideration, in cash or kind, from any source, on behalf of the recipient-patient and includes a paid donor or a commercial donor;
(l) “replacement donor” means a donor who is a family friend or a relative of the patient-recipient.]
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1. Ins. by G.S.R. 28(E), dt. 22-1-1993.
2. Ins. by G.S.R. 245 (E), dt. 5-04-1999.
3. Subs. by G.S.R. 899 (E), dt. 27-12-2011.
4. Ins. by G.S.R. 899 (E), dt. 27-12-2011.
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4[(m) “umbilical cord blood” is the whole blood including Hematopoietic Progenitor Cells collected from placental and or Umbilical cord blood vessels after the umbilical cord have been clamped.]
122-F. Form of application for licence for operation of Blood Bank/processing of whole human blood for components/manufacture of blood products for sale or distribution 4[, collection, processing, testing, storage, banking and release of umbilical cord blood stem cells.]- (1) Application for the grant and/or renewal of licence for the operation of a Blood Bank/processing of human blood for components/manufacture of blood products 4 [ collection, processing, testing, storage, banking and release of umbilical cord blood stem cells] shall be made to the Licensing Authority appointed under Part VII in 1[Form 27- C or 5[Form 27-E or Form 27-F], as the case may be], and shall be accompanied by 3[licence fee of rupees six thousand and an inspection fee of rupees one thousand and five hundred for every inspection thereof or for the purpose of renewal of licence]:
Provided that if the applicant applies for renewal of licence after its expiry but within six months of such expiry the fee payable for the renewal of the licence 3[shall be rupees six thousand and inspection fee of rupees one thousand and five hundred plus an additional fee at the rate of rupees one thousand per month or a part thereof in addition to the inspection fee]:
5[Provided further that a licensee holding a license in Form 28-C, Form 28-E or Form 28- F as the case may be, for operation of Blood Bank/ processing of whole human blood for components / manufacture of blood products / collection, processing testing storage, banking and release of umbilical cord blood stem cells shall apply for grant of license under sub Rule (1) before the expiry of the said license in Form 27-C, Form 27-E or Form 27-F as the case may be and he shall continue to operate the same till the orders on his application are communicated to him.]
2[***]
(2) A fee of 3[rupees one thousand] shall be paid for a duplicate copy of a licence issued under this rule, if the original is defaced, damaged or lost.
(3) Application by a licensee to manufacture additional drugs listed in the application shall be accompanied by a fee of 3[rupees three hundred] for each drug listed in the application.
(4) On receipt of the application for the grant or renewal of such licence, the Licensing Authority shall,–
(i) verify the statements made in the application form;
(ii) cause the manufacturing and testing establishment to be inspected in accordance with the provision of rule 122-I; and
(iii) in case the application is for renewal of licence, call for information of past performance of the licensee.
(5) If the Licensing Authority is satisfied that the applicant is in a position to fulfil the requirements laid down in the rules, he shall prepare a report to that effect and forward it 6[along with the application and the licence (in triplicate) to be granted or renewed, duly completed] to the Central Licence Approving Authority:
Provided that if the Licensing Authority is of the opinion that the applicant is not in a position to fulfil the requirements laid down in these rules, he may, by order, for reasons to be recorded in writing, refuse to grant or renew the licence, as the case may be.
(6) If, on receipt of the application and report of the Licensing Authority referred to in sub-rule 7[(5)] and after taking such measures including inspection of the premises by the Inspector, appointed by the Central Government under section 21 of the Act, and/or along with the Expert in the field concerned if deemed necessary, the Central Licence Approving Authority is satisfied that the applicant is in a position to fulfil the requirements laid down in these rules, he may grant or renew the licence, as the case may be:
1. Subs. by G.S.R. 245(E), dt. 5.4.1999.
2. Explanation omitted by G.S.R. 733 (E), dt. 21.12.2005 earlier Ins. by G.S.R. 89(E), dt. 14-2-1996.
3. Subs. by G.S.R. 601(E), dt. 24-8-2001.
4. Ins. by G.S.R. 899 (E), dt. 27-12-2011.
5. Subs. by G.S.R. 899 (E), dt. 27-12-2011.
6. Ins. by G.S.R. 89 (E), dt. 14.2.1996.
7. Corrected by corrigendum G.S.R. 447 (E), dt. 10-06-1993.
Provided that if the Central Licence Approving Authority is of the opinion that the applicant is not in a position to fulfil the requirements laid down in these rules he may, notwithstanding the report of the Licensing Authority, by order, for reasons to be recorded in writing, reject the application for grant or renewal of licence, as the case may be, and shall supply the applicant with a copy of the inspection report.
122G. Form of Licence for the operation of a Blood Bank/processing of whole human blood for components and manufacture of blood products 3[/manufacture of blood products/collection, processing, testing, storage, banking and release of umbilical cord blood stem cells] and the conditions for the grant or renewal of such licence.− 2[(1)] A licence for the operation of a Blood Bank or for processing whole human blood for components and 3[/manufacture of blood products/collection, processing, testing, storage, banking and release of umbilical cord blood stem cells] shall be issued in 1[Form 28C or Form 28E or 3[Form 28F or Form 26G or Form26-I or Form 26J, as the case may be, before a license in Form 28C or Form 28E or Form28-F or Form 26G or Form 26-I or Form 26-J], as the case may be,] is granted or renewed the following conditions shall be complied with by the applicant:-
1[(i) The operation of Blood Bank and/or processing of whole human blood for components shall be conducted under the active direction and personal supervision of competent technical staff consisting of at least one person who is whole time employee and who is Medical Officer, and possessing-
(a) Postgraduate degree in Medicine – M.D (Pathology/Transfusion Medicines); or
(b) Degree in Medicine (M.B.B.S.) with Diploma in Pathology or Transfusion Medicines having adequate knowledge in blood group serology, blood group methodology and medical principles involved in the procurement of blood and/or preparation of its components; or
(c) Degree in Medicine (M.B.B.S.) having experience in Blood Bank for one year during regular service and also has adequate knowledge and experience in blood group serology, blood group methodology and medical principles involved in the procurement of blood and/or preparation of its components,
the degree or diploma being from a University recognized by the Central Government.
Explanation.- For the purposes of this condition, the experience in Blood Bank for one year shall not apply in the case of persons who are approved by the Licensing Authority and/or Central Licence Approving Authority prior to the commencement of the Drugs and Cosmetics (Second Amendment) Rules, 1999].
(ii) The applicant shall provide adequate space, plant and equipment for any or all the operations of blood collection or blood processing. The space, plant and equipment required for various operation is given in Schedule ‘F‘, Part XIIB and/or XIIC 4[or XIID].
(iii) The applicant shall provide and maintain adequate technical staff as specified in Schedule F, Part XIIB and/or XIIC 4[or XIID].
(iv) The applicant shall provide adequate arrangements for storage of whole human blood, human blood components and blood products.
(v) The applicant shall furnish to the Licensing Authority, if required to do so, data on the stability of whole human blood, its components or blood products which are likely to deteriorate, for fixing the date of expiry which shall be printed on the labels of such products on the basis of the data so furnished.
1. Ins. by GSR 245(E), dt. 5-4-1999.
2. Renumbered as sub-rule (1) by GSR 733(E), dt. 21-12-2005.
3. Subs. by GSR 899(E), dt. 27-12-2011. 4. Ins. by GSR 899(E), dt. 27-12-2011.
3[(2) Application for grant or renewal of a licence for operation of Blood Bank or processing of human blood components shall be made by the Blood Bank run by the Government, Indian Red Cross Society, hospital, charitable trust or voluntary organization approved by a State/ Union Territory Blood Transfusion Council only.
Explanation.– For the purpose of this sub-rule, “renewal” shall include renewal of any licenceissued prior to the commencement of the Drugs and Cosmetics ( Amendment) Rules,2005.]
122H. Duration of licence.- An original licence in 1[Form 28C or Form 28E 4[or Form 28F] or a renewed licence in Form 26G or Form 26-I] 4[or Form 26J] unless sooner suspended or cancelled shall be 2[valid for a period of five years on and from the date on which] it is granted or renewed.
122-I. Inspection before grant or renewal of licence for operation of Blood Bank, processing of whole human blood for components and manufacture of blood products.- Before a licence in 1[Form 28C or Form 28E 4[or Form 28F] is granted or a renewal of licence in form 26G or Form 26-I 4[or Form 26J] is made, as the case may be,] the Licensing Authority or the Central Licence Approving Authority, as the case may be, shall cause the establishment in which Blood Bank is proposed to be operated/whole human blood for components is processed/ blood products are manufactured to be inspected by one or more Inspectors, appointed under the Act and/or along with the Expert in the field concerned. The Inspector or Inspectors shall examine all portions of the premises and appliances/equipments and inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for operation of blood bank/processing of whole human blood for components/manufacture of blood products together with their testing facilities and also enquire into the professional qualification of the expert staff and other technical staff to be employed.
122J. Report by Inspector.- The Inspector or Inspectors shall forward a detailed descriptive report giving his findings on each aspect of inspection along with his recommendation in accordance with the provisions of rule 122-I to the Licensing Authority or to the Central Licence Approving Authority.
122K. Further application after rejection.- If within a period of six months from the rejection of application of a licence the applicant informs the Licensing Authority that the conditions laid down have been satisfied and deposits an inspection 2[fee of rupees two hundred and fifty] the Licensing Authority may, if after causing further inspection to be made is satisfied that the conditions for the 1[grant or renewal of a licence have been complied with, shall grant or renew the licence in Form 28C or Form 28E 4[or Form 28F]:
Provided that in the case of a drug notified by the Central Government under rule 68-A, the application, together with the inspection report and the Form of licence (in triplicate to be granted or renewed), duly completed shall be sent, to the Central Licence Approving Authority, who may approve the same and return it to the Licensing Authority for issue of the licence.]
122L. Delegation of powers by the Central Licence Approving Authority.- The Central Licence Approving Authority may, with the approval of the Central Government, by notification delegate his powers of signing licences and any other power under rules to persons under his control having same qualifications as prescribed for Controlling Authority under rule 50-A, for such areas and for such periods as may be specified.
122M. Provision for appeal to the State Government by a party whose licence has not been granted or renewed.- Any person who is aggrieved by the order passed by the Licensing Authority or Central Licence Approving Authority, as the case may be, may within thirty days from the date of receipt of such order, appeal to the State Government or Central Government, as the case may be, after such enquiry into the matter as it considers necessary and after giving the said person an opportunity for representing his view in the matter may pass such order in relation thereto as it thinks fit.
1. Ins. by G.S.R 245(E), dt. 5-4-1999.
2. Subs. by G.S.R 601(E), dt. 24-8-2001.
3. Ins. by G.S.R 733(E), dt. 21-12-2005.
4. Ins. by GSR 899(E), dt. 27-12-2011.
122-N. Additional information to be furnished by an applicant for licence or by a licensee to the Licensing Authority.- The applicant for the grant of licence or any person granted a licence under the Part shall, on demand furnish to the Licensing Authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership or occupation, rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm or any other relevant matter, which may be required for the purpose of verifying the correctness of the statement made by the applicant or the licensee, while applying for or after obtaining the licence, as the case may be.
122-O. Cancellation and suspension of licences.− (1) The Licensing Authority or Central Licence Approving Authority may for such licences granted or renewed by him after giving the licensee an opportunity to show cause why such an order should not be passed by an order in writing stating the reason thereof, cancel a licence issued under this part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates 1[or direct the licensee to stop collection, storage, processing, manufacture and distribution of the said substances and 2[thereupon order the destruction of substances and] stocks thereof in the presence of an Inspector], if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or Rules thereunder.
(2) A licensee whose licence has been suspended or cancelled may, within three months of the date of the order under sub-rule (1) prefer an appeal against the order to the State Government or Central Government, which shall decide the same.
122-P. Conditions of licence.- 3[A licence in Form 28C, Form 28E, 4[Form 28F, Form 26G, Form 26-I or Form 28J shall be subject to the special conditions set out in Schedule F, Part XII-B and Part XII C, Part XIID,] as the case may be, which relate to the substance in respect of which the licence is granted or renewed and to the following general conditions, namely:-]
(i) (a) The licensee shall provide and maintain adequate staff, plant and premises for the proper operation of a Blood Bank for processing whole human blood, its components and/or manufacture of blood products.
(b) The licensee shall maintain staff, premises and equipment as specified in Rule 122-G. The licensee shall maintain necessary records and registers as specified in Schedule F, Parts XII-B and XII-C.
(c) The licensee shall test in his own laboratory whole human blood, its components and blood products and maintain records and registers in respect of such tests as specified in Schedule F, Parts XIIB and XIIC 5[or XIID]. The records and register shall be maintained for a period of five years from the date of manufacture.
(d) The licensee shall maintain/preserve reference sample and supply to the Inspector the reference sample of the whole human blood collected by him in an adequate quantity to conduct all the prescribed tests. The licensee shall supply to the Inspector the reference sample for the purpose of testing.
1. Subs. by G.S.R. 20(E), dt. 11-1-1996.
2. Ins. by (Corrigenda) G.S.R. 514 (E), dt. 6-11-1996.
3. Subs. by G.S.R. 245(E), dt. 5-4-1999.
4. Subs. by GSR 899(E), dt. 27-12-2011.
5. Ins. by GSR 899(E), dt. 27-12-2011.
(ii) The licensee shall allow an Inspector appointed under the Act to enter, with or without prior notice, any premises where the activities of the Blood Bank are being carried out for the processing of Whole Human Blood and/or Blood Products, to inspect the premises and plant and the process of manufacture and the means employed for standardizing and testing the substance.
(iii) The licensee shall allow an Inspector appointed under the Act to inspect all registers and records maintained under these rules and to take samples of the manufactured product and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and rules thereunder have been observed.
(iv) The licensee shall from time to time report to the Licensing Authority any changes in the expert staff responsible for the operation of a Blood Bank/processing of whole human blood for components and/or manufacture of blood products and any material alterations in the premises or plant used for that purpose which have been made since the date of last inspection made on behalf of the Licensing Authority before the grant of the licence.
(v) The licensee shall on request furnish to the Licensing Authority, or Central Licence Approving Authority or to such Authority as the Licensing Authority, or the Central Licence Approving Authority may direct, from any batch unit of drugs as the Licensing Authority or Central Licence Approving Authority may from time to time specify, sample of such quantity as may be considered adequate by such Authority for any examination and, if so required, also furnish full protocols of the test which have been applied.
(vi) If the Licensing Authority or the Central Licence Approving Authority so directs, the licensee shall not sell or offer for sale any batch/unit in respect of which a sample is, or protocols are furnished under the last preceding sub-paragraph until a certificate authorizing the sales of batch/unit has been issued to him by or on behalf of the Licensing Authority or the Central Licence Approving Authority.
(vii) The licensee shall on being informed by the Licensing Authority or the Controlling Authority that any part of any batch/unit of the substance has been found by the Licensing Authority or the Central Licence Approving Authority not to conform with the standards of strength, quality or purity specified in these Rules and on being directed so to do, withdraw, from sales and so far as may in the particular circumstances of the case be practicable recall all issues already made from that batch/unit.
(viii) No drug manufactured under the licence shall be sold unless the precautions necessary for preserving its properties have been observed throughout the period after manufacture. Further no batch/unit manufactured under this licence shall be supplied/distributed to any person without prescription of a Registered Medical Practitioner.
(ix) The licensee shall comply with the provisions of the Act and of these Rules and with such further requirements, if any, as may be specified in any Rules subsequently made under Chapter IV of the Act, provided that where such further requirements are specified in the Rules, these would come in force four months after publication in the Official Gazette.
(x) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impression and defects noticed.
(xi) The licensee shall destroy the stock of batch/unit which does not comply with standard tests in such a way that it would not spread any disease/infection by way of proper disinfection method.
1[(xii) All bio-medical waste shall be treated, disposed of or destroyed as per the provisions of the Bio-Medical Wastes (Management and Handling) Rules, 1996.
(xiii) The licensee shall neither collect blood from any professional donor or paid donor nor shall he prepare blood components and/or manufacture blood products from the blood drawn from such a donor.]
PART XI
EXEMPTIONS
123. The drugs specified in Schedule K shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that Schedule.
PART XII
STANDARDS
2[124. Standards of drugs: –
(1) For drugs included in the Indian Pharmacopoeia—
(a) The standards for identity, purity and strength shall be those as may be specified in the edition of the Indian Pharmacopoeia for the time being in force.
(b) In case the standards for identity, purity and strength for drugs are not specified in the edition of the Indian Pharmacopoeia for the time being in force but are specified in the edition of the Indian Pharmacopoeia immediately preceding, the standards for identity, purity and strength shall be those occurring in such immediately preceding edition of the Indian Pharmacopoeia.
(2) For other drugs–
(a) The standards for identity, purity and strength shall be those as may be specified in the edition of the official pharmacopoeia, for the time being in force, of any country to which the drug claims to comply with,
(b) In case the standards for identity, purity and strength for drugs are not specified in the edition of such official pharmacopoeia for the time being in force, but are specified in the edition immediately preceding, the standards for identity, purity and strength shall be those occurring in such immediately preceding edition of such official pharmacopoeia to which the drug claims to comply with.
(c) For drugs for which standards are not included in the edition of the official pharmacopoeia, for the time being in force, of any country or in edition immediately preceding, but included in the official compendia of drug standards, namely, the British Pharmaceutical Codex or the National Formulary of the United States, for the time being in force, to which the drug claims to comply with.]
3[124A. Standards for veterinary drugs.– For drugs intended for veterinary use, the standards shall be those given in the current edition for the time being in force of the 4[British Pharmacopoeia (Veterinary)].
1. Subs. by G.S.R. 245(E), dt. 5-4-1999.
2. Subs. by G.S.R. 19, dt. 15-12-1977.
3. Ins. by notification F. 1-6/62-D (SO 2889), dt. 2-7-1969.
4. Subs. by G.S.R. 647 (E), dt. 28-10-1998.
1[124B. Standards for patent or proprietary medicines.— The standards for patent or proprietary medicines shall be those laid down in Schedule V and such medicines shall also comply with the standards laid down in the Second Schedule to the Act.
2[124C. Standards for Surgical Dressings.- The standards for Surgical Dressings shall be such as are laid down in Schedule F (II).]
3[124D. Standards for Sterilised Umbilical tapes.- The standards for Sterilised Umbilical tapes shall be as laid down in Schedule F(III).]
4[125. Standards for substances (other than food) intended to affect the structure or any function of human body—contraceptives.— (1) The standards for mechanical contraceptives shall be such as are laid down in Schedule R.
(2) The standards which other contraceptives will have to comply with shall be in conformity with the formulae approved as safe and efficacious by the Central Government. Such formula shall be displayed on the label of every container of such contraceptive.
5[125A. Standards for Medical Devices.— The standards for the Medical Devices shall be such as are laid down in Schedule R-1.]
6[126. Standards for substances intended to be used for the destruction of vermin or insects which cause 9[***] disease in human beings or animals.- Disinfectants.
The standards of disinfectants shall be such as are laid down in Schedule O.]
7[126A Standards for ophthalmic preparations 8[including Homoeopathic ophthalmic preparations].— The standards for ophthalmic preparations 8[including Homoeopathic ophthalmic preparations] shall be those laid down in Schedule FF, and such preparations shall also comply with the standards set out in the Second Schedule to the Act.]
_
1. Ins. by G.S.R. 665, dt. 28-5-1977.
2. Ins. by G.S.R. 318 (E), dt. 1-5-1984.
3. Ins. by G.S.R. 1115 (E), dt. 30-9-1986.
4. Amended by F-1-28/65D (SO 886), dt. 8-3-1966.
5. Ins. by G.S.R. 109 (E), dt. 22-2-1994.
6. Amended by F.1-20/60-D, dt. 24-1-1964.
7. Ins. by F 1-113/60-D (SO 23), dt. 23-12-1969.
8. Subs. by G.S.R. 245 (E), dt. 17-6-1996.
9. Subs heading “Insecticides” and the entry relating thereto omitted by GSR 139, dt. 8-1-1976.
1[127. List of colours permitted to be used in drugs.− (1) No drug shall contain a colour other than specified below :-
(1) Natural Colours
Annatto
Carotene
Chlorophyll
Cochineal
Curcumin
Red Oxide of iron
Yellow Oxide of iron
2[Titanium Oxide]
3[Black Oxide of iron]
6[Titanium dioxide coated mica pearlescent pigments]
(2) Artificial Colours
Caramel
4[Riboflavin]
(3) Coal Tar Colours
| Common name of the colour |
Colour Index Number |
Chemical Name |
| 1 |
2 |
3 |
| GREEN |
|
|
| Quinazarine Green S.S |
61565 |
1, 4-bis (p-Toluino) anthraquinone. |
| Alizarin Cyanine Green F. |
61570 |
Disodium salt of 1, 4-bis (O-sulfo-pToluino) anthra-quinone. |
| 2[Fast Green F.C.F. |
42053 |
Disodium salt of 4-{[4-(N-ethyl-p Sulfobenzylamino)-phenyl-]-(4-hydroxy2- sulfoniumphenyl)-methylene} [1-(N-ethyl-N-p-sulfobenzyl]∆ 2, 5-cyclohexadienimine]. |
| 5[** * * *] |
|
|
| YELLOW |
|
|
| Tartrazine |
19140 |
Trisodium salt of 3-carboxy-5- hydroxy-lp-sulfophenyl-4-p- Sulfophenyl azopyrazole. |
| Sunset Yellow FCF |
15985 |
Disodium salt of 1-p-sulfophenyl azo-2-naphthol-6-sulfonic acid. |
| 1[Quinoline Yellow WS |
47005 |
Disodium salt of disulfonic acid of 2(2- quinolyl)-1, 3-indandione.] |
| RED |
|
|
| 2[** ** *] |
|
|
| Erythrosine |
45430 |
Disodium salt of 9-0-carboxyphenyl 6-hydroxy 2,4-5,7-tetriodo-3-isoxanthone |
| Eosin YS or Eosine G |
45380 |
Disodium of salt of 2,4,5, 7-Tetrabromo- 9-pcarboxyphenyl-6-hydroxy 3-isoxanthone. |
| Toney Red or Sudan III |
26100 |
1-p-phenylazophenylaze-2-naphthol. |
| Ponceau 4 R |
16255 |
Trisodium salt of 1-(4-sulpho-1-1- Napthylazo)- 2 napthol-6 : 8-disulphonic acid. |
| Carmoisine |
14720 |
Disodium salt of 2-(4-sulpho-1-napthylazo)-1 napthol-4 sulphonic acid. |
| 3[*** * *] |
|
|
| BLUE |
|
|
| Indigo Carmine |
73015 |
Disodium salt of indigotin-5 : 5 Disu lphonic Acid |
| 4[Brilliant Blue FCF |
42090 |
Disodium salt of 4-[ {4-(N-ethyl-psulfobenzylamino)-phenyl }-](2- sulfonium phenyl)-methylene)-1-(N- ethyl-N-psulfobenzyl)- ∆ 2, 5-cyclohexadienimine. |
| ORANGE |
|
|
| Orange G |
16230 |
Disodium salt of 1-phenylazo-2- naphthol-6, 8- disulfonic acid. |
| BROWN |
|
|
| Resorcin Brown |
20170 |
Monosodium salt of 4-p-sulfophenylazo-2-(2, 4- xylylazo-1, 3 resorcinol. |
| BLACK |
|
|
| Naphthol Blue Balck |
20470 |
Disodium salt of 8-amino-7-p-nitro- phenylazo2-phenylazo-1-naphthol-3, 6-disulfonic acid. |
_
1. Amended by S.O. 289, dt. 20-12-1972.
2. Ins. by X.11013/3/76-DM.S (SO 1074), dt. 19-8-1978.
3. Ins. by G.S.R. 370 (E), dt. 7-4-1994.
4. Ins. by G.S.R. 681 (E), dt. 6-6-1988.
5. “Green S” omitted by G.S.R. 753 (E), dt. 4-11-1999. 6. Ins. by G.S.R. 76 (E), dt. 8-2-2012.
_
1. Subs. by G.S.R. 11(E), dt. 7-1-1991.
2. ‘Amaranth‘ omitted by G.S.R. 753(E) dt. 4.11.1999.
3. Fast Red omitted by G.S.R. 753, dt. 4-11-1999.
4. Ins. by X.11013/3/76-DM.S, dt. 19-8-1978.
_
(4) LAKES
The aluminum or calcium salts (lakes) of any of the water-soluble colours listed above:
5[Provided that disinfectants may also contain colours specified under Schedule Q, which are non-staining.]
(2) The label on the container of a drug containing a permitted colour shall indicate the common name of the colour.]
128. The following rules are hereby repealed except as respects things done or omitted to be done under these rules, namely :—
Andhra Pradesh Drugs Rules, 1945.
Assam Drugs Rules, 1945.
Bihar Drugs Rules, 1945.
Bombay Drugs Rules, 1946.
East Punjab Drugs Rules, 1945.
C.P. & Berar Drugs Rules, 1945.
Madras Drugs Rules, 1945.
Orissa Drugs Rules, 1945.
Rajasthan Drugs Rules, 1953.
Saurashtra Drugs Rules, 1953.
Travancore-Cohin Drugs Rules, 1953.
United Provinces Drugs Rules, 1945.
West Bengal Drugs Rules, 1946.
2[Mysore Drugs Rules, 1954].
1[PART XIII
3[IMPORT AND REGISTRATION OF COSMETICS]
4[129. Registration of cosmetic products imported into the country.- No cosmetic shall be imported into India unless the product is registered under the rules by the licensing authority appointed by the Central Government under rule 21 or by any person to whom such powers may be delegated under rule 22.
129A. Form and manner of application for Registration Certificate.- (1) An application for issue of a Registration Certificate for cosmetics intended to be imported into India shall be made in Form 42 either by the manufacturer himself or by his authorised agent or importer in India or by the subsidiary in India authorised by the manufacturer and shall be accompanied by a fee of two hundred and fifty US dollars or its equivalent to Indian rupees for each brand of cosmetic. The application shall be accompanied by a treasury challan as specified in sub- rule (3) along with the information and undertaking as specified in Schedule D (III) duly signed by or on behalf of the manufacturer or by his authorised agent or importer in India or by the subsidiary in India authorised by the manufacturer.
1. Ins. by G.S.R. 1183 dt. 17-8-1964. 5. Ins. by G.S.R. 76 (E), dt. 8-2-2012.
2. Added by notification F. 1-37/58-D, dt. 21-7-1958.
3. Subs. by G.S.R. 426 (E), dt. 19-5-2010.
4. Rules 129 to 129H subs. by G.S.R. 426 (E), dt. 19-5-2010.
_
(2) An authorisation by the manufacturer to his agent in India shall be duly authenticated either in India before a First Class Magistrate or in the country of origin before such an equivalent authority.
(3) The fees shall be paid through a challan in the designated branches of Bank of Baroda either in US dollars or in equivalent Indian rupees under Head of Account “0210-MEDICAL AND PUBLIC HEALTH, 04 PUBLIC HEALTH, 104-FEES AND FINES” and the original copy of the treasury challan shall be submitted along with the application for product registration.
Provided that in the case of any direct payment of fees by a manufacturer in the country of origin, the fees shall be paid through Electronic Clearance System (ECS) from any bank in the country of origin to the Bank of Baroda, Kasturba Gandhi Marg, New Delhi, through the Electronic Code of the bank in the Head of Account “0210-MEDICALAND PUBLIC HEALTH, 04 PUBLIC HEALTH, 104-FEES AND FINES” and the original receipt of the said transfer shall be treated as an equivalent to the bank challan subject to the approval by the Bank of Baroda that they have received the payment.
(4) The applicant shall be liable for the payment of testing fees directly to a testing laboratory approved by the Central Government, as may be, required for examination, tests and analysis of cosmetics.
(5) A fee of one hundred US dollars or its equivalent shall be paid for a duplicate copy of the Registration Certificate, if the original is defaced, damaged or lost.
129B. Registration Certificate for the import of cosmetics manufactured by one manufacturer.- A single application may be made and a single Registration Certificate in Form 43 may be issued in respect of import of one or more than one cosmetics manufactured by the same manufacturer: Provided that the cosmetics are manufactured at one factory or more than one factory functioning conjointly as a single manufacturing unit.
129C. Grant of Registration Certificate.- (1) On receipt of an application for Registration Certificate in the form and manner specified in rule 129A, the licensing authority shall, if satisfied, issue a Registration Certificate in form 43 subject to the conditions of the registration certificates in form 43:
Provided that if the application is complete in all respects and information specified in Schedule D III is in order, the licensing authority shall, within six months from the date of receipt of an application, issue such Registration Certificate, and in exceptional circumstances and for reasons to be recorded in writing, the Registration Certificate may be issued within such extended period, not exceeding three months, as the licensing authority may deem fit.
(2) If the applicant does not receive the Registration Certificate within the period as specified above, he may appeal to the Central Government and the Central Government may after such enquiry into the matter, as it considers necessary, may pass such orders in relation thereto as it thinks fit.
129D. Duration of Registration Certificate.- A Registration Certificate, unless it is sooner suspended or cancelled, shall be valid for a period of three years from the date of its issue: Provided that if application for a fresh Registration Certificate is made within six months before the expiry of the said certificate, the existing Registration Certificate shall be deemed to continue to remain in force until orders are passed on the application.
129E. Suspension and cancellation of Registration Certificate.- If the manufacturer fails to comply with any of the conditions of the Registration Certificate, the licensing authority may after giving him an opportunity to show cause why such an order should not be passed, by an order in writing, stating the reasons therefor, suspend or cancel the Registration Certificate for such period as it thinks fit either wholly or in respect of some of the cosmetics to which it relates: Provided that a person who is aggrieved by the order passed by the licensing authority under this rule may, within thirty days of the receipt of the order, appeal to the Central Government and the Central Government may after such enquiry into the matter as it considers necessary and after giving the said appellant an opportunity of being heard pass orders as it thinks fit.
129F. Prohibition of import of certain cosmetic.- No cosmetic, the manufacture, sale or distribution of which is prohibited in the county of origin, shall be imported under the same name or under any other name except for the purpose of examination, test or analysis.
129G. Standard for imported cosmetics.- No cosmetic shall be imported unless it complies with the specifications prescribed under Schedule S and Schedule Q or any other standards of quality and safety, applicable to it, and other provisions under the rules. In case the cosmetic is not included under Schedule S, it shall meet with specifications under the rules and standards applicable to it in the country of origin.
129H. Labeling and Packing of Cosmetics.- No cosmetic shall be imported unless it is packed and labeled in conformity with the rules in Parts XV. Further the label of imported cosmetics shall bear registration certificate number of the product and the name and address of the registration certificate holder for marketing the said product in India.]
130. Documents to be supplied to the Collector of Customs.− Before any cosmetics are imported, a declaration signed by or on behalf of the manufacturer or by on behalf of the importer that the cosmetics comply with the provisions of Chapter III of the Act, and the Rules made there under, shall be supplied to the Collector of Customs.
131. Procedure for the import of cosmetics.− (1) If the officer appointed at the post of entry by the Central Government has reason to believe that any cosmetic contravenes any of the provisions of the Act or the rules made thereunder he may take sample of the cosmetic from the consignment for inspection. If on examination of the sample defects are noticed the officer shall advise the Collector of Customs for further action to be taken.
If the suspected contravention of the provisions of the Act or the Rules is such as may have to be determined by test, the officer shall send the sample to the laboratory established for the purpose for performing such tests. The consignment of the said cosmetic shall be detained till such time that the test report on such sample is received from the Director of the said laboratory or any other officer of the laboratory empowered by him in this behalf with the approval of the Central Government:
Provided that if the importer gives an undertaking in writing not to dispose of the cosmetic without the consent of the Collector of Customs and to return the consignment or such portion thereof as may be required, the Collector of Customs shall make over the consignment to the importer.
(2) If the importer who has given an undertaking under the proviso to sub-rule (1) is required by the Collector of Customs to return the consignment or portion thereof, he shall return the consignment or portion thereof within ten days of receipt of the notice.
Further procedure on receipt of the report of analysis
(3) If the Director of the Laboratory established for the purpose by the Central Government or any other officer of the laboratory empowered by him in this behalf with the approval of the Central Government, reports to the Collector of Customs or to the officer mentioned in sub-rule (1) above that the sample of any cosmetic in a consignment contravenes the provisions of Chapter III of the Act or the Rules made thereunder and that the contravention is such that it cannot be remedied by the importer, the Collector of Customs shall communicate the report forthwith to the importer who shall within two months of receiving such a communication either send back all the cosmetic of that description to the country in which it was manufactured or to the country from which it was imported or hand it over to the Central Government which shall cause it to be destroyed:
Provided that the importer may within thirty days of receipt of the report make a representation against the report to the Collector of Customs who shall forward the representation with a fresh sample of the cosmetic to the Drugs Controller, India, who after obtaining, if necessary, the report of the Director of the Central Drugs Laboratory shall pass orders thereon which shall be final.
(4) If the Drugs Controller or any other officer empowered by him in this behalf with the approval of Central Government reports to the Collector of Customs after the inspection of the sample of cosmetic and if necessary, after obtaining a test report thereon that the sample of the said cosmetic contravenes in any respect the provisions of Chapter III of the Act or the Rules made thereunder but that the contravention is such that it can be remedied by the importer, the Collector of Customs shall communicate the report forthwith to the importer and permit him to import the cosmetic on his giving an undertaking in writing not to dispose of the cosmetic without the permission of the officer authorised in this behalf by the Central Government.
132. Exemption of cosmetics— Cosmetics as may be specified in Schedule D shall be exempted from the provisions of Chapter III of the Act and the Rules made thereunder to the extent and subject to the conditions specified in that Schedule.
133. Import through points of entry— No cosmetic shall be imported into India except through the points of entry specified in rule 43A.
1[134. Cosmetic to contain Dyes, Colours and Pigments.- No Cosmetic shall contain Dyes, Colours and Pigments other than those specified by the Bureau of Indian Standards (IS:4707 Part 1 as amended) and Schedule Q.
The permitted Synthetic Organic Colours and Natural Organic Colours used in the Cosmetic shall not contain more than:-
(i) 2 parts per million of arsenic calculated as arsenic trioxide.
(ii) 20 parts per million of lead calculated as lead.
(iii) 100 parts per million of heavy metals other than lead calculated as the total of the respective metals.]
2[134-A Prohibition of import of cosmetic containing Hexachlorophene.— No cosmetic containing hexachlorophene shall be imported.
135. Import of cosmetic containing Lead or Arsenic compound prohibited.— No cosmetic shall be imported in which a Lead or Arsenic compound has been used for purposes of colouring.
3[135-A. Import of cosmetics containing mercury compounds prohibited.– No cosmetic shall be imported which contains mercury compounds.]
5[135-B. Prohibition of import of cosmetics tested on animals.– No cosmetic that has been tested on animals after the commencement of the Drugs and Cosmetics (Fifth Amendment) Rules, 2014 shall be imported into the country.]
136. Import of cosmetic for personal use— Small quantities of cosmetics the import of which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to the following conditions: —
(i) The cosmetics shall form part of a passenger‘s baggage and shall be the property of and intended for, the bona fide use of the passenger; and
(ii) The cosmetics shall be declared to the Customs authorities, if they so direct.
4[PART XIV
MANUFACTURE OF COSMETIC FOR SALE OR FOR DISTRIBUTION]
137. Manufacture on more than one set of premises. — If cosmetics are manufactured on more than one premises, a separate application for each such premises shall be made and a separate licence obtained for each such premises.
_____________
1. Subs. by G.S.R. 811 (E), dt. 14-11-1994.
2. Added by G.S.R. 116, dt. 25-1-1975.
3. Ins. by X.11013/76-D & MS, dt. 19-8-1978.
4. Subs. by G.S.R. 788 (E), dt. 10-10-1985.
5. Ins. by G.S.R. 718 (E), dt. 13-10-2014.
_____________
138. Application for 5 [licence to manufacture cosmetics for sale and distribution]— 3[(1) Application for grant or renewal of 5 [ licence to manufacture any cosmetic for sale or for distribution] 1[shall be made up to ten items of each category of cosmetics categorized in Schedule MII to the Licensing Authority appointed by the State Government for the purpose of this Part (hereinafter in this Part referred to as the Licensing Authority) in Form 31 and shall be accompanied by a licence fee of rupees two thousand and five hundred and an inspection fee of rupees one thousand for every inspection
thereof or for the purpose of renewal of licence].
2[* * * **]
3[(2) If a person applies for the renewal of licence after expiry but within six months of such expiry, the fee payable for the renewal of such licence shall be 1[rupees two thousand five hundred plus an additional fee at the rate of rupees four hundred per month or part thereof in addition to an inspection fee of rupees one thousand.]
2[* * * * *]
(3) Application by a licensee to manufacture additional items of cosmetics shall be accompanied by a fee of 1[rupees one hundred for each item subject to a maximum of rupees three thousand for each application.]
2[* * * * *]
6[(4) A fee of 1[rupees two hundred and fifty] shall be paid for a duplicate copy of a licence under sub-rule (1), if the original is defaced, damaged or lost.]
4[138A. Application for loan licence to manufacture cosmetics.− (1) Application for grant or renewal of a loan licence for the manufacture for sale of cosmetics 1[shall be made up to ten items of each category of cosmetics categorized in Schedule M-II in Form 31-A to the Licensing Authority and shall be accompanied by a licence fee of rupees two thousand and five hundred and an inspection fee of rupees one thousand for every inspection thereof].
Explanation.– For the purpose of this rule a ‘loan licence‘ means a licence, which a Licensing Authority may issue to an applicant who does not have his own arrangements to manufacture but who intends to avail himself of the manufacturing facilities owned by a licensee in Form 32.
(2) If a person applies for the renewal of a loan licence after the expiry but within six months of such expiry, the fee payable for the renewal of such a licence shall be
_
1. Subs. by G.S.R. 601(E), dt. 24-8-2001.
2. Omitted by G.S.R. 331(E),dt. 8.5.1984.
3. Amended by G.S.R. 245, dt. 21.2.1976.
4. Ins. by G.S.R. 444, dt. 28-4-1973.
5. Subs. by G.S.R. 788 (E), dt. 10-10-1985.
6. Subs. by G.S.R. 331(E),dt. 8.5.1984.
_
1[rupees two thousand and five hundred plus an additional fee at the rate of rupees four hundred for each month or part thereof.]
(3) The Licensing Authority shall before the grant of a loan licence satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities to undertake the manufacture on behalf of the applicant for a loan licence.
(4) The loan licence shall be granted by the Licensing Authority to only such applicants who propose to avail of the facilities of manufacture of cosmetics in the premises of a manufacturer located in the same State where the applicant is located. In case the manufacture of cosmetic involves any special process of manufacture or use of equipment which are not available in the State where the applicant is located, the Licensing Authority after consulting the Licensing Authority where the manufacturing unit is located, may grant the loan licence.
(5) Subject to the provisions of sub-rule (2), application for manufacture of additional items on a loan licence shall be accompanied by a fee of 1[rupees one hundred for each item subject to a maximum of rupees three thousand per application.]
(6) A fee of 1[rupees two hundred and fifty] shall be paid for a duplicate copy of a licence issued under sub-rule (1) if the original is defaced, damaged or lost.
139. Conditions for the grant or renewal of a licence in Form 32— Before a licence in Form 32 is granted or renewed, the following conditions shall be complied with by applicant:-
(1) The manufacture shall be conducted under the direction and personal supervision of a competent technical staff consisting of at least one person who is a whole time employee and who possesses any one of the following qualifications:
(a) holds a Diploma in Pharmacy approved by the Pharmacy Council of India under the Pharmacy Act, 1948 (8 of 1948), or
(b) is registered under the Pharmacy Act, 1948 (8 of 1948), or
(c) has passed the Intermediate Examination with Chemistry as one of the subjects or an examination recognized by the Licensing Authority as equivalent to it.
2[ * * * * *]
1. Subs. by G.S.R. 601(E), dt. 24-8-2001.
2. Omitted by. G.S.R. 331(E), dt. 8.5.1984
1[(2) The factory premises shall comply with the requirements and conditions specified in Schedule M-II.]
2 [ * * * * *]
(5) The applicant shall either–
(i) provide and maintain adequate staff, premises and laboratory equipment for testing the cosmetic manufactured, and the raw materials used in the manufacture; or
(ii) make arrangements with some institution approved by the Licensing Authority 3[under Part XV (A) of these rules] for such tests to be regularly carried out in this behalf by the institution.
4[139A. Form of 5[licence to manufacture cosmetics for sale or for distribution].— A 5[licence to manufacture cosmetics for sale or for distribution] against application in Form 31, shall be granted in Form 32.]
6[139AA. Inspection before grant or renewal of licence.- Before a licence under this Part is granted or renewed in Form 32, Form 32A or Form 33, the Licensing Authority shall cause the establishment, in which the manufacture is proposed to be conducted or being conducted, to be inspected by one or more Inspectors appointed under the Act. The Inspector or Inspectors shall examine all portions of the premises, plant and appliances and also inspect the process of manufacture intended to be employed or being employed along with the means to be employed or being employed for standardizing and testing the substances to be manufactured and enquire into the professional qualifications of the technical staff to be employed. He shall also examine and verify the statements made in the application in regard to their correctness, and the capability of the applicant to comply with the requirements of competent technical staff, manufacturing plant, testing equipments and the requirements of plant and equipments as laid down in Schedule M-II read with requirements of maintenance of records as laid down in Schedule U-1.]
6[139AB. Report by Inspector.- The Inspector or Inspectors shall forward a detailed descriptive report giving his or their findings on each aspect of inspection along with his or their recommendations after completion of his or their inspection to the Licensing Authority.]
6[139AC. Grant or refusal of licence.- (1) If the Licensing Authority after such further enquiry, if any, as he may consider necessary is satisfied that the requirements of the rules under the Act have been complied with and that the conditions of the licence and the rules under the Act shall be observed, he shall grant or renew a licence in form 32, Form 32-A or Form 33.
1. Subs. by G.S.R. 723 (E), dt. 11-8-1992.
2. Omitted condition (3) and (4) by G.S.R. 723 (E), dt. 11-8-1992. 3. Ins. by G.S.R. 1172 (E), dt. 23-8-1977.
4. Ins. by G.S.R. 444, dt. 28-4-1973.
5. Subs. by G.S.R. 788 (E), dt. 10-10-1985.
6. Ins. by G.S.R. 493 (E), dt. 9-6-1995.
(2) If the Licensing Authority is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before a licence can be granted or renewed and shall supply the applicant with a copy of inspection report.]
1[139AD. Further application after rejection.– If within a period of six months from the rejection of an application for a licence, the applicant informs the Licensing Authority that the conditions laid down have been fulfilled and deposits an inspection 2[fee of rupees two hundred and fifty], the Licensing Authority may, if, after causing further inspection to be made, he is satisfied that the conditions for the grant of licence have been complied with, issue a licence in Form 32, Form 32-A or Form 33.]
1[139AE. Appeal to the State Government.- Any person who is aggrieved by the order passed by the Licensing Authority refusing to grant or renew a licence under this Part may, within ninety days from the date of receipt of such order, appeal to the State Government and the State Government may, after such enquiry into the matter as is considered necessary and after giving the said person an opportunity for representing the case, pass such order as it thinks fit.]
3[139B. Form of loan 4[licence to manufacture cosmetics for sale or for distribution].− A loan 4[licence to manufacture cosmetics for sale or for distribution] against application in Form 31-A shall be granted in Form 32-A.
140. Duration of licence.- An original licence or a renewed licence shall unless sooner suspended or cancelled be 2[valid for a period of five years on and from the date on which] it is granted or renewed:
5[Provided that if the application for renewal of a licence in force is made before its expiry or if the application is made within six months of its expiry, after payment of additional fee, the licence shall continue to be in force until orders are passed on the application and the licence shall be deemed to have expired, if application for its renewal is not made within six months of its expiry.]
141. Certificate of renewal.− The certificate of renewal of a licence in Form 32 shall be issued in Form 33.
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1. Ins. by G.S.R. 493 (E), dt. 9-6-1995.
2. Subs. by G.S.R. 601 (E), dt. 24-8-2001.
3. Ins. by G.S.R. 444, dt. 28-4-1973.
4. Subs. by G.S.R. 493 (E), dt. 9-6-1995.
5. Amended by S.O. 2139, dt. 12.8.1972.
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1[141A. Certificate of renewal of a loan licence— The certificate of renewal of a licence in Form 32-A shall be issued in Form 33-A.]
1[141AA. Duration of a loan licence.– An original loan licence in Form 32A or a renewed loan licence in Form 33-A, unless sooner suspended or cancelled, shall be 2[valid for a period of five years on and from the date on which] it is granted or renewed:
Provided that if the application for the renewal of a licence is made before its expiry, or if the application is made within six months of its expiry, after payment of the additional fee, the licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.]
142. Conditions of licence— A licence in Form 32 shall be subject to the conditions stated therein and to the following other conditions, namely: –
(a) the licensee shall provide and maintain staff, premises and equipment as specified in rule 139;
(b) the licensee shall comply with the provisions of the Act and the Rules made thereunder and with such further requirements, if any, as may be specified in any rules to be made hereafter under Chapter IV of the Act;
3 [(b1) the licensee shall keep records of the details of each batch of cosmetic manufactured by him and of raw materials used therein as per particulars specified in Schedule U(1) and such records shall be retained for a period of three years;]
(c) the licensee shall test each batch or lot of the raw materials used by him for the cosmetics and also each batch of the final product and shall maintain records or registers showing the particulars in respect of such tests. The records or registers shall be retained for a period of three years from the date of manufacture;
(d) the licensee shall allow any 1 [ Inspector appointed under the Act] to enter with or without prior notice any premises where the manufacture of a substance in respect of which the licence is issued is carried on, to inspect the premises and to take samples of the manufactured products under a receipt;
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1. Ins. by G.S.R. 444, dt. 28-4-1973.
2. Subs. by G.S.R. 601 (E), dt. 24-8-2001.
3. Ins. by G.S.R. 1594, dt. 28-10-1976.
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(e) the licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the Rules made thereunder have been complied;
1[(f) the licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impression and the defects noticed:
2[Provided that clauses (b-1) and (c) shall not apply to the manufacture of soap and the procedure for testing of raw materials and the records to be maintained by the manufacturer of soap shall be such as are approved by the Licensing Authority.]
4[142A. Additional information to be furnished by an applicant for licence or a licensee to the Licensing Authority.— The applicant for the grant of a licence or any person granted a licence under this Part shall, on demand, furnish to the Licensing Authority, before the grant of the licence or during the period the licence is in force, as the case may be, documentary evidence in respect of the ownership or occupation on rental or other basis of the premises, specified in the application for licence or in the licence granted, constitution of the firm, or any other relevant matter, which may be required for the purpose of verifying the correctness of the statements made by the applicant or the licensee, while applying for or after obtaining the licence as the case may be.]
1[142B. Conditions of licence in Form 32-A.–
(a) A licence in Form 32-A shall be deemed to be cancelled or suspended, if the licence owned by the licensee, in Form 32, whose manufacturing facilities are cancelled or suspended, as the case may be under these rules.
(b) The licensee shall comply with the provisions of the Act and these rules and with each further requirements, if any, as may be specified from time to time in Chapter IV of the Act, provided that where such further requirements are specified in the rules, these would come into force four months after publication in the Official Gazette.
3[(b1) The licensee shall keep records of the details of each batch of cosmetic manufactured by him and of raw materials used therein as per particulars specified in Schedule U(1) and such records shall be retained for a period of three years.]
(c) The licensee shall test each batch or lot of the raw materials used by him for the manufacture of the cosmetics and also each batch of the final product and shall maintain records of registration showing the particulars in respect of such tests. The records or registers shall be retained for a period of three years from the date of manufacture.
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1. Ins. by G.S.R. 444, dt. 28-4-1973.
2. Ins. by G.S.R. 681 (E), dt. 6-6-1988.
3. Ins. by G.S.R. 1594, dt. 28-10-1976.
4. Ins. by S.O.2139, dt. 12-8-1972.
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(d) The licensee shall allow an Inspector appointed under the Act to enter with or without prior notice any premises where the manufacture of a substance in respect of which licence is issued is carried on, to inspect the premises and to take samples of the manufactured products under a receipt.
(e) The licensee shall allow an Inspector to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act, and the rules made thereunder have been complied.
(f) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.]
143. Cancellation and suspension of licence.− (1) The Licensing Authority may, after giving the licensee an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the substances to which it relates, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act or the rules made thereunder.
(2) A licensee whose license has been suspended or cancelled may appeal within a period of three months from the date of the order to the State Government which shall after considering the appeal, pass orders, and such orders shall be final.
1[144. Prohibition of manufacture of cosmetics containing colours other than those prescribed.- No Cosmetic shall be manufactured which contains Dyes, Colours and Pigments other than the one specified by the Bureau of Indian Standards (IS: 4707 Part I as amended) and Schedule Q.
The permitted Synthetic Organic colours and Natural Organic colours used in the Cosmetic shall not contain more than−
(i) 2 parts per million of arsenic calculated as arsenic trioxide.
(ii) 20 parts per million of lead calculated as lead.
(iii) 100 parts per million of heavy metals other than lead calculated as the total of the respective metals.]
2[144A. Prohibition of manufacture of cosmetics containing Hexachlorophene.— No cosmetic containing Hexachlorophene shall be manufactured:]
1. Subs. by G.S.R. 811(E), dt. 14-11-1994.
2. Ins. by G.S.R. 116, dt. 15.1.1975.
1[Provided that in the case of soaps Hexachlorophene may be used in concentrations not exceeding one per cent weight by weight:
Provided further that the following cautionary note shall be printed and shall appear in a conspicuous manner on the wrapper of package of each soap, namely:-
“Contains Hexachlorophene – not to be used on babies”.]
145. Use of Lead and Arsenic compounds for the purpose of colouring cosmetics prohibited.— The use of Lead and Arsenic compounds for the purpose of colouring cosmetics is prohibited.
2[145A. Form of intimation for purpose of taking samples of cosmetics.— Where an Inspector takes a sample of a cosmetic for the purpose of test or analysis, he shall intimate such purpose in writing in Form 17 to the person from whom he takes it.]
3[145AA. Form of receipt of samples of cosmetics where fair price tendered is refused.- Where the fair price, for the samples of Cosmetics taken for the purpose of test or analysis, tendered under sub-section (1) of section 23 has been refused, the Inspector shall tender a receipt therefor to the person from whom the said samples have been taken as specified in Form 17A.]
2[145B. Form of receipt for seized cosmetics.− A receipt by an Inspector for the stock of any cosmetic seized under clause (c) of sub-section (1) of section 22 of the Act shall be in Form 15.]
4[145BA. Manner of certifying copies of seized documents.- The Drugs Inspector shall return the documents, seized by him under clause (cc), or produced before him under clause (cca), of sub-section (1) of section 22 of the Act, within a period of twenty days of the date of such seizure or production, to the person from whom they were seized or, as the case may be, the person who produced them, after copies thereof or extracts therefrom have been signed by the Drugs Inspector concerned and the person from whom they were seized, or, as the case may be, who produced such records.]
5[145C. Form of order not to dispose of stocks of cosmetics— An order in writing by an Inspector under clause (c) of sub-section (1) of section 22 of the Act requiring a person not to dispose of any stock of cosmetics in his possession shall be in Form 15.]
6[145D. Prohibition of manufacture of cosmetics containing mercury compounds.– No cosmetics containing mercury compounds shall be manufactured.]
1. Ins. by G.S.R. 1049 (E), dt. 29-8-1986.
2. Ins. by S.O. 2139, dt. 5.6.1972.
3. Ins. by G.S.R. 292 (E), dt. 29-5-1997.
4. Ins. by G.S.R. 89(E), dt. 16-2-1985.
5. Ins. by G.S.R. 1594, dt. 28-10-1976.
6. Ins. by G.S.R. 1074, dt. 19.8.1978 (w.e.f. 2.9.1978).
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PART XV
1[LABELLING, PACKING AND STANDARDS OF COSMETICS]
146. Prohibition of sale or distribution.– Subject to other provisions of these rules, no person shall sell or distribute any cosmetic unless the cosmetic, if of Indian origin is manufactured by a licensed manufacturer and labelled and packed in accordance with these rules.
2[147. Exemption of cosmetics not manufactured for consumption or sale in India from the provisions of this Part.– Labels on packages or containers of cosmetics not manufactured for consumption or sale in India shall be adopted to meet the specific requirements, if any, of the consignee:
Provided that where a cosmetic is required by the consignee to be not labelled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the Licensing Authority mentioned in rule 21.]
148. Manner of labelling.– Subject to other provisions of the rules, a cosmetic shall carry.–
(1) on both the inner and outer labels;
(a) the name of the cosmetic,
3[(b) the name of the manufacturer and complete address of the premises of the manufacturer where the cosmetic has been manufactured.
Provided that if the cosmetic is contained in a very small size container where the address of the manufacturer cannot be given, the name of the manufacturer and his principal place of manufacture shall be given along with pin code.]
(2) On the outer label.–
A declaration of the net contents expressed in terms of weight for solids, fluid measure for liquids, weight for semi-solids, combined with numerical count if the content is sub-divided:
Provided that this statement need not appear in case of a package of perfume, toilet water or the like the net content of which does not exceed 60 ml or any package of solid or semi- solid cosmetic the net content of which does not exceed 30 grams.
(3) On the inner label, where a hazard exists–
(a) adequate direction for safe use,
(b) any warning, caution or special direction required to be observed by the consumer,
(c) a statement of the names and quantities of the ingredients that are hazardous or poisonous.
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1. Subs. by S.O. 3408, dt. 1.11.1996.
2. Subs. by G.S.R. 682 (E), dt. 5-12-1980.
3. Subs. by G.S.R. 352 (E), dt. 26-4-2000.
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1[(4) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figures representing the batch number being preceded by the letter “B”:
Provided that this clause shall not apply to any cosmetic containing 10 grams or less if the cosmetic is in solid or semi-solid state, and 25 millilitres or less if the cosmetic is in a liquid state:
2[Provided further that in the case of soaps, instead of the batch number, the month and year of manufacture of soap shall be given on the label.]
1[(5) manufacturing licence number, the number being preceded by the letter ‘M‘.]
(6) Where a package of a cosmetic has only one label, such label shall contain all the information required to be shown on both the inner and the outer labels, under these Rules.
5[(7) The list of ingredients, present in concentration of more than one percent shall be listed in the descending order of weight or volume at the time they are added, followed by those inconcentration of less than or equal to one percent, in any order, and preceded by the words ‘INGREDIENTS‘.
Provided that this statement need not appear for packs of less than 60 ml of liquid and30 gm of solid and semi-solids.
(8) Labeling requirement, if any, specified in the relevant Indian standard as laid down by the ‘Bureau of Indian Standards‘ for the cosmetics covered under Schedule S.]
3[148A. Prohibition against altering inscriptions on containers, labels or wrappers of cosmetics.- No person shall alter, obliterate or deface any inscription or mark made or recorded by the manufacturer on the container, label or wrapper of any cosmetic:
Provided that nothing in this rule shall apply to any alteration, inscription or mark made on the container, label or wrapper of any cosmetic at the instance or direction or with the permission of the licensing authority.]
5[148B – Prohibition against false or misleading claims:- No cosmetic may purport or claimto purport or convey any idea which is false or misleading to the intending user.]
149. 4[Labelling of Hair dyes containing Dyes, Colours and Pigments.— Hair dyes containing Para-Phenylenediamine or other Dyes, Colours and Pigments] shall be labelled with the following legend in English and local languages and these shall appear on both the inner and the outer labels.
“Caution—This product contains ingredients which may cause skin irritation in certain cases and so a preliminary test according to the accompanying direction should first be made. This product should not be used for dyeing the eye-lashes or eye-brows; as such a use may cause blindness”.
Each package shall also contain instructions in English and local languages on the following lines for carrying out the test:
“This preparation may cause serious inflammation of the skin in some cases and so a preliminary test should always be carried out to determine whether or not special sensitivity exists. To make the test, cleanse a small area of skin behind the ear or upon the inner surface of the forearm, using either soap and water or alcohol. Apply a small quantity of the hair dye as prepared for use to the area and allow it to dry.
After twenty-four hours, wash the area gently with soap and water. If no irritation or inflammation is apparent, it may be assumed that no hypersensitivity to the dye exists. The test should, however, be carried out before each and every application. This preparation should on no account be used for dyeing eye- brows or eye-lashes as severe inflammation of the eye or even blindness may result.]
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1. Subs. by G.S.R. 245, dt. 3-2-1976.
2. Ins. by. 681(E), dt. 6-8-1988.
3. Ins. by G.S.R. 351 (E), dt. 26-4-2000.
4. Subs. by G.S.R. 811 (E), dt. 14-11-1994.
5. Ins. by. 46 (E), dt. 22-1-2009.
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1[149A. Special provisions relating to toothpaste containing fluoride.-
(i) Fluoride content in tooth paste shall not be more than 1000 ppm and the content of fluoride in terms of ppm shall be mentioned on the tube and carton.
(ii) Date of expiry should be mentioned on tube and carton.]
150. Report of result of test or analysis of cosmetics.— Test reports on samples of cosmetics taken for test or analysis under these rules shall be supplied in Form 34.
2[150-A. Standard for cosmetics.- Subject to the provisions of these rules, the standards for cosmetics shall be such as may be prescribed in Schedule S.]
3 [PART XV (A)
APPROVAL OF INSTITUTIONS FOR CARRYING OUT TESTS ON DRUGS, COSMETICS AND RAW MATERIALS USED IN THEIR MANUFACTURE ON BEHALF OF LICENSEES FOR MANUFACTURE FOR SALE OF DRUGS / COSMETICS
150-B. Application for grant of testing drugs/cosmetics— (1) Application for grant or renewal of approval for carrying out tests for identity, purity, quality and strength on drugs or cosmetics or the raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of drugs or cosmetics, shall be made in Form 36 to the Licensing Authority appointed by the State Government for the purposes of Part VII, VII (A) or XIV of these Rules, as the case may be and referred to as the “approving authority” under this Part and shall be accompanied by an inspection fee of 2[rupees six thousand] in the case of testing of drugs specified in Schedules C and C (1) and 2[rupees one thousand five hundred] in the case of testing of drugs other than those specified in Schedules C and C (1), homoeopathic drugs and cosmetics:
Provided that the applicant shall furnish to the approving authority such additional information as may be required by him in connection with the application in Form 36:
4[Provided further that if the applicant applies for renewal of approval after its expiry but within six months of such expiry, the inspection fee payable shall be rupees six thousand in the case of testing of drugs specified in Schedules C and C (1) and rupees one thousand five hundred in the case of testing of drugs other than those specified in Schedules C and C (1), Homoeopathic medicines and cosmetics plus an additional fee at the rate of rupees one thousand per month.]
4[(2) A separate application shall be made for grant of approval for carrying out tests on additional categories of drugs or items of cosmetics and shall be accompanied by an inspection fee of rupees one thousand five hundred in the case of drugs specified in Schedule C and Schedule C(1) and rupees one thousand each in case of drugs other than those specified in Schedule C and Schedule C(1), homeopathic medicines and cosmetics.
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1. Ins. by G.S.R. 223 (E), dt. 19-4-1991.
2. Ins. by G.S.R. 510 (E), dt. 26-7-1982.
3. Ins. rule 150B to 150K by X.1104/7/76-D&M, dt. 23-8-1977.
4. Subs. by G.S.R. 601(E), dt. 24-8-2001.
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Explanation— For the purpose of this Part, the words ‘drugs‘ and ‘cosmetics‘ shall also mean and include the raw materials used in the manufacture of drugs including Homoeopathic drugs or cosmetics, as the case may be.]
150-C. Form in which approval to be granted for carrying out tests on drugs / cosmetics on behalf of licensees for manufacture of drugs/cosmetics and conditions for grant or renewal of such approval.– (1) Approval for carrying out such tests of identity, purity, quality and strength of drugs or cosmetics as may be required under the provisions of these rules, on behalf of licensee for manufacture of drugs or cosmetics shall be granted in Form 37.
(2) Before approval in Form 37 is granted or renewed, the following conditions shall be complied with by the applicant–
(1) The premises where the tests are being carried out shall be well lighted and properly ventilated except where the nature of tests of any drug or cosmetic warrants otherwise. Wherever necessary, the premises shall be air conditioned so as to maintain the accuracy and functioning of laboratory instruments or to enable the performance of special tests such as sterility tests, microbiological tests, etc.
(2) The applicant shall provide adequate space having regard to the nature and number of samples of drugs or cosmetics proposed to be tested.
Provided that the approving authority shall determine from time to time whether the space provided continues to be adequate.
(3) If it is intended to carry out tests requiring the use of animals, the applicant shall provide for an animal house and comply with the following requirements–
(a) The animal house shall be adequate in area, well lighted and properly ventilated and the animals undergoing tests shall be kept in air conditioned area.
(b) The animals shall be suitably housed in hygienic surroundings and necessary provisions made for removal of excreta and foul smell.
(c) The applicant shall provide for suitable arrangements for preparation of animal feed.
(d) The applicant shall provide for suitable arrangements for quarantining of all animals immediately on their receipt in the institution.
(e) The animals shall be periodically examined for their physical fitness.
(f) The applicant shall provide for isolation of sick animals as well as animals under test.
(g) The applicant shall ensure compliance with the requirements of the Prevention of Cruelty to Animals Act, 1960 (59 of 1960).
(h) The applicant shall make proper arrangements for the disposal of the carcasses of animals in a manner as not to cause hazard to public health.
(4) The applicant shall provide and maintain suitable equipment having regard to the nature and number of samples of drugs or cosmetics intended to be tested which shall be adequate in the opinion of the approving authority.
(5) The testing of drugs or cosmetics, as the case may be, shall be under the active direction of a person whose qualifications and experience are considered adequate in the opinion of the approving authority and who shall be held responsible for the reports of test or analysis issued by the applicant.
(6) The testing of drugs or cosmetics, as the case may be, for identity, purity, quality and strength shall be carried out by persons whose qualifications and experience of testing are adequate in the opinion of the approving authority.
(7) The applicant shall provide books of standards recognized under the provisions of the Act and the Rules made thereunder and such books of reference as may be required in connection with the testing or analysis of the products for the testing of which approval is applied for.
150D. Duration of approval.– An approval granted in Form 37 or renewed in Form 38, unless sooner suspended or withdrawn, shall be 1[valid for a period of five years on and from the date on which] it is granted or renewed:
Provided that if an application for the renewal of an approval in Form 37 is made before its expiry or if the application is made within six months of its expiry after the payment of the additional fee, the approval shall continue to be in force until orders are passed on the applications and the approval shall be deemed to have expired if the application for its renewal is not made within six months of its expiry.
150E. Conditions of approval– An approval in Form 37 shall be subject to the following general conditions: —
(a) The institution granted approval under this Part (hereinafter referred to as the approved institution) shall provide and maintain an adequate staff and adequate premises and equipment as specified in rule 150-C 2[and Schedule L-1].
(b) The approved institution shall provide proper facilities for storage so as to preserve the properties of the samples to be tested by it.
(c) The approved institution shall maintain records of tests for identity, purity, quality and strength carried out on all samples of drugs or cosmetics and the results thereof together with the protocols of tests showing the readings and calculation in such form as to be available for inspection and such records shall be retained in the case of substances for which an expiry date is assigned for a period of two years from the expiry of such date and in the case of other substances for a period of six years.
(d) The approved institution shall allow the Inspector appointed under this Act to enter with or without prior notice the premises where the testing is carried on and to inspect the premises and the equipment used for test and the testing procedures employed. The institution shall allow the Inspectors to inspect the registers and records maintained under these Rules and shall supply to such Inspectors such information as they may require for the purpose of ascertaining whether the provisions of the Act and Rules made thereunder have been observed.
(e) The approved institution shall from time to time report to the approving authority any changes in the person-in-charge of testing of drugs or cosmetics or in the expert staff responsible for testing as the case may be and any material alteration in the premises or changes in the equipment used for the purposes of testing which have been made since the date of last inspection made on behalf of the approving authority before the grant or renewal of approval.
_
1. Subs. by G.S.R. 601 (E), dt. 24-8-2001.
2. Ins. by G.S.R. 780 (E), dt. 10-11-2008.
_
(f) The approved institution shall furnish reports of the results of test or analysis in Form 39.
(g) In case any sample of a drug or a cosmetic is found on test to be not of standard quality, the approved institution shall furnish the approving authority 1[and the licensing authority of the State where the manufacturer and/or sender of the drug or cosmetic is located] with copy of the test report on the sample with the protocols of tests applied.
(h) The approved institution shall comply with the provisions of the Act and Rules made thereunder and with each further requirements, if any, may be specified in the rules subsequently made under Chapter IV of the Act of which the approving authority has given the approved institution not less than four months notice.
(i) The approved institution shall maintain an Inspection Book to enable the Inspectors to record his impression or defects noticed.
150F. Inspection before grant of approval.— Before an approval in Form 37 is granted, the approving authority shall cause the institution at which the testing of drugs or cosmetics, as the case may be, is proposed to be carried out to be inspected jointly by the Drugs Inspectors of the Central Drugs Standard Control Organisation and the State Drugs Control Organisation who shall examine the premises and the equipment intended to be used for testing of drugs or cosmetics and inquire into the professional qualifications of the expert staff to be employed.
150G. Report of Inspection.— The Drug Inspector mentioned in rule 150-F shall forward to the approving authority a detailed report of the result of the inspection.
150H. Procedure of approving authority.— (1) If the approving authority after such further enquiry, if any, as he may consider necessary, is satisfied that the requirements of the rules made under the Act have been complied with and that the conditions of the approval and the rules made under the Act will be observed, he shall grant an approval in Form 37.
(2) If the approving authority is not so satisfied, he shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which must be satisfied before an approval could be granted.
150-I. Further application after rejection.— If within a period of six months from the rejection of an application for approval, the applicant informs the approving authority that the conditions laid down have been satisfied and deposits inspection fee of 2[rupees two hundred and fifty], the approving authority may, if, after causing a further inspection to be made, he is satisfied that the conditions for grant of approval have been complied with, grant the approval in Form 37.
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1. Ins. by G.S.R 93 (E), dt. 24-2-1995.
2. Subs.by G.S.R 601 (E), dt. 24-8-2001.
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150J. Renewal.– On an application being made for renewal the approving authority may cause an inspection to be made and if satisfied that the conditions of the approval and the rules made under the Act are and shall continue to be observed shall issue a certificate of renewal in Form 38.
150K. Withdrawal and suspension of approvals – (1) The approving authority may, after giving the approved institution an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, withdraw an approval granted under this Part or suspend it for such period as he thinks fit either wholly or in respect of some of the categories of drugs or items of cosmetics to which it relates, if in his opinion the approved institution has failed to comply with any of the conditions of the approval or with any provisions of the Act or the Rules made thereunder.
(2) Any approved institution whose approval has been suspended or withdrawn may within three months of the date of the order, appeal to the State Government which shall dispose of the appeal in consultation with a panel of competent persons appointed by it in this behalf and notified in the Official Gazette.]
1[PART XVI
MANUFACTURE FOR SALE OF AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS
151. Manufacture on more than one set of premises.— If Ayurvedic (including Siddha) or Unani drugs are manufactured on more than one set of premises, a separate application shall be made and a separate licence shall be obtained in respect of each such set of premises.
152. Licensing Authorities.— For the purpose of this Part the State Government shall appoint such Licensing Authorities and for such areas as may be specified in this behalf by notification in the Official Gazette.
153. Application for licence to manufacture Ayurvedic (including Siddha) or Unani drugs.— (1) An application for the grant or renewal of a licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 24-D to the Licensing Authority along with 2[a fee of rupees one thousand]:
Provided that in the case of renewal the applicant may apply for the renewal of the licence before its expiry or within one month of such expiry:
Provided further that the applicant may apply for renewal after the expiry of one month but within three months of such expiry in which case the 2[fee payable for renewal of such licence shall be rupees one thousand and two hundred plus an additional fee of rupees six hundred].
(ii) 2[A fee of rupees three hundred] shall be payable for a duplicate copy of a licence issued under this rule, if the original licence is defaced, damaged or lost.
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1. Parts XVI, XVII and XVII added by S.O. 642, dt. the 2-2-1970 (w.e.f. 21.2.1970) 2. Subs. by G.S.R 79 (E), dt. 14-2-2005.
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1[153A. Loan Licence.— (i) An application for the grant of renewal of a loan licence to manufacture for sale of any Ayurvedic (including Siddha) or Unani drugs shall be made in Form 25-E to the Licensing Authority along with 2[a fee of rupees six hundred.]
Explanation—For the purpose of this rule, a loan licence means a licence which a Licensing Authority may issue to an applicant who does not have his own arrangements for manufacture but intends to avail himself of the manufacturing facilities owned by a licence in Form 25-D:
Provided that in the case of renewal the applicant may apply for the renewal of the licence before its expiry or within one month of such expiry:
Provided further that the applicant may apply for renewal after the expiry of one month, but within three months of such expiry in which case 2[the fee payable for renewal of such licences shall be rupees six hundred plus an additional fee of rupees three hundred.]]
(ii) 2[A fee of rupees one hundred and fifty] shall be payable for a duplicate copy of a licence issued under this rule, if the original licence is defaced, damaged or lost.]
154. Form of licence to manufacture Ayurvedic (including Siddha) or Unani drugs.— (1) Subject to the conditions of rule 157 being fulfilled, a licence to manufacture for sale any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25-D. The licence shall be issued within a period of three months from the date of receipt of the application.
(2) A licence under this rule shall be granted by the licensing authority after consulting such expert in Ayurvedic (including Siddha) or Unani Systems of medicine as the case may be, which the State Government may approve in this behalf.
1[154A. Form of loan licence to manufacture for sale of Ayurvedic (including Siddha) or Unani drugs.—
(1) A loan licence to manufacture for sale of any Ayurvedic (including Siddha) or Unani drugs shall be issued in Form 25E.
(2) A licence under this rule shall be granted by the Licensing Authority after consulting such expert in Ayurvedic (including Siddha) or Unani systems of medicine, as the case may be, which the State Government may approve in this behalf.
(3) The Licensing Authority shall, before the grant of a loan licence, satisfy himself that the manufacturing unit has adequate equipment, staff, capacity for manufacture and facilities for testing, to undertake the manufacture on behalf of the applicant for a loan licence.]
155. Certificate of renewal— The certificate of renewal of a licence in Form 25-D shall be issued in Form 26-D.
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1. Ins. by G.S.R. 376(E), dt. 20-7-1978.
2. Subs. by G.S.R 79 (E), dt. 14-2-2005.
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1[155A. Certificate of renewal of a loan licence.— The certificate of renewal of a loan licence in Form 25-E shall be issued in Form 26-E.]
2[155B. Certificate of award of G.M.P. of Ayurveda, Siddha and Unani Drugs.— 3[(1)]The certificate of Good Manufacturing Practices to manufacturers of Ayurveda, Siddha or Unani drugs shall be issued to licensees who comply with the requirements of Good Manufacturing Practice of Ayurveda, Siddha and Unani drugs as laid down in Schedule T.]
4[(2) The certificate referred to in sub-rule (1) shall be issued for a period of five years from the date of issuance of the license.]
156. Duration of licence— An original licence in Form 25-D or a renewed licence in Form 26-D, unless sooner suspended or cancelled shall be 5[ valid for a period of 6[five years] from the date of its issue]:
Provided that if the application for the renewal of a licence is made before its expiry or within one month of its expiry after payment of the additional fee of rupees thirty, the licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired, if the application for its renewal is not made within three months of its expiry.]
1[156A. Duration of loan licence.— An original loan licence in Form 25-E or a renewed loan licence in Form 26-E, unless sooner suspended or cancelled, shall be valid up to the 31st December of the year following the year in which it is granted or renewed:
Provided that if the application for the renewal of a loan licence is made in accordance with rule 153-A, the loan licence shall continue to be in force until orders are passed on the application. The licence shall be deemed to have expired, if the application for its renewal is not made within three months of its expiry.]
157. Conditions for the grant or renewal of a licence in Form 25-D.— Before a licence in Form 25-D is granted or renewed in Form 26-D the following conditions shall be complied with by the applicant, namely: —
(1) The manufacture of Ayurvedic (including Siddha) or Unani drugs shall be carried out in such premises and under such hygienic conditions as are specified in Schedule T.
2[(IA) For issuing of the certificate of Good Manufacturing Practices, the Licensing Authority shall verify the requirements as per schedule T and issue the Good Manufacturing Practices certificate in form 26 E-I, simultaneously along with grant or renewal of licence in form 25D].
7[(IB) No manufacturer shall use any prefix or suffix with the name of any Ayurvedic, Siddha or UnaniTibb drug falling under clause (a) of section 3 of the Act, except as described in the authoritative books specified in the First Schedule to the Act:
Provided that a formulation without any specific name, described in the authoritative books may be named on the basis of the ingredients of the formulation.
(IC) The name of any Ayurvedic, Siddha or UnaniTibb drug falling under clause (a) of section 3 of the Act shall not be used for naming any patent or proprietary medicine relating to Ayurvedic, Siddha or UnaniTibb systems of medicine referred to in sub-clause (i) of clause (h) of the said section:
Provided that this rule shall not be applicable for single plant-ingredient based Ayurvedic, Siddha or UnaniTibb formulation licensed or to be licensed as patent or proprietary medicine under sub-clause (i) of clause (h) of section 3 of the Act.]
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1. Ins. by G.S.R. 376 (E),dt. 20-7-1978. 7. Ins. by G.S.R. 390 (E),dt. 18.5.2015.
2. Subs. by G.S.R. 376 (E),dt. 3-5-2010. Earlier Ins. by G.S.R. 198 (E), dt. 7-3-2003.
3. Rule 155B renumbered as sub-rule (1) by G.S.R. 376 (E),dt. 3-5-2010. 4. Ins. by G.S.R. 376 (E),dt. 3-5-2010.
5. Subs. by G.S.R 79 (E), dt. 14-2-2005.
6. Subs. by G.S.R. 376 (E),dt. 3-5-2010.
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(ID) Notwithstanding the period for renewal of licence provided in rules 156 and 156 A, the licensee of the Ayurvedic, Siddha or UnaniTibb drug, which is not in conformity with sub-rules (1B) and (1C), shall seek renewal of the licence with appropriate name of the drug within a period of one year from the date of commencement of Drugs and Cosmetics (4th Amendment) Rules, 2015:
Provided that this rule shall not be applicable to any batch of Ayurvedic, Siddha or UnaniTibb drugs manufactured prior to the date of commencement of the Drugs and Cosmetics (4th Amendment) Rules, 2015.
(IE) Whoever contravenes the provisions of rules (IB) to (ID) shall be punishable under section 33-I of the Act.]
(2) The manufacture of Ayurvedic (including Siddha) or Unani drugs shall be conducted under the direction and supervision of competent technical staff consisting at least of one person, who is a whole time employee and who possesses the following qualifications, namely:–
(a) A degree in Ayurveda or Ayurvedic Pharmacy, Siddha or Unani system of medicine, as the case may be, conferred by a University, a State Government or Statutory Faculties, Councils and Boards of Indian Systems of Medicines recognized by the Central Government or a State Government for this purpose, or
(b) a diploma in Ayurveda, Siddha or Unani system of medicine granted by a State Government for this purpose, or
(c) a graduate in Pharmacy or Pharmaceutical Chemistry or Chemistry or Botany of a University recognized by the Central Government with experience of at least two years in the manufacture of drugs pertaining to the Ayurvedic or Siddha or Unani systems of medicines, or
(d) a Vaid or Hakim registered in a State Register of Practitioners of indigenous systems of medicines having experience of at least four years in the manufacture of Ayurvedic or Siddha or Unani drugs, or
(e) a qualification as Pharmacist in Ayurvedic (including Siddha) or Unani systems of medicines, possessing experience of not less than eight years in the manufacture of Ayurvedic or Siddha or Unani drugs as may be recognized by the Central Government.
(3) The competent technical staff to direct and supervise the manufacture of Ayurvedic drugs shall have qualifications in Ayurveda and the competent technical staff to direct and supervise the manufacture of Siddha drugs and Unani drugs shall have qualification in Siddha or Unani, as the case may be.
3[157A. Maintaining of records of raw material used by licensed manufacturing unit of Ayurveda, Siddha and Unani drugs in the preceding financial year.- Each licensed manufacturing unit of Ayurveda or Siddha or Unani drugs shall keep a record of raw material used by each licensed manufacturing unit of Ayurveda, Siddha or Unani drugs as the case may be in the proforma given in Schedule TA in respect of all raw materials utilized by that unit in the manufacture of Ayurveda or Siddha or Unani drugs in the preceding financial year, and shall submit the same by the 30th day of June of the succeeding financial year to the State Drug Licensing Authority of Ayurveda, Siddha and Unani drugs and to the National Medicinal Plants Board or any agency nominated by the National Medicinal Plant Board for this purpose.]
158. Conditions of licence.— A licence in Form 25D shall be subject to the conditions stated therein and to the following further conditions, namely:–
(a) The licensee shall maintain proper records of the details of manufacture and of the tests, if any, carried out by him, or by any other person on his behalf, of the raw materials and finished products.
(b) The licensee shall allow an Inspector appointed under the Act to enter any premises where the manufacture of a substance in respect of which the licence is issued is carried on, to inspect the premises, to take samples of the raw material as well as finished the products, and to inspect the records maintained under these rules.
1[(c) The licensee shall maintain an Inspection Book in Form 35 to enable an Inspector to record his impressions and the defects noticed.]
2[158-A. Condition of loan licence.— A licence in Form 25E shall be subject to the conditions stated therein and to the following conditions, namely:—
(a) The licence in Form 25E shall be deemed to be cancelled or suspended, if the licence owned by the licensee in Form 25D whose manufacturing facilities have been availed of by the licensee is cancelled or suspended, as the case may be, under these rules.
(b) The licensee shall comply with the provisions of the Act and of the rules and with such further requirements, if any, as may be specified in any rules subsequently made under Chapter IV-A of the Act, provided that where such further requirements are specified in the rules; these would come into force four months after publication in the Official Gazette.
(c) The licensee shall maintain proper records of the details of manufacture and of the tests, if any, carried out by him, or any other person on his behalf, of the raw materials and finished products.
(d) The licensee shall allow an Inspector appointed under the Act to inspect all registers and records maintained under these rules and shall supply to the Inspector such information as he may require for the purpose of ascertaining whether the provisions of the Act and the rules have been observed.
1[(e) The licensee shall maintain an Inspection Book in form 35 to enable an Inspector to record his impressions and the defects noticed.]
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1. Ins. by G.S.R. 331 (E),dt. 8.5.1984.
2. Ins. by G.S.R. 376 (E), dt. 20.7.1978.
3. Ins. by G.S.R. 512 (E),dt. 9.7.2008.
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1[158(B) Guidelines for issue of license with respect to Ayurveda, Siddha or Unani drugs.-
I. (A). Ayurveda, Siddha Unani Medicines under section 3(a):- Ayurveda, Siddha or Unani drugs includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb system of medicine, as specified in the First Schedule;
(B). Patent or Proprietary medicine under section 3(h);
(i) In relation to Ayurvedic, Siddha and Unani Tibb system of medicine of all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb system of medicines specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as specified in clause (a);
(ii) Balya/Poshak/Muqawi/Unavuporutkal/positive health Promoter formulations having ingredients mentioned in books of First Schedule of the Drugs and Cosmetics Act and recommended for promotional and preventive health.
(iii) Saundarya Prasadak (Husane afza)/Azhagh-sadhan formulation having ingredients mentionedin Books of First Schedule of the Drugs and Cosmetics Act and recommended for oral, skin, hair and body care.
(iv) Aushadh Ghana (Medicinal plant extracts – dry/wet) extract obtained from plant mentioned in books of First Schedule of the Act including Aqueous or hydro-alcohol.
II.(A) For issue of licence to the medicine with respect to Ayurvedic, Siddha and Unani, the conditions relating to safety study and the experience or evidence of effectiveness shall be such as specified in columns (5) and (6) of The Table given below:-
| Serial number |
Category |
Ingredient (S) |
Indication (s) |
Safety study |
Experience/Evidence of Effectiveness |
| 1 |
2 |
3 |
4 |
5 |
6 |
| |
|
|
|
|
Published Literature |
Proof of Effectiveness |
| 1 |
(A) Ayurveda, siddha and Unani drugs, given in 158 B as referred in 3(a) |
As per text |
As per text |
Not Required |
Required |
Not Required |
| 2 |
(B) Any change in dosage form of Ayurveda, siddha and Unani drugs, as described in section 3 (a) of the Drugs and Cosmetics Act, 1940 |
As per text |
As per text |
Not Required |
Required |
Not Required |
| 3 |
(C) Ayurveda, siddha and Unani drugs, referred in 3(a) to be used for new indication |
As per text |
New |
Not Required |
If Required |
Required |
II.B For issue of license with respect to Patent or Proprietary medicine. The condition relating to Safety studies and experience or evidence of effectiveness shall be specified as follows:-
| Serial number |
Category |
Ingredient (S) |
Indication (s) |
Safety study |
Experience/Evidence of Effectiveness |
| 1 |
2 |
3 |
4 |
5 |
6 |
|
|
|
|
|
Published Literature |
Proof of Effectiveness |
| 1 |
Patent orPropri etary medicine |
As per text |
Textual Rationale |
Not Required |
Of Ingredients |
Pilot study as per relevant protocol for Ayurveda, siddha and Unani drugs |
| 2 |
Ayurveda, siddha and Unani drugswith any of the ingredients of Schedule E(1) of the Drugs and Cosmetics Act, 1940 |
As per text |
Existing |
Required |
Required |
Required |
III. For issue of license with respect to Balya and Poshak medicines the person who applied for license is required to submit the following:
(i) Photo-copy of the textual reference of ingredients used in the formulation as mentioned in the book of 1st schedule;
(ii) Conduct safety studies in case the product contains of any of the ingredients as specified in the Schedule E (1), as per the guidelines for evaluation of Ayurveda Siddha and Unani Drugs formulations;
(iii) For textual indications the safety and effectiveness study is not required.
IV. For issue of license with respect to Saundarya Prasadak (Husane afza/Azhagu Sodhan) the person who applied for license is required to:-
(i) Submit photo-copy of the textual reference of ingredients used in the formulation as mentioned in the book of 1st schedule;
1. Ins. by G.S.R. 663 (E),dt. 10.10.2010.
(ii) Conduct safety studies, in case the formulation contains of any of the ingredients as specified in the Schedule E (1), as per the guidelines for evaluation of Ayurveda, Siddha and Unani formulation;
(iii) For textual indications the safety and effectiveness study is not required.
V. For issue of license with respect to medicine Aushadh Ghana extract of medicinal plant (dry or wet).
| Serial number |
Category |
Ingredien t (S) |
Indication (s) |
Safety study |
Experience/Evidence of Effectiveness |
| 1 |
2 |
3 |
4 |
5 |
6 |
|
|
|
|
|
PublishedLiterature |
Proof ofEffectiveness |
| 1 |
(A)Aqueous |
As pertext |
As per text |
Not Required |
NotRequired |
Not Required |
| 2 |
(Al).Aqueous |
As pertext |
New Indication** |
Not Required |
Not Required |
Required |
| 3 |
(B) Hydro- Alcohol |
As per text |
As per text |
Not Required |
If Required |
Not Required |
| 4 |
(B1)Hydro- Alcohol |
As specified |
New Indication** |
Required |
If Required |
Required |
| 5 |
Other than Hydro/ HydroAlc ohol |
As specified |
As specified |
Required Acute, Chronic, mutagenicity and teratogenicity |
If Required |
Required |
* The standard protocol will also include concept of Anupan, Prakriti & Tridosh etc. published by Central Research Councils Ayurveda, Siddha, Unani and other Government/Research Bodies.
** New indication means which is other than mentioned in 1st schedule books of Drugs & Cosmetics Act 1940.]
1[158C. Form of Free Sale Certificate and Non-Conviction Certificate. – The State Drug Controller or Licensing Authority shall, on request by the Ayurveda, Siddha and Unani Drugs manufacturer, issue, within 15 days; from the date of application, Free Sale Certificate in Form 26 E2-I for original License holder or in Form 26 E2-II for loan license and Non Conviction Certifacate for both original and loan license holder in Form 26 E3 or in the format as specified by the importing country or tenderer respectively, after fulfilment of all requisite formalities as required in the respective formats.]
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1. Ins. by G.S.R. 153 (E),dt. 5.3.2014.
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159. Cancellation and suspension of licences— (1) The Licensing Authority may, after giving an opportunity to show cause within a period which shall not be less than fifteen days from the date of receipt of such notice, why such an order should not be passed, by an order in writing stating the reasons therefor, cancel a licence issued under this Part or suspend it for such period as he thinks fit, either wholly or in respect of some of the drugs to which it relates, if in his opinion, the licensee has failed to comply with any of the conditions of the licence or with any provisions of the Act and the rules made thereunder.
(2) A licensee whose licence has been suspended or cancelled may appeal to the State Government within a period of three months from the date of receipt of the order which shall, after considering the appeal, decide the same.
160. Identification of raw materials.— Raw materials used in the preparation of Ayurvedic (including Siddha) or Unani drugs shall be identified and tested, wherever tests are available for their genuineness, and records of such tests as are carried out for the purpose and the methods thereof shall be maintained.
1[PART XVI (A)
APPROVAL OF INSTITUTIONS FOR CARRYING OUT TESTS ON AYURVEDIC, SIDDHA AND UNANI DRUGS AND RAW MATERIALS USED IN THEIR MANUFACTURE ON BEHALF OF LICENSEES FOR MANUFACTURE FOR SALE OF AYURVEDIC, SIDDHA AND UNANI DRUGS
160-A. Application for grant of approval for testing Ayurvedic, Siddha and Unani drugs.- Application for grant or renewal of approval for carrying out tests for identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs or the raw materials used in the manufacture thereof on behalf of licensees for manufacture for sale of the said Ayurvedic, Siddha and Unani drugs, shall be made in Form 47 to the Licensing Authority appointed by the State Government for the purposes of Part XVI, XVII or XVIII of these rules, as the case may be, and referred to as the ‘approving authority‘ under this Part and shall be accompanied by an inspection fee of six thousand rupees in respect of the drugs specified in the books prescribed in First Schedule to the Act.
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1. Subs. by G.S.R.73 (E), dt. 31-01-2003 and earlier Ins. by G.S.R. 701(E), dt. 27-9-2001.
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Provided that the applicant shall furnish to the approving authority such additional information as may be required by it in connection with the application in Form 47:
Provided further that if the applicant applies for renewal of approval after its expiry but within six months of such expiry, the inspection fee payable shall be six thousand rupees plus an additional inspection fee at the rate of one thousand rupees per month in the case of testing of Ayurvedic, Siddha and Unani drugs specified in First Schedule to the Act.
Explanation. – For the purpose of this Part, the words “Ayurvedic, Siddha and Unani drugs” shall also mean and include the raw materials used in the manufacture of Ayurvedic, Siddha and Unani drugs, as the case may be.
160B. Form in which approval to be granted for carrying out tests on Ayurvedic, Siddha and Unani drugs on behalf of licensees for manufacture of Ayurvedic, Siddha and Unani drugs and conditions for grant or renewal of such approval.– (1) Approval for carrying out such tests of identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs as may be required under the provisions of these rules, on behalf of licensee for manufacture of Ayurvedic, Siddha and Unani drugs shall be granted in Form 48.
(2) Before approval in Form 48 is granted or renewed, the following conditions shall be complied with by the applicants, namely:-
(i) The premises where the tests are carried out shall be well lighted and properly ventilated except where the nature of tests of any Ayurvedic, Siddha and Unani drug warrants otherwise. Wherever necessary, the premises shall be air-conditioned so as to maintain the accuracy and functioning of laboratory instruments or to enable the performance of special tests such as sterility tests and microbiological tests.
(ii) (a) The applicant shall provide adequate space having regard to the nature and number of samples of drugs proposed to be tested:
Provided that the approving authority shall determine from time to time whether the space provided continues to be adequate:
Provided further that separate section shall be provided for (i) Chemistry, (ii) Pharmacognosy, (iii) Ayurveda, Siddha and Unani, (iv) Microbiology, (v) Sample Room, (vi) Office-cum-Record Room, with proper partitions and minimum required area is 800 sq. ft.
1[(b) The applicant shall provide a list of persons who may be employed with him as experts, such as Chemist, Botanist and expert in Ayurveda/Siddha/Unani or Pharmacist who shall possess a degree in Chemistry, Botany, Ayurveda/Siddha/Unani/Bachelor in Pharmacy from a recognized University or equivalent, with experience for 2 years for carrying out tests or analysis as per the Ayurvedic, Siddha and Unani Pharmacopoeias].
The applicant shall provide adequate equipment essential for carrying out tests for identity, purity, quality and strength of Ayurvedic, Siddha and Unani drugs as per pharmacopoeial standards or other available standards.
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1. Subs. by G.S.R. 674 (E), dt. 10-11-2005.
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List of equipment recommended is given below:
Chemistry Section
1. Alcohol determination apparatus complete set.
2. volatile oil determination apparatus.
3. Boiling point determination apparatus.
4. Melting point determination apparatus.
5. Refractometer.
6. Polarimeter.
7. Viscometer (Ostwalds, Redwood Viscometer).
8. Tablet disintegration apparatus.
9. Moisture determination apparatus (IC filtrator).
10. U.V.Spectro-photometer.
11. Muffle furnace.
12. Electronic Balance.
13. Hot air oven(s) different range of temperature/vacuum oven.
14. Refrigerator.
15. Glass distillation apparatus/plant.
16. Water supply demineralised exchange equipment/distillation equipment.
17. Air conditioner.
18. LPG Gas cylinder with burners.
19. Water bath (temperature controlled).
20. Heating mantle(4) or as required.
21. TLC apparatus with all accessories.
22. Sieves 10 to 120 with sieve shaker.
23. Centrifuge machine.
24. Dehumidifier.
25. pH meter.
26. G.L.C. with F.I. detector.
27. Silica crucible.
28. Tablet friability tester.
29. Tablet dissolution tester.
30. Other related equipment, reagents, glasswares etc.
Pharmacognosy Section
1. Microscope binocular.
2. Dissecting Microscope.
3. Microtome.
4. Chemical balance.
5. Microslide cabinet.
6. Aluminium slide trays.
7. Hot air oven.
8. Occular Micrometer.
9. Stage Micrometer.
10. Camera Lucida Prism type and mirror type.
11. Hot plates.
12. Refrigerator.
13. LPG Cylinder with burners.
14. Other related equipments, reagents, glasswares etc.
Note: Instuments like HPLC, HPTLC, Atomic Absorption spectrophotometer could be arranged by tie up with other laboratories.
Microbiology section
1. Laminar air flow bench (L.A.F.)
2. B.O.D. Incubator.
3. Plain Incubator.
4. Serological water bath.
5. Oven.
6. Autoclave/sterilizer.
7. Microscope (high power).
8. Colony counter.
9. Other related equipment and reagents.
(3). The applicant shall provide and maintain suitable equipment having regard to the nature and number of samples of Ayurvedic, Siddha and Unani drugs intended to be tested which shall be adequate in the opinion of the approving authority.
(4) The testing of Ayurvedic, Siddha and Unani drugs, as the case may be, for identity, purity, quality and strength shall be carried out under the active direction of one of the experts stated in clause (b) of sub-rule (2) who shall be the person-in-charge of testing and shall be held responsible for the reports of test issued by the applicant.
(5) The testing of Ayurvedic, Siddha and Unani drugs, as the case may be, for identity, purity, quality and strength shall be carried out by persons whose qualifications and experience of testing are adequate as stated in clause (b) of sub-rule (2).
(6) The applicant shall provide books of standards recognized under the provisions of the Act and the rules made thereunder and such books of reference as may be required in connection with the testing or analysis of the products for the testing of which approval is applied for.
(7) The applicant shall provide list of standard Ayurvedic, Siddha and Unani drugs (Reference samples) recognized under the provisions of the Act and rules made thereunder and such reference samples kept in the laboratory may be required in connection with the testing or analysis of the products of which approval is applied for.
160C. Duration of approval.- An approval granted in Form 48 or renewed in Form 49 unless sooner suspended or withdrawn, shall be valid for a period of three years from the date on which it is granted or renewed:
Provided that if an application for the renewal of an approval in Form 40 is made before its expiry or if the application is made within six months of its expiry after the payment of the additional inspection fee, the approval shall continue to be in force until orders to the contrary are passed on the application and approval shall be deemed to have expired if the application for renewal is not made within six months of expiry.
160D. Conditions of approval.– An approval in Form 48 shall be subject to the following conditions, namely:-
I. The Institution granted approval under this Part (hereinafter referred to as the approved laboratory) shall provide and maintain adequate staff and adequate premises and equipment as specified in rule 160-B.
II. The approved laboratory shall provide proper facilities for storage so as to preserve the properties of the samples to be tested by it.
III. The approved laboratory shall maintain records of tests for identity, purity, quality and strength carried out on all samples of Ayurvedic, Siddha and Unani drugs and the results thereof together with the protocols of tests showing the readings and calculation in such form as to be available for inspection and such records shall be retained in the case of substances for which date of expiry is assigned; for a period of two years from such date of expiry and in the case of other substances, for a period of three years.
IV. The approved laboratory shall allow the Inspector appointed under this Act to enter with or without prior notice the premises where testing is carried out and to inspect the premises and the equipment used for test and the testing procedures employed. The laboratory shall allow the Inspectors to inspect the registers and records maintained under these rules and shall supply to such Inspectors such information as they may require for the purpose of ascertaining whether the provisions of the Act and rules made thereunder have been observed.
V. The approved laboratory shall from time to time report to the approving authority any changes in the person-in-charge of testing of Ayurvedic, Siddha and Unani drugs or the expert staff responsible for testing, as the case may be, and any material alterations in the premises or changes in the equipment used for the purposes of testing which have been made since the date of last inspection made on behalf of the approving authority before the grant or renewal of approval.
VI. The approved laboratory shall furnish reports of the results of tests or analysis in Form 50.
VII. In case any sample of Ayurvedic, Siddha and Unani drug is found on test to be not of standard quality, the approved laboratory shall furnish to the approving authority and the licensing authority of the State where the manufacturer and/or sender of the Ayurvedic, Siddha and Unani drugs is located, a copy of the test report of the sample with the protocols of tests applied.
VIII. The approved laboratory shall comply with the provisions of the Act and rules made thereunder and with such further requirements, if any, as may be specified in the rules made from time to time under Chapter IV-A of the Act of which the approving authority has given the approved laboratory not less than four months‘ notice.
IX. The approved laboratory shall maintain an inspection book to enable the Inspector to record his impression or defects noticed.
160-E. Inspection before grant of approval.— Before an approval in Form 48 is granted, the approving authority shall cause the laboratory at which the testing of Ayurvedic, Siddha and Unani drugs, as the case may be, is proposed to be carried out to be inspected jointly by the Inspectors appointed or designated by the Central Government and State Government for this purpose, who shall examine the premises and the equipment intended to be used for testing of drugs and verify into the professional qualifications of the expert staff who are or may be employed by the laboratory.
160F. Report of inspection.— The Inspectors appointed by the Central Government as stated in Rule 160-E shall forward to the approving authority a detailed report of the results of the inspection.
160G. Procedure of approving authority.- (1) If the approving authority after such further enquiry, if any, as it may consider necessary, is satisfied that the requirements of the rules made under the Act have been complied with and that the conditions of the approval and the rules made under the Act have been observed, it shall grant approval in Form 48.
(2) If the approving authority is not satisfied, it shall reject the application and shall inform the applicant of the reasons for such rejection and of the conditions which shall be satisfied before approval could be granted.
160H. Application after rejection.- If within a period of six months from the rejection of an application for approval, the applicant informs the approving authority that the conditions laid down have been satisfied and deposits inspection fee of two thousand rupees, the approving authority may, if, after causing a further inspection to be made and after being satisfied that the conditions for grant of approval have been complied with, grant the approval in Form 48.
160-I. Renewal. – On an application being made for renewal, the approving authority shall, after causing an inspection to be made and if satisfied that the conditions of the approval and the rules made under the Act have been complied with, shall issue a certificate of renewal in Form 49.
160J. Withdrawal and suspension of approvals. – (1) The approving authority may, after giving the approved laboratory an opportunity to show cause why such an order should not be passed, by an order in writing stating the reasons therefor, withdraw an approval granted under this Part or suspend it for such period as it thinks fit either wholly or in respect of testing of some of the categories of Ayurvedic, Siddha and Unani drugs to which it relates, if in his opinion the approved laboratory had failed to comply with any of the conditions of the approval or with any provision of the Act or the rules made thereunder.
(2) Any approved laboratory, whose approval has been suspended or withdrawn, may, within three months of the date of the order of suspension or withdrawal, appeal to the State Government which shall dispose of the appeal in consultation with a panel of competent persons appointed by the Department of Indian Systems of Medicine & Homoeopathy, Government of India in this behalf and notified in the Official Gazette.]
1[PART XVII
2[LABELLING, PACKING AND LIMIT OF ALCOHOL IN] AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS
161. 2[Labelling, packing and limit of alcohol.]— (1) There shall be conspicuously displayed on the label of the container or package of an Ayurvedic (including Siddha) or Unani drug, the true list of all the ingredients 3[with the botanical names of plant based ingredients along with plant part(s) and form of ingredients, in which, these are] used in the manufacture of the preparation together with quantity of each of the ingredients incorporated therein and a reference to the method of preparation thereof as detailed in the standard text and Adikarana, as are prescribed in the authoritative books specified in the First Schedule to the Act 3[and in respect of Patent or Proprietary Ayurveda, Siddha or Unani drugs, the true list of all ingredients with the botanical names of plant based ingredients along with part(s) and form of ingredients, in which, these are used in the formulation, with their quantity]:
Provided that if the list of ingredients contained in the medicine is large and cannot be accommodated on the label, the same may be printed separately and enclosed with packing and reference be made to this effect on the label.
(2) The container of a medicine for internal use made up ready for the treatment of human ailments shall, if it is made up from a substance specified in Schedule E (1), be labelled conspicuously with the words ‘Caution: To be taken under medical supervision‘ both in English and Hindi language.
____________
1. Ins. by notification F.1-23/6, dt. 2.2.1970. 3. Ins. by G.S.R. 844(E), dt. 26.11.2012 2. Subs. by G.S.R. 904(E), dt. 2.11.1992.
____________
(3) Subject to the other provisions of these rules, the following particulars shall be either printed or written in indelible ink and shall appear in a conspicuous manner on the label of the innermost container of any Ayurvedic (including Siddha) or Unani drug 2[Patent or Proprietary Ayurveda, Siddha or Unani drugs] and on any other covering in which the container is packed’, namely−
(i) The name of the drug. 3[For Ayurveda, Siddha or Unani drugs] this purpose the name shall be the same as mentioned in the authoritative books included in the First Schedule of the Act.
(ii) A correct statement of the net content in terms of weight, measure or number as the case may be. The weight and volume shall be expressed in metric system.
(iii) The name and address of the manufacturer.
(iv) The number of the licence under which the drug is manufactured, the figure representing the manufacturing licence number being preceded by the words
‘Manufacturing Licence Number‘ or ‘Mfg. Lic. No.‘ or ‘M.L.‘.
(v) A distinctive batch number, that is to say, the number by reference to which details of manufacture of the particular batch from which the substance in the container is taken are recorded and are available for inspection, the figure representing the batch number being preceded by the words “Batch No.” or “Batch” or “Lot Number” or “Lot No.” or “Lot” or any distinguishing prefix.
(vi) The date of manufacture. For this purpose the date of manufacture shall be the date of completion of the final products, or the date of bottling or packing for issue.
(vii) The words “Ayurvedic medicine” or “Siddha medicine” or “Unani medicine” as the case may be.
(viii) The words “FOR EXTERNAL USE ONLY” if the medicine is for external application.
(ix) Every drug intended for distribution to the medical profession, as a free sample shall, while complying with the labelling provisions under clauses (i) to (viii), further bear on the label of the container the words “Physicians sample. Not to be sold” which shall be over-printed.
1 [(x)(a) Preparation (Asavas) with high content of alcohol as base
Name of the drug Maximum size of packing
(i) Karpur Asava 15 ml
(ii) Ahiphenasava 15 ml
(iii) Margamadasava 15 ml
(ix)(b) Preparations containing self-generated alcohol
Name of the drug Maximum content of alcohol
(Ethyl alcohol v/v)
Maximum
size of
packing
(i) Mritsanjivani Sura 16 per cent 30 ml.
(ii) Mahadrakshasava 16 per cent 120 ml.]
_____________
1. Subs. by G.S.R. 904 (E), dt. 2-11-1992.
2. Ins. by G.S.R. 844(E), dt. 26.11.2012.
3. Subs. by G.S.R. 844(E), dt. 26.11.2012.
____________
(4) Nothing in these rules shall be deemed to require the labelling of any transparent cover or of any wrapper case or other covering used solely for the purpose of packing, transport or delivery.
1[161A. Exemption in labeling and packing, provisions for export of Ayurvedic (including Siddha) and Unani drugs.- (1) Labels and packages or containers of Ayurvedic, Siddha and Unani drugs for export may be adopted to meet the specific requirements of the law of the country to which the said drug is to be exported, but the following particulars shall appear in conspicuous position on the container in which drug is packed and on every other covering in which that container is packed, namely :
(a) Name of the Ayurvedic, Siddha and Unani drug (Single or compound formulations;
(b) the name, address of the manufacturer and the number of licence under which the drug has been manufactured;
(c) batch or lot number;
(d) date of manufacture, along with the date for “Best for use before”;
(e) main ingredients, if required by the importing country;
(f) for export:
Provided that where Ayurvedic, Siddha and Unani Single or compound drug not classified under the First Schedule or Schedule E-(I), is required by the consignee to be not labeled with the name and address of the manufacturer, the labels on packages or containers shall bear a code number as approved by the Licensing Authority mentioned in rule 152.
(2) the provisions of Rule 161 shall not apply to a medicine made up “ready for treatment”, whether after, or without, alteration, which is supplied on the prescription of a registered medical practitioner if the medicine is labeled with the following particulars, namely:–
(a) the name and address of the suppliers;
(b) the words “For External Use Only”, if the medicine is for external application.]
2[161B. 1. The date of expiry of Ayurveda, Siddha and Unani medicines shall be conspicuously displayed on the label of container or package of an Ayurvedic, Siddhas and Unani medicines, and after the said date of expiry, these medicines shall not be in circulation.
2. The Shelf-life i.e. for Ayurveda, Siddha and Unani medicines shall be as follows:-
(i) Shelf life or date of expiry for Ayurvedic medicines.
| Sl. No. |
Name of the Group of Ayurvedic Medicine |
Shelf life and date ofexpiry with effect fromthe date of manufacture |
| 1. |
Churna, Kwatha Churna |
2 years |
| 2. |
Gutika (Vati-Gutti, Pills, Tablets except Gutika with Rasa) |
3 years |
| 3. |
(i) Gutika Tablet containing Kasth aushadhi (ii) Gutika,Tablet containing Kasth aushadi and Rasa, Uprasa, Metallic Bhasmas, and Guggulu. |
3 years 5 years |
| 4. |
Rasaushadhies |
No expiry date1 |
| 5. |
Asava Arista |
No expiry date1 |
| 6. |
Avaleha |
3 years |
| 7. |
Guggulu |
5 years |
| 8. |
Mandura – Lauha |
10 years |
| 9. |
Ghrita |
2 years |
| 10. |
Taila |
3 years |
| 11. |
Arka |
1 year |
| 12. |
Dravaka, Lavana, Ksara |
5 years |
| 13. |
Lepa Churna |
3 years |
| 14. |
Dant Manjan Powder |
2 years |
| 15. |
Dant Manjan Paste |
2 years |
| 16. |
Lepa Guti |
3 years |
| 17. |
Lepa Malahar (Ointment)/Liniment/Gels/ lotions /creams |
3 years |
| 18. |
Varti |
2 years (one time use) |
| 19. |
Ghana Vati |
3 years |
| 20. |
Kupipakva Rasayan |
No expiry date1 |
| 21. |
Parpati |
No expiry date1 |
| 22. |
Sveta parpati |
2 years |
| 23. |
Pisti and Bhasma |
No expiry date1 |
| 24. |
Svarna, Rajata, Lauha, Mandura, Abhraka bhasma,Godanti, ShankhaBhasma, etc. |
No expiry date1 |
| 25. |
Naga Bhasma, Vanga Bhasma, Tamra Bhasma2 |
5 years2 |
| 26. |
Capsules made of soft gelatin (depending upon thecontent material) for Kashtha aushadhi |
3 years |
| 27. |
Capsules of hard gelatin (depending upon the content material)-containing Kasth aushdhi with Rasa, Bhasma,Parad-Gandhak |
5 years2 |
| 28. |
Syrup/liquid oral |
3 years |
| 29. |
(Kama/Nasa Bindu) Ear/Nasal drops Eye drops |
2 years 1 year |
| 30. |
Khand/Granule/Pak |
3 years |
| 31. |
Dhoopans-Inhalers |
2 years |
| 32. |
Pravahi Kwatha (with preservatives) |
3 years |
1. Ins. by G.S.R. 787 (E), dt. 17-10-2000.
2. Ins. by G.S.R. 764 (E), dt. 15-10-2009.
Note 1. Item at Sr. No.4, 5, 19, 20, 22, 23 have very long shelf life and they became more efficacious with the passage of time and period of ten years shall be mandatory for keeping the records of such items.
Note 2. Bhasmas at Sr. No. 23, start solidifying after five years and they need one or two ‘Puta‘again before using in the dosage form.
(ii) Shelf life or date of expiry for Siddha Medicines
| Sl. No. |
Name of the Group of Medicine |
Shelf life and date ofexpiry with effect
from the date of manufacture |
| 1. |
Karpam |
No expiry date* |
| 2. |
Cunnam |
5 years |
| 3. |
Kalanku |
No expiry date* |
| 4. |
Kattu |
No expiry date* |
| 5. |
Parpam |
No expiry date* |
| 6. |
Centuram |
No expiry date* |
| 7. |
Karuppu |
No expiry date* |
| 8. |
Patankam |
5 years |
| 9. |
Kulampu |
5 years |
| 10. |
Meluku |
5 years |
| 11. |
Tinir |
2 years |
| 12. |
Tiravakam |
2 years |
| 13. |
Mattirai |
3 years |
| 14. |
Tailam |
3 years |
| 15. |
Ilakam |
3 years |
| 16. |
Iracayanaam |
3 years |
| 17. |
Ney |
2 years |
| 18. |
Manappaku |
3 years |
| 19. |
Venney |
3 years |
| 20. |
Vatakam |
3 years |
| 21. |
Curanam |
2 years |
| 22. |
Pura Maruntukal |
5 years |
Note. * Items at Sr. No.1, 3, 4, 5, 6, 22 have very long shelf life and they became more efficacious with the passage of time and period of ten years shall be mandatory for keeping the records of such items.
(iii) Shelf life or date of expiry for Unani System of Medicines
| Sl. No. |
Name of the Group of Medicine |
Shelf life and date ofexpiry with effect
from the date of manufacture |
| 1. |
Habb (Pills) |
3 years |
| 2. |
Qurs (Tablets) |
3 years |
| 3. |
Majoon/Dawa |
3 years |
| 4. |
Khamira |
3 years |
| 5. |
Itrifal |
3 years |
| 6. |
Tiryaq |
3 years |
| 7. |
Laooq |
2 years |
| 8. |
Laboob |
2 years |
| 9. |
Halwa |
2 years |
| 10. |
Mufarreh/Yaqooti |
2 years |
| 11. |
Burood/Surma/Kohal |
3 years |
| 12. |
Kushta |
5 years |
| 13. |
Raughaniyat |
3 years |
| 14. |
Marham/Zimad/Qairooti |
3 years |
| 15. |
Ayarij/Sufoof |
2 years |
| 16. |
Safoof (Namak wala/containing salt) |
1 year |
| 17. |
Sharbat/Sikanjabeen |
3 years |
| 18. |
Jawarish |
3 years |
| 19. |
Capsule |
3 years |
| 20. |
Arq |
1 year |
| 21 |
Qutoor |
1 year |
| 22. |
Nabeez |
5 years |
| 23. |
Murabba |
1 year |
| 24. |
Tila |
2 years] |
1[PART XVIII
GOVERNMENT ANALYSTS AND INSPECTORS FOR AYURVEDIC (INCLUDING SIDDHA) OR UNANI DRUGS
162. Duties of Inspectors specially authorised to inspect the manufacture of Ayurvedic (including Siddha) or Unani drugs— Subject to the instructions of the controlling authority, it shall be the duty of an Inspector authorised to inspect the manufacture of Ayurvedic (including Siddha) or Unani drugs–
_____________
1. Ins. by notification F.1-23/6, dt. 2-2-1970.
_____________
(i) to inspect not less than twice a year, all premises licensed for manufacture of Ayurvedic (including Siddha) or Unani drugs within the area allotted to him and to satisfy himself that the conditions of the licence and the provisions of the Act and the rules made thereunder are being observed;
(ii) to send forthwith to the controlling authority after each inspection a detailed report indicating whether or not the conditions of the licence and the provisions of the Act and the rules made thereunder are being observed;
(iii) to take samples of the drugs manufactured on the premises and send them for test or analysis in accordance with these rules;
(iv) to institute prosecutions in respect of violation of the Act and the Rules made thereunder.
1[162A. Qualifications of the State Drug Licensing Authority for Licensing of Ayurvdeda , Siddha and Unani drugs− (a) The Ayurvedic/ Siddha/ Unani qualifications as per Schedule II of the Indian Medicine Central Council Act, 1970 (84 of 1970)/ B Pharma (Ayurveda) of a recognized University.
(b) At least 5 years experience in the Ayurveda/ Siddha/ Unani drug manufacturing or testing of Ayurvedic, Siddha and Unani drugs or enforcement of provisions of Chapter IVA of the Drugs and Cosmetics Act,1940 and Rules made thereunder or teaching/ research on clinical practice of Ayurveda/ Siddha/ Unani System.]
163. Procedure for despatch of sample to Government Analyst and its receipt by the Government Analyst—(1) Sample for test or analysis shall be sent to the Government Analyst by registered post or by hand in a sealed package, enclosed together with a memorandum in Form 18-A in an outer cover addressed to the Government Analyst.
(2) The package as well as the outer cover shall be marked with a distinguishing number.
(3) A copy of the memorandum and a specimen impression of the seal used to seal the package shall be sent by registered post or by hand to the Government Analyst.
(4) On receipt of the package from an Inspector, the Government Analyst or an Officer authorised by him in writing in this behalf shall open the package and shall also record the conditions of the seals on the package.
(5) After the test or analysis has been completed, one copy of the results of the test or analysis shall be supplied forthwith to the sender in Form 13-A. A copy of the result in Form 13A shall also be sent simultaneously to the Controlling Authority and to the Drugs Controller, India.
2[PHARMACOPOEIAL LABORATORY FOR INDIAN MEDICINES TO FUNCTION AS CENTRAL DRUGS LABORATORY FOR THE PURPOSE OF TESTING OR ANALYSIS OF AYURVEDA, SIDDHA AND UNANI DRUGS
163.A Functions – The Pharmacopoeial Laboratory for Indian Medicine at Ghaziabad shall function as a Central Drugs Laboratory for the purpose of testing or analysis of Ayurveda, Siddha and Unani Drugs.
Its functions shall be:-
(1) to develop Pharmacopoeial standards and draft monographs and amendments alongwith standardized methods for the Ayurvedic, Siddha, Unani drugs;
(2) to act as Central Appellate Drug Laboratory for testing of Ayurveda, Siddha and Unani drugs,
(3) to analyse or test such samples of Ayurvedic, Siddha, Unani drugs as may be sent to it under sub-section (2) of section 11, or under sub-section (4) or section 25, of the Act;
(4) to maintain reference museum and herbarium for the drugs used in Ayurveda, Siddha and Unani (ASU) system.
(5) to run a training centre for quality control methods in the Ayurveda, Siddha or Unani systems of medicines;
(6) to carry out such other duties as may be entrusted to it by the Government of India.
1. Ins. by G.S.R. 76 (E), dt. 3.2.2003.
2. Ins. by G.S.R. 352 (E), dt. 1.6.2006.
163B. The functions of the Central Drug Laboratory in respect of Ayurvedic, Siddha and Unani drugs shall be carried out at the Pharmacopoeial Laboratory for Ayurvedic, Siddha and Unani medicine, Ghaziabad, (Uttar Pradesh) and the functions of the Director in respect of the said drugs shall be exercised by the Director of the said laboratory.
163C. Despatch of samples for test or analysis- (1) Samples for testing or analysis of Ayurveda, Siddha and Unani drugs under Sub-section (2) of Section 11 or sub-section (1) of section 25 and section 33-H of the Act shall be sent by registered post in a sealed packet, enclosed with a memorandum in Form 1 A, specified in Schedule A, in an outer cover addressed to the Director, Pharmacopoeial Laboratory for Indian Medicine.
(2) The packet as well as the outer cover, shall be marked with a distinguished number.
(3) A copy of the memorandum in Form 1A and a specimen impression of the seal used to seal the packet shall be sent separately by registered post to the Director, Pharmacopoeial Laboratory for Indian Medicine.
163D. Recording of condition of seals- On receipt of the packet, it shall be opened by an officer authorized in writing on that behalf by the Director, Pharmacopoeial laboratory for Indian Medicine, who shall record the condition of the seal on the packet.
163E. Report of result of test or analysis- After test or analysis, the result of the test or analysis, together with full protocols of the tests applied, shall be supplied forthwith to the sender in Form 2A of as specified in the said schedule.
163F. Fees – The fees for test and analysis shall be as specified in Schedule B-1
163G. Signature on certificates- Certificates issued under these rules by the Pharmacopoeial Laboratory for Indian Medicine, shall be signed by the Director or by an officer authorized by the Central Government to sign such certificates.
164. Method of test or analysis to be employed in relation to Ayurvedic (including Siddha) or Unani drugs.— The method of test or analysis to be employed in relation to an Ayurvedic (including Siddha) or Unani drug shall be such as may be specified in the Ayurvedic (including Siddha) or Unani Pharmacopoeia, or if no such pharmacopoeias are available or if no tests are specified in such pharmacopoeias, such tests as the Government Analyst may employ, such tests being scientifically established to determine whether the drug contains the ingredients as stated on the label.
165. Qualifications of Government Analyst.— A person who is appointed a Government Analyst under section 33 F of the Act shall be a person possessing the qualifications prescribed in rule 44 or a degree in Ayurveda, Siddha or Unani System, as the case may be, conferred by a University, a State Government or Statutory Faculties, Councils and Boards of Indian Systems of Medicine recognized by the Central or State Government, as the case may be, for this purpose and has had not less than three years‘ post graduate experience in the analysis of drugs in a laboratory under the control of (i) a Government Analyst appointed under the Act, or (ii) a Chemical Examiner to Government, or (iii) the Head of an institution specially approved for the purpose by the appointing authority.
166. Duties of Government Analyst– (1) The Government Analyst shall analyze or test or cause to be analyzed or tested such samples of Ayurvedic (including Siddha) or Unani drugs as may be sent to him by Inspectors or any other persons or authority authorised by the Central Government or State Government under the provisions of Chapter IV A of the Act and shall furnish reports of the results of test or analysis in accordance with these rules.
(2) A Government Analyst appointed under section 33F shall from time to time forward to the Government reports giving the result of analytical work and research with a view to their publications at the discretion of the Government.]
1[167. Qualifications of Inspector.– A person who is appointed an Inspector under section 33G shall be a person who—
(a) has the qualifications laid down under rule 49 and shall have undergone practical training in the manufacture of Ayurvedic (including Siddha) or Unani drug, as the case may be; or
(b) has a degree in Ayurvedic or Siddha or Unani System or a degree in Ayurveda Pharmacy, as the case may be, conferred by a University or State Government or a Statutory Faculty, Council or Board of Indian Systems of Medicine recognized by the Central Government or the State Government for this purpose; or
(c) has a diploma in Ayurveda, Siddha or Unani Systems, as the case may be, granted by a State Government or an Institution recognized by the Central Government or a State Government for this purpose.
2[PART XIX
STANDARDS OF AYURVEDIC, SIDDHA AND UNANI DRUGS
168. Standards to be complied with in manufacture for sale or for distribution of Ayurvedic, Siddha and Unani Drugs.-
| Class of Drugs |
Standards to be complied with |
| 1. 3 [* * *] drugs included in Ayurvedic Pharmacopoeia. |
The standards for identity, purity and strength as given in the editions of Ayurvedic Pharmacopoeia of India for the time being in force. |
| 2. Asavas and Arishtas |
The upper limit of alcohol as self generated alcohol should not exceed 12% v/v excepting those that are otherwise notified by the Central Government from time to time.] |
_____________
1. Amended by G.S.R. 376 (E), dt. 20.7.1978.
2. Ins. by G.S.R. 519(E), dt. 26.6.1995.
3. The word “Single” omitted by G.S.R. 422(E), dt. 11.6.2002.
_____________
1[169. Permitted Excipients.- Permitted Excipients along with their standards i.e. additives, preservatives, antioxidants, flavouring agents, chelating agents etc. permitted in the Indian Pharmacopoeia (IP), Prevention of Food Adulteration Act, 1954 and Bureau of Indian Standard Act, 1986 are permitted for use in Ayurveda, Siddha and Unani drugs with the following conditions, namely:-
1. The above excipients shall be used in the permissible limits as prescribed in the Indian Pharmacopoeia/ Prevention of Food Adulteration Act, 1954/ Food Product Order/ Bureau of Indian Standard Act, 1986 and they shall comply with the respective quality specifications, not exceeding any specified limits of usage therein, and except Hydrogenated vegetable oil.
2. Only Natural coloring agents as permitted under rule 26 of Prevention of Food Adulteration Rules, 1955 will be used for Ayurveda, Siddha and Unani drugs and additionally, colors permitted under Rule 127 of the Drugs and Cosmetics Rules, 1945 shall be used for Proprietary Ayurveda, Siddha and Unani drugs as defined in subclause (i) of clause (h) of section 3 of Drugs and Cosmetics Act, 1940, not exceeding any specified limits of usage therein.
3. Preservatives and Coloring agents shall be mentioned on the label for the information of the consumer as required under rule 161 of the Drugs and Cosmetics Rules, 1945.
4. Additives used in various processes and in formulating dosage forms shall be mentioned clearly with quantities used, in the application for licenses and the record for the same shall be maintained by the manufacturers.
5. Manufacturers shall be responsible to ensure rationality, safety and quantity used of various excipients in the formulation.
6. If any excipients or additive or preservative etc. referred in Indian Pharmacopoeia/ Prevention of Food Adulteration Act, 1954/ Food Product Order/ Bureau of Indian Standard Act, 1986 is deleted at a particular point of time, this will also be deleted simultaneously for the use in Ayurveda, Siddha and Unani drugs.
7. Following artificial sweeteners as per maximum limit indicated below may be used in various dosage forms of Ayurveda, Siddha, Unani Proprietary Medicines:-
Artificial sweeteners may be used only in proprietary ASU products and the label of such products should carry a statutory warning stating the name and quantity of the artificial sweetener used.
The recommended Acceptable Daily Intake (ADI) of these sweeteners as laid down by US FDA is as follows:
| Sr. No. |
Sucralose |
Aspartame |
Saccharin |
Acesulfame K |
| 1 |
5 mg/kg body weight |
40 mg/kg body weight |
5 mg/kg body |
15 mg/kg body weight weight |
One third of the above ADI would be permissible for use in Ayurveda, Siddha, Unani Patent and Proprietary Drugs.
8. Any previous notification issued by the Department of AYUSH regarding use of excipients / additives or preservatives in Ayurveda, Siddha and Unani medicines stands superseded.]
__
1. Subs. by G.S.R. 755 (E), dt. 23.10.2008. Earlier ins. by G.S.R. 285 (E), dt. 11.5.2005.
__
SCHEDULE A
FORM 1
(See rule 4)
Memorandum to the Central Drugs Laboratory
Serial Number …………………………….
To the Director, Central Drugs Laboratory ……………………………..
From………………………………..
I send herewith, under the provisions of section 25 (4) of the Drugs and Cosmetics Act, 1940, sample(s) of a drug purporting to be for test or analysis and request that a report of the result of the test or analysis may be supplied to this Court.
(2) The distinguishing number on the packet is ……………………………………..
(3) Particulars of offence alleged ………………………………………………………….
(4) Matter on which opinion is required …………………………………
(5) A fee of Rs………………..has been deposited in Court.
Date ………………..
……………….
1[SCHEDULE B
(See rules 7 and 48)
Fees for test or analysis by the Central Drugs Laboratories or State Drugs Laboratories
1. I. Fees for test and assay of Drugs requiring use of animals
|
Rupees |
| Adrenocorticotrophic hormone assay |
1000 |
| Gonadotrophic hormone for LH activity |
1000 |
| FSH Activity |
1000 |
| Posterior pituitary extract or its synthetic substitute for oxytocin activity |
400 |
| Vasopressor activity |
400 |
| Insulin and insulin in combination for hypoglycaemic activity |
2000 |
| Hyaluronidase |
500 |
| Glucagon |
2000 |
| Heparin for anticoagulant activity |
600 |
| Protamine sulphate |
300 |
| Depressor or Histamine like substane |
300 |
| Pyrogen test |
500 |
| Antigenecity or foreign protein test |
300 |
| Abnormal or undue toxicity or safety test |
200 |
| Determination of Lethal doses, LD10 or LD 50 in mice |
800 |
| Skin sensitivity/eye irrigation |
250 |
| Implantation test |
2000 |
| 2. Microbiological tests and assays- |
|
| Bioassay of Antibiotic |
400 |
| Microbiological assay of vitamins |
300 |
| Phenol coefficient |
300 |
| Preservatives – Microbial challenge test |
2000 |
| Sterility test – Parenteral preparations |
100 |
| Surgical dressings |
200 |
| Syringes and needles |
300 |
| Transfusion and infusion sets or assemblies Other sterile devices |
400 |
__________
1. Subs. by G.S.R. No.478(E), dt. 7-8-1998.
__________
| 3. Identification tests- |
|
| (a) Chemical Methods |
50 |
| (b) Microscopical |
50 |
| (c) IR Spectroscopy |
150 |
| (d) UV Spectroscopy |
100 |
| (e) Chromotography |
|
| (i) Paper |
100 |
| (ii) Thin layer |
150 |
| (iii) Column |
100 |
| (iv) GLC |
250 |
| (v) HPLC |
500 |
| (vi) Gel Filtration |
300 |
| (f) Electrophoresis |
|
| (i) Paper and Cellulose acetate |
100 |
| (ii) Polyacrylamide Gel, starch gel, agar gel |
300 each |
| 4. Physical tests – |
|
| (a) Optical rotation, specific gravity, refractive index, weight per ml, fluorescence. |
75 each |
| (b)Viscocity |
100 |
| (c) pH, Solubility, loss on drying, net content, ash, sulphated ash etc. |
20 each |
| (d) Absorbancy, wt/unit area (surgical), foreign matter, extractive value, thread count etc. |
30 each |
| (e) Uniformity of weight |
|
| (i) Tablets |
15 |
| (i) Capsules |
20 |
| (f) Acid value, iodine value, peroxide value, Soponification value, acetyl value. |
100 each |
| (g) Disintegration tests– |
|
| (i) Ordinary tablets |
20 |
| (ii) Capsule |
30 |
| (iii) Sugar Coated tablets |
50 |
| (iv) Enteric coated tablets |
100 |
| (h) Dissolution test |
250 |
| (i) Uniformity of content. |
500 |
| (j) Wt. per unit area (powder), particle size, count, methoxy value. |
200 each |
| (k) Limit test for impurities |
100 each |
| (l) Related substances |
|
| (i) T LC method |
|
| (A) Without reference standard |
150 |
| (B) With reference standard |
250 |
| (ii) Gas Liquid Chromatography |
|
| (A) Without reference standard |
250 |
| (B) With reference standard |
350 |
| (iii)High pressure Liquid Chromatography |
100 |
| (A)Without reference standards |
500 |
| (B)With reference standards |
500 |
| (m) Water (Karl Fisher) |
200 |
| (5) Assays- |
|
| (a) General chemical methods |
100 for each ingredient |
| (b) Non-aqueous/instrumental |
200 for each ingredient |
| (c) Chromatography |
|
| (i) TLC |
250 |
| (ii) Column |
200 |
| (iii) GLC |
350 |
| (iv) HPLC |
500 |
| (v) Gel filtration |
400 |
| (d) Nitrogen determination |
200 |
| (e) Medicinal gases |
400 |
| (6) Polymorph test- |
300 |
| (Content of polymorph A in chloramphenicol palmitate) |
|
| Surgical sutures (Depending on number of tests to be carried) |
200-500 |
| Other miscellaneoustests |
100-500 |
| II Fees for Sera and Vaccine – |
|
| Sterility test |
100 |
| Abnormal toxicity test |
400 |
| Specific toxicity test |
800 |
| Inactivation test (Rabies) |
200 |
| Potency testing of rabies vaccine |
2025 |
| Potency testing of pertussis fraction of DPT vaccine |
2025 |
| Potency testing of tetanus fraction of DPT/DT/TT vaccine. |
2500 |
| Potency testing of diphtheria Fraction of DPT/DTE vaccine. |
2700 |
| Testing of antisera for the specific titre |
1000 |
| Potency testing measles/Mumps/Rubella vaccine |
760 each |
| Testing of Oral Polio Vaccine (OPV) – |
|
| Potency |
4550 |
| Identity |
1000 |
| Stability |
800 |
| Potency testing of Japanese Encephalitis Vaccine |
3900 |
| Potency testing of Snake |
400 |
| Venom serum |
for each venom |
| Identity testing for vaccines/sera |
|
| Cell culture (Other than OPV) |
400 |
| Other than cell culture |
100 |
| Estimation of volume/pH/totalsolids/No. of organisms/Physical checking. |
50 each |
| Estimation of total proteins/aluminium content/phenol/formaldehyde/thiomersal/moisture. |
200 each |
| Pyrogen testing |
500 |
| Stability test for vaccines other than Oral Polio Vaccine |
4550 |
| III Cosmetics |
400 – 1500 |
| (The exact amount of the fee shall be determined by the Director of Laboratory or the Government Analyst, as the case may be). |
|
| IV Rubber Condoms |
1000 |
| IV Homoeopathic medicines: |
|
| 1. Identification test for raw material of botanical origin (other than assay of constituents). |
125 |
| 2. Identification test for raw material of chemical origin (other than assay) |
100 |
| 3. Limit test for drugs of chemical origin |
150 |
| 4. Assay of total alkaloids or of drugs of chemical origin |
100 |
| 5. Identification test for drugs of animal origins or microbiological |
100 |
| 6. Fees for testing of Mother tincture, lower potencies upto 3x or equivalent. |
100 |
| 7. U.V. or I.R. or H.P.C.L. defect determination |
75 |
| Determination of Biochemic drug through atomic absorbance spectrophotometer. |
75 |
Note :-
1. For tests not listed in the Schedule, charges will be determined by the Director or the Government Analyst of the laboratory / institute as the case may be.
2. For the tests relating to Ayurvedic, Unani and Siddha medicines, charges will be determined by the Adviser (Indigenous System of Medicine), Director or Government Analyst of the Laboratory / Institute, as the cased may be.]
___________
1. Subs by G.S.R. 478 (E), dt:7.8.1998.
___________
1[SCHEDULE B(1)
(See rules 163F)
FEES FOR THE TEST OR ANALYSIS BY THE PHARMACOPOEIAL LABORATORY FOR INDIAN MEDICINE (PLIM) OR THE GOVERNMENT ANALYST
|
Type of testing/analysis |
Cost of testing oranalysis in Rupees |
|
(1) |
(2) |
| 1. |
Test for sterlity |
250.00 |
| 2. |
Abnormal toxicity or undue toxicity or safety test |
750.00 |
| 3. |
Determination of lethal does LD 50 to 10 on mice |
2500.00 |
| 4. |
Chemical test for each ingredient |
500.00 |
| 5. |
Disinfectants |
1000.00 |
| 6. |
Any other test requiring animal experimentation |
500.00 |
| 7. |
Microbiological assay |
750.00 |
| 8. |
Microscopic examination of single drugs |
250.00 |
| 9. |
Microscopic examination of raw material of compounddrug |
500.00 |
| 10. |
Chemical identification as per Pharmacopoeia |
250.00 |
| 11. |
Disintegration of tablets and capsules
(a)ordinary
(b)sugar coated
(c)enteric coated |
100.00200.00400.00 |
| 12. |
Psysiochemical Assays |
300.00 |
| 13. |
Test other than assay (limit tests for impurities, ashcontent, total solids, acid value, saponification value, loss on drying etc.) for each test. |
100.00 |
| 14. |
Optical rotation |
250.00 |
| 15. |
Refractive index |
250.00 |
| 16. |
Arsenic testing |
250.00 |
| 17. |
Paper chromatography |
250.00 |
| 18. |
Thin layer chromatography |
300.00 |
| 19. |
Column chromatography |
2500.00 |
| 20. |
Gas liquid chromatography |
1000.00 |
| 21. |
HPTLC restricted to single drugs qualitative |
1000.00 |
| 22. |
Atomical absorption spectrophotometry for Hg, Pb, As,Cd |
500.00 |
| 23. |
Cosmetics/ tails/ creams |
500.00 |
| 24. |
Identification test for raw material of plant origin (otherthan assay of constitutents) |
125.00 |
| 25. |
Identification test for raw material of chemical origin(other than assay) |
100.00 |
| 26. |
Limit test for drug of chemical origin |
150.00 |
| 27. |
Other miscellaneous tests |
1000.00 |
Note: Sample testing charges will be determined / revised by the Director or Government Analyst of the Pharmacopoeial laboratory for Indian Medicine, as the case may be, in consultation with the Department of Ayurveda, Yoga, Unani, Siddha and Homoeopathy, Ministry of Health and Family Welfare.
1[SCHEDULE C
(See rules 23, 61 and 76 and Part X)
Biological and Special Products
1. Sera.
2. Solution of serum proteins intended for injection.
2[3. Vaccines for parenteral injections.
4. Toxins.
5. Antigen.
6. Antitoxins.
7. Neo-arsphenamine and analogous substances used for the specific treatment of infective diseases.
8. Insulin.
9. Pituitary (Posterior Lobe) Extract.
10. Adrenaline and Solutions of Salts of Adrenaline.
3[11. Antibiotics and preparations thereof in a form to be administered parenterally.]
4[12 Any other preparation which is meant for parenteral administration as such or after being made up with a solvent or medium or any other sterile product and which-
(a) requires to be stored in a refrigerator; or
(b) does not require to be stored in a refrigerator.]
13. Sterilized surgical ligature and sterilized surgical suture.
2[14. Bacteriophages.
5[15 Ophthalmic preparations.]
6[16 Sterile Disposable Devices for single use only.]
___________
1. Amended by Notfn. No. F. 1-30/47-A, dt. 5-1-1950
2. Amended by Notfn. No. F. 1-8/60-D, dt. 31-8-1960
3. Subs. by No. G.S.R. 487(E) ,dt. 2.7.1984.
4. Amended by Notfn. No. F. 1-14/68-D, dt. 26-10-1968
5. Ins. by Notfn. No. G.S.R. 1242(E) ,dt. 17.9.1979
6. Ins. by Notfn. No. G.S.R. 109(E) ,dt. 22.2.1994.
___________
1[SCHEDULE C (1)
(See Rule 23, 61 and 76)
Other Special Products
1 Drugs belonging to the Digitalis group and preparations containing drugs belonging to the Digitals group not in a form to be administered parenterally.
2 Ergot and preparations containing Ergot not in a form to be administered parenterally.
3 Adrenaline and preparations containing Adrenaline not in a form to be administered parenterally.
4 Fish Liver Oil and preparations containing Fish Liver Oil.
5 Vitamins and preparations containing any vitamins not in a form to be administered parenterally.
6 Liver extract and preparations containing liver extract not in a form to be administered parenterally.
7 Hormones and preparations containing Hormones not in a form to be administered parenterally.
8 Vaccine not in a form to be administered parenterally.
2[9. Antibiotics and preparations thereof not in a form to be administered parenterally.]
3[10. In-vitro Blood Grouping Sera.
11. In-vitro Diagnostic Devices for HIV, HbsAg and HCV.]
___________
1. Amended by. Notfn. No. F. 1-22/59-D, dt. 9-4-1960
2. Subs. by.G.S.R.487(E) ,dt. 2-7-1984.
3. Ins. By G.S.R. 601(E), dt. 27.8.2002.
___________
SCHEDULE D
[See Rule 43]
|
Class of drugs |
Extent and conditions of exemption |
| 1. |
Substances not intended for medicinal use |
All provisions of Chapter III of the Act and rules thereunder subject to the condition that if the substance is imported in bulk, the importer shall certify that the substance is imported for non- medicinal uses, and if imported otherwise than in bulk, each container shall bear a label indicating that the substance is not intended for medicinal use or is of commercial quality. 1[Further, permission from licensing authority as defined in clause (b) of rule 21 has to be obtained for import of the substance for non-medicinal use without registration and import license.] |
| 2. |
2[***] |
|
| 3. |
3[***] |
|
| 4. |
4[5. The following substances, which are used both as articles of food as well as drugs:-
(i) All condensed or powdered milk whether pure, skimmed or malted, fortified with vitamins and minerals.
(ii) Farex, Oats, Lactose and all other similar cereal preparations whether fortified with vitamins or otherwise excepting those for parenteral use.
(iii) Virol, Bovril, Chicken essence and all other similar predigested foods.
(iv) Ginger, Pepper, Cumin, Cinnamon and all other similar spices and condiments unless they are specifically labelled as conforming to the standards in the 5[Indian Pharmacopoeia or the official pharmacopoeias and the official compendia of the drug standards prescribed under the Act and rules made thereunder]. |
All provisions of Chapter III of the Act and rules thereunder. |
| 5. |
6[6. Drugs and cosmetics imported for manufacture and export by units situated in “Special Economic Zones” as notified by the Government of India from time to time. |
The provisions of Chapter III of the Act and rules thereunder which required them to be covered by an import licence, import registration and import through notified port of entry, subject to the conditions that these drugs and cosmetics shall not be diverted for sale in the country:
Provided that such imported drugs and cosmetics may be permitted to the domestic area if they meet the requirements of standard procedure for import and registration as required under Chapter III of the Act and rules thereunder. |
| 6. |
7[7. Custom Made Devices |
All provisions of Chapter III of the Act and the rules made thereunder, subject to the condition that the device is specifically made in accordance with a duly qualified medical practitioner‘s written prescription under his responsibility, in accordance with specific design characteristics and is intended for the sole use of a particular patient and the label should bear the word “custom made device.” Explanation.––Mass produced devices which only need adoption to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom made devices.] |
___________
1. Ins. By G.S.R 724 (E), dt:7-11-2013.
2. Serial no 2, 3, omitted by Notfn. No. F-1-6/62-D (S.O.2889), dt: 2-7-1969.
3. Serial no 4, omitted by G.S.R.604 (E) ,dt. 24-8-2001
4. Amended by Notfn. F. 1-53/55-D, dt. 7.1.1957.
5.Amended by G.S.R. 19, dt: 15-12-1977.
6. Ins. by G.S.R. 528(E), dt. 8.7.2003.
7. Ins. By G.S.R 690 (E) dated 25-09-2014.
___________
1[SCHEDULE D(I)
(See rule 21 (d) and rule 24 A)
Information and undertaking required to be submitted by the manufacturer or his authorized agent with the Application Form for a Registration Certificate. The format shall be properly filled in for each application in Form 40. The detailed information, secret in nature, may be furnished on a Computer Floppy.
1. Particulars of the manufacturer and manufacturing premises
1.1 Name and address of the manufacturing premises (Telephone No., Fax No., E-mail address) to be registered.
1.2 Name(s) and address(es) of the Proprietor /Partners / Directors.
1.3 Name and address of the authorized Agent in India, responsible for the business of the manufacturer.
1.4 A brief profile of the manufacturer‘s business activity, in domestic as well as global market.
1.5 A copy of Plant Master File (duly notarised)
1.6 A copy of Plant Registration / approval Certificate issued by the Ministry of Health/National Regulatory Authority of the foreign country concerned (duly notarised)
1.7 A brief profile of the manufacturer‘s research activity.
2. Particulars of the manufactured drugs to be registered under Registration Certificate.
2.1 Names of drugs (Bulk/Formulation/Special product) to be registered meant for import into and use in India.
2.2 A copy of the approved list showing the bulk drugs/formulations/special products mentioned in 2.1 above are permitted for manufacturing / marketing in the country of origin (duly notarized).
2.3 2[A copy of Good Manufacturing Practice (GMP) certificate as per WHO – GMP guidelines or Certificate of Pharmaceutical Products (CPP) or written confirmation for active substances exported to European Union which is equivalent to GMP certificate issued as per WHO – GMP guidelines, by the National Regulatory Authority of the country of origin or a copy of the certificate equivalent to GMP certificate as per WHO GMP guidelines issued by National Regulator of United States of America or Japan or Australia or Canada or the European Union for the purpose of marketing of the drugs in their country, in relation to bulk drugs or formulations or special product meant for import into India.]
2.4 The domestic prices of the drugs to be registered in India, in the currency of the country of origin.
2.5 The name(s) of the drug(s) which are original research products of the manufacturer.
___________
1. Ins. by G.S.R. No.604(E) , dt. 24-8-2001 (w.e.f. 1-1-2003).
2. Subs. by G.S.R. No. 897(E) , dt. 21-9-2016.
___________
3. Undertaking to declare that:-
3.1. We shall comply with all the conditions imposed on the Registration Certificate, read with rules 74 and 78 of the Drugs and Cosmetics rules, 1945.
3.2 We declare that we are carrying on the manufacture of the drugs mentioned in this Schedule, at the premises specified above, and we shall from time to time report any change of premises on which manufacture will be carried on and in cases where manufacture is carried on in more than one factory any change in the distribution of functions between the factories.
3.3 We shall comply with the provisions of Part IX of the Drugs and Cosmetics Rules, 1945.
3.4 Every drug manufactured by us for import under the Registration Certificate into India shall be as regard strength, quality and purity conforms with the provisions of Chapter III of Drugs and Cosmetics Act, 1940 and Part IV of the Drugs and Cosmetics Rules 1945, and their amendments from time to time.
3.5 We shall from time to time report for any change or manufacturing process, or in packaging, or in labelling, or in testing, or in documentation of any of the drugs, pertaining to the Registration Certificate, to be granted to us. Where any change in respect of any of the drugs under the Registration Certificate has taken place, in respect of any of the above matters, we shall inform the same to the licensing authority in writing within 30 days from the date of such changes. In such cases, where there will be any major change/modification in manufacturing or in processing or in testing, or in documentation, as the case may be, at the discretion of the licensing authority, we shall obtain necessary approval within 30 days by submitting a separate application, alongwith the registration fee as specified in clause (ii) of sub rule (3) of rule 24-A.
3.6 We shall from time to time report for any administrative action taken due to adverse reaction, viz. market withdrawal regulatory restriction, or cancellation of authorization and/or “not of standard quality report” of any drug pertaining to the Registration Certificate declared by any Regulatory Authority of any country where the drug is marketed/sold or distributed. The despatch and marketing of the drug in such cases, shall be stopped immediately and the licensing authority shall be informed immediately. Further action in respect of stop marketing of drug shall be taken as per the directions of the licensing authority. In such cases, action equivalent to that taken with reference to the concerned drug(s) in the country of origin or in the country of marketing will be followed in India also, in consultation with the licensing authority. The licensing authority may direct any further modification to this course of action, including the withdrawal of the drug from Indian market within 48 hours time period.
3.7 We shall comply with such further requirements, if any, as may be specified, by the Government of India, under the Act and the rules made there under.
3.8 We shall allow the licensing authority and/or any person authorized by him in that behalf to enter and inspect the manufacturing premises and to examine the process/procedure and documents in respect of any drug manufactured by us for which the application for Registration Certificate has been made.
3.9 We shall allow the licensing authority or any person authorized by him in that behalf to take samples of the drugs concerned for test, analysis or examination, if considered necessary by the licensing authority.
Place:
Date:
Signature of the manufacturer
1[or his authorized agent]
Seal / Stamp
___________
1. Ins. by G.S.R. 35(E), dt. 20.1.2005.
___________
SCHEDULE D(II)
[See rule 21 (d) and rule 24 A]
Information required to be submitted by the manufacturer or his authorized agent with the Application Form for the registration of a bulk drug/formulation/special product for its import into India.
The format shall be properly filled in and the detailed information, secret in nature, may be furnished on a Computer Floppy
1. GENERAL
1.1. Name of the drug/formulation/special product, a brief description and the therapeutic class to which it belongs.
1.2 Regulatory status of the drug. Free Sale Certificate and/or Certificate of Pharmaceutical Products (CPP) issued by the Regulatory Authority of the country of origin. Free sale approval issued by the Regulatory Authorities of other major countries.
1.3 Drugs Master File (DMF) for the drug to be registered (duly notarised).
1.4 1[GMP certificate as per WHO-GMP format, or Certificate of Pharmaceutical Products (CPP), or written confirmation for active substances exported to the European Union which is equivalent to GMP certificate issued as per WHO – GMP guidelines, by the National Regulatory Authority of the country of origin or a duly notarised copy of the certificate equivalent to GMP certificate as per WHO-GMP guidelines issued by United States of America or Japan or Australia or Canada or the European Union for the purpose of marketing of the drug in their country.]
1.5 List of countries where marketing authorization or import permission for the said drug is granted with date (respective authorisation shall be enclosed).
1.6 List of countries where marketing authorisation or import permission for the said drug is cancelled/withdrawn with date.
1.7 List of countries where marketing authorisation or import permission for the said drug is pending since (date).
1.8 Domestic price of the drug in the currency followed in the country of origin.
1.9 List of countries where the said drug is patented.
2. CHEMICAL AND PHARMACEUTICAL INFORMATION OF DRUGS.
2.1 Chemical name.
Code name or number, if any.
Non-proprietary or generic name, if any. Structure.
Physico-chemical properties.
2.2 Dosage form and its composition.
Qualitative and Quantitative composition in terms of the active substances(s) and excipient(s). List of active substance(s) separately from the constituent(s) of excipients.
2.3 Specifications of active and inactive ingredient (s) including pharmacopoeial references.
2.4 Source of active ingredient(s), name and address.
2.5 Tests for identification of the active ingredient(s), Method of its assays and tests for impurity profile with reference standards for the impurities (Protocol to be submitted alongwith reference standards for the impurities / relative substances).
2.6 Outline method and flow chart of manufacture of the bulk drug or finished formulation or special product.
2.7 Detailed test protocol for the drug with pharmacopoeial reference or in- house specification as approved by the registration authority, in the country of origin.
2.8 Stability data including accelerated stability and real time stability analysis.
___________
1. Subs. by G.S.R. 897 (E), dt. 21.9.2016.
___________
2.9 Documentation on pack size.
2.10 Numerical expression on EAN bar code on the labels and cartons,
2.11 Safety documents on containers and closures.
2.12 Documentation on storage conditions.
2.13 Three samples of medicinal product/drug and outlet packing are to be submitted with batch certificates. Additional samples as well as reference substances with batch certificates including date of manufacture, shelf life, and storage conditions of reference substance may be required both during registration procedure and during validity of registration decision.
2.14 Batch test reports/certificate of five consecutive production batches in details of the medicinal product are to be submitted for every site of manufacturing premises.
2.15 Manner of labelling as per rule 96 of the Drugs and Cosmetics Rules 1945.
2.16 Package insert.
2.17 Details of safety handling procedure of the drug.
2.18 Details of PMS study report for marketing period not exceeding five years.
3. BIOLOGICAL AND BIOPHARMACEUTICAL INFORMATION OF DRUGS
3.1 Biological control tests applied on the starting material, if applicable.
3.2 Biological control tests applied on the intermediate products, if applicable.
3.3 Biological control tests applied on the finished medical products, if applicable.
3.4 Stability of the finished products in terms of biological potency of the drug, if applicable.
3.5 Sterility tests, if applicable, specification and protocol therein.
3.6 Pyrogen tests, if applicable, specification and protocol therein.
3.7 Acute and sub-acute toxicity tests, if applicable specification and protocol therein.
3.8 Bio-availability studies and bio-equivalence data, if applicable.
3.9 Data relating to the environmental risk assessment for r-DNA products.
3.10 Other information relevant under the section.
4. PHARMACOLOGICAL AND TOXICOLOGICAL INFORMATION OF DRUGS.
Executive summary of the product is to be submitted mentioning the specific and general pharmacological actions of the drug and pharmacokinetic studies on absorption, metabolism, distribution and excretion. A separate note is to be given on acute and sub-acute toxicity studies and long term toxicity studies. Specific studies on reproductive toxicity, local toxicity and carcinogenic activity of the drug is to be elaborated, as far as possible.
5 CLINICAL DOCUMENTATION
A new drug as defined under rule 122-E of the Drugs and Cosmetics Rules, 1945 is required to be permitted separately by the licensing authority under rule 122-A of the said rules prior to its registration. Such a new drug requires a brief summary and clinical documentation, alongwith permission under 122-A of the said rules for its Registration Certificate.
6. LABELLING AND PACKAGING INFORMATION OF DRUGS.
6.1 Labels should conform as per the specifications under the Drugs and Cosmetics Rules 1945.
6.2 Package insert should be in English and shall indicate the following therapeutic indications:-
Posology and method of administration. Contra-indications.
Special warnings and special precautions for use, if any.
Interaction with other medicaments and other forms of interaction.
Pregnancy and lactation, if contra-indicated.
Effects on ability to drive and use machines, if contra-indicated.
Undesirable effects/side effects.
Antidote for overdosing.
6.3 Package insert should indicate the following pharmaceutical information:-
List of excipients.
Incompatibilities.
Shelf life in the medical product as packaged for sale.
Shelf life after dilution or reconstitution according to direction.
Shelf life after first opening the container.
Special precautions for storage.
Nature and specification of the container.
Instructions for use/handling.
7 SPECIFIC INFORMATION REQUIRED FOR THE SPECIAL PRODUCTS (to be supplied, separately in Annexures, as ‘A‘, ‘B‘ and ‘C‘)
The information submitted above is true to the best of my knowledge and belief.
Place:
Date:
Signature of the manufacturer
1[or his authorized agent]
Seal/Stamp
NB: 1. Any change in the process of manufacture, method of testing, labelling, packaging, designing of the sale pack, medical literature and documentation is to be intimated to the licensing authority forthwith and permission to be obtained from him within 30 days time period.
2. Information relating to Serial No.4 and Serial No.5 are not applicable for drugs figuring in Indian Pharmacopoeia and also for the drugs figuring in United States of Pharmacopoeia, European Pharmacopoeia, and British Pharmacopoeia provided such drugs have already been approved for marketing in India for the applicant under rules 122A, 122B, 122C or 122D of the Drugs and Cosmetics Rules 1945.
___________
1.Ins. by G.S.R. 35(E), dt. 20.1.2005.
___________
ANNEXURE A
(See Schedule D-II, item No.7)
INFORMATION TO BE SUBMITTED IN SCHEDULE D-II
SPECIFIC INFORMATION REQUIRED FOR THE BLOOD PRODUCTS
A product dossier showing the:
1. Details of source Plasma, its viral screening, storage and transport from Collection Centres to Fractionation Centre. Regulatory status of Collection Centres.
2. Details of Fractionation Centre, Regulatory Status, Method of Fractionation and Control Processes.
3. Details of viral inactivation process for enveloped and non-enveloped virus(es) and viral validation studies to assess the viral load of the product.
Testing of viral screening at any stage is to be highlighted with the details of the kits used with their respective sensitivity and specificity.
4. Bulk filtration prior to pharmaceutical packing giving the full details of Micro-filtration or nanofiltration followed.
5. Complete details of pharmaceutical processing and utilization.
6. Test protocol of the product showing the specifications and pharmacopoeial method followed for various testing parameters.
Specific batch test report for at least 3 batches showing the specifications of each testing parameter.
7. Pack size and labelling.
8. Product insert.
9 Specimen Batch Release Certificate issued by the National Regulatory Authority of the country of origin.
Specific processings like safe handling, material control, area control, pasteurization, stability studies, storage at quarantine stage and finished stage and packaging should be highlighted in the product dossier.
The information submitted above is true to the best of my knowledge and belief.
Place:
Date:
Signature of the manufacturer
Seal / Stamp
NB: 1. Any change in the process of manufacture, method of testing, labelling, packaging, designing of the sale pack, medical literature and documentation is to be intimated to the licensing authority forthwith and permission to be obtained from him within 30 days time period.
ANNEXURE-B
(See Schedule D-II, item No.7)
INFORMATION TO BE SUBMITTED IN SCHEDULE D-II SPECIFIC INFORMATION REQUIRED FOR THE DIAGNOSTIC KITS
A Product dossier showing the:
1. The details of source antigen or antibody as the case may be and characterization of the same. Process control of coating of antigen or antibody on the base material like Nitrocellulose paper, strips or cards or ELISA wells etc.
Detailed composition of the kit and manufacturing flow chart process of the kit showing the specific flow diagram of individual components or source of the individual components.
2. Test protocol of the kit showing the specifications and method of testing. In house evaluation report of sensitivity, specificity and stability studies carried out by the manufacturer.
3. The report of evaluation in details conducted by the National Control Authority of country of origin.
Specimen batch test report for at least consecutive 3 batches showing specification of each testing parameter.
4. The detailed test report of all the components used/packed in the finished kit.
5. Pack size and labelling.
6. Product insert.
Specific evaluation report, if done by any laboratory in India, showing the sensitivity and specificity of the kit.
Specific processing like safe handling, material control, area control, process control, stability studies, storage at quarantine stage and finished stage, packaging should be highlighted in the product dossier.
The information submitted above is true to the best of my knowledge and belief.
Place:
Date:
Signature of the manufacturer
Seal/Stamp
NB: 1.Any change in the process of manufacture, method of testing, labelling, packaging, designing of the sale pack, medical literature and documentation is to be intimated to the licensing authority forthwith and permission to be obtained from him within 30 days time period.
ANNEXURE-C
(See Schedule D-II, item No.7)
INFORMATION TO BE SUBMITTED IN SCHEDULE D-II
SPECIFIC INFORMATION REQUIRED FOR VACCINES
A Product dossier showing the:
1. History, source, date of receipt, storage, identity and characterization of the seed strain.
2. Detailed flow chart of manufacturing process showing all the details of in-process control on toxicity, potency study and stability data of the final bulk and the final finished product including the storage temperature.
3. Complete details of chemical and pharmaceutical data for the product.
Composition and dosage form – method of manufacture with detailed flow chart – control of starting material – control tests on intermediate and finished products – certificate of analysis of finished products – validation of critical manufacturing steps.
4. Test protocol of the vaccines showing the specification and method of testing including pharmacopoeial specification.
5. Specimen batch test report for at least consecutive three batches showing the specification of each testing parameter.
6. The detailed test reports of all the components used / packed in the finished vaccine.
7. Pack-size and labelling.
8. Product insert
9. Specimen batch release certificates issued by the National Regulatory Authority of the country of origin.
10. Summary of pre-clinical and clinical data including:
(a) Prescribing information.
(b) Pharmacological and toxicological data pertaining to tests on animals Characterisation of immuno response and safety study in human use, in specific conditions.
Specific information on source of seed strain, its characterization, inactivation, etc. and processings like safe handling, material control, area control, process control, stability studies, storage at quarantine stage and finished state, packaging should be highlighted in the product dossier.
Specimen production and quality control protocols for at least three consecutive lots showing the specifications for each quality control parameter including pharmacopoeial requirement shall be submitted for study.
The information submitted above is true to the best of my knowledge and belief.
Place:
Date:
Signature of the manufacturer
Seal / Stamp
NB: 1. Any change in the process of manufacture, method of testing, labelling, packaging, designing of the sale pack, medical literature and documentation is to be intimated to the licensing authority forthwith and permission to be obtained from him within 30 days time period.
2. All vaccines shall be new drugs unless certified otherwise by the liencesing authority approved under rule 21 of the Drugs and Cosmetic Rules, 1945. A copy of approval of the vaccine issued by the said licensing authority is to be enclosed, prior to issue of Registration Certificate of the said vaccines.
1[SCHEDULE D (III)
(See rule 129 A)
INFORMATION AND UNDERTAKING REQUIRED TO BE SUBMITiED BY THE MANUFACTURER OR HIS AUTHORISED IMPORTER/DISTRIBUTOR/AGENT WITH THE APPLICATION FORM FOR A REGISTRATION CERTIFICATE.
(The format shall be properly filled in for each application in form 42)
1. PARTICULARS OF THE MANUFACTURER AND MANUFACTURING PREMISES.-
(a) Name and address of the manufacturer and manufacturing premises to be registered along with telephone numbers, Fax numbers and e-mail address.
(b) Name(s) and address of the Partners/Directors.
(c) Name and address of the authorised importer/distributor/agent in India, responsible for the business of the manufacturer.
(d) A brief profile of the manufacturer ‘s business activity, in domestic as well as global market.
2. PARTICULARS OF THE COSMETICS TO BE REGISTERED UNDER REGISTRATION CERTIFICATE.-
(a) Names of cosmetics along with their brands name, category, pack sizes and variants to be registered and meant for import into and use in India.
(b) Particulars of the manufacturing licenses/registration/marketing authorizations (if any) under which the cosmetics are being manufactured in the country of origin along with the copy of the licenses/ marketing authorization/registration issued by the Regulatory Authority of that country.
(c) List of countries where marketing authorization or import permission for the said cosmetic has been granted.
3. CHEMICAL INFORMATION OF COSMETICS.-
(a) Name(s) of ingredients in the nomenclature of standard references, along with percentages contained in the cosmetic.
(b) Specification and testing method for testing of the cosmetic(s).
(c) Manner of labelling as per Drugs and Cosmetics Rules, 1945.
(d) Package insert (if any).
4. UNDERTAKINGTO DECLARETHAT.-
(a) We shall comply with all the conditions imposed on the Registration Certificate for the import of cosmetics as required under the provisions of Drugs and Cosmetics rules, 1945.
(b) We declare that we are carrying on the manufacture of the cosmetics mentioned in this Schedule, at the premises specified above, and we shall from time to time report any change of premises on which manufacture will be carried on and in cases where manufacture is carried on in more than one factory any change in the distribution of functions between the factories.
(c) We shall comply with the provisions of Part XIII of the Drugs and Cosmetics Rules, 1945.
(d) Every cosmetic manufactured by us for import under the Registration Certificate into India shall conform to the specifications given in the Drugs & Cosmetics Rules, 1945 as amended from time to time.
(e) We shall inform to the licensing authority, within 30 days in the event of any change in variants or in category or in manufacturing location or in labelling or in documentation of any of the cosmetic pertaining to the certificate to be granted to us.
___________
1. Ins. By G.S.R. 426 (E) dated 19-05-2010, read with corrigendum G.S.R. 263(E) dated 30-05-2011, corrigendum G.S.R. dated 29-09-2011, corrigendum G.S.R. 270(E) dated 30-03-2012 and corrigendum G.S.R. 733(E), dated 29-09-2012.
___________
(f) We shall from time to time report for any administrative action taken due to adverse reaction, viz. market withdrawals/regulatory restriction, or cancellation of authorisation and/or “not of standard quality report” of any cosmetic pertaining to the Registration Certificate declared by any Regulatory Authority of any country where the cosmetic is marketed/sold or distributed. The despatch and marketing of the cosmetic in such cases, shall be stopped and the licensing authority shall be informed immediately.
(g) We shall comply with such further requirements, if any, as may be specified, by the Government of India, under the Act and the Rules, made thereunder.
(h) We shall allow the licensing authority or any person authorised by him in that behalf to take samples of the cosmetics for testing if considered necessary by the licensing authority.
The information submitted above is true to the best of my/our knowledge and belief.
Place:
Date:
Signature of the manufacturer or his authorized agent
Seal/Stamp.
1[***]
2[SCHEDULE E(1)
[See rule 161 (2)]
List of poisonous substances under the Ayurvedic (including Siddha) and Unani Systems of Medicine
A. AYURVEDIC SYSTEM
I Drugs of vegetable origin
| 1. |
Ahipena (Except seeds) |
Papaver somniferum Linn. |
| 2. |
Arka |
Calotropis procera (Ait.) R.Br. ex. |
| 3. |
Bhallataka |
Semecarpus anacardium Linn. F. |
| 4. |
Bhanga (Except seeds) |
Cannabis sativa Linn. (Except seeds) |
| 5. |
Danti |
Baliospermum montanum Mull. Arg. |
| 6. |
Dhattura |
Datura metal Linn. |
| 7. |
Gunja (seed) |
Abrus precatorium Linn. (seed) |
| 8. |
Jaipala (seed) |
Croton tiglium Linn. |
| 9. |
Karaveera |
Rerium indicum Mill. |
| 10. |
Langali |
Gloriosa superba Linn. |
| 11. |
Parasika Yavani |
Hyoscyamus niger Linn. |
| 12 |
Vatsanabha |
Acontium chasmanthum Stapf ex Holm. |
|
Vishamushti |
Strychnox nuxvomica Linn. |
| 13. |
Shringivisha |
Acontium chasmanthum Stapf ex Holm. |
II Drugs of Animal Origin.
| 14. |
Sarpa Visha |
Snake poison. |
III Drugs of Mineral Origin
| 15. |
Gauripashana |
Arsenic. |
| 16. |
Hartala |
Arseno sulphide. |
| 17. |
Manahashila |
Arseno sulphide. |
| 18. |
Parada |
Mercury. |
| 19. |
Rasa Karpura |
Hydrargyri subchloridum. |
| 20. |
Tuttha |
Copper sulphate. |
| 21. |
Hingula |
Cinnabar. |
__________
1 “Schedule E” omitted No.G.S.R. 462(E),dt 22-6-1982. 2. Subs. By G.S.R. 683(E) dated 19-08-2010.
__________
B. SIDDHA SYSTEM
| 1. |
Abini |
Papaver somniferum Linn. |
| 2. |
Alari |
Nerium indicum Mill. |
| 3. |
Attru thummatti |
Citrullus colocynthis (L.) Schrad |
| 4. |
Umathai |
Datura stramonium Linn. |
| 5. |
Etti |
Stychnos nux vomica Linn. |
| 6. |
Ganja (except seed) |
Cannabis sativa Linn. |
| 7. |
Kalappaki Kizahangu |
Glorisa superba Linn. |
| 8. |
Kodikkalli (exempted for external use) |
Euphorbia tirucalli Linn. |
| 9. |
Kattu Thumatti |
Cucumis trigonus Roxb. |
| 10. |
Kunri (except root) |
Arbus precatorius Linn. |
| 11. |
Cheramkottai |
Semecarpus anacardium Linn f. |
| 12. |
Thillai |
Exoecoria agallocha Linn. |
| 13. |
Nabi |
Aconitum ferox Wall. |
| 14. |
Nervalam |
Croton tiglium Linn. |
| 15. |
Pugaielai |
Nicotiana tabacum Linn. |
| 16. |
Mancevikkalli |
Euphorbia species |
C. UNANI SYSTEM
I Drugs of vegetable origin
| 1. |
Afiyun (except seed) |
Papaver somniferum Linn. |
| 2. |
Bazrul-banj |
Hyoscyamus niger Linn. |
| 3. |
Bish |
Aconitum chasmanthum Strapfex Holmes. |
| 4. |
Bhang |
Cannabis sativa Linn. |
| 5. |
Charas |
Canabis sativa Linn. |
| 6. |
Dhatura seeds |
Datura metal Linn (seeds). |
| 7. |
Kuchla |
Strychnos nuxvomica Linn. |
| 8. |
Shokran |
Conium maculatum Linn. |
II Drugs of Animal origin
| 9. |
Sanp (head) |
Snake (head). |
| 10. |
Telni makkhi |
Mylabris cichori Linn. Mylabaris pustulata Thund. Mylabris macilenta. |
III Drugs of Mineral origin
| 1. |
Darchikna |
Hydrargryi perchloridum. |
| 2. |
Hira |
Diamond. |
| 3. |
Ras Kapoor |
Hydrargryi Subchloridum (calomel). |
| 4. |
Shingruf |
Hydrargryi bisulphuratum. |
| 5. |
Zangar |
Cupri subacetas. |
| 6. |
Sammul-Far |
(Abyaz, Asfar, Aswad and Ahmar) (white, yellow, black and red, Arsenic). |
| 7. |
Tootiya |
Copper Sulphate |
| 8. |
Para |
Hydrargyrum. |
| 9. |
Hartal |
Arsenic trisulphide (yellow).] |
SCHEDULE F
(See rule 78 and Part X)
1[***]
2[PART XII B
REQUIREMENTS FOR THE FUNCTIONING AND OPERATION OF A BLOOD BANK AND / OR FOR PREPARATION OF BLOOD COMPONENTS.
I. BLOOD BANKS / BLOOD COMPONENTS
A. GENERAL
1. Location and Surroundings : The blood bank shall be located at a place which shall be away from open sewage, drain, public lavatory or similar unhygienic surroundings.
2. Building : The building (s) used for operation of a blood bank and/or preparation of blood components shall be constructed in such a manner so as to permit the operation of the blood bank and preparation of blood components under hygienic conditions and shall avoid the entry of insects, rodents and flies. It shall be well lighted, ventilated and screened (mesh), wherever necessary. The walls and floors of the rooms, where collection of blood or preparation of blood components or blood products is carried out shall be smooth, washable and capable of being kept clean. Drains shall be of adequate size and where connected directly to a sewer, shall be equipped with traps to prevent back siphonage.
3. Health, clothing and sanitation of staff: The employees shall be free from contagious or infectious diseases. They shall be provided with clean overalls, head-gears, foot-wears and gloves, wherever required. There shall be adequate, clean and convenient hand washing and toilet facilities.
B. ACCOMMODATION FOR A BLOOD BANK.
A blood bank shall have an area of 100 square meters for its operations and an additional area of 50 square meters for preparation of blood components. It shall be consisting of a room each for –
(1) registration and medical examination with adequate furniture and facilities for registration and selection of donors;
(2) blood collection (air-conditioned);
________
1. Part I to Part XIIA omitted by G.S.R. 663 (E), dated 03-07-1992 corrected vide corrigendum G.S.R. 27(E) dated 22-01-1993.
2. Part XIIB and Part XIIC, were sub. By G.S.R. 245 (E) dated 05-04-1999, previously Part XIIB and XIIC, were substituted for Part XIIB by G.S.R. 28(E) dated 22-01-1992 and before that Part XIIB was added by notification number F 1-17/67-D, 24-06-1967.
________
(3) blood component preparation. (This shall be air-conditioned to maintain temperature between 20 degree centigrade to 25 degree centigrade);
(4) laboratory for blood group serology (air-conditioned);
(5) laboratory for blood transmissible diseases like Hepatitis, Syphilis, Malaria, HIV-antibodies (air-conditioned);
(6) sterilization-cum-washing;
(7) refreshment-cum-rest room (air-conditioned);
(8) store-cum-records.
NOTES:
(1) The above requirements as to accommodation and area may be relaxed, in respect of testing laboratories and sterilization-cum-washing room, for reasons to be recorded in writing by the Licensing Authority and/or the Central Licence Approving Authority, in respect of blood banks operating in hospitals, provided the hospital concerned has a pathological laboratory and a sterilization-cum-washing room common with other departments in the said hospital.
(2) Refreshments to the donor after phlebotomy shall be served so that he is kept under observation in the blood bank.
C PERSONNEL
Every blood bank shall have following categories of whole time competent technical staff:-
(a) Medical Officer, possessing the qualifications specified in condition (i) of rule 122-G.
(b) Blood Bank Technician(s) possessing –
(i) Degree in Medical Laboratory Technology (M.L.T) with six months‘ experience in the testing of blood and/or its components; or
(ii) Diploma in Medical Laboratory Technology (M.L.T) with one year‘s experience in the testing of blood and / or its components, the degree or diploma being from a University / Institution recognized by the Central Government or State Government.
(c) Registered Nurse(s);
(d) Technical supervisor (where blood components are manufactured), possessing-
(i) Degree in Medical Laboratory Technology (M.L.T) with six months‘ experience in the preparation of blood components; or
(ii) Diploma in Medical Laboratory Technology (M.L.T) with one year‘s experience in the preparation of blood components, the degree or diploma being from a University / Institution recognized by the Central Government or State Government.
NOTES :
(1) The requirements of qualification and experience in respect of Technical Supervisor and Blood Bank Technician shall apply in the cases of persons who are approved by the Licensing Authority and/or Central Licence Approving Authority after the commencement of the Drugs and Cosmetics (Amendment) Rules, 1999*.
(2) As regards, the number of whole time competent technical personnel, the blood bank shall comply with the requirements laid down in the Directorate General of Health Services Manual.
(3) It shall be the responsibility of the licensee to ensure through maintenance of records and other latest techniques used in blood banking system that the personnel involved in blood banking activities for collection, storage, testing and distribution are adequately trained in the current Good Manufacturing Practices/Standard Operating Procedures for the tasks undertaken by each personnel. The personnel shall be made aware of the principles of Good Manufacturing Practices / Standard Operating Procedures that affect them and receive initial and continuing training relevant to their needs.
D. MAINTENANCE
The premises shall be maintained in a clean and proper manner to ensure adequate cleaning and maintenance of proper operations. The facilities shall include:-
(1) Privacy and thorough examination of individuals to determine their suitability as donors.
(2) Collection of blood from donors with minimal risk of contamination of exposure to activities and equipment unrelated to blood collection.
(3) Storage of blood or blood components pending completion of tests.
(4) Provision for quarantine, storage of blood and blood components in a designated location, pending repetition of those tests that initially give questionable serological results.
(5) Provision for quarantine, storage, handling and disposal of products and reagents not suitable for use.
(6) Storage of finished products prior to distribution or issue.
(7) Proper collection, processing, compatibility testing, storage and distribution of blood and blood components to prevent contamination.
(8) Adequate and proper performance of all procedures relating to plasmapheresis, plateletpheresis and leucapheresis.
(9) Proper conduct of all packaging, labelling and other finishing operations.
(10) Provision for safe and sanitary disposal of –
(i) Blood and/or blood components not suitable for use, distribution or sale.
(ii) Trash and items used during the collection, processing and compatibility testing of blood and / or blood components.
________
*Note : 2nd Amendment Rules, 1999 (w.e.f. 5-4-1999)
________
E. EQUIPMENT
Equipment used in the collection, processing, testing, storage and sale/distribution of blood and its components shall be maintained in a clean and proper manner and so placed as to facilitate cleaning and maintenance. The equipment shall be observed, standardized and calibrated on a regularly scheduled basis as described in the Standard Operating Procedures Manual and shall operate in the manner for which it was designed so as to ensure compliance with the official requirements (the equipments) as stated below for blood and its components.
Equipment that shall be observed, standardized and calibrated with at least the following frequencies:
| SR No. |
EQUIPMENT |
PERFORMANCE |
FREQUENCY |
FREQUENCY OF CALIBRATION |
| 1. |
Temperature Recorder |
Compare against thermometer |
Daily |
As often as necessary |
| 2. |
Refrigerated centrifuge |
Observe speed and temperature |
Each day of use |
As often as necessary |
| 3. |
Hematocrit centrifuge |
– |
– |
Standardise before initial use, after repair or adjustments and annually. |
| 4. |
General lab. Centrifuge |
– |
– |
Tachometer, every 6 months |
| 5. |
Automated typing |
Observe controls for correct results |
Each day of use |
– |
| 6. |
Haemoglobinometer |
Standardize against cyanamethemoglob ulin standard |
−ditto− |
– |
| 7. |
Refractiometer or Urinometer |
Standardize against distilled water |
−ditto− |
– |
| 8. |
Blood container weighing device |
Standardize against container of known weight. |
−ditto− |
As often as necessary |
| 9. |
Water Bath |
Observe temperature |
−ditto− |
−ditto− |
| 10. |
Rh view box (wherever necessary) |
−ditto− |
−ditto− |
−ditto− |
| 11. |
Autoclave |
Observe temperature |
Each day of use |
As often as necessary |
| 12. |
Serologic rotators |
Observe controls for correct results |
−ditto− |
Speed as often as necessary |
| 13. |
Laboratory thermometers |
– |
– |
Before initial use |
| 14. |
Electronic thermometers |
– |
Monthly |
– |
| 15. |
Blood agitator |
Observe weight of the first container of blood filled for correct results |
Each day of use |
Standardize with container of known mass or value before initial use, and after repairs or adjustments. |
F. SUPPLIES AND REAGENTS:
All supplies and reagents used in the collection, processing, compatibility, testing, storage and distribution of blood and blood components shall be stored at proper temperature in a safe and hygienic place, in a proper manner and in particular:–
(a) all supplies coming in contact with blood and blood components intended for transfusion shall be sterile, pyrogen-free, and shall not interact with the product in such a manner as to have an adverse effect upon the safety, purity, potency or effectiveness of the product.
(b) supplies and reagents that do not bear an expiry date shall be stored in a manner that the oldest is used first.
(c) supplies and reagents shall be used in a manner consistent with instructions provided by the manufacturer.
(d) all final containers and closures for blood and blood components not intended for transfusion shall be clean and free of surface solids and other contaminants.
(e) each blood collecting container and its satellite container(s), if any, shall be examined visually for damage or evidence of contamination prior to its use and immediately after filling. Such examination shall include inspection for breakage of seals, when indicated, and abnormal discoloration. Where any defect is observed, the container shall not be used or, if detected after filling, shall be properly discarded.
(f) representative samples of each lot of the following reagents and/or solutions shall be tested regularly on a scheduled basis by methods described in the Standard Operating Procedures Manual to determine their capacity to perform as required,
| Reagents and solutions |
Frequency of testing alongwith controls |
| Anti-human serum |
Each day of use |
| Blood grouping serums |
Each day of use |
| Lectin |
Each day of use |
| Antibody screening and reverse grouping cells |
Each day of use |
| Hepatitis test reagents |
Each run |
| Syphilis serology reagents |
Each run |
| Enzymes |
Each day of use |
| HIV I and II reagents |
Each run |
| Normal saline (LISS and PBS) |
Each day of use |
| Bovine Albumin |
Each day of use |
G. GOOD MANUFACTURING PRACTICES (GMPs) /STANDARD OPERATING PROCEDURES (SOPs):
Written Standard Operating Procedures shall be maintained and shall include all steps to be followed in the collection, processing, compatibility testing, storage and sale or distribution of blood and/or preparation of blood components for homologous transfusion, autologous transfusion and further manufacturing purposes. Such procedures shall be available to the personnel for use in the concerned areas. The Standard Operating Procedures shall inter alia include:
1. (a) criteria used to determine donor suitability.
(b) methods of performing donor qualifying tests and measurements including minimum and maximum values for a test or procedure, when a factor in determining acceptability;
(c) solutions and methods used to prepare the site of phlebotomy so as to give maximum assurance of a sterile container of blood;
(d) method of accurately relating the product (s) to the donor;
(e) blood collection procedure, including in-process precautions taken to measure accurately the quality of blood drawn from the donor;
(f) methods of component preparation, including any time restrictions for specific steps in processing;
(g) all tests and repeat tests performed on blood and blood components during processing;
(h) pre-transfusion testing, wherever applicable, including precautions to be taken to identify accurately the recipient blood components during processing;
(i) procedures of managing adverse reactions in donor and recipient reactions:
(j) storage temperatures and methods of controlling storage temperatures for blood and its components and reagents;
(k) length of expiry dates, if any assigned for all final products;
(l) criteria for determining whether returned blood is suitable for re-issue;
(m) procedures used for relating a unit of blood or blood component from the donor to its final disposal;
(n) quality control procedures for supplies and reagents employed in blood collection, processing and re-transfusion testing;
(o) schedules and procedures for equipment maintenance and calibration;
(p) labelling procedures to safeguard its mix-ups, receipt, issue, rejected and in-hand;
(q) procedures of plasmapheresis, plateletphersis and leucapheresis if performed, including precautions to be taken to ensure re-infusion of donor‘s own cells;
(r) procedures for preparing recovered (salvaged) plasma if performed, including details of separation, pooling, labelling, storage and distribution;
(s) all records pertinent to the lot or unit maintained pursuant to these regulations shall be reviewed before the release or distribution of a lot or unit of final product. The review or portions of the review may be performed at appropriate periods during or after blood collection, processing, testing and storage. A thorough investigation, including the conclusions and follow-up, of any unexplained discrepancy or the failure of a lot or unit to meet any of its specification shall be made and recorded.
(2) A licensee may utilise current Standard Operating Procedures, such as the Manuals of the following organizations, so long as such specific procedures are consistent with, and at least as stringent as, the requirements contained in this Part, namely :-
(i) Directorate General of Health Services Manual.
(ii) Other Organisations or individual blood bank‘s manuals, subject to the approval of State Licensing Authority and Central Licence Approving Authority.
H. CRITERIA FOR BLOOD DONATION:
Conditions for donation of blood:
(1) General – No person shall donate blood and no blood bank shall draw blood from a person, more than once in three months. The donor shall be in good health, mentally alert and physically fit and shall not be inmates of jail, persons having multiple sex partners and drug-addicts. The donors shall fulfil the following requirements, namely:-
1[(a) the donor shall be in the age group of 18 to 65 years;]
(b) the donor shall not be less than 45 kilograms;
( c) temperature and pulse of the donor shall be normal;
(d ) the systolic and diastolic blood pressure are within normal limits without medication;
(e) haemoglobin which shall not be less than 12.5 grams;
(f) the donor shall be free from acute respiratory diseases;
(g) the donor shall be free from any skin diseases at the site of phlebotomy;
(h) the donor shall be free from any disease transmissible by blood transfusion, insofar as can be determined by history and examination indicated above;
(i) the arms and forearms of the donor shall be free from skin punctures or scars indicative of professional blood donors or addiction of self injected narcotics.
(2) Additional qualifications of donor – No person shall donate blood, and no blood bank shall draw blood from a donor, in the conditions mentioned in column (1) of the Table given below before the expiry of the period of deferment mentioned in the column (2) of the said Table.
Table: Deferment of blood donation
| CONDITIONS (1) |
PERIOD OF DEFERMENT (2)_ |
| (a) Abortions |
6 months |
| (b) History of Blood transfusion |
6 months |
| (c) Surgery |
12 months |
| (d) Typhoid |
12 months after recovery |
| (e) History of Malaria and duly treated |
2 months (endemic) 3 years (non endemic area) |
| (f) Tattoo |
6 months |
| (h) Breast feeding |
12 months after delivery |
| (i) Immunization (Cholera, Typhoid, Diphtheria, Tetanus, Plague, Gammaglobulin) |
15 days |
| (j) Rabies vaccination |
1 year after vaccination |
| (k) History of Hepatitis in family or close contact |
12 months |
| (l) Immunoglobulin |
12 months |
________
1. Subs. By G.S.R 101 (E), dt:18-2-2011
________
(3) No person shall donate blood and no blood bank shall draw blood from a person, suffering from any of the diseases mentioned below, namely:–
(a) Cancer
(b) Heart disease
(c) Abnormal bleeding tendencies
(d) Unexplained weight loss
(e) Diabetes-controlled on insulin
1[(f) Hepatitis infection]
(g) Chronic nephritis
(h) Signs and symptoms, suggestive of AIDS
(i ) Liver diseases
(j) Tuberculosis
(k) Polycythemia Vera.
(l) Asthma
(m) Epilepsy
(n) Leprosy
(o) Schizophrenia
(p) Endocrine disorders
I. GENERAL EQUIPMENTS AND INSTRUMENTS.
1. For blood collection room:
(i) Donor beds, chairs and tables: These shall be suitably and comfortably cushioned and shall be of appropriate size.
(ii) Bedside table
(iii) Sphygmomanometer and stethoscope
(iv) Recovery beds for donors.
(v) Refrigerators, for storing separately tested and untested blood, maintaining temperature between 2 to 6 degree centigrade with digital dial thermometer, recording thermograph and alarm device, with provision for continuous power supply.
(vi) Weighing devices for donor and blood containers.
2. For haemoglobin determination:
(i) Copper sulphate solution (specific gravity 1.053)
(ii) Sterile lancet and impregnated alcohol swabs.
(iii) Capillary tube (1.3 x 1.4 x 96 mm for Pasteur pipettes)
(iv) Rubber bulbs for capillary tubings.
(v) Sahli‘s haemoglobinometer / Colorimetric method.
3. For temperature and pulse determination.
(i) Clinical thermometers
(ii) Watch (fitted with a second-hand) and a stop-watch.
4. For blood containers:
(a) Only disposable PVC blood bags shall be used (closed system) as per specifications of IP/USP/BP.
(b) Anti-coagulants: The anti-coagulant solution shall be sterile, pyrogen-free and of the following composition that will ensure satisfactory safety and efficacy of the whole blood and/or for all the separate blood components.
(i) Citrate Phosphate Dextrose Adenine solution (CPDA) or Citrate Phosphate Dextrose Adenine – 1 (CPDA-1) – 14 ml solution shall be required for 100 ml of blood.
________
1. Subs. by G.S.R. No. 40(E), dated 29-01-2001.
________
Note 1.- (i) In case of single/double/triple/quadruple blood collection bags used for blood component preparations, CPDA blood collection bags may be used.
(ii) Acid Citrate Dextrose solution (A.C.D. with Formula-A) I.P. – 15 ml solution shall be required for 100 ml of blood,
(iii) Additive solutions such as SAGM, ADSOL, NUTRICEL may be used for storing and retaining Red Blood Corpuscles up to 42 days.
Note 2.- The licensee shall ensure that the anti-coagulant solutions are of a licensed manufacturer and the blood bags in which the said solutions are contained have a certificate of analysis of the said manufacturer.
5. Emergency equipments/items:
(i) Oxygen cylinder with mask, gauge and pressure regulator.
(ii) 5 per cent Glucose or Normal Saline.
(iii) Disposable sterile syringes and needles of various sizes.
(iv) Disposable sterile I.V. infusion sets.
(v) Ampoules of Adrenaline, Noradrenaline, Mephentin, Betamethasone or Dexamethasone, Metoclorpropamide injections.
(vi) Aspirin.
6. Accessories:
(i) Such as blankets, emesis basins, haemostats, set clamps, sponge forceps, gauze, dressing jars, solution jars, waste cans.
(ii) Medium cotton balls, 1.25 cm adhesive tapes.
(iii) Denatured spirit, Tincture Iodine, green soap or liquid soap.
(iv) Paper napkins or towels.
(v) Autoclave with temperature and pressure indicator.
(vi) Incinerator
(vii) Stand-by generator
7. Laboratory equipment:
(i) Refrigerators, for storing diagnostic kits and reagents, maintaining a temperature between 4 to 6 degree centigrade (plus/minus 2 degrees centigrade) with digital dial thermometer having provision for continuous power supply.
(ii) Compound Microscope with low and high power objectives.
(iii) Centrifuge Table Model.
(iv) Water bath: having range between 37 degree centigrade to 56 degree centigrade.
(v) Rh viewing box in case of slide technique.
(vi) Incubator with thermostatic control.
(vii) Mechanical shakers for serological tests for Syphilis.
(viii) Hand-lens for observing tests conducted in tubes.
(ix) Serological graduated pipettes of various sizes.
(x) Pipettes (Pasteur).
(xi) Glass slides.
(xii) Test tubes of various sizes / micrometer plates (U or V type).
(xiii) Precipitating tubes 6mm x 50mm of different sizes and glass beakers of different sizes.
(xiv) Test tube racks of different specifications.
(xv) Interval timer electric or spring wound.
(xvi) Equipment and materials for cleaning glass wares adequately.
(xvii) Insulated containers for transporting blood, between 2 degree centigrade to 10 degree centigrade temperatures, to wards and hospitals.
(xviii) Wash bottles.
(xix) Filter papers.
(xx) Dielectric tube sealer.
(xxi) Plain and EDTA vials.
(xxii) Chemical balance (wherever necessary).
(xxiii) ELISA reader with printer, washer and micropipettes.
J. SPECIAL REAGENTS :
(1) Standard blood grouping sera Anti A, Anti B and Anti D with known controls. Rh typing sera shall be in double quantity and each of different brand or if from the same supplier each supply shall be of different lot numbers.
(2) Reagents for serological tests for syphilis and positive sera for controls.
(3) Anti Human Globulin Serum (Coomb‘s serum).
(4) Bovine Albumin 22 percent Enzyme reagents for incomplete antibodies.
1[(5) ELISA or RPHA test kits for Hepatitis and HIV I & II.
(6) Detergent and other agents for cleaning laboratory glass wares.
K. TESTING OF WHOLE BLOOD :
(1) It shall be responsibility of the licensee to ensure that the whole blood collected, processed and supplied conforms to the standards laid down in the Indian Pharmacopoeia and other tests published, if any,
by the Government.
(2) Freedom from HIV antibodies (AIDS) Tests. – Every licensee shall get samples of every blood unit tested, before use, for freedom from HIV 1 and HIV II antibodies either from laboratories specified for the purpose by the Central Government or in his own laboratory. The results of such testing shall be recorded on the label of the container.
(3) Each blood unit shall also be tested for freedom from 2[(Hepatitis B surface antigen and Hepatitis C Virus antibody)] VDRL and malarial parasite and results of such testing shall be recorded on the label
of the container.
NOTES
(a) Blood samples of donors in pilot tube and the blood samples of the Recipient shall be preserved for 7 days after issue.
(b) The blood intended for transfusion shall not be frozen at any stage.
(c) Blood containers shall not come directly in contact with ice at any stage.
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1. Subs. By G.S.R. 733(E) dated 21-12-2005
2. Subs. by G.S.R. 40(E) dated 29-01-2001
________
L RECORDS :
The records which the licensee is required to maintain shall include inter alia the following particulars, namely:
(1) Blood donor record: It shall indicate serial number, date of bleeding, name, address and signature of donor with other particulars of age, weight, haemoglobin, blood grouping, blood pressure, medical examination, bag number and patient‘s detail for whom donated in case of replacement donation, category of donation (voluntary / replacement) and deferral records and signature of Medical Officer In-charge.
(2) Master records for blood and its components: It shall indicate bag serial number, date of collection, date of expiry, quantity in ml. ABO/Rh Group, results for testing of HIV I and HIV II antibodies, Malaria, V.D.R.L. 1[(Hepatitis B surface antigen and Hepatitis C Virus antibody)] and irregular antibodies (if any), name and address of the donor with particulars, utilization issue number, components prepared or discarded and signature of the Medical Officer in charge.
(3) Issue Register: It shall indicate serial number, date and time of issue bag serial number, ABO/RH Group, total quantity in ml, name and address of the recipient, group of recipient, unit/institution, details of cros-matching report, indication for transfusion.
(4 ) Records of components supplied: Quantity supplied; compatibility report, details of recipient and signature of issuing person.
(5) Records of ACD/CPD/CPD-A/SAGM bags giving details of manufacturer, batch number, date of supply, and results of testing.
(6) Register for diagnostic kits and reagents used: name of the kits/reagents, details of batch number, date of expiry and date of use.
(7) Blood bank must issue the cross matching report of the blood to the patient together with the blood unit.
(8) Transfusion adverse reaction records.
(9) Records of purchase, use and stock in hand of disposable needles, syringes, blood bags, shall be maintained.
NOTE : The above records shall be kept by the licensee for a period of five years.
M. LABELS :
The labels on every bag containing blood and/or component shall contain the following particulars, namely;
(1) The proper name of the product in a prominent place and in bold letters on the bag.
(2) Name and address of the blood bank
(3) Licence number
________
1 Subs. by G.S.R. 40(E), dt. 29.1.2001 (w.e.f. 1.6.2001).
________
(4) Serial number
(5) The date on which the blood is drawn and the date of expiry as prescribed under Schedule P to these rules.
(6) A colored label shall be put on every bag containing blood. The following color scheme for the said labels shall be used for different groups of blood:
| Blood Group |
Colour of the label |
| O |
Blue |
| A |
Yellow |
| B |
Pink |
| AB |
White |
(7) The results of the tests for 1[(Hepatitis B surface antigen and Hepatitis C Virus antibody)] syphilis, freedom from HIV I and HIV II antibodies and malarial parasite.
(8) The Rh. Group.
(9) Total volume of blood, the preparation of blood, nature and percentage of anti- coagulant.
(10) Keep continuously temperature at 2 degree centigrade to 6 degree centigrade for whole human blood and/or components as contained under III of Part XII B.
(11) Disposable transfusion sets with filter shall be used in administration equipment.
(12) Appropriate compatible cross-matched blood without atypical antibody in recipient shall be used.
(13) The contents of the bag shall not be used if there is any visible evidence of deterioration like haemolysis, clotting or discoloration.
(14) The label shall indicate the appropriate donor classification like “Voluntary Donor” or “Replacement Donor” in no less prominence than the proper name.
NOTES :
1. In the case of blood components, particulars of the blood from which such components have been prepared shall be given against item numbers (5), (7), (8), (9) and (14).
2. The blood and/or its components shall be distributed on the prescription of a Registered Medical Practitioner.
II. BLOOD DONATION CAMPS.
A blood donation camp may be organized by –
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1. Subs. by G.S.R 40(E), dt. 29.1.2001.
___________
(a) a licensed designated Regional Blood Transfusion Centre ; or
(b) a licensed Government blood bank; or
(c) the Indian Red Cross society; or
NOTES:
(i) ” Designated Regional Blood Transfusion Centre” shall be a center approved and designated by a Blood Transfusion Council constituted by a State Government to collect, process and distribute blood and its components to cater to the needs of the region and that center has also been licensed and approved by the Licensing Authority and Central Licence Approving Authority for the purpose.
(ii) The designated Regional Blood Transfusion Centre, Government blood bank and Indian Red Cross Society shall intimate within a period of seven days, the venue where the blood camp was held and details of group wise blood units collected in the said camp to the Licensing Authority and Central Licence Approving Authority.
For holding a blood donation camp, the following requirements shall be fulfilled/complied with, namely:-
(A) Premises, personnel etc.
(a) Premises under the blood donation camp shall have sufficient area and the location shall be hygienic so as to allow proper operation, maintenance and cleaning.
(b) All information regarding the personnel working, equipment used and facilities available at such a Camp shall be well documented and made available for inspection, if required, and ensuring –
(i) Continuous and uninterrupted electrical supply for equipment used in the Camp;
(ii) Adequate lighting for all the required activities;
(iii) Hand-washing facilities for staff;
(iv) Reliable communication system to the central office of the Controller/ Organizer of the Camp;
(v) Furniture and equipment arranged within the available space;
(vi) Refreshment facilities for donors and staff;
(vii) Facilities for medical examination of the donors;
(viii) Proper disposal of waste.
(B) Personnel for Out-door Blood Donation Camp:
To collect blood from 50 to 70 donors in about 3 hours or from 100 to 200 donors in 5 hours, the following requirements shall be fulfilled / complied with:
(i) one Medical Officer and two nurses or phlebotomists for managing 6-8 donor tables;
(ii) two medico social workers;
(iii) three blood bank technicians;
(iv) two attendants;
(v) vehicle having a capacity to seat 8-10 persons, with provision for carriage of donation goods including facilities to conduct a blood donation camp;
(C) Equipments :
1. BP apparatus.
2. Stethoscope.
3. Blood bags (single, double, triple, quadruple).
4. Donor questionnaire.
5. Weighing device for donors.
6. Weighing device for blood bags.
7. Artery forceps, scissors.
8. Stripper for blood tubing.
9. Bed sheets, blankets/mattress.
10. Lancets, swab stick/tooth picks.
11. Glass slides.
12. Portable Hb meter/copper sulphate.
13. Test tube (big) and 12x100mm (small).
14. Test tube stand.
15. Anti-A, Anti-B and Anti-AB, Antisera and Anti-D.
16. Test tube sealer film.
17. Medicated adhesive tape.
18. Plastic waste basket.
19. Donor cards and refreshment for donors.
20 Emergency medical kit.
21 Insulated blood bag containers with provisions for storing between 2 degree centigrade to 10 degree centigrade.
22. Dielectric sealer or portable tube sealer.
23. Needle destroyer (wherever necessary).
III. PROCESSING OF BLOOD COMPONENTS FROM WHOLE BLOOD BY A BLOOD BANK
The Blood components shall be prepared by blood banks as a part of the Blood Bank services. The conditions for grant or renewal of licence to prepare blood components shall be as follows:-
A. ACCOMMODATION:
(1) Rooms with adequate area and other specification, for preparing blood components depending on quantum of workload shall be as specified in item B under the heading “1. BLOOD BANKS/BLOOD COMPONENTS‘ of this Part.
(2) Preparation of Blood components shall be carried out only under closed system using single double, triple or quadruple plastic bags except for preparation of Red Blood Cells Concentrates, where single bags may be used with transfer bags.
B. EQUIPMENT :
(i) Air Conditioner;
(ii) Laminar air flow bench;
(iii) Suitable refrigerated centrifuge;
(iv) Plasma expresser;
(v) Clipper and clips and/or dielectric sealer;
(vi) Weighing device;
(vii) Dry rubber balancing material;
(viii) Artery forceps, scissors;
(ix) Refrigerator maintaining a temperature between 2 degree centigrade to 6 degree centigrade, a digital dial thermometer with recording thermograph and alarm device, with provision for continuous power supply;
(x) Platelet agitator with incubator (wherever necessary);
(xi) Deep freezers maintaining a temperature between minus 30 degree centigrade to minus 40 degree centigrade and minus 75 degree centigrade to minus 80 degree centigrade;
(xii) Refrigerated Water bath for Plasma Thawing;
(xiii) Insulated blood bag containers with provisions for storing at appropriate temperature for transport purposes;
C. PERSONNEL:
The whole time competent technical staff meant for processing of Blood Components (that is Medical Officer, Technical Supervisor, Blood Bank Technicians and Registered Nurse) shall be as specified in item C, under the heading ” 1. BLOOD BANKS/BLOOD COMPONENTS” of this Part.
D. TESTING FACILITIES:
General: Facilities for A, B, AB and O groups and Rh(D) grouping. 1[(Hepatitis B surface antigen and Hepatitis C Virus antibody)], VDRL, HIV I and HIV II antibodies and malarial parasites shall be mandatory for every blood unit before it is used for the preparation of blood components. The results of such testing shall be indicated on the label.
E. CATEGORIES OF BLOOD COMPONENTS:
(1) CONCENTRATED HUMAN RED BLOOD CORPUSCLES:
The product shall be known as “Packed Red Blood Cells” that is Packed Red Blood Cells remaining after separating plasma from human blood.
General Requirements:
(a) Storage: Immediately after processing, the Packed Red Blood Cells shall be kept at a temperature maintained between 2 degree centigrade to 6 degree centigrade.
(b) Inspection: The component shall be inspected immediately after separation of the plasma, during storage and again at the time of issue. The product shall not be issued if there is any abnormality in color or physical appearance or any indication of microbial contamination.
(c) Suitability of Donor: The source of blood for Packed Red Blood Cells shall be obtained from a donor who meets the criteria for Blood Donation as specified in item H under the heading “I. BLOOD BANKS/BLOOD COMPONENTS” of this Part.
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1. Subs. by G.S.R. 40(E), dt. 29.1.2001.
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(d) Testing of Whole Blood: Blood from which Packed Red Blood Cells are prepared shall be tested as specified in item K relating to Testing Of Whole Blood under the heading “I. BLOOD BANKS/BLOOD COMPONENTS” of this Part.
(e) Pilot samples: Pilot samples collected in integral tubing or in separate pilot tubes shall meet the following specifications:
(i) One or more pilot samples of either the original blood or the Packed Red Blood Cells being processed shall be preserved with each unit of Packed Red Blood Cells which is issued.
(ii) Before they are filled, all pilot sample tubes shall be marked or identified so as to relate them to the donor of that unit or Packed Red Blood Cells.
(iii) Before the final container is filled or at the time the final product is prepared, the pilot samples tubes accompanying a unit of Packed Red Blood Cells, shall be attached in a tamper-proof manner that shall conspicuously identify removal and re- attachment.
(iv) All pilot sample tubes, accompanying a unit of packed red blood cells, shall be filled immediately after the blood is collected or at the time the final product is prepared, in each case, by the person who performs the collection of preparation.
F. Processing:
(i) Separation: Packed Red Blood Cells shall be separated from the whole blood, —
(a) if the whole blood is stored in ACD solution within 21 days, and
(b) if the whole blood is stored in CPDA-1 solution, within 35 days, from the date of collection. Packed Red Blood Cells may be prepared either by centrifugation done in a manner that shall not tend to increase the temperature of the blood or by normal undisturbed sedimentation method. A portion of the plasma, sufficient to ensure optimal cell preservation, shall be left with the packed Red Blood Cells.
(ii) Packed Red Blood Cells Frozen: Cryophylactic substance may be added to the Packed Red Blood Cells for extended manufacturer‘s storage not warmer than minus 65 degree centigrade provided the manufacturer submits data to the satisfaction of the Licensing Authority and Central Licence Approving Authority, as adequately demonstrating through in-vivo cells survival and other appropriate tests that the addition of the substance, the material used and the processing methods results in a final product meets the required standards of safety, purity and potency for Packed Red Blood Cells, and that the frozen product shall maintain those properties for the specified expiry period.
(iii) Testing: Packed Red Blood Cells shall conform to the standards as laid down in the Indian Pharmacopoeia.
(2) PLATELETS CONCENTRATES:
The product shall be known as “Platelets Concentrates” that is platelets collected from one unit of blood and re-suspended in an appropriate volume of original plasma.
General Requirements:
(i) Source: The source material for platelets shall be platelet rich plasma or buffy coat which may be obtained from the whole blood or by plateletpheresis.
(ii) Processing :
(a) Separation of buffy-coat or platelet-rich plasma and platelets and re- suspension of the platelets shall be in a closed system by centrifugal method with appropriate speed, force and time.
(b) Immediately after collection, the whole blood or plasma shall be held in storage between 20 degree centigrade to 24 degree centigrade. When it is to be transported from the venue of blood collection to the processing laboratory, during such transport action, the temperature as close as possible to a range between 20 degree centigrade to 24 degree centigrade shall be ensured. The platelet concentrates shall be separated within 6 hours after the time of collection of the unit of whole blood or plasma.
(c) The time and speed of centrifugation shall be demonstrated to produce an unclamped product, without visible haemolysis, that yields a count of not less than 3.5 x 1010 (3.5 x 10 raised to the power of 10) and 4.5 x 1010 (4.5 x 10 raised to the power ten) i.e. platelets per unit from a unit of 350 ml and 450 ml blood respectively. One percent of total platelets prepared shall be tested of which 75 per cent of the units shall conform to the above said platelet count.
(d) The volume of original plasma used for re-suspension of the platelets shall be determined by the maintenance of the pH of not less than 6 during the storage period. The pH shall be measured on a sample of platelets which has been stored for the permissible maximum expiry period at 20 degree centigrade to 24 degree centigrade.
(e) Final containers used for platelets shall be colorless and transparent to permit visual inspection of the contents. The caps selected shall maintain a hermetic seal to prevent contamination of the contents. The container material shall not interact with the contents, under the normal conditions of the storage and use, in such a manner as to have an adverse effect upon the safety, purity, potency, or efficacy of the product. At the time of filling, the final container shall be marked or identified by number so as to relate it to the donor.
(iii) Storage: Immediately after re-suspension, platelets shall be placed in storage not exceeding for a period of 5 days, between 20 degree centigrade to 24 degree centigrade, with continuous gentle agitation of the platelet concentrates maintained throughout such storage
(iv) Testing: The units prepared from different donors shall be tested at the end of the storage period for –
(a) Platelet count;
(b) pH of not less than 6 measured at the storage temperature of the unit;
(c) measurement of actual plasma volume;
(d) one percent of the total platelets prepared shall be tested for sterility;
(e) the tests of functional viability of the platelets shall be done by swirling movement before issue.
(f) if the results of the testing indicate that the product does not meet the specified requirements, immediate corrective action shall be taken and records maintained;
(v) Compatibility Test: Compatible transfusion for the purpose of variable number of Red Blood Cells, A, B, AB and O grouping shall be done if the platelets concentrate is contaminated with red blood cells.
(3) GRANULOCYTE CONCENTRATES:
(i) Storage: It shall be kept between 20 degree centigrade to 24 degree centigrade for a maximum period of 24 hours;
(ii) Unit of granulocytes shall not be less than 1 x 1010 (i.e. 1 x 10 raised to the power of 10) when prepared on cell separator;
(iii) Group specific tests/HLA test wherever required shall be carried out.
(4) FRESH FROZEN PLASMA:
Plasma frozen within 6 hours after blood collection and stored at a temperature not warmer than minus 30 degree centigrade, shall be preserved for a period of not more than one year.
(5) CRYOPRECIPITATE:
Concentrate of anti-hemophiliac factor shall be prepared by thawing of the fresh plasma frozen stored at minus 30 degree centigrade.
(a) Storage:
Cryoprecipitate shall be preserved at a temperature not higher than minus 30 degree centigrade and may be preserved for a period of not more than one year from the date of collection.
(b) Activity:
Anti-hemophiliac factor activity in the final product shall be not less than 80 units per bag. One percent of the total cryoprecipitate prepared shall be tested of which seventy five percent of the unit shall conform to the said specification.
F PLASMAPHERESIS, PLATELETPHERESIS, LEUCAPHERESIS, USING A CELL SEPARATOR.
An area of 10 square meters shall be provided for apheresis in the blood bank.
The blood banks specifically permitted to undertake the said apheresis on the donor shall observe the criteria as specified in item H relating to Criteria for blood donation “I. Blood Banks/Blood Components” of this Part. The written consent of the donor shall be taken and the donor must be explained, the hazards of apheresis. The Medical Officer shall certify that the donor is fit for apheresis and it shall be carried out by a trained person under supervision of the Medical Officer.
(A) PLASMAPHERESIS, PLATELETPHERESIS AND LEUCAPHERESIS:
The donors subjected to plasmapheresis, plateletpheresis and leucapheresis shall, in addition to the criteria specified in item H relating to the CRITERIA FOR BLOOD DONATION, under the heading “I. BLOOD BANKS/BLOOD COMPONENTS” of this Part being observed, be also subjected to protein estimation on post-pheresis/first sitting whose results shall be taken as reference for subsequent/sitting. It shall also be necessary that the total plasma obtained from such donor and periodicity of Plasmapheresis shall be according to the standards described under validt. Standard Operating Procedures.
NOTE :
(i) At least 48 hours must elapse between successive apheresis and not more than twice in a week.
(ii) Extracoporeal blood volume shall not exceed 15% of donor‘s estimated blood volume.
(iii) Platelet pheresis shall not be carried out on donors who have taken medication containing Asprin within 3 days prior to donation.
(iv) If during plateletpheresis or leucapheresis, RBCs cannot be re-transfused then at least 12 weeks shall elapse before a second cytapheresis procedure is conducted.
(B) MONITORING FOR APHERESIS:
Before starting apheresis procedure, hemoglobin or haematocrit shall be done. Platelet count, WBC counts, differential count may be carried out. In repeated plasmapheresis, the serum protein shall be 6 gm./ml.
(C) COLLECTION OF PLASMA:
The quantity of plasma separated from the blood of donor shall not exceed 500 ml. per sitting and once in a fortnight or shall not exceed 1000 ml per month.
PART XII C
I. REQUIREMENTS FOR MANUFACTURE OF BLOOD PRODUCTS
The blood products shall be manufactured in a separate premises other than that meant for blood bank. The requirements that are essential for grant or renewal of licence to manufacture blood products such as Albumin, Plasma Protein Fraction, Immunoglobins and Coagulation Factor Concentrates, shall be as follows, namely:-
A. GENERAL REQUIREMENTS:
1. Location and surroundings, buildings and water supply:
The requirements as regards location and surrounding, buildings and water supply as contained in paragraphs 1.1.1, 1.1.2, 1.1.3 of Part 1 of Schedule M shall apply mutatis mutandis to the manufacture of blood products.
2. Disposal of waste and infectious materials:
(i) The requirements as regards disposal of waste and infectious materials as contained in paragraph 1.1.4 of Part 1 of Schedule M shall apply mutatis mutandis to the manufacture of blood products.
(ii) Proper facility shall also be provided for potentially infectious materials, particularly HIV I & HIV II 1[(Hepatitis B surface antigen and Hepatitis C Virus antibody)] through autoclaving, incineration or any other suitable validt. methods.
3. Health, clothing and sanitation personnel:
(i) The requirement as contained in paragraph 3 of Part I of Schedule M shall be complied with.
(ii) The personnel working in the manufacturing areas shall be vaccinated against Hepatitis B virus and other infectious transmitting diseases.
4. Requirements for manufacturing area for Blood Products:
(i) For the manufacture of blood products, separate enclosed areas specifically designated for the purpose shall be provided. These areas be provided with air locks for entry and shall be essentially dust free and ventilated with an air supply. Air supply for manufacturing area shall be filtered through bacteria retaining filters (HEPA Filters) and shall be at a pressure higher than in the adjacent areas.
The filters shall be checked for performance on installation and periodically thereafter, and records thereof shall be maintained.
(ii) Interior surfaces (walls, floors and ceilings) shall be smooth and free from cracks, they shall not shed matter and shall permit easy cleaning and disinfection. Drains shall be excluded from aseptic areas.
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1. Subs. by G.S.R. 40(E) dated 29-01-2001
___________
Routine microbial counts of the manufacturing area shall be carried out during manufacturing operations. The results of such counts shall be checked against well documented in-house standards and records maintained.
Access to the manufacturing areas shall be restricted to a minimum number of authorized personnel. Special procedures for entering and leaving the manufacturing areas shall be prominently displayed.
(iii) Sinks shall be excluded from aseptic areas. Any sink installed in other clean areas shall be of suitable material such as stainless steel, without an overflow, and be supplied with water of potable quality. Adequate precautions shall be taken to avoid contamination of the drainage system with dangerous effluents and airborne dissemination of pathogenic micro-organisms.
(iv) Lighting, air-conditioning, ventilation shall be designed to maintain a satisfactory temperature and relative humidity to minimize contamination and to take account of the comfort of personnel working with protective clothing.
(v) Premises used for the manufacture of blood products shall be suitably designed and constructed to facilitate good sanitation.
(vi) Premises shall be carefully maintained and it shall be ensured that repair and maintenance operations do not present any hazard to the quality of products. Premises shall be cleaned and, where applicable, disinfected according to detailed written validt. procedures.
(vii) Adequate facilities and equipments shall be used for the manufacture of blood products derived from blood plasma.
(viii) All containers of blood products, regardless of the stage of manufacture, shall be identified by securely attached labels. Cross contamination shall be prevented by adoption of the following measures, namely: –
(a) processing and filling shall be in segregated areas;
(b) manufacture of different products at the same time shall be avoided;
(c) simultaneous filling of the different products shall be avoided;
(d) ensure transfer, containers/materials by means of airlocks, air extraction, clothing change and careful washing and decontamination of equipment;
(e) protecting containers/materials against the risk of contamination caused by re-circulation of untreated air or by accidental re-entry of extracted air;
(f) using containers that are sterilized or are of documented low “bioburden”,
(ix) Positive pressure area shall be dedicated to the processing area concerned; (x) Air- handling units shall be dedicated to the processing area concerned;
(xi) Pipe work, valves and vent filters shall be properly designed to facilitate cleaning and sterilization. Valves on fractionation/reacting vessels shall be completely steam sterilisable. Air vent filters shall be hydrophobic and shall be validated for their designated use.
5. Ancillary Areas :
(i) Rest and refreshment rooms shall be separated from other areas.
(ii) Facilities for changing and storing clothes and for washing and toilet purposes shall be easily accessible and appropriate for the number of users. Toilets shall not be connected directly with production or storage areas.
(iii) Maintenance workshops shall be separated from production areas. Wherever parts and tools are stored in the production area, they shall be kept in rooms or lockers reserved for that use.
(iv) Animal houses shall be well isolated from other areas with separate entrance.
B. COLLECTION AND STORAGE OF PLASMA FOR FRACTIONATION
(a) Collection:
(1) Plasma shall be collected from the licensed Blood Banks through a cold chain process and stored in frozen condition not warmer than minus twenty degree centigrade.
(2) Individual plasma shall remain in quarantine till it is tested for 1[( Hepatitis B and Hepatitis C Virus antibody)], HIV I and HIV II.
(3) A sample from pooled – lot plasma of about 10-12 units of different donors shall be tested for 1[(Hepatitis B and Heptitis C Virus antibody)] HIV I and HIV II and if the same sample found negative, only then it shall be taken up for fractionation.
(b) Storage Area :
(1) Storage areas shall be of sufficient space and capacity to allow orderly storage of the various categories of materials, intermediates, bulk and finished products, products in quarantine, released, rejected, returned, or recalled products.
(2) Storage areas shall be designed or adopted to ensure good storage conditioning. In particular, they shall be clean, dry and maintained within temperature required for such storage and where special storage conditions are required (e.g. temperature, humidity), these shall be provided, checked and monitored.
(3) Receiving and dispatch bays shall protect materials and products from the weather and shall be designed and equipped to allow containers of incoming materials to be cleaned, if necessary, before storage.
(4) Where quarantine status is ensured by storage in separate areas, these areas shall be clearly marked and their access restricted only to authorized personnel.
(5) There shall be separate sampling area for raw materials. If sampling is performed in the storage area, it shall be conducted in such a way so as to prevent contamination or cross-contamination.
(6) Segregation shall be provided for the storage of rejected, recalled, or returned materials or products.
(7) Adequate facility shall be provided for supply of ancillary material, such as ethanol, water, salts and polyethylene glycol. Separate facilities shall be provided for the recovery of organic solvents used in fractionation.
___________
1. Subs. by G.S.R 40(E), dt. 29.1.2001 (w.e.f. 1.6.2001)
___________
C. PERSONNEL :
(1) Manufacture :
The manufacture of blood products shall be conducted under the active direction and personal supervision of competent technical staff, consisting of at
least one person who shall be a whole time employee, with one year practical experience in the manufacture of blood products / plasma fractionation and possesses –-
(a) Post-graduate degree in Medicine–M.D. (Microbiology/Pathology/ Bacteriology/Immunology/Biochemistry); or
(b) Post-graduate degree in Science (Microbiology); or
(c) Post-graduate degree ib Pharmacy (Microbiology), from a recognized University or Institution.
2. Testing:
The head of the testing unit shall be independent of the manufacturing unit and testing shall be conducted under the active direction and personal supervision of competent technical staff consisting at least one person who shall be a whole time employee. The Head of the testing unit shall have eighteen months practical experience in the testing of drugs, especially the blood products and possesses –
(a) Post-graduate degree in Pharmacy or Science– (Chemistry/ Microbiology/ Bio-chemistry); or
(b) Post-graduate degree in Medicine– M.D(Microbiology/Pathology/ Biochemistry), from a recognized University or Institution.
D. PRODUCTION CONTROL:
(1) The production area and the viral inactivation room shall be centrally air- conditioned and fitted with HEPA filters having Grade C (Class 10,000) environment as given in the Table below.
(2) The filling and sealing shall be carried out under aseptic conditions in centrally air-conditioned areas fitted with HEPA Filters Grade A or, as the case may be, Grade B (Class 100) environment given in the said Table.
TABLE
AIR CLASSIFICATION SYSTEM FOR MANUFACTURE OF STERILE PRODUCTS.
| Grade |
Maximum number of particles permitted per m3 |
Maximum number of Viable Micro-organism permitted per m3 |
|
0.5 – 5 micron |
Less than 5 micron |
|
| A (Class 100) (Laminar – Airflow workstation) |
3500 |
None |
Less than 1 |
| B (Class 100) |
3500 |
None |
Less than 5 |
| C (Class 10,000) |
3,50,000 |
2000 |
Less than 100 |
(3) The physical and chemical operations used for the manufacture of plasma fractionation shall maintain high yield of safe and effective protein.
(4) The fractionation procedure used shall give a good yield of products meeting the in-house quality requirements as approved by the Licensing Authority and Central Licence Approving Authority reducing the risk of microbiological contamination and protein denaturation to the minimum.
(5) The procedure adopted shall not affect the antibody activity and biological half- life or biological characteristics of the products.
E. VIRAL INACTIVATION PROCESS :
The procedure used by the licensee to inactivate the pathogenic organisms such as enveloped and non-enveloped virus, especially infectivity from HIV I & HIV II, 1[(Hepatitis B surface antigens and Hepatitis C Virus antibody)], the viral inactivation and validation methods adopted by the licensee, shall be submitted for approval to the Licensing Authority and Central Licence Approving Authority.
NOTES:
(1) No preservative (except stabilizer to prevent – protein denaturation such as glycine, sodium chloride or sodium caprylate) shall be added to Albumin, Plasma Protein Fraction, Intravenous Immunoglobulins or Coagulation Factor Concentrates without the prior approval of Licensing Authority and Central Licence Approving Authority.
(2) The licensee shall ensure that the said stabilizers do not have deleterial effect on the final product in the quantity present so as not to cause any untoward or adverse reaction in human beings.
F. QUALITY CONTROL:
Separate facilities shall be provided for Quality Control such as Hematological, Bio-chemical, Physico-chemical, Microbiological, Pyrogens, Instrumental and Safety testing. The Quality Control Department shall have inter alia the following principal duties, namely :-
(1) To prepare detailed instructions for carrying out test and analysis.
(2) To approve or reject raw material, components, containers, closures, in- process materials, packaging material, labelling and finished products.
(3) To release or reject batch of finished products which are ready for distribution.
(4) To evaluate the adequacy of the conditions under which raw materials, semi- finished products and finished products are stored.
_________
1. Subs. by G.S.R 40(E), dt. 29.1.2001 (w.e.f. 1.6.2001)
_________
(5) To evaluate the quality and stability of finished products and when necessary of raw materials and semi-finished products.
(6) To review production records to ensure that no errors have occurred or if errors have occurred that they have been fully investigated.
(7) To approve or reject all procedures, or specifications impacting on the identity, strength, quality and purity of the product.
(8) To establish shelf-life and storage requirements on the basis of stability tests related to storage conditions.
(9) To establish and when necessary revise, control procedures and specifications.
(10) To review complaints, recalls, returned or salvaged products and investigations conducted there under for each product.
(11) To review Master Formula Records/Cards periodically.
G. TESTING OF BLOOD PRODUCTS:
The products manufactured shall conform to the standards specified in the Indian Pharmacopoeia and where standards of any product is not specified in the Pharmacopoeia, the standard for such product shall conform to the standard specified in the United States Pharmacopoeia or the British Pharmacopoeia. The final products shall be tested for freedom from HIV I and HIV II antibodies 1[(Hepatitis B surface antigen and Hepatitis C Virus antibody)].
H. STORAGE OF FINISHED PRODUCT:
(i) The final products shall be stored between two degree centigrade to eight degree centigrade, unless otherwise specified by the Central Licence Approving Authority.
(ii) The shelf-life assigned to the products by the licensee shall be submitted for approval to the Licensing Authority and Central Licence Approving Authority.
I. LABELLING :
The products manufactured shall be labelled as specified in the Indian Pharmacopoeia, the British Pharmacopoeia or the United Stated Pharmacopoeia which shall be in addition to any other requirement stated under Part IX or Part X of these rules. The labels shall indicate the results of test for 1[(Hepatitis B surface antigen and Hepatitis C Virus antibody)] freedom from HIV I and HIV II antibodies.
J. RECORDS:
The licensee shall maintain records as per Schedule U and also comply with Batch manufacturing records as specified in Paragraph 9 of Part -I of Schedule M and any other requirement as may be directed by Licensing Authority and Central Licence Approving Authority.
K. MASTER FORMULA RECORDS:
The licensee shall maintain Master Formula Records relating to all manufacturing and quality control procedures for each product, which shall be prepared and endorsed by the Competent Technical Staff, i.e. Head of the manufacturing unit. The Master Formula Records shall contain: –
(i) the patent or proprietary name of the product along with the generic name, if any, strength and the dosage form;
(ii) a description or identification of the final containers, packaging materials, labels and closures to be used;
_________
1. Subs. by G.S.R 40(E), dt. 29.1.2001(w.e.f. 1.6.2001)
_________
(iii) the identity, quantity and quality of each raw material to be used irrespective of whether or not it appears in the finished product. The permissible overage that may be included in a formulated batch shall be indicated;
(iv) a description of all vessels and equipments and the sizes used in the process;
(v) manufacturing and control instructions along with parameters for critical steps such as mixing, drying, blending, sieving and sterilizing the product;
(vi) the theoretical yield to be expected from the formulation at different stages of manufacture and permissible yield limits;
(vii) detailed instructions on precautions to be taken in the manufacture and storage of drugs and of semi finished products; and
(viii) the requirements in-process quality control tests and analysis to be carried out during each stage of manufacture including the designation of persons or departments responsible for the execution of such tests and analysis.
II. REQUIREMENTS FOR MANUFACTURE OF BLOOD PRODUCTS FROM BULK FINISHED PRODUCTS
Where the blood products, such as Albumin, Plasma Protein Fraction, Immunoglobulins and Coagulation Factor Concentrates are manufactured through the manufacturing activities of filling and sealing the blood products from bulk powder or solution or both, the requirements as they apply to the manufacture of blood products from whole blood shall apply mutatis mutandis to such manufacture of blood products, unless other requirements have been approved by the Central Licence Approving Authority.]
1[PART XIID
REQUIREMENTS FOR COLLECTION, PROCESSING, TESTING, STORAGE, BANKING AND RELEASE OF UMBILICAL CORD BLOOD DERIVED STEM CELLS
(A) GENERAL REQUIREMENTS
1. Location, Surroundings and Building: The building (s) for storage of Umbilical cord blood shall be so situated and shall have such measures as to avoid risk of contamination from external environment including open sewage, drain, public lavatory or any factory which produces disagreeable or obnoxious odour or fumes, excessive soot, smoke, chemical or biological emissions.
2. Buildings and premises: (1) The premises used for processing and storage shall be designed, constructed and adapted and maintained to ensure that the above operations and other ancillary functions are performed smoothly under hygienic conditions and in sterile areas wherever required. They shall also conform to the conditions laid down in the Factories Act, 1948 (63 of 1948).
The premises shall be:
(a) Adequately provided with working space to allow orderly and logical placement of equipment, material and movement of personnel so as to maintain safe operations and prevent contamination;
(b) Designed / constructed / maintained to prevent entry of insects, pests, birds, vermins and rodent. interior surfaces (walls, floors, ceilings and doors) shall be smooth and free from cracks, and permit easy cleaning, painting and disinfection, and in aseptic areas the surfaces shall be impervious, non-shedding, non-flaking and non-cracking;
(c) Flooring shall be unbroken and provided with a cove both at the junction between the wall and the floor as well as the wall and the ceiling.
_________
1. Inserted by G.S.R. 899(E) dated 27-12-2011
_________
(d) Provided with light fitting and grills which shall flush with the walls and not hanging from the ceiling to prevent contamination;
(e) If provided with fire escapes, these shall be suitably installed in the walls without any gaps;
(f) Provided with the furniture in aseptic areas which is smooth, washable and made of stainless steel or any other appropriate non shedding material other than wood;
(g) Provided with separate areas for processing and storage of products to prevent mix- ups, product contaminations and cross contamination;
(h) Provided with defined environmental conditions for temperature, humidity, ventilation and air filtration. Classifications shall be defined and, if appropriate, monitored.
(2) A periodical record of cleaning and renovating of the premises shall be maintained.
3. Disposal of waste and infectious materials:
(a) Waste materials awaiting disposal shall be stored safely;
(b) The disposal of sewage and effluents from the facility shall be in conformity with the requirements of the Pollution Control Board;
(c) All bio-medical waste shall be dealt with in accordance with the provisions of the Bio- medical Waste Management and Handling Rules, 1996.
4. Health, clothing and Sanitation of personnel:
(a) All personnel shall undergo medical examination prior to employment and shall be free from infectious and contagious diseases and thereafter they should be medically examined periodically at least once a year and for this purpose records shall be maintained thereof:
(b) All personnel, prior to and during employment, shall be trained in practices which ensure personal hygiene and a high level of personal hygiene shall be observed by all those engaged in the collection, processing, banking of umbilical cord blood;
(c) All persons shall wear clean body coverings appropriate for their duties before entering the Processing Zone and the Change Rooms with adequate facilities shall be provided prior to entry into any specific zone;
(d) Smoking, eating, drinking is prohibited inside the Laboratory;
(e) All personnel working in the Laboratory shall be protected against virus infections.
5. Requirements for Processing, Testing and Storage Areas for Umbilical cord blood stem cells:
(a) Separate dedicated areas specifically designed for the purpose and the workload shall be provided:
(b) There shall be separate areas for designated work purposes namely:-
(i) Cord blood Reception: cord blood reception area with space for transient storage of units and physical examination shall have adequate facilities for registration, date entry and generation of bar-coded labels. Air condition area of at lease 10.00 Sq. meters shall be provided;
(ii) Cord blood processing area: The room shall be clean and have an air handling System to provide a Class 10,000 environment. Entry to this area shall be through air lock. The room will house Class 100 biological safety cabinets for Umbilical cord blood processing. The temperature of the clean room shall be maintained 20 ºC to 25ºC and with a positive differential pressure of 10-15 pascals and Relative humidity of 50-60% Minimum area shall be 10.00 Sq. meters for the activity;
(iii) Haematology and Serology Laboratory: The laboratory shall be equipped and utilized for the purpose of independently testing of Umbilical Cord Blood for ABO grouping and Rh Typing, Total Nucleated Cell Count, Progenitor cell count and viability test. The room shall be air-conditioned and area of at least 10.00 Sq. meters shall be provided.
(iv) Transfusion Transmissible Disease Screening Laboratory: The Laboratory shall be equipped and utilized for screening tests on maternal blood for infectious diseases viz. HIV I & II; Hepatitis B & C virus, syphilis, malaria, CMV and HTLV. The room shall be air-conditioned and area of at least 10.00 Sq. meters shall be provided.
(v) Sterility Testing Laboratory: The laboratory shall be used for performing Sterility tests on Umbilical Cord blood unit. The premises may be classified depending on the testing method used. The room shall be air-conditioned with adequate and ancillary area for media prepar ation, sterilization, incubation and decontamination. Area of at least 10.00 Sq. meters shall be provided.
(vi) HLA Typing Laboratory: The Umbilical Cord blood unit shall have arrangements for HLA typing and genetic disease testing. In-house testing can be done by providing a well demarcated laboratory from the processing area for evaluation of possible genetic disease and HLA typing. The area shall have Class 100,000 environment and air-conditioned and area of at least 10.00 Sq. meters shall be provided.
(vii) Sterilization-cum-washing: Appropriate facility shall be provided within the premises for proper washing and sterilization. This facility would be optional for laboratories using entirely disposable items.
(viii) Records and Store Rooms: There shall be designed record room(s) and store room(s) of at least 10.00 Sq. meters each. The access to record room shall be permitted only to authorized person. The room will have adequate protective facilities as the documents and records are to be preserved for long years.
(ix) Cryogenic Storage room: A minimum space of 20.00 sq. meters shall be provided by the licensee. The cryogenic storage room shall have provision for temperature monitoring of storage vessels, liquid nitrogen level in storage vessels and oxygen meter. The service space between each liquid nitrogen storage vessel, supply cylinders and connecting hose should be minimum 1.00 sq. Meters. Separate storage space for other accessories required shall be provided. The room shall be air- conditioned.
(x) General Storage area: General storage area shall be provided to store all the consumables, under conditions deemed optimum for storage by manufacturers.
B. COLLECTION AND STORAGE OF PROCESSED UMBILICAL CORD BLOOD COMPONENT
1. Collection:
(a) Umbilical Cord blood unit specific for an individual will be collected after signing an agreement with the parents, whose child‘s Umbilical Cord blood is to be collected and the cord blood bank. Private and Public Umbilical Cord blood banking to have different agreements;
(b) Umbilical Cord blood shall be collected from hospitals, nursing homes, birthing centers and from any other place where a consenting mother delivers, under the supervision of the qualified Registered Medical Practitioner responsible for the delivery;
(c) The cord blood shall be collected aseptically in a disposable PVC bag, containing adequate quantity of sterile, pyrogen free anti-coagulant and sealed effectively and such PVC Bags shall be procured from licensed manufacturer;
(d) The Umbilical Cord blood would be collected from a premises operating in hygienic condition to allow proper operation, maintenance and cleaning.
2. Transportation:
(a) Umbilical Cord blood shall be transported from the birthing center to the designated laboratory under and as per procedure prescribed by the cord blood bank;
(b) The transportation procedure shall be validated to ensure optimum survival of the Stem Cells;
(c) The transportation temperature should be between 18 to 28ºC;
(d) The time period between collection and processing shall not exceed 72 hours.
3. Storage:
(a) The Umbilical Cord blood shall be stored at room temperature between 20 to 25ºC in the reception area prior to processing;
(b) Samples pending tests for specific transfusion transmittable infectious diseases shall be stored in a segregated manner.
Note:- Temperature range between 4 to 37 degrees Celsius, for the whole time period of transit may be allowed beyond the 18ºC to 28ºC in exceptional cases. The effects of deviation of transit temperature from the optimum, on the product shall be adequately explained by the licensee in the client education booklet.
C. PERSONNEL
Cord blood bank shall have following categories of whole time competent technical staff, namely:-
1. Medical Director:- The operation of cord blood bank shall be conducted under the active directions and supervision of a Medical Director who is a whole time employee and is possessing a Post Graduate degree in medicine – MD [Pathology/Transfusion Medicine/Microbiology] and has experience / training in cord blood processing and Cryogenic Storage.
2. Laboratory In-charge: The laboratory in-charge shall have Post Graduate qualification in Physiology or Botany or Zoology or Cell Biology or Microbiology or Biochemistry or Life Sciences or Graduate in Pharmacy and one year working experience in pathological laboratory licensed by the local health authority or any microbiology laboratory of a licensed drug manufacturing / testing unit and or experience / training in cord blood processing and cryogenic storage.
3. Technical Supervisor (cord blood processing):- The technical supervisor shall have a:
(a) Degree in Physiology or Botany or Zoology, Pharmacy or Cell Biology or Bio Sciences or Microbiology or Biochemistry or Medical Laboratory Technology (M.L.T.) with minimum of three years of experience in the preparation of blood components and / or experience or training in cord blood processing and Cryogenic Storage; or
(b) Diploma in Medical Laboratory Technology (M.L.T.) with five years experience in the preparation of blood components and experience or training in cord blood processing and Cryogenic Storage shall be essential.
4. Cord Blood Bank Technician(s):- The technicians employed shall have a:
(a) A degree in Physiology or Botany or Zoology or Pharmacy or Cell Biology or Bio Science or Microbiology or Biochemistry or Medical Laboratory Technology (M.L.T.) with six months experience and or training in cord blood processing and cryogenic storage; or
(b) Diploma in Medical Laboratory Technology (MLT) with one year experience in the testing of bloodand / or its components and / or experience or training in cord blood processing and Cryogenic Storage.
D. AIR HANDLING SYSTEM
1. Air handling for sterile areas shall be different from those for other areas. The filter configuration in the air handling system shall be suitably designed to achieve the grade of air as given in the Table I. The environmental microbiological monitoring of clean areas shall be in accordance to the recommended limits given in Table II.
2. The Processing area shall have HVAC system and fitted with HEPA Filters having Grade C (Class 10,000) environment as given in Table I.
3. The entire processing shall be done conforming to Grade A (Class 100) Standard of air quality.
TABLE I
AIR BORNE PARTICULATE CLASSIFICATIONS FOR MANUFACTURE OF STERILE PRODUCTS
| Grade |
Maximum number of permitted particles per cubic meter equal to or above |
|
At rest (b) |
In Operation (a) |
|
0.5µm |
5 µm |
0.5µm |
5 µm |
| A |
3,500 |
0 |
3,500 |
0 |
| B(a) |
3,500 |
0 |
3,50,000 |
2000 |
| C(a) |
3,50,000 |
2000 |
35,00,000 |
20,000 |
| D(a) |
35,00,000 |
20,000 |
Not defined |
Not defined |
Notes:-
(a) In order to reach the B, C and D air grades, the number of air changes shall be related to the size of the room and the equipment and personnel present in the room. The air system shall be provided with the appropriate filters such as HEPA for grades A, B and C. The maximum permitted number of particles in the “at rest” condition shall approximately be as under:-
[Grade A and B corresponds with class 100 or M 3.5 or class 5]; Grade C with Class 10,000 or M 5.5 or ISO Class 7; Grade D with Class 1,00,000 or M 6.5 or ISO Class 8.
(b) The requirement and limit for the area shall depend on the nature of the operation carried out.
TABLE II
RECOMMENDED LIMITS FOR MICROBIOLOGICAL MONITORING OF CLEAN AREAS “IN OPERATION”
| Grade |
Air samples Cfu/m3 |
Settle Plates (dia 90mm) cfu/2hrs |
Contact plates (dia 55 mm) cfu per plate |
Glove points (Five fingers) cfu per glove |
| A |
Less than 1 |
Less than 1 |
Less than 1 |
Less than 1 |
| B |
10 |
5 |
5 |
5 |
| C |
100 |
50 |
25 |
– |
| D |
500 |
100 |
50 |
– |
Notes:-
(a) These are average values.
(b) Individual settle plates may be exposed for not less than two hours in Grade B, C and D areas and for not less than thirty minutes in Grade A area.
E. QUALITY CONTROL
1. Facilities shall be provided for Quality Control such as Haematological, Microbiological and Instrumental testing.
2. Following duties shall be performed under the function of quality control:
(a) To prepare detailed instructions for carrying out such tests and analysis;
(b) To approve or reject raw materials and consumables, used in any step, on the basis of approved specifications;
(c) Haematological tests like Total Nucleated Cell Counts, Mononuclear Cell Count, Enumeration of the population of Stem Cells, Stem Cell viability shall be performed on samples of processed Umbilical cord blood unit;
(d) Microbiological Tests shall be done on Maternal Blood samples for freedom from Hepatitis B Surface Antigen, Hepatitis C Virus antibody, HIV I and II antibodies. Syphilis, Malaria, CMV and HTLV. Bacterial and Fungal Culture shall be done on the umbilical cord blood samples;
(e) Instruments which would be used to process test and store the UCB unit would be validated before commissioning and calibrated from time to time to check their conformity to specific standards according to an approved and valid protocol;
(f) The environmental monitoring of the clean rooms would be done at periodic intervals according to an accepted and validated protocol;
(g) All tests mentioned above shall be done in house except tests under itme numbers (e), (f) and test for enumeration of Stem Cell Population, HLA typing and Genetic Disease Testing which may be outsourced to a competent third party approved by the licensing authority.
F. SCREENING TESTS
1. The maternal blood sample shall be tested for
(a) Hepatitis B;
(b) Hepatitis C;
(c) HIV 1 & 2;
(d) Syphilis;
(e) Malaria;
(f) CMV;
(g) HTLV
2. The Umbilical Cord Blood shall be tested for
(a) Total Nucleated Cell count;
(b) Total Mononuclear Cell Count;
(c) Progenitor Cell (CD34+) enumeration;
(d) Cell Viability;
(e) ABO Group and Rh Type;
(f) Sterility as regards Bacterial and Fungal contamination status;
(g) HLA Matching (Only for allogenic Cord Blood Units).
G. STORAGE
1. The Umbilical cord blood shall be cryopreserved using a controlled rate freezing or equivalent validated procedures. The frozen storage shall be at minus 196ºC and shall not be warmer than minus 150ºC.
2. There will be no shelf life for this class of product.
H. REFERENCE SAMPLES
1. At least two reference samples shall be collected from cord blood unit product prior to cryopreservation and stored at minus 196ºC and shall not be warmer than minus 150ºC.
2. At least one additional reference sample shall be stored at minus 76ºC or colder for the purposes other than viability analysis.
I. LABELLING
1. Initial label placed during collection shall specify:
(a) Human Umbilical Cord Blood;
(b) Approximate Volume or weight of contents in the collection bag [UCB+ Anticoagulant];
(c) Mother ‘s name;
(d) Place of collection;
(e) Date and time of collection;
(f) Collected by;
(g) To be labeled in bold, “ROOM TEMPERATURE ONLY– DO NOT REFRIGERATE, DO NOT IRRADIATE”;
(h) Manufacturing license number.
2. Label at completion of processing and before issue – Cryogenic Storage Label [Statutory label] shall indicate the following:-
(a) Name of product:- Human Progenitor Cell [HPC] – Cord Blood;
(b) Volume or weight of contents;
(c) Percentage of Cryoprotectant [DMSO];
(d) Percentage of any other additive / preservant;
(e) Date of collection [birth] ;
(f) Date of processing ;
(g) Name of manufacturer ;
(h) Manufacturing license number;
(i) Storage temperature – not less than, – 196ºC and shall not be warmer than minus 150ºC,
(j) Unique Traceability Number and / or BAR Code.
3. Issue label at the time of release of Cord Blood Unit shall indicate the following namely:-
(a) Name of manufacturer;
(b) License number;
(c) All details of the Cryogenic Storage Label;
(d) The results of Total Nucleated Cells, Progenitor Cell percentage {CD34+), Viability;
(e) Results of Transfusion Transmittable diseases testing on maternal blood;
(f) ABO Group and Rh Type;
(g) Date of processing;
(h) Result of HLA typing (allogenic);
(i) Statement “properly identify intended Recipient and Product”;
(j) A statement indicating that leukoreduction filters should not be used;
(k) Statement “Do not irradiate”
(l) Name and address of receiving hospital.
J. RECORDS OR DOCUMENTATION
1. The licensee shall maintain the following records
(a) Client / donor enrolment / agreement record;
(b) Collection of unit and transportation record;
(c) Master record of stored unit;
(d) HLA Matching record;
(e) Unit Release Register;
(f) Stock Register for Blood Collection Bag Cryoprotectant and Preservant, RBC Sedimentation Enhancer;
(g) Stock Register for Diagnostic Kits, Reagents and other consumables;
(h) Record on feedback after use of cord blood / Adverse reaction record.
2. The following Standard Operating Procedures shall be maintained by the licensee, namely:-
(a) Umbilical Cord Blood collection;
(b) Transportation of the collected Umbilical cord Blood unit;
(c) Processing of Umbilical cord blood unit;
(d) Cryogenic storage of processed umbilical cord blood unit;
(e) Testing of maternal blood for transfusion transmittable infections;
(f) Testing of Umbilical cord blood for ABO Grouping and Rh Typing;
(g) Testing of Umbilical cord blood unit for Total Nucleated Cell Count, Mononuclear Cell Count, Progenitor Cell (CD34+) enumeration, and viability;
(h) Testing of Umbilical cord blood stem cell unit for sterility;
(i) Disposal of bio medical waste;
(j) Dispensation of Umbilical cord blood unit;
(k) Preventive maintenance Protocol for all Instruments;
(l) Acceptance / Rejection procedure of consumables;
(m) Environment monitoring of classified areas;
(n) Any other standard operative procedure as per requirements.
K. CORD BLOOD RELEASE
1. There shall be designated area with adequate space for procedures and records related to cord blood unit selection and release.
2. The cord blood bank shall obtain written or electronic request from the transplant physician or designee for shipment of the cord blood unit.
3. Accompanying documentation at the time of issue from the cord blood bank shall include indications, contra-indications, caution, instruction for handling and use of the cord blood unit including short-term storage and preparation for transplantation.
4. Procedure for transportation of cryopreserved cord blood unit within the facility shall be designed to protect the integrity of the unit and the health and safety of the personnel.
5. Cryopreserved cord blood unit stored at -150ºC or colder shall be transported in a liquid nitrogen cooled dry shipper that contains adequate absorbed liquid nitrogen and has been validated to maintain temperature below -150ºC for at least 48 hours beyond the expected time of arrival at the receiving facility.
1[PART XIII]
GENERAL
1. For the purposes of this Schedule, any test or method of testing described in the 2[Indian Pharmacopoeia] shall be deemed to be a method approved by the Licensing Authority.
2. The Licensing Authority shall publish in the Official Gazette from time to time particulars of any test or method of testing approved by him.
_________
1. Renumbered by Notification No. F-18-1/46, dt. 18-6-48
2. Subs. by G.S.R. 19, dated 15-12-1977
_________
1[SCHEDULE F(I)
PART 1–VACCINES
(A) PROVISIONS APPLICABLE TO THE PRODUCION OF BACTERIAL VACCINES:
1. Definition.–. (1) This part of the Schedule applies to bacterial vaccines made from any micro-organism pathogenic to man or other animal and to vaccines made from other micro-organisms which have any antigenic value.
(2) For the purposes of this part of the Schedule, a bacterial vaccine means a sterile suspension of a killed culture of the micro-organism from which the vaccine derives its name or a sterile extract or derivative of a micro-organism, or a pure suspension of living micro- organisms which have been previously made avirulent.
2. Staff of Establishment.– A competent expert in bacteriology with sufficient experience in the manufacture and standardisation of biological products shall be in charge of the establishment responsible for the production of bacterial vaccine and he shall be assisted by a staff adequate for carrying out the tests required during the preparation and standardisation of the vaccines.
3. Proper Name.– The proper name of any vaccine shall be the name of the micro- organism from which it is made followed by the word “Vaccine” unless this Schedule otherwise provides or if there is no other special provision in this Schedule, some other name as approved by the Licensing Authority. Provided that in the case of the undermentioned preparations the proper name of the vaccine may be as follows: –
1. Anthrax Spore Vaccine (Living).
2. Blackquarter Vaccine.
3. Enterotoxaemia Vaccine.
4. Fowl Cholera Vaccine.
5. Haemorrhagic Septicaemia Adjuvant Vaccine.
6. Haemorrhagic Septicaemia Vaccine (Broth).
2[7. Multi Component Clostridial Vaccine.
8. Hemorrhagic Septicaemia Vaccine – Alum Treated.]
4. Records.– Cultures used in the preparation of vaccine before being manipulated into a vaccine, should be thoroughly tested for identity by the generally accepted tests applicable to the particular micro-organisms.
The permanent records which the licensee is required to keep shall include amongst others, a record of the origin, properties and characteristics of the cultures.
5. Combined Vaccines.– Vaccines may be issued either singly or combined in any proportion in the same container. In the case of combination of vaccines, a name for the combined vaccine may be submitted by the licensee to the Licensing Authority, and if approved, may be used as the proper name of the vaccine.
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1. Added by Ministry of Health F.P., W.H and U.D. Notfn. No. F.1-6/62-D (SO. 2889), dt. 2-7-1969
2. Ins. by G.S.R. 659(E) ,dt. 31.8.1994.
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6. Preparation– Bacterial vaccines, simple or polyvalent, are prepared from selected cultures after careful examination for their identity, specificity, purity and antigencity. They may be prepared in the following manner:.–
(a) Formal Cultures or Bacterins.– The selected pure culture strain or strain are grown in a suitable fluid medium, at an optimum temperature, for an appropriate period. The pure growth is then exposed to the action of solution of Formaldehyde I.P. in suitable concentration and temperature. The product is finally filled in suitable sterilised containers which are subsequently sealed.
(b) Vaccine of Bacterial Products or Bacterial Derivatives.–These vaccines are prepared by growing the organisms on suitable media and then deriving specific antigenic constituents of the bacteria by various special methods.
(c) Living Bacterial Vaccines.– They are prepared from non-pathogenic but fully immunogenic strains of micro-organism. Strict aseptic precautions are taken throughout the preparation against the introduction of microbial contaminants.
7. General Standards:.
(a )Description.– Bacterial vaccines are colourless to yellowish brown liquids containing dead or viable bacteria in homogenous suspension.
(b) Identification.–All types of vaccines confer active immunity in the susceptible animals which can be demonstrated by injecting suitable experimental animals with the calculated doses of the product and subsequently determining the presence of the protective antibodies in their serum and/or by challenging the vaccinated animals by injecting virulent strain of the homologous organisms. The protected animals should survive the challenge.
(c) Test for Sterility.–All bacterial vaccines shall be tested for sterility in accordance with the provision of Rules 115 to 119 (both inclusive). If the vaccine contains added bactericide or bacteriostatic, a quantity of medium sufficient to render the growth inhibitor ineffective is added to the sample, or a suitable substance is added to the sample, or a suitable substance is added in concentration sufficient to render the growth inhibitor ineffective but not itself to inhibit the growth of micro-organism.
(d) Purity Tests for Living Bacterial Vaccine.–Petri dishes containing suitable media are streaked with the final product and incubated at 37˚ C for 72 hours. The vaccine passes the test if no growth of micro-organisms other than those from which the vaccine was prepared is observed. Other tests include examination for motility of the organisms, fermentation reactions and thermoagglutination test and dye-inhibitor tests in case of bruceliza vaccine.
(e) Safety Test.– The safety of the vaccine shall be assessed by injecting it in appropriate doses in suitable susceptible animals. No animal should show any untoward, general or local reaction within seven days after inoculation.
(f). Potency Test.–Wherever applicable, susceptible experimental animals are inoculated with the calculated doses of the final product. The animals are challenged after the period of immunisation, with virulent infective dose of the homologous culture along with the controls. The potency of the vaccine is assessed by the survival of the vaccinated animals and the death of the controls.
8. Labelling:
(a) The label on the ampoule or the bottle shall indicate:.–
(i) Proper name.
(ii) Contents in millilitres or doses.
(iii) Potency, if any.
(iv) Batch number.
(v) Expiry date.
(b) The label on the outside container shall indicate:
(i) Proper name.
(ii) Contents in Millilitres or doses.
(iii) Batch number.
(iv) Date of manufacture.
(v) Manufacturing licence No.
(vi) Manufacturer‘s name and address.
(vii) “For animal treatment only”.
(viii) Storage conditions.
9. Storage.–- Bacterial vaccines shall be stored, protected from light at temperature between 2˚C to 4˚C and shall not be frozen.
10. Date of manufacture.– The date of manufacture shall be, unless otherwise specified in the individual monograph in this part, as defined in clause (b) of sub-rule (3) of rule 109.
Anthrax Spore Vaccine (Living)
1. Synonyms.–- Avirulent Anthrax Spore Vaccine or Bacillus Anthracis Vaccine (Living).
2. Definition.–- The vaccine is a suspension of living spores of an uncapsulated avirulent strain of B anthracis in 50 per cent glycerine saline.
3. Preparation.–- Avirulent B, anthracis of known antigenicity is grown on suitable medium at pH 7.4 in Roux flasks. After 72 hours incubation at 37˚ C, the pure sporulated culture growth which shows 70 to 80 per cent sporulation is washed with normal saline and glycerinated to the extent of 50 per cent by weight of the culture washing and the whole suspension is kept at room temperature for twenty-one days to allow for the stabilization of the spores.
4. Standard:.
(a) Description.–- It is slightly opalescent or pale brown semi-viscous liquid.
(b) Identification.–-Uncapsulated B anthracis which is avirulent can be isolated from the vaccine.
(c) Sterility test.–- Should comply with the test for sterility described in the general monograph on “Bacterial Vaccine”.
(d) Purity Test.–- Complies with the “Purity Tests for Living Bacterial Vaccine” described under the general monograph on “Bacterial Vaccines”.
(e) Safety Test.–-Four healthy adult guinea-pigs each weighing 300-450 g. not previously treated with any material which will interfere with the test are inoculated subcutaneously, two with 0.2 ml. each and two with 0.5 ml. each of the unglycerinated suspension respectively. Four more guinea-pigs are injected with 1:5 dilution of the glycerinated product in the same manner. No untoward reaction should be observed and none of the animals should die of anthrax during the period of observation for seven days.
(f) Safety and Potency Test in sheep and goat–Spore count of the glycerinated suspension is made after twenty-one days from the date of glycerination. Three plates for each of the three dilution 105, 106 and 107 are made.
Eight sheep and eight goats each weighing not less than 18 kg. are injected subcutaneously in the following manner:–
two sheep : Each subcutaneously with 10 ml. of the stock suspension (for safety).
two goats : Each subcutaneously with 5 ml. of the stock suspension (for safety).
six sheep : Each subcutaneously with one million spores suspended in 50 per cent glycerine saline solution.
six goats : Each subcutaneously with one million spores suspended in 50 per cent glycerine saline solution.
None of these animals should die of anthrax. Twenty one days after vaccination, the animals are challenged with 100 lethal doses of virulent B. anthracis spores along with two healthy sheep and two goats as controls.
All the controls should die of anthrax within 72 hours after challenge and at least 66 per cent of the vaccinated animals should survive. The animals shall be observed for a minimum of ten days from the date of challenge.
1[(g) Viable Count.– The vaccine when plated on suitable media should show 10 million viable spores per cattle dose and 5 million spores per sheep dose.]
5. Labelling and Storage.– Should comply with the requirements for “Labelling” and “Storage” as laid down in the general monograph on “Bacterial Vaccines”.
2[6. Expiry Date.– The date of expiry of the potency of the vaccine shall be not more than two years from the date of manufacture if stored in 4o C and six months, if stored at room temperature.]
Blackquarter Vaccine
1. Synonym.– Blackleg vaccine or Quarter Evil Vaccine.
2. Definition.– Blackquarter Vaccine is a culture of Clostridium chauvoei grown in a suitable anaerobic fluid medium and rendered sterile and toxic by the addition of Solution of Formaldehyde I.P. in such a manner that it retains its immunising properties.
3. Preparation.– Cultures of Cl. Chauvoei are grown in a suitable anaerobic fluid medium and killed by the addition of a suitable concentration of Solution of Formaldehyde I.P. The final product shall be adjusted to pH.7.0.
4. Standards:.
(a) Description.–It is a yellowish brown liquid containing dead bacteria in suspension.
(b) Identification.–It protects susceptible animals against infection with Cl. Chauvoei.
(c) Sterility Test.–Should comply with the test for sterility described in the general monograph on “Bacterial Vaccine”.
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1. Subs. by. G.S.R 659 (E) ,dt.. 31-8-1994.
2. Ins. by. G.S.R 659 (E) ,dt.. 31-8-1994.
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(d) Safety and Potency Tests.–At least six adult healthy guinea-pigs each weighing 300 g to 450 g are injected subcutaneously each with 3 ml. of the product followed a week later by a second injection with the same dose. They should not show any systemic reaction but may show only a minimum of local reaction. Fourteen days after the second injection six of the vaccinated guinea-pigs are challenged intramuscularly with 25 viable spores of Cl. Chauvoei equivalent to 5 c.h.d. along with 0.2 ml. of a 5 per cent solution of calcium chloride. Two controls are used. The controls should die of the specific injection and at least 4 of the six vaccinated animals should survive before the product is passed for issue.
5. Labelling and Storage.– Should comply with the requirements of “Labelling” and “Storage” as laid down in the general monograph on “Bacterial Vaccines”.
6. Expiry Date.–- The date of expiry of the potency of the vaccine shall not be more than twenty-four months from the date of manufacture.
Brucella Abortus ( Strain 19 Vaccine) (Living)
1. Synonym.– Contagious Abortion Vaccine, (Strain 19) (Living).
2. Definition.– Brucella Abortus (Strain 19) Vaccine (Living) is a suspension of a pure smooth living culture of Br. Abortus of low virulence in normal saline solution.
3. Preparation.– Forty eight to seventy-two hour old growth of Br. Abortus (Strain 19) on potato agar medium in Roux flasks washed with buffered normal saline solution pH 6.4 and the pure growth from the flasks are pooled together, 0.5 ml. of the pooled product is mixed with 4.5 ml. of normal saline solution at pH 6.4 in graduated centrifuge tube and centrifuge at 3000 r.p.m for one hour. The percentage of cell deposit is assessed by reading the amount of cell deposit obtained.
The concentrated suspension is then diluted with buffer normal saline solution so that the final product contains 0.72 per cent bacterial cell deposit.
4. Standard:
(a) Description.–It is an almost white turbid liquid containing live bacteria in suspension.
(b) Identification.–It consists of Gram-negative bacilli capable of protecting susceptible animals against Brucellosis.
(c) Sterility Test.–Should comply with the test for sterility described in the general monograph on “Bacterial Vaccine”.
(d) Purity Test.–A smear of the finished products is examined microscopically after staining by Gram‘s method for evidence of any contamination. When grown on suitable media, Br. Abortus should be obtained in a pure state.
(e) Safety Test.–Two healthy guinea-pigs each weighing 300 g. to 450g. are inoculated subcutaneously each with 1.0 ml. of the final product. The guinea-pigs should not show excessive reaction of a toxic nature during the period of observation of ten days.
(f) Potency Test.–Each of a group of four healthy guinea-pigs, drawn from a uniform stock and each weighing 300 g. to 450 g. is injected intra-muscularly with 1 ml. of the vaccine, and is challenged nine weeks after vaccination by the intramuscular injection of 1 ml. of a suspension containing 5,000 fully virulent Br. Abortus organisms. Each of a group of two unvaccinated guinea-pigs is similarly injected. After a further six weeks, the guinea-pigs are killed and cultures are made from their spleens. More than half of the vaccinated guinea-pigs contain no demonstrable Br. Abortus in the spleen; all the controls are infected.
(g) Viable Count.–The vaccine when plated on suitable media should show between 14, 000 million and 18,000 million Br. Abortus organisms per ml. At least 80 per cent brucella organisms should be in the smooth phase.
4. Labelling and storage.– Should comply with the requirements of “Labelling” and “Storage” as laid down in the general monograph on “Bacterial Vaccines”. The liquid vaccine shall be issued fresh as far as possible without allowing any period of storage after manufacture.
5. Expiry Date– The date of expiry of the vaccine shall be not more than five weeks from the date of manufacture.
Enterotoxaemia Vaccine
1. Synonyms.– Clostridium Welchii, Type D, Formal Culture: Pulpy Kidney Vaccine.
2. Definition.– Enterotoxaemia Vaccine is a culture of a highly toxigenic strain of Clostridium type D, group is an anaerobic medium rendered sterile and toxic by the addition of Solution of Formaldehyde I.P in such a manner that it retains its immunising properties.
3. Preparation.– Selected toxigenic strain of Cl. Welchii type D, is grown in a liquid medium under conditions which ensure maximum epsilon toxin production. The culture is checked for purity and toxicity as tested in mice. Solution of Formaldehyde I.P. is added in suitable concentration and the formolised culture is kept at 37˚ C till the production is sterile and non-toxic.
4. Standard:
(a) Description- It is a yellowish brown liquid containing dead bacteria in suspension.
(b) Identification- When injected into susceptible animals it stimulates the production of epsilon antitoxin of Cl. Welchii, type D.
(c) Sterility Test- Complies with the test for sterility described in the general monograph on ‘Bacterial Vaccines‘.
(d) Safety and Potency Tests- At least eight sheep each weighing not less than 18 kg. or twelve rabbits each weighing 1 kg. to 1.5 kg. are used for testing the safety and potency of each brew of the vaccine. Two sheep receive subcutaneously 10 ml. each and the other six sheep receive each 2.5 ml. of the product subcutaneously. The rabbits are given subcutaneously a dose of 5 ml. each. The sheep and rabbits are observed for five days. They should show only a minimum local reaction and no systemic reaction.
The sheep receiving 10 ml. are withdrawn from experiments after five days. Each of the other six sheep is inoculated with a second dose of 2.5 ml. fourteen days after the first injection. The rabbits are inoculated with 5 ml. as a second dose, after one month of the first inoculation. Ten days after the second inoculation the sera of sheep or rabbits are pooled separately. The pooled serum of each group of animal shall contain in each ml. not less than two international units of Cl. Welchii epsilon antitoxin which is determined by testing on mice as follows:
One ml. of the pooled serum is mixed with one ml. of the epsilon toxin of Cl. Welchii type D, containing 300 mouse-minimum-lethal-doses (mouse m.l.d.) and kept at room temperature for half an hour. At least two mice each weighing not less than 18 g. are each given intravenously 0.2 ml. of the mixture. As control two mice each weighing not less than 18 g. should each receive 0.2 ml. of the toxin containing 300 mouse m.l.d per ml. diluted with equal volume of normal saline. The control mice should die within 1 to 2 hours while the mice receiving the mixture of serum and toxin should survive for at least two days. Sera containing one International Unit of epsilon antitoxin per ml. will be able to neutralise 150 mouse m.l.d. of epsilon toxin of Cl. Welchii, type D.
5. Labelling and Storage.– Should comply with the requirements regarding “Labelling” and “Storage” as laid down in the general monograph on “Bacterial Vaccines”.
6. Expiry Date.– The expiry date of potency of the vaccine shall be not more than twelve months from the date of manufacture.
Fowl Cholera Vaccine (Polyvalent)
1. Synonym.– Pasteurella Septica Vaccine (Avian).
2. Definition.– Fowl Cholera Vaccine is a formolised pure broth culture of virulent strains of Pasteurella Septica (Avian).
3. Preparation.– The strains are grown separately in nutrient broth for 48 hours at 37˚C. The pure growth is killed by the addition of a Solution of Formaldehyde I.P in a suitable concentration. The cultures are then mixed in equal proportions and the final vaccine is bottled in suitable containers.
4. Standard-
(a) Description.–It is a light yellow liquid containing dead bacteria in suspension.
(b) Identification.–It protects susceptible birds against P. aviseptica infection.
(c) Sterility test.–Complies with the test for “Sterility” described under the general monograph on “Bacterial Vaccines”..
(d) Safety Test.–Two healthy young fowls each weighing not less than 400 g. or twelve healthy mice are inoculated subcutaneously each with 1 ml. of the final product. The birds should not show any untoward reaction during the period of observation for seven days.
5. Labelling and Storage.– Should comply with the requirements of “Labelling” and “Storage” as laid down in the general monograph on “Bacterial Vaccines”.
6. Expiry Date.– The date of expiry of potency of the Vaccine shall be not more than six months from the date of manufacture.
Hemorrhagic Septicaemia Adjuvant Vaccine
1. Synonym.– Pasteurella Septica Adjuvant Vaccine.
2. Definition.– The vaccine is a homogenous suspension of formolised agar-washed Pasteurella septica with liquid paraffin and lanolin.
3. Preparation.– Pure growth of a highly antigenic strain of P. Septica in phase 1 grown on nutrient agar medium containing 0.5 per cent yeast extract is washed with 0.5 per cent formol saline. The pooled suspension is diluted with normal saline to contain approximately 2100 million P. Septica organisms per ml. The safety test of this adjusted suspension is conducted on four white mice each weighing not less than 18 g. and observed for three days before it is mixed with liquid paraffin and lanolin in suitable proportion.
The mixture is blended until a homogenous emulsion is obtained which is filled in suitable containers.
4. Standard:
(a) Description− It is a white thick oily liquid containing dead bacteria in suspension.
(b) Identification.–It protects susceptible animals against infection with P. Septica.
(c) Sterility Test.–It complies with the test for “Sterility” described in the general Monograph on “Bacterial Vaccines”.
(d) Safety Test.– Six white mice each weighing not less than 18 g. are inoculated intraperitoneally each with 0.5 ml. of the vaccine. None of the mice should die of pasteurellosis during the observation period for seven days.
(e) Potency Test.–Three susceptible calves in good condition between the ages of nine months to three years are injected intramuscularly, each with 2 ml. of the vaccine, in the case of animals weighing upto 140 kg. and 3 ml. for heavier ones.
Three weeks later these animals along with two healthy animals of the same type and species are challenged subcutaneously with 18 hours old broth culture of P. Septica equivalent to at least 50 million mouse minimum infective dose. Both the controls should die of pasteurellosis and at least two out of the three protected animals should survive the challenge dose for a period of seven days.
5. Labelling and storage- Should comply with the requirements for “Labelling” and “Storage” as laid down in the general monograph on “Bacterial Vaccines”.
6. Expiry Date- The date of expiry of potency of the vaccine shall be not more than twelve months from the date of manufacture.
Haemorrhagic Septicaemia Vaccine (Broth)
1. Synonym.– Pasteurella Septica Vaccine (Broth).
2. Definition.– Haemorrhagic Septicaemia Vaccine is formolised culture of a virulent strain of Pasteurella septica in nutrient broth.
3. Preparation.– .Septica culture is grown in nutrient broth at 37˚C. The pure growth is killed by the addition of a solution of Formaldehyde I.P. in a suitable concentration.
4. Standard:
(a) Description.–It is a pale yellow liquid containing dead bacteria in suspension.
(b) Identification.–It protects susceptible animals against infection with P.Septica.
(c) Sterility Test.–Complies with the test for “Sterility” described under the general monograph on “Bacterial Vaccines”.
(d) Safety Test.–Four healthy rabbits each weighing 1 kg. to 1.5 kg. are inoculated subcutaneously each with 5 ml. of the product. There should be no untoward reaction during the period of observation for seven days. Alternately two rabbits and six mice may be employed. The dose for mice will be 0.5 ml.
5. Labelling and Storage.– Should comply with the requirements of “Labelling” and “Storage” as laid down in the general monograph on “Bacterial Vaccines”.
6. Expiry Date.– The date of expiry of potency of the vaccine shall be not more than six months from the date of manufacture.
Salmonella Abortus Equi Vaccine
1. Synonym.– Equine Abortion Vaccine.
2. Definition.– Equine Abortion Vaccine is a mixture of equal parts of pure formolised cultures of smooth laboratory strains of Salmonella abortus equi.
3. Preparation.– The strains are grown separately on plain agar in Roux flasks, for 24- 28 hours at 37˚ C. The pure growth is washed with normal saline solution and the washings are pooled together. The suspension is standardised to contain approximately 600 million Sal.Abortus equi organisms per ml. using normal saline solution as diluent. The culture is killed by the addition of sufficient quantity of solution of Formaldehyde I.P in a suitable concentration and the product is kept at 37˚C for seven days. Potassium alum is added to give a final concentration of 1 per cent
4. Standard:
(a) Description.–It is an opalescent liquid containing dead bacteria in suspension.
(b) Identification.–It protects susceptible animals against infection with Sal. Abortus equi.
(c) Sterility Test.–Complies with the test for sterility described in the general monograph on “Bacterial Vaccines”.
(d) Safety Test- Six white mice each weighing not less than 18 g. are inoculated intraperitoneally each with 0.5 ml. of the product. None of the mice should die of salmonellosis. The mice are observed for ninety-six hours.
5. Labelling and Storage- Should comply with the requirements for “Labelling” and “Storage” as laid down in the general monograph on “Bacterial Vaccines”.
6. Expiry Date- The date of expiry of potency of the vaccine shall be not more than six months from the date of manufacture.
Streptococcus Equi vaccine
1. Synonym.– Strangles Vaccine
2. Definition.– Streptococcus equi Vaccine is a phenolised culture of a number of different isolates of Streptococcus equi in glucose serum broth.
3. Preparation.– Equal proportions of forty-eight hours old pure cultures of different isolates of Str. Equi in serum glucose both are mixed together. The suspension is centrifuged and the deposit is washed with normal saline solution after removing the supernatant. The washed cells are suspended in normal saline and heated in a water bath 65˚C for two hours. Phenol and normal saline are added to give a final concentration of 1200 million Str. Equi organisms per ml. and 0.5 per cent of phenol in the vaccine.
4. Standard-
(a) Description.– It is a slightly opalescent liquid containing dead bacteria in suspension.
(b) Identification.–It protects susceptible animals against infection with Str. Equi.
(c) Sterility Test.–Complies with the test for “Sterility” described in the general monograph on “Bacterial Vaccines”, the nutrient broth being replaced by glucose broth.
(e) Safety Test.– Two ponies and two rabbits (each weighing not less than 1 kg.) are inoculated each with 10 ml. and 2 ml. respectively of the final product. The animals should not show any untoward reaction during the period of observation of seven days.
5. Labelling and Storage.–. Should comply with the requirements for “Labelling” and “Storage” as laid down in the general monograph on “Bacterial Vaccines”
6. Expiry Date.– The date of expiry of potency of the vaccine shall be not more than six months from the date of manufacture.
Old Adjuvant Vaccine against Pasteurellosis in Sheep and Goats.
1. Synonym- Pasteurella Septica Adjuvant Vaccine for ovines and Caprines.
2. Definition- The vaccine is a homogenous suspension of formolised agarwashed Pasteurella septica of ovine origin with liquid paraffin and lanolin.
3. Preparation− Pure growth of highly antigenic strains (R1, R2, R4) in phase I grown separately on nutrient agar medium containing 0.5 per cent yeast extract is washed with 0.5 per cent Normal saline. Equal quantities of the suspension of three strains diluted with Normal saline to contain approximately 2100 million organisms per ml. is pooled together. The safety test of this adjusted pooled suspension is conducted in for white mice each weighing not less than 18 g. and observed for three days before it is mixed with liquid paraffin and lanolin in suitable proportion.
The mixture is blended until a homogenous emulsion is obtained which is filled in suitable containers.
4. Standards:
(a) Description- It is a white thick oily liquid containing dead bacteria in suspension.
(b) Identification- It protects susceptible animals against infection with P. Septica.
(c) Sterility Test- Complies with the test for sterility described in the general monograph on “Bacterial Vaccines”.
(d) Safety Test- Six white mice each weighing not less than 18 g. are inoculated intra-peritoneally each with 0.5 ml. of the vaccine. None of the mice should die of Pasteurellosis druing the observation period of seven days.
The vaccine is also inoculated into six sheep and six goats in a dose of 3 ml. each intramuscularly and are observed for a period of seven days. During this period none should die of Pasteurellosis.
(e) Potency Test- Not being done at present.
5. Labelling and Storage- Should comply with the requirements for “Labelling” and “Storage” as laid down in the general monograph on “Bacterial Vaccines.
6. Expiry Date- The expiry date of Potency of the Vaccine shall be not more than twelve months from the date of manufacture.
1[Multicomponent of Clostridial Vaccine
1. Synonyms.– Combined anaculture of Clostridium perfringens type C and D, C1. septicum and CI. oedematiens.
2. Definition– It consists of four highly antigenic components containing the toxoids of C. perfringens type D, CI. Perfringens type C, Cl. oedematiens and CI. septicum which are prepared in double strength and then combined in such a proportion that would invoke adequate anti-toxin response in the vaccinated sheep against each antigen incorporated in the vaccine
3. Preparation – The above strains are grown separately in suitable liquid media under conditions which ensure maximum toxin production. The cultures are checked for purity and toxicity in mice. Solution of Formaldehyde I.P. of analytical grade is added to a 0.5 per cent final concentration and formalized cultures are kept at 37oC till the product is sterilized and atoxic. The formalized anacultures are pooled, precipitated by the addition of Aluminium Chloride, 20 per cent solution in distilled water to have a final concentration of the chemical to 10 per cent and pH adjusted to 6.0.the sedimented toxoid is reconstituted to have its original volume in normal saline.
____________
1. Ins. by G.S.R. No. 659(E) ,dt. 31-8-1994
____________
4 Standards:
(a) Description – It is whitish liquid when shaken thoroughly to contain killed bacteria and toxoid in suspension.
(b) Identification – When injected to susceptible animals it stimulates the production of epsilon and beta antitoxins against CI. perfrigens type D and C and also antitoxins against CI. septicum and toxin of CI. Oedematiens.
(c) Sterility Test – Complies with the test of sterility described in general monograph on “Bacterial Vaccines.”
(d) Safety Test – Four sheeps each are inoculated with 10 ml. S/C of the product and these are observed for 7 days during which period animals shall not show any local or systemic reaction.
(e) Potency Test – Eight sheep each are inoculated with 2 doses of vaccines S/C at an interval of 21 days and bled on 10th day after 2nd inoculation for collection of serum for assessing the antitoxin titre against each antigen incorporated in the vaccine. The post-inoculation serum should contain not less than 2 i.u. of epsilon and beta antitoxins of CI. perfringens and 2.5 i.u. of CI. septicum antitoxin and 4 i.u. of CI. oedematiens antitoxin.
5. Labelling and storage- Shall comply with the requirements regarding labelling and storage as laid down in the general monograph on “Bacterial Vaccine”.
6. Expirty date– The expiry date of potency of vaccine shall not be more than 6 months from the date of manufacture.
Haemorrhagic Septicaemia Vaccine – Alum Treated
1. Synonyms– Pasterulla multocida/(Yersinia Multocida) vaccine – Alum treated.
2. Definition — The vaccine is a formalized culture of a virulent strain of Pasteurella multocida in nutrient broth treated with potash alum.
3. Preparation — A highly potent strain of Pasteurella multocida type I in Phase I is grown on nutrient broth at 37oC. The pure growth is killed by the addition of a solution of Formalin I.P in suitable concentration (0.5 per cent). This is treated with Potassium Alum I.P to give a final concentration of 1 per cent.
4. Standard:
(a) Description – It is a white suspension containing dead bacteria and alum.
(b) Identification – It protects susceptible animals against infection with P. multocida.
(c) Sterility Test — It complies with the test for sterility described under general monograph on “Bacterial Vaccines”.
(d) Safety Test — Four healthy rabbits each weighting 1 to 1.5 kg. are inoculated subcutaneously each with 5 ml. of the product. There shall be no untoward reaction during the period of observation for 7 days except slight local swelling. Alternatively two rabbits and six mice may be employed. The dose for mice will be 0.5 ml.
5. Labelling and Storage:- Shall comply with the requirements of labelling and storage as laid down in the general monograph on “Bacterial Vaccines”.
6. Expiry date – The date of expiry of potency of the vaccine shall be not more than six months from the date of manufacture.]
(B) PROVISIONS APPLICABLE TO THE PRODUCTION OF VIRAL VACCINES
1. Definition- (i) This part of the Schedule applies to viral vaccines live or inactivated made from any virus pathogenic to domestic animals and poultry and made from other modified viruses which have any antigenic value.
(ii) For the purpose of this Part of the Schedule, a virus vaccine means a sterile suspension or a freeze dried powder containing the modified living or inactivated virus particles, which in its original unaltered stage, causes disease from which the vaccine derives its name and which has been prepared from the blood or tissues of a suitable host in which it has been grown in vivo or from tissue culture.
2. Staff of Establishment- The establishment in which viral vaccines are prepared must be under the direction and control of an expert in bacteriology with specialized training in virology and sufficient experience in the production of viral vaccines, and he shall be assisted by a staff adequate for carrying out the tests required during the preparation and standardisation of the vaccines.
3. Proper Name- The proper name of any viral vaccine shall be the name of the disease which is caused by the particular virus from which the vaccine is produced followed by the word “vaccine” unless the Schedule otherwise provides, if there is no special provision in the Schedule such other name as is approved by the Licensing Authority. Provided that in the case of the undermentioned preparations the proper name of the vaccine shall be as follows:
(i) Fowl Pox Vaccines, Chick Embryo Virus (Living).
(ii) Fowl Pox Vaccine, Pigeon Pox Virus (Living).
(iii) Horse Sickness Vaccine (Living)
(iv) Ranikhet Disease Vaccine (Living)
(v) Ranikhet Disease Vaccine F Strain (Living)
(vi) Rinderpest Goat Adapted Tissue Vaccine (Living)
(vii) Rinderpest Lapinised Vaccine (Living)
(viii) Rinderpest Lapinised Avianised Vaccine (Living)
(ix) Sheep and Goat Pox Vaccine (Living)
(x) Swine fever vaccine (crystal violet)
(xi) Swine fever vaccine lapinised (Living).
1[(xii) Foot and Mouth Dieseas Vaccine (Inactivated).
(xiii) Canine Hepatitis Vaccine (Living).]
2[4. Records- The seed virus used in the preparation of vaccine shall, before being used for preparing a batch, be thoroughly tested for purity, safety, sterility and antigenicity by the generally accepted tests applicable to a particular virus. It shall not be more than five passages away from the stock seed virus, unless otherwise prescribed for a particular virus. The stock seed virus shall be maintained by seed-lot system at specified passage level and tested for bacterial, mycoplasmal and extraneous viral contamination. The permanent record which the licensee is required to keep shall include a record of the origin, properties and characteristics of the seed virus from which the vaccines are made.]
5. Tests- Viral vaccine shall be tested for sterility, safety and potency on suitable test animals and for viability in the case of live vaccines.
(a) Sterility Test- All vaccines shall be tested for sterility in accordance with rules 115 to 119. If the vaccine contains added bactericides or bacteriostatic, a quantity of medium sufficient to render the growth inhibitor ineffective is added to the sample or a suitable substance is added in a concentration sufficient to render the growth inhibitor ineffective but not itself to inhibit the growth of micro-organisms.
(b) Safety Test- Suitable laboratory animals or large animals or birds may be employed to test the vaccine for safety. Details of the safety test are given in the individual monograph.
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1. Ins. by G.S.R. 659(E) ,dt. 31-8-1994.
2. Subs. by G.S.R. 659(E) ,dt. 31-8-1994.
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(c) Potency Test- All virus vaccines for which potency test has been prescribed shall be tested for potency and only those which pass the potency test shall be issued. Details of the potency test are given in the individual monograph.
6. Storage- Live viral vaccines shall be stored, protected from light at sub-zero temperature as required. Other viral vaccines shall be stored at 2 ˚ C to 4 ˚ C but shall not be frozen.
7. Condition of housing of animals- (i) The animals used in the production of vaccine must be housed in hygienic conditions in premises satisfactory for this purpose.
(ii) Only healthy animals may be used in the production of vaccine. Each animal intended to be used as a source of vaccine must, before being passed for the production of vaccine be subjected to a period of observation in quarantine for at least seven days. During the period of quarantine the animal must remain free from any sign of disease and must be well kept.
1[(iii) The poultry birds from which eggs and cell culture for production of vaccines are obtained should be housed in a manner so as to keep them free from extraneous infection and shall be screened at frequent intervals for common bacterial, mycoplasmal and viral infection. The record of the tests and their results shall be maintained by the manufacturers.]
8. Labelling- The provisions of “Labelling” as laid down for Bacterial Vaccines shall also apply to Viral Vaccines. The following additional information shall also be included on the label of the outside container:
(i) The name and percentage of bacteriostatic agent contained in the vaccine.
(ii) If the vaccine as issued for sale contains any substance other than the diluent, the nature and strength of such substances.
9. Date of Manufacture- For the purpose of this part of the Schedule, the date of manufacture shall be what is given unless otherwise stated in the individual monograph, as defined in sub-clause (b) of sub-rule (3) of rule 109.
Fowl Pox Vaccine Chick- Embryos Virus (Living)
1. Synonym- Egg adapted Fowl Pox Vaccine (Living).
2. Definition- Fowl-pox Vaccine, Chick-Embryo Virus (Living) is a suspension of a modified living virus (e.g. Mukteswar Strain) prepared from the chorioallantoic membrane (CAM) of the infected embryo and is either freeze dried or is issued as glycerinated liquid vaccine.
3. Preparation- Active chick-embryos obtained from Salmonella pullorum free flock, are used. 1[Twelve to thirteen days old embryos are injected with a suitable dilution of the suspension of the infected membrane (seed virus) of chick embryo adopted fowl pox virus.] The suspension of the stock seed virus is dropped on the CAM. After an incubation at 37˚C for a suitable period membranes showing discrete or confluent lesions (pocks) are harvested. These are homogenised with adequate quantity of antibiotics (penicillin and streptomycin) ampouled in 0.5 ml. quantities and freeze dried.
4. Standard-
(a) Description- Light mauve coloured scales.
(b) Identification- When reconstituted vaccine is applied to scarified area of the skin of a fowl it produces characteristic lesions of fowl pox. This product should afford protection against fowl pox.
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1. Ins. by. GSR 659(E) , dt. 31-8-1994.
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(c) Moisture Content- Moisture Content in the finished product should not exceed 1.0 per cent.
(d) Safety Test- For testing each batch of fowl pox vaccine twelve healthy cockerels, or other suitable young chicken each weighing not less than 400 g. from the same source are taken. This group of twelve birds is immunized at least twenty-one days previous to the test, with fowl pox vaccine. The vaccine under test is reconstituted in 5 ml. of 50 per cent glycerine saline and administered to fowls as follows:-
Three of the test birds are injected subcutaneously with 0.8 ml. or 10 times the field doses of the vaccine under test. This group serves to indicate whether the product is free from other viruses and bacteria causing septicaemia or not.
Three of the test birds are injected intratrecheally with 0.3 ml. or 10 times the field dose of vaccine under test. This group serves to indicate whether the product is free from the virus of infectious laryngotracheitis and similar disease.
1[Three of the test birds are injected intranasally with 0.2 ml. of 10 t imes of t he f i eld dose of the vaccine under test. This group serves to indicate whether the product is free from the virus of infectious laryngotracheitis and similar disease.]
The three remaining birds serve as controls. They are isolated and kept under observation for twenty-one days. The birds that succumb during the period of twenty-one days are subjected to a careful postmortem examination. The product is withheld from issue until the vaccine and the test birds are shown to be free from the causative agents of any extraneous disease.
(e) Sterility test- Complies with the tests for sterility as described under the general monograph on “Viral Vaccines”.
(f) Potency Test- For testing of potency three unsusceptible birds each weighing not less than 400 g. are vaccinated using the field dose by the stick method and examined for “takes”. Three weeks after vaccination these birds along with two unvaccinated controls are exposed to challenged virus and observed for fourteen days. The vaccinated birds should not manifest any reaction, while the controls should show active “takes”.
5. Labelling- Should comply with the requirement for “Labelling” as laid down in the general monograph on “Viral Vaccines”.
6. Storage and Expiry date- Freeze dried vaccine shall be expected to retain its potency for periods at temperatures as specified below:-
-15 ˚ C to – 20˚ C–Twenty-four months.
2˚ C to 4˚ C–Twelve months.
Room temperature– upto one month.
The liquid vaccine shall be expected to retain its potency for periods and temperatures as specified below:
2˚ C to 4 ˚C – six months.
Room temperature– seven days.
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1. Ins. by. GSR 659(E) , dt. 31-8-1994.
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Fowl- Pox Vaccine, Pigeon Pox Virus (Living)
1. Synonym- Fowl Pox Vaccine (Pigeon pox scab).
2. Definition- Fowl Pox Vaccine, Pigeon-pox Virus (living) consists of pigeon pox virus in scabs collected from artificially infected pigeons and dried.
3. Preparation- Healthy pigeon are scarified on the legs and breast, with a suitable dilution of the suspension of pigeon-pox virus. The pigeons reacting satisfactorily and showing good takes are selected and the superficial skin layer scraped by means of sharp scalpel. The material so collected is freed from feathers, homogenised and dried or freeze dried. The dried pulp is powdered, sieved and ampouled in 0.3 g. quantities and sealed
4. Standard-
(a). Description- Light cream coloured powder.
(b) Identification- When applied to feather follicles by vigorous rubbing, it produces mild reaction in fowls. The product should afford protection to fowls upto six weeks against fowl pox.
(c) Safety Test- For testing a batch of vaccine, twelve healthy cockerels, or other suitable young chicken from the same source are made available at the same time. This group of twelve birds is immunised at least twenty-one days previous to the test with fowl pox vaccine. The vaccine under test is reconstituted in 10 ml. of 50 per cent glycerine saline and administered to fowls as follows:-
Three of the test birds are injected subcutaneously with 0.3 ml. or 10 times the field dose of the vaccine to be tested. This group serves to indicate whether the product is free from organisms of septicaemia disease.
Three of the test birds are injected intranasally with 0.2 ml. of the vaccine to be tested. This group serves to indicate whether the product is free from virus of Coryza and similar diseases.
1[Three of the test birds are injected intratricheally with 0.2 ml or 10 times of the field dose of vaccine under test. This group serves to indicate whether the product is free from the virus of infectious laryngotracheitis and similar diseases.]
The three remaining birds serve as controls. All the birds under test are isolated and held under observation for twenty-one days. All those that succumb are subjected to careful post-mortem examination. The product is withheld from issue until the vaccine and test birds are shown to be free from the causative agents of any extraneous diseases.
(d) Sterility Test- Complies with the tests for sterility described under the general monograph on “Viral Vaccines”.
(e) Potency Test- For testing the potency of a batch of vaccines three susceptible birds each weighing not less than 400 g. are vaccinated using the field dose by the follicular method and examined for ‘takes‘. Three weeks after vaccination these birds and two healthy susceptible controls are exposed to challenge virus and are observed for fourteen days. The vaccinated birds shall manifest no reaction, while the controls must have active “takes”.
5. Storage and Labelling- Should comply with the requirements of ‘Labelling‘ as laid down in the general monograph on ‘Viral Vaccines‘.
6. Expiry date- The vaccine shall be expected to retain its potency for periods at temperature as specified below:-
-15 ˚ C to – 20 ˚C– two years. 2˚ C to 4 ˚C– twelve months.
Room temperature- Upto one month.
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1. Ins. by. GSR 659(E) , dt. 31-8-1994.
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Fowl Pox Vaccine- Pigeon Pox- Chick Embryos Virus (Living)
1. Synonym- Chick embryo adapted pigeon pox vaccine (Living).
2. Definition- Fowl pox vaccine (Pigeon Pox virus) chick embryo adapted virus (living) is a suspension of a modified living virus prepared from the chorioallantoic membranes of the infected embryos and is freeze dried.
3. Preparation- Active chick embryos obtained from Salmonella Pullorum free stock are used. Twelve to thirteen days old embryos are injected with a suitable dilution of the suspension of the infected membrane (stock seed virus) of chick embryo adapted pigeon pox virus. The suspension of the stock seed virus is dropped on the membrane. The inoculated eggs are incubated at 37 ° C for four days. One of the fourth day embryos that are living, are removed to a refrigerator for chilling for about one hour. Membranes showing discrete lesions (Pocks) are harvested. These are homogenised with adequate quantities of antibiotics, ampouled in 0.5 ml. quantities and freeze dried.
4. Standards-
(a) Description- Light mauve coloured scales.
(b) Identification- When reconstituted vaccine is applied to scarified area of the skin of a fowl, it produces characteristics lesions of Fowl Pox. This product should afford protection against pox.
(c) Moisture content- Moisture content in the finished product should not exceed 1.0 per cent.
(d) Safety test- For testing each batch of chicks aged four to six weeks from the same source are taken. This groups of twelve birds is immunised at least twenty-one days previous to the test, with fowl-pox vaccine. The vaccine under test is reconstituted in 3 ml. of normal saline solution and administered as under:-
Three of the test chicks are injected subcutaneously with 0.3 ml. or 10 times the field dose of the vaccine under test. This group serves to indicate whether the product is free from other viruses and bacteria causing of septicaemia or not.
Three of the test chicks are injected intratracheally with 0.3 ml. or ten times the field dose. This group serves to indicate whether the product is free from the viruses of infections laryngeotracheitis and similar diseases.
Three of the test chicks are injected with 0.2 ml 1/N of the vaccine under test. This group serves to indicate whether the product is free from the virus of coryza and similar diseases.
The remaining three chicks serve as controls. They are isolated and kept under observation for twenty-one days. The birds that succumb during the period of observation are subjected to careful post-mortem examination. The product is withheld from issue until the vaccine and the test birds are shown to be free from the causative agents of any extraneous disease.
In addition to the above, similar groups of pigeons aged six to nine months old are also injected in a similar way to eliminate psittacosis.
(e) Sterility Test- Should comply with the tests for sterility described under the general monograph on ‘Viral Vaccine‘.
(f) Potency test- For testing potency of a batch of vaccine three susceptible chicks of three to four weeks of age are vaccinated by feather forthicle method ( a few forthicles on one leg are injected) and these are examined for ‘takes‘.
Three weeks after vaccination these chicks along with two unvaccinated chicks are exposed to challenge virus (virulent fowl pox virus) and observed for fourteen days. The vaccinated chicks should not manifest any reaction while controls should show active ‘takes‘.
5. Labelling- Should comply with the requirements for ‘Labelling‘ as laid down in the general monograph on ‘Viral Vaccines‘.
6 Storage- The freeze dried product is expected to retain its potency for periods at temperatures as specified below:
-15 ° C to 20 ° C–two years.
2° C to 4 ° C–twelve months.
Room temperature- up to one month.
Sheep Pox Vaccine (Living)
1. Synonym- Sheep Pox vaccine; Goat pox vaccine.
2. Definition- Sheep pox vaccine consists of sheep pox virus collected from sheep artificially infected with sheep pox virus and freeze dried.
3. Preparation- Healthy yearling sheep are infected artificially by subcutaneous infection on the undersurface of the previously shaved abdomen with 200- 300 cc. of the freeze dried sheep pox virus (seed material) diluted in 1 : 1 Normal saline solution. On the sixth or seventh day after injection oedematous swelling develops in the injected area with thermal reaction. The sheep which develop good swelling are slaughtered and the gelatinous material present under the skin in the infected area is collected under sterile conditions. This material is mixed with 2 parts by volume of sterile peptone broth of pH 7.2 and homogenised. The homogenised suspension is filtered, ampouled in 0.5 ml. quantities and freeze dried.
4. Standard:
(a) Description- White scales.
(b) Identification- Reconstituted vaccine when applied over the scarified area of the skin of the abdominal region of sheep will produce characteristic local lesion of pox.
(c) Moisture content- The moisture content should not exceed 1.0 per cent.
(d) Safety test- Two rabbits each weighing not less than 1 kg. are injected subcutaneously each with 1 ml. of 1 : 100 dilution of the vaccine in normal saline solution. These animals are observed for fourteen days. The animals should remain normal.
(e) Sterility Test- Complies with the tests for sterility described under the general monograph on ‘Viral Vaccines‘.
(f) Potency Test- Four yearling sheep are vaccinated on the inner surface of the ear by scarification method. The contents of one ampoule of F.D. Sheep Pox vaccine are constituted in 10 cc. of 50 % glycerin saline solution, characteristic ‘takes‘ develop in the scarified area with ulceration and scab formation. Three weeks later these and two more susceptible sheep (Controls) are challenged by scarifying with a suspension of the previous brow of the vaccine of the undersurface of the abdomen. The controls should develop typical lesions of pox and the vaccinated should remain normal.
5. Labelling- Should comply with the requirements of ‘labelling‘ as laid down in the general monograph in ‘Viral Vaccine‘.
6. Storage and expiry date- The vaccine is expected to retain potency for period and temperature as specified below:-
-15 ° C to – 20 ° C– two years
2 ° C to 4 ° C–three months.
Room temperature- Fifteen days.
Horse Sickness Vaccine (Living)
1. Synonym- African Horse Sickness Vaccine, Mouse adapted Polyvalent Horse Sickness Vaccine (Living).
2. Definition- Horse sickness vaccine is a suspension of live mouse adapted strains of Horse Sickness Virus (Onderstepoort) prepared from the brains of infected mice and is freeze dried.
3. Preparation- Thirty to thirty-five days old white mice are infected intracerebrally with 0.05 ml. of a suitable dilution of the seed virus (6 or 7 types, as the case may be). Groups of large numbers of mice are injected separately with each type of the virus and are housed at 27 ° C to 32 ° C. A majority of these become paralytic on the third and fourth day when they are sacrificed and their brains collected and stored at – 15 ° C to – 20 ° C till the day of processing. For preparing the polyvalent vaccine, equal number of brains collected from mice infected with different types of the virus are homogenised with 5-10 times its volume of sterile lactose buffer medium (pH 7.2 ) containing antibiotics. The suspension is centrifuged at 1500 r.p.m. for five minutes. The supernatant liquid is distributed in ampoules in suitable quantities and freeze dried.
4. Standard:
(a) Description- White scaly material.
(b) Identification- This product affords protection to horse against horse sickness.
(c) Safety Test- Four healthy mice thirty to thirty-five days old are injected intraperitoneally with 0.2 ml. of 10:1 dilution of the vaccine and kept under observation for ten days. All the mice should remain normal throughout the period of observation.
(d) Sterility Test- Should comply with the test for sterility described under the general monograph on ‘Viral Vaccines‘.
(e) Viability Test- Each batch of vaccine is titrated in tenfold dilutions using four mice of thirty to thirty-five days old for each dilution. Each mouse is injected intracerebrally with 0.05 ml and kept under observation for ten days. Mortality and survival ratios are noted and LD50 ml is determined. The minimum acceptable titre is 10–4 LD50 per 0.05 ml.
(5) Labelling- Should comply with the requirements of ‘labelling‘ as laid down in the general monograph in ‘Viral Vaccines‘.
(6) Storage- The vaccine may be expected to retain its potency for twelve months if stored – 15 ° C to 20° C and about six months if stored in refrigerator at 2 ° C to 4° C.
Rabies Vaccine (Inactivated)
1. Synonym- Antirabic Vaccine (Inactivated)
2. Definition- Rabies vaccine is a suspension of the brain tissue of animals, that have been infected with a suitable strain of rabies fixed virus, inactivated with phenol or some other suitable agent.
3. The following particulars relating to this vaccine are the same as those relating to Antirabic vaccine described in Part D of Schedule F to these rules, namely:-
(i) Strain of fixed Rabies Virus to be used;
(ii) Staff of Establishment;
(iii) Condition and housing of animals;
(iv) Precaution to be observed in preparation;
(v) Records;
(vi) Issue.
4. Preparation- Healthy sheep or any other suitable species of animal are inoculated subdurally or intracerebrally with an appropriate dose of suspension of a suitable strain of rabbit brain passaged rabies fixed virus. The sheep or animals which get paralysed from the sixth day onwards after the inoculation are sacrificed and their brains collected aseptically. Brain tissue is weighed individually and a suspension of suitable concentration of brain tissue prepared in buffered saline is strained through gauze. The suspension treated with phenol or some other suitable inactivating agent is incubated for an appropriate period.
5. Standard-
(a) Description- A grey to pale yellow opalescent suspension.
(b) Identification- Appropriate doses protect mice against subsequent intracerebral inoculation with suitable strain of fixed rabies virus.
(c) Safety test- Not less than five mice, each weighing at least 18 gm., are inoculated intracerebrally with not less than 0.03 ml. of the suitably diluted vaccine. None of the animals should show symptoms of rabies or die of the disease during period of observation of three weeks.
(d) Sterility Test- Should comply with the test for sterility described under the general monograph on ‘Viral Vaccine‘.
6. Labelling- Should comply with the requirements of ‘Labelling‘ as laid down in the general monograph on ‘Viral Vaccines‘. In addition the label on the container shall indicate the percentage of brain tissue present in the vaccine.
7. Storage- The vaccine may be expected to retain its potency for about six months if stored in refrigerator at 2˚ to 4 ° C.
Rabies Vaccine (Living)
1. Definition- Rabies vaccine (living) is a freeze-dried suspension of chick-embryo tissue infected with a suitable attenuated strain of rabies virus.
2. Preparation- It may be prepared by the following method. Seed virus consisting of a suspension of the Flury or other suitable strain of chick adapted virus that has been maintained by passage in chick embryos is injected into the yolk-sacs of fertile eggs incubated for a suitable period. After incubation for a further ten days, the embryos are harvested and grind in water for injection to give 33 percent suspension. The suspension is centrifuged to remove coarse particles and the supernatant fluid is distributed into ampoules in 3 millilitre quantities, and freeze dried. The vaccine is reconstituted immediately before use by adding 3 millilitres of water for injection to the contents of an ampoule.
3. Standard- It complies with the requirements of general standard of viral vaccines for abnormal toxicity, sterility, and labelling with the following additions.
(a) Description- Dry honey-coloured flakes or powder, readily dispersible in water.
(b) Identification- It protects guinea pig against a subsequent inoculation of rabies street virus. It is distinguished from the inactivated Rabies vaccine by its ability to produce rabies encephalitic on intracerebral injection into mice.
(c) Safety- The guinea pigs used in the test for potency should not show any marked local or systemic reaction during the three weeks following injection with the vaccine.
(d) Sterility Test- Complies with the tests for sterility described under the general monograph on ‘Viral Vaccines‘.
(e) Potency Test- The contents of an ampoule are dispersed in water for injection to give a 5 per cent suspension and not fewer than twenty guinea pigs, drawn from a uniform stock and each weighing 350 g. to 500 g., are each injected intramuscularly with 0.25 ml. of this suspension. Three weeks later, these guinea pigs and an equal number of similar unvaccinated control guinea pigs are each inoculated with 0.1 ml. of a suitable dilution of canine salivary gland suspension of street virus which is maintained as a 20 per cent suspension at 70 ° C or lower. The guinea pigs are observed for thirty days; not less than 80 per cent of the control guinea-pigs die of rabies and not less than 70 per cent of the vaccinated guinea-pigs are protected.
4. Storage- Freeze-dried vaccine should be stored at refrigeration temperatures of 2 ° C to 4 ° C.
5. Labelling- The life of the vaccine at room temperature and at refrigeration temperature should be stated on the label.
6. (a) Action and uses- Rabies vaccine (living) is used for the prophylactic inoculation of dogs against rabies; one injection should provoke a serviceable immunity lasting for at least a year. The vaccine has been used to a limited extent on cattle.
(b) Dose- By intramusclar injection: Dogs, the contents of one ampoule reconstituted in 3 ml. of water for injection; cattle five times the dog dose.
Ranikhet Disease Vaccine (Living)
1. Synonym- New Castle Disease Vaccine (Living); pheumoenteritis Vaccine (Living).
2. Definition- Ranikhet Disease vaccine is a suspension of a modified living virus e.g. (Mukteswar strain) prepared from infected embryos and fluids and is freeze dried.
3. Preparation- Good fertile eggs obtained from Salmonella pullorum free flock are incubated in an egg incubator. Ten days old vigorous embryos are infected with 0.1 ml. of a suitable dilution of a suspension of the virus. Inoculation is done in the allantoic cavity. Embryos are incubated at a suitable temperature. Eggs showing dead embryos twenty-four hours after incubation are discarded. After forty-eight hours incubation the eggs are candled and those showing dead embryos are chilled for a suitable period of time, while embryos alive beyond forty-eight hours are discarded. The fluids and embryos are then collected and spot haemogglutination carried out. The material is homogenised in a blender and ampouled in aliquots of 0.5 ml. quantities and freeze-dried.
4. Standards-
(a) Description- Light brown scales.
(b) Identification- This product affords protection to fowls against Ranikhet Disease.
(c) Safety Test- For testing each batch of freeze dried Ranikhet Disease Vaccine, twelve healthy young chickens, all from the same source each weighing not less than 100g. are taken and immunised against Ranikhet Disease. Fourteen days later, these birds, are tested as follows with the contents of one ampoule suspended in 100 ml. of normal saline.
Three of the test birds are injected subcutaneously with 0.1 ml. equivalent to ten times the field dose of the vaccine to be tested. This group serves to indicate whether the product is free from viruses or organisms of speticaemia disease.
Three of the test birds are injected intratracheally with 0.1 ml. equivalent to ten times the field dose of he vaccine to be tested. This group serves to indicate whether the product is free from the virus of infectious laryngotracheitis, 1[***] and similar diseases.
The three remaining birds serve as controls.
2[Three of the test birds are injected intranasally with 0.2 ml of the vaccine to be tested. This group serves to indicate whether the product is free from virus of Coryza and similar diseases.]
All the treated birds and controls are observed daily for fourteen days. All the test birds that succumb are subjected to careful postmortem examination. The product is not issued until the birds under test are shown to be free from the causative agents of any extraneous diseases.
(e) Sterility Test- Should comply with the test for sterility described in the general monograph on ‘Viral Vaccine‘.
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1. The word “Coryza” omitted by. GSR 659(E) ,dt.. 31-8-1994.
2. Ins. by G.S.R. 659(E) ,dt.. 31-8-1994
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(f) Potency Test- Four susceptible birds eight to twelve weeks old and each weighing not less than 400 g. are vaccinated by injecting subcutaneously 1 ml. of a 10-5 dilution of the product. Two weeks after vaccination these birds and four non-protected birds are challenged by injecting subcutaneously each with 1.0 ml. of a 1: 100 dilution of virulent virus (liver and spleen suspension) or 1.0 ml. of a 1 : 100 dilution of fluid from the embryo infected with virulent Ranikhet Disease virus. The non-protected birds should show symptoms of Ranikhet Disease and die and all the protected birds should remain normal during an observation period of fourteen days.
5. Labelling- Should comply with the requirements of ‘Labelling as laid down in the general monograph on ‘Viral Vaccines‘.
6. Storage- The vaccine when stored at – 15° C to 20° C. may be expected to retain the potency for about one year and about three months if stored in a refrigerator at 2° C to 4° C. The product should not be used if stored for more than ten days outside the refrigerator.
Ranikhet Disease Vaccine F strain (Living)
1. Synonyms- New castle disease vaccine F Strain (Living).
2. Definition- Ranikhet disease vaccine F. strain is a suspension of a naturally modified living virus (F strain) prepared from the infected embryos, devoid of beaks and eyes and fluids in a frozen state.
3. Preparation- Good fertile eggs obtained from Salmonella pullorum free flock are incubated in an egg incubator. Eight days old vigorous embryos are infected with 0.1 ml. of 1 : 100 suspension of Ranikhet disease vaccine F strain virus. Inoculation is done via the allantoic cavity. Embryos are incubated at 37° C. Eggs are candled every day upto four days and the dead ones are discarded. Final candling of the embryos is carried out on the fourth day and only the living ones are chilled in a refrigerator for one hour. The fluids embryos are collected separately. The fluids are tested for spot haemagglutination and sterility test is carried out. The beaks and eye balls of the embryos are removed. The materials are homogenised with adequate quantities of antibiotics in a cool warning blender and ampouled in aliquots of 0.5 ml. quantity and freeze dried.
4. Standard-
(a) Description- Light brown scales.
(b) Identification- This product affords protection to baby chicks against Ranikhet disease.
(c) Moisture content- The moisture content should not exceed 1[1.0] per cent.
(d) Potency test- For testing each batch of the vaccine twelve one-day old chicks are given two drops 1/N o the field dose of the vaccine (5 ampoules selected at random may be reconstituted in 50 ml.) of cold normal saline solution. These are observed for fourteen days and the vaccinated chicks should remain normal throughout the period of observation. This serves the safety test also.
On the fourteenth days the vaccinated chicks are challenged two drops with 1:50 virulent Ranikhet disease virus alongwith 8 control chicks. Four of the controls receive two drops 1/N of the virulent virus while the rest of the four receive 0.5 ml. of the virulent virus. The control chicks should succumb to the challenge virus showing symptoms of Ranikhet Disease while the protected chicks should remain normal throughout the observation period of fourteen days.
(e) Sterility Test- Should comply with the tests for sterility described in the general monograph on ‘Viral Vaccines‘
5. Labelling- Should comply with the requirements of “Labelling” as laid down in the general monograph on ‘Viral Vaccines‘.
6. Storage- The vaccine when stored at – 15 ° C to –20 ° C may be expected to retain the potency for about one year and about three months if stored in a refrigerator at 2 ° C to 4° C. When removed from the refrigerator, the product should not be used later than ten days.
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1. Ins. by G.S.R. 659(E) ,dt.. 31-8-1994
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Rinderpest Goat adapted Tissue Vaccine (Living)
1. Synonym- Goat-adapted Cattle Plague Vaccine; Goat Tissue Vaccine (Living).
2. Definition- Rinderpest Goat-adapted Tissue Vaccine is the homogenised freeze dried preparation of spleen pulp of goats artificially infected with the suitable strain of rinderpest virus.
3. Preparation- Healthy susceptible goats are quarantined for a period of ten days. After this period a batch of selected goats are injected subcutaneously with 2 ml. of a suitable dilution of the suspension of the seed virus. The donor goats are sacrificed after a suitable period when the titre of the virus in the animal body is expected to be maximum, usually four days, and the spleen from animals free from any pathological change or signs are collected under sterile conditions. Smear from each spleen is examined microscopically to exclude spleen which are contaminated from the production batch.
The spleen is freed from fat and fascia and is blended into a smooth pulp in a grinder.
The pulp is spread on a shallow dish of glass or stainless steel and is freeze dried.
The freeze dried pulp is then ground into a fine powder and sieved. The powder is ampouled in 0.25 g. or 0.125 g. quantities and freeze dried.
4. Standard:
(a) Description- Dark brown or chocolate coloured scales or powder.
(b) Identification- The product affords protection to susceptible animals against rinderpest.
(c) Moisture content- Not more than 1.0 per cent.
(d) Safety Test- Each batch of vaccine shall be tested for safety in laboratory animals and cattle or buffalo calves as follows:-
(i) Small animals- At least two guinea pigs each weighing 300 g. to 450 g. and two adult rabbits each weighing 1 kg. to 1.5 kg. should be injected each with 1 ml. of 1: 100 suspension of the vaccine subcutaneously and kept under observation for seven days. None of the animals should die. Alternatively, a batch of six white mice each weighing not less than 18 g. may be used, each mouse receiving 0.5 ml. of a dilution 1 : 100 suspension subcutaneously. None of the animals should die.
(ii) Large animals- Either cattle of good grade of susceptibility (hill cattle) or buffalo calves may be employed. For each batch of vaccine, three animals should be injected subcutaneously with 1 ml. of 1 : 8000 dilution of the vaccine. These animals should be kept under observation for twelve to fourteen days. None of the animals should show any untowards reactions.
(e) Sterility Test- Complies with the tests for sterility described under the general monograph in ‘ Viral Vaccines‘.
(f) Potency Test- The animals receiving 1 ml. of 1 : 8000 dilution of vaccine used under safety test mentioned above and kept under observation for fourteen days, should be challenged with 1 ml. of 1 per cent suspension of stock Rinderpest Virulent virus. None of the animals should die of rinderpest within a period of ten days. This test serves as a short potency test for each of the batches.
For conducting a detailed potency test the following procedure may be followed:-
Dilution 1: 8000, 1: 12,000 and 1 : 16,000 shall be tested and for each dilution three susceptible cattle or buffalo calves should be used. Each animal is inoculated subcutaneously with 1 ml. of a dilution of the vaccine, followed twelve to fourteen days later with a standard challenge dose of virulent rinderpest bull virus containing in 1 ml. of a 1 : 100 suspension of spleen tissue. Two unvaccinated bovines, each receiving the same quantity of the challenge dose acts as controls. These are kept under observation for fourteen days. The end point of protection titre is assessed on the death or survival rate and the dose contained in one gramme of vaccine calculated on the basis of 20 to 40 minimum protective doses being equivalent to one vaccinating dose.
(g) Virulence and Viability Test- Two to four goats each weighing not less than 18 kg. are injected with 2 ml. of 1 : 100 suspension of the vaccine and kept under observation for ten days. These animals should show reaction characterised by pyrexia (rise of about 2˚ C) anorexia and dullness.
5. Labelling- Should comply with the requirement of ‘Labelling‘ as laid down in the general monograph on ‘ Viral Vaccines‘.
6. Storage- The vaccine may be expected to retain its potency for twelve months if stored at – 15˚ C to -20˚ C or about three months if stored at 2˚C to 4 ˚ C.
Rinderpest Lapinised Vaccine (Living)
1. Synonym- Rabbit Adapted Cattle Plague Vaccine (Living) Lapinised Vaccine (Living).
2. Definition- Rinderpest lapinised vaccine is a suspension of a modified living virus (e.g. Nakamura III Strain) prepared with the blood, spleen and mesenteric lymph glands of infected rabbits and is freeze dried.
3. Preparation- Adult rabbits possibly from a known stock, each weighing not less than 1 kg. free from cocidiosis and snuffles, are injected intravenously with 1 ml. of a suitable dilution of a suspension of the stock seed virus. Donor rabbits are sacrificed after a suitable period when the titre of the virus in the animals is expected to be the maximum usually the third day.
Ten millilitres of blood is collected from each rabbit in a defibrinating flask under aseptic condition. Later the animals are sacrificed and the spleen and mesenteric lymph glands collected. Each rabbit is subjected to a thorough post-mortem examination to observe lesions of rinderpest infection.
After harvesting, the blood and the organs (spleen and glands) are homogenised in a suitable proportion if necessary. Adequate quantities of penicillin and streptomycin may be added. The homogenized material is ampouled in suitable quantities and freeze dried.
4. Standard-
(a) Description- Dark chocolate coloured mass.
(b) Identification- This product affords protection to susceptible animals against rinderpest.
(c) Moisture content- Not more than 1.0 per cent.
(d) Safety Test- For testing a batch 2 guinea pigs each weighing not less than 300g. are injected subcutaneously with 1 ml. of a 1 : 100 suspension of the vaccine. Alternatively, a group of six white mice each weighing not less than 18 g. is used. Each animal receives subcutaneously 0.5 ml. of 1 : 100 suspension of the vaccine. None of the test animals should die within a period of seven days.
(e) Sterility Test- Should comply with the tests for sterility described in the general monograph on ‘Viral Vaccines‘. If antibiotics have been added the inoculum should be neutralised before doing the test.
(f) Potency Test- Dilution 1: 100, 1 : 200, 1 : 400 and 1 : 800 shall be tested and for each dilution 2 susceptible cattle ( hill bulls) or buffalo calves should be used. Each animal is inoculated subcutaneously with 1 ml. of a dilution of the vaccine, followed twenty-one days later with a standard challenge dose of a virulent rinderpest bulls virus contained in 1 ml. of a 1 : 100 suspension of spleen tissue. Two unvaccinated bovines each receiving the same quantity of the challenge virus serve as controls. These animals are kept under observation for fourteen days. The end point of the protecting titre is assessed on the death or survival rate and the dose contained in one gramme of vaccine calculated on the basis of twenty minimum protective doses being equivalent to one vaccinating dose.
(g) Virulence and Viability Test- Four rabbits each weighing 1 to 1.5 kg. are injected subcutaneously with 1 ml. of 1 : 100 suspension of the vaccine. The animals should react typically showing all the symptoms of rinderpest in rabbits.
5. Labelling- Should comply with the requirements of ‘Labelling‘ as laid down in the general monograph on ‘Viral Vaccines‘.
6. Storage- The vaccine may be expected to retain its potency for six months if stored at 15 ˚C to –20 ˚C or about a month if stored at 2 ˚C to 4 ˚C.
Rinderpest Lapinised Avianised Vaccine (Living)
1. Synonym- Lapinised Avianised Vaccine (Living).
2. Definition- Rinderpest Lapinised Avianised Vaccine is a suspension of a modified live rinderpest virus of low virulence prepared either with the whole chick embryo or the viscera of the infected chick embryo.
3. Preparation- Twelve or thirteen days old active chick embryos from a flock free from Salmonella pullorum infection are injected intravenously with a suitable dilution of the suspension of the stock seed virus in six per cent glucose solution. The embryos are incubated at 38.5˚ C for five days. At the end of this incubation period, eggs which show living embryos are selected for the preparation of the vaccine. The viscera of the chicks are harvested, care being taken to reject the gizzard and gall bladders. The material is homogenised in a blender with adequate quantities of antibiotics (penicillin and streptomycin added if necessary), and primary freeze dried done. This freeze dried material is ground into a fine powder, ampouled in suitable quantities and finally subjected to secondary freeze drying and sealed under vacuum.
4. Standard-
(a) Description- Pale cream or yellow coloured sterile powder.
(b) Identification- This product affords good grade of immunity to susceptible animals against rinderpest.
(c) Moisture content- Not more than 1.0 per cent.
(d) Safety Test- For testing each batch, a group of six mice each weighing not less than 18g. is used. Each mouse is injected subcutaneously with 0.5 ml. of a 1 : 100 suspension. Alternatively, two guinea pigs each weighing not less than 300 g. and two rabbits each weighing not less than 1 kg. are injected with 1 ml. of 1 : 100 suspension subcutaneously. These animals should not show any untoward reaction during the period of observation for seven days.
(e) Sterility Test- Should comply with the test or sterility as laid down in the general monograph on ‘Viral Vaccines‘.
(f) Potency Test- Healthy highly susceptible cattle (hill bulls) or buffalo calves should be used for testing the potency of each batch of vaccine in suitable dilution. For each dilution two highly susceptible animals should be used. Each animal is inoculated subcutaneously with 1 ml. of a dilution of the vaccine, followed twenty-one to twenty- eight days after with a standard challenge dose of a virulent rindepest bull virus contained in 1 ml. of a 1 : 100 suspension of spleen tissue. Two unvaccinated bovines, each receiving the same quantity of the challenge virus serve as controls. All these animals are kept under observation for fourteen days. The end point of protective titre is assessed on the death or survival rate and the dose contained in one gramme of vaccine calculated on the basis of forty minimum protective doses being equivalent to one vaccinating dose.
5. Labelling- Should comply with the requirements of ‘Labelling‘ as laid down in the general monograph on ‘Viral Vaccines‘.
6. Storage and Expiry date- The vaccine shall be expected to retain its potency for the period at temperatures as specified below:-
-15˚ C to – 20˚ C .. Six months.
2˚ C to 4˚ C . .. One month.
Sheep and Goat Pox Vaccine (Living)
1. Synonym- Sheep Pox Vaccine. Goat Pox Vaccine (Living).
2. Definition-. Sheep and Goat Pox Vaccine consists of the virus contained in the scabs collected from sheep artificially infected with the virus.
3. Preparation- Healthy yearling sheep are infected artificially on the shaved portion of the abdomen with a suitable dilution of the suspension of the stock seed virus 50 per cent glycerine saline solution. The material from the semi-dried areas where the pock lesions are evident is collected and dried over calcium chloride or phophorus pentoxide under vacuum. Dry scabs are powdered, sieved, ampouled in suitable quantities and sealed.
4. Standard:
(a) Description- Light cream coloured powder.
(b) Identification- This product when applied to scarified area of the skin of the sheep or goats produces characteristic local lesions of pox and should afford protection to sheep and goat against Sheep and Goat Pox.
(c) Safety Test- Two rabbits each weighing not less than 1 kg. are injected subcutaneously each with 1 ml. of a 1 : 100 dilution of the vaccine in normal saline solution. These animals are observed for fourteen days. The animals should remain normal.
(d) Sterility Test- Complies with the tests for sterility described under the general monograph on ‘Viral Vaccines‘.
(e) Potency Test- Four yearling sheep are inoculated with 1 : 100 suspension of the vaccine in 50 per cent glycerine saline on a scarified area on the abdomen. Fourteen days later, these and two more susceptible sheep are inoculated by the same method with stock virus and observed for a period of fourteen days. The control animals should develop typical lesions of pox and vaccinated animals should remain normal.
5. Labelling- Should comply with requirement of ‘Labelling‘ as laid down in the general monograph on ‘Viral Vaccines‘.
6. Storage and Expiry date- The vaccine shall be expected to retain its potency for period at temperatures as specified below:-
-15˚ C to – 20˚ C : Twenty months.
2˚ C to 4˚ C : Three months.
Room Temperature : Fifteen days.
Fowl Spirochaetosis Vaccine ( Chick Embryo Origin)
1. Synonym- Tick Fever Vaccine.
2. Definition- The vaccine consists of a merthiolated suspension of chorioallantoic membrane, internal viscera and blood of chick embryos infected with a vaccine strain of spirochaetes and freeze dried.
3. Preparation- Eleven days old developing chick embryos are infected with 0.2 ml. of sterile fresh blood containing spirochaetosis via the chorioallantoic membrane. The inoculated embryos are incubated at 37 ˚C and candled daily and the dead one are discarded. On the seventh day the living embryos are chilled in the refrigerator for two hours. The chilled embryos are harvested separately and necrotic lesions in liver noted. Representative samples of blood should be examined for teaming spirochaetes. The internal viscera, chorio-allantoic membranes and the blood are collected. The material is pooled, weighed and held in deep freeze at – 15 ˚C to –20 ˚C for a period of one week. Thereafter the material is blended with equal quantity of Merthiolate (final concentration of merthiolate in the suspension should be 1 : 10, 000) thoroughly for three times, each time the motor running at full speed and the vaccine is ampouled in 2 ml. quantities and freeze dried.
4. Standard-
(a) Description- Light brownish scales.
(b) Identification- The vaccine affords protection when inoculated into the fowls against spirochetosis.
(c) Moisture content- The moisture content should not exceed 1.0 per cent.
(d) Safety and potency test- Six healthy cockerals ten to twelve weeks old are used for this purpose. Each ampoule of vaccine is reconstituted in 10 ml. of cold distilled water and the six cockerals are injected intramuscularly each with 1 ml. of the reconstituted vaccine and the birds are observed for a period of ten days and the vaccinated birds should remain normal throughout the period of observation. The vaccinated birds are challenged with 0.2 ml. intramuscularly with virulent spirochaete blood along with two susceptible controls. Temperature and blood smear examination of the challenged birds and controls should be carried out daily for a period of ten days. The blood smears of vaccinated birds should remain negative for spirochaetes during the entire period of observation. The controls should react and show spirochaetes in the blood.
(e) Sterility Test- Complies with the tests for sterility described in the general monograph on ‘ Bacterial Vaccine‘.
5. Labelling- Should comply with the requirement of ‘Labelling‘ as laid down in the general monograph on ‘Viral Vaccines‘.
6. Storage- The vaccine when stored at –15 ˚C to – 20 ˚C may be expected to retain the potency for about one year and about two months if stored in refrigerator at 2 ˚C to 4 ˚C.
Swine Fever Vaccine Crystal Violet
1. Synonym- Crystal Violet Swine fever vaccine, Hog Cholera Vaccine.
2. Definition- Swine fever vaccine, crystal violet is a suspension of blood of swine that have been infected with a suitable virulent antigenic strain of swine fever virus, inactivated with 0.25 per cent crystal violet ethylene glycol at 37 ˚C for fourteen days.
3. Preparation- Susceptible healthy pigs of six to seen months of age belonging to a well established strain or bred are used. Body weight of these animals at this age may vary according to the breed but optimum weight is considered as between 75 to 100 kg. Animals used for production may be procured from well established farms and kept under quarantine for fourteen days. These are injected intramuscularly with a suitable dilution of the suspension of the virulent blood viruses. Bleeding of the clinically injected animals is carried out on the sixth day. The defibrinated blood from each animal is strained and stored separately in sterile glass containers. To the four parts of defibrinated blood, one part of 0.25 per cent crystal violet- ethylene glycol is added and the suspension after thorough mixing, is stored at 37˚ C ( +0.5) for two weeks. The product is filled in 20 ml. volumes in sterile vials and labelled on the completion of tests.
4. Standard-
(a) Description- Very dark violet suspension.
(b) Identification- This product affords protection against swine fever but not against African Swine Fever.
(c) Safety Test- Two young pigs weighing about 15 to 30 kg. are injected subcutaneously each with 40 ml. of the vaccine batch to be tested. In addition, one unvaccinated susceptible pig is placed in contact.
(d) Sterility Test- Should comply with the test for sterility described under general monograph on ‘Viral Vaccines‘.
(e) Abnormal toxicity test- Two guinea pigs are given 1 ml. of vaccine intramuscularly.
Two guinea pigs are given 2 ml. of the vaccine intraperitoneally. Two mice are given 0.5 ml. of the vaccine subcutaneously.
(f) Potency Test- Four susceptible pigs weighing between 20-30 kg. are injected with 5 ml. of the vaccine subcutaneously. After twenty-one days these are challenged with 1 ml. of suitable dilution of the challenge virus subcutaneously. The dose must contain at least 1000 minimum infective doses. At least two control pigs should be used.
5. Labelling- Should comply with requirement of ‘Labelling‘ as laid down in the general monograph on ‘Viral Vaccines‘.
6. Storage- The vaccine may be expected to retain its potency for twelve months if stored in refrigerator at 2 ˚C to 4 ˚C.
Swine Fever Vaccine Lapinised (Living)
1. Synonym- Lapinised swine fever vaccine, freeze dried lapinised swine fever vaccine.
2. Definition- Swine fever lapinised vaccine consists of the suspension of a modified live swine fever virus prepared from spleens of infected rabbits and is freeze dried.
3. Preparation- Healthy adult rabbits weighing approximately 1000 gms. or over, free from coccidiosis snuffles etc. are injected intravenously with a suitable dose of a dilution of the modified rabbit adapted virus. Rabbits are sacrificed at the height of reaction and spleens are collected with sterile precautions. The collection is later homogenised in a blender using ten per cent yolk phosphate buffer as a diluent. The suspension is ampouled in 0.5 ml. quantities and freeze dried.
4. Standard-
(a) Description- Light scales.
(b) Identification- This product affords protection against swine fever.
(c) Moisture content- The moisture content should not exceed 1.0 per cent.
(d) Safety Test- Six mice are injected each with 0.5 ml. of a 1 : 100 suspension of the vaccine. These are kept under observation for seven days. Non should die.
(e) Viability Test- Two healthy rabbits are injected intramuscularly with 1 ml. of 1 : 100 suspension of the vaccine. These animals show thermal reaction.
(f) Sterility Test- Should comply with the test for sterility described under the general monograph on ‘Viral Vaccines‘.
(g) Potency Test- The vaccine batch under test should be tested on susceptible healthy pigs weighing between 20-30 kg. Two animals for each dilution may be used. The dilutions tested are 1 : 10, 1 : 25, 1 : 50 and 1 : 100. One millilitre of each of these dilutions is injected subcutaneously. One healthy, susceptible, unvaccinated in contact animal should be kept along with the vaccinated animals.
Fourteen to twenty-one days later these animals along with two controls are injected subcutaneously with 1 ml. of the challenge virus containing at least 1000 minimum infective doses.
5. Labelling- Should comply with requirements of ‘Labelling‘ as laid down in the general monograph on ‘Viral Vaccines‘.
6. Storage- The vaccine may be expected to retain its potency for six months if stored at temperature ranging between – 10˚ C to – 15˚ C and for seven days at 2˚ C to 4˚ C in the refrigerator.
1[Foot and Mouth Disease Vaccine (Inactivated)
1. Synonym.– Inactivated Tissue culture mono or polyvalent Foot and Mouth Disease Vaccine.
2 Definition.– Foot and Mouth Disease Vaccine is a liquid product or preparation containing one or more types of foot and mouth disease virus which have been inactivated in such a way that its immunogenic property is maintained. It may also contain an adjuvant. The vaccine is described as monovalent, bivalent, trivalent or polyvalent depending on the number of types of virus used.
3. Preparation.– The virus is propagated in suitable cell culture. The cell culture is infected with an appropriate inoculum of virus and incubated at a suitable temperature for multiplication of virus. The virus is harvested and cellular debris removed by filteration. Inactivation is carried out by a suitable agent such as formaldehyde solution or aziridine compound. The adjuvant may be aluminium hydroxide and/or saponin. In case of inactivated gel vaccine the antigen is concentrated by sedimentation at plus 4 degree C. For preparing a polyvalent vaccine, monovalent antigens are mixed in appropriate quantities to give the final mixture which is the formulated vaccine.
4. Standards:
(a) Description :- Aluminium hydroxide gel vaccines settle down to variable degree on storage leaving the supernatant clear.
__________
1. Ins. by G.S.R. No. 659(E) ,dt.. 31-8-1994.
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(b) Identification – It protects cattle against Foot and Mouth Disease due to homologous type/subtype of virus.
(c) Sterility test – It shall comply with the tests for sterility as prescribed under the “general monograph on “Viral Vaccines”.
(d) Safety test – The test is carried out on fully susceptible cattle not less than 12 months of age and which have not been sensitized either by vaccination or previous infection. Inoculate 3 susceptible cattles each with 2 ml. of finished product at multiple sites on tongue by intradermal route and observe for 4 days. The same animals are inoculated on 4th day with 3 cattle doses subcutaneously and are observed for a further period of 6 days. The animals should not develop any signs of FMD and remain normal.
(e) Potency test – Each batch of the vaccine is to be tested in susceptible cattle of not less than 15 months of age. The potency test in cattle can be done either by :–
(i) PD50 Method : The vaccine shall be tested by the determination of PD50 in susceptible cattle by challenging animals vaccinated with appropriate dilution of the vaccine made in adjuvanted or non-adjuvanted diluent as appropriate.
A minimum of 5 animals should be used per dilution and 2 unvaccinated animals to be included as controls to the challenge. All animals are needle challenged with 10,000 ID50 of the homologous strain of virus by inoculation on the tongue on the 21st day of post-vaccination.
The control animals are to be similarly challenged. Animals are observed for 10 days for the development of lesions. Unprotected animals show generalised lesions due to FMD. Control animals must shown generalized lesions. From the number of animals protected in each group the PD50 content of the vaccine is calculated. The vaccine passes the test if an observed PD50 value of 3 or greater is obtained in the test.
(ii) Percentage protection method in which groups of ten health susceptible cattle are each injected subcutaneously with the vaccinating dose and 14 – 21 days later the cattle are challenged by intradermal injection into three separate sites on the tongue with 10,000 ID50 of the strain of virus used in the preparation of the vaccine. The vaccine can be passed if atleast seven out of the ten in the group are protected against the development of generalized infection whereas all the controls should react by developing primary and secondary lesions observable in the mouth and feet.
For other reasons if cattle testing is not possible then the potency of the vaccine may be assed in guineapigs either by Lucam ‘C‘ index or PD50 method by challenging those which have been previously vaccinated, provided that the correlation has been established between guinea pig challenge test and cattle challenge results.
The estimation of the serum neutralizing antibody titre cattle may be considered as a supportive test to evaluate potency of vaccine.
However, potency testing of vaccines, in cattle, of batches whenever by other accepted methods of testing is in doubt, at aleast one out of every five batches, be undertaken.
5 Labelling:- It is labelled as described under the requirements of ‘labelling‘ as laid down in the general monograph, with the additional requirements that the label on the container states the virus types used in the preparation.
6. Storage:- It should be protected from the light and stored between 4o C to 8o C. Under these conditions it may be expected to retain its potency for not less than 12 months. Freezing of aluminium hydroxide vaccine must be avoided. The frozen product will not be fit for use.
Canine Hepatitis Vaccine (Living)
1. Synonyms: Infectious Canine Hepatitis Vaccine (Living), Canine Hepatitis Cell Culture Vaccine.
2. Definition: Canine Hepatitis Vaccine (Living) is a freeze dried preparation of tissue culture fluid containing the cell culture adopted canine hepatitis virus.
3. Preparation : Canine hepatitis vaccine shall be prepared from virus bearing cell culture fluid.
Only stock seed virus which has been established as pure, safe and immunogenic shall be used in the preparation of the vaccine.
Immunogenicity test : Each lot of stock seed virus shall be tested for immunogenicity as follows :
Thirteen canine hepatitis susceptible dogs, 8-14 weeks old shall be used for the test (10 vaccinates and 3 controls). Blood samples may be drawn from these animals and individual serum samples tested for the presence of antibodies, against canine hepatitis virus. Ten dogs shall be injected subcutaneously with predetermined quantity of the virus and remaining 3 dogs are kept as unvaccinated controls. The dose calculation will be based on virus titration in suitable cell culture system. Not less than 14 days post vaccination, the vaccinated and control shall each be challenged intravenously with virulent infectious canine hepatitis virus and observed daily for 14 days. At least 2 out of 3 controls should die and the survivors shall show the clinical signs of canine hepatitis. Nine out of ten vaccinated dogs shall survive and shall not show any signs of infectious canine hepatitis during the observation period.
The stock seed virus shall be tested once in 5 years and maintained under standard conditions as prescribed.
The stock seed virus may be inoculated on a suitable tissue culture system and may be incubated for five to seven days.
The tissue culture fluid is then harvested and titrated in cell culture system for virus content. After appropriate dilution and pooling, the material is stored at minus 20o C until freeze dried. Each vaccine dose shall contain not less than 103.5 TCID50 dose.
4. Standards :-
(a) Description. – The dried product is a pinkish cream material readily dispersible in water. The reconstituted vaccine is a pinkish liquid.
(b) Identification.- It causes characteristic cytopathic effect in dog, pig and ferret kidney monolayers. This can be neutralized by specific antiserum. When inoculated into dogs, the development of specific neutralizing antibodies can be demonstrated by suitable serological tests.
(c) Moisture content.- In the finished product moisture content shall not exceed 1.0 per cent.
(d) Sterility Test.– Shall comply with the tests of sterility as described under the general monograph on “Viral Vaccines”.
(e) Safety Test.– Mouse safety test – Vaccine prepared for use as recommended on the label shall be tested. Eight mice shall be inoculated intracerebrally with 0.03 ml and 8 mice shall be inoculated intraperitoneally with 0.5ml. Both the groups shall be observed for seven days. If unfavourable reaction attributable to the product occurs in two or more mice in either group during their observation period, the batch is unsatisfactory.
(f) Dog Safety Test.– Each of the two susceptible pups aged 8 – 14 weeks shall be injected with vaccine equivalent of 10 vaccinating doses from the batch reconstituted with sterile diluent and administered in the manner recommended on the label and observed for 21 days. None of the pups shall show any unfavourable reaction during the period of observation.
(g) Potency test, Virus Titration: – Samples of finished product shall be tested for virus titre in suitable cell culture system. The batch shall have a virus titre of not less than 103.5 TCID50 dose.
(h) Potency test in dog:– Two healthy susceptible dogs of 8-14 weeks of age shall be injected subcutaneously with one Vaccine dose. 14 days after vaccination, specific neutralizing antibodies from both the dogs shall be demonstrable by serological tests.
5 Labelling: Shall comply with the requirement for labelling as laid down in the general monograph on “Viral Vaccines”.
6 Storage: The dry product shall be stored at temperature of minus 20o C or below. The vaccine is expected to retain its potency for about 6 months in the freezing chamber of the refrigerator (temperature) approximately minus 8oC
Duck Plague Vaccine
1 Definition.- Duck plague vaccine is a suspension of modified living virus prepared from infected chick embryos.
2 Preparation.-
Fresh fertile hen‘s eggs obtained from salmonella free flocks are . incubated in an incubator. Nine days old embryos are injected with 0.2 ml of the suitable dilution ( 1 in 100) of the suspension of the virus on the CAM and incubated at 37o C for 5 days post-inoculation. Dead embryos of the 3rd, 4th and 5th days post-inoculation are harvested. The embryos (devoid of head and legs). Clear fluid and the membranes are collected and homogenized in a Blender, ampoulded in 0.5ml quantities and freeze dried.
3 Standards:-
(a) Description.- Light brown scales.
(b) Identification.- This product affords protection to the ducks against duck plague.
(c) Safety Test.- Four healthy, 8 to 12 weeks old ducks weighting not less than 600 gms are inoculated subcutaneously with 1ml of 10-1 dilution of the vaccine and observed for a period of 14 days. During the period of observation, the ducks shall not show any untoward reaction.
(d) Sterility test.- Shall comply with the test for sterility described in the general monograph on “Viral Vaccines”.
(e) Potency Test.- Six susceptible ducks 8 to 12 weeks old each weighing not less than 600 gms are inoculated subcutaneously with 1 ml of 10-3 dilution of the vaccine. The minimum virus contents in 1 ml. dose of the vaccine shall be 103.5 EID50. 14 days later these ducks are challenged subcutaneously each with 1 ml. of 10-2 dilution of the virulent duck plague virus (1000 DEID50) along with 2 unprotected young ducks of about 8-12 weeks age. The unprotected ducks shall show symptoms of duck plague and die within 10 days, while the protected ducks shall remain normal during the observation period of 14 days.
4. Labelling.- Should comply with the requirements of labelling as laid down in the general monograph on “Viral Vaccine”.
5. Storage.- Vaccine when stored at minus 15o C to minus 20o C may be expected to retain its potency for one year and about three months if stored in the freezing chamber of Refrigerator i.e. minus 5o C.
Avian Encephalomyelitis Vaccine (Living)
1. Synonyms.- Avin-encephalomyelitis Vaccine Freeze dried.
2. Definition.- A virus bearing tissue and fluid suspension from embryonated hen‘s legs.
3. Preparation.- The stock seed virus which has been established as pure, safe and immunogenic shall be used for preparing the vaccine.
(i) Each lot of stock seed virus shall be tested for pathogenicity by chicken embryo inoculation test:
(a) One dose of the seed lot shall be mixed with 9 volume of sterile heat inactivated specific, antiserum to neutralize vaccine virus in the product.
(b) After neutralization, 0.2 ml of serum vaccine mixture shall be inoculated into each of at least 20 fully susceptible chicken embryos (0.1ml of the inoculum shall be inoculated on CAM of 9-11 days old embryos and 0.1 ml in the allantoic sac).
(c) Eggs shall be candled for 7 days. Deaths occurring during first 24 hours shall be discarded but at least 18 viable embryos shall survive 24 hours post inoculation for a valid test. All embryos and CAMs from embryos which die after the first day shall be examined.
(d) If the death or abnormality attributable to inoculums occur, the seed lot is unsatisfactory.
(ii) Immunogenicity test.- Avian encephalomyelitis susceptible chicks, all of same age 8 weeks old) shall be used 20 chickens shall be inoculated with the field dose of the virus by prescribed route. Ten additional chickens of same age and flock shall be held as unvaccinated controls.
At least 21 days post vaccination, the controls and vaccinates shall be challenged intracerebrally with Virulent avian encephalomyelitis virus and observed each for 21 days. At least 80 percent of controls shall show signs of avian encephalomyelitis or die. At least 19 to 20 vaccinates shall remain free from clinical avian encephalomyelitis during the observation period for the stock seed virus to be satisfactory
4. Standards:-
(a) Description:- Greyish white flakes easily dispersible in the diluent.
(b) Identification:- At least 5–6 days old embryonated eggs (from hens with no history of infection with avian encephalomyelitis) shall be inoculated with 0.1 ml of undiluted vaccine into the yolk sac and kept in incubator and then transferred to the brooder where they are allowed to hatch. The hatched chicks shall be raised for 7 days. More than 5 per cent of hatched chicks shall manifest the typical symptoms (weak-leg, leg paralysis tremor etc.) at the end of this period.
(c) Moisture Content:- Shall not exceed 1.0 per cent.
(d) Sterility Test:- Shall comply with the test for sterility described under general monograph on “Viral Vaccines”.
(e) Safety Test:- At least 25 avian encephalomyelitis susceptible birds (6-10 weeks of age) shall be vaccinated with 10 field doses by the recommended route and observed each day for 21 days. If unfavourable reactions attributable to the vaccine occur during the observation period, the batch of vaccine is unsatisfactory.
(f) Potency Test:-
(i) The vaccine shall be titrated for virus content. To be eligible for release, the batch shall have a virus titre of at least 102.5 EID50 per dose.
(ii) At least 10 susceptible chickens shall be vaccinated with the field dose of the vaccine by prescribed route and 10 chickens from same batch and source shall be kept as unvaccinated controls.
At least 21 days post-vaccination, both the groups shall be challenged intracerebrally with Virulent avian encephalomyelitis virus and observed for 21 days. At least 8 out of 10 controls shall develop recognizable signs or lesions of avian encephalomyelitis and at least 8 out of 10 vaccines should remain normal
5. Labelling: Shall comply with the requirement of labelling as laid down in general monograph on “Viral Vaccines”.
Marek’s Disease Vaccine (Living)
1. Synonyms.- Herpes virus of Turkey Vaccine HVT vaccine (Living).
2. Definition:- Marek‘s disease vaccine is a suspension of cell free fluid containing live virus.
3. Preparation.- The stock seed virus which has been established as pure, safe and immunogenic in avian species shall be used for preparing the seed virus for vaccine production.
(i) Safety Test – The stock seed virus shall be non-pathogenic for chickens as determined by the following procedure:
The groups of at least 25 chickens each at one day of age shall be used. These chickens shall be of the same source and batch be susceptible to Marek‘s disease and be kept in isolated group.
Group 1: Each chicken shall be injected with 0.2 ml of 10 times as much viable virus as will be contained in one dose of vaccine by intramuscular route.
Group II : Shall serve as controls. At least 20 chickens in each group shall survive for four days postinjection. All chickens that die shall be necropsied and examined for lesions of Marek‘s disease and cause of death. The test shall be judged according to the following :
At 120 days o age, the remaining chicken in both the groups shall be weighted, killed and necropoised. If at least 15 chicken in each of these two groups have not survived the 120 days period if any of the chicken of Group-I have gross lesions of Marek‘s disease at necroposy or if the average body weight of the chickens in Group-I is significantly (statistically) different from the average of Group-II at the end of 120 days, the lot of stock seed virus is unsatisfactory.
(ii) Purity test – Shall conducted in chickens and no lesions other than those typical of Turkey Herpes virus shall be evidenced.
(iii) Immunologenicity test – Sixty susceptible day old chicks are used. Thirty of them inoculated with the seed virus in a dose corresponding to the field dose of the final vaccine and 14-21 days later challenged by intrabdominal route with virulent Marek‘s diseas virus, alongwith the other 30 non-vaccinated control chicks. At the end of the observation period when the chicks are 20 weeks old, the surviving chickens are examined for the presence of antibody against Marek‘s disease by serological tests and postmortem inspection for lesions of Marek‘s disease.
Any bird dead is thoroughly examined and the cause of death ascertained by necropsy/histopathological examination. All the surviving birds are killed and necropsied. The protection index (P1) is determined by following procedure :
1. Percent MD =
No. with MD lesions
——————— x 100
No. with MD lesions + No. of –ve Surviviours (effective No.)
2. P.I. =
Percent MD in controls – Percent MD in vaccinated
———————–x 100
Percent MD controls
Master seed virus should have P.1 of at least 80 per cent.
Eighty per cent of the chicks in the control group must fall ill specifically. If more than 80 per cent of the vaccinated chickens do not show symptoms or signs of Marek‘s disease, the seed virus is regarded as sufficiently effective and can be used for production of vaccine.
The seed virus is propagated in duck embryo fibro-blast cell culture, chick embryo fibroblast or any other suitable cell culture (specific pathogen free SPF flock) and when the peak passage level is attained the cell monolayer is suspended in cold diluent of the following composition:
SPGA Stablizer
0.218% Sucrose.
0.0038% monosodium phosphate.
0.0072% dipotassium phosphate.
L Monosodium glutanate 0.0049 M.
1 per cent bovine albumin fraction (V).
0.25 per cent EDTA (Sterilised by Seitz filteration and stored at minus 10o C). The virus is freed from cell by ultrasonication for 3 minutes interrupted after every 30 seconds) at 100 MA and freeze dried at times 60o C preferably in shelf freeze dried in convenient volumes. The doses per ampoule vial is calculated after titrating the freeze dried product in terms of plaque forming units (PFU) in the corresponding cell monolayers.
4. Standards:
(a) Description:- The cell free freeze dried HVT vaccine look uniformly grayish in colour and easily dispersible in the specified diluent.
(b) Identification. – The vaccine on inoculation in suitable cell culture system shall cause cytopathic effect typical of Herpes virus of Turkey. Specific antiserum of Herpes virus of Turkey shall neutralize the cytopathic effect.
(c) Moisture content. – Moisture content shall not exceed one per cent.
(d) Sterility test. – Shall comply with the test prescribed in general monograph on “Viral Vaccines”.
(e) Safety Test.- At least 25 one day old chickens shall be injected with ten times of the field dose of vaccine by intramuscular route. The chickens shall be observed each day for 21 days. Chickens dying during the period shall be examined, cause of death determined and the results recovered as follows :
(i) If at least 20 chickens do not survive the observation period, the test is inconclusive.
(ii) If lesions of any disease or cause of death are directly attributable to the vaccine the vaccine is unsatisfactory.
(f) Potency test. – The sample shall be titrated in the cell culture system. A satisfactory batch shall contain at least 1500 plaque forming units (PFU) as per dose at the time of release and maintain at least 1000 PFU till the end of expiry period.
5. Labelling.- Shall comply with the requirements of labelling as laid down in general monograph on “Viral Vaccines”.
6. Storage and expiry date.- The freeze-dried cell free HVT vaccine may be stored at 4oC for 6 months.
Goat Pox Vaccine (Living Cell Culture)
1. Synonym.- Goat Pox Vaccine (living), Attenuated Goat Pox Vaccine.
2. Definition.- Goat Pox vaccine is freeze-dried preparation, prepared by growing attenuated goat pox virus in kid kidney/testicular cell culture.
3. Preparation.- Primary kidney/testicular cell cultures of disease free kid are used. The monolayers infected with the seed virus are incubated at 37o C. The cultures are harvested by three cycles of freezing and thawings 6 to 7 days post infection when more than 80 per cent cells show CPE. The suspension is centrifuged at 1000 rpm for 10 minutes to remove cellular debris being stored at minus 20o C. The suspension is freeze dried after addition of 5 per cent Lactalbumin hydrolysate and 10 per cent sucrose.
4. Standards:
(a) Description. – Light yellow colour.
(b) Identification – The product affords protection to goat against goat pox.
(c) Moisture content. – The moisture content shall not exceed 1.0 per cent.
(d) Safety tests.-
(i) Laboratory animals. – Six mice, 3 guinea pigs and 3 rabbits are inoculated with 0.2ml intraperitoneally, 0.5 ml and 1.0 ml subcutaneously, respectively with 10 field doses of the vaccine. The inoculated animals during the observation period of 80 days shall remain normal.
(ii) Goat. – Two susceptible goats of 6 to 8 months of age are inoculated in postaxillary region by subcutaneous route with one-hundred field doses of the vaccine. The inoculated animals shall not develop more than a local reaction of 2 to 3 cms. These animals shall be observed for 10 days.
(e) Sterility test.- Shall comply with the test for sterility described under the general monograph on “Viral Vaccines”.
(f) Titration in cell culture.- Four randomly selected samples are inoculated in kid kidney cell cultures using 5 tubes for each dilution. The titration shall be repeated thrice. One thousands TCID50 is used as a field dose.
(g) Potency Test.- The three susceptible goats (8-10 months) are inoculated with 1/10th field dose and 3 susceptible goats (8-10 months) with one field dose, subcutaneously. Three in contract controls are also kept with the inoculated goats. These animals are observed for a period of 14 days and their body temperature recorded daily. The vaccinated animals shall not show any termal, local or generalized reaction. Twenty one days post infection, the vaccinated and controls and challenged with 10,000 TCID50 of virulent goat pox virus by intradermal route. The temperature of these goats are recorded for a period of 14 days. The vaccinated goats shall not develop localized or generalized reaction while control goats shall develop high fever, localized reaction or even generalized reaction in some cases.
5. Labelling.- Shall comply with requirements of labelling as laid down in the general monograph on “Viral Vaccines”.
6. Storage and expiry date.- The vaccine is expected to retain its potency for 12 months if stored at minus 15o C to minus 20o C and for three months at 2o C to 4o C.
Sheep Pox Vaccine (Inactivated)
1. Synonym.- Formal gel sheep pox vaccine.
2. Definition.- Sheep pox vaccine is a formaline inactivated gel treated tissue vaccine.
3. Preparation.- Healthy susceptible sheep of 8-12 months of age are inoculated subcutaneously with 500 ml of the 1:100 dilution of the Russian Virulent Sheep Pox Virus. Seven to eight day post inoculation skin of the abdomen alongwith the oedema is collected. The infected tissues are homogenized in 10 percent concentration in phosphate buffer (pH 7.4-7.6) which after the extraction of the virus is mixed with sterile gel and buffer in the following proportion :-
6 percent aluminium hydroxide gel-50 per cent.
Phosphate Buffer (pH 7.6)- 35 per cent.
10 per cent suspension – 15 per cent
This is later formalized and kept at 20-25oC/10oC for varying periods.
4. Standards.-
(a) Description .- It is a greyish white suspension. During storage the gel settles at the bottom, upper layer of the suspension is clear.
(b) Identification.- This product affords protection to sheep against sheep pox.
(c) Safety test.- This is carried out by inoculating 2 white mice with 0.2 ml., one guinea pig with 1.0 ml and one rabbit with 3,0 ml of vaccine. The animals should remain clinically healthy for 10 days.
(d) Sterility test.- This is done by seeding the vaccine on usual bacterial media. The plates and tubes are incubated for 10 days at 37o C. If the pathogenic bacteria are found, the vaccine is rejected while with non-pathogenic bacteria the vaccine is passed for field use.
(e) Potency test.- This is done by inoculating 4 non immune susceptible sheep preferably exotic breed of 1-2 years with 3 ml of vaccine in the thigh, subcutaneously.
The vaccinated sheep are challenged 15 days after inoculation alongwith 3 controls each with 0.1 ml of virulent virus containing 200 infective doses intradermally under the tail.
The sheep are observed for 10 days and their skin reaction recorded. The vaccine is considered potent if all the vaccinated, sheep do not show thermal or local skin reaction. Vaccine is also potent if 3 vaccinated animals do not develop any reaction and one shows abortive skin reaction, while at least 2 of the 3 controls develop typical sheep pox reaction at the site of inoculation.
5. Labelling.- Shall comply with the requirements of labelling as laid down in the general monograph on ” Viral Vaccines”.
6. Storage.- The vaccine shall be stored at 4o C to 5oC. it keeps well at above temperature upto 12 months.
Sheep Pox Vaccine (Living Cell Culture)
1. Synonym.- Sheep pox vaccine (Living), attenuated sheep pox vaccine.
2. Definition.- Sheep pox vaccine is freeze dried preparation prepared by growing attenuated sheep pox virus in lamb kidney/testicular cell cultures.
3. Preparation.- Primary cell cultures prepared from kidney/testicles of disease free lambs are used. The mono layers infected with the seed virus are incubated at 37o C. The cultures are harvested by 3 cycles of freezing and thawing 6 to 7 days post infection when more than 80 per cent Cells show C.P.E. The suspension is centrifuged at 1000 r.p.m. for 10 minutes to remove cellular debris before being stored at minus 20o C. The suspension is freeze dried after addition of 5 per cent Lactalbumin hydrolysate and 10 per cent sucrose.
4. Standards:-
(a) Description.- Light yellow colour.
(b) Identification.- The product affords protection to sheep against sheep pox.
(c) Moisture contents.- The moisture contents should not exceed 1.00 per cent.
(d) Safety tests.-
(i) Six mice, 3 guinea pig and 3 rabbits are inoculated with 0.2 ml intraperitoneally 0.5ml and 1.0 ml subeutaneously, respectively containing 10 field doses of the vaccine. The inoculated animals during the observation period of 10 days should remain normal.
(ii) One hundred field doses of the vaccine are inoculated subcutaneously into each of 2 susceptibles sheep in postaxillary region. Inoculated animals shall not develop more than a local reaction of 2 to 3 cms.
(e) Sterility test. – Shall comply with the test for sterility as described under the general monograph on “Viral Vaccines”.
(f) Titration in cell culture. – Four randomly selected samples reconstituted in a maintenance medium are inoculated in lamb kidney cell cultures using 5 tubes for each dilution. The titrations shall be repeated thrice. The TCID50 to be calculated by Read and Muonch method. One thousand TCID50 is calculated as one field dose.
(g) Potency test. – Three susceptible sheep 8-10 months old are inoculated with 1/10th, field dose and 3 susceptible sheep with one field dose, subcutaneously. Three in contact controls are also kept with the inoculated sheep. These animals are observed for a period of 14 days and their temperature is recorded daily. The vaccinated animals should not show any thermal, local or generalize reactions. Twenty-one days post infection the vaccinated and controls are challenged with 10,000 ID50 of virulent sheep poxvirus by intradermal route. The temperature of these sheep are recorded for a period of 14 days. The vaccinated sheep should not develop localised or generalized reaction while control sheep should develop high fever, localized reaction or even generalized reaction in some cases.
5. Labelling.- Shall comply with requirements of labelling as laid down in the general monograph on “Viral Vaccines”.
6. Storage and expiry date.- The vaccine is expected to retain its potency for 12 months if stored at minus 15o C to minus 20o C and three months at 2 o C to 4 o C
Tissue Culture Rinderpest Vaccine
1. Synonyms.- Cell Culture Rinderpest Vaccine.
2. Definition.- Tissue Culture Rinderpest Vaccine is a freeze dried preparation of live modified rinderpest virus adapted to and propagated in cell culture.
3. Preparations.- Primary or secondary monolayer cultures of the kidney cells (Bovine or any other suitable animals) taken from kidney from healthy animals free from any pathological changes shall be used. When secondary cultures are used they shall have retained their original morphology and Karyotype. Kabete ‘O‘ stain of Rinderpest virus developed by East African veterinary Research Organisation (Plowrights strain between the passage levels of 99th and 100th passages) shall be used. The virus harvested from cell monolayer culture prepared from the kidneys of a single calf or serially cultivated bovine kidneys cells (Not more than 10 passages away from the Primary) inoculated with the same seed and harvested together, will be freeze dried with stabilizers in suitable quantities.
4. Standards.- It complies with the requirements of general standards of viral vaccines:
(a) Description.- Dry light yellow coloured flakes readily soluble in chilled and saline or buffered saline.
(b) Identifications.-
(i) Protects cattle against a subsequent challenge with virulent or caprinised rinderpest virus.
(ii) It is titrable in tissue culture systems capable of supporting the multiplication of this virus. The test shall be made on at least three separate occasions using a cell culture derived from different animals.
(iii) Specificity test shall be performed using an appropriate scrum neutralization test.
(c) Sterility test. – Each batch shall be tested for bacterial and mycotic sterility as given in general monograph on “Viral Vaccines”.
(d) Innocuity test.- Shall be made on each batch in at least two guinea pigs and six mice. These animals shall be observed for at least two weeks for any untoward reaction.
(e) Safety and efficacy test.- The test for safety and efficacy shall be performed using the pooled reconstituted contents of not less than 4 ampoules taken at random. The vaccine shall be injected subcutaneously into each of at least two susceptible cattle free from specific antibodies using the quantity containing not less than 100 fields doses and two further cattle and using 1/10th of the field dose (calculated on the basis of 1000 TCID50 one field dose). The animals shall be housed with at least two unvaccinated animals and observed for a period of three weeks. The vaccine passes the safety test if the cattle show no signs of unusual clinical reactions.
At the end of three weeks all the four animals will be challenged alongwith two in contact cattle with a challenge dose of not less than 104 ACID50 of virulent Rinderpest virus. The vaccine passes the potency/efficacy test if the in contact animals develop rinderpest and all the vaccinated animals remain normal.
5 Labelling.- Shall comply with general monograph on “Viral Vaccines”. Each ampoule or at least 50 percent ampoules in a lot shall contain at least following print :
(i) TCRP Volume.
(ii) Batch No. with year.
(iii) General instructions for use.
6 Storage.- The vaccine when stored at minus 20o C and plus 4 degree C will maintain its titre for 2 years and 6 months respectively.
Canine Distemper Vaccine
1. Synonyms.- Cannine Distemper Vaccine (Living)- Freeze-dried.
2. Definition.- It is freeze dried preparation of either tissues from chick embryo containing eggs adapted strain of cannine distemper virus or the cell culture in which modified virus has been cultivated.
3. Preparation.- Canine distemper vaccine shall be prepared from virus bearing cell culture, fluid or infected chroioalantoic membrane. Only stock seed virus which has been established as pure, safe and immunogenic shall be used for preparation of vaccine. Stock seed virus propagated in chicken embryo shall be tested for pathogen by chicken embryo test. One volume of the virus shall be mixed with 9 volume of specific sterile heat inactivated serum to neutralize the virus. Mixture shall be inoculated into twenty (9 to 11 days old ) chicken embryo (with 0.1 ml on CAM and 0.1 ml in alantoic sac). Embryonated eggs shall be candled for 7 days daily. Death occurring in the first 24 hours shall be discarded. CAMS of embryos which die after 24 hours shall be examined. When necessary embryo sub-culture shall be made to determine the cause of death. The test should be concluded on the 7th day post inoculation.
The surviving embryos and their CAMS are examined. If deaths or abnormality due to the inoculums occur, the seed virus is unsatisfactory.
Immunogenicity test : Thirteen susceptible dogs 8-14 weeks old shall be used for the test (ten vaccinates and 3 controls). Blood samples are drawn from these animals and individual sample is tested for antibodies against canine distemper. Ten dogs shall be injected with a predetermined quantity of the virus and remaining 3 dogs are used as unvaccinated controls. The dose shall be based on the virus tiltration. At least 21 days post infection the vaccinated and controls shall be challenged intramuscularly with the same dose of virulent canine distemper virus and the animals are observed each day for 21 days. At least 2 out of 3 controls should die and survivor should show the symptoms typical of canine distemper. At least 9 out of 10 vaccinated animals should survive and should not show any clinical signs of canine distemper during the observation period. The stock seed virus should be tested for immunogenicity at least once in 5 years, if maintained under suitable conditions of storage. Eight days old chicken embryos from a healthy flock are inoculated on their chorioallantoic membrane with bacteriologically sterile virus suspension of egg adapted strain. After incubation for a period of five days, infected membrane and embryos are harvested. The individual embryo is tested for bacterial sterility. Those free from bacterial contamination are made into a 20 percent suspension in a suitable medium. The suspension is distributed in a single dose quantity into the ampoules of vials and freeze-dried.
The ampoules are sealed under vacuum or with pure dry sterile nitrogen before sealing. Alternatively, the virus may be grown on the suitable cell culture. Cells along with the suspending fluid is harvested, distributed in single dose quantity in ampoules and freeze dried.
4. Standard.-
(a) Description. – It is a dry product, pinkish cream material, readily dispersible in water or a suitable solvent.
(b) Identification. – It infects CAM of fertile eggs. This is neutralized by canine distemper antiserum. It does not cause distemper after injection into susceptible ferrets or dogs but immunizes them against the disease.
(c) Moisture content. – Moisture content in the finished product shall not exceed more than 1.0 per cent.
(d) Sterility test. – Shall comply with the test for sterility as described in the general monograph on “Viral Vaccines.”
(e) Safety tests. – (i) Mice safety test: Reconstituted vaccine as recommended on the label shall be tested.
Eight mice, 4 weeks old shall be inoculated intracerebally with 0.03 ml and 8 mice shall be inoculated intraperitoneally with 0.5ml. Both groups shall be observed for 7 days, if unfavourable reaction attributable to the product in either 2 or more mice in either group is observed during observation period, the batch is unsatisfactory.
(ii) Dog Safety test.-Inject two healthy dogs eight to fourteen weeks old that have previously been shown to be free from distemper virus-neutralising antibodies by the recommended route with twice the dose stated on the label and observe for 21 days. No significant local or general reaction develops.
(i) Potency test. – (i) Titration : Final samples of finished product shall be tested for virus titre, and when tested at any time within the expiry period, it should contain not less than 103 ID50 per dose.
(ii) It shall be carried out in dogs. Two healthy susceptible dogs each of 8-14 weeks of age free from distemper neutralizing antibodies are injected subcutaneously each with one vaccination dose. Serum samples shall be collected from each dog 14 days after vaccination and these shall have specific neutralizing antibodies at a dilution of 1: 100.
6. Labelling.- Shall comply with the requirements of labelling as laid down in the general monograph on “Viral Vaccines”.
7. Storage and expiry date.- For the freeze-dried product the expiry date is one year when stored at minus 20oC.
Avian Infectious Bronchitis Vaccine (Living)
1. Synonyms.- Avian Infectious Bronchitis Vaccine (Living) freeze-dried.
2. Definition.- It is a freeze-dried product of low virulent Avian Infectious Bronchitis Virus grown in embryonated hen‘s eggs of cultivated in cell culture.
3. Preparation.- Only stock seed virus which has been established as pure, safe and immunogenic shall be used. Each jot of stock seed virus shall be tested for other pathogens by chicken embryo inoculation tests as follows:-
A lot of seed virus shall be mixed with 9 volumes of sterile heat inactivated specific anti- serum to neutralize and the vaccine virus serum mixture shall be inoculated into each of at least 20 fully susceptible chicken embryos of 9-11 days old (0.1 ml on CAM and 0.1 ml in the allantoic sac). Eggs are candled daily for 7 days. Deaths occurring during first 24 hours shall be discarded but at least 18 viable embryos shall survive 24 hours post inoculation for a valid test. All embryo and CAMS from embryos shall be examined which die after 24 hours. If necessary embryo subcultures shall be made to determine the cause of death. The test shall be concluded on the 7th day post inoculation and surviving embryos including the CAM shall be examined. If death and or abnormality attributable to the stock seed virus occur, the seed lot is unsatisfactory.
Each lot of stock seed virus shall be tested for immunogenicity as below:-
Bronchitis susceptible chickens of the same age and source shall be used. For each method of administration recommended on the label and for each serotype against which protection is claimed, 20 chicks shall be used as vaccinates. Ten additional chickens for each serotypes against which protection is claimed shall be held as unvaccinated controls.
21 to 28 days post vaccination all vaccinates and controls shall be challenged by eye drops with virulent Bronchitis virus. A separate set of vaccinates and controls shall be used for each serotype against which protection is claimed. The challenge virus shall have a titre of at least 104.6 EID50 per ml. Trachea swabs shall be taken once 5 days post challenge from each vaccinated and controls. Each swab shall be placed in test tube containing 3 ml of tryptose phosphate broth and antibiotics. The tubes and swabs shall be swirled thoroughly and stored at minus 40o C pending egg inoculation. For each chicken swabs at least 5 chicken embryos, 9-11 days old shall be inoculated in the allantoic cavity with 0.2 ml of broth from each tube. All the embryos surviving 3rd day post inoculation shall be used in evaluation. A tracheal swab shall be positive for virus recovery when any of the embryos show typical infections bronchitis virus lesions such as stunting, curling, kidney urates, clubbed down or death during 4-7 days post inoculation period.
90 percent of the controls should prove positive for virus recovery. If less than 90 per cent of the controls are negative for virus recovery, the stock seed is unsatisfactory. The stock seed virus should be tested for immunogenicity once in 5 years provided it is maintained under standard conditions of the bronchitis virus storage.
4. Standards. –
(a) Descriptio: It is greyish-white product easily dispersible in the diluent.
(b) Identification: (i) The contents of the ampoule are suspended as per the instructions for the field use. The 0.2ml of the suspension shall be inoculated in the allantoic cavity of 9-11 days old chicken embryo and are incubated for 7 days. The lesions typical of infectious bronchitis shall be observed in the embryos at the end of incubation period. The allantoic fluid shall not agglutinate the chicken RBC’s.
(ii) Specific antisera against avian infectious bronchitis virus should neutralize the vaccine virus.
(c) Moisture content. – Moisture content in the finished product should not exceed 1.0 per cent.
(d) Sterility test. – Complies with the test for sterility as described under the general monograph on “Viral Vaccines”.
(e) Safety test. – Ten healthy susceptible chickens 5-10 days old from the same source batch shall be vaccinated with ten field dose of the vaccine and along with five chicks from same batch as unvaccinated controls by the prescribed route and observed 7 or 21 days post vaccination. Neither severe respiratory symptoms nor death shall occur to more than one experimental chicks, none of the unvaccinated control shall show any clinical symptoms.
(f) Potency test. – The minimum virus content of the freeze-dried product shall not be less than 103.5 EID50 per bird. The virus content of the vaccine shall be titrated as below:
Serial ten-fold dilution of the freeze-dried material will be made in tryptose phosphate broth. Three to five embryonated eggs (9-11 days old) shall be in inoculated with 0.1 ml of each dilution into the allantoic cavity and observed daily for 7 days.
Deaths occurring during the first 24 hours shall be discarded. The surviving embryos are examined for the evidence of infection and EID50 shall be calculated by the Reed and Muench Method/spearman and Karber method.
5. Labelling.- Shall comply with the requirement of labelling as laid down in the general monograph on “Viral Vaccine”.
6. Storage and expiry date.- Shall be stored at 4o C for six months].
PART II –ANTISERA
Provisions applicable to the production of all Sera from Living Animals
1. Definitions- (i) This Part of the Schedule applies to antibacterial sera, anti-viral sera and anti-toxic sera which are prepared by injecting bacteria or viruses or their products into buffalo- bulls or other suitable animals so as to produce active immunity which is manifested by the formation of anti-body.
(ii) For the purpose of this Part of the Schedule an anti-serum means sterile liquid anti- serum concentrated and unconcentrated, solutions of globulins or their derivatives or solid forms which can be reconstituted when necessary.
2. Staff of Establishment- The establishment shall be under the direction and control of a competent expert in bacteriology and serology with adequate training in immunology and standardisation of biological products and knowledge of animal management. He shall be assisted by a staff adequate for carrying out the tests required during the course of preparation of the sera and standardisation of the finished products.
3. Proper Name- The proper name of he antiserum shall be the recognised scientific name of the diseases or its causative organism or some generally recognised abbreviations thereof preceded by the prefix ‘anti‘, and followed by the word ‘serum; as for example, ‘Anti- Anthrax serum‘. The proper name of any antitoxin may be formed from the word ‘Anti-toxin‘ preceded by the name of the organism from which the toxin was prepared, and followed, if desired, by a term indicating the source or the strain of that organism provided where there is no special provision in the Schedule, the name as approved by the Licensing Authority may be adopted.
4. Records-
(1) The permanent records which the licensee is required to keep shall include the following particulars:-
(a) As to the culture- Evidence of the identity and specificity of the cultures.
(b) As to the procedure used in immunising the animals;
(i) The method of preparing the cultures or antigen used for immunisation.
(ii) The dosage and methods employed in administering the culture or antigen.
(iii) The period in the course of immunisation at which blood is withdrawn for the preparation of the serum.
(c) Any test which may have been applied to the serum to determine its content of specific antibodies or its specific therapeutic potency and purity.
(2) If the licensee desired to treat the performance of any tests recorded under sub- paragraph (i) (c) of this paragraph as determining the date of completion of manufacture for the purpose of rule 109 he shall submit full particulars of the proposed test to the Licensing Authority and obtain his approval.
5. Cultures- The cultures used in immunising the animals shall be at all times open to inspection, and specimens shall be furnished for examination at the request of the Licensing Authority.
6. Quantity –
(a) Any antiserum shall be issued for veterinary use in the form of either.
(i) Actual serum, i.e., the liquid product of decantation of the coagulated blood or plasma without any addition, other than antiseptic or subtraction, or
(ii) A solution of the purified serum proteins containing the specific antibodies.
(b) At the time of issue, the liquid shall be clear or show at the most a slight opalescence or precipitate. Preparations of the natural serum shall not contain more than 10 per cent of solid matter. A solution of serum protein shall not contain more than 20 per cent of solid matter.
1. Precautions to be observed in preparations-
(i) Laboratories where sera are exposed to the air in the course of the process of preparation must be separated by a sufficient distance from stables and animals houses to avoid the risk of aerial contamination with bacteria from animal excreta, and must be rendered fly proof to prevent such contamination by insects. Such laboratories must have impervious walls and floors and must be capable of being readily disinfected when necessary.
(ii) A special room with impervious walls must be provided for the collection of blood from the living animals.
(iii) An efficient system of manure removal must be used which will prevent its accumulation in the vicinity of any room where blood or serum is collected or handled.
(iv) An adequate number of sterilizers must be provided for the sterilization of all glassware or other apparatus with which the serum may come into contact in the course of its preparation.
(v) All processes to which the serum is subjected during and after the collection from the animals, must be designed to preserve its sterility, but in the case of a artificially concentrated sera, it shall suffice that the process of concentration is conducted with scrupulous cleanliness and in such a manner as to avoid unnecessary dangerous contamination.
(vi) The laboratories in which the testing of sera for potency, sterility and freedom from abnormal toxicity are carried out must be adequate for the purpose. An adequate supply of animals for use in such tests and suitable housing for such animals must be provided.
(vii) Provision must be made for complying with any special conditions which may be laid down in the Schedule relating to the production and issue of the particular serum, in respect of which the licence is granted.
8. Unhealthy or Infected Animals- If an animal used in the production of sera is found to be suffering from an infection except one produced by living organisms against which it is being immunized, or shows signs of serious or persistent ill health not reasonably attributable to the process of immunisation, the licensee shall immediately report the matter to the Licensing Authority and shall, if the authority orders an inspection and the Inspectors so directs, cause such animals to be killed and a postmortem examination of it to be made, and take steps to prevent any serum obtained from the animal being sold or offered for sale until permission is given by the Licensing Authority. If the result of the postmortem is such as to bring under suspicion, the health of any of the other animals used for the production of sera, the Licensing Authority may prohibit the use of those animals for the production of sera or may take such other steps as may be necessary to prevent the issue of sera which may be dangerous to animal health.
Provided in the case of emergency, the person in charge of the establishment may order the destruction of an animal used in the production of sera and suspected of infection, and shall in that case given notice forthwith to the Licensing Authority and shall permit an Inspector to be present at the postmortem examination.
9. Conditions and Housing of animals:
(i) The animals used in the production of sera should be adequately housed under hygienic environments.
(ii) Only healthy animals free from disease should be used in the preparation of sera.
(iii) Every animal intended to be used as the source of serum must be subjected to a period of observation in quarantine for at least seven days before being admitted to the animal sheds in which the serum yielding animals are housed.
(iv) In case of horses and other equidae, every animal used as source of serum shall either be actively immunized against tetanus or shall be passively immunized against the disease by injection of tetanus antitoxin in such doses as to ensure the constant presence of that antitoxin in the blood during the whole period of the use of the animals as a source of serum.
Anti-Sera and their General Standard
Anti-sera contain the immune substances that have a specific prophylactic or therapeutic action when injected into animals exposed to or suffering from a disease due to a specific microorganism or its toxin. Anti-sera are classified into three groups.
(i) Antitoxic sera (Antitoxin)
(ii) Antibacterial sera.
(iii) Antiviral sera.
Antisera are usually issued in an unconcentrated form for animal use but may be concentrated and also freeze dried. However, for the purpose of the Schedule the word ‘antisera‘ is also used for the unconcentrated liquid sera only. A suitable bacteriostatic agent in a concentration sufficient to prevent the growth of microorganisms is added to the liquid serum.
General Standard
1. Description- Liquid native or unconcentrated antisera are yellow or yellowish brown in colour. They are initially transparent but may become turbid with age. They are almost odourless except for the odour of any bacteriostatic agent that may have been added.
2. Identification- The test for identity is described in the individual monograph.
3. Acidity or Alkalinity- All native antisera have a pH of 7.0 to 8.5.
4. Abnormal Toxicity- All anti-sera shall comply with the following tests or freedom from abnormal toxicity.
(a) Two healthy mice each weighing not less than 18 g. are injected subcutaneously each with 0.5 ml. of the sample and observed for five days. None of the mice should show any abnormal reaction or die.
(b) Two healthy guinea pigs each weighing 300 g. to 450 g. are injected subcutaneously each with 5 ml. of the sample and observed for seven days. None of the guinea-pigs should show any abnormal reaction or die.
5. Sterility- All anti-sera shall comply with the tests for sterility described in rules 115 to 119.
6. Potency- The potency of each preparation, when the available methods permit, is determined by the appropriate biological assay, and it is described under the individual monograph.
7. Total Solids- Native antisera should not contain more than 10 per cent solid matter.
8 Labelling- Should comply with the provisions for ‘Labelling‘ as laid down for’Bacterial Vaccines.‘
9. Storage- Liquid preparations of antisera shall be stored, protected from light at temperature between 2 ˚C to 4 ˚C and shall not be frozen.
10 Date of Manufacture- The date of manufacture shall be unless otherwise specified in the individual monograph in this part is as defined in clause (b) of sub-rule (3) of rule 109.
11. Containers- All antisera are distributed in sterilised containers of a material which is inert towards the substance and which are sealed to exclude micro-organisms.
12. Expiry Date- The expiry date of potency of all sera shall not be more than twenty- four months after the date of a manufacture.
Anti-Anthrax Serum
1. Synonym- Bacillus Anthracis Anti-serum.
2. Definition- Anti-anthrax serum is the serum of animals that confers a specific protection against Baccillus anthracis.
3. Preparation- The antiserum may be prepared in buffalo bulls after repeated injections of cultures of B. anthracis of a virulent strain.
4. Standard- It complies with the requirements in the general provisions for antisera under Description, Acidity or Alkalinity, Abnormal Toxicity, Sterility, Solids, Labelling, Storage and Expiry date.
Identification– It protects animals against infection with B. Anthracis
Anti-Blackquarter Serum
1. Synonym- Blackleg Antiserum, Clostridium Chauvoei-Anti serum
2. Definition- Anti-Blackquarter serum is the serum of suitable animals containing the Substances that have a specific neutralising effect on Clostridium Chauvoei.
3. Preparation- It is prepared by injecting subcutaneously or intramuscularly increasing doses of formolised cultures of Cl. Chauvoei into buffalo bulls.
4. Standards- It complies with the requirements described in the general provisions for antisera under Description, Acidity or Alkalinity, Abnormal Toxicity, Sterility, Solids, Labelling, Storage and Expiry date.
Identification- It protects susceptible animals against infection with virulent strains of Cl. Chauvoei.
Anti-Fowl-Cholera Serum
1. Synonym- Pasteurella Septica Antiserum (Avian).
2. Definition- Fowl Cholera Antiserum is the serum of animals containing the substances that confer a specific protection to fowls against virulent strain of Pasteurella Septica (Avian).
3. Preparation- Antiserum is prepared from buffalo bulls after they have been subjected to an injection of killed cultures of virulent strain of Pasteurella Septica (Avian) followed by injections of living cultures of the same organism.
4. Standard- It complies with the requirements described in the general provision for anti-sera under Description, Acidity or Alkalinity, Abnormal Toxicity, Sterility, Solids, Labelling, Storage and Expiry date.
Identification- It protects susceptible fowls against infection with Pasteurella Septica (Avian) and its homologous strains.
Anti- Haemorrhagic Septicaemia Serum
1. Synonym- Pasteurella Septica Antiserum.
2. Definition- Anti-Haemorrhagic Septicaemia Serum is the serum of animals containing the substances that confer a specific protection to susceptible animals against virulent strains of Pasteurella Septica.
3. Preparation– The antiserum is prepared from buffalo bulls after they have been subjected to repeated injections of formolised cultures of standard strain Pasteurella Septica with adjuvants, followed by suitable doses of virulent culture of the organism.
4. Standard.- It complies with the requirements described in the general provisions for antisera under Description, Acidity or Alkalinity, Abnormal Toxicity, Sterility, Solids, Labelling, Storage and Expiry date.
Identification- It protects susceptible animals against infection with homologous strains of Pasteurella Septica.
Anti-Rinderpest Serum
1. Synonym- Cattle Plague Antiserum
2 Definition- Anti-Rinderpest Serum is the serum of buffalo bulls containing the substances that confer a specific immunity to susceptible animals against virulent strains of the virus of rinderpest
3. Preparation– The antiserum is prepared from buffalos who have reacted to a dose of virulent rinderpest virus, which is injected simultaneously with a predetermined quantity of anti rinderpest serum so as to control the severity of the reaction (serum-simultaneous- method).
4 Standard- It complies with the requirements described in the general provisions for antisera under Description, Acidity or Alkalinity, Abnormal Toxicity, Solids, Labelling, Storage and Expiry date.
(i) Identification- It protects susceptible animals against rinderpest.
(ii) Potency-Five Buffalo-calves of about one year of age in good condition are used for the test. Three are injected subcutaneously with the anti-rinderpest serum under test at the rate of 10 ml. per 46 kg. body weight, subject to a minimum of 20 ml. per animal. These together with the two remaining, are simultaneously injected subcutaneously at a different site with 1 ml. of a 1: 100 dilution of spleen suspension of virulent bull-virus.
The animals should be observed for fourteen days during which time the serum treated animals should exhibit no symptoms of rinderpest other than rise in temperature and slight intestinal disturbances, while the controls develop more severe symptoms or die.
Salmonella Pullorum Anti Serum
1. Synonym- Salmonella Pullorum Anti Serum.
2. Definition- Salmonella Pullorum anti-serum is the sera from fowls and contains antibodies against Salmonella Pullorum. It is used for standardizing batches of Salmonella Pullorum antigens and also used as a control along with the sera suspected for pullorum disease.
3. Preparation- The serum is prepared after intravenous inoculation with smooth culture suspension of Salmonella Pulloram in healthy birds.
4. Standards- It complies with the requirements in the general provisions for anti- sera under Description, Acidity, Alkalinity, Sterility, Solids, Labelling, Storage and Expiry date.
5. Identification- It should give positive agglutination with Salmonella pullorum
antigen.
Standard Anti-Brucella Abortus Serum
1. Synonym- National counterpart of standard anti-Brucella Abortus serum.
2. Definition- Standard Anti-Brucella abortus serum is the serum which contains 1000 International Units (I.U) per ml. and is used for standardizing batches of brucella antigens and is also used as a control along with the sera suspected for brucellosis.
3. Preparation- The serum is prepared after intravenous inoculation of suspension of smooth culture of B. abortus (strain 99) in rabbits or cattle and subsequently diluting it suitably with brucella-free healthy serum so that when tested with standardized Brucella abortus tube test antigen, it gives 50% agglutination at 1/500 final serum dilution.
4. Standard- It complies with the requirements in the general provision for anti- sera under Description, Acidity, Alkalinity, Sterility, Solids, Labelling, Storage and Expiry date.
Identification- It should give agglutination with Brucella antigen.
PART III- DIAGNOSTIC ANTIGENS
Provisions Applicable to the Manufacture and Standardisation of Diagnostic Agents (Bacterial Origin)
1 Definition- This Part of the Schedule applies to reagents of bacterial origin employed for various tests.
2 Staff of establishment- A competent expert in bacteriology with sufficient experience in the manufacture and standardisation of veterinary biological products shall be in charge of the establishment responsible for the production of various diagnostic agents of bacterial origin and he may be assisted by a staff adequate or carrying out the tests required during the preparation and standardisation of various diagnostic agents.
3 Proper Name- The proper name of any diagnostic agent is the name of micro- oraganism from which it is made, followed by the word ‘antigen‘ unless the Schedule otherwise provides, or, it may be derived from the name of the organism responsible for the causation of the disease or if there is no special provision in the Schedule, the name approved by the Licensing Authority. In the case of the undermentioned preparations the proper name of the diagnostic agent may be as follows:
1. Abortus Bang Ring (A.B.R. ) Antigen.
2. Brucella Abortus Coloured Antigen.
3. Brucella Abortus Plain Antigen.
4. Johnin.
5. Mallein.
6. Salmonella Abortus Equi “H” Antigen.
7. Salmonella Pullorum Coloured Antigen.
8. Salmonella Pullorum Plain Antigen.
9. Tuberculin.
4. Records- Cultures used in the preparation of diagnostic agents of bacterial origin must, before being manipulated into an agent be thoroughly tested for identity by the generally accepted tests applicable to the particular micro-organism. The permanent record which the licensee is required to keep shall amongst other include a record of the origin, properties and characteristics of the cultures.
5. Preparation- Diagnostic agents of bacterial origin are prepared from selected cultures after their careful examination for the identity, specificity, purity and antigenicity. They may be prepared in the following manner:
(a) Formolised Antigens- The selected pure culture strain grown in a suitable medium at an optimum temperature for an appropriate period. The pure growth is then exposed to the action of a solution of Formaldehyde I.P. in a suitable concentration and at an appropriate temperature for a suitable period.
(b) In some cases, the diagnostic agents are prepared by growing the organisms on suitable media and then deriving specific protein constituents of the bacteria by various methods.
6. General Standard:-
(a) Description- Diagnostic agents may be clear opalescent or coloured liquids.
(b) Identification- Some exhibit specific agglutination when mixed with the serum of the animals infected with homologous organisms and others when injected into the animal body in appropriate doses cause specific reactions like hypersensitiveness, local and general reaction, if the animal is infected with homologous organisms.
(c) Sterility Test- All antigens shall be tested for sterility in accordance with rules 114 to 119.
(d) Standardisation- It is carried out either by determining the definite concentration in the product or by observing the general and local reactions in healthy and artificially infected animals with various standard dilutions of the product.
7. Labelling- As under general provisions for the bacterial vaccines with the addition that it is meant for diagnostic purposes only.
8. Storage- All antigens are stored, protected from light at a temperature between 2 ˚ C to 4 ˚ C.
9. Date of manufacture- The date of manufacture shall be unless otherwise specified in the individual monograph in this part as defined in clause (b) of sub- rule (3) of rule 109.
Abortus Bang Ring (A.B.R.) Antigen
1. Synonym- Milk Ring Test Antigen.
2. Definition- The antigen is a suspension of pure growth culture of standard strain of Brucella abortus strain 99 strained supravitally with 2,3,5, triphenyl tetrazolium chloride suspended in 0.85 per cent saline containing 1 per cent glycerol and 1 per cent phenol.
3. Preparation- Smooth strain of Brucella abortus strain 99 is grown in potato infusion agar for 48 to 72 hours in Roux flasks, at 37 ˚ C. Condensation fluid if any is pipetted off before washing. Each flask is washed with about 20 ml. of normal saline. The pooled washing is filtered through a gauze and the filtrate is collected in a measuring cylinder. To every 500 ml. of the filtrate 1 g. of 2, 3, 5, triphenyl tetrazolium chloride is added immediately. The container is shaken for thirty minutes till the tetrazolium salt is dissolved. The product is taken out and kept at 37 ˚ C for two hours. After incubation the product is heated at 65˚ C in a water bath for thirty minutes. It is cooled and centrifuged at 3000 r.p.m for one hour. The supernatant is pipetted off and sediment is suspended in normal saline containing 1 per cent glycerol and 1 per cent phenol and filtered through sterile cotton wool. This forms concentrated antigens.
Standardization of the Strained Antigen
An aliquot portion of the microbial suspension stained with phenylte-trazolium is taken, representing the initial undiluted suspension. 1 ml. per tube of this initial undiluted stained suspension is added to six test tubes, followed by increasing quantities of the glycerolphenol diluent as follows:-
| Tube |
Undiluted Stained Suspension |
Diluent |
| 1 |
1 |
0.6 |
| 2 |
1 |
0.8 |
| 3 |
1 |
1.0 |
| 4 |
1 |
1.2 |
| 5 |
1 |
1.4 |
| 6 |
1 |
1.6 |
The contents of each tube are then diluted tenfold with the same diluent and serve as antigen for a tube agglutination test with the Standard Serum (or its national counterpart). In this way, six sero-reactions will be carried out. During this procedure, the concentrated strained microbial suspension should be kept in the refrigerator at 4 ˚ C.
The agglutination reactions are read after forty-eight hours at the agglutination titre of the Standard Serum, previously determined with the usual unstained antigen in the tube test, corresponding to the correct dilution of the standard antigen.
The next step, therefore, is to dilute the concentrated stained suspension to the same extent as the tube whose tenfold dilution has given the correct agglutination titre, i.e. the concentration of antigen in the tube before the tenfold dilution had been made.
4. Standard:
(a) Description- It is a red colour liquid containing dead bacteria in suspension.
(b) Identification- It shows formation of a specific cherry red coloured ring in the cream layer when mixed with pooled samples of milk taken from animals suffering from burcellosis.
(c) Sterility Test- Should comply with tests for sterility described in the general monograph on ‘Diagnostic Antigen‘. The test shall, however, be done before colouring.
5. Labelling and Storage- Should comply with the requirements of ‘Labelling‘ and ‘Storage‘ as laid down in the general monograph on ‘Diagnostic Antigens‘.
6. Expiry Date- The date of expiry of potency shall be not more than nine months from the date of manufacture when stored 2 ° C to 4° C.
Brucella Abortus Coloured Antigen
1. Synonym- Brucella abortus Cotton Strain 99 coloured Antigen.
2. Definition- Brucella Abortus colured Antigen, is a suspension of pure smooth cultures of Brucella abortus strain 99 in phenolised glycerine saline, the bacteria being coloured by the addition of crystal violet and brilliant green. This antigen is used for plate test for serological diagnosis of brucella infection.
3. Preparation- Seventy-two hours old growth of Brucella Abortus strain ninety-nine in smooth form on potato infusion agar medium in Roux flasks is washed with phenolised glycerine saline (containing 12 per cent sodium chloride, 20 per cent glycerine and 0.5 per cent phenol). The washed growth is filtered through a pad of absorbent cotton wool and the suspension is coloured by the addition of 1 ml. each of 1 per cent aqueous solution of crystal violet and brilliant green for very 250 ml. of the suspension. The product is heated for sixty minutes in a water bath at 60° C before it is standardised.
4. Standard:
(a) Description- It is a greenish violet liquid containing dead bacteria in suspension.
(b) Identification-It gives specific agglutination when mixed with the serum of the animal infected with brucella organism.
(c) Sterility Test- Should comply with the tests for sterility described in the general monograph on ‘Diagnostic Antigens‘
(d) Standardisation- 0.5 ml. of the antigen is mixed with 4.5 ml of normal saline solution in Hopkins graduated tube. The mixture is centrifuged at 3000 r.p.m. for sixty minutes and the percentage of bacterial cells present in the original antigen is assessed by noting the height of the cell deposit. The antigen is then standardised so as to contain 10 per cent cell deposit.
5. Labelling and Storage- Should comply with the requirements of ‘Labelling‘ and ‘Storage‘ as laid down in the general monograph on ‘Diagnostic Antigens‘.
6. Expiry Date- The date of expiry of potency shall be not more than nine months from the date of manufacture when stored at 2 ° C to 4°C.
Brucella Abortus Plain Antigen
1. Synonym- Brucella Abortus Strain 99 Plain Antigen.
2. Definition- Brucella Abortus Plain Antigen is a suspension of a pure smooth culture of Brucella abortus strain 99 in phenol-saline.
3. Preparation- Seventy-two hours old growth of Br. Abortus strain 99 in smooth form on potato infusion agar medium in Roux flasks is washed with normal saline solution. The washed growth is filtered through a pad of absorbent cotton wool and the suspension is kept at 60 ° C per cent. for sixty minutes on a water bath to kill the organisms. It is then preserved by the addition of phenol in a final concentration of 0.5 per cent.
4. Standard:
(a) Description- An opalescent liquid containing dead bacteria in suspension.
(b) Identification –It gives specific agglutination when mixed with the serum of animals infected with brucella organism.
(c) Sterility Test- Should comply with the tests for sterility described in the general monograph in ‘Diagnostic Antigen‘.
(d) Standardisation- Mix the concentrated antigen well and dilute 1 ml. with 0.5 per cent phenol saline until it corresponds to about Tube 4 of Brown‘s opacity tubes. Further dilutions of the antigen adjusted to opacity tube No. 4 are made. The particular dilution that gives 50 per cent agglutination with anti-brucella abortus serum ( containing 1000 International Units) at 1 : 500 final serum dilution, is assessed as the diluting factor for the concentrated antigen. The bulk of the concentrated antigens is accordingly diluted for issue as standard antigen.
5. Labelling and Storage- Should comply with the requirements of ‘Labelling and Storage‘ as laid down in the general monograph on ‘Diagnostic Antigen‘.
6. Expiry Date- The date of expiry of potency shall be not more than nine months from the date of manufacture when stored at 2° C to 4° C.
Johnin
1. Definition- Johnin is a preparation of a fluid medium in which Mycobacterium Paratuberculosis has been grown in artificial culture and which has been freed by filtration from the bacilli.
2. Preparation- Young culture of selected strain of Myco-Paratuberculosis of bovine origin is grown on synthetic medium and incubated at 37 ° C for ten to twelve weeks. Flasks showing lucurient and pure growth are steamed for three hours thereafter kept at room temperature overnight. The contents are filtered through fine meshed sieve. The filtrate is concentrated over a steam bath to one-tenth of its original volume and kept in cold storage for fourteen days before being filtered through Seitz filter. The product is dispensed in ampoules and hermetically sealed.
3. Standards:-
(a) Description- A yellowish brown to brownish liquid.
(b) Identification- It produces hot, painful and oeodemateus swelling at the site of inoculation in animals infected with Myco-paratuberculosis organism.
(c) Sterility Test- Should comply with the test for sterility described in the general monograph on ‘Diagnostic Antigens‘.
(d) Potency Test- Two animals, previously infected with Myco-paratuberculosis and two healthy animals are each injected intrademally in the neck region with 0.1 ml. of the product. Forty-eight hours later, the injection is repeated at the same site. The product should produce a typical reaction in the infected animals in the form of a hot painful and oedemetous swelling at the site of inoculation persisting for at least forty-eight hours after the second injection. Control animals should not show such reaction.
4. Labelling and Storage- Should comply with the requirements of ‘Labelling‘ and ‘Storage‘ as laid down in general monograph on ‘Diagnostic Antigens‘.
5. Expiry Date- The date of expiry of potency shall be not more than two years from the date of manufacture when stored at 2 ˚ C to 4 ˚ C.
Malleins
1. Definition- (i) Malleins are preparations of fluids media in which the Actinobacillus mellei has been grown in artificial culture and which have been freed by filtration from the bacilli.
(ii) For the purposes of this Schedule malleins are classified into (a) Mallein- subcutaneous and (b) Mallein intradermo-palpebral (I.D.P.)
2. Preparation:-
(a) Mallein Subcutaneous- Three to four weeks old pure growth of standard strain of A. mallei grown on synthetic medium is steamed for one hour in Koch‘s steam sterilizer. One part of 5 per cent phenol solution is added to every nine part of the dead culture which is then filtered through Seitz filter.
(b) Mallein Concentrated. – The procedure is the same as for Mallein Subcutaneous except, that the filtrate is evaporated in porcelain dish over steam to half the original volume before addition of phenol. Five per cent phenol solution is added in sufficient quantity to the concentrated product, to give a final concentrated of 0.5 per cent.
3. Standards:
(a) Description- A yellowish to brown viscous liquid.
(b) Identification- It produces hot tense, painful swelling when injected into the animals infected with A. mallei organisms.
(c) Sterility Test- Should comply with the tests for sterility described in the general monograph on ‘Diagnostic Antigens‘.
(d) Potency Test:-
(i) Mallein subcutaneous- Two ponies, previously sensitised with A. Mallei and controls, are injected each with 1 ml. of the product subcutaneously in the neck region. The animals are observed for local reaction and rise in temperature. Local reaction is manifested by a hot tense, painful swelling becoming prominent within twenty-four hours. The rise in temperature is observed by recording the body temperature at the time of inoculation and subsequently at short intervals. A rise in temperature of 1˚ C or more above normal is indicative of infection.
(ii) Mallein Intra-dermo-Palpebral (I.D.P.)- Two ponies, previously sensitized with A. mallei and two healthy ponies are injected intradermally with 0.2 ml. of the product near the rim of the lower eye lid of one eye. Typical reactions such as painful swelling of the palpebral tissue with mucopurulent discharge from the eye is indicative of infection. The two healthy ponies should not show such reactions.
Similar test in other eye is performed with a previously determined patient mallein using as a standard. When the local reactions produced by intradermo palpebral infections of the two preparations are comparable the batch is passed for issue.
4. Labelling and Storage- Should comply with the requirement of ‘Labelling‘ and ‘Storage‘ as laid down in the general monograph on ‘Diagnostic Antigen‘.
5. Expiry Date- The date of expiry of potency shall be not more than two years from the date of manufacture when stored at 2 ˚ C to 4 ˚ C. Salmonella Abortus Equi ‘H’ Antigen
1. Synonym- Equine Abortion Diagnostic Antigen.
2. Definition- Salmonella Abortus Equi Antigen is suspension of a pure smooth culture of actively motile Salmonella Abortus equi in formal saline.
3. Preparation- Standard strain of S.abortus equi is grown on nutrient agar in Roux flasks at 37 ˚ C for twenty-four hours. The pure growth in Roux flasks is washed with normal saline and diluted to contain approximately 800 million organisms per ml. Solution of Formaldehyde I.P. is added to give a final concentration 0.5 per cent and the formolised product is incubated at 37 ˚ C for twenty-four hours. The final product is dispensed in suitable containers.
4. Standards:-
(a) Description- A slightly opalescent liquid containing dead bacteria in suspension.
(b) Identification- It gives specific agglutination when mixed with the serum of the animals infected with S.abortus equi organisms.
(c) Sterility Test- Should comply with the test for sterility described in the general monograph on ‘Diagnostics Antigens‘.
5. Labelling and storage- Should comply with the requirements of ‘Labelling‘ and ‘Storage‘ as laid down in the general monograph on ‘Diagnostic Antigens‘.
6. Expiry Date- The date of expiry of potency shall be not more than nine months from the date of manufacture when stored at 2 ˚ C to 4 ˚ C.
Salmonella Pullorum Coloured Antigen
1. Synonym- Bacillary White Diarrhoes (B.W.D) Antigen.
2. Definition- The antigen is a suspension in a solution containing 1 per cent Formaline, 1 per cent KH2PO4 and 0.85 per cent Sodium Chloride of pure smooth culture of standard strain of Salmonella Pullorum.
3 Preparation- Standard strain of S. Pullorum is grown on sulphur agar medium in Roux flasks for five days at 37 ˚ C. The pure growth is washed with 1.0 per cent Formal Saline.
Standardisation
The antigenic cell suspension is then centrifuged (preferably in cold centrifuge) for half an hour at 4000 rotations per minute and the packed cell volume determined. The packed cell is then re-suspended in a solution containing 1 per cent formalin, 1 per cent KH2 PO4 and 0.85 per cent sodium chloride, 1 ml. of packed cell is suspended in 10 ml. of the resuspendiary solution, mixed thoroughly and is passed through a cotton wool pad. The turbidity of the antigenic suspension is usually between 100 to 125 times Mac Farland scale standard and optimum 3 cc. of a 1 per cent aqueous solution of crystal violet are added to 100 ml. of the antigenic suspension. After making the dye the antigen is allowed to stand forty-eight hours before use. The average yield per Roux flasks of culture medium is about 50 ml. The antigen should be bottled in 10 ml. or 20 ml. quantity in amber-coloured bottles and corked with rubber caps and paraffin sealed and preserved until required for use within the expiry period. This antigen reacts instantly with the blood of all carrier birds and remains permanently negative with that of non-infected birds.
This antigen gives good reactions with positive sera whose titre is even as low as 1 : 20.
4. Standard:-
(a) Description- Violet coloured liquid containing dead bacteria in suspension.
(b) Identification- It gives specific agglutination when mixed with the serum of birds in infected with S. Pullorum infection. It is used for carrying out plate agglutination tests for serological diagnosis for S. Pullorum infection in birds.
(c) Sterility Test- Should comply with the test for sterility described in the general monograph on ‘ Diagnostic Antigen‘. The tests shall be done before addition of ‘Crystal Violet‘.
5. Labelling and Storage- Should comply with the requirements of ‘Labelling‘ and ‘Storage‘ as laid down in the general monograph 0n ‘Diagnostic Antigens‘.
6. Expiry Date- A six month expiration date for this antigen is recommended. However, it is advisable to use fresh ones as far as possible. This antigen should be preserved at 4 ˚ C to 6 ˚ C in dark place in the refrigerator and should not be exposed to hot weather condition for longer than necessary before use in the field.
Salmonella Pullorum Plain Antigen
1. Synonym- Bacillary White Diarrhoes (B.W.D) Plain Antigen.
2. Definition- The antigen is a suspension of pure smooth culture of Salmonella pullorum in phenol saline.
3. Preparation- Forty-eight hours old pure culture of smooth strain of S. Pullorum is washed with 0.5 percent phenol saline and the pooled suspension is adjusted to contain approximately 800 million organisms per ml. by the addition of more carbol saline. The suspension is kept at room temperature of twenty-four hours, and dispensed in suitable containers.
4. Standard:-
(a) Description- An opalescent liquid containing dead bacteria in suspension.
(b) Identification- It gives specific agglutination when mixed with the serum of birds infected with S. Pullorum.
(c) Sterility Test- Should comply with the tests for sterility described in the general monograph on ‘Diagnostic Antigen‘.
5. Labelling and Storage- Should comply with the requirments of ‘Labelling‘ and ‘Storage‘ as laid down in the general monograph on ‘Diagnostic Antigens‘.
6. Expiry Date- The date of expiry of potency shall be not more than nine months from the date of manufacture when stored at 2 ˚ C to 4 ˚ C. Tuberculin
1. Definitions:
(i) Tuberculins are preparations of fluid media on which Mycobacterium tuberculosis has been grown in artificial culture and which has been freed by filtration from the bacilli.
(ii) For the purposes of the Schedule tuberculins are classified in (a) Tuberculin- Subcutaneous (b) Heat Concentrated Synthetic Medium (H.C.S.M) Tuberculin (c) Avian tuberculin.
2. Preparation:-
(a) Tuberculin subcutaneous- Flasks containing Henley and Dorset synthetic medium are inoculated with standard human strains of Myco-Tuberculosis previously grown on glycerol- beef broth medium for ten days. After ten to twelve weeks of incubation at 37 ˚ C, flasks containing pure growth are steamed for three hours. The contents are filtered through fine meshed sieve and the volume is made up to its original with phenolised distilled water such that the final concentration of phenol is 0.5 per cent. It is then filtered through Seitz filter.
(b) Heat Concentrated Sythetic Medium (H.C.S.M) Tuberculin- To the strained liquid obtained after sieving as in the method of preparation of Tuberculin subcutaneous, glycerol is added in the proportion of 122 ml. per litre of the original volume of medium used. The mixture is evaporated to one-fifth of the original volume on a steam bath. An equal volume of 1 per cent phenol in distilled water is added after the mixture is cooled. The product is stored at 47 ˚ C for fourteen days before it is filtered through Seitz filter. It is then dispensed in ampoules.
(c) Avian Tuberculin Concentrated- The procedure is the same as for Tuberculin Concentrated (H.C.S.M) except that standard strain of Myco-tuberculosis (Avian) is used in its preparation.
3. Standard:-
(a) Description- A yellowish brown viscous liquid.
(b) Identification- When injected intradermally into the animal infected with tuberculosis diffused swelling occurs depending upon the allergic status of the animal, the magnitude of dose and specificity of the product. In non-infected animals this reaction is not observed.
(c) Sterility Test- Should comply with the test for sterility described in the general monograph on ‘Diagnostic Antigens‘.
(d) Potency Test- (i) Tuberculin subcutaneous-Six large white guinea-pigs each weighing not less than 300-450 g. are individually inoculated intramuscularly with 0.5 mg. (Moist growth from solid plants) of Mycobacterium tuberculosis three weeks prior to test of each batch of tuberculin; the following dilutions of (a) test tuberculin and (b) standard tuberculin are used:-
1 in 200, 1 in 400, 1 in 800 and 1 in 1600.
The six sensitized guinea pigs are depilated on one flank and after about twenty- four hours each animal inoculated intradermally with 0.2 ml. of each dilution of the two tuberculins in two rows. The reactions are read after twenty-four and forty-eight hours. When the local reactions produced by the graded inter-dermal injections of the two preparations are comparable the brew is passed for issue.
(ii) Heat Concentrated Synthetic Medium (H.C.S.M) Tuberculin-Six adult white guinea-pigs each weighing not less than 300-450 g. and sensitized three weeks previously with 0.5 mg. (moist growth from solid plants) of Myco-Tuberculosis bovine type, injected intramuscularly are used for test of each batch. The following dilutions of (a) test tuberculin and (b) standard tuberculin are used:- 1 in 500, 1 in 1000, 1 in 2000 and 1 in 4000.
The six sensitized guinea pigs are depilated on one flank and after about twenty- four hours each animal is inoculated intradermally with 0.2 ml. of each dilution of the two tuberculins in two rows. The reactions are read after twenty-four and forty-eight hours. When the local reactions produced by the graded inter-dermal injections of the two preparations are comparable, the test tuberculin is passed for issue. The tuberculin is dispensed in ampoules.
(iii) Avian Tuberculin- Six adults fowls, with well developed wattles, sensitized at least three weeks previously by intramuscular injection with 10 mg. moist weight (from solid plants) of twenty-one days old culture of Mycobacterium tuberculosis (Avian Type) are used for potency test of each batch. In each fowl, one wattle is inoculated with 0.2 ml. of undiluted test tuberculin and the other wattle with similar quantity of undiluted standard tuberculin. The reactions in each fowl are read after twenty-four hours and forty-eight hours and if comparable the product is passed for issue.
4. Labelling and Storage- Should comply with the requirments of ‘Labelling‘ and’Storage‘ as laid down in the general monograph on ‘Diagnostic Antigens‘.
5. Expiry Date- The date of expiry of potency shall be not more two years months from the date of manufacture when stored at 2 ˚ C to 4 ˚ C.
PART IV GENERAL
1. For the purpose of this Schedule any test or method of testing described in the 1[British Pharmacopoeia (Veterinary)] shall be deemed to be a method approved by the Licensing Authority.
2. The Licensing Authority shall publish in the official Gazette from time to time particulars of any test or method of testing approved by him.]
__________
1. Subs. by G.S.R. 647(E) dated 28-10-1998.
__________
1[SCHEDULE F (II)
(See Rule 124-C)
STANDARDS FOR SURGICAL DRESSINGS
Synonyms:
Bandage Cloth, Bleached Bandage Cloth, Rolled Bandage, Open Wove Bandage, Cotton Bandage Cloth.
Bandage Cloth consists of cotton cloth of plain weave made from machine spun yarn of suitable count to comply with a bleached count between 20 tex and 25 tex for warp and between 25 tex and 30 tex for weft. The fabric contains no filling, sizing or dressing material. It may be supplied uncut and folded or cut to suitable size and rolled.
Description for uncut bandages:
Uncut bandages are cotton cloth of plain weave, in one continuous length showing no joints or seams, with well-formed selvedges. The cloth is bleached to a good white, is clean and odourless and reasonably free from weaving defects and from seed and leaf debris.
Description for cut bandage:
Same as for uncut bandages, except for selvedges which shall not be included in cut bandages. In addition, both the extremes and edges of cut bandages shall be straight and evenly cut, with reasonable freedom and loose threads.
Threads per dm: – Warp not less than 150 and weft not less than 85.
Weight in g/m2:- 57 ± 5.
Length and Width:- The length and width shall not be less than 99 per cent each of the length and width stated on the label. For cut bandages, each of the bandages in a packing complies with this requirement.
Foreign matter:- Not more than 2 per cent.
Fluorescence:
When viewed under screened ultra-violet light, not more than occasional points of fluorescence are observed.
Packing, Labelling and Storage:
Bandage Cloth shall be packed securely so as to allow normal handling and transport without tearing and exposing the contents. In packages of cut and rolled bandages, each bandage shall also individually be wrapped in a suitable paper. The net content is stated on the label in terms of length and width. Bandage Cloth must be stored in packed condition protected from dust. The packings of Bandage Cloth shall be labelled prominently with the words “Non-Sterile”.
Absorbent Gauze.
Synonyms.- Gauze; Unmedicated Gauze; absorbent Cotton Gauze.
Absorbent Gauze is cotton fabric of plain weave, supplied in various widths and lengths. The Gauze is bleached and free from any sizing, dressing or filling material. The yarn used is machine spun cotton yarn, of suitable count to comply with a bleached count between 17 and 25 tex in the finished fabric.
____________
1. Ins. by G.S.R. No.318(E), dt.. 1-5-1985.
____________
Description:
Cotton cloth, plain weave, with a simple selvedge present on both sides to prevent unravelling of yarn. The cloth is bleached to a good white, is clean, odourless, reasonably free from fabric defects and adhering sand debris from cotton seeds and leaves, or any other foreign matter.
Threads per dm:.- Warp not less than 75 and weft not less than 55.
Weight in g/m2:- 30 ± 5.
Length and widt:- Not less than 98 per cent each of the length and width stated on the label.
Absorbency:- Average sinking time not more than 10 seconds.
Fluorescence:- When viewed under screened ultra-violet light not more than
occasional points of fluorescence are observed.
Foreign matter:- Not more than 1 per cent.
Sterility:- If sterile, the contents comply with the test for sterility.
Packing, Labelling and Storage:
Absorbent Gauze is folded and packed with such materials and so securely as to protect its absorbency and allow normal handling and transport without tearing and exposing the contents. The net content is stated on the label in terms of length and width. The packages shall be labelled prominently with the words “Non-Sterile”. If sterile, it shall be so stated on the label, and the packing method and material shall be such as to maintain the sterility. The Absorbent Gauze must also comply with the Sterility Test. Absorbent Gauze must be stored in packed conditions protected from moisture and dust.
METHODS OF TEST
Defect in fabric:.
The sample is unfolded, opened and held against diffused daylight or spread on black topped table to locate and identify prominently visible defects in yarn and fabric construction. The fabric shall be reasonably free from holes, slubs, snarls and naps as well as the following:-
Odour.- Misty odour, or any objectionable smell like that of chemicals or materials used in sizing and bleaching.
Skewness.- (For Bandage Cloth only) A condition where warp and weft do not keep at right angles to each other.
Defective Selvedge. – The selvedge tearing and allowing yarn to unravel and loop formation at selvedge.
Cracks.- Prominent steaks of space or gaps between warp or weft yarns.
Double ends.- More warp threads woven as one, due to wrong draw.
Sloughing.- Entanglement in the fabric of a bulk of yarn that has slipped off the weft yarn due to loose widing.
Measurement of length and width.
Length is the distance from end to end, along one edge of the fabric, and width is the perpendicular distance from one edge to the opposite edge.
Length. – Fix a meter scale to a table or mark off the division of one metre on a table edge. Starting from one end, spread the fabric flat on that table in a single layer keeping one selvedge parallel to the scale; smoothen the fabric without stretching it, to avoid creases, and mark off with a coloured pencil, on the selvedge exactly one metre. Shift the fabric and measure the same way the second metre and so on for the entire length of the fabric making a mark at each metre. Note down the total length in metres. Repeat this at the opposite selvedge, as well as on the fabric folded approximately about the middle. The average of the three readings is the length. For cut bandages, one measurement at the middle of the bandages by folding it length-wise will suffice.
Width. – Lay the portion of the fabric to be measured flat and smooth on the tables, but do not stretch fabric except sufficiently to render it creaseless. At the place where mark had been made on the selvedge in measuring the length measure the perpendicular distance to the opposite selvedge with a metre scale. Note the width, repeat this at every mark made in measuring the length. The average of all the readings is the width of the fabric. For cut bandages, width shall be measured at every 50 cms., and average reported as width.
Threads per dm.- (For examples not less than 15 m. in length).
Weft. – At the third metre from one extreme locate three places one at about 5 cm. below the top selvedge, a second in the middle and third at about 5 cm. below the top selvedge, a second in the middle and third about 5 cm. above the bottom selvedge, all three in a vertical row. Take a rectangular plate (made of suitable material such as plastic or aluminium) with the rectangular opening of 5 cm. x 10 cm. cut in it. Keep the plate on the fabric horizontally so that the left 5 cm. side and bottom (10 cm. side) edges of the opening coincides with a weft and warp yarns respectively; count the number of weft yarns within the opening for the length of 10 cm.. Repeat this at the other two selected places, and note down the average of three readings. Repeat this at every third metre in the sample and calculate the average weft per dm.
Warp.- Keep the rectangular plate, this time vertically with left (10 cm. side) and bottom (5 cm. side) edge of opening coinciding with a weft and warp yarn respectively. Count the number of warp yarns within the opening for 10 cm. and note down. Repeat this for about 10 selected places in the samples taking care that the same set of warp yarns is not counted more than twice and calculate the average warp per dm. Magnifying glass mounted on stand may be used for counting.
For samples less than 15 m. in length, locate as many different places as the dimension of the fabric permits, the total being not less than 10 for each sample and calculate the warp and weft per dm. as above.
For cut bandages, all the warp threads in the samples are counted, taking care to leave 5 mm at the cut edge, and weft is counted at every 50 cm. at any place about the middle of the bandage.
Weight per unit area.
For samples not less than 15 m. in length, cut out pieces of fabric from the entire length of sample, representative places being taken from areas at every third or fourth metre so that the total area of all the pieces so collected is not less than 3 sq. metre. Weigh the pieces accurately, measure the dimension of each of the pieces and calculate the area and weight of all the pieces. From the average area and average of weight thus obtained, calculate the area per sq. metre.
For samples less than 15 m. length, take pieces in such a manner that the total area of the selected pieces is not less than 20 per cent of the total area of the sample.
For cut bandages, pieces of 50 cm. in length, cut from 5 different cut bandages in a packing should be taken and weight calculated as an average of 5 readings.
Absorbency. – Take a glass trough of approximate size length 30 cm. x width 30 cm. x depth 25 cm. with straight thick walls and flat bottom. Fill it almost full with distilled water leaving only about 5 cm. from the top rim of trough. Maintain the water at 27o C ± 1o C.
Cut out from any five places located equidistant down the length of the entire sample, square pieces, each weighting one gm. (±10 per cent). Fold each piece in such a manner that a square of approximately 5 cm. x 5 cm. is obtained. Keep one of the folded test specimen between two glass plates and place 1 kg weight on the top for 10 minutes. Remove the weight. Lift the specimen with forceps and gently place it on to the surface of water (the specimen should be lightly pinched in the middle with a blunt forceps having no serrations). As soon as the specimen touches the water surface start a stopwatch which is stopped when the entire sample disappears below the surface of the water. Record the time taken. Repeat the test with the other four-test specimens. Calculate the average time in seconds.
Foreign Matter
Dry about 5 g. of the sample to constant weight at 105o C and weigh the dried sample accurately. Extract the dried sample with chloroform for one hour in an apparatus for the continuous extraction of drugs. Remove the extracted sample to a beaker and allow the evaporation of residual chloroform. Wash the material 12 times with hot water, using about 1000 ml. for each washing and wringing the material by hand after each washing; pass all water through a fine sieve (100 mesh). Place the washed material and any loose threads or fibres from sieve in a beaker, cover with a 0.5 per cent aqueous solution of diastase and maintain at 50oC until free from starch. Allow to cool, filter the solution through a sieve; return sample and loose fibre to a beaker. Repeat the washing process as before with hot water. Dry the material to constant weight at 105oC, and determine the loss in weight. Calculate the percentage of foreign matter, which is equal to the loss in weight, with reference to the sample dried to constant weight, at 105o C.
If the sample is tested with iodine and is known to be free from starch, the treatment with solution of diastase and the second series of washing with hot water may be omitted.
Cloth for manufacture of Plaster of Paris Bandages, cut and uncut.
Synonyms.- Bleached Bandage Cloth for Plaster of Paris, Rolled Bandage for Plaster of Paris.
Cloth for Plaster of Paris Bandages shall consist of cotton cloth of leno weave made from yarn of suitable count. It may be supplied cut or uncut of various widths and lengths.
Description
(a) For uncut bandages.- Cotton cloth of leno weave, in one continuous length showing no joints or seams, and with selvedges. The cloth is bleached to a good white, is clean and odourless and reasonably free from weaving defects as well as from seed and leaf debris; the cloth may be dressed if necessary and if so, shall not dust off when unrolled.
(b) For cut bandages. – Same as for uncut bandages except for selvedges which shall not be included and the bandages shall be cut evenly with straight edges and be reasonably free from loose threads.
Threads per dm:
Warp. – Average not less than 150/dm; and Weft.- average not less than 75/dm.
Weight in gm/m2:- 35 ± 5
Length and width:
The length and width for uncut bandages shall not be less than 98 per cent each of the length and width stated. For cut bandages a tolerance of ±5 cm. in length and ±0.5 cm. in width may be allowed, and each of the bandages in packing complies with these requirements.
Fluorescene
When viewed under screened ultra-violet light not more than occasional points of fluorescence are observed.
Packing, Labelling and Storage
Bandage Cloth for Plaster of Paris shall be packed securely so as to allow normal handling and transport without tearing and exposing the contents. In packages of cut and rolled bandages, each bandage shall also individually be warpped in suitable paper. The package shall be labelled as “Cloth for Plaster of Paris Bandage”. The net content is stated on the label in terms of number of rolls and length and width. Bandage Cloth for Plaster of Paris must be stored in packed condition protected from dust.
1[SCHEDULE F (III)
(See rule 124-D)
STANDARDS FOR UMBILICAL TAPES
(A) Standards for Sterilised Umbilical Polyster Tape.
Description. – A uniform strand of Polyester yarn prepared by braiding and may be finished with a suitable silicone finishing material, white to yellowish-white in colour. Tape shall be sterilized by Gamma Radiation or other suitable method approved by the Licensing Authority.
Other requirements. – The Umbilical Polyester Tape shall conform to the claims made on the label in respect of length and width.
Tensile strength. – The Umbilical Polyester Tape shall have Tensile strength of not less than 4 kg. on straight pull.
Packing and labelling. – The Umbilical Polyester Tape shall be packed in sealed Polythene bags or sealed plastic containers which ensure that when packed, the tape is sterile. The packing shall protect the tape from contamination and damage. Every packing offered for sale shall bear a clear and permanent marking with the following particulars:-
(i) The proper name of the drug i.e. Umbilical Polyester Tape ‘Sterile‘
(ii) Manufacturer‘s name and address.
(iii) Batch number.
(iv) Licence number under which the tape is manufactured.
(v) Date of manufacture and date of expiry.
(vi) Length and width of the Tape.
Storage condition. – It should be stored in a cool place protected from light.
(B) Standards for Sterilised Umbilical Cotton Tape–
Description. – A uniform strand of cotton yarn prepared by braiding and may be finished with a suitable silicone finishing material, white to yellowish-white in colour. The tape shall be sterilized by Gamma Radiation or by any other suitable method approved by the Licesing Authority.
Other Requirement. – The Umbilical Cotton Tape shall conform to the claims made on the label in respect of length and width.
Tensile strength. – The Umbilical Cotton Tape shall have a Tensile strength of not less than 4 kg. on straight pull.
Packing and labelling. – The Umbilical Cotton Tape shall be packed in sealed Polythene bags or sealed plastic containers which ensure that when packed the tape is sterile. The packing shall protect the tape from contamination and damage. Every packing offered for sale shall bear a clear and permanent marking with the following particulars:-
(i) The proper name of drug i.e. Umbilical Cotton Tape “Sterile”.
(ii) Manufacturer‘s name and address.
____________
1. Ins. by G.S.R. No.1115(E), dt.. 30-9-1986.
____________
(iii) Batch number.
(iv) Licence number under which the tape is manufactured.
(v) Date of manufacture and the date of expiry.
(vi) Length and width of the Tape.
Storage condition.- It should be stored in a cool place protected from light.]
1[SCHEDULE FF
( See rule 126-A)
Standards for ophthalmic preparations.
Part-A. Ophthalmic Solutions and suspensions.
Ophthalmic Solutions and Suspensions shall-
(a) be sterile when dispensed or when sold in the unopened container of the manufacturer, except in case of those ophthalmic solutions and suspensions which are not specifically required to comply with the test for ‘Sterility‘ in the Pharmacopoeia;
(b) contain one or more of the following suitable substances to prevent the growth of micro-organisms:-
(i) Benzalkonium Chloride, 0.01 per cent (This should not be used in solutions of nitrates or salicylates).
(ii) Phenyl mercuric nitrate, 0.001 per cent.
(iii) Chlorbutanol 0.5 per cent.
(iv) Phenyl ethyl alcohol 0.5 per cent.
Provided that solutions used in surgery shall not have any preservative and be packed in single dose container.
Provided further that the Licensing Authority may in his discretion authorise the use of any other preservative or vary the concentration prescribed on being satisfied that its use affords equal guarantee for preventing the growth of micro-organisms:-
(c) be free from foreign matter;
(d) be contained in bottles made of either neutral glass or soda glass specially treated to reduce the amount of alkali released when in contact of aqueous liquids, or in suitable plastic containers which would not in any way be incompatible with the solutions;
The droppers to be supplied with the containers of ophthalmic solutions and suspensions shall be made of neutral glass or of suitable plastic material and when supplied separately shall be packed in sterile cellophane, or other suitable packings;
(e ) In addition to complying with the provisions of labelling laid down in the rules the following particulars shall also be shown on the label:-
____________
1. Added by Notification No. F-1-13/69-D , dt.. 3-1-1970.
____________
(1) of the containers
(i) The statement ‘Use the solution within one month after opening the container‘.
(ii) Name and concentration of the preservative, if used.
(iii) The words ‘NOT FOR INJECTION‘.
(2) of container or carton or package leaflet
(i) Special instructions regarding storage, wherever applicable.
(ii) A cautionary legend reading as
“WARNING (i) if irritation persists or increases, discontinue the use and consult the phycian.
(ii) Do not touch the dropper tip or other dispensing tip to any surface since this may contaminate solutions”.
Part B: Ophthalmic Ointments
Ophthalmic Ointments shall-
(a) be sterile when dispensed or when sold in the unopened container of the manufacturer;
(b) be free from foreign matter;
(c) in addition to complying with the provisions for labelling laid down in the rules the following particulars shall be shown on the container or carton or package leaflet-
(i) Special instructions regarding storage wherever applicable;
(ii) A cautionary legend reading
“Warning :- If irritation persists or increases discontinue the use and consult Physicians”].
1[SCHEDULE G]
(See Rule 97)
Aminopterin
L-Asparaginase
Bleomycin
Busulphan; its salts
Carbutamide
Chlorambucil;its salts
Chlorothiazide and other derivatives of 1, 2, 4 benzothiadiazine
Chlorpropamide; its salts
Chlorthalidone and other derivatives of Chlorobenzene compound.
2[(Cis-Platin)]
Cyclophosphamide; its salts
2[(Cytarabine)]
Daunorubicin
Di-Isopropyl Eluorophosphate
Disodium Stilboestrol Diphosphate
Doxorubicin Hydrochloride
Ethacrynic Acid, its salts
Ethosuximide
Glibenclamide
Hydantoin; its salts; its derivatives, their salts
Hydroxyurea
Insulin, all types
2[(Lomustine Hydrochloride)]
Mannomustine; its salts
Mercaptopurine; its salts
Metformin; its salts
Methsuximide
Mustine, its salts
Paramethadione
Phenacemide
Phenformin; its salts
5-Phenylhydantoin; its alkyl and aryl derivatives; its salts
Primadone
1[(Procarpazine Hydrochloride])
_________
1. Subs.. by G.S.R. No.462(E) , dt. 22-6-1982 (w.e.f. 22.6.1982).
2. Ins. by G.S.R. No.626(E) , dt. 2-7-1987 w.e.f. 2-7-1987.
_________
Quinthazone
Sarcolysine
1[(Sodium-2-Mercaptoethanesulfonate]
Tamoxiten Citrate
Testolactone
Thiotepa Tolbutamide
Tretamine; its salts
Troxidone
Antihistaminic substances the following, their salts, their derivatives,
salts of their derivatives
Antazoline
Bromodiphenhydramine
Buclizine
Chlorcyclizine
Chlorpheniramine Clemizole
Cyproheptadine
Diphenhydramine
Diphenylpyraline Doxylamine
Succinate Isothipendyl
Mebhydrolin Napadisylate
Meclozine
Phenindamine
Pheniramine
Promethazine
Thenalidine
Triprolidine
Substances being tetra-N-Subs. derivatives of Ethylene Diamine or Prophylenediamine.
Note.– Preparations containing the above substances excluding those intended for topical or external use are also covered by this Schedule.]
___________
1. Subs.. by G.S.R. No.462(E) , dt. 22-6-1982 (w.e.f. 22.6.1982).
___________
1[SCHEDULE- H
(See Rules 65 and 97)
PRESCRIPTION DRUGS
1. Abacavir
2. Abciximab
3. Acamprosate calcium
4. Acebutol hydrochloride
5. Aclarubicin
6. Albendazole
7. Alclometasone dipropionate
8. Actilyse
9. Acyclovir
10. Adenosine
11. Adrenocorticotrophic hormone (acth)
12. Alendronate sodium
13. Alopurinol
14. Alphachymotrypsin
15. 2[Alprazolam
16. Alprostadil
17. Amantadine hydrochloride
18. Amifostine
19. Amikacin sulphate
20. Amiloride hydrochloride
21. Amineptine
22. Aminoglutethimide
23. Amino salicylic acid
24. Amiodarone hydrochloride
25. Amitriptyline
26. Amlodipine besylate
27. Amoscanate
28. Amoxopine
29. Amrinonelactate
30. Analgin
31. Androgenic anabolic, oestrogenic & progestational substances
32. Antibiotics
33. Apraclonidine
34. Aprotinin
35. Organic compound of arsenic
36. Arteether
37. Artemether
38. Artesunate
39. Articaine hydrochloride
40. Atenolol
41. Atracurium besylate injection
42. Atorvastatin
43. Auranofin
44. Azathioprine
45. Aztreonam
46. Bacampicillin
47. Baclofen
48. Balsalazide
49. Bambuterol
50. Barbituric acid
51. Basiliximab
52. Benazepril hydrochloride
53. Benidipine hydrochloride
54. Benserazide hydrochloride
55. Betahistine dihydrochloride
56. Bethanidine sulphate
57. Bezafibrate
58. Bicalutamide
59. Biclotymol monohydrate /lactate
60. Bifonazole
61. Bimatoprost
62. Biperiden hydrochloride
63. Biphenyl acetic acid
64. Bitoscanate
65. Bleomycin
66. Primonidine tartrate
67. Bromhexine hydrocloride
68. Bromocriptine mesylate
69. Budesonide
70. Bulaquine
71. Bupivacaine hydrochloride
72. Bupropion
73. Buspirone
74. Butenafine hydrochloride
75. Butorphanol tartrate
76. Cabergoline
77. Calcium dobesilate
78. Candesartan
79. Capecitabine
80. Captopril
81. Carbidopa
82. Carbocisteine
83. Carboplatin
84. Carboquone
85. Carisoprodol
86. L-carnitine
87. Carteolol hydrochloride
88. Carvedilol
89. Cefadroxyl
90. Cefatoxime sodium
91. Cefazolin sodium
92. 2[Cefdinir
93. Cefepime hydrochloride
94. Cefetamet pivoxil
95. Cefpirome
96. Cefpodoximepoxetil
97. Ceftazidime pentahydrate
98. Ceftizoxime sodium]
99. Cefuroxime
100. Celecoxib
101. Centchroman
102. Centbutindole
103. Centpropazine
104. Cetirizine hydrochloride
105. 2[Chlordiazepoxide
106. Chlormezanone
107. 3[ ** *]
108. Chlorpromazine
109. Chlorzoxazone
110. Ciclopiroxolamine
111. Cimetidine
112. Cinnarizine
113. Ciprofloxacin hydrochloride
114. Cisplatin
115. Citalopram hydrobromide
116. Clarithromycin
117. Clavulanic acid
118. Clidiniumbromide
119. Clindamycin
120. Clobazam
121. Clobetasol propenate
122. Clobetasone 17-butyrate
123. 2[Clofazimine]
124. Clofibrate
125. Clonazepam
126. Clonidine hydrochloride
127. Clopamide
128. Clopidogrel bisulphate
129. Clostebolacetate
130. Clotrimazole
131. Clozapine
132. 2[Codeine]
133. Colchicine
134. Corticosteroids
135. Cotrimoxazole
136. Cyclandelate
137. Cyclosporins
138. Daclizumab
139. Danazole
140. Dapsone
141. Desloratadine
142. Desogestrol
143. Dexrazoxane
144. Dextranomer
145. 2[** *]
146. Dextropropoxyphene
147. 2[Diazepam]
148. Diazoxide
149. Diclofenac sodium/potassium/acid
150. Dicyclomin hydrochloride
151. Didanosine
152. Digoxine
153. Dilazep hydrochloride
154. Diltiazem
155. Dinoprostone
156. 2[Diphenoxylate, its salts]
157. Dipivefrin hydrochloride
158. Di-sodiumpamidronate
159. Disopyramide
160. Docetaxel
161. Domperidone
162. Donepezil hydrochloride
163. Dopamine hydrochloride
164. Dothiepin hydrochloride
165. Doxapram hydrochloride
166. Doxazosin mesylate
167. Doxepin hydrochloride
168. Doxorubicin hydrochloride
169. Drotrecogin-alpha
170. Ebastine
171. Econozole
172. Efavirenz
173. Enalapril meleate
174. Enfenamic acid
175. Epinephrine
176. Epirubicine
177. Eptifibatide
178. Ergot, alkaloids of whether hyd rogenated or not, their homologoues, salts
179. Esomeprazole
180. Estradiol succinate
181. Estramustine p hosphate
182. Etanercept
183. Ethacridine lactate
184. 2[Ethambutol hydrochloride]
185. Ethamsylate
186. Ethinyloestradiol
187. 2[Ethionamide]
188. Etidronate disodium
189. Etodolac
190. Etomidate
191. Etoposide
192. Exemestane
193. Famciclovir
194. Famotidine
195. Fenbendazole
196. Fenofibrate
197. Fexofenadine
198. Finasteride
199. Flavoxate hydrochloride
200. 5-fluorouracil
201. Fludarabine
202. Flufenamic acids
203. Flunarizine hdrochloride
204. Fluoxetine ydrochloride
205. Flupenthixol
206. Fluphenazine enanthate and decanoate
207. Flurazepam
208. Flurbiprofen
209. Flutamide
210. Fluticasone propionate
211. Fluvoxamine maleate
212. Formestane
213. Fosfestril sodium
214. Fosinopril sodium
215. Fossphenytoin sodium
216. Fotemustine
217. Gabapentin
218. Galanthamine hydrobromide
219. Galamine, its salts, its quaternary compound
220. Gancyclovir
221. Ganirelix
222. Gatifloxacin
223. Gemcitabine
224. Gemfibrozil
225. Gemtuzumab
226. Genodeoxycholic acid
227. Gliclazide
228. Glimepiride
229. Glucagon
230. Glycopyr rolate
231. Glydiazinamide
232. Goserelin acetate
233. Granisetron
234. Guanethidine
235. Gugulipid
236. Halogenated hydroxyquinolines
237. Haloperidol
238. Heparin
239. Hepatitis b. Vaccine
240. Hyaluronidase
241. Hyd rocorisone 17-butyrate
242. Hydrotalcite
243. Hydroxizine
244. Ibuprofen
245. Idebenone
246. Indapamide
247. Imipramine
248. Indinavir sulphate
249. Indomethacin
250. Insulin human
251. Interferon
252. Intravenous fat emulsion
253. Iobitridol
254. Iohexol
255. Iopamidol
256. Iomeprol
257. Iopromide
258. Irbesartan
259. Irinotecan hydrochloride
260. Iron p reparation for parenteral use
261. Isepamicine
262. Isocarboxside
263. Isoflurane
264. Isonicot nic acid hydr azine and other-hydragine derivatives of isonicotinic acid
265. Isosorbide dinitrate/ mononitrate
266. Isotretinoin
267. Isoxsuprine
268. Itopride
269. 4[***]
270. Ketoconazole
271. Ketoprofen
272. Ketorolactromethamine
273. Labetalol hydrochloride
274. Lacidipine
275. Lamivudine
276. Lamotrigine
277. Latanoprost
278. Lefunomide
279. Lercanidipine hydrochloride
280. Letrozole
281. Leuprolide acetate
282. Levamesole
283. Levarterenol
284. Levobunolol
285. Levocetirizine
286. Levodopa
287. 2[Levofloxacin]
288. Levovist
289. Lidoflazine
290. Linezplid
291. Lithium carbonate
292. Lofepramine decanoate
293. Loperamide
294. Lorazepam
295. Losartan potassium
296. Lotepred nol
297. Lovastatin
298. Loxapine
299. Mebendazole
300. Mebeverine hydrochloride
301. Med roxyprogesterone acetate
302. Mefenamic acid
303. Mefloquine hydrochloride
304. Megestrol a cetate
305. Meglumine iocarmate
306. Melagenina
307. Elitracenhydrochloride
308. Meloxicam
309. Mep henesin, its esters
310. Mephentermine
311. 2[Meropenam]
312. Me sterolone
313. Metaxalone
314. Methicillin sodium
315. Methocarbamol
316. Methotraxate
317. Metoclopramide
318. Metoprolol tartrate
319. Metrizamide
320. Metronidazole
321. Mexiletine hydrochloride
322. Mianserin hydrochloride
323. Miconazole
324. 2[Midazolam]
325. Mifepristone
326. Milrinone lactate
327. Miltefosine
328. Minocycline
329. Minoxidil
330. Mirtazapine
331. Misoprostol
332. Mitoxantrone hydrochloride
333. Mizolastine
334. Moclobemide
335. Mometa sone furoate
336. Montelukast sodium
337. Morphazinamide hydrochloride
338. Mosapride
339. 2[Moxifloxacin]
340. Mycophenolate mofetil
341. Nadifloxacin
342. Nadolol
343. Nafarelin a cetate
344. Nalidixic acid
345. Naproxen
346. Narcotics drugs listed in Narcotic Drugs & Psychotropic Substances Act, 1985
347. Natamycin
348. Nateglinide
349. N-butyl-2-cyanoacrylate
350. Nebivolol
351. Nebumetone
352. Nelfinavir mesilate
353. Netilmicin sulphate
354. Nevirapine
355. Nicergoline
356. Nicorandil
357. Nifedipine
358. Nimesulide
359. Nimustine hydrochloride
360. 2[Nitrazepam]
361. Nitroglycerin
362. Norethisterone enanthate
363. Norfloxacin
364. Octylonium bromide
365. Ofloxacin
366. Olanzapine
367. Omeprazole
368. Ornidazole
369. Orphenadrine
370. Orthoclone sterile
371. Oxazepam
372. Oxazolidine
373. Oxcarbazepine
374. Oxethazaine hydrochloride
375. Oxiconazole
376. Oxolinic acid
377. Oxprenolol hydrochloride
378. Oxybutynin chloride
379. Oxyfedrine
380. Oxymetazoline
381. Oxyphenbutazone
382. Oxytocin
383. Ozothine
384. Paclitaxel
385. Pancuronium bromide
386. Pantoprazole
387. Para-amino benzene sulphonamide, its salts & derivatives
388. Parp-amino salicylic acid, its salts, its derivatives
389. Parecoxib
390. Paroxetine hydrochloride
391. D-penicilamine
392. 2[Pentazocine]
393. Pentoxifylline
394. Pepleomycin
395. Phenelzineh sulphate
396. Phenobarbital
397. Phenothiazine, derivatives of and salts of its derivatives
398. Phenylbutazine
399. Pimozide
400. Pindolol
401. Pioglitazone hydrochloride
402. Piracetam
403. Piroxicam
404. Pituitory gland, active principles of, not otherwise specified in this schedule and their salts
405. Polidocanol
406. Polyestradiol phosphate
407. Poractant alfa
408. Praziquantel
409. Prednimustine iothalamates
410. Prednisolone stearoylglycolate
411. Prenoxdiazinhydro-chloride
412. Promazine hydrochloride
413. Promegestone
414. Propafenon hydrochloride
415. Propanolol hydrochloride
416. Propofol
417. Protristyline hydrochloride
418. 2[Pyrazinamide]
419. Pyrvinium
420. Quetiapine fumerate
421. Quinapril
422. Quinidine sulphate
423. Rabeprazole
424. Racecadotril
425. Raloxifene hydrochloride
426. Ramipril hydrochloride
427. Ranitidine
428. Rauwolfia, alkaloids of, their salts, derivatives of the alkaloids or rauwolfia
429. Reboxetine
430. Repaglinide
431. Reproterol hydrochloride
432. Rilmenidine
433. Riluzone
434. Risperidone
435. Ritonavir
436. Ritodrine hydrochloride
437. Rituximab
438. Rivastigmine
439. Rocuronium bromide
440. Ropinirole
441. Rosoxacin.
442. Rosiglitazone meleate
443. Salbutamol sulphate
444. Salicyl-azo-sulphapyridine
445. Salmon calcitonin
446. Saquinavir
447. Satranidazole
448. Secnidazole
449. Septopal bead s & chains
450. S erratiopeptidase
451. Sertraline hydrochloride
452. Sibutramine hydrochloride
453. Sildenafil citrate
454. Simvastatin
455. Sirolimus
456. Sisomicin sulphate
457. S-neominophagen
458. Sodiumpico sulphate
459. Sodium cromoglycate
460. Sodium hyaluronate
461. Sodium valproate
462. Sodium and maglumine iothalamates
463. Somatostatin
464. Somatotropin
465. Sotalol
466. 2[Sparfloxacin]
467. Spectinomycin hydrochloride
468. Spironolactone
469. Stavudine
470. Sucralfate
471. Sulphadoxine
472. Sulphamethoxine
473. Sulphamethoxypyridazine
474. Sulphaphenazole
475. Sulpiride
476. Sulprostone hydrochloride
477. Sumatriptan
478. Tacrine hydrochloride
479. Tamsulosin hydrochloride
480. Trapidil
481. Tegaserod maleate
482. Teicoplanin
483. Telmisartan
484. Temozolamide
485. Terazosin
486. Terbutaline sulphate
487. Terfenadine
488. Terizidone
489. Terlipressin
490. Testosteroneun decoanoate
491. Teratolol hydrochloride
492. Thalidomide
493. 2[Thiacetazone]
494. Thiocolchicoside
495. Thiopropazate, its salts
496. Thymogene
497. Thymosin-alpha1
498. Tiaprofenic acid
499. Tibolone
500. Timolol maleate
501. Tinidazole
502. Tizanidine
503. Tabramycin
504. Tolfenamic acid
505. Topiramate
506. Topotecan hydrochloride
507. 2[Tramadolhydrochloride]
508. Tranexamic acid
509. Tranylcypromine, its salts
510. Trazodone
511. Tretinoin
512. Trifluperazine
513. Trifluperidol hydrochloride
514. Triflusal
515. Trimetazidine dihydrochloride
516. Trimipramine
517. Tripotassium dicitrate bismuthate
518. Tromantadine hydrochloride
519. Urokinase
520. Valsartan
521. Vasopressin
522. Vecuronium bromide
523. Venlafaxine hydrochloride
524. Verapamil hydrochloride
525. Verteporfin
526. Vincristine sulphate
527. Vinblastine sulphate
528. Vindesine sulphate
529. Vinorelbine tatrate
530. Xipamide
531. Zidovudine hydrochloride
532. Zip rasidone hydrochloride
533. Zoledronic acid
534. 2[Zolpidem]
535. Zopiclone
536. Zuclopenthixol
____________
1. Subs. by G.S.R. No.160(E), dated 16.3.2006 .
2. Omitted by G.S.R 588(E) dated 30-8-2013
3. Omitted by G.S.R 602(E) dated 19-7-2010
4. Omitted by G.S.R 724(E) dated 7-11-2013
____________
Note:- 1. Preparations exempted under proviso to para 2 of Note to Schedule X shall also be covered by this Schedule.
2. The salts, esters, derivatives and preparations containing the above substances excluding those intended for topical or external use (except ophthalmic and ear / nose preparations con – taining antibiotics and/ or steroids) are also covered by this Schedule.
3. The inclusion of a substance in this Schedule does not imply or convey that the substance is exempted from the provisions of Rule 122A/122B.”
1[SCHEDULE H1
(See Rules 65 and 97)
| Alprazolam |
Doripenam |
| Balofloxacin |
Ertapenem |
| Buprenorphine |
Ethambutol Hydrochloride |
| Capreomycin |
Ethionamide |
| Cefdinir |
Feropenam |
| Cefditoren |
Gemifloxacin |
| Cefepime |
Imipenem |
| Cefetamet |
Isoniazide |
| Cefixime |
Levofloxacin |
| Cefoperazone |
Meropenem |
| Cefotaxime |
Midazolam |
| Cefpirome |
Moxifloxacin |
| Cefpodoxime |
Nitrazepam |
| Ceftazidime |
Pentazocine |
| Ceftibuten |
Prulifloxacin |
| Ceftizoxime |
Pyrazinamide |
| Ceftriaxone |
Rifabutin |
| Chlorodiazepoxide |
Rifampicin |
| Clofazimine |
Sodium Para-aminosalicylate |
| Codeine |
Sparfloxacin |
| Cycloserine |
Thiacetazone |
| Diazepam |
Tramadol |
| Diphenoxylate |
Zolpidem |
Note:- Preparations containing the above drug substances and their salts excluding those intended for topical or extrenal use (except ophthalmic and ear or nose preparations) containing above substances are also covered by this Schedule.
_________
1. Ins. by G.S.R 588(E) , dt. 30.8.203.
_________
1SCHEDULE I
(Omited)
2[SCHEDULE J
(See rule 106)
DISEASES AND AILMENTS (BY WHATEVER NAME DESCRIBED) WHICH A DRUG MAY NOT PURPORT TO PREVENT OR CURE OR MAKE CLAIMS TO PREVENT OR CURE.
1. AIDS
2. Angina Pectoris
3. Appendicitis
4. Arteriosclerosis
5. Baldness
6. Blindness
7. Bronchial Asthma
8. Cancer and Benign tumour
9. Cataract
10. Change in colour of the hair and growth of new hair.
11. Change of foetal sex by drugs.
12. Congenital malformations
13. Deafness
14. Diabetes
15. Diseases and disorders of uterus.
16. Epilepticfits and psychiatric disorders
17. Encephalitis
18. Fairness of the skin
19. Form, structure of breast
20. Gangrene
21. Genetic disorders
22. Glaucoma
23. Goitre
24. Hernia
25. High/low Blood Pressure
26. Hydrocele
27. Insanity
28. Increase in brain capacity and improvement of memory.
29. Improvement in height of children/adults.
30. Improvement in size and shape of the sexual organ and in duration of sexual performance
31. Improvement in the strength of the natural teeth.
32. Improvement in vision
33. Jaundice/Hepatitis/Liver disorders
34 Leukaemia
35. Leucoderma
36. Maintenance or improvement of the capacity of the human being for sexual pleasure.
37 Mental retardation, subnormalities and growth
38. Myocardial infarction
39. Obesity
40. Paralysis
41. Parkinsonism
42. Piles and Fistulae
43. Power to rejuvinate
44. Premature ageing
45. Premature greying of hair
46. Rheumatic Heart Diseases
47. Sexual Impotence, Premature ejaculation and spermatorrhoea
48. Spondylitis
49. Stammering
50. Stones in gall-bladder, kidney, bladder
51. Vericose Vein.]
___________
1. Schedule I omitted by G.S.R 462(E) , dt. 22.6.1982
2. Subs. by G.S.R. 21(E) , dt. 11.1.1996.
___________
SCHEDULE K
(See rule 123)
| Class of Drugs |
Extent and Conditions of Exemption |
| 1. Drugs falling under clause (b) (i) of Section 3 of the Drugs and Cosmetics Act, not intended for medicinal use. |
All the provisions of Chapter IV of the Act and the Rules thereunder, subject to the conditions that the drug is not sold for medicinal use or for use in the manufacture of medicines and that each container is labelled conspicuously with the words “NOT FOR MEDICINAL USE.” |
| 1[2.* * *] |
|
| 2[2A. Quinine and other antimalarial drugs. |
3[Persons selling the drugs by retail under arrangements made by State Government for sale and distribution of the drugs will be exempted from the requirement to take out licences for retail sale under clause (c) of Section 18 of the Act.] |
| 4[3.* * *] |
|
| 4[4.* * *] |
|
| 5[5. Drugs supplied by a registered medical practitioner to his own patient or any drug specified in Schedule C supplied by a registered medical practitioner at the request of another such practioner if it is specially prepared with reference to the condition and for the use of an individual patient provided the registered medical practitioner is not (a) keeping an open shop or (b) selling across the counter or (c) engaged in the importation, manufacture, distribution or sale of drugs in India to a degree which render him liable to the provisions of Chapter IV of the Act and the rules thereunder. |
All the provisions of Chapter IV of the Act and the Rules made thereunder, subject to the following conditions :
5[1. The drugs shall be purchased only from a dealer or a manufacturer licensed under these rules, and records of such purchases showing the names and quantities of such drugs, together with their batch numbers and names and addresses of the manufacturers shall be maintained. Such records shall be open to inspection by an Inspector appointed under the Act, who may, if necessary, make enquiries about purchases of the drugs and may also take samples for test.]
2. In the case of medicine containing a substance specified in 6[Schedule G, H or X] of the following additional conditions shall be complied with:-
a. the medicine shall be labelled with the name and address of the registered medical practitioner by whom it is supplied;
b. if the medicine is for external application it shall be labelled with the words 7[***]
“For external use only” or, if it is for internal use with the dose;
c. the name of the medicine or ingredients of the preparation and the quantities thereof, the dose prescribed, the name of the patient & the date of supply and the name of the person who gave the prescription shall be entered at the time of supply in register to be maintained for the purpose;
d. the entry in the register shall be given a number and that number shall be entered on the label of the container;
e. the register and the prescription, if any, on which the medicines are issued shall be preserved for not less than two years from the date of the last entry in the register or the date of the prescription, as the case may be.
8[3. The drug will be stored under proper storage conditions as directed on the label.]
9[4. No drug shall be supplied or dispensed after the date of expiration of potency recorded on its container, label or wrapper or in violation of any statement or direction recorded on such container, label or wrapper.] |
| 10[5A. Drugs supplied by a hospital or dispensary maintained or supported by Government or local body 11[***] |
The provisions of Chapter IV of the Act and the Rules thereunder which require them to be covered by a sale licence, subject to the following conditions :
(1) The dispensing and supply of drugs shall be carried out by or under the supervision of a qualified person;
(2) The premises where drugs are supplied or stocked shall be open to inspection by an Inspector appointed under the Drugs and Cosmetics Act who can, if necessary, take samples for test;
(3) The drugs shall be stored under proper storage conditions.
(4) 12[The drugs shall be purchased from a manufacturer or a dealer licensed under these rules or received as transferred stocks from hospital stores for distribution. Records of such purchases or receipts shall be maintained.]
(5) 13[No drug shall be supplied or dispensed after the date of expiration of potency recorded on its container, label or wrapper or in violation of any statement or direction recorded on such container, label or wrapper.] |
| 14[5B. Whole Human Blood IP and / or its components stored for transfusion by a First Referral Unit, Community Health Centre, Primary Health Centre and a Hospital. |
The provisions of Chapter IV of the Act and the rules made thereunder which require obtaining of a licence for operation of a Blood Ban k or processing Whole Human Blood and / or its components, subject to the following conditions, namely:-
(1) The First Referral Unit, Community Health Centre, Primary Health Centre and / or any Hospital shall be approved by the State / Union Territory Licensing Authority after satisfying the conditions and facilities through inspection.
(2) The captive consumption of Whole Human Blood IP or its components in the First Referral Unit, Community Health Centre, Primary Health Centre and / or any Hospital shall not be more than 2000 units annually.
(3) The Whole Human Blood an d / or its components shall be procured only from Government Blood Bank and / or Indian Red Cross Society Blood Bank and / or Regional Blood Transfusion Centre duly licensed.
(4) The approval shall be valid for a period of two years from the date of issue unless sooner suspended or cancelled and First Referral Unit, Community Health Centre, Primary Health Centre and / or any Hospital shall apply for renewal to the State Licensing Authority three months prior to the date of expiry of the approval.
(5) The First Referral Unit, Community Health Centre, Primary Health Centre and / or any Hospital shall have the following technical staff for storage of blood or its components:
(a) A trained Medical Officer for proper procurement, storage and cross matching of blood and / or its components. He / she shall also be responsible for identifying haemolysed blood and ensure non-supply of date expired blood or its components.
(b) A blood bank Technician with the qualification and experience as specified in Part XII B of Schedule F or an experienced laboratory technician trained in blood grouping and cross matching.
(6) The First Referral Unit, Community Health Centre, Primary Health Centre and / or any Hospital shall have an area of 10 sq. metres. It shall be well lighted, clean and preferably air- conditioned. Blood bank refrigerator of appropriate capacity fitted with alarm device and temperature indicator with regular temperature monitoring shall be provided to store blood units between 2° C to 8° C and if the components are proposed to be stored, specialized equipment‘s as specified in Part XII B of Schedule F shall also be provided.
(7) The First Referral Unit, Community Health Centre, Primary Health Centre and / or any Hospital shall maintain records and registers including details of procurements of Whole Human Blood IP and / or blood components, as required under Part XII B Schedule F.
(8) (8) The First Referral Unit, Community Health Centre, Primary Health Centre and / or any Hospital shall store samples of donors blood as well as patients sera for a period seven days after transfusion. |
| 15[6.* * *] |
|
| 7. Quinine Sulphate |
The provisions of sub-section (a) (i) of Section 18 of the Act to the following extent-
(i) the colour of the drug may be pink, owing to its being coloured with an edible pink colouring matter;
(ii) the B. P. tests for readily carbonisable substances produce a yellow colour of an intensity about four times the colour produced with quinine sulphate conforming to the B.P. standard;
(iii) other Cinchona alkaloids present shall not exceed six per cent; and
(iv) the residue on incineration shall not exceed 0.14 per cent. |
| 16[8.* * *] |
|
| 17[9. Magnesium Sulphate |
The provisions of sub-clause (i) of clause (a) of Section 18 of the Act to the following extent:-
Chlorides present in the salt shall not exceed 0.12 per cent in the case of the produce prepared from sea water.] |
| 18[10. The following substances which are used both as articles of food as well as drugs –
(i) all condensed or powdered milk whether pure, skimmed or malted, fortified with vitamins and minerals or otherwise.
(ii) Farex, Oats, 19[***] and all other similar cereal preparations whether fortified with vitamins or otherwise excepting those for parenteral use.
(iii) Virol, Bovril, Chicken essence and all other similar predigested foods.
(iv) 20[Ginger, Pepper, Cumin, Cinnamon and all other similar spices and condiments unless they are specially labelled as conforming to the standards in the Indian Pharmacopoeia or the Official Pharmacopoeia and official compendia of drug standards prescribed under the Act and Rules made thereunder.] |
All provisions of Chapter IV of the Act and the Rules thereunder |
| 21[11.* * *] |
|
| 22[12. Substances intended to be used for destruction of vermin or insects which cause disease in human beings or animals, viz. Insecticides and Disinfectants.] |
The provision of Chapter IV of the Act and Rules thereunder, which require them to be covered by a sale licence 23[subject to the condition that provision of condition (17) of Rule 65 of the Drugs and Cosmetics Rules, 1945 are complied with by the person stocking or selling such substances.] |
| 24[13. The following household remedies, namely-
(1) 25[Aspirin tablets.]
(2) 26[Paracetamol Tablets.]
(3) Analgesic Balms.
(4) Antacid preparations.
(5) Gripe Water for use of infants.
(6) Inhalers, containing drugs for treatment of cold and nasal congestion.
(7) Syrups, lozenges, pills and tablets for cough.
(8) Liniments for external use.
(9) Skin ointments and ointments for burns.
(10) Absorbent cotton wool, bandages absorbent guaze and adhesive plaster.
(11) Castor Oil, liquid Paraffin and Epsom Salt.
(12) Eucalyptus Oil
(13) Tincture Iodine, Tincture Benzoi n C o. and Mercurochrome in containers not exceeding 100 ml.
(14) Tablets of Quinine Sulphate I.P.
(15) Tablets of Iodochlorohydroxy quinoline-250 mg. |
The provisions of Chapter IV of the Act and the Rules thereunder which require them to be covered with a sales licence in Form 20-A subject to the following conditions—
(a) The drugs are sold only in a village having population of not more than one thousand persons and where there is no licensed dealer under the Drugs and Cosmetics Act;
(b) The drugs do not contain any substance specified in 27[Schedules G, H or X];
(c) The drugs are sold in the original unopened containers of the licensed manufacturers;
(d) When the drugs are sold under clause (a) condition 3 under “Conditions of licence” of Form 20-B shall not apply. |
| 28[14. Mechanical Contraceptives. |
The provisions of Chapter IV of the Act and Rules thereunder, which require them to be covered by a sale licence 29[subject to the condition that the provisions of condition (17) of Rule 65 of the Drugs and Cosmetics Rules, 1945, are complied with by the person stocking or selling mechanical contraceptives.] |
| 30[14A. Vaginal contraceptive pessaries containing Nonoxynol. |
The provisions of Chapter IV of the Act and the Rules made thereunder which require them to be covered by a sale licence subject to the condition that the provisions of clause (17) of Rule 65 of the Drugs and Cosmetics Rules, 1945 are complied with by the person stocking or selling this contraceptive.] |
| 31[15. Chemical contraceptive having the following composition per tablet :
(1) DL-Norgestrel-0.30 mg. Ethinyloestradiol-0.03 mg.
(2) Levonorgestrel-0.15 mg. Ethinyloestradiol-0.03 mg.
(3) Centchroman-30mg.
(4) 32[Desogestrel -0.150mg. Ethinyloestradiol 0.030mg.
(5) Levonorgestrel 0.1mg. Ethinyloestradiol 0.02mg |
The provisions of Chapter IV of the Act and the rules made thereunder which required them to be covered by a sale licence.] |
| 33[16. Cosmetics |
The provisions of Chapter IV of the Act and the Rules made thereunder, which require them to be covered by a licence for sale
provided that the cosmetics sold, if of Indian origin, are manufactured by licensed manufacturers.] |
| 34[17. Ophthalmic ointments of the Tetracycline group of drugs |
Persons authorised by the Government to distribute or sell the drugs under the National Trachoma Control Programme shall be exempted from the provisions of Chapter IV of the Act and the Rules made thereunder, which require the drugs to be covered by a sale licence.] |
| 35[18.* * *] |
|
| 36[19. Hair Fixers, namely mucilaginous preparations containing gums, used by men for fixing beard. |
The provisions of Chapter IV of the Act and the rules thereunder.] |
| 37[20. Radio Pharmaceuticals. |
All the provisions of Chapter IV of the Act and the rules made thereunder.] |
| 38[21. Tablets of Chloroquine Salts. |
The provisions of Chapter IV of the Act and Rules thereunder, which require them to be covered by a sale licence, provided the drug in strip pack is sold under the Commercial Distribution Scheme of the National Malaria Eradication Programme and duly labelled as “National Malaria Eradication Programme- Ministry of Health and Family Welfare, Government of India.”] |
| 39[22. Sales from restaurant cars of trains and from coastal ships of household remedies, which do not require the supervision of a qualified person for their sale. |
The provisions of Chapter IV of the Act and the rules thereunder which require them to be covered by a sale licence, subject to the following conditions, namely –
(a) the records of purchase and sale of drugs shall be maintained by the person in charge of sale of such drugs, which shall be available for inspection by an Inspector appointed under the Act;
(b) the place where such drugs are stocked shall be open to inspection by a n Inspector appointed under the Act who can, if necessary, takes samples for test.] |
40[23. Drugs supplied by ( i ) Multipurpose Workers attached to Primary Health Centres/Sub- Centres, (ii) Community Health Volunteers under the Rural Health Scheme,
(iii) Nurses, Auxiliary Nurses, Midwives an d Lady Health Visitors attached to Urban Family Welfare Centres/Primary Health Centres/Sub- Centres and 41[(iv) Anganwadi Workers]. |
All The provisions of Chapter IV of the Act and Rules thereunder, which require them to be covered by a sale licence, provided the drugs are supplied under the Health or Family Welfare Programme of the Central or State Government.] |
| 42[24. Homoeopathic medicines supplied by a registered Homoeopathic medical practitioner to his own patient or Homoeopathic medicines supplied by a registered Homoeopathic medical practitioner at the request of another such practitioner provided the registered Homoeopathic medical practitioner is not (a) keeping an open shop, or (b) selling across the counter or, (c) engaged in the importation, manufacture, distribution or sale of Homoeopathic medicines in India to a degree which renders him liable to the provisions of Chapter IV of the Act and the rules made thereunder |
All the provisions of Chapter IV of the Act and the rules made thereunder subject to the following conditions:—
(1) The Homoeopathic medicines shall be purchased only from a dealer or a manufacturer licensed under the Drugs and Cosmetics Rules, 1945.
(2) The premises where the Homoeopathic Medicines are stocked shall be open to inspection by an Inspector appointed under the Act, who may, if necessary, “take samples for test.]” |
| 43[25. Preparations applied to human body for the purpose of repelling insects like mosquitoes. |
The provisions of Chapter IV of the Act and Rules thereunder which require them to be covered by a sale licence subject to the conditions that such a product has been manufactured under a valid drug manufacturing licence. |
| 44[26. Medicated Dressing and Bandages for First Aid. |
The provisions of Chapter IV of the Act and Rules thereunder which require them to be covered by a sale licence subject to the conditions that such a product has been manufactured under a valid drug manufacturing licence.] |
45[27. Oral Rehydration Salts (Manufactured as per the following formula) :
o Sodium chloride 3.5 g/litre.
o Trisodium citrate dehydrate 2.9 g/litre
o Potassium Chloride 1.5 g/ litre.
May be replaced by Sodium bicarbonate(Sodium hydrogen Carbonate) 2.5 g/ litre, when citrate salt is not available. |
The provisions of Chapter IV of the Act and Rules thereunder which required them to be covered by a sale licence, subject to the conditions that such a product has been manufactured under a valid drug manufacturing Licence.] |
| 46[28. White or Yellow Petroleum Jelly I.P. (Non-perfumed). |
The provisions of Chapter IV of the Act and Rules thereunder which required them to be covered by a sale licence, subject to the condition that such a product has been manufactured under a valid drug manufacturing Licence. |
| 47[29. Morphine Tablets |
The provisions of Chapter IV of the Act and the rules made thereunder which require them to be covered by a sale licence, subject to the following conditions, namely:-
(i) The drug shall be supplied by the Palliative Care Centres approved by the State Government to terminally ill cancer patients
(ii) The drug shall be kept under the custody of the Medical Officer in charge of the said Centre.
(iii) The drug shall be purchased from a dealer or a manufacturer who holds licence under these rules and records of such purchases showing the names and quantities together with their batch numbers and names and addresses of the manufacturers or dealers and the names and addresses of the patients to whom supplies have been made shall be maintained. Such records shall be open to inspection by an inspector appointed under the Act, who may also take samples for test. |
| 30. Whole Human Blood collected and transfused by Centres r un by Armed Forces Medical Services in border areas, small mid- zonal hospitals including peripheral hospitals, Field Ambulances, Mobile medical units and other field medical units including blood supply units in border, sensitive and field areas. |
All the provisions of Chapter IV of the Act and rules made thereunder which require them to be covered by a licence to operate a Blood Bank for collection, storage and processing of whole human blood for sale or distribution subject to the following conditions:-
(i) These Centres shall collect, process and transfuse blood in emergent situations which require lifesaving emergency surgeries/or transfusion.
(ii) These Centres shall be under the active direction and personal supervision of a qualified Medical Officer, possessing the qualifications and experiences specified in condition (i) of rule 122-G.
(iii) Each blood unit shall be tested before use for freedom from HIV I and II antibodies, Hepatitis B surface antigen, malarial parasites and other tests specified under the monograph “Whole Human Blood” in current edition of Indian Pharmacopoeia
(iv) These Centres shall have adequate infrastructure facilities for storage and transportation of blood.
(v) The blood collected and tested by such Centres shall be transfused by the Centre itself and may be made available for use of other peripheral Armed Forces hospitals or Centres during operational circumstances.] |
| 48[31. The following Homoeopathic Medicines, namely:-
49[(a) ***
(b) Homoeopathic Ointments, each 50[in 25gm. Tube]:
(i) Arnica Montana
(ii) Calendula Officinalis
(iii) Cantharis
(iv) Rhus Toxicodendron
(c) Biochemic tissue remedies in tablet forms, in generic names only, each in 20gm. Packing in 3X and 6X trituration-
(i) Calcarea Phosphorica
(ii) Calcarea Sulphurica
(iii) Ferum Phosphoricum
(iv) Kali Muriaticum
(v) Kali Phosphoricum
(vi) Kali Sulphuricum
(vii) Magnesium Phophoricum
(viii) Magnesia Sulphurica
(ix) Natrum Muriaticum
(x) Natrum Phophoricum
(xi) Natrum Sulphuricum
(xii) Silica
(d) Homoeopathic medicines, mentioned below, in pills, each in 30C potency, in sealed original packing of manufacturer of 8 gms:
(i) Arnica Montana
(ii) Aconitum Napellus
(iii) Arsenicum Album
(iv) Aloe Socotrina
(v) Apis Mellifica
(vi) Allium Cepa
(vii) Bryonia Alba
(viii) Borax
(ix) Belladonna
(x) Cantharis
(xi) Carbo Vegatabilis
(xii) Cina
(xiii) Colocythis
(xiv) Calendula Officinalis
(xv) Caulophyllum Thalictroides
(xvi) Cocculus Indicus
(xvii) Chamomilla
(xviii) Drosera Rotundifolia
(xix) Hypeicum Perforatum
(xx) Hepar Sulphur
(xxi) Ipecacuanha
(xxii) Ledum Palustre
(xxiii) Millefolium
(xxiv) Mercurius Solubilis
(xxv) Nux Vomica
(xxvi) Pulsatilla Nigricans
(xxvii) Podophyllum Peltatum
(xxviii) Plantago Major
(xxix) Rhus Toxicodendron
(xxx) Ruta Graveolens
(xxxi) Symphytum Officinalis
(xxxii) Veratrum Album
51[(e) All biochemic and its combinations (1 to 28), in tablet forms, in sealed original packing of the manufacture.] |
The provisions of Chapter IV of the Act and the rules made thereunder which require them to be covered with a sale licence in Form 20- C, subject to the following conditions:-
(i) These homoeopathic medicines shall be sold in the original sealed small quantity packings of the licensed manufacturers.
(ii) These medicines may be stocked and sold by retail of medicines licensed under rule 61.
(iii) These medicines shall be stored separately from other allopathic drugs.
(iv) These medicines shall be purchased from a manufacturer or a dealer licensed under these rules.
(v) The purchase and sale records of these medicines shall be maintained by the dealer for minimum period of three years.
(vi) These medicines shall be labelled in generic / pharmacopoeial names only. |
| 52[32. First Aid kit supplied along with motor vehicle by the manufacturer or its distributors at the time of first sale of vehicle. |
The provisions of Chapter IV of the Act and rules made thereunder which require them to be covered by a sale licence, subject to the condition that the drug items are procured from a manufacturer or a dealer licensed under the rules.] |
| 53[33. Nicotine gum 54[and Lozenges] containing upto 2 mg of nicotine |
The provisions of Chapter IV of the Act and the Rules made thereunder which require them to be covered by a sale license subject to the condition that such a product has been manufactured under a valid drug manufacturing license.] |
| 55[34. Production of Oxygen 93 per cent USP, produced from air by the molecular sieve process, by a hospital or Medical Institute for their captive consumption. |
The provisions of Chapter IV of the Act and the Rules made thereunder which require them to be covered by manufacturing licence under the rules, provided that the production facilities shall be open to inspection by an Inspector appointed under the Act, who can, if necessary, take samples For test”.] |
| 56[35. Homoeopathic hair oils having active ingredients up to 3X potency only |
The provisions of Chapter IV of the Act and the rules made thereunder which require them to be covered with a sale licence 57[***] subject to the condition that such a product has been manufactured under a valid manufacturing licence and sold in the original sealed packing of the licensed manufacturers.] |
| 58[36. Custom made devices |
All provisions of Chapter IV of the Act and the rules made thereunder, subject to the condition that the device being specifically made in accordance with a duly qualified medical practitioner‘s written prescription under his responsibility, in accordance with specific design characteristics and is intended for the sole use of a particular patient and the label should bear the word “custom made device.”
Explanation.–– Mass produced devices which only need adoption to meet the specific requirements of the medical practitioner or any other professional user shall not be considered to be custom made devices.] |
_____________
1. Item 2 omitted by Government of India Notification No. F.1-56/47-D, dt. 16.1.1950).
2. Added by Notification No .F. I-2/47-D dt. 13-2-1950.
3. Amended by Notification No. F. I-22/59-D dt.. 9-4-1960.
4. Item 3 and 4 omitted by Notification No. F.I-6/62-D dt. 2-7-1969. 5. Subs. by G.S.R. 1074, dt: 19.8.1978.
6. Subs. by G.S.R. 462 (E), dt: 22.6.1982.
7. Certain words omitted by G.S.R. 462 (E), dt: 22.6.1982. 8. Ins. by G.S.R. 460 (E), dt: 20.6.1984.
9. Ins. by G.S.R. 592 (E), dt: 13.8.2008.
10. Added by notification No. F.1-22/59-D, dt: 9.4.1960.
11. Certain words omitted by G.S.R. 812 (E), dt: 14.11.1994. 12. Ins. by G.S.R. 648 (E), dt: 16.9.2002.
13. Ins. by G.S.R. 592 (E), dt: 13.8.2008.
14. Ins. by G.S.R. 909 (E), dt: 20.12.2001.
15. Item 6 omitted by G.S.R. 681 (E), dt: 5.12.1980.
16. Item 8 omitted by G.S.R.1185 (E), dt: 18.8.1964.
17. Added by notification No. F.1-19/50-D.S, dt: 30.3.1953.
18. Added by notification No. DR/Sch.Ddk/F.1-40/54-D.S., dt: 27.1.1955. 19. Omitted by G.S.R. 665 (E), dt: 6.5.1977.
20. Subs. by G.S.R. 19, dt: 15.12.1977.
21. Item 11 omitted by notification No. F.1-36/64-D (G.S.R 1188), dt: 17.8.1964.
22. Amended by notification No. F.1-20/60-D (S.O.400), dt: 24.1.1964. 23. Added by G.S.R. 926, dt: 24.6.1977.
24. Added by notification No. F.1-19/59-D, dt: 13.6.1961. 25. Subs by S.O. 2139, dt: 5.6.1972.
26. Subs. by G.S.R. 1060(E), dt: 5.9.1986.
27. Subs. by G.S.R. 462 (E), dt: 22.6.1982.
28. Added by notification No. F.1-39/61-D (S.O. 1057), dt: 23.3.1964. 29. Added by G.S.R. 926, dt: 24.6.1977.
30. Ins. by G.S.R. 784 (E), dt: 28.8.1989.
31. Subs by G.S.R. 730 (E), dt: 10.12.1991.
32. Ins. by G.S.R. 648 (E), dt: 16.9.2002.
33. Added by notification No. F.1-36/64-D (G.S.R 1183), dt: 17.8.1964.
34. Added by notification No. F.1-21/63-D (G.S.R 70), dt: 4.1.1965. 35. Item 18 is omitted by G.S.R. 1594, dt: 28.10.1976.
36. Added by S.O. 2139, dt: 5.6.1972.
37. Added by G.S.R. 926, dt: 24.6.1977.
38. Added by G.S.R. 697 (E), dt: 11.11.1977.
39. Ins. by G.S.R. 1241, dt: 15.9.1979.
40. Ins. by G.S.R. 540 (E), dt: 22.9.1980.
41. Ins. by G.S.R. 784 (E), dt: 28.8.1989.
42. Ins. by G.S.R. 680 (E), dt: 5.12.1980.
43. Ins. by G.S.R. 1060 (E), dt: 5.9.1989.
44. Ins. by G.S.R. 371 (E), dt: 24.3.1988.
45. Ins. by G.S.R. 677 (E), dt: 2.6.1988.
46. Ins. by G.S.R. 753 (E), dt: 4.11.1999.
47. Ins. by G.S.R. 6 (E), dt: 4.1.2001.
48. Ins. by G.S.R. 218 (E), dt: 28.3.2001.
49. Sub-item (a) relating to “Arnica Montana Hair Oil” omitted by G.S.R. 917 (E), dt: 22.12.2009. 50. Subs. by G.S.R. 592 (E), dt: 13.8.2008.
51. Ins. by G.S.R. 592 (E), dt: 13.8.2008.
52. Ins. by G.S.R. 648 (E), dt: 16.9.2002.
53. Ins. by G.S.R. 549 (E), dt: 16.7.2003.
54. Ins. by G.S.R. 101 (E), dt: 18.2.2001.
55. Ins. by G.S.R. 734 (E), dt: 21.12.2005.
56. Ins. by G.S.R. 917 (E), dt: 22.12.2009.
57. The words “in Form 20C” omitted by G.S.R. 107 (E), dt: 17.2.2015. 58. Ins. By G.S.R. 890 (E), dt: 25.9.2014.
_____________
1[SCHEDULE L
(Omitted)
2[SCHEDULE L-I
(see rules 74, 78 and 150E)
GOOD LABORATORY PRACTICES AND REQUIREMENTS OF PREMISES AND EQUIPMENTS
1. General Requirements:-
(a) The laboratory or the organisation of which it is a part must be an entity that is legally authorised to function and can be held legally responsible.
(b) It is the responsibility of the management to ensure that the laboratory carry out its testing, calibration, validation, and all other technical activities in such a way as to meet Good Laboratory Practices (GLP) requirements.
(c) Laboratory management shall have a qualified individual to be known as quality manager or technical manager for carrying out all technical activities and for the implementation of documented quality system and shall report to the top management directly.
(d) The quality manager shall prepare a schedule for technical audit of the laboratory for GLP compliance by an expert or experts appointed by the top-management other than the in-charge of the laboratory and shall ensure the maintenance of documented quality system as per quality manual.
2. Premises:-
(a) (i) the laboratories shall be designed, constructed and maintained so as to prevent entry of insects and rodents besides cross contamination;
(ii) interior surface (walls, floor, and ceilings) shall be smooth and free from cracks, and permit easy cleaning and disinfection;
(iii) adequate provision is made not only for space and equipment for carrying out necessary test but also for utilities like water, power and gas;
(iv) air ventilation system shall ensure dust free environment.
(b) The laboratories shall be provided with adequate lighting and ventilation and if necessary, air- conditioning to maintain satisfactory temperature and relative humidity that will not adversely affect the testing and storage of drugs or the accuracy of the functioning of the laboratory equipments or instruments.
(c) The drainage system facilities shall be such as to facilitate proper maintenance and prevent water logging in the laboratory.
(d) Tabletops shall be constructed with acid, alkali and solvent resistant material and shall be smooth and free from crevices as far as possible.
(e) All bio-medical laboratory waste shall be destroyed as per the provisions of the Bio– Medical waste (Management and Handling) Rules, 1996.
(f) Adequate space with proper storage conditions in the laboratory shall be provided for keeping reference and working standards and be maintained by the quality control department. Standard Operating Procedure (SOP) for the maintenance of reference standards and evaluation of Working and Secondary standards shall be prepared by the laboratory.
(g) The air circulation is maintained in the area where sterility test is carried out as per Schedule‘M‘.
(h) Bio-burden shall be routinely maintained in the controlled and uncontrolled area, (e.g. air locks)
_________
1. Schedule L omitted by G.S.R. 462 (E), dt: 22.6.1982. 2. Ins. by G.S.R. 780 (E), dt: 10.11.2008.
_________
(i) Animals House:-
(i) Animal House shall have the approval of the Committee for the Purpose of Control and Supervision on Experiments on Animals (CPCSEA).
(ii) Designed in such a way that there is an arrangement to quarantine the new animals procured or purchased and have a provision for clean corridor and dirty corridor.
(iii) In case of a diseased animal proper diagnosis shall be done and proper record of treatment shall be maintained.
(iv) Different types of animals shall be housed separately with proper identification.
(v) A Standard Operating Procedure shall be prepared for breeding and care of animals, maintenance, cleaning or sanitation with suitable schedule for cleaning of animal cages, racks, floor and other equipments.
(vi) The animal house shall have proper air-conditioning (temperature and humidity) with proper lighting and be monitored regularly and documented periodically.
3. Personnel-
(a) Staff in the laboratory shall possess necessary qualification, proper training and shall have adequate, experience for the assigned duties.
(b) A training record of all the personnel shall be maintained.
(c) Head of the laboratory must be of high professional standing with experience in drug analysis and laboratory management who is responsible for.
(i) ensuring the control and maintenance of documents including the quality system as per the requirements of regulatory authorities which involves all raw data, SOPs, documentation exhibits, protocols, training charts, etc;
(ii) planning and organising the audit of the quality system and initiation as well as follow up action of the corrective actions, if any;
(iii) investigation of technical complaints;
(iv) taking finai responsibilities for recommending any regulatory action in the event of noncompliance of tested samples.
4. Equipments:-
(a) The laboratory shall be furnished with all types of equipments as may be necessary for carrying out the different activities within the laboratory.
(b) The analytical instruments shall be housed in dust-free environment and whenever required, conditions of temperature and humidity shall be maintained and periodic checks on temperature and humidity be made and recorded.
(c) The instruments, instrument bench and surrounding areas shall be kept clean and tidy at ail times.
(d) Instruments requiring calibration shall be calibrated at regular intervals and records of such calibration or maintenance be maintained and there shall be written instructions in the form of Standard Operating Procedures for the operation, maintenance and calibration of instruments.
(e) Equipment records shall be maintained and such records shall contain the following:-
(i) name of equipment or machine or apparatus;
(ii) manufacturer ‘s name, model number and type of identification;
(iii) serial number;
(iv) date on which equipment was received in laboratory;
(v) current location;
(vi) condition when received (e.g. new, used, re-conditioned);
(vii) copy of the manufacturer ‘s operating instructions;
(viii) frequency of calibration;
(ix) frequency of maintenance;
(x) log Book (day to day entry including status of the equipment)
(xi) staff responsible for monitoring the calibration and maintenance status of the equipment;
(xii) calibrating records;
(xiii) list of authorised users or operators, if any;
(xiv) history of any damage, malfunction, modification or upgradation, repair and calibration;
(xv) list of spares and accessories, if any.
(f) A progress register for non-functional equipments and action for procurement of spares and accessories, monitoring thereof, shall be maintained.
(g) A Standard Operating Procedure for preventive maintenance of machine or equipment or apparatus shall be prepared by the laboratory.
(h) Other equipments such as burettes, pipettes, volumetric flasks, weight boxes, thermometers, etc., shall be thoroughly checked for accuracy of calibration before acceptance for use.
(i) Maintenance procedure in the form of Standard Operating Procedures must be prepared and regular servicing must be performed by the maintenance engineer or specialist
(j) Equipments, instruments giving anomalous results or defective must be labeled as ‘out- of- order‘ till they are repaired and after instrument is repaired it should be calibrated before use.
(k) The maintenance of equipments for services like electricity, gas, water, steam, and compressed gas shall be handled by competent person.
(l) Autoclaves must meet the requirements described for operations, safety and validation procedures, and the validation carried out by the laboratory shall be recorded.
(m) Fume Cupboards.-
Work involving the evolution of harmful and obnoxious vapours shall be carried out in a fume cupboard. The exhaust system of the fume cupboard shall be checked frequently to ensure that it is in order. There should be a water drainage system inside the fume cupboard and shall be checked frequently to ensure that there is no water logging and it is in order.
5. Chemicals and Reagents:
(a) The storage and handling of chemicals and reagents shall be done in a manner considering the physicochemical properties of these substances and the hazards involved in their use.
(b) All reagents and solutions in the laboratory shall be properly identified with a label.
(c) A standardisation register shall be maintained by the laboratory along with its raw data and Standard Operating Procedure for preparation and standardisation on stock solutions, standard solutions, volumetric solutions must be prepared for the guidance of staff.
(d) Containers of stock solutions and of standard solutions shall bear the following details:-
(i) name of analytical chemist who prepared the solution;
(ii) date of preparation;
(iii) Each volumetric solution shall have “use before date” depending upon the stability of the solution; and
(iv) standardization records.
(e) The transfer of hazardous chemicals and regents from one container to another container shall be carried out with suitable equipment by taking the care of safety and no make-shift or hazardous methods must be resorted to.
6. Good house keeping and safety.-
(a) General and specific written down instructions for safety shall be circulated to each staff member and the instructions be revised periodically as appropriate (e.g., poster displays, audio- visual material and by seminars/conferences)
(b) Standard Operating Procedure for safety, house-keeping and loss prevention shall be prepared in accordance with the various rules, and regulations of the Government of India and include the following requirements, namely:-
(i) safety data sheets must be made available to staff before testing is carried out;
(ii) drinking, eating and smoking shall not be permitted in the laboratories; food for human consumption shall not be kept in working or storage areas; food meant for test animals shall be handled by the workers under the guidance of a veterinary doctor or qualified person. In the animal house, the facilities for collection and disposal of animal waste or safe sanitary storage of waste before removal from testing be provided;
(iii) staff must wear laboratory coats or other protective clothing including gloves and face masks and eye protection wherever required;
(iv) the laboratories shall have adequate first aid kit and fire fighting equipments located at the right places and the staff must be familiar and trained with the use of fire fighting equipment including fire extinguishers, fire blankets and gas masks,
(v) operators carrying out sterility tests shall wear sterilised garments including headgear, face masks and shoes;
(vi) the staff must be educated in the first aid techniques, emergency care and use of antidotes; and
(vii) safety rules in handling cylinders of compressed gases must be observed and staff must be familiar with relevant colour identification codes;
(c) Protective Precautions to be taken in Laboratories:
(i) water showers shall be installed at appropriate places in the laboratory;
(ii) rubber suction bulbs must be used on manual pipettes and siphons;
(iii) warnings, precautions, and written instructions must be given for work with violent, uncontrollable or dangerous reactions (e.g. mixing water and acids, biological such as infectious agents, etc.);.
(iv) appropriate facilities for the collection, storage, and disposal of wastes shall be made available;
(v) staff must be aware of methods for safe disposal of corrosive or dangerous products by neutralisation or deactivation and of the need for complete disposal of mercury and its salts.
(vi) staff must also be aware about the safety precautions to be adopted while handling potassium cyanide and cyanogen bromide.
(vii) a Standard Operating Procedure for handling, collection, disposal of chemical and biological wastes be prepared.
7. Maintenance, calibration, and validation of equipments:-
(a) All equipments, instruments and other devices used in the laboratory shall use appropriate methods and procedures for all tests or calibrations and they shall be regularly calibrated and validated. The frequency of calibration may differ from instrument to instrument.
(b) The original equipment manufacturer ‘s recommendations along with the experience of the laboratory staff and the use of equipment per day may also be considered while fixing the frequency of calibration.
(c) For most of the equipments and instruments, Standard Operating Procedures for calibration and calibration schedule be prepared by the laboratory and a logbook shall also be prepared by each laboratory for proper documentation of calibration results.
8. Reference materials:-
(a) Reference materials are necessary for the testing and, or calibration, validation or verification of a sample or of equipment, instruments or other devices and all such materials shall be traceable to agency authorised by Government of India or any other International body .
(b) The laboratory shall prepare working standard by comparing with the reference standards and shall be routinely checked for their purity by selecting parameters such as identity, loss on drying or on water, impurity and assay, etc.
(c) Whenever, any new reference material is received by the laboratory, a code number shall be assigned and this code number shall be quoted on the laboratory note book and analytical work sheet. The working standard shall also be provided with identification code.
(d) A register pertaining to reference and working materials must be maintained by the laboratory. The following details may be mentioned in the register:
(i) source of supply;
(ii) code number of the reference material;
(iii) date of receipt;
(iv) batch number or identification number of the supplying agency;
(v) details like assay value, water content or any other information provided;
(vi) storage condition of the material; and
(vii) date of expiry, if any and date of manufacturing if possible
(e) All working standards shall be checked at appropriate intervals or before use to ensure that it has not deteriorated or decomposed during storage. These observations be recorded in a register: All the reference and working standards shall be stored at appropriate storage condition; those requiring storage between 2 -8°C shall be stored in a refrigerator. Wherever recommended the material may not be allowed to be frozen.
9. Microbiological Cultures:-
(a) Standard Operating Procedure for maintenance of microbial culture and sub-culture must be prepared by the laboratories.
(b) If the cultures have become non-viable or mutant, proper procedure shall be followed to destroy these cultures by autoclaving under an authorised personnel for biological testing. Preferably not more than five passages may be prepared.
(c) All activities be carried out in a aseptic area by authorised person.
(d) The laboratories shall perform standard biochemical tests on the sub-culture as given in literature to ensure their viability.
10. Quality system.-
The quality system shall be designed to ensure the following objectives:-
(a) The measurements and calibrations shall fully conform to the compendial requirements and the methods demonstrably based on validation protocols are followed.
(b) It shall be effective in providing necessary assurance that the activities or processes or techniques or practices comply with planned arrangements.
(c) It helps in early detection and correction of non conformities.
(d) Remedial action on the observations by internal and external audits are taken appropriately and
(e) It shall have a documented quality policy for the organisation.
11. Internal quality system audits.-
(a) Internal audits are done to assure the integrity of the analysis‘ and such audits shall be conducted periodically with a predetermined schedule and procedure with appropriate checklist, to verify that the operations continue to comply with the requirements of quality system and requirements of regulatory authorities. Internal quality audits shall be carried out by trained and qualified personnel who are independent of the activity to be audited.
(b) The periodicity of quality audit shall be fixed by the Head of the laboratory so that each activity is audited at least once in a year.
(c) Head of the laboratory will be responsible for initiation of the corrective action arising from audits and verification of corrective action.
(d) Whenever any non-compliance or any diversion is noticed by the team in implementing quality policy or quality system, protocols, the same will be attended by the Quality Manager. The problem will be analysed and necessary actions will be taken with proper documentation.
(e) The Quality Manager shall maintain all the records of the analysis being conducted which includes test system, the type of analysis, date on which analysis is done, etc and quality Manager shall also maintain copies of all protocols pertaining to different activities being checked by the audit team.
12. Management review–
Quality system reviews shall be conducted by the top management at least once in every twelve months and the agenda of review shall generally cover the following:-
(i) report or input of internal audits;
(ii) matter arising from previous reviews;
(iii) report of external audits, if any;
(iv) surveillance report, if any;
(v) result of proficiency testing;
(vi) complaints or feedback received from users of laboratory services;
(vii) details of in-house quality control checks;
(viii) need of amendment of the quality system and documentation;.
(ix) induction training of new staff; and
(x) any other requirements of the laboratory.
13. Standard Operating Procedures:-
(a) Standard Operating Procedures are written procedures for different activities being conducted in a laboratory and shall include the following characteristics:
(i) they shall be written in a chronological order listing different steps leading to an analysis of drugs or calibration of an instrument:
(ii) testing laboratories shall have Standard Operating Procedure manuals and have its periodic review;
(iii) it shall be user friendly documents and shall include designation of the person responsible for intended activity.
(b) Standard Operating Procedures in addition to those recommended under various activities shall also be prepared to the minimum in respect of the following:
(i) sample handling and accountability;
(ii) receipt identification, storage, mixing and method sampling of the test and control articles;
(iii) record keeping, reporting, storage and retrieval of data;
(iv) coding of different studies, handling of data including use of computerized data system;
(v) operation of technical audit personnel in performing and reporting audits, inspections and final report reviews;
(vi) routine inspection of cleaning, maintenance, testing, calibration and standardisation of instruments;
(vii) action to be taken in respect of equipment failure;
(viii) analytical data methods;
(ix) the raw data;
(x) data handling and storage retrieval;
(xi) health and safety protection;
(xii) animal room preparations;
(xiii) animal care;
(xiv) storage and maintenance of microbial cultures;
(xv) maintenance of sterility room (i.e. constant maintenance and monitoring of Aseptic condition of sterility room);
(xvi) use and storage of reference standards;
(xvii) procurement of stores and equipment;
(xviii) monitoring of testing of samples;
(xix) method of retention of unexpended samples, their location, maintenance and disposal;
(xx) document control;
(xxi) redressal of technical complaints;
(xxii) housing-keeping;
(xxiii) corrective and preventing action;
(xxiv) working procedure (test methods);
(xxv) calibration Manual; and
(xxvi) training manual.
14. Protocols and specifications archive.-
(a) Every laboratory shall have a specification archive and. current versions of all necessary specifications shall be kept as per the requirements of the Act and the rules made thereunder and the National Pharmacopoeia (Indian Pharmacopoeia).
(b) All updates and corrections must be noted in the master volumes of Pharmacopoeias to prevent the use of obsolete sections; supplement and addendum shall also be made available in the laboratory.
(c) The specification archive shall contain the following :-
(i) list of all the pharmacopoeias;
(ii) a file on patent and proprietary medicines (non-pharmacopoeial) test methods to specifications prepared and validated by the manufacturer or by the laboratory itself. The test methods shall be submitted to the •concerned Drug Control Authority. The validated test methods developed by the manufacturer or the laboratory shall stand to the requirements of compendial parameters in regard to its precision, accuracy, reproducibility, specificity, linearity, and ruggedness etc.
15. Raw data:-
(a) Raw data refers to the laboratory work sheet, note books or analysis sheet, records, and other activities and such raw data shall include hand written notes, photographs, software, drawings, computer printouts, spectral charts, dictated observations or recorded data from automated equipments. The raw data also includes record on receipt of animals, result of environmental monitoring, calibration, records of equipments, integrator output from analytical equipment, including work-sheet used to read a note, information from Light Emitting Diode (LED) display of any equipment.
(b) A single line shall strike through the data being changed; the correct information shall be recorded along with the old data and the reason of change. The analyst making the change shall be identified by his signature with date. In case of automated data collection system, the person responsible shall be identified at the time of data output. The original entry must be saved and the system have audit trial for all the data.
(c) Data integrity and security shall be maintained and the data shall not be accessible to any unauthorised person.
16. Storage and archival.-
(a) The residual sample shall be retained in proper storage condition for a period of one year after the final report.
(b) The laboratory must establish and maintain procedures for the identification collection, indexing, retrieval, storage, maintenance, and disposal of all quality documents.
(c) All the raw data, documentation, Standard Operating Procedures, protocols, and final reports are to be retained and there shall be archives for orderly storage and expeditious retrieval of all raw data, documentation, protocols, interim and final report. The archive shall provide a suitable environment that will prevent modification, damage, or deterioration and/or loss.
(d) The condition under which the original documents are stored must ensure their security and confidentiality,
(e) Paper documents shall not be kept for long periods under high humidity and raw data in the form of tape and discs are to be preserved with care,
(f) In case of storage of only optical disc, the life of disc shall be longer than the storage time,
(g) Raw data on thermal paper might fade away with time; therefore, a photocopy of the thermal paper shall also be retained in the archive.
(h) Time for which records are retained shall be prescribed in the documents.
1[SCHEDULE M
(See Rules 71, 74, 76 and 78)
GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR PHARMACEUTICAL PRODUCTS
Note: To achieve the objectives listed below, each licensee shall evolve appropriate methodology, systems and procedures which shall be documented and maintained for inspection and reference; and the manufacturing premises shall be used exclusively for production of drugs 2[and no other manufacturing activity shall be undertaken therein except in respect of units licensed prior to 11th December, 2001].
PART 1
GOOD MANUFACTURING PRACTICES FOR PREMISES AND MATERIALS
1 GENERAL REQUIREMENTS:
1.1. Location and surroundings.- The factory building(s) for manufacture of drugs shall be so situated and shall have such measures as to avoid risk of contamination from external environment including open sewage, drain, public lavatory or any factory which produce disagreeable or obnoxious odour or fumes, excessive soot, dust, smoke, chemical or biological emissions.
1.2. Buildings and premises.- The building(s) used for the factory shall be designed, constructed, adapted and maintained to suit the manufacturing operations so as to permit production of drugs under hygienic conditions. They shall conform to the conditions laid down in the Factories Act, 1948 (63 of 1948).
The premises used for manufacturing, processing, warehousing, packaging, labelling and testing purposes shall be –
(i) compatible with other drug manufacturing operations that may be carried out in the same or adjacent area / section;
(ii) adequately provided with working space to allow orderly and logical placement of equipment, materials and movement of personnel so as to:
(a) avoid the risk of mix-up between different categories of drugs or with raw materials, intermediates and in-process material;
(b) avoid the possibilities of contamination and cross- contamination by providing suitable mechanism;
(iii) designed / constructed / maintained to prevent entry of insects, pests, birds, vermins and rodents. Interior surface (walls, floors and ceilings) shall be smooth and free from cracks, and permit easy cleaning, painting and disinfection;
_________
1. Subs. by G.S.R. 894(E) , dt. 11.12.2001.- applicable to manufacturers licensed to manufacture drugs, for the period up to 31.12.2003.
2. Subs. by Act 431(E), dt. 30.6.2005.
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(iv) air-conditioned, where prescribed for the operations and dosage forms under production. The production and dispensing areas shall be well lighted, effectively ventilated, with air control facilities and may have proper Air Handling Units (wherever applicable) to maintain conditions including temperature and, wherever necessary, humidity, as defined for the relevant product. These conditions shall be appropriate to the category of drugs and nature of the operation. These shall also be suitable to the comforts of the personnel working with protective clothing, products handled, operations undertaken within them in relation to the external environment. These areas shall be regularly monitored for compliance with required specifications;
(v) provided with drainage system, as specified for the various categories of products, which shall be of adequate size and so designed as to prevent back- flow and/or prevent insects and rodents entering the premises. Open channels shall be avoided in manufacturing areas and, where provided, these shall be shallow to facilitate cleaning and disinfection;
(vi) the walls and floors of the areas where manufacture of drugs is carried out shall be free from cracks and open joints to avoid accumulation of dust. These shall be smooth, washable, coved and shall permit easy and effective cleaning and disinfection. The interior surfaces shall not shed particles. A periodical record of cleaning and painting of the premises shall be maintained.
1.3 Water System. – There shall be validt. system for treatment of water drawn from own or any other source to render it potable in accordance with standards specified by the Bureau of Indian Standards or Local Municipality, as the case may be, so as to produce Purified Water conforming to Pharmacopoeial specification. Purified Water so produced shall only be used for all the operations except washing and cleaning operations where potable water may be used. Water shall be stored in tanks, which do not adversely affect quality of water and ensure freedom from microbiological growth. The tank shall be cleaned periodically and records maintained by the licensee in this behalf.
1.4. Disposal of waste. –
(i) The disposal of sewage and effluents (solid, liquid and gas) from the manufactory shall be in conformity with the requirements of Environment Pollution Control Board.
(ii) All bio-medical waste shall be destroyed as per the provisions of the Bio- Medical Waste (Management and Handling) Rules, 1996.
(iii) Additional precautions shall be taken for the storage and disposal of rejected drugs. Records shall be maintained for all disposal of waste.
(iv) Provisions shall be made for the proper and safe storage of waste materials awaiting disposal. Hazardous, toxic substances and flammable materials shall be stored in suitably designed and segregated, enclosed areas in conformity with Central and State Legislations.
2. Warehousing Area:
2.1 Adequate areas shall be designed to allow sufficient and orderly warehousing of various categories of materials and products like starting and packaging materials, intermediates, bulk and finished products, products in quarantine, released, rejected, returned or recalled, machine and equipment spare parts and change items.
2.2 Warehousing areas shall be designed and adapted to ensure good storage conditions. They shall be clean, dry and maintained with acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity), these shall be provided, monitored and recorded. Storage areas shall have appropriate house-keeping and rodent, pests and vermin control procedures and records maintained. Proper racks, bins and platforms shall be provided for the storage of materials.
2.3 Receiving and dispatch bays shall protect materials and products from adverse weather conditions.
2.4. Where quarantine status is ensured by warehousing in separate earmarked areas in the same warehouse or store, these areas shall be clearly demarcated. Any system replacing the physical quarantine, shall give equivalent assurance of segregation. Access to these areas shall be restricted to authorized persons.
2.5. There shall be a separate sampling area in the warehousing area for active raw materials and excipients. If sampling is performed in any other area, it shall be conducted in such a way as to prevent contamination, cross-contamination and mix-up.
2.6. Segregation shall be provided for the storage of rejected, recalled or returned materials or products. Such areas, materials or products shall be suitably marked and secured. Access to these areas and materials shall be restricted.
2.7. Highly hazardous, poisonous and explosive materials such as narcotics, psychotropic drugs and substances presenting potential risks of abuse, fire or explosion shall be stored in safe and secure areas. Adequate fire protection measures shall be provided in conformity with the rules of the concerned civic authority.
2.8. Printed packaging materials shall be stored in safe, separate and secure areas.
2.9. Separate dispensing areas for β (Beta) lactum, Sex Hormones and Cytotoxic substances or any such special categories of product shall be provided with proper supply of filtered air and suitable measures for dust control to avoid contamination. Such areas shall be under differential pressure.
2.10. Sampling and dispensing of sterile materials shall be conducted under aseptic conditions conforming to Grade A, which can also be performed in a dedicated area within the manufacturing facility.
2.11. Regular checks shall be made to ensure adequate steps are taken against spillage, breakage and leakage of containers.
2.12. Rodent treatments (Pest control) should be done regularly and at least once in a year and record maintained.
3. Production area:
3.1. The production area shall be designed to allow the production preferably in uni-flow and with logical sequence of operations.
3.2. In order to avoid the risk of corss-contamination, separate dedicated and self- contained facilities shall be made available for the production of sensitive pharmaceutical products like penicillin or biological preparations with live micro-organisms. Separate dedicated facilities shall be provided for the manufacture of contamination causing and potent products such as Beta-Lactum, Sex Hormones and Cytotoxic substances.
3.3. Working and in-process space shall be adequate to permit orderly and logical positioning of equipment and materials and movement of personnel to avoid cross- contamination and to minimize risk of omission or wrong application of any manufacturing and control measures.
3.4. Pipe-work, electrical fittings, ventilation openings and similar service lines shall be designed, fixed and constructed to avoid 1[accumulation of dust]. Service lines shall preferably be identified by colours and the nature of the supply and direction of the flow shall be marked/indicated.
4. Ancillary Areas:
4.1 Rest and refreshment rooms shall be separate from other areas. These areas shall not lead directly to the manufacturing and storage areas.
4.2 Facilities for changing, storing clothes and for washing and toilet purposes shall be easily accessible and adequate for the number of users. Toilets, separate for males and females, shall not be directly connected with production or storage areas. There shall be written instructions for cleaning and disinfection of such areas.
4.3 Maintenance workshops shall be separate and away from production areas. Whenever spares, changed parts and tools are stored in the production area, these shall be kept in dedicated rooms or lockers. Tools and spare parts for use in sterile areas shall be disinfected before these are carried inside the production areas.
4.4. Areas housing animals shall be isolated from other areas. The other requirements regarding animal houses shall be those as prescribed in rule 150-C(3) of the Drugs and Cosmetics Rules, 1945 which shall be adopted for production purposes.
5. Quality Control Area.
5.1. Quality Control Laboratories shall be independent of the production areas. Separate areas shall be provided each for physico-chemical, biological, microbiological or radio-isotope analysis. Separate instrument room with adequate area shall be provided for sensitive and sophisticated instruments employed for analysis.
5.2 Quality Control Laboratories shall be designed appropriately for the operations to be carried out in them. Adequate space shall be provided to avoid mix-ups and cross-contamination. Sufficient and suitable storage space shall be provided for test samples, retained samples, reference standards, reagents and records.
5.3. The design of the laboratory shall take into account the suitability of construction materials and ventilation. Separate air handling units and other requirements shall be provided for biological, microbiological and radioisotopes testing areas. The laboratory shall be provided with regular supply of water of appropriate quality for cleaning and testing purposes.
5.4. Quality Control Laboratory shall be divided into separate sections i.e. for chemical, microbiological and wherever required, biological testing. These shall have adequate area for basic installation and for ancillary purposes. The microbiology section shall have arrangements such as airlocks and laminar air flow work station, wherever considered necessary.
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1. Subs. by G.S.R. 431(E), dt. 30.6.2005.
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6. Personnel:
6.1. The manufacture shall be conducted under the direct supervision of competent technical staff with prescribed qualifications and practical experience in the relevant dosage form and / or active pharmaceutical products.
6.2 The head of the Quality Control Laboratory shall be independent of the manufacturing unit. The testing shall be conducted under the direct supervision of competent technical staff who shall be whole time employees of the licensee.
6.3. Personnel for Quality Assurance and Quality Control operations shall be suitably qualified and experienced.
6.4. Written duties of technical and Quality Control personnel shall be laid and followed strictly.
6.5. Number of personnel employed shall be adequate and in direct proportion to the workload.
6.6. The licensee shall ensure in accordance with a written instruction that all personnel in production area or into Quality Control Laboratories shall receive training appropriate to the duties and responsibility assigned to them. They shall be provided with regular in-service training.
7. Health, clothing and sanitation of workers:
7.1 The personnel handling Beta-lactum antibiotics shall be tested for Penicillin sensitivity before employment and those handling sex hormones, cytotoxic substances and other potent drugs shall be periodically examined for adverse effects. These personnel should be moved out of these sections (except in dedicated facilities), by rotation, as a health safeguard.
7.2 Prior to employment, all personnel, shall undergo medical examination including eye examination, and shall be free from Tuberculosis, skin and other communicable or contagious diseases. Thereafter, they should be medically examined periodically, at least once a year. Records shall be maintained thereof. The licensee shall provide the services of a qualified physician for assessing the health status of personnel involved in different activities.
7.3 All persons prior to and during employment shall be trained in practices which ensure personnel hygiene. A high level of personal hygiene shall be observed by all those engaged in the manufacturing processes. Instructions to this effect shall be displayed in change- rooms and other strategic locations.
7.4 No person showing, at any time, apparent illness or open lesions which may adversely affect the quality of products, shall be allowed to handle starting materials, packaging materials, in-process materials, and drug products until his condition is no longer judged to be a risk.
7.5 All employees shall be instructed to report about their illness or abnormal health condition to their immediate supervisor so that appropriate action can be taken.
7.6 Direct contact shall be avoided between the unprotected hands of personnel and raw materials, intermediate or finished, unpacked products.
7.7 All personnel shall wear clean body coverings appropriate to their duties. Before entry into the manufacturing area, there shall be change rooms separate for each sex with adequate facilities for personal cleanliness such as wash basin with running water, 1[clean towels or hand dryers], soaps, disinfectants, etc. The change rooms shall be provided with cabinets for the storage of personal belongings of the personnel.
7.8 Smoking, eating, drinking, chewing or keeping plants, food, drink and personal medicines shall not be permitted in production, laboratory, storage and other areas where they might adversely influence the product quality.
8. Manufacturing Operations and Control:
8.1 All manufacturing operations shall be carried out under the supervision of technical staff approved by the Licensing Authority. Each critical step in the process relating to the selection, weighing and measuring of raw material addition during various stages shall be performed by trained personnel under the direct personal supervision of approved technical staff.
The contents of all vessels and containers used in manufacture and storage during the various manufacturing stages shall be conspicuously labelled with the name of the product, batch number, batch size and stage of manufacture. Each label should be initialled and dt. by the authorised technical staff.
Products not prepared under aseptic conditions are required to be free from pathogens like Salmonella, Escherichia coli, Pyocyanea, etc.
8.2. Precautions against mix-up and cross-contamination:
8.2.1. The licensee shall prevent mix-up and cross-contamination of drug material and drug product (from environmental dust) by proper air-handling system, pressure differential, segregation, status labelling and cleaning. Proper records and Standard Operating Procedures thereof shall be maintained.
8.2.2 The licensee shall ensure processing of sensitive drugs like Beta-Lactum antibiotics, sex hormones and cytotoxic substances in segregated areas or isolated production areas within the building with independent air-handling unit and proper pressure differentials. 1[The effective segregation of these areas shall be validated with adequate records of maintenance and services].
8.2.3 To prevent mix-ups during production stages, material under process shall be conspicuously labelled to demonstrate their status. All equipment used for production shall be labelled with their current status.
8.2.4 Packaging lines shall be independent and adequately segregated. It shall be ensured that all left-overs of the previous packaging operations, including labels, cartons and caps are cleared before the closing hour.
8.2.5 Before packaging operations are begun, steps shall be taken to ensure that the work area, packaging lines, printing machines, and other equipment are clean and free from any products, materials and spillages. The line clearance shall be performed according to an approximate check list and recorded.
8.2.6 The correct details of any printing (for example of batch numbers or expiry dates) done separately or in the course of the packaging shall be rechecked at regular intervals. All printing and overprinting shall be authorized in writing.
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1. Subs. by G.S.R. 431(E), dt. 30.6.2005.
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8.2.7 The manufacturing environment shall be maintained at the required levels of temperature, humidity and cleanliness.
8.2.8 Authorised persons shall ensure change-over into specific uniforms before undertaking any manufacturing operations including packaging.
8.2.9 1[There shall be segregated secured areas for recalled or rejected material and for such material which are to be reprocessed or recovered.]
9. Sanitation in the Manufacturing Premises:
9.1 The manufacturing premises shall be cleaned and maintained in an orderly manner, so that it is free from accumulated waste, dust, debris and other similar material. A validt. cleaning procedure shall be maintained.
9.2 The manufacturing areas shall not be used for storage of materials, except for the material being processed. It shall not be used as a general thoroughfare.
9.3 A routine sanitation program shall be drawn up and observed, which shall be properly recorded and which shall indicate–
(a) specific areas to be cleaned and cleaning intervals;
(b) cleaning procedure to be followed, including equipment and materials to be used for cleaning; and
(c) personnel assigned to and responsible for the cleaning operation.
9.4 The adequacy of the working and in-process storage space shall permit the orderly and logical positioning of equipment and materials so as to minimize the risk of mix- up between different pharmaceutical products or their components to avoid cross contamination, and to minimise the risk of omission or wrong application of any of the manufacturing or control steps.
9.5 Production areas shall be well lit, particularly where visual on-line controls are carried out.
10. Raw Materials:
10.1 The licensee shall keep an inventory of all raw materials to be used at any stage of manufacture of drugs and maintain records as per Schedule U.
10.2 All incoming materials shall be quarantined immediately after receipt or processing. All materials shall be stored under appropriate conditions and in an orderly fashion to permit batch segregation and stock rotation by a ‘first in/first expiry‘ – ‘first-out‘ principle. All incoming materials shall be checked to ensure that the consignment corresponds to the order placed.
10.3 All incoming materials shall be purchased from approved sources under valid purchase vouchers. Wherever possible, raw materials should be purchased directly from the producers.
10.4 Authorized staff appointed by the licensee in this behalf, which may include personnel from the Quality Control Department, shall examine each consignment on receipt and shall check each container for integrity of package and seal. Damaged containers shall be identified, recorded and segregated.
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1. Subs. by G.S.R. 431(E), dt. 30.6.2005.
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10.5 If a single delivery of material is made up of different batches, each batch shall be considered as a separate batch for sampling, testing and release.
10.6 Raw materials in the storage area shall be appropriately labelled. Labels shall be clearly marked with the following information:
(a) designated name of the product and the internal code reference, where applicable, and analytical reference number;
(b) manufacturer‘s name, address and batch number;
(c) the status of the contents (e.g. quarantine, under test, released, approved, rejected); and
(d) the manufacturing date, expiry date and re-test date.
10.7 There shall be adequate separate areas for materials “under test”, “approved” and “rejected” with arrangements and equipment to allow dry, clean and orderly placement of stored materials and products, wherever necessary, under controlled temperature and humidity.
10.8 Containers from which samples have been drawn shall be identified.
10.9 Only raw materials which have been released by the Quality Control Department and which are within their shelf-life shall be used. It shall be ensured that shelf life of formulation product shall not exceed with that of active raw materials used.
10.10 It shall be ensured that all the containers of raw materials are placed on the raised platforms/racks and not placed directly on the floor.
11. Equipment:
11.1 Equipment shall be located, designed, constructed, adapted and maintained to suit the operations to be carried out. The layout and design of the equipment shall aim to minimise the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt and, in general, any adverse effect on the quality of products. Each equipment shall be provided with a logbook, wherever necessary.
11.2 Balances and other measuring equipment of an appropriate range, accuracy and precision shall be available in the raw material stores, production and in-process control operations and these shall be calibrated and checked on a scheduled basis in accordance with Standard Operating Procedures and records maintained.
11.3 The parts of the production equipment that come into contact with the product shall not be reactive, additive or adsorptive to an extent that would affect the quality of the product.
11.4 To avoid accidental contamination, wherever possible, non-toxic/edible grade lubricants shall be used and the equipment shall be maintained in a way that lubricants do not contaminate the products being produced.
11.5 Defective equipment shall be removed from production and Quality Control areas or appropriately labelled.
12. Documentation and Records:– Documentation is an essential part of the Quality assurance system and, as such, shall be related to all aspects of Good Manufacturing Practices (GMP). Its aim is to define the specifications for all materials, method of manufacture and control, to ensure that all personnel concerned with manufacture know the information necessary to decide whether or not to release a batch of a drug for sale and to provide an audit trail that shall permit investigation of the history of any suspected defective batch.
12.1 Documents designed, prepared, reviewed and controlled, wherever applicable, shall comply with these rules.
12.2 Documents shall be approved, signed and dt. by appropriate and authorized persons.
12.3 Documents shall specify the title, nature and purpose. They shall be laid out in an orderly fashion and be easy to check. Reproduced documents shall be clear and legible. Documents shall be regularly reviewed and kept up to date. Any alteration made in the entry of a document shall be signed and dt..
12.4 The records shall be made or completed at the time of each operation in such a way that all significant activities concerning the manufacture of pharmaceutical products are traceable. Records and associated Standard Operating Procedures (SOP) shall be retained for at least one year after the expiry date of the finished product.
12.5 Data may be recorded by electronic data processing systems or other reliable means, but Master Formulae and detailed operating procedures relating to the system in use shall also be available in a hard copy to facilitate checking of the accuracy of the records. Wherever documentation is handled by electronic data processing methods, authorized persons shall enter or modify data in the computer. There shall be record of changes and deletions. Access shall be restricted by ‘passwords‘ or other means and the result of entry of critical data shall be independently checked. Batch records electronically stored shall be protected by a suitable back-up. During the period of retention, all relevant data shall be readily available.
13. Labels and other Printed Materials:– Labels are absolutely necessary for identification of the drugs and their use. The printing shall be done in bright colours and in a legible manner. The label shall carry all the prescribed details about the product.
13.1 All containers and equipment shall bear appropriate labels. Different colour coded labels shall be used to indicate the status of a product (for example under test, approved, passed, rejected).
13.2 To avoid chance mix-up of printed packaging materials, product leaflets, relating to different products, shall be stored separately.
13.3 Prior to release, all labels for containers, cartons and boxes and all circulars, inserts and leaflets shall be examined by the Quality Control Department of the licensee.
13.4 Prior to packaging and labelling of a given batch of a drug, it shall be ensured by the licensee that samples are drawn from the bulk and duly tested, approved and released by the quality control personnel.
13.5 Records of receipt of all labelling and packaging materials shall be maintained for each shipment received indicating receipt, control reference numbers and whether accepted or rejected. Unused coded and damaged labels and packaging materials shall be destroyed and recorded.
13.6 The label or accompanying document of reference standards and reference culture shall indicate concentration, lot number, potency, date on which containers was first opened and storage conditions, where appropriate.
14. Quality Assurance:– This is a wide-ranging concept concerning all matters that individually or collectively influence the quality of a product. It is the totality of the arrangements made with the object of ensuring that products are of the quality required for their intended use.
14.1 The system of quality assurance appropriate to the manufacture of pharmaceutical products shall ensure that: –
(a) the pharmaceutical products are designed and developed in a way that takes account of the requirements of Good Manufacturing Practices (hereinafter referred as GMP) and other associated codes such as those of Good Laboratory Practices (hereinafter referred as GLP) and Good Clinical Practices (hereinafter referred as GCP);
(b) adequate arrangements are made for manufacture, supply and use of the correct starting and packaging materials.
(c) adequate controls on starting materials, intermediate products and bulk products and other in-process controls, calibrations, and validations are carried out.
(d) the finished product is correctly processed and checked in accordance with established procedures;
(e) the pharmaceutical products are not released for sale or supplied before authorized persons have certified that each production batch has been produced and controlled in accordance with the requirements of the label claim and any other provisions relevant to production, control and release of pharmaceutical products.
15. Self Inspection and Quality audit:– It may be useful to constitute a self-inspection team supplemented with a quality audit procedure for assessment of all or part of a system with the specific purpose of improving it.
15.1 To evaluate the manufacturer‘s compliance with GMP in all aspects of production and quality control, concept of self-inspection shall be followed. The manufacturer shall constitute a team of independent, experienced, qualified persons from within or outside the company, who can audit objectively the implementation of methodology and procedures evolved. The procedure for self-inspection shall be documented indicating self-inspection results, evaluation, conclusions and recommended corrective actions with effective follow up program. The recommendations for corrective action shall be adopted.
15.2 The program shall be designed to detect shortcomings in the implementation of Good Manufacturing Practice and to recommend the necessary corrective actions. Self- inspections shall be performed routinely and on specific occasions, like when product recalls or repeated rejections occur or when an inspection by the licensing authorities is announced. The team responsible for self-inspection shall consist of personnel who can evaluate the implementation of Good Manufacturing Practice objectively; all recommendations for corrective action shall be implemented.
15.3 Written instructions for self-inspection shall be drawn up which shall include the following:-
(a) Personnel.
(b) Premises including personnel facilities.
(c) Maintenance of buildings and equipment
(d) Storage of starting materials and finished products.
(e) Equipment.
(f) Production and in-process controls.
(g) Quality control.
(h) Documentation.
(i) Sanitation and hygiene.
(j) Validation and revalidation programmes.
(k) Calibration of instruments or measurement systems.
(l) Recall procedures.
(m) Complaints management.
(n) Labels control.
(o) Results of previous self-inspections and any corrective steps taken.
16. Quality Control System.- Quality control shall be concerned with sampling, specifications, testing, documentation, release procedures which ensure that the necessary and relevant tests are actually carried and that the materials are not released for use, nor products released for sale or supply until their quality has been judged to be satisfactory. It is not confined to laboratory operations but shall be involved in all decisions concerning the quality of the product. It shall be ensured that all quality control arrangements are effectively and reliably carried out.The department as a whole shall have other duties such as to establish, evaluate, validate and implement all Quality Control Procedures and methods.
16.1 Every manufacturing establishment shall establish its own quality control laboratory manned by qualified and experienced staff.
16.2 The area of the quality control laboratory may be divided into Chemical, Instrumentation, Microbiological and Biological testing.
16.3 Adequate area having the required storage conditions shall be provided for keeping reference samples. The quality control department shall evaluate, maintain and store reference samples.
16.4 Standard operating procedures shall be available for sampling, inspecting and testing of raw materials, intermediate bulk finished products and packing materials and, wherever necessary, for monitoring environmental conditions.
16.5 There shall be authorized and dt. specifications for all materials, products, reagents and solvents including test of identity, content, purity and quality. These shall include specifications for water, solvents and reagents used in analysis.
16.6 No batch of the product shall be released for sale or supply until it has been certified by the authorized person(s) that it is in accordance with the requirements of the standards laid down.
16.7 Reference/retained samples from each batch of the products manufactured shall be maintained in quantity which is at least twice the quantity of the drug required to conduct all the tests, except sterility and pyrogen/Bacterial Endotoxin Test performed on the active material and the product manufactured. The retained product shall be kept in its final pack or simulated pack for a period of three months after the date of expiry.
16.8 Assessment of records pertaining to finished products shall include all relevant factors, including the production conditions, the results of in-process testing, the manufacturing (including packaging) documentation, compliance with the specification for the finished product, and an examination of the finished pack. Assessment records should be signed by the in-charge of production and countersigned by the authorised quality control personnel before a product is released for sale or distribution.
16.9 Quality control personnel shall have access to production areas for sampling and investigation, as appropriate.
16.10 The quality control department shall conduct stability studies of the products to ensure and assign their shell life at the prescribed conditions of storage. All records of such studies shall be maintained.
16.11 The in-charge of Quality Assurance shall investigate all product complaints and records thereof shall be maintained.
16.12 All instruments shall be calibrated and testing procedures validt. before these are adopted for routine testing. Periodical calibration of instrument and validation of procedures shall be carried out.
16.13 Each specification for raw materials, intermediates, final products, and packing materials shall be approved and maintained by the Quality Control Department. Periodic revisions of the specifications shall be carried out whenever changes are necessary.
16.14 Pharmacopoeia, reference standards, working standards, references, spectra, other reference materials and technical books, as required, shall be available in the Quality Control Laboratory of the licensee.
17. Specification
17.1 For raw materials and packaging materials. – They shall include-
(a) the designated name and internal code reference;
(b) reference, if any, to a pharmacopoeial monograph;
(c) qualitative and quantitative requirements with acceptance limits;
(d) name and address of manufacturer or supplier and original manufacturer of the material;
(e) specimen of printed material;
(f) directions for sampling and testing or reference to procedures;
(g) storage conditions; and
(h) maximum period of storage before re-testing.
17.2 For product containers and closures:–
17.2.1 All containers and closures intended for use shall comply with the pharmacopoeial requirements. Suitable validt. test methods, sample sizes, specifications, cleaning procedure and sterilization procedure, wherever indicated, shall be strictly followed to ensure that these are not reactive, additive, absorptive, or leach to an extent that significantly affects the quality or purity of the drug. No second hand or used containers and closures shall be used.
17.2.2 Whenever bottles are being used, the written schedule of cleaning shall be laid down and followed. Where bottles are not dried after washing, they should be rinsed with de-ionised water or distilled water, as the case may be.
17.3. For in-process and bulk products. – Specifications for in-process material, intermediate and bulk products shall be available. The specifications should be authenticated.
17.4 For finished products. – Appropriate specifications for finished products shall include:-
(a) the designated name of the product and the code reference;
(b) the formula or a reference to the formula and the pharmacopoeial reference;
(c) directions for sampling and testing or a reference to procedures;
(d) a description of the dosage form and package details;
(e) the qualitative and quantitative requirements, with the acceptance limits for release;
(f) the storage conditions and precautions, where applicable, and
(g) the shelf-life.
17.5 For preparation of containers and closures. – The requirements mentioned in the Schedule do not include requirements of machinery, equipments and premises required for preparation of containers and closures for different dosage forms and categories of drugs. The suitability and adequacy of the machinery, equipment and premises shall be examined taking into consideration the requirements of each licensee in this respect.
18. Master Formula Records:
There shall be Master Formula records relating to all manufacturing procedures for each product and batch size to be manufactured. These shall be prepared and endorsed by the competent technical staff i.e. head of production and quality control. The Master Formula shall include:-
(a) the name of the product together with product reference code relating to its specifications;
(b) the patent or proprietary name of the product along with the generic name, a description of the dosage form, strength, composition of the product and batch size;
(c) name, quantity, and reference number of all the starting materials to be used. Mention shall be made of any substance that may ‘disappear‘ in the course of processing.
(d) a statement of the expected final yield with the acceptable limits, and of relevant intermediate yields, where applicable.
(e) a statement of the processing location and the principal equipment to be used.
(f) the methods, or reference to the methods, to be used for preparing the critical equipments including cleaning, assembling, calibrating, sterilizing;
(g) detailed stepwise processing instructions and the time taken for each step;
(h) the instructions for in-process control with their limits;
(i) the requirements for storage conditions of the products, including the container, labelling and special storage conditions where applicable;
(j) any special precautions to be observed;
(k) packing details and specimen labels.
19. Packing Records:
There shall be authorised packaging instructions for each product, pack size and type.
These shall include or have a reference to the following:-
(a) name of the product;
(b) description of the dosage form, strength and composition;
(c) the pack size expressed in terms of the number of doses, weight or volume of the product in the final container;
(d) complete list of all the packaging materials required for a standard batch size, including quantities, sizes and types with the code or reference number relating to the specifications of each packaging material.;
(e) reproduction of the relevant printed packaging materials and specimens indicating where batch number and expiry date of the product have been applied;
(f) special precautions to be observed, including a careful examination of the area and equipment in order to ascertain the line clearance before the operations begin.
(g) description of the packaging operation, including any significant subsidiary operations and equipment to be used;
(h) details of in-process controls with instructions for sampling and acceptance; and
(i) upon completion of the packing and labelling operation, a reconciliation shall be made between number of labelling and packaging units issued, number of units labelled, packed and excess returned or destroyed. Any significant or unusual discrepancy in the numbers shall be carefully investigated before releasing the final batch.
20. Batch Packaging Records:
20.1 A batch packaging record shall be kept for each batch or part batch processed. It shall be based on the relevant parts of the packaging instructions, and the method of preparation of such records shall be designed to avoid transcription errors.
20.2 Before any packaging operation begins, check shall be made and recorded that the equipment and the work stations are clear of the previous products, documents or materials not required for the planned packaging operations, and that the equipment is clean and suitable for use.
21. Batch Processing Records
21.1 There shall be Batch Processing Record for each product. It shall be based on the relevant parts of the currently approved Master Formula. The method of preparation of such records included in the Master Formula shall be designed to avoid transcription errors.
21.2 Before any processing begins, check shall be performed and recorded to ensure that the equipment and work station are clear of previous products, documents or materials not required for the planned process are removed and the equipment is clean and suitable for use.
21.3 During processing, the following information shall be recorded at the time each action is taken and the record shall be dt. and signed by the person responsible for the processing operations:-
(a) the name of the product,
(b) the number of the batch being manufactured,
(c) dates and time of commencement, of significant intermediate stages and of completion of production,
(d) initials of the operator of different significant steps of production and where appropriate, of the person who checked each of these operations,
(e) the batch number and/or analytical control number as well as the quantities of each starting material actually weighed,
(f) any relevant processing operation or event and major equipment used,
(g) a record of the in-process controls and the initials of the person(s) carrying them out, and the results obtained,
(h) the amount of product obtained after different and critical stages of manufacture (yield),
(i) comments or explanations for significant deviations from the expected yield limits shall be given,
(j) notes on special problems including details, with signed authorization, for any deviation from the Master Formula,
(k) addition of any recovered or reprocessed material with reference to recovery or reprocessing stages.
22. Standard Operating Procedures (SOPs) and Records, regarding:
22.1 Receipt of materials:
22.1.1 There shall be written Standard Operating Procedures and records for the receipt of each delivery of raw, primary and printed packaging material.
22.1.2 The records of the receipts shall include;
(a) the name of the material on the delivery note and the number of containers;
(b) the date of receipt;
(c) the manufacturer‘s and/ or supplier‘s name;
(d) the manufacturer‘s batch or reference number;
(e) the total quantity, and number of containers, quantity in each container received;
(f) the control reference number assigned after receipt;
(g) any other relevant comment or information.
22.1.3 There shall be written standard operating procedures for the internal labelling, quarantine and storage of starting materials, packaging materials and other materials, as appropriate.
22.1.4 There shall be Standard Operating Procedures available for each instrument and equipment and these shall be placed in close proximity to the related instrument and equipment.
22.2 Sampling:
22.2.1 There shall be written Standard Operating Procedures for sampling which include the person(s) authorized to take the samples.
22.2.2 The sampling instructions shall include:
(a) the method of sampling and the sampling plan,
(b) the equipment to be used,
(c) any precautions to be observed to avoid contamination of the material or any deterioration in its quality,
(d) the quantity of samples to be taken,
(e) instructions for any required sub-division or pooling of the samples,
(f) the types of sample container to be used,
(g) any specific precautions to be observed, especially in regard to sampling of sterile and hazardous materials.
22.3. Batch Numbering:
22.3.1 There shall be Standard Operating Procedures describing the details of the batch (lot) numbering set up with the objective of ensuring that each batch of intermediate, bulk or finished product is identified with a specific batch number.
22.3.2 Batch numbering Standard Operating Procedures applied to a processing stage and to the respective packaging stage shall be same or traceable to demonstrate that they belong to one homogenous mix.
22.3.3 Batch number allocation shall be immediately recorded in a logbook or by electronic data processing system. The record shall include date of allocation, product identity and size of batch.
22.4. Testing:
22.4.1 There shall be written procedures for testing materials and products at different stages of manufacture, describing the methods and equipment to be used. The tests performed shall be recorded.
22.5 Records of analysis:
22.5.1 The records shall include the following data:
(a) name of the material or product and the dosage form,
(b) batch number and, where appropriate the manufacturer and/ or supplier,
(c) references to the relevant specifications and testing procedures,
(d) test results, including observations and calculations, and reference to any specifications (limits),
(e) dates of testing,
(f) initials of the persons who performed the testing,
(g) initials of the persons who verified the testing and the detailed calculations,
(h) a statement of release or rejection, and
(i) signature and date of the designated responsible person.
22.5.2 There shall be written standard operating procedures and the associated records of actions taken for:
(a) equipment assembly and validation
(b) analytical apparatus and calibration,
(c) maintenance, cleaning and sanitation;
(d) personnel matters including qualification, training, clothing, hygiene;
(e) environmental monitoring;
(f) pest control;
(g) complaints;
(h) recalls made; and
(i) returns received.
23. Reference Samples:-
23.1 Each lot of every active ingredient, in a quantity sufficient to carry out all the tests, except sterility and pyrogens/Bacterial Endotoxin Test, shall be retained for a period of 3 months after the date of expiry of the last batch produced from that active ingredient.
23.2. Samples of finished formulations shall be stored in the same or simulated containers in which the drug has been actually marketed.
24. Reprocessing and Recoveries:
24.1. Where reprocessing is necessary, written procedures shall be established and approved by the Quality Assurance Department that shall specify the conditions and limitations of repeating chemical reactions. Such reprocessing shall be validt..
24.2. If the product batch has to be reprocessed, the procedure shall be authorized and recorded. An investigation shall be carried out into the causes necessitating re- processing and appropriate corrective measures shall be taken for prevention of recurrence. Re-processed batch shall be subjected to stability evaluation.
24.3. Recovery of the product residue may be carried out, if permitted, in the master production and control records by incorporating it in subsequent batches of the product.
25. Distribution records:
25.1. Prior to distribution or dispatch of given batch of a drug, it shall be ensured that the batch has been duly tested, approved and released by the quality control personnel. Pre-dispatch inspection shall be performed on each consignment on a random basis to ensure that only the correct goods are dispatched. Detailed instructions for warehousing and stocking of Large Volume Parenterals, if stocked, shall be in existence and shall be complied with after the batch is released for distribution. Periodic audits of warehousing practices followed at distribution centers shall be carried out and records thereof shall be maintained. Standard Operating Procedures shall be developed for warehousing of products.
25.2. Records for distribution shall be maintained in a manner 1[so as] to facilitate prompt and complete recall of the batch, if and when necessary.
26. Validation and process validation:
26.1. Validation studies shall be an essential part of Good Manufacturing Practices and shall be conducted as per the pre-defined protocols. These shall include validation of processing, testing and cleaning procedures.
26.2. A written report summarizing recorded results and conclusions shall be prepared, documented and maintained.
26.3. Processes and procedures shall be established on the basis of validation study and undergo periodic revalidation to ensure that they remain capable of achieving the intended results. Critical processes shall be validt., prospectively or retrospectively.
26.4. When any new Master Formula or method of preparation is adopted, steps shall be taken to demonstrate its suitability for routine processing. The defined process, using the materials and equipment specified shall be demonstrated to yield a product consistently of the required quality.
26.5. Significant changes to the manufacturing process, including any change in equipment or materials that may affect product quality and/or the reproducibility of the process, shall be validt..
_________
1. Subs. by G.S.R. 431(E), dt. 30.6.2005. for ” such that finished batch of a drug can be traced to the retail level”.
_________
27. Product Recalls:
27.1 A prompt and effective product recall system of defective products shall be devised for timely information of all concerned stockists, wholesalers, suppliers, upto the retail level within the shortest period. The licensee may make use of both print and electronic media in this regard.
27.2. There shall be an established written procedure in the form of Standard Operating Procedure for effective recall of products distributed by the licensee. Recall operations shall be capable of being initiated promptly so as to effectively reach at the level of each distribution channel.
27.3 The distribution records shall be readily made available to the persons designated for recalls.
27.4 The designated person shall record a final report issued, including reconciliation between the delivered and the recovered quantities of the products.
27.5 The effectiveness of the arrangements for recalls shall be evaluated from time to time.
27.6 The recalled products shall be stored separately in a secured segregated area pending final decision on them.
28. Complaints and Adverse Reactions:.
28.1 All complaints thereof concerning product quality shall be carefully reviewed and recorded according to written procedures. Each complaint shall be investigated/evaluated by the designated personnel of the company and records of investigation and remedial action taken thereof shall be maintained.
28.2. Reports of serious adverse drug reactions resulting from the use of a drug along with comments and documents shall be forthwith reported to the concerned licensing authority.
28.3 There shall be written procedures describing the action to be taken, recall to be made of the defective product.
29. Site Master File.– The licensee shall prepare a succinct document in the form of ‘Site Master File‘ containing specific and factual Good Manufacturing Practices about the production and/or control of pharmaceutical manufacturing preparations carried out at the licensed premises. It shall contain the following:-
29.1 General information:
(a) brief information of the firm;
(b) pharmaceutical manufacturing activities as permitted by the licensing authority;
(c) other manufacturing activities, if any, carried out on the premises;
(d) type of products licensed for manufacture with flow charts mentioning procedure and process flow;
(e) number of employees engaged in the production, quality control, storage and distribution;
(f) use of outside scientific, analytical or other technical assistance in relation to manufacture and analysis;
(g) short description of the Quality Management System of the firm; and
(h) products details registered with foreign countries.
29.2 Personnel:
(a) organisational chart showing the arrangement for quality assurance including production and quality control;
(b) qualification, experience and responsibilities of key personnel;
(c) outline for arrangements for basic and in-service training and how the records are maintained;
(d) health requirements for personnel engaged in production; and
(e) personnel hygiene requirements, including clothing.
29.3 Premises:
(a) simple plan or description of manufacturing areas drawn to scale;
(b) nature of construction and fixtures/fittings;
(c) brief description of ventilation systems. More details should be given for critical areas with potential risk of airborne contamination (schematic drawing of systems). Classification of the rooms used for the manufacture of sterile products should be mentioned;
(d) special areas for the handling of the highly toxic, hazardous and sensitizing materials;
(e) brief description of water system (schematic drawings of systems), including sanitation;
(f) description of planned preventive maintenance programs for premises and of the recording system.
29.4 Equipment:
(a) brief description of major equipment used in production and Quality Control Laboratories (a list of equipment required);
(b) description of planned preventive maintenance programs for equipment and of the recording system; and
(c) qualification and calibration including the recording systems and arrangements for computerized systems validation.
29.5 Sanitation:
(a) availability of written specifications and procedures for cleaning manufacturing areas and equipment.
29.6 Documentation. –
(a) arrangements for the preparation, revision and distribution of;
(b) necessary documentation for the manufacture;
(c) any other documentation related to product quality that is not mentioned elsewhere (e.g. microbiological controls about air and water).
29.7 Production:.
(a) brief description of production operations using, wherever possible, flow sheets and charts specifying important parameters;
(b) arrangements for the handling of starting materials, packaging materials, bulk and finished products, including sampling, quarantine, release and storage;
(c) arrangements for the handling of rejected materials and products;
(d) brief description of general policy for process validation.
29.8 Quality Control:
(a) description of the quality control system and of the activities of the Quality Control Department. Procedures for the release of the finished products.
29.9 Loan licence manufacture and licensee:
(a) description of the way in which compliance of Good Manufacturing Practices by the loan licensee shall be assessed.
29.10 Distribution, complaints and product recall:
(a) arrangements and recording system for distribution;
(b) arrangements for the handling of complaints and product recalls.
29.11 Self inspection. –
(a) short description of the self-inspection system indicating whether an outside, independent and experienced external expert was involved in evaluating the manufacturer‘s compliance with Good manufacturing Practices in all aspects of production.
29.12 Export of drugs. –
(a) products exported to different countries;
(b) complaints and product recall, if any.
PART IA
SPECIFIC REQUIREMENTS FOR MANUFACTURE OF STERILE PRODUCTS, PARENTERAL PREPARATIONS (SMALL VOLUME INJECTABLES AND LARGE VOLUME PARENTERALS) AND STERILE OPHTHALMIC PREPARATIONS.
Note.- The general requirements as given in Part 1 of this Schedule relating to Requirements of Good Manufacturing Practices for Premises and Materials for pharmaceutical products shall be complied with, mutatis mutandis, for the manufacture of sterile products, Parenteral preparations (Small Volume Injectables and Large Volume Parenterals) and Sterile Ophthalmic Preparations. In addition to these requirements, the following specific requirements shall also be followed, namely:-
1. General :
Sterile products, being very critical and sensitive in nature, a very high degree of precautions, prevention and preparations are needed. Dampness, dirt and darkness are to be avoided to ensure aseptic conditions in all areas. There shall be strict compliance in the prescribed standards especially in the matter of supply of water, air, active materials and in the maintenance of hygienic environment.
2. Buildings and Civil Works:
2.1 The buildings shall be built on proper foundation with standardized materials to avoid cracks in critical areas like aseptic solution preparation, filling and sealing rooms.
2.2 Location of services like water, steam, gases etc. shall be such that their servicing or repair shall not pose any threat to the integrity of the facility. Water lines shall not pose any threat of leakage to aseptic area.
2.3. The manufacturing areas shall be clearly separated into support areas (e.g. washing and component preparation areas, storage areas etc.), preparation areas (e.g. bulk manufacturing area, non-aseptic blending areas etc.) change areas and aseptic areas. Operations like removal of outer cardboard wrappings of primary packaging materials shall be done in the de-cartoning areas which are segregated from the washing areas. Wooden pallets, fiber board drums, cardboard and other particle shedding materials shall not be taken inside the preparation areas.
2.4. In aseptic areas –
(a) walls, floors and ceiling should be impervious, non-shedding, non-flaking and non-cracking. Flooring should be unbroken and provided with a cove both at the junction between the wall and the floor as well as the wall and the ceiling.
(b) walls shall be flat, and ledges and recesses shall be avoided. Wherever other surfaces join the wall (e,g, sterilizers, electric sockets, gas points etc.) these shall flush the walls. Walls shall be provided with a cove at the joint between the ceiling and the floor;
(c) ceiling shall be solid and joints shall be sealed. Light-fittings and air-grills shall flush with the walls and not hanging from the ceiling, so as to prevent contamination;
(d) there shall be no sinks and drains in Grade A and Grade B areas;
(e) doors shall be made of non-shedding material. These may be made preferably of Aluminium or Steel material. Wooden doors shall not be used. Doors shall open towards the higher-pressure area so that they close automatically due to air pressure;
(f) Windows shall be made of similar material as the doors, preferably with double panel and shall be flush with the walls. If fire escapes are to be provided, these shall be suitably fastened to the walls without any gaps;
(g) The furniture used shall be smooth, washable and made of stainless steel or any other appropriate material other than wood.
2.5. The manufacturing and support areas shall have the same quality of civil structure described above for aseptic areas, except the environmental standards which may vary in the critical areas.
2.6 Change rooms with entrance in the form of air-locks shall be provided before entry into the sterile product manufacturing areas and then to the aseptic area. Separate exit space from the aseptic areas is advisable. Change rooms to the aseptic areas shall be clearly demarcated into ‘black‘. ‘grey‘, and ‘white rooms‘ with different levels of activity and air cleanliness. The ‘black‘ change room shall be provided with a hand-washing sink. The sink and its drain in the un-classified (first) change rooms may be kept clean all the time. The specially designed drain shall be periodically monitored to avoid presence of pathogenic micro-organisms. Change room doors shall not be opened simultaneously. An appropriate inter-locking system and a visual and/or audible warning system may be installed to prevent the opening of more than one door at a time.
2.7. For communication between aseptic areas and non-aseptic areas, intercom telephones or speak-phones shall be used. These shall be minimum in number.
2.8 Material transfer between aseptic areas and outside shall be through suitable airlocks or pass-boxes. Doors of such airlocks and pass-boxes shall have suitable interlocking arrangements.
2.9. Personal welfare areas like rest rooms, tea room, canteen and toilets shall be outside and separated from the sterile product manufacturing area.
2.10 Animal houses shall be away from the sterile product manufacturing area and shall not share a common entrance or air handling system with the manufacturing area.
3. Air Handling System (Central Air-Conditioning):
3.1 Air Handling Units for sterile product manufacturing areas shall be different from those for other areas. Critical areas, such as the aseptic filling area, sterilized components unloading area and change room conforming to Grades B, C and D respectively shall have separate air handling units. The filter configuration in the air handling system shall be suitably designed to achieve the Grade of air as given in Table1. Typical operational activities for clean areas are highlighted in Table II and Table III.
3.2 For products which are filled aseptically, the filling room shall meet Grade B conditions at rest unmanned. This condition shall also be obtained within a period of about 30 minutes of the personnel leaving the room after completion of operations.
3.3. The filling operations shall take place under Grade A conditions which shall be demonstrated under working of simulated conditions which shall be achieved by providing laminar air flow work stations with suitable HEPA filters or isolator technology.
3.4. For products, which are terminally sterilized, the filling room shall meet Grade C conditions at rest. This condition shall be obtainable within a period of about 30 minutes of the personnel leaving the room after completion of operations.
3.5. Manufacturing and component preparation areas shall meet Grade C conditions.
3.6. After completion of preparation, washed components and vessels shall be protected with 1[Grade D background and should be handled in such a way that they are not recontaminated].
3.7. The minimum air changes for Grade B and Grade C areas shall not be less than 20 air changes per hour in a room with good air flow pattern and appropriate HEPA filters. For Grade A laminar air flow work stations, the air flow rate shall be 0.3 meter per second ± 20% (for vertical flows) and 0.45 meter per second ± 20% (for horizontal flows).
3.8. Differential pressure between areas of different environmental standards shall be at least 15 Pascal (0.06 inches or 1.5 mm water gauge). Suitable manometers or gauges shall be installed to measure and verify pressure differential.
__________
1. Subs. by G.S.R. 431(E), dt. 30.6.2005
__________
3.9 The final change room shall have the same class of air as specified for the aseptic area. The pressure differentials in the change rooms shall be in the descending order from ‘white‘ to ‘black‘.
3.10 Unless there are product specific requirements, temperature and humidity in the aseptic areas 1[shall be 27 ± 2 degree centigrade and relative humidity 55% ± 5, respectively].
1[TABLE I
AIR BORNE PARTICULATE CLASSIFICATION FOR MANUFACTURE OF STERILE PRODUCTS
| Grade |
Maximum number of permitted particles per cubic metre equal t to or above |
|
At rest (b) |
In operation (a) |
|
0.5µm |
5µm |
0.5µm |
5µm |
| A |
3500 |
0 |
3500 |
0 |
| B (a) |
3500 |
0 |
3,50,000 |
2,000 |
| C (a) |
350,000 |
2,000 |
35,00,000 |
20,000 |
| D (a) |
35,00,000 |
20,000 |
Not defined (c) |
Not defined (c)] |
Notes :
(a) In order to reach the B, C and D air grades, the number of air changes shall be related to the size of the room and the equipment and personnel present in the room. The air system shall be provided with the appropriate filters such as HEPA for Grades A, B and C. The maximum permitted number of particles in the “at rest” condition shall approximately be as under:
1[Grade A and B corresponds with class 100 or M 3.5 or class 5]; Grade C with Class 10,000 or M 5.5 or ISO Class 7; Grade D with Class 1,00,000 or M 6.5 or ISO Class 8.
(b) The requirement and limit for the area shall depend on the nature of the operation carried out.
(c) Type of operations to be carried out in the various grades are given in Table II and Table III as under:
TABLE II
TYPES OF OPERATIONS TO BE CARRIED OUT IN THE VARIOUS GRADES FOR ASEPTIC PREPARATIONS
Grade Types of operations for aseptic preparations
A Aseptic preparation and filling
B Background room conditions for activities requiring Grade A
C Preparation of solution to be filtered
D Handling of components after washing
____________
1. Subs. by G.S.R. 431(E), dt. 30.6.2005.
____________
TABLE III
TYPES OF OPERATIONS TO BE CARRIED OUT IN THE VARIOUS GRADES FOR TERMINALLY STERILIZED PRODUCTS
Grade Types of operations for terminally sterilized products.
A Filling of products, which are usually at risk.
C Placement of filling and sealing machines, preparation of solutions when 1[unusually at risk]. Filling of product when unusually at risk.
D Moulding, blowing (pre-forming) operations of plastic containers, preparations of solutions and components for subsequent filling.
4. Environmental Monitoring:
4.1 All environmental parameters listed under para 3.1 to 3.10 shall be verified and established at the time of installation and thereafter monitored at periodic intervals. The recommended frequencies of periodic monitoring shall be as follows :-
(a) Particulate monitoring in air – 6 Monthly.
(b) HEPA filter integrity testing (smoke testing) – Yearly
(c) Air change rates – 6 Monthly.
(d) Air pressure differentials – Daily.
(e) Temperature and humidity – Daily
(f) Microbiological monitoring by settle plates and/or swabs in aseptic areas– Daily, and at decreased frequency in other areas.
`Note: The above frequencies of monitoring shall be changed as per the requirements and load in individual cases.
4.2 There shall be a written environmental monitoring program and microbiological results shall be recorded. Recommended limits for microbiological monitoring of clean areas “in operation” are as given in the table below:
TABLE
RECOMMENDED LIMITS FOR MICROBIOLOGICAL MONITORING OF CLEAN AREAS ” IN OPERATION”
| Grade |
Air sample Cfu/m |
Settle plates (dia. 90mm. Cfu/2 hrs. |
Contact plates (dia. 55mm) cfu per plate |
(five fingers) cfu per glove |
| A |
<1 |
<1 |
<1 |
<1 |
| B |
10 |
5 |
5 |
5 |
| C |
100 |
50 |
25 |
— |
| D |
500 |
100 |
50 |
— |
Notes:
(a) These are average values.
(b) Individual settle plates may be exposed for not less than two hours in Grade B, C and D areas and for not less than thirty minutes in Grade A area.
___________
1. Subs. by G.S.R. 431(E), dt. 30.6.2005.
___________
4.3 Appropriate action shall be taken immediately if the result of particulate and microbiological monitoring indicates that the counts exceed the limits. The Standard Operating Procedures shall contain corrective action. After major engineering modification to the HVAC system of any area, all monitoring shall be re-performed before production commences.
5. Garments.
5.1 This section covers garments required for use by personnel working only in aseptic area. Outdoor clothing shall not be brought into the sterile areas.
5,2 The garments shall be made of non-shedding and tight weave material. Cotton garments shall not be used. The garments shall shed virtually no fibres or particulate matter.
5.3 The clothing and its quality shall be adopted to the process and the work place and worn in such a way as to protect the product from contamination. Garments shall be single piece with fastenings at cuffs, neck and at legs to ensure close fit. Trouser legs shall be tucked inside the cover boots. Suitable design of garments shall either include a hood (head- cover) or a separate hood which can be tucked inside the over-all. Pockets, pleats and belts shall be avoided in garments. Zips (if any) shall be of plastic material. Garments with damaged zips shall not be used.
5.4. Only clean, sterilized and protective garments shall be used at each work session where aseptic filtration and filling operations are undertaken and at each work shift for products intended to be sterilized, post-filling. The mask and gloves shall be changed at every work session in both instances.
5.5 Gloves shall be made of latex or other suitable plastic materials and shall be powder-free. These shall be long enough to cover wrists completely and allow the over-all cuff to be tucked in.
5.6. The footwear shall be of suitable plastic or rubber material and shall be daily cleaned with a bactericide.
5.7. Safety goggles or numbered glasses with side extension shall be used inside aseptic areas. These shall be sanitized by a suitable method.
5.8. Garment changing procedures shall be documented and operators trained in this respect. A full size mirror shall be provided in the final change room for the operator to verify that he is appropriately attired in the garments. Periodic inspection of the garments shall be done by responsible staff.
6. Sanitation:
6.1. There shall be written procedures for the sanitation of sterile processing facilities. Employees carrying out sanitation of aseptic areas shall be trained specifically for this purpose.
6.2. Different sanitizing agent shall be used in rotation and the concentrations of the same shall be as per the recommendations of the manufacturer. Records of rotational use of sanitizing agents shall be maintained.
6.3. Distilled water freshly collected directly from the distilled water plant or water maintained above 70 degree centigrade from the re-circulation loop shall be used for dilution of disinfectants. Alternatively, distilled water sterilized by autoclaving or membrane filtration shall be used. The dilution shall be carried out in the ‘white‘ change room.
6.4. 1[Where alcohol or isopropyl alcohol is used for dilution of disinfectants for use as hand sprays, the preparation of the same shall be done in the bulk preparation area in grade C.]
6.5. Diluted disinfectants shall bear the label ‘use before‘, based on microbiological establishment of the germicidal properties. The solutions shall be adequately labelled and documents maintained.
6.6. Formaldehyde or any other equally effective fumigant is recommended for the fumigation of aseptic areas or after major civil modifications. There shall be Standard Operating Procedures for this purpose. Its use for routine purpose shall be discouraged and an equally effective surface cleaning regime shall be followed.
6.7. Cleaning of sterile processing facilities shall be undertaken with air suction devices or with non-linting sponges or clothes.
6.8. Air particulate quality shall be evaluated on a regular basis and record maintained.
7. Equipment:
7.1 The special equipment required for manufacturing sterile products includes component washing machines, steam sterilizers, dry heat sterilizers, membrane filter assemblies, manufacturing vessels, blenders, liquid filling machines, powder filling machines, sealing and labelling machines, vacuum testing chambers, inspection machines, lyophilisers, pressure vessels etc. Suitable and fully integrated washing sterilizing filling lines may be provided, depending upon the type and volume of activity.
7.2. Unit-sterilizers shall be double-ended with suitable inter-locking arrangements between the doors. The effectiveness of the sterilization process shall be established initially by biological inactivation studies using microbial spore indicators and then at least once a year by carrying out thermal mapping of the chamber. Various sterilization parameters shall be established based on these studies and documented. For membrane filters used for filtration, appropriate filter integrity tests that ensure sterilization shall be carried out before and after filtration.
7.3. Filling machines shall be challenged initially and then at periodic intervals by simulation trials including sterile media fill. Standard Operating Procedures and acceptance criteria for media fills shall be established, justified and documented. Special simulation trial procedures shall be developed, validt. and documented for special products like ophthalmic ointments.
7.4. The construction material used for the parts which are in direct contact with products and the manufacturing vessels may be stainless steel 316 or Boro-silicate glass (if glass containers) and the tubing shall be capable of being washed and autoclaved.
7.5 On procurement, installation qualification of each of the equipment shall be done by engineers with the support of production and quality assurance personnel. Equipment for critical processes like aseptic filling and sterilizers shall be suitably validt. according to a written program before putting them to use.
7.6. Standard Operating Procedures shall be available for each equipment for its calibration and operation and cleaning. Gauges and other measuring devices attached to equipment shall be calibrated at suitable intervals against a written program. Calibration status of equipment gauges shall be adequately documented and displayed.
___________
1. Subs. by G.S.R. 431(E), dt. 30.6.2005.
___________
8. Water and Steam Systems:
8.1. Potable water meeting microbiological specification of not more than 500 cfu/ml and indicating absence of individual pathogenic micro-organisms. Escherichia coli, Salmonella, Staphylococcus aureus and Pseudomonas aeruginosa per 100 ml sample shall be used for the preparation of purified water.
8.2 Purified water prepared by de-mineralization shall meet the microbiological specification of not more than 100 cfu per ml and indicate absence of pathogenic micro- organisms in 100 ml. Purified water shall also meet IP specification for chemical quality. Purified water shall be used for hand washing in change rooms. Containers, closures and machine parts may be washed with potable water followed by suitably filtered purified water. Purified water shall be stored in stainless steel tanks or plastic tanks.
8.3. Water for Injection (hereinafter as WFI) shall be prepared from potable water or purified water meeting the above specifications by distillation. Water for Injection shall meet microbiological specification of not more than 10 cfu per 100 ml. WFI shall also meet IP specification for Water for Injection and shall have an endotoxin level of not more than 0.25 EU/Ml. Bulk solutions of liquid parenterals shall be made in WFI. Final rinse of product containers and machine parts shall be done with WFI. Disinfectant solutions for use in aseptic areas shall be prepared in WFI.
8.4. Water for Injection for the manufacture of liquid injectables shall be freshly collected from the distillation plant or from a storage or circulation loop where the water has been kept at above 70 degree centigrade. At the point of collection, water may be cooled using suitable heat exchanger.
8.5 Water for non-injectable sterile products like eye drops shall meet IP specifications for purified water. In addition, microbiologial specification of not more than 10 cfu per 100 ml and absence of Pseudomonas aeruginosa and Enterobacter coli in 100 ml shall also be met.
8.6. Water for Injection shall be stored in steam jacketed stainless steel tanks of suitable size and the tanks shall have hydrophobic bacterial retention with 0.22 µ vent filters. The filters shall be suitably sterilized at periodic intervals. The distribution lines for purified water and distilled water shall be of stainless steel 316 construction and shall not shed particles.
8.7. There shall be a written procedure and program for the sanitation of different water systems including storage tanks, distribution lines, pumps and other related equipment. Records of sanitation shall be maintained.
8.8. There shall be written microbiological monitoring program for different types of water. The results shall justify the frequency of sampling and testing. Investigation shall be carried out and corrective action taken in case of deviation from prescribed limits.
1[8.9 Steam coming in contact with the product, primary containers and other product contact surfaces shall be sterile and pyrogen free.]
9. Manufacturing Process:
9.1. Manufacture of sterile products shall be carried out only in areas under defined conditions.
___________
1. Omitted by G.S.R. 431(E), dt. 30.6.2005.
___________
9.2. Bulk raw materials shall be monitored for bio-burden periodically. Bio- burden of bulk solution prior to membrane filtration shall be monitored periodically and a limit of not more than 100 cfu per ml is recommended.
9.3 The time between the start of the preparation of the solution and its sterilization or filtration through a micro-organism retaining filter shall be minimized. There shall be a set maximum permissible time for each product that takes into account its composition and method of storage mentioned in the Master formula record.
9.4. Gases coming in contact with the sterile product shall be filtered through two 0.22 µ hydrophobic filters connected in-series. These filters shall be tested for integrity. Gas cylinders shall not be taken inside aseptic areas.
9.5. Washed containers shall be sterilized immediately before use. Sterilized containers, if not used within an established time, shall be rinsed with distilled or filtered purified water and re-sterilized.
9.6. Each lot of finished product shall be filled in one continuous operation. In each case, where one batch is filled in using more than one operation, each lot shall be tested separately for sterility and held separately till sterility test results are known.
9.7. Special care shall be exercised while filling products in powder form so as not to contaminate the environment during transfer of powder to filling machine-hopper.
10. Form-Fill-Seal Technology or Blow, Fill-Seal Technology:
10.1 Form-Fill-Seal units are specially built automated machines in which through one continuous operation, containers are formed from thermoplastic granules, filled and then sealed. Blow, fill-seal units are machines in which containers are moulded / blown (pre- formed) in separate clean rooms, by non-continuous operations.
Note:
(i) These shall be installed in at least Grade C environment.
(ii) These shall comply with the limits as recommended in Table at Item 4.2.
10.2. Form-Fill-Seal/Blow, Fill-Seal machines used for the manufacture of products for terminal sterilization shall be installed in at least Grade C environment and the filling zone within the machine shall fulfil Grade A requirements.
10.3. Terminally sterilized products.–
10.3.1. Preparation of primary packaging material such as glass bottles, ampoules and rubber stoppers shall be done in at least Grade D environment. Where there is unusual risk to the product from microbial contamination, the above operation shall be done in Grade C environment. All the processes used for component preparation shall be validt..
10.3.2. Filling of products requiring terminal sterilization shall be done under Grade A environment with a Grade C background.
10.4 Preparation of solutions, which are to be sterilized by filtration, shall be done in Grade C environment, and if not to be filtered, the preparation of materials and products shall be in a Grade A environment with Grade B in background.
10.5 Filtration (Membrane).-
(i) Solutions for Large Volume Parenterals shall be filtered through a non-fibre releasing, sterilizing grade cartridge/membrane filter of nominal pore size of 0.22 µ for aseptic filling whereas 0.45 µ porosity shall be used for terminally sterilized products.
(ii) A second filtration using another 0.22 µ sterilizing grade cartridge / membrane filter shall be performed immediately prior to filling. Process specifications shall indicate the maximum time during which a filtration system may be used with a view to precluding microbial build-up to levels that may affect the microbiological quality of the Large Volume Parenterals.
(iii) The integrity of the sterilized filter shall be verified and confirmed immediately after use by an appropriate method such as Bubble Point, Diffusive Flow or Pressure Hold Test.
10.6 Sterilization (Autoclaving).–
10.6.1. Before any sterilization process is adopted, its suitability for the product and its efficacy in achieving the desired sterilizing conditions in all parts of each type of load pattern to be processed, shall be demonstrated by physical measurements and by biological indicators, where appropriate.
10.6.2 All the sterilization process shall be appropriately validt.. The validity of the process shall be verified at regular intervals, but at least annually. Whenever significant modifications have been made to the equipment and product, records shall be maintained thereof.
10.6.3 The sterilizer shall be double ended to prevent mix-ups.
10.6.4 Periodic bio-burden monitoring of products before terminal sterilization shall be carried out and controlled to limits specified for the product in the Master Formula.
10.6.5 The use of biological indicators shall be considered as an additional method of monitoring the sterilization. These shall be stored and used according to the manufacturer‘s instructions. Their quality shall be checked by positive controls. If biological indicators used, strict precautions shall be taken to avoid transferring microbial contamination from them.
10.6.6 There shall be clear means of differentiating ‘ sterilized‘ and ‘un-sterilized‘ products. Each basket, tray or other carrier of products or components shall be clearly labelled with the name of the material, its batch number, and sterilization status. Indicators shall be used, where appropriate, to indicate whether a batch (or sub-batch) has passed through the sterilization process.
10.6.7 Sterilization records shall be available for each sterilization-run and may also include thermographs and sterilization monitoring strips. They shall be maintained as part of the batch release procedure.
10.7. Sterilization (By dry heat).–
10.7.1 Each heat sterilization cycle shall be recorded on a time/temperature chart of a suitable size by appropriate equipment of the required accuracy and precision. The position of temperature probes used for controlling and/or recording shall be determined during the validation and, where applicable, shall also be checked against a second independent temperature probe located in the same position. The chart shall form a part of the batch record. Container mapping may also be carried out in the case of Large Volume Parenterals.
10.7.2 Chemical or biological indicators may also be used, but shall not take the place of physical validation.
10.7.3. Sufficient time shall be allowed for the load to reach the required temperature before measurement of sterilization time commences. This time shall be separately determined for each type of load to be processed.
10.7.4. After the high temperature phase of a heat sterilization cycle, precautions shall be taken against contamination of sterilized load during cooling. Any cooling fluid or gas in contact with the product shall be sterilized unless it can be shown that any leaking container would not be approved for use. Air inlet and outlets shall be provided with bacterial retaining filters.
10.7.5. The process used for sterilization by dry heat shall include air-circulation within the chamber and the maintenance of a positive pressure to prevent the entry of non- sterile air. Air inlets and outlets should be provided with micro-organism retaining filters. Where this process of sterilization by dry heat is also intended to remove pyrogens, challenge tests using endotoxins would be required as part of the validation process.
10.8. Sterilization (By Moist Heat).-
10.8.1 Both the temperature and pressure shall be used to monitor the process. Control instrumentation shall normally be independent of monitoring instrumentation and recording charts. Where automated control and monitoring systems are used for these applications, these shall be validt. to ensure that critical process requirements are met. System and cycle faults shall be registered by the system and observed by the operator. The reading of the independent temperature indicator shall be routinely checked against the chart-recorder during the sterilization period. For sterilizers fitted with a drain at the bottom of the chamber, it may also be necessary to record the temperature at this position throughout the sterilization period. There shall be frequent leak tests done on the chamber during the vacuum phase of the cycle.
10.8.2 The items to be sterilized, other than products in sealed containers, shall be wrapped in a material which allows removal of air and penetration of steam but which prevents re-contamination after sterilization. All parts of the load shall be in contact with the sterilizing agent at the required temperature for the required time.
10.8.3. No Large Volume Parenteral shall be subjected to steam sterilization cycle until it has been filled and sealed.
10.8.4 Care shall be taken to ensure that the steam used for sterilization is of a suitable quality and does not contain additives at a level which could cause contamination of the product or equipment.
10.9. Completion/finalisation of sterile products–
10.9.1. All unit operations and processes in the manufacture of a batch shall have a minimum time specified and the shortest validt. time shall be used from the start of a batch to its ultimate release for distribution.
10.9.2. Containers shall be closed by appropriately validt. methods. Containers closed by fusion e.g. glass or plastic ampoules shall be subjected to 100% integrity testing. Samples of other containers shall be checked for integrity according to appropriate procedures.
10.9.3 Containers sealed under vacuum shall be tested for required vacuum conditions.
10.9.4 Filled containers of parenteral products shall be inspected individually for extraneous contamination or other defects. When inspection is done visually, it shall be done under suitably controlled conditions of illumination and background. Operators doing the inspection shall pass regular eye-sight checks with spectacles, if worn, and be allowed frequent rest from inspection. Where other methods of inspection are used, the process shall be validt. and the performance of the equipment checked at suitable intervals. Results shall be recorded.
11. Product Containers and Closures. –
11.1 All containers and closures intended for use shall comply with the pharmacopoeial and other specified requirements. Suitable samples sizes, specifications, test methods, cleaning procedures and sterilization procedures, shall be used to assure that containers, closures and other component parts of drug packages are suitable and are not reactive, additive, adsorptive or leachable or presents the risk of toxicity to an extent that significantly affects the quality or purity of the drug. No second hand or used containers and closures shall be used.
11.2 Plastic granules shall also comply with the pharmacopoeial requirements including physio-chemical and biological tests.
11.3. All containers and closures shall be rinsed prior to sterilization with Water for Injection according to written procedure.
11.4. The design of closures, containers and stoppers shall be such as to make cleaning, easy and also to make airtight seal when fitted to the bottles.
11.5 It shall be ensured that containers and closures chosen for a particular product are such that when coming into contact they are not absorbed into the product and they do not affect the product adversely. The closures and stoppers should be of such quality substances as not to affect the quality of the product and avoid the risk of toxicity.
11.6. Whenever glass bottles are used, the written schedule of cleaning shall be laid down and followed. Where bottles are not dried after washing, these shall be finally rinsed with distilled water or pyrogen free water, as the case may be, according to written procedure.
11.7. Individual containers of parenteral preparations, ophthalmic preparations shall be examined against black/white background fitted with diffused light after filling so as to ensure freedom from foreign matters.
11.8 Glass Bottles. –
11.8.1 Shape and design of the glass bottle shall be rational and standardized. Glass bottles made of USP Type-I and USP Type-II glass shall only be used. Glass bottles shall not be reused. Before use, USP Type-II bottles shall be validt. for the absence of particulate matter generated over a period of the shelf -life of the product and shall be regularly monitored after the production, following statistical sampling methods. USP Type- III glass containers may be used for non-parenteral sterile products such as Otic Solutions.
11.9. Plastic Containers. –
11.9.1 Pre-formed plastic containers intended to be used for packing of Large Volume Parenteral shall be moulded in-house by one-continuous operation through an automatic machine.
11.9.2. Blowing, filling and sealing (plugging) operation shall be conducted in room(s) conforming to requirements as mentioned in Table III of Item 3.10. Entry to the area where such operations are undertaken, shall be through a series of airlocks. Blowers shall have an air supply which is filtered through 0.22µ filters. Removal of runners and plugging operations shall be conducted under a laminar airflow workstation.
11.10 Rubber Stoppers. –
11.10.1 The rubber stoppers used for Large Volume Parenterals shall comply with specifications prescribed in the current edition of the Indian Pharmacopoeia.
12. Documentation:
12.1 The manufacturing records relating to manufacture of sterile products shall indicate the following details:-
(1) Serial number of the Batch Manufacturing Record.
(2) Name of the product
(3) Reference to Master Formula Record.
(4) Batch/Lot number
(5) Batch/Lot size.
(6) Date of commencement of manufacture and date of completion of manufacture.
(7) Date of manufacture and assigned date of expiry.
(8) Date of each step in manufacturing.
(9) Names of all ingredients with the grade given by the quality control department.
(10) Quality of all ingredients.
(11) Control reference numbers for all ingredients.
(12) Time and duration of blending, mixing, etc. whenever applicable.
(13) pH of solution whenever applicable.
(14) Filter integrity testing records
(15) Temperature and humidity records whenever applicable
(16) Records of plate-counts whenever applicable.
(17) Results of pyrogen and/or bacterial endotoxin & toxicity.
(18) Records of weight or volume of drug filled in containers.
(19) Bulk sterility in case of aseptically filled products.
(20) Leak test records.
(21) Inspection records.
(22) Sterilization records including autoclave leakage test records, load details, date, duration, temperature, pressure, etc.
(23) Container washing records.
(24) Total number of containers filled.
(25) Total numbers of containers rejected at each stage
(26) Theoretical yield, permissible yield, actual yield and variation thereof.
(27) Clarification for variation in yield beyond permissible yield.
(28) Reference numbers of relevant analytical reports.
(29) Details of reprocessing, if any.
(30) Name of all operators carrying out different activities.
(31) Environmental monitoring records.
(32) Specimens of printed packaging materials.
(33) Records of destruction of rejected containers and printed packaging materials.
(34) Signature of competent technical staff responsible for manufacture and testing.
Note: (1) Products shall be released only after complete filling and testing.
(2) Result of the tests relating to sterility, pyrogens, and Bacterial endotoxins shall be maintained in the analytical records.
(3) Validation details and simulation trial records shall be maintained separately,
(4) Records of environmental monitoring like temperature, humidity, microbilogical data, etc. shall be maintained. Records of periodic servicing of HEPA filters, sterilizers and other periodic maintenance of facilities and equipment carried out also be maintained.
(5) Separate facilities shall be provided for filling-cum-sealing of Small Volume Injectables and Large Volume Parenterals.
(6) It is advisable to provide separate facilities for manufacture of Large Volume Parenterals in glass containers and / or plastic containers.
(7) For manufacture of Large Volume Parenterals in plastic containers, it is advisable to instal automatic (with all operations) Form–Fill- Seal machines having one continuous operation.
PART IB
SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL SOLID DOSAGE FORMS (TABLETS AND CAPSULES)
Note:- The General Requirements as given in Part 1 of this Schedule relating to requirements of Good Manufacturing Practices for Premises and materials for pharmaceutical products shall be complied with, mutatis mutandis, for the manufacture of oral Solid Dosage Forms (Tablets and Capsules). In addition to these requirements, the following Specific Requirement shall also be followed, namely :-
1. General:
1.1 The processing of dry materials and products creates problems of dust control and cross-contamination. Special attention is therefore, needed in the design, maintenance and use of premises and equipment in order to overcome these problems. Wherever required, enclosed dust control manufacturing systems shall be employed.
1.2. Suitable environmental conditions for the products handled shall be maintained by installation of air-conditioning wherever necessary. Effective air-extraction systems, with discharge points situated to avoid contamination of other products and processes shall be provided. Filters shall be installed to retain dust and protect the factory and local environment.
1.3. Special care shall be taken to protect against subsequent contamination of the product by particles of metal or wood. The use of metal detector is recommended. Wooden equipment should be avoided. Screens, sieves, punches and dies shall be examined for wear and tear or for breakage before and after each use.
1.4. All ingredients for a dry product shall be sifted before use unless the quality of the input material can be assured. Such sifting shall normally be carried out at dedicated areas.
1.5. 1[Where the facilities are designed to provide special environmental conditions of pressure differentials between rooms, these conditions shall be regularly monitored and any deviation shall be brought to the immediate attention of the production and quality assurance departments].
1.6. Care shall be taken to guard against any material lodging and remaining undetected in any processing or packaging equipment. Particular care shall be taken to ensure that any vacuum, compressed air or air-extraction nozzles are kept clean and that there is no evidence of lubricants leaking into the product from any part of the equipments.
2. Sifting, Mixing and Granulation:
2.1. Unless operated as a closed system, mixing, sifting and blending equipments shall be fitted with dust extractors 1[or in a dedicated area for each operation].
2.2. Residues from sieving operations shall be examined periodically for evidence of the presence of unwanted materials.
2.3. Critical operating parameters like time and temperature for each mixing, blending and drying operation shall be specified in a Master Formula, monitored during processing, and recorded in the batch records.
2.4. Filter bags fitted to fluid-bed dryer shall not be used for different products, without being washed in-between use. With certain highly potent or sensitizing products, bags specific to one product only shall be used. Air entering the dryer shall be filtered. Steps shall be taken to prevent contamination of the site and local environment by dust in the air leaving the dryer due to close positioning of the air-inlets and exhaust.
2.5. Granulation and coating solutions shall be made, stored and used in a manner which minimizes the risk of contamination or microbial growth.
3. Compressions (Tablets):
3.1. Each tablet compressing machine shall be provided with effective dust control facilities to avoid cross-contamination. Unless the same product is being made on each machine, or unless the compression machine itself provides its own enclosed air controlled environment, the machine shall be installed in separate cubicles.
3.2. Suitable physical, procedural and labelling arrangements shall be made to prevent mix up of materials, granules and tablets on compression machinery.
3.3. Accurate and calibrated weighing equipment shall be readily available and used for in-process monitoring of tablet weight variation. Procedures used shall be capable of detecting out-of-limits tablets.
___________
1. Ins. by G.S.R. 431(E), dt. 30.6.2005.
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3.4. At the commencement of each compression run and in case of multiple compression points in a compression machine, sufficient individual tablets shall be examined at fixed intervals to ensure that a tablet from each compression station or from each compression point has been inspected for suitable pharmacopoeial parameters like ‘appearance‘, ‘weight variation‘, ‘disintegration‘, ‘hardness‘, ‘friability‘ and ‘thickness‘. The results shall be recorded as part of the batch documentation.
3.5. Tablets shall be de-dusted, preferably by automatic device and shall be monitored for the presence of foreign materials besides any other defects.
3.6. Tablets shall be collected into clean, labelled containers.
3.7. Rejected or discarded tablets shall be isolated in identified containers and their quantity recorded in the Batch Manufacturing Record.
3.8 In-process control shall be employed to ensure that the products remain within specification. During compression, samples of tablets shall be taken at regular intervals of not greater than 30 minutes to ensure that they are being produced in compliance with specified in-process specification. The tablets shall also be periodically checked for additional parameters such as ‘appearance‘, ‘weight variation‘, ‘disintegration‘, ‘hardness‘, ‘friability‘ and ‘thickness‘ and contamination by lubricating oil.
4. Coating (Tablets):
4.1. Air supplied to coating pans for drying purposes shall be filtered air and of suitable quality. The area shall be provided with suitable exhaust system and environmental control (temperature, humidity) measures.
4.2 Coating solutions and suspensions shall be made afresh and used in a manner, which shall minimize the risk of microbial growth. Their preparation and use shall be documented and recorded.
5. Filling of Hard Gelatin Capsule:
Empty capsules shells shall be regarded as ‘drug component‘ and treated accordingly. They shall be stored under conditions which shall ensure their safety from the effects of excessive heat and moisture.
6. Printing (Tablets and Capsules)
6.1. Special care shall be taken to avoid product mix-up during any printing of tablets and capsules. Where different products, or different batches of the same product, are printed simultaneously, the operations shall adequately be segregated. Edible grade colours and suitable printing ink shall be used for such printing.
6.2. After printing, tablets and capsules shall be approved by Quality Control before release for packaging or sale.
7. Packaging (Strip and Blister):
7.1. Care shall be taken when using automatic tablet and capsule counting, strip and blister packaging equipment to ensure that all ‘rogue‘ tablets, capsules or foils from packaging operation are removed before a new packaging operation is commenced. There shall be an independent recorded check of the equipment before a new batch of tablets or capsules is handled.
7.2. Uncoated tablets shall be packed on equipment designed to minimize the risk of cross-contamination. Such packaging shall be carried out in an isolated area when potent tablets or Beta-Iactum containing tablets are being packed.
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1. Ins. by G.S.R. 431(E), dt. 30.6.2005.
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7.3. The strips coming out of the machine shall be inspected for defects such as misprint, cuts on the foil, missing tablets and improper sealing.
7.4. Integrity of individual packaging strips and blisters shall be subjected to vacuum test periodically to ensure leak proofness of each pocket strip and blister and records maintained.
PART IC
SPECIFIC REQUIREMENTS FOR MANUFACTURE OF ORAL LIQUIDS (SYRUPS, ELIXIRS, EMULSIONS AND SUSPENSIONS)
Note: The General Requirements as given in Part I of this Schedule relating to Requirements of Good Manufacturing Practices for Premises and Materials for pharmaceutical products shall be complied with, mutatis mutandis, for the manufacture of (Syrups, Elixirs, Emulsions and Suspensions). In addition to these requirements, the following Specific Requirements shall also be followed, namely:-
1. Building and Equipment:.
1.1. The premises and equipment shall be designed, constructed and maintained to suit the manufacturing of Oral Liquids. The layout and design of the manufacturing area shall strive to minimize the risk of cross-contamination and mix-ups.
1.2. Manufacturing area shall have entry through double door airlock facility. It shall be made fly proof by use of ‘fly catcher‘ and/or ‘air curtain‘.
1.3. Drainage shall be of adequate size and have adequate traps, without open channels and the design shall be such as to prevent back flow. Drains shall be shallow to facilitate cleaning and disinfecting.
1.4. The production area shall be cleaned and sanitized at the end of every production process.
1.5. Tanks, containers, pipe work and pumps shall be designed and installed so that they can be easily cleaned and sanitized. Equipment design shall be such as to prevent accumulation of residual microbial growth or cross-contamination.
1.6. Stainless steel or any other appropriate material shall be used for parts of equipments coming in direct contact with the products. The use of glass apparatus shall be minimum.
1.7. Arrangements for cleaning of containers, closures and droppers shall be made with the help of suitable machines/devices equipped with the high pressure air, water and steam jets.
1.8. The furniture used shall be smooth, washable and made of stainless steel 1[or any other appropriate material which is scratch proof, washable and smooth].
2. Purified Water.
2.1. The chemical and microbiological quality of purified water used shall be specified and monitored routinely. The microbiological evaluation shall include testing for absence of pathogens and shall not exceed 100 cfu/ml (as per Appendix 12.5 of IP 1996.)
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1. Added by G.S.R. 431(E), dt. 30.6.2005.
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2.2. There shall be a written procedure for operation and maintenance of the purified water system. Care shall be taken to avoid the risk of microbial proliferation with appropriate methods like re-circulation, use of UV treatment, treatment with heat and sanitizing agent. After any chemical sanitisation of the water system, a flushing shall be done to ensure that the sanitizing agent has been effectively removed.
3. Manufacturing:
3.1. 1[Manufacturing personnel shall wear wherever required, non-fiber shedding clothing to prevent contamination of the products].
3.2. Materials likely to shed fibre like gunny bags, or wooden pallets shall not be carried into the area where products or cleaned-containers are exposed.
3.3. Care shall be taken to maintain the homogenecity of emulsion by use of appropriate emulsifier and suspensions by use of appropriate stirrer during filling. Mixing and filling processes shall be specified and monitored. Special care shall be taken at the beginning of the filling process, after stoppage due to any interruption and at the end of the process to ensure that the product is uniformly homogenous during the filling process.
3.4. The primary packaging area shall have an air supply which is filtered through 5 micron filters. The temperature of the area shall not exceed 30 degrees centigrade.
3.5. When the bulk product is not immediately packed, the maximum period of storage and storage conditions shall be specified in the Master Formula. The maximum period of storage time of a product in the bulk stage shall be validt..
PART ID
SPECIFIC REQUIREMENTS FOR MANUFACTURE OF TOPICAL PRODUCTS , i.e. EXTERNAL PREPARATIONS (CREAMS, OINTMENTS, PASTES, EMULSIONS, LOTIONS, SOLUTIONS, DUSTING POWDERS AND IDENTICAL PRODUCTS)
Note: The General Requirements as given in Part I of this Schedule relating to Requirements of Good Manufacturing Practices for Premises and Materials for pharmaceutical products shall be complied with, mutatis mutandis, for the manufacture of Topical Products i.e. External preparations (Creams, Ointments, Pastes, Emulsions, Lotions, Solutions, Dusting powders and identical products used for external applications). In addition to these requirements, the following Specific Requirements shall also be followed, namely:-
1. The entrance to the area where topical products are manufactured shall be through a suitable airlock. Outside the airlock, insectocutors shall be installed.
2. The air to this manufacturing area shall be filtered through at least 20µ air filters and shall be air-conditioned. 2 [***].
3. The area shall be fitted with an exhaust system of suitable capacity to effectively remove vapours, fumes, smoke, floating dust particles.
4. The equipment used shall be designed and maintained to prevent the product from being accidentally contaminated with any foreign matter or lubricant.
5. 3[Suitable cleaning equipment and material] shall be used in the process of cleaning or drying the process equipment or accessories used.
6. Water used in compounding shall be Purified Water IP.
7. Powders, wherever used, shall be suitably sieved before use.
8. Heating vehicles and a base like petroleum jelly shall be done in separate mixing area in suitable stainless steel vessels, using steam, gas, electricity, solar energy, etc.
9. A separate packing section may be provided for primary packaging of the products.
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1. Subs. by G.S.R. 431(E), dt. 30.6.2005.
2. The words “The air shall be ventilated.” omitted by G.S.R. 431(E), dt. 30.6.2005.
3. Subs. by G.S.R. 431(E), dt. 30.6.2005, for ” no rags or dusters”.
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PART 1E
SPECIFIC REQUIREMENTS FOR MANUFACTURE OF METERED-DOSE-INHALERS (MDI)
Note: The General Requirements as given in Part I of this Schedule relating to Requirements of Good Manufacturing Practices for Premises and Materials for pharmaceutical products shall be complied with, mutatis mutandis, for the manufacture of Metered-Dose-Inhalers (MDI). In addition to these requirements, the following Specific Requirements shall also be followed, namely:-
1. General:
Manufacture of Metered-Dose-Inhalers shall be done under conditions which shall ensure minimum microbial and particulate contamination. Assurance of the quality of components and the bulk product is very important. Where medicaments are in suspended state, uniformity of suspension shall be established.
2. Building and Civil Works:
2.1. The building shall be located on a solid foundation to reduce risk of cracking walls and floor due to the movement of equipment and machinery.
2.2 All building surfaces shall be impervious, smooth and non-shedding. Flooring shall be continuous and provided with a cove between the floor and the wall as well as the wall to the ceiling. Ceiling shall be solid, continuous and covered to walls. Light fittings and air-grills shall be flush with the ceiling. All service lines requiring maintenance shall be erected in such a manner that these are accessible from outside the production area.
2.3. The manufacturing area shall be segregated into change rooms for personnel, container preparation area, bulk preparation and filling area, quarantine area and spray testing and packing areas.
2.4. Secondary change rooms shall be provided for operators to change from factory clothing to special departmental clothing before entering the manufacturing and filling area.
2.5. Separate area shall be provided for de-cartoning of components before they are air washed.
2.6. The propellants used for manufacture shall be delivered to the manufacturing area distribution system by filtering them through 2µ filters. The bulk containers of propellants shall be stored, suitably identified, away from the manufacturing facilities.
3. Environmental Conditions:
3.1. Where products or clean components are exposed, the area shall be supplied with filtered air of Grade C.
3.2. The requirements of temperature and humidity in the manufacturing area shall be decided depending on the type of product and propellants handled in the facility. Other support areas shall have comfort levels of temperature and humidity.
3.3. There shall be a difference in room pressure between the manufacturing area and the support areas and the differential pressure shall be not less than 15 Pascals (0.06 inches or 1.5 mm water gauge).
3.4. There shall be a written schedule for the monitoring of environmental conditions. Temperature and humidity shall be monitored daily.
4. Garments:
4.1. Personnel in the manufacturing and filling section shall wear suitable single- piece-garment made out of non-shedding, tight weave material. Personnel in support areas shall wear clean factory uniforms.
4.2. Gloves made of suitable material having no interaction with the propellants shall be used by the operators in the manufacturing and filling areas. Preferably, disposable gloves shall be used.
4.3. Suitable department-specific personnel protective equipment like footwear and safety glasses shall be used wherever hazard exists.
5. Sanitation:
5.1. There shall be written procedures for the sanitation of the MDI manufacturing facility. Special care should be taken to handle residues and rinses of propellants.
5.2. Use of water for cleaning shall be restricted and controlled. Routinely used disinfectants are suitable for sanitizing the different areas. Records of sanitation shall be maintained.
6. Equipment:
6.1. Manufacturing equipment shall be of closed system. The vessels and supply lines shall be of stainless steel.
6.2. Suitable check weights, spray testing machines and labelling machines shall be provided in the department.
6.3. All the equipment shall be suitably calibrated and their performance validt. on receipt and thereafter periodically.
7. Manufacture:
7.1. There shall be an approved Master Formula Records for the manufacture of metered dose inhalers. All propellants, liquids and gases shall be filtered through 2µ filters to remove particles.
7.2. The primary packing material shall be appropriately cleaned by compressed air suitably filtered through 0.2µ filter. The humidity of compressed air shall be controlled as applicable.
7.3. The valves shall be carefully handled and after de-cartoning, these shall be kept in clean, closed containers in the filling room.
7.4. For suspensions, the bulk shall be kept stirred continuously.
7.5. In-process controls shall include periodical checking of weight of bulk formulation filled in the containers. In a two-shot-filling process (liquid filling followed by gaseous filling), it shall be ensured that 100% check on weight is carried out.
7.6. Filled containers shall be quarantined for a suitable period established by the manufacturer to detect leaking containers prior to testing, labelling and packing.
8. Documentation-
8.1. In addition to the routine good manufacturing practices documentation, manufacturing records shall show the following additional information:-
(1) Temperature and humidity in the manufacturing area.
(2) Periodic filled weights of the formulation.
(3) Records of rejections during on-line check weighing.
(4) Records of rejection during spray testing.
PART 1F
SPECIFIC REQUIREMENTS OF PREMISES, PLANT AND MATERIALS FOR MANUFACTURE OF ACTIVE PHARMACEUTIAL INGREDIENTS
(BULK DRUGS)
Note: The General Requirements as given in Part I of this Schedule relating to Requirements of Good Manufacturing Practices for premises and Materials for pharmaceutical products shall be complied with, mutatis mutandis, for the manufacture of active pharmaceutical ingredients (Bulk Drugs). In addition to these requirements, the following Specific Requirements shall also be followed, namely:-
1. Building and Civil Works:
1.1. Apart from the building requirements contained in Part I, General ante, the active pharmaceutical ingredients facilities for manufacture of hazardous reactions, Beta- Lactum antibiotics. Steroids and Steroidal Hormones / Cytotoxic substances shall be provided in confined areas to prevent contamination of the other drugs manufactured.
1.2. The final stage of preparation of a drug, like isolation/filtration/drying/ milling / sieving and packing operations shall be provided with air filtration systems including pre-filters and finally with a 5 micron filter. Air handling systems with adequate number of air changes per hour or any other suitable system to control the air borne contamination shall be provided. Humidity / Temperature shall also be controlled for all the operations wherever required.
1.3. Air filtration systems including pre-filters and particulate matter retention air filters shall be used, where appropriate, for air supplies to production areas. If air is re- circulated to production areas, measures shall be taken to control re-circulation of floating dust particles from production. In areas where air contamination occurs during production, there shall be adequate exhaust system to control contaminants.
1.4. Ancillary area shall be provided for Boiler-house. Utility areas like heat exchangers, chilling workshop, store and supply of gases shall also be provided.
1.5. For specified preparation like manufacture of sterile products and for certain antibiotics, sex hormones, cytotoxic and oncology products, separate enclosed areas shall be designed. The requirements for the sterile active pharmaceutical ingredient shall be in line with the facilities required for formulation to be filled aseptically.
2. Sterile Products:
Sterile active pharmaceutical ingredient filled aseptically shall be treated as formulation from the stage wherever the process demands like crystallization, lyophilisation, filtration etc. All conditions applicable to formulations that are required to be filled aseptically shall apply mutatis mutandis for the manufacture of sterile active pharmaceutical ingredients involving stages like filtration, crystallization and lyophilisation.
3. Utilities / Services:
Equipment like chilling plant, boiler, heat exchangers, vacuum and gas storage vessels shall be serviced, cleaned, sanitized and maintained at appropriate intervals to prevent mal-functions or contamination that may interfere with safety, identity, strength, quality or purity of the drug product.
4. Equipment Design, Size and Location:
4.1. Equipment used in the manufacture, processing, packing or holding of an active pharmaceutical ingredient shall be of appropriate design, adequate size and suitably located to facilitate operations for its intended use and for its cleaning and maintenance.
4.2. If equipment is used for different intermediates and active pharmaceutical ingredients, proper cleaning before switching from one product to another becomes particularly important. If cleaning of a specific type of equipment is difficult, the equipment may need to be dedicated to a particular intermediate or active pharmaceutical ingredient.
4.3. The choice of cleaning methods, detergents and levels of cleaning shall be defined and justified. Selection of cleaning agents (e.g. solvents) should depend on :
(a) the suitability of the cleaning agent to remove residues of raw materials; intermediates, precursors, degradation products and isomers, as appropriate.
(b) whether the cleaning agent leaves a residue itself;
(c) compatibility with equipment construction materials like centrifuge/ filtration, dryer/fluid bed dryer, rotocone proton dryer, vacuum dryer, frit mill, multi-mill/jet mills/sewetters cut sizing;
(d) test for absence of intermediate or active pharmaceutical ingredient in the final rinse.
4.4. Written procedures shall be established and followed for cleaning and maintenance of equipment, including utensils used in the manufacture, processing, packing or holding of active pharmaceutical ingredients. These procedures shall include but should not be limited to the following :
(a) assignment of responsibility for cleaning and maintaining equipment;
(b) maintenance and cleaning program schedules, including where appropriate, sanitizing schedules;
(c) a complete description of the methods and materials used to clean and maintain equipment, including instructions for de-assembling and re- assembling each article of equipment to ensure proper cleaning and maintenance.;
(d) removal or obliteration of previous batch identification;
(e) protection of clean equipment from contamination prior to use;
(f) inspection of equipment for cleanliness immediately before use;
(g) establishing the maximum time that may elapse between completion of processing and equipment cleaning as well as between cleaning and equipment reuse.
4.5. Equipment shall be cleaned between successive batches to prevent contamination and carry-over of degraded material or contaminants unless otherwise established by validation.
4.6. As processing approaches the final purified active pharmaceutical ingredient, it is important to ensure that incidental carry over between batches does not have adverse impact on the established impurity profile. However, this does not generally hold good for any biological, active pharmaceutical ingredient where many of the processing steps are accomplished aseptically and where it is necessary to clean and sterilize equipment between batches.
5. In-Process Controls:
5.1. In-process control for chemical reactions may include the following:
(a) reaction time or reaction completion;
(b) reaction mass appearance, clarity, completeness or pH solutions;
(c) reaction temperature;
(d) concentration of a reactant;
(e) assay or purity of the product;
(f) process completion check by TLC / any other means.
5.2. In-process control for physical operations may include the following:
(a) appearance and colour;
(b) uniformity of the blend;
(c) temperature of a process;
(d) concentration of a solution;
(e) processing rate or time;
(f) particle size analysis;
(g) bulk/tap density;
(h) pH determination;
(i) moisture content.
6. Product Containers and Closures:
6.1. All containers and closures shall comply with the pharmacopoeial or any other requirement, suitable sampling methods, sample sizes, specifications, test methods, cleaning procedures and sterilization procedures, when indicated, shall be used to assure that containers, closures and other component parts of drug packages are suitable and are not reactive, additive, adsorptive or leachable to an extent that significantly affects the quality or purity of the drug.
6.2. The drug product container shall be tested or re-examined as appropriate and approved or rejected and shall be identified and controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which these are unsuitable.
6.3 Container closure system shall provide adequate protection against foreseeable external factors in storage / transportation and use that may cause deterioration or contamination of the active pharmaceutical ingredient.
6.4. Bulk containers and closures shall be cleaned and, where indicated by the nature of the active pharmaceutical ingredient, sterilized to ensure that they are suitable for their intended use.
6.5. The container shall be conspicuously marked with the name of the product and the following additional information concerning :
(a) quality and standards, if specified;
(b) manufacturing licence number/drug master file number (whichever applicable), batch number;
(c) date of manufacture and date of expiry;
(d) method for container disposal (label shall give the methodology, if required);
(e) storage conditions, if specified and name and address of the manufacturer, if available.
6.6. Areas for different operation of active pharmaceutical ingredients (bulk drugs) section shall have appropriate area which may be suitably partitioned for different operations.
PART II
REQUIREMENTS OF PLANT AND EQUIPMENT
1. External Preparations:
The following equipment is recommended for the manufacture of ‘External preparations‘ i.e. Ointments, Emulsion, Lotions, Solutions, Pastes, Creams, Dusting powders and such identical products used for external applications, whichever is applicable, namely :-
(1) 1[Mixing and storage tanks preferably of stainless steel or any other appropriate material].
(2) 2[Stainless steel container] (steam, gas or electrically heated).
(3) Mixer (electrically operated).
(4) Planetary mixer.
(5) A colloid mill or a suitable emulsifier.
(6) A triple roller mill or an ointment mill.
1. Subs. by G.S.R. 431(E), dt. 30.6.2005; for “mixing and storage tanks (Stainless steel)”.
2. Subs. by G.S.R. 431(E), dt. 30.6.2005; for “Jacketted Kettle”.
(7) Liquid filling equipment (electrically operated).
(8) Jar or tube filling equipment 1 [***]
Area.- (1) A minmum area of thirty square meters for basic installation and ten square meters for Ancillary area is recommended.
(2) Areas for formulations meant for external use and internal use shall be separately provided to avoid mix-up.
2[Note: The requirement for ancillary area in this part shall not apply to units registered before 1st January, 2002.]
2. Oral Liquid Preparations:
The following equipments are recommended for the manufacture of oral/internal use preparations i.e. Syrups, Elixirs, Emulsions and Suspensions, whichever is applicable, namely:-
(1) 3[Mixing and storage tanks preferably of Stainless steel or any other appropriate material].
(2) Jacketted Kettle / Stainless steel tank (steam, gas or electrically heated).
(3) Portable stirrer (electrically operated).
(4) A colloid mill or suitable emulsifier (electrically operated).
(5) Suitable filtration equipment (electrically operated).
(6) Semi-automatic/automatic bottle filling machine.
(7) Pilfer proof cap sealing machine.
(8) Water distillation unit or deionizer.
(9) Clarity testing inspection units.
Area.- A minimum area of thirty square meters for basic installation and ten square meters for Ancillary area is recommended.
2[Note: The requirement for ancillary area in this part shall not apply to units registered before 1st January, 2002.]
3. Tablets:
The Tableting section shall be free from dust and floating particles and may be air- conditioned. For this purpose, each 4[tablet compression machine] shall be isolated into cubicles and connected to a vacuum dust collector or an exhaust system. For effective operations, the tablet production department shall be divided into four distinct and separate sections as follows:-
(a) Mixing, Granulation and Drying section.
(b) Tablet compression section.
(c) Packaging section (strip/blister machine wherever required).
(d) Coating section (wherever required).
3.1. The following electrically operated equipments are recommended for the manufacture of compressed tablets and hypodermic tablets, in each of the above sections, namely:-
(a) Granulation-cum-Drying section:
(1) Disintegrator and sifter.
(2) Powder mixer.
(3) Mass mixer/Planetary mixer/Rapid mixer granulator.
1. The word ‘electrically operated‘ Omitted by G.S.R. 431(E), dt. 30.6.2005.
2. Ins by G.S.R. 431(E), dt. 30.6.2005.
3 Subs. by G.S.R. 431(E), dt. 30.6.2005, for “mixing and storage tanks (Stainless steel)”.
4. Subs. by G.S.R. 431(E), dt. 30.6.2005, for ‘tablet machine‘.
(4) 1[Granulator wherever required].
(5) Thermostatically controlled hot air oven with trays (preferably mounted on a trolley)/Fluid bed dryer.
(6) Weighing machines.
(b) Compression section:
(1) Tablet compression machine, single/multi punch/rotatory.
(2) Punch and dies storage cabinets.
(3) Tablet de-duster
(4) Tablet inspection unit/belt.
(5) 1[Dissolution test apparatus wherever required].
(6) In-process testing equipment like single pan electronic balance, hardness tester, friability and disintegration test apparatus.
(7) Air-conditioning and dehumidification arrangement (wherever necessary)
(c) Packaging section:
(1) Strip/blister packaging machine.
(2) Leak test apparatus (vacuum system).
(3) Tablet counters (wherever applicable).
(4) Air-conditioning and dehumidification arrangement (wherever applicable).
Area.– A minimum area of sixty square meters for basic installation and twenty square meters for Ancillary area is recommended for un-coated tablets.
(d) Coating section:
(1) Jacketted kettle 2[stainless steel container or any other appropriate material] (steam, gas or electrically heated for preparing coating suspension).
(2) Coating pan (Stainless steel).
(3) Polishing pan (where applicable).
(4) Exhaust system (including vacuum dust collector).
(5) Air-conditioning and Dehumidification Arrangement.
(6) Weighing balance.
2[Note: The requirement for ancillary area in this part shall not apply to units registered before 1st January, 2002.]
3.2. The coating section shall be made dust free with suitable exhaust system to remove excess powder and fumes resulting from solvent evaporation. It shall be air- conditioned and dehumidified wherever considered necessary.
Area.– A minimum additional area of thirty square meters for coating section for basic installation and ten square meters for Ancillary area is recommended.
Separate area and equipment for mixing, granulation, drying, tablet compression, coating and packing shall be provided for Penicillin group of drugs on the lines indicated above. In case of operations involving dust and floating particles, care shall be exercised to avoid cross-contamination.
2[Note: The requirement for ancillary area in this part shall not apply to units registered before 1st January, 2002.]
3.3. The manufacture of Hypodermic tablets shall be conducted under aseptic conditions in a separate air-conditioned room, the walls of which shall be smooth and washable. The granulation, tableting and packing shall be done in this room.
1. Subs. by G.S.R. 431(E), dt. 30.6.2005.
2. Ins. by G.S.R. 431(E), dt. 30.6.2005.
3.4. The manufacture of effervescent and soluble 1 [***] tablets shall be carried out in air-conditioned and dehumidified areas.
4. Powders:
The following equipment is recommended for the manufacture of powders, namely:-
(1) Disintegrator.
(2) Mixer (electrically operated).
(3) Sifter.
(4) Stainless steel vessels and scoops of suitable sizes.
(5) Filling equipment 1[***].
(6) Weighing balance.
In the case of operation involving floating particles of fine powder, suitable exhaust system shall be provided. Workers should be provided with suitable masks during operation.
Area.– A minimum area of thirty square meters is recommended to allow for the basic installations. Where the actual blending is to be done on the premises, an additional room shall be provided for the purpose.
2[Note: The requirement for additional room in this part shall not apply to units registered before 1st January, 2002.]
5. Capsules:
For the manufacture of capsules, separate enclosed area suitably air-conditioned and dehumidified with an airlock arrangement shall be provided. The following equipment is recommended for filling Hard Gelatin Capsules, namely:-
(1) Mixing and blending equipment (electrically or power driven).
(2) Capsules filling units 1[***].
(3) Capsules counters (wherever applicable).
(4) Weighing balance.
(5) Disintegration test apparatus.
(6) Capsule polishing equipment.
Separate equipment and, filling and packaging areas shall be provided in penicillin and non-penicillin sections. In case of operations involving floating particles of fine powder, a suitable exhaust system shall be provided. Manufacture and filling shall be carried out in air- conditioned area. The room shall be dehumidified.
Area.– A minimum area of twenty-five square meters for basic installation and ten square meters for Ancillary area each for penicillin and non-penicillin sections is recommended.
2[Note: The requirement for ancillary area in this part shall not apply to units registered before 1st January, 2002.]
6. Surgical Dressing:
The following equipment is recommended for the manufacture of Surgical Dressings other than Absorbent Cotton Wool, namely:-
1. Omitted by G.S.R. 431(E), dt. 30.6.2005.
2. Ins. by G.S.R. 431(E), dt. 30.6.2005.
(1) Rolling machine.
(2) Trimming machine.
(3) Cutting equipment.
(4) Folding and pressing machine for gauze.
(5) Mixing tanks for processing medicated dressing.
(6) Hot air dry oven.
(7) Steam sterilizer or dry heat sterilizer or other suitable equipment.
(8) Work tables/benches for different operations.
Area. – A minimum area of thirty square meters is recommended to allow for the basic installations. In case medicated dressings are to be manufactured, another room with a minimum area of thirty square meters shall be provided.
7. Ophthalmic Preparations:.
For the manufacture of Ophthalmic preparations, separate enclosed areas with airlock arrangement shall be provided. The following equipment is recommended for the manufacture under aseptic conditions of Eye-Ointment, Eye-Lotions and other preparations for external use, namely:-
(1) Thermostatically controlled hot air ovens (preferably double ended).
(2) Jacketted kettle/stainless steel tanks (steam, gas or electrically heated).
(3) Mixing and storage tanks of stainless steel/Planetary mixer.
(4) Colloid mill or ointment mill.
(5) Tube filling and crimping equipment (semi-automatic or automatic filling machines).
(6) Tube cleaning equipment (air jet type).
(7) Tube washing and drying equipment, if required.
(8) Automatic vial washing machine.
(9) Vial drying oven.
(10) Rubber bung washing machine.
(11) Sintered glass funnel, Seitz filter and filter candle (preferably cartridge and membrane filters).
(12) Liquid filling equipment (semi-automatic or automatic filling machines).
(13) Autoclave (preferably ventilator autoclave).
(14) Air conditioning and dehumidification arrangement (preferably centrally air- conditioned and dehumidification system).
(15) Laminar airflow units.
Area.– (1) A minimum area of twenty-five square meters for basic installation and ten square meters for Ancillary area is recommended. Manufacture and filling shall be carried out in air-conditioned areas under aseptic conditions. The rooms shall be further dehumidified as considered necessary if preparations containing antibiotics are manufactured.
(2) Areas for formulations meant for external use and internal use shall be separately provided to avoid mix up.
1[Note: The requirement for ancillary area in this Part shall not apply to units registered before 1st January, 2002.]
8. Pessaries and Suppositories:
(i) The following equipment is recommended for manufacture of Pessaries and Suppositories, namely:-
(1) Mixing and pouring equipment
(2) Moulding equipment.
(3) Weighing devices.
1. Ins. by G.S.R. 431(E), dt. 30.6.2005.
Area.– A minimum area of twenty square meters is recommended to allow for the basic installation.
(ii) In the case of pessaries manufactured by granulation and compression, the requirements as indicated under “Item 3 of Tablet”, shall be provided.
9. Inhalers and Vitrallae:
The following equipment is recommended for manufacture of inhalers and vitrallae, namely:-
(1) Mixing equipment.
(2) Graduated delivery equipment for measurement of the medicament during filling.
(3) Sealing equipment.
Area.– An area of minimum twenty square meters is recommended for the basic installations.
10. Repacking of drugs and pharmaceutical chemicals:
The following equipment is recommended for repacking of drugs and pharmaceuticals chemicals, namely:-
(1) Powder disintegrator.
(2) Powder sifter (electrically operated).
(3) Stainless steel scoops and vessels of suitable sizes.
(4) Weighing and measuring equipment.
(5) Filling equipment (semi-automatic / automatic machines).
(6) Electric sealing machine.
Area. – An area of minimum thirty square metres is recommended for the basic installation. In case of operations involving floating particles of fine powder, a suitable exhaust system shall be provided.
11. Parenteral Preparations
The whole operation of manufacture of parenteral preparations (small volume injectables and large volume parenterals) in glass and plastic containers may be divided into the following separate areas/rooms, namely:-
11.1 Parenteral preparations in glass containers: –
(1) Water management area: This includes water treatment and storage.
(2) Containers and closures preparation area: This includes washing and drying of ampoules, vials, bottles and closures.
(3) Solution preparation area: This includes preparation and filtration of solution.
(4) Filling, capping and sealing area: This includes filling and sealing of ampoules and/or filling, capping and sealing of vials and bottles.
(5) Sterilization area
(6) Quarantine area
(7) Visual inspection area.
(8) Packaging area
The following equipment is recommended for different above-mentioned areas, namely:-
(a) Water management area:
(1) De-ionised water treatment unit.
(2) Distillation (multi-column with heat exchangers) unit.
(3) Thermostatically controlled water storage tank.
(4) Transfer pumps.
(5) Stainless steel service lines for carrying water into user areas.
(b) Containers and closures preparation area:
(1) Automatic rotary ampoule/vial/bottle washing machine having separate air, water distilled water jets.
(2) Automatic closures washing machine,
(3) Storage equipment for ampoules, vials, bottles and closures.
(4) Dryer/sterilizer (double ended)
(5) Dust proof storage cabinets.
(6) Stainless steel benches/stools.
(c) Solution preparation area:
(1) Solution preparation and mixing stainless steel tanks and other containers.
(2) Portable stirrer.
(3) Filtration equipment with cartridge and membrane filters/bacteriological filters.
(4) Transfer pumps.
(5) Stainless steel benches/stools
(d) Filling, capping and sealing area:
(1) Automatic ampoule/vial/bottle filling, sealing and capping machine under laminar air flow workstation.
(2) Gas lines (Nitrogen, Oxygen, Carbon dioxide) wherever required.
(3) Stainless steel benches / stools.
(e) Sterilization area:
(1) Steam sterilizer (preferably with computer control for sterilization cycle along with trolley sets for loading/unloading containers before and after sterilization).
(2) Hot air sterilizer (preferably double ended).
(3) Pressure leak test apparatus.
(f) Quarantine area. –
(1) Storage cabinets.
(2) Raised platforms/steel racks.
(g) Visual inspection area:
(1) Visual inspection units (preferably conveyor belt type and composite white and black assembly supported with illumination).
(2) Stainless steel benches/stools.
(h) Packaging area. –
(1) Batch coding machine (preferably automatic).
(2) Labelling unit (preferably conveyor belt type).
(3) Benches/stools.
Area. – (1) A minimum area of one hundred and fifty square meters for the basic installation and an Ancillary area of one hundred square meters for Small Volume Injectables is recommended. For Large Volume Parenterals, an area of one hundred and fifty square meters each for the basic installation and for Ancillary area is recommended. These areas shall be partitioned into suitable enclosures with airlock arrangements.
(2) Areas for formulations meant for external use and internal use shall be separately provided to avoid mix up.
(3) Packaging materials for large volume parenteral shall have a minimum area of 100 square meters.
1[Note: The requirement for ancillary area in this part shall not apply to units registered before 1st January, 2002.]
11.2 Parenteral preparations in plastic containers by Form-Fill-Seal/Blow, Fill- Seal Technology.-The whole operation of manufacture of large volume parenteral preparations in plastic containers including plastic pouches by automatic (all operations in one station) Form-Fill-Seal machine or by semi-automatic blow moulding, filling-cum-sealing machine may be divided into following separate areas/rooms, namely:-
(1) Water management area.
(2) Solution preparation area.
(3) Containers moulding-cum-filling and sealing area.
(4) Sterilization area.
(5) Quarantine area .
(6) Visual inspection area.
(7) Packaging area.
The following equipment is recommended for different above mentioned areas namely:-
(a) Water management area:
(1) De-ionised water treatment unit.
(2) Distillation unit (multi column with heat exchangers).
(3) Thermostatically controlled water storage tank.
(4) Transfer pumps.
(5) Stainless steel service lines for carrying water into user areas.
(b) Solution preparation area:
(1) Solution preparation and storage tanks.
(2) Transfer pumps.
(3) Cartridge and membrane filters.
(c) Container moulding-cum-filling and sealing area:
(1) Sterile Form-Fill-Seal machine (all operations in one station with built-in laminar air flow workstation having integrated container output conveyor belt through pass box).
(2) Arrangement for feeding plastic granules through feeding-cum-filling tank into the machine.
1. Ins. by 431(E), dt. 30.6.2005.
(d) Sterilization area: Super heated steam sterilizer (with computer control for sterilization cycle along with trolley sets for loading/unloading containers for sterilization).
(e) Quarantine area:- Adequate number of platforms/racks with storage system.
(f) Visual inspection area. – Visual inspection unit (with conveyor belt and composite white and black assembly supported with illumination).
(g) Packaging area:
(1) Pressure leak test apparatus (pressure belt or rotating disc type).
(2) Batch coding machine (preferably automatic).
(3) Labelling unit (preferably conveyor belt type).
Area.– (1) A minimum area of two hundred and fifty square meters for the basic installation and an Ancillary area of one hundred and fifty square metres for large volume parenteral preparations in plastic containers by Form-Fill-Seal technology is recommended. These areas shall be partitioned into suitable enclosures with airlock arrangements.
(2) Areas for formulations meant for external use and internal use shall be separately provided to avoid mix up.
(3) Packaging materials for large volume parenteral shall have a minimum area of 100 square meters.]
1[Note: The requirement for ancillary area in this part shall not apply to units registered before 1st January, 2002.]
1[Note I: There are certain categories of drugs such as chemicals and pharmaceutical aids, gauzes and bandages, medicinal gases, empty gelatin capsules, non- chemical/mechanical contraceptives, diagnostic kits and reagents, medical devices, new dosage forms and their delivery systems, disinfectant fluids, antacids, raw-materials manufactured from sea bittern, veterinary biologicals including poultry vaccines, re-packing of drugs, etc. for which this Schedule does not prescribe specific requirements of space and equipments. The Licensing Authority, as the case may be, in respect of such categories of drugs, have the discretion to modify the requirements of this Schedule, if he is of the opinion that having regard to the nature off the products and extent of manufacturing operations and for reasons to be recorded in writing, it is necessary to relax or alter them in the circumstances of a particular case and direct the manufacturer to carry out necessary modifications in them and the modifications having been made, approve the manufacturer of such categories of the drugs.
Note II: In case of manufacturers licensed to manufacture drugs prior to the 11th December, 2001, the requirements of this Schedule shall also apply to them from 1st July, 2005.]
1. Ins. by G.S.R. 431(E), dt. 30.6.2005.
1[SCHEDUE M-I
[See Rule 85E (2)]
GOOD MANUFACTURING PRACTICES AND REQUIREMENTS OF PREMISES, PLANT AND EQUIPMENT FOR HOMOEOPATHIC MEDICINES
1. GENERAL REQUIREMENTS:
1.1 Location and Surroundings:- The premises shall be situated at a clean place which shall not be adjacent to open drains, public lavatory or any factory producing pollution of any kind, garbage dump, slaughter house or any other source likely to cause contamination from the external environment. The premises shall be located away from railway lines so that the performance of sensitive electronic equipment is not affected by vibrations. There shall be no open drains inside or outside the manufacturing premises. It shall be so designed that the entry of rodents is checked. The drains shall facilitate easy flow of the effluent and shall be cleared periodically.
1.2 Building:- The premises shall not be used for any purpose other than manufacture of homoeopathic drugs and no part of the manufacturing premises shall be used for any other purpose. Other facilities, if needed, could be provided in separate building(s) in the same campus. Crude raw materials, packing materials, etc. shall be stored and handled in places earmarked for them and shall not be taken inside areas where critical operations of manufacture are done excepting processed raw material. Heating, washing, drying, packing and labelling etc. wherever needed, shall be done in dedicated ancillary areas adjacent to the manufacturing sections concerned. The walls and floorings of manufacturing areas shall be smooth and free from chinks, cracks and crevices and shall be washable. The design of the windows, windowpanes and all fittings shall be such that they will not facilitate accumulation / lodging of dust and other contaminants.
1. Subs. by G.S.R. No. 678(E) , dt. 31-10-2006, for Schedule MI. Earlier Schedule MI was inserted by G.S.R. 507 (E), dt: 12.6.1987. Schedule M1, before substitution, stood as under.:
“SCHEDUE M-I
[See Rule 85E (2)]
1. Requirement of factory premises for manufacture of Homeopathic preparations-
(a) Location and surroundings. – The factory shall be situated in a place which shall not be adjacent to an open sewage drain, public lavatory or any factory which produces a disagreeable or obnoxious odour or fumes or large quantities of soot, dust or smoke. The factory shall be located in a sanitary place, remove from filthy surroundings.
(b) Buildings. – The part of the building used for manufacturing shall not be used for a sleeping place and no sleeping place adjoining to it shall communicate therewith except through open air or through an intervening open space. The walls of the room in which manufacturing operations are carried out shall, upto a height of six feet from the floor, be smooth, waterproof and shall be capable of being kept clean. The flooring shall be smooth, even and washable and shall be such as not to permit retention or accumulation of dust. There shall be no chinks or crevices in the walls or floor.
(c) The building used for the factory shall be constructed so as to permit production under hygienic conditions laid down in the Factories Act, 1948 (63 of 1948).
(d) Water Supply. – The water used in manufacture shall be pure and drinkable quality, free from pathogenic microorganisms.
(e) Disposal of waste. – There should be adequate arrangement for disposal of waste-water and other residues from the laboratory.
(f) The rooms should be airy and clean and the temperature of the room should be moderately comfortable.
(g) Health, Clothing and Sanitary requirement of the Staff. – All workers shall be free from contagious or obnoxious disease. Their clothing shall consist of a white or coloured uniform suitable to the nature of the work and the climate, and shall be clean. Adequate facilities for personal cleanliness, such as clean towels, soap and hand scrubbing brushes, shall be provided separately for each sex. The workers shall be required to wash and change into clean footwear before entering the rooms where the manufacturing operations are carried on. Workers shall be required to wear either a clean cap or a suitable headgear so as to avoid any possibility of contamination by air or perspiration.
(h) Medical services. – The manufacturer shall provide adequate facilities for First Aid, Medical inspection of workers at the time of employment and periodically check-up thereafter at least once a year.
(i) Working benches. – Working benches shall be provided for carrying out operations such as filling, labelling, packing etc. Such benches shall be fitted with smooth, impervious tops capable of being washed.
(j) Container management. – Where operations involving use of containers such as bottles, phials and jars are conducted, there shall be adequate arrangements separated from potentisation chamber for washing, cleaning and drying such containers, with
suitable equipment for the purpose. Wherever these are attended manually adequate precaution of perfection in respect of cleanliness and avoidance of pollutants shall be taken.
2. Requirements of Plant and Equipment:
(a) Mother tinctures. External tinctures and Mother solution section. – The following plant and equipment shall be provided namely:-
(i) Disintegrator.
(ii) Sieved Separator.
(iii) Balances and fluid measures.
(iv) Chopping boards and knives.
(v) Macerators with lids.
(vi) Percolators with lids and regulated discharge.
(vii) Moisture determination apparatus or other suitable arrangement.
(viii) Filtering arrangement.
(ix) Mixing vessels and suitable non-metallic storage containers.
(x) Portable stirrers.
(xi) Water still.
Note: (1) As far as possible metal contacts may be avoided once the drug is processed. (2) An area of 55 sq. meters is recommended for basic installations.
(3) Adequate separate storage facility should be provided for raw material quarantine, storage and bonded room for alcohol where applicable.
(4) Separate and suitable storage facility should be provided for fresh herbs and odorous raw materials.
(5) Adequate laboratory facility shall be provided for testing of raw materials and finished products,
(b) Potentisation Section. – (1) The following arrangements are recommended for container for closure preparation section namely:
(i) Washing tanks with suitable brushing arrangement manual or mechanical.
(ii) Purified Water rinsing tank
(iii) Closure macerating or washing tanks.
(iv) Drying chambers.
An area of 20 sq. meters is recommended for basic installations.
(2) The following arrangements are recommended for potency preparation section, namely:–
(i) Working tables with washable top.
(ii) Facilities for separate storage of different grades of back potencies.
(iii) Suitable measuring devices for discharge of drug and diluent in potentisation vial,
(iv) Potentiser with counter or suitable manual arrangement.
Note:- (1) Different droppers shall be used for different drugs potencies.
(2) All measuring devices shall be of metric system and be made of glass and shall be free from metallic contents.
(3) It is desired that glass droppers etc. intended for re-use after cleaning should be sterilized by autoclave or heating in a hot air oven.
(4) Plastics, rubber tubes, bulks etc. coming in contact with tinctures or back potencies should not be re-used for other tincture and potencies.
(5) Method of potentisation will be adopted as specified in Homoeopathic Pharmacopoeia of India Vol. I.
3. Triturating, Tableting and Pill/Globules section-(3) The following arrangements are recommended:
(i) Triturating machine for suitable device.
(ii) Disintegrator.
(iii) Mass Mixer.
(iv) Granulator.
(v) Oven.
(vi) Tableting punches or machines.
(vii) Kettle (Steam/gas/electrically heated) for preparation solution.
(viii) Dryers.
(ix) Sieved separator, tablet counters and balances.
Note: Tablet section shall be free from dust and floating particles. An area of 55 sq. meters is recommended for basic installations.
(4) Ointments and lotion section:
The following arrangements are recommended namely:-
(i) Mixing tank
(ii) Kettle (Steam, gas or electrically heated).
(iii) Suitable powder mixer
(iv) Ointment mill
(v) Filling equipment or arrangement.
An area of 20 sq. meters is recommended for basic installations. (5) Syrups and tonics:
The following arrangements are recommended namely:- (i) Mixing and storage tank.
(ii) Potable mixer.
(iii) Filtering equipment. (iv) Water still / Deioniser.
(v) Filling and sealing equipment.
An area of 20 sq. meters is recommended for basic installations. (6) Ophthalmic Preparations:
The following equipment is recommended for manufacture under aseptic conditions of Eye- Ointments, Eye-Drops, Eye-lotions and other preparations for external use, namely:-
(i) Hot air even electrically heated with thermostatic control. (ii) Colloid mill or ointment mill.
(iii) Kettle (gas or electrically heated) with suitable mixing arrangement. (iv) Tube filling equipment.
(v) Mixing and storage tanks of stainless steel or of other suitable material.
(vi) Sintered glass funnel, Seitz filter or filter candle. (vii) Liquid filling equipment.
(viii) Autoclaves.
Adequate precaution should be taken to ensure that the finished product is sterile. An area of 20 sq. meters is recommended for basic installations.
(7) Adequate arrangements for space and equipment should be made for labelling and packing.”
2. PLANT AND EQUIPMENT:
2.1 General:- The design of the plant shall be suitable for the nature and quantum of the activities involved. Equipment shall be installed in such a manner as to facilitate easy flow of materials and to check criss-cross movement of the personnel. The entry to all manufacturing sections shall be regulated and persons not associated with the activities in the sections shall not have access to them. There shall be arrangements for personal cleanliness of workers and toilets. These shall be separate for men and women workers. There shall be suitable arrangement, separate for men and women, to change from their outside dress and footwear into the factory dress and footwear. Uniforms of suitable colours and fabric which facilitate proper washing and which do not shed fibres other contaminants shall be provided. Suitable head- covers and gloves shall be provided to the workers. The manufacturing premises shall not be used for dining. There shall be separate area for the personnel to take food or rest. Toilets shall be located in or adjacent to any of the areas concerned with any manufacturing activity. Spitting, smoking, chewing, littering, etc. in the manufacturing or ancillary areas shall not be permitted. Standard operating practices (SOPs) for cleaning and sanitation, personal hygiene of the workers, general and specific upkeep of the plant, equipment and premises and every activity associated with manufacture of drugs including procurement, quarantine, testing and warehousing of material shall be written and adopted. No person with any contagious disease shall be involved in any of the manufacturing activities. There shall be proper arrangements for maintenance of the equipment and systems. The performance of every equipment and system shall be properly validated and their use shall be monitored. Dos and don‘ts in the matter of the use of the plant and equipment as may be applicable shall be written and displayed in all places.
There shall be separate dedicated areas for each ancillary activity such as receipt, cleaning, warehousing and issue of raw materials, packaging materials, containers and closures, finished goods etc. Adequate measures shall be taken to prevent entry/presence etc. of insects, rodents, birds, lizards and other animals into the raw material handling areas. Every material shall have proper identification and control numbers and inventory tags and labels displaying status of the quality being used, etc. There shall be proper arrangements and SOPs for preventing mix-up of materials at every stage of handling. There shall be separate arrangements for handling and warehousing of materials of different origins. Materials with odour shall be kept in tightly closed containers and shall be well protected from other materials. Fresh materials and odorous materials shall, preferably be stored in separate dedicated areas. Where bonded manufacturing and / or warehousing facilities are required as per Excise laws, the facilities required shall be provided without compromise on the requirements specified above.
A well equipped laboratory for quality control/quality assurance of raw materials and finished products and for carrying out in-process controls shall be provided.
(a) Rooms:- The rooms shall be airy, ventilated, and maintained at temperatures which are moderate and comfortable. Sections which are required to be sterile, air- conditioned and provided with air handling system shall be designed accordingly. All sections shall be free from insects, birds, rodents, worms etc. and suitable measures shall be taken to prevent the same from finding ways to the sections and equipment.
(b) Water:- The water used for manufacture of drugs shall be of the quality as prescribed in the rules or in the Homoeopathic Pharmacopoeia concerned, as the case may be, and shall be prepared from pure drinking quality water, free from pathogenic organisms.
(c) Disposal of waste:- Effluents, organic and inorganic wastes shall be disposed of in such a manner as may be prescribed in the laws pertaining to pollution control and if no such law exists in the place of manufacture, they shall be rendered harmless and shall be disposed of in such a manner that they are not hazardous to health of the public or cattle or plants.
(d) Factories Act:- The provisions of the Factories Act, 1948(Act 63 of 1948), as applicable shall be adhered to.
(e) Medical Services:- All persons concerned with any activity pertaining to manufacture of drugs including handling of raw materials, packing materials, packing and labelling of drugs, etc. shall be medically examined for fitness at the time of employment and subsequently at periodic intervals and records thereof shall be maintained.
(f) Safety measures:- First-aid facilities shall be provided in such a manner that they are easily accessible and staff shall be imparted knowledge and training in first- aid measures as may be needed. Fire control equipment in suitable numbers shall be provided at easily accessible places near all sections including stores and warehouses.
(g) Workbenches:- Workbenches suitable to the nature and quantum of the work involved shall be provided in all sections. Such work benches in general, shall have smooth, washable and impervious tops and the parts shall not be rough or rusty or damaged otherwise.
(h) Container management:- Proper arrangements shall be made for receiving containers, closures and packing materials in secluded areas and for de-dusting the same, removal of wastes, washing, cleaning and drying. Suitable equipment shall be provided as may be needed, considering the nature of work involved. Where soaps and detergents are used to wash containers and closures used for primary packing, suitable procedure shall be prescribed and adopted for total removal of such materials from the containers and closures. Plastic containers which are likely to absorb active principle or which are likely to contaminate the contents may not be used.
Glass containers used shall be made of neutral glass. The closures and washers used shall be of inert materials which shall not absorb the active principles or contaminate the contents or which may otherwise be likely to cause deterioration of quality. The containers, closures and packing materials shall protect the properties of the medicines, Tablets, if blister-packed, shall have secondary protective packaging to protect the medicines from moisture, odour etc. Neutral glass phials and epoxy-coated closure shall be used for eye-drops. Transparent plastic containers may be used for eye-drops containing only aqueous preparations. Sterile plastic nozzles may be provided to eye-drops separately along with the medicine, whatever needed.
2.2. Personnel.- Manufacture of drugs shall be under the control of approved technical staff that shall possess the qualifications prescribed in rule 85.
3. REQUIREMENT OF EQUIPMENT AND FACILITIES:
3.1 Mother tinctures and mother solutions:- The following equipment and facilities shall be provided:-
(i) Disintegrator;
(ii) Sieved separator;
(iii) Balances, weights and fluid measures, all in metric system;
(iv) Chopping table/board and knives;
(v) Macerators with lids (all made of stainless steel of grade 304 or neutral glass);
(vi) Percolators (all made of stainless steel of grade 304);
(vii) Moisture determination apparatus;
(viii) Filter press/Sparkler filter (all metal parts shall be of stainless steel);
(ix) Mixing and storage vessels (Stainless steel of grade 304);
(x) Portable stirrers (Rod, blades and screws shall be of stainless steel);
(xi) Water still/water purifier;
(xii) Macerators and percolators for preparing mother solutions of materials of chemical origin. These shall be of material, which will not react with the chemicals, used and which do not bleach; and
(xiii) Filling and sealing machine.
The area and facilities for manufacture of mother tinctures and mother solutions shall be separate and shall be 55 square meters for each for basic installations.
3.2 Potentisation section:- The section shall have the following facilities:-
(i) Work benches with washable impervious tops;
(ii) Facilities for orderly storage of different potencies and back-potencies of various drugs;
(iii) Suitable devices for measuring and dispensing of potencies/back-potencies into the potentisation phials;
(iv) Potentiser with counter.
An area of 20 square meters shall be provided for basic installations.
Note:-
(a) The requirement of potentiser is not mandatory. The process may be done manually also with proper SOPs. Potentiser, if used, shall be properly validated and shall be calibrated every time before commencement of work for proper performance.
(b) The manufactur er sh all use back-poten cies procur ed fr om Licen sed manufacturers and the firm shall maintain proper records of purchase or shall prepare own-back potencies . Every container of potencies and back-potencies shall be kept properly labelled and there shall not be mix-up of different medicines and different potencies.
3.3 Containers and Closures Section:- Separate area for preparation of containers and closures shall be provided adjacent to the potentisation section. This area shall have the following facilities:-
(i) Washing tanks with suitable mechanical or hand operated brushes;
(ii) Rinsing tanks. Purified water shall be used for rinsing;
(iii) Closures washing / macerating tanks;
(iv) Driers;
Note:-
(a) Different droppers shall be used only for each different medicine and different potency.
(b) All measures shall be in metric system. Measures used shall be of neutral glass. Metal droppers and plastic droppers shall not be used.
(c) Glass droppers shall be reused only after proper cleaning and sterilization.
(d) Potentisation shall be done by the method(s) prescribed in the Homoeopathic Pharmacopoeia of India.
3.4 Trituration, Tableting, Pills and Globules making sections:- The following basic equipment and facilities shall be provided:-
(i) Triturating Machine;
(ii) Disintegrator;
(iii) Mass Mixer;
(iv) Granulator;
(v) Electrical Oven;
(vi) Tablets punching Machine;
(vii) Kettle (steam or electrically heated ) for preparing solutions;
(viii) Driers for drying granules and tablets;
(ix) Sieved separator (stainless steel);
(x) Tablet counter;
(xi) Balances;
(xii) Coating Pan with spray-gun;
(xiii) Multi-sifter
(xiv) Mill with perforations.
An area of 55 square meters shall be provided for basic installations. The area shall be suitably divided into cubicles to minimize cross contamination, mix-up etc.
Note:- The section shall be free from insects, worms, rodents, dust and other floating particles and moisture.
3.5 Syrups and other oral liquids section:- The following basic equipment and facilities shall be provided:-
(i) Mixing and storage tanks (stainless steel of grade 304);
(ii) Portable stirrer (rod, blades and screws shall be of stainless steel);
(iii) Filter press / Sparkler filter (all metal parts shall be of stainless steel);
(iv) Filling and sealing machine;
(v) pH meter.
An area of 20 square meters shall be provided for basic installations. The section shall be free from dust and other floating particles, cobwebs, flies, ants and other insects, birds, lizards and rodents.
(1) Adequate number of workbenches shall be provided.
(2) Visual inspection table shall be provided. This shall comprise of a colour con trast backgr ound with lamp for providing diffused ligh t, mounted on a suitable table.
3.6 Ointments and lotions section:- The following basic equipments and facilities shall be provided:-
(i) Mixing tanks (Stainless steel)
(ii) Kettle (steam or electrically heated) for preparing solutions
(iii) Suitable powder / planetary Mixer
(iv) Ointment mill / colloidal Mill / Emulsifier
(v) Filling and sealing machine / Crimping machine
(vi) Filtering equipment
(vii) Balance and weights
A minimum area of 20 square meters shall be provided for basic installations. An ancillary area for washing vessels and equipment shall be provided. An ancillary area for heating purposes shall also be provided.
3.7 Ophthalmic preparations section:- The following basic equipment and facilities shall be provided:-
(i) Hot air oven, electrically heated, with thermostatic control;
(ii) Laminar Air Flow bench;
(iii) Air Handling Unit with HEPA filters to provide filtered air and positive pressure to the section and air-locks;
(iv) Ointment mill / colloidal mill;
(v) Mixing and storage tanks (Stainless steel of grade 304);
(vi) Pressure vessels, as may be needed;
(vii) Sintered glass funnels, Seitz Filter / Filter candle;
(viii) Vacuum pump;
(ix) Filling machines for liquids ointments etc.;
(x) Autoclaves with pressure and temperature gauges; and
(xi) Necessary workbenches, visual inspection bench, etc.
Area: Minimum area of 20 square meters shall be provided for basic installations.
Note:-
1. The section shall have a clean room facility of Class 100 specification.
2. The section shall be air-conditioned and humidity controlled.
3. Entry to the sections shall be regulated through air-locks with differential air pressures with the air-lock adjacent to the section having higher pressure and the first one through which entry is made with the least pressure.
4. Materials shall be passed to the sections through suitable hatches.
5. The personnel shall wear sterile clothing including headgear, which shall not shed fibre.
6. Washing of phials shall be done in separate areas with proper equipment. Proper facilities shall be provided in the area for washing vessels.
7. Separate area shall be provided for packing and labelling.
4. QUALITY CONTROL DIVISION:
4.1 Functions:- A separate quality control division shall be provided in the premises. The section shall be under the control of an approved technical officer, independent of the manufacturing division and directly responsible to the management. The section shall be responsible for ensuring the quality of all raw materials, packing materials and finished goods. The section shall also carry out in-process quality checks of the products. The section shall be responsible for the stability of the products and for prescribing their shelf life wherever applicable.
The functions of the division shall include:-
(1) To test the identity, quality and purity of the raw materials and to recommend rejection of the material of poor quality and approve materials of the prescribed quality only.
(2) To test the identity, quality and purity of the finished products and to recommend rejection of the material of poor quality and to approve materials of the prescribed quality only.
(3) To prepare and validate the methods of analysis, validate the equipment, monitor their use, take steps for proper maintenance, etc.
(4) To approve or reject container s, closures and packaging materials in accordance with the prescribed norms.
(5) To exercise / carry out in-process control of products.
(6) To prescribe SOPs on all matters concerning quality of materials and products.
(7) To monitor the storage and handling of raw materials, finished products, containers, closures and packaging materials.
(8) To investigate complaints on quantity of products and take / recommend appropriate measures and to examine returned goods and recommend their proper disposal.
4.2 Personnel:- The quality control staff shall be full-time personnel. Analysis and tests of drugs, raw materials, etc. shall be done by qualified and approved technical staff. The technical staff shall have the minimum qualification of degree in Homoeopathic Pharmacy or Science with Chemistry or Botany as the principal subject and experience of not less than two years in the test and analysis of medicines including handling of instruments.
4.3 Equipment:- The following equipment shall be provided:-
(i) Microscope of suitable magnification and photographic device;
(ii) Dissecting microscope;
(iii) TLC apparatus;
(iv) UV lamp viewer;
(v) Monopan Digital Electronic Balance;
(vi) Hot air oven;
(vii) Distillation apparatus;
(viii) Water Bath;
(ix) Polarimeter;
(x) Refractometer;
(xi) Melting point apparatus;
(xii) pH meter;
(xiii) Magnetic stirrer;
(xiv) Table Centrifuge;
(xv) Muffle furnace / electric Bunsen;
(xvi) Moisture determination apparatus;
(xvii) U.V. Spectrophotometer;
(xviii) Rotary microtome / Section cutting facilities;
(xix) Tablet Disintegration Machine.
5. RAW MATERIALS:
5.1 Raw materials of Plant Origin:-
(a) The raw materials of plant origin used for manufacture of drugs shall be of the following specifications:-
(i) the materials shall be those recently collected and dried and shall be free from moisture so as to eliminate the risk of deterioration and infestation with pests moulds, etc. The materials shall be collected when the atmospheric temperature is suitable where its active constituents are not changed / damaged / destroyed.
(ii) when fresh materials are to be used, the time lapse from the time of collection to use shall be minimized to the extent possible;
(iii) the materials should be taken from healthy plants and shall be free from parasites, moulds, etc.;
(iv) the materials shall be free of inorganic or organic foreign matter;
(v) when dry materials are procured, they shall be from healthy plants and shall be in unprocessed form, free from all extraneous matters such as fungus, insects, moulds, pathogenic organisms, etc. and should not be more than six months old. Plant materi alsof Agaricaceae, which are perishable shall be used within one week of ollection.
(b) To facilitate proper identification and purity of the material and to exercise proper quality control of the material, the following conditions must be satisfied:-
(i) a small twig of the plant with leaves shall be available if the part used is bark of the plant;
(ii) an entire plant or part or aerial twig with leaves and some uncut roots / rhizomes / bulbs shall be available if the part used is a root /rhizome / bulb;
(iii) if plants with flowers are to be used, a few dry flowers shall also be available with the aerial twig;
(iv) if the material used is a mould or of the plant families Agaricaceae, Polyporaceae/ amanitacaea / Boletaceae / Russulaceae, a whole specimen plant / mould shall be available in properly dried form;
(v) the materials shall be free from insecticides, fungicides, etc;
(vi) the materials shall be in open mesh bags or in suitable material which permits the passage of air inside;
(vii) each consignment of the material shall be accompanied by a statement of the supplier‘s name; name of the plant with description of the part supplied. The pharmacopoeial reference, place of collection /harvest, date and time of collection and packaging and weight.
5.2 Raw material of Chemical origin:- They shall be of respective pharmacopoeial standards and statements of their specification shall accompany the materials.
5.3 Raw materials of animal origin:- The materials shall be those collected from healthy animals and shall be of pharmacopoeial specifications. The materials shall be those collected, packed and transported under proper hygienic conditions and well protected from all contamination. The materials shall be accompanied by statements as in para ‘a‘ above. In case of drugs derived from a whole insect, bulk of such drugs along with some uncut whole insect should be provided / maintained for records.
5.4 Sarcodes:- The materials shall be those collected from healthy animals and shall be of pharmacopoeial specification. The materials shall be those collected, packed and transported under proper hygienic conditions and well protected from all contamination. The materials shall be accompanied by statements as in the Para ‘a‘ above. The materials shall be tested to see that they are free from pathogenic organisms such as E. Coli, Salmonella, etc.
5.5 Nosodes:- These shall be of pharmacopoeial specifications. As these are derived from diseased animals or human beings, they shall be autoclaved immediately after collection and preserved and transported under proper hygienic conditions and well protected from all contamination. Before use, these shall be sterilized by autoclaving and shall comply with the test for sterility as specified in the Homoeopathic Pharmacopoeia.
6. PROCEDURES:
6.1 Manufacture of Mother tinctures:-
(a) Every material shall be identified and checked for its purity. They shall be cleaned and processed by cutting, chopping, etc. for use in macerators / percolators. A specimen of the material shall be preserved till approval of the product for release for sale.
(b) The design and procedures adopted shall ensure reproduction of the product of the same quality every time.
(c) Mother tinctures shall be preserved in tight closed neutral containers at temperatures preferably below 250 C, protected from light.
6.2 Manufacture of Attenuations:-
(a) Attenuations shall be prepared in a clean room environment with filtered air and positive pressure inside suitable for the operations.
(b) The methods used shall be reproducible and shall be validated.
(c) The containers, tubings, etc. of the machines used for manufacture of attenuations shall be thoroughly washed, cleaned and dried after attenuation of a drug. Regular checks shall be carried out on the materials.
(d) The parts of the equipment that come into contact with the attenuation materials shall be of neutral quality and shall not cause any contamination to the material.
(e) Attenuations shall be preserved in properly labeled glass containers.
(f) Alcohol and other vehicles used shall be of Homoeopathic pharmacopoeia specification and shall be free from impurities.
6.3 Trituration:- Trituration technique is used to manufacture drugs from insoluble strains. The procedure / method specified in the Homoeopathic pharmacopoeia shall be adopted.
6.4 Formulations:- Compound formulations shall preferably be in liquid and solid forms and the potency of the ingredients shall be in detectable quantity preferably be in 3x except in case of highly poisonous material and toxins which should not be below 6x. The ingredients shall be compatible to each other. Complete pharmacopoeial name of each ingredient shall be printed on the label along with composition.
6.5 Medicated Insert Pellets:- (a) Pellets shall be manufactured in clean rooms free from particulate contaminants. The equipment used shall enable prevention of contamination and cross- contamination.
(b) The procedures shall be validated.
7. LABORATORY CONTROLS:
Tests as per the pharmacopoeia and requirements shall be carried out on products and materials. The stability of the products shall be established by proper methods. Sterility tests,
wherever applicable, shall be carried out. Control samples shall be preserved for not less than three years after the last sales.
8. PACKINGAND LABELLING:
A minimum area of 50 square meters shall be provided for packing and labeling section.
9. EXPIRYDATE:
Not exceeding sixty (60) months from the date of manufacture.
10. STANDARD OPERATING PRACTICES:
Standard Operating Practices (SOPs) shall be developed for various activities such as receipt, identification, cleaning, drying, warehousing, issue, handling, sampling etc. of all materials. Labels and packing materials shall be examined for correctness and compliance with rules. Records shall be maintained for their printing, use, destruction etc.
11. RECORDSAND REGISTERS:
Records shall be maintained for all the activities. These shall include records of production, records of raw materials, records of testing, records of sales and other supplies, records of rejection, complaints and actions taken, SOPs and records in respect of compliance thereof, log books of equipment, master formula records, records of medical examination and fitness of personnel etc. All records shall be maintained for a period of one year after the expiry of a batch or for three years whichever is later.
1[SCHEDULE M-II
[See Rule 139]
REQUIREMENTS OF FACTORY PREMISES FOR MANUFACTURE OF COSMETICS
I. GENERAL REQUIREMENTS
(A) Location and surroundings.–The factory shall be located in a sanitary place and hygienic conditions shall be maintained in the premises. Premises shall not be used for residence or be interconnected with residential area. It shall be well ventilated and clean.
(B) Buildings.– The buildings used for the factory shall be constructed so as to permit production under hygienic conditions and not to permit entry of insects, rodents, files, etc.
The walls of the room in which manufacturing operations are carried out, shall be up to a height of six feet from the floor, be smooth, waterproof and capable of being kept clean. The flooring shall be smooth, even and washable and shall be such as not to permit retention or accumulation of dust.
(C) Water supply:- The water used in manufacture shall be of potable quality.
(D) Disposal of water. –- Suitable arrangements shall be made for disposal of waste-water.
(E) Health, clothing and sanitary requirements of the staff.– All workers shall be free from contagious or infectious diseases. They shall be provided with clean uniforms, masks, headgears, and gloves wherever required. Washing facilities shall also be provided.
(F) Medical Services. – Adequate facilities for first aid shall be provided.
(G) Work benches shall be provided for carrying out operations such as filling, labelling, packing, etc. Such benches shall be fitted with smooth, impervious tops capable of being washed.
(H) Adequate facilities shall be provided for washing and drying of glass containers if the same are to be used for packing the product.
II. REQUIREMENTS OF PLANT AND EQUIPMENT
The following equipment, area and other requirements are recommended for the manufacture of: −
A. Powders:− Face powder, cake make-up, compacts, face packs, masks and rouges, etc.
1. Equipment:
(a) Powder mixer of suitable type provided with a dust collector.
(b) Perfume and colour blender.
(c) Sifter with sieves of suitable mesh size.
(d) Ball mill or suitable grinder.
(e) Trays and scoops (stainless steel).
(f) Filling and sealing equipment provided with dust extractor.
(g) For compacts:-
(i) a separate mixer, (ii) compact pressing machine.
(h) Weighing and measuring devices
(i) Storage tanks.
1. Ins. by G.S.R 723(E) , dt. 11-8-1992.
An area of 15 square meters is recommended. The section is to be provided with adequate exhaust fans.
B. Creams, lotions, emulsions, pastes, cleansing milks, shampoos, pomade, brilliantine, shaving creams and hair-oils etc.
(a) Mixing and storage tanks of suitable materials.
(b) Heating kettle – steam, gas or electrically heated.
(c) Suitable agitator.
(d) Colloidal mill or homogeniser (wherever necessary).
(e) Triple roller mill (wherever necessary).
(f) Filling and sealing equipment.
(g) Weighing and measuring devices.
An area of 25 square meters is recommended.
C. Nail Polishes and Nail lacquers.
1. Equipment:
(a) A suitable mixer.
(b) Storage tanks.
(c) Filling machine – hand operated or power driven.
(d) Weighing and Measuring devices.
An area of 15 square meters is recommended. The section shall be provided with flameproof exhaust system.
2. Premises:– The following are the special requirements related to Nail Polishes and Nail Lacquers:-
(a) It shall be situated in an industrial area.
(b) It shall be separate from other cosmetic-manufacturing areas by metal/brick partition up to ceiling.
(c) Floors, walls, ceiling and doors shall be fireproof.
(d) Smoking, cooking and dwelling shall not be permitted and no naked flame shall be brought in the premises.
(e) All electrical wiring and connections shall be concealed and main electric switch shall be outside the manufacturing area.
(f) All equipment, furniture and light fittings in the section shall be flameproof.
(g) Fire extinguisher like foam and dry powder and sufficient number of buckets containing sand shall be provided.
(h) All doors of the section shall open outwards.
3. Storage:
All explosive solvents and ingredients shall be stored in metal cupboards or in a separate enclosed area.
4. Manufacture:
(a) Manufacture of lacquer shall not be undertaken unless the above conditions are complied with.
(b) Workers shall be asked to wear shoes with rubber soles in the section.
5. Other requirements:
No objection certificate from the local Fire Brigade Authorities shall be furnished.
D. Lipsticks and Lip-gloss, etc.
1. Equipment
(a) Vertical mixer.
(b) Jacketted kettle – steam, gas or electrically heated.
(c) Mixing vessel (stainless steel).
(d) Triple roller mill/Ball mill.
(e) Moulds with refrigeration facility.
(f) Weighing and measuring devices. An area of 15 square meters is recommended.
E. Depilatories.
1. Equipment:
(a) Mixing tanks.
(b) Mixer
(c) Triple roller mill or homogeniser (where necessary).
(d) Filling and sealing equipment.
(e) Weighing and measuring devices.
(f) Moulds (where necessary).
An area of 10 square meters is recommended.
F. Preparations used for Eyes:- Such preparations shall be manufactured under strict hygienic conditions to ensure that these are safe for use.
1. Eyebrows, Eyelashes, Eyeliners, etc.
1 Equipment:
(a) Mixing tanks.
(b) A suitable mixer.
(c) Homogeniser (where necessary)
(d) Filling and sealing equipment.
(e) Weighing and measuring devices.
An area of 10 square meters is recommended.
2. Kajal and Surma
1. Equipment:
(a) Base sterilizer.
(b) Powder sterilizer (dry heat oven).
(c) Stainless steel tanks.
(d) A suitable Mixer.
(e) Stainless steel sieves.
(f) Filling and sealing arrangements.
(g) Weighing and measuring devices.
(h) Homogeniser (where necessary).
(i) Pestle and Mortar (for Surma).
An area of 10 square meters with a separate area of 5 square meters for base sterilization is recommended.
Other requirements for 1 and 2:
(a) False ceiling shall be provided wherever required.
(b) Manufacturing area shall be made fly proof. An airlock or an aircurtain shall be provided.
(c) Base used for Kajal shall be sterilized by heating the base at 150 degree C for required time in a separate enclosed area.
(d) The vegetable carbon black powder shall be sterilized in a drying oven at 120 degree C for required time.
(e) All utensils used for manufacture shall be of stainless steel and shall be washed with detergent water, antiseptic liquid and again with distilled water.
(f) Containers employed for ‘Kajal‘ shall be cleaned properly with bactericidal solution and dried.
(g) Workers shall put on clean overalls and use hand gloves wherever necessary.
G. Aerosol.
1. Equipment:-
(a) Air-compressor (wherever necessary).
(b) Mixing tanks.
(c) Suitable propellant filling and crimping equipments.
(d) Liquid filling unit.
(e) Leak testing equipment.
(f) Fire extinguisher (wherever necessary)
(g) Suitable filtration equipment.
(h) Weighing and measuring devices. An area of 15 square meters is recommended.
2. Other requirements:- No objection certificate from the Local Fire Brigade Authorities shall be furnished.
H. Alcoholic Fragrance Solutions.
Equipment:-
(a) Mixing tanks with stirrer
(b) Filtering equipment.
(c) Filling and sealing equipment.
(d) Weighing and measuring devices.
An area of 15 square meters is recommended.
I. Hair Dyes.
Equipment:
(a) Stainless steel tanks.
(b) Mixer.
(c) Filling Unit.
(d) Weighing and measuring devices.
(e) Masks, gloves and goggles.
An area of 15 square meters with proper exhaust is recommended.
J. Tooth powders and toothpastes, etc.:
1. Tooth-powder in General.
Equipment:
(a) Weighing and measuring devices.
(b) Dry mixer (powder blender).
(c) Stainless steel sieves.
(d) Powder filling and sealing equipments.
An area of 15 square meters with proper exhaust is recommended.
2. Toothpastes.
Equipment:
(a) Weighing and measuring devices.
(b) Kettle – steam, gas or electrically heated (where necessary).
(c) Planetary mixer with de-aerator system.
(d) Stainless steel tanks.
(e) Tube filling equipment.
(f) Crimping machine.
An additional area of 15 square meters with proper exhaust is recommended.
3. Tooth-powder (Black)
Equipment:
(a) Weighing and measuring devices.
(b) Dry mixer powder blender.
(c) Stainless steel sieves.
(d) Powder filling arrangements.
An area of 15 square meters with proper exhaust is recommended. Areas for manufacturing “Black” and “White” tooth powders should be separate.
K. Toilet Soaps:
Equipment:-
(a) Kettles/pans for saponification.
(b) Boiler or any other suitable heating arrangement.
(c) Suitable stirring arrangement.
(d) Storage tanks or trays.
(e) Driers.
(f) Amalgamator/chipping machine.
(g) Mixer.
(h) Triple roller mill.
(i) Granulator.
(j) Plodder.
(k) Cutter.
(l) Pressing, stamping and embossing machine.
(m) Weighing and measuring devices.
A minimum area of 100 square meters is recommended for the small-scale manufacture of toilet soaps.
The areas recommended above are for basic manufacturing of different categories of cosmetics. In addition to that separate adequate space for storage of raw materials, finished products, packing materials shall be provided in factory premises.1[***]
Note No. I−The above requirements of the Schedule are made subject to modification at the discretion of the Licensing Authority, if he is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter them in the circumstances of a particular case.
Note No. II.−The above requirements do not include requirements of machinery, equipments and premises required for preparation of containers and clousers of different categories of cosmetics. The Licensing Authority shall have the discretion to examine the suitability and adequacy of the machinery, equipments and premises for the purpose of taking into consideration of the requirements of the licensee.
Note No. III.−Schedule M-II specifies equipments and space required for certain categories of cosmetics only. There are other cosmetics items, viz. Attars, perfumes, etc., which are not covered in the above categories. The Licensing Authority shall, in respect of such items or categories of cosmetics have the discretion to examine the adequacy of factory premises, space, plant and machinery and other requisites having regard to the nature and extent of the manufacturing operations involved and direct the licensee to carry on necessary modification in them.
1. The words “A testing laboratory shall also be provided” omitted by G.S.R.285 (E) , dt. 16.7.1996.
1[SCHEDULE M-III
[See rules 69, 69A, 75, 75A and 76]
QUALITY MANAGEMENT SYSTEM –FOR NOTIFIED MEDICAL DEVICES AND IN- VITRO DIAGNOSTICS
1. General Requirements:
1.1. This schedule specifies requirements for a quality management system that shall be used by the manufacturer for the design and development, manufacture, packaging, labeling, testing, installation and servicing of medical devices and in-vitro diagnostics. If the manufacturer does not carry out design and development activity, the same shall be recorded in the quality management system. The manufacturer shall maintain conformity with this Schedule to reflect the exclusions.
1.2. If any requirement in clause 7(product realisation) of this Schedule is not applicable due to the nature of the medical device and in-vitro diagnostics for which the quality management system is applied, the manufacturer does not need to include such a requirement in its quality management system.
1.3. The processes required by this Schedule, which are applicable to the medical device and in- vitro diagnostic devices, but which are not performed by the manufacturer are the responsibility of the manufacturer and are accounted for in the manufacturer‘s quality management system.
1.4. If a manufacturer engages in only some operations subject to the requirements of this part, and not in others, that manufacturer need only to comply with those requirements which are applicable to the operations in which it is engaged.
1.5. It is emphasised that the quality management system requirements specified in this Schedule are in addition to complementary to technical requirements for products.
1.6. Manufacturers of components or parts of finished devices and in-vitro diagnostics are encouraged to use appropriate provisions of this regulation as guidance.
2. Applicability:
The provisions of this Schedule shall be applicable to manufacturers of finished devices, In-Vitro Diagnostics, mechanical contraceptives (condoms, intrauterine devices, tubal rings), surgical dressings, surgical bandages, surgical staplers, surgical sutures and ligatures, blood and blood components collection bags with or without anticoagulants intended for human or animal use.
________
1. Subs.by G.S.R. 640 (E) , dt. 29.6.2016. Previously, Ins. by G.S.R. 109 (E) , dt. 22.2.1994.
________
3. Terms and definitions:
3.1 Active implantable medical device.- Active medical device which is intended to be totally or partially introduced, surgically or medically, into the human or animal body or by medical intervention into a natural orifice and which is intended to remain after the procedure.
3.2 Active medical device.- Medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human or animal body or gravity.
3.3 Advisory notice.- Notice issued by the manufacturer, subsequent to delivery of the medical device and in-vitro diagnostic devices, to provide supplementary information or to advise what action should be taken in or both in:-
a. the use of a medical device and in-vitro diagnostic devices;
b. the modification of a medical device and in-vitro diagnostic devices;
c. the return of the medical device and in-vitro diagnostic devices to the organization that supplied it; or
d. the destruction of a medical device and in-vitro diagnostic devices.
3.4 Customer complaint.- Written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a medical device and in-vitro diagnostic devices that has been placed on the market.
3.5 Implantable medical device.- Medical device intended:-
a. to be totally or partially introduced into the human or animal body or a natural orifice; or
b. to replace an epithelial surface or the surface of the eye;
by surgical intervention, and which is intended to remain after the procedure for at least thirty days, and which can only be removed by medical or surgical intervention.
3.6 Component means any raw material, substance, piece, part, software, firmware, labeling, or assembly which is intended to be included as part of the finished, packaged, and labeled device.
3.7 Design input means the physical and performance requirements of a device that are used as a basis for device design.
3.8 Design output means the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. The total
finished design output consists of the device, its packaging and labeling, and the device master record.
3.9 Design review means a documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to identify problems.
3.10 Finished device means any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled or sterilized.
3.11 In-vitro Diagnostic means in-vitro diagnostics referred in this Schedule including diagnostics kits and reagents that fall under sub-clause (i) of clause (b) of section 3 of Drugs and Cosmetics Act, 1940.
3.12 Management with executive responsibility means those senior employees of a manufacturer who have the authority to establish or make changes to the manufacturer’s quality policy and quality system.
3.13 Medical device referred in this Schedule means devices that are notified under clause (iv) of sub-section (b) of section 3 of Drugs and Cosmetics Act, 1940.
3.14 Quality audit means a systematic, independent examination of a manufacturer’s quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives.
3.15 Quality policy means the overall intention and direction of an organization with respect to quality, as established by management with executive responsibility.
3.16 Quality system means the organisational structure, responsibilities, procedures, processes, and resources for implementing quality management.
3.17 Rework means action taken on a nonconforming product that will fulfill the specified Device Master File requirements before it is released for distribution.
3.18 Specification means any requirement with which a product, process, service, or other activity must conform.
3.19 Validation means confirmation by examination and provision of objective evidence that the particular requirement for a specific intended use can be consistently fulfilled;
3.19.1 Process validation means establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.
3.19.2 Design validation means establishing by objective evidence that device specifications conform with user needs and intended use(s).
3.20 Verification means confirmation by examination and provision of objective evidence that specified requirements have been fulfilled.
4 Quality management system.-
4.1 General:
The manufacturer shall establish, document, implement and maintain a quality management system and maintain its effectiveness in accordance with the requirements of this schedule.
The manufacturer shall;-
(a) identify the processes needed for the quality management system and their application throughout the organization;
(b) determine the sequence and interaction of these processes;
(c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective;
(d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes;
(e) monitor, measure and analyse these processes; and
(f) implement actions necessary to achieve planned results and maintain the effectiveness of these processes.
These processes shall be managed by the manufacturer in accordance with the requirements of this Schedule. Where a manufacturer chooses to outsource any process that affects product conformity with requirements, the manufacturer shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.
NOTE: Processes needed for the quality management system referred to above shall include processes for management activities, provision of resources, product realization and measurement.
4.2 Documentation requirements.-
4.2.1 General
The quality management system documentation shall include;-
(a) documented statements of a quality policy and quality objectives;
(b) a quality manual;
(c) documented procedures required by this schedule;
(d) documents needed by the manufacturer to ensure the effective planning, operation and control of its processes;
(e) records required by this schedule, and
where this schedule specifies that a requirement, procedure, activity or special arrangement be “documented”, it shall, in addition, be implemented and maintained.
For each type or model of medical device or In-vitro Diagnostics, the manufacturer shall establish and maintain a file either containing or identifying documents defining product specifications and quality management system requirements. These documents shall define the complete manufacturing process and, if applicable, installation.
The manufacture shall prepare documentation for device or in-vitro diagnostics in a form of a Device Master File containing specific information as referred to in Annexure-A appended to this Schedule.
Data may be recorded by electronic data processing systems or other reliable means, but documents and record relating to the system in use shall also be available in a hard copy to facilitate checking of the accuracy of the records. Wherever documentation is handled by electronic data processing methods, authorized persons shall enter or modify data in the computer. There shall be record of changes and deletions. Access shall be restricted by ‘passwords‘ or other means and the result of entry of critical data shall be independently checked. Batch records electronically stored shall be protected by a suitable back-up. During the period of retention, all relevant data shall be readily available.
4.2.2 Quality manual.-
The manufacturer shall establish and maintain a quality manual that includes:-
(a) the scope of the quality management system, including details of and justification for any exclusion or non-application or both;
(b) the documented procedures established for the quality management system, or reference to them; and
(c) a description of the interaction between the processes of the quality management system. The quality manual shall outline the structure of the documentation used in the quality management system.
The manufacturer shall prepare documentation in a form of a Plant Master File containing specific information about the facilities, personnel and other details as prescribed in Annexure B appended to this Schedule.
4.2.3 Control of documents.-
Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in the control of records. Documents shall be approved, signed and dated by the appropriate and the authorised person.
A documented procedure shall be established to define the controls needed.-
(a) to review and approve documents for adequacy prior to issue;
(b) to review and update as necessary and re-approve documents;
(c) to ensure that changes and the current revision status of documents are identified;
(d) to ensure that relevant versions of applicable documents are available at points of use;
(e) to ensure that documents remain legible and readily identifiable;
(f) to ensure that documents of external origin are identified and their distribution controlled; and
(g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
Changes to document shall be reviewed and approved. Change records shall be maintained which will include a description of the change, identification of the affected documents, the signature of the approving individual, the approval date, and when the change becomes effective.
The manufacturer shall ensure that changes to documents are reviewed and approved either by the original approving functionary or another designated functionary which has access to pertinent background information upon which to base its decisions.
The manufacturer shall define the period for which at least one copy of obsolete controlled documents shall be retained. This period shall ensure that documents to which medical devices or in- vitro diagnostics have been manufactured and tested are retained for at least one year after the date of expiry of the medical device or in-vitro diagnostic as defined by the manufacturer.
4.2.4 Control of records.-
Records shall be established and maintained to provide evidence of conformity to the requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the
controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
The manufacturer shall retain the records for a period of time at least one year after the date of expiry of the medical device or in-vitro diagnostics as defined by the manufacturer, but not less than two years from the date of product release by the manufacturer.
5 Management responsibility.-
5.1 Management commitment:
Top management of the manufacturer shall provide evidence of its commitment to the development and implementation of the quality management system and maintaining its effectiveness by:-
(a) communicating to the employees the importance of meeting customer as well as statutory and regulatory requirements;
(b) establishing the quality policy;
(c) ensuring that quality objectives are established;
(d) conducting management reviews; and
(e) ensuring the availability of resources.
5.2 Customer focus:
Top management of the manufacturer shall ensure that customer requirements are determined and are met.
5.3 Quality policy:
Top management of the manufacturer shall ensure that the quality policy:-
(a) is appropriate to the purpose of the manufacturing facility;
(b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system;
(c) provides a framework for establishing and reviewing quality objectives;
(d) is communicated and understood within the manufacturer‘s organization; and
(e) is reviewed for continuing suitability.
5.4 Planning.
5.4.1 Quality objectives:
Top management of the manufacturer shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the manufacturing organization. The quality objectives shall be measurable and consistent with the quality policy.
5.4.2 Quality management system planning:
Top management of the manufacturer shall ensure that.-
(a) the planning of the quality management system is carried out in order to meet the specified requirements, as well as the quality objectives; and
(b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
5.5 Responsibility, authority and communication.-
5.5.1 Responsibility and authority:
Top management of the manufacturer shall ensure that responsibilities and authorities are defined, documented and communicated within the manufacturing organisation.
Top management of the manufacturer shall establish the interrelation of all personnel who manage, perform and verify work affecting quality, and shall ensure the independence and authority necessary to perform these tasks.
5.5.2 Management representative:
Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes:-
(a) ensuring that processes needed for the quality management system are established, implemented and maintained;
(b) reporting to top management on the performance of the quality management system and any need for improvement; and
(c) ensuring the promotion of awareness of regulatory and customer requirements throughout the manufacturing organization.
5.5.3 Internal communication:
Top management shall ensure that appropriate communication processes are established within the Manufacturing organization and that communication takes place regarding the effectiveness of the quality management system.
5.6 Management review.-
5.6.1 General:
Top management shall review the organization‘s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews shall be maintained.
5.6.2 Review input:
The input to management review shall include information on:-
(a) results of audits,
(b) customer feedback,
(c) process performance and product conformity,
(d) status of preventive and corrective actions,
(e) follow-up actions from previous management reviews,
(f) changes that could affect the quality management system,
(g) recommendations for improvement, and
(h) new or revised regulatory requirements as and when issued.
5.6.3 Review output:
The output from the management review shall include any decisions and actions related to:-
(a) improvements needed to maintain the effectiveness of the quality management system and its processes,
(b) improvement of product related to customer requirements, and
(c) resource needs.
6 Resource management.-
6.1 Provision of resources:
The manufacturing organization shall determine and provide the resources needed
(a) to implement the quality management system and to maintain its effectiveness, and
(b) to meet regulatory and customer requirements.
6.2 Human resources.-
6.2.1 General:
Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience. Number of personnel employed shall be adequate and in direct proportion to the workload. Prior to employment, all personnel, shall undergo medical examination including eye examination, and shall be free from communicable or contagious diseases. Thereafter, they should be medically examined periodically, at least once a year. Records shall be maintained thereof.
6.2.2 Competence, awareness and training:
The manufacturer shall:-
(a) determine the necessary competence for personnel performing work affecting product quality,
(b) provide training or take other actions to satisfy these needs,
(c) evaluate the effectiveness of the actions taken,
(d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives,
(e) maintain appropriate records of education, training, skills and experience, and
(f) establish documented procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities.
6.3 Infrastructure:
The organisation shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable:-
(a) buildings, workspace and associated utilities.
(b) process equipment (both hardware and software), and
(c) supporting services (such as transport or communication).
The manufacturer shall establish documented requirements for maintenance activities, including their frequency, when such activities or lack thereof can affect product quality. Records of such maintenance shall be maintained.
6.4 Work environment:
The organisation shall determine and manage the work environment needed to achieve conformity to product requirements. The following requirements shall apply, namely:-
(a) the manufacturer shall establish documented requirements for health, cleanliness and clothing of personnel if contact between such personnel and the product or work environment could adversely affect the quality of the product;
(b) if work environment conditions can have an adverse effect on product quality, the manufacturer shall establish documented requirements as per Annexure-C of this schedule for the work environment conditions and documented procedures or work instructions to monitor and control these work environment condition;
(c) the manufacturer shall ensure that all personnel who are required to work temporarily under special environmental conditions within the work environment are appropriately trained and supervised by a trained person;
(d) if appropriate, special arrangements shall be established and documented for the control of contaminated or potentially contaminated product in order to prevent contamination of other product, the work environment or personnel.
(e) all personnel shall bear clean body covering appropriate to their duties. Smoking, eating, drinking, chewing or keeping food and drink shall not be permitted in production, laboratory and storage areas.
7 Product realisation.-
7.1 Planning of product realization:
The manufacturer shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system.
In planning product realisation, the manufacturer shall determine the following, as appropriate:-
(a) quality objectives and requirements for the product;
(b) the need to establish processes, documents, and provide resources specific to the product;
(c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
(d) records needed to provide evidence that the realisation processes and resulting product meet requirements.
The output of this planning shall be in a form suitable for the manufacturer‘s method of operations.
The manufacturer organisation shall establish documented requirements for risk management (as per the IS or ISO 14971) throughout product realisation. Records arising from risk management shall be maintained.
7.2 Customer-related processes.-
7.2.1 Determination of requirements related to the product:
The manufacturer shall determine:-
(a) requirements specified by the customer, including the requirements for delivery and post- delivery activities,
(b) requirements not stated by the customer but necessary for specified or intended use, where known;
(c) statutory requirements related to the product, and
(d) any additional requirements determined by the manufacturer.
7.2.2 Review of requirements related to the product:
The manufacturer shall review the requirements related to the product. This review shall be conducted prior to the manufacturer’s commitment to supply a product to the customer and shall ensure that:-
(a) product requirements are defined and documented;
(b) contract or order requirements differing from those previously expressed are resolved; and
(c) the manufacturer has the ability to meet the defined requirements.
Records of the results of the review and actions arising from the review shall be maintained.
Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the manufacturer before acceptance.
Where product requirements are changed, the manufacturer shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
7.2.3 Customer communication:
The manufacturer shall determine and implement effective arrangements for communicating with customers in relation to:-
(a) product information;
(b) enquiries, contracts or order handling, including amendments;
(c) customer feedback, including customer complaints; and
(d) advisory notices.
7.3 Design and development.-
7.3.1 Design and development planning:
The manufacturer shall establish documented procedures for design and development. The manufacturer shall plan and control the design and development of product. During the design and development planning, the manufacturer shall determine :-
(a) the design and development stages;
(b) the review, verification, validation and design transfer activities that are appropriate at each design and development stage; and
(c) the responsibilities and authorities for design and development.
The manufacturer shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.
Planning output shall be documented, and updated as appropriate, as the design and development progresses.
NOTE: Design transfer activities during the design and development process ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications.
7.3.2 Design and development inputs:
Inputs relating to product requirements shall be determined and records maintained. The design requirements relating to a device are appropriate and address the intended use of the device, including the needs of the user and patients.
These inputs shall include:-
(a) functional, performance and safety requirements, according to the intended use;
(b) applicable statutory and regulatory requirements;
(c) where applicable, information derived from previous similar designs;
(d) other requirements essential for design and development; and
(e) output(s) of risk management.
These inputs shall be reviewed for adequacy and approved by designated individual. Requirements shall be complete, unambiguous and not in conflict with each other.
7.3.3 Design and development outputs:
The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be documented, reviewed, and approved prior to release.
Design and development outputs shall:-
(a) meet the input requirements for design and development;
(b) provide appropriate information for purchasing, production and for service provision;
(c) contain or reference product acceptance criteria; and
(d) specify the characteristics of the product that are essential for its safe and proper use.
Records of the design and development outputs shall be maintained.
Records of design and development outputs can include specifications, manufacturing procedures, engineering drawings, and engineering or research logbooks.
7.3.4 Design and development review:
At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements:-
(a) to evaluate the ability of the results of design and development to meet requirements; and
(b) to identify any problems and propose necessary actions.
Participants in such reviews shall include representatives of functions concerned with the design and development stage being reviewed, as well as other specialist personnel.
Records of the results of the reviews and any necessary actions shall be maintained
7.3.5 Design and development verification:
Verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall be maintained.
7.3.6 Design and development validation:
Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use.
Design validation shall be performed under defined operating conditions on initial production units, lots, or batches or their equivalence. Design validation shall include software validation and risk analysis, where appropriate validation shall be completed prior to the delivery or implementation of the product.
Records of the results of validation and any necessary actions shall be maintained.
As part of design and development validation, the manufacturer shall perform clinical evaluations and/or evaluation of performance of the medical device or In-vitro Diagnostics.
NOTE 1.- If a medical device or In-vitro Diagnostic can only be validated following assembly and installation at point of use, delivery is not considered to be complete until the product has been formally transferred to the customer.
NOTE 2.- Provision of the medical device for purposes of clinical evaluations and/or evaluation of performance is not considered to be delivery.
7.3.7 Control of design and development changes:
Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. Records of the results of the review of changes and any necessary actions shall be maintained.
Note.-Each manufacturer shall establish and maintain a Design History File for each type of device. The Design History File shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of design and development.
7.4 Purchasing.-
7.4.1 Purchasing process:
The manufacturer organisation shall establish documented procedures to ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realisation or the final product.
The manufacturer shall evaluate and select suppliers based on their ability to supply product in accordance with the manufacturer‘s requirements. Criteria for selection, evaluation and re-evaluation shall be established.
Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.
7.4.2 Purchasing information:
Purchasing information shall describe the product to be purchased, including where appropriate:-
(a) requirements for approval of product, procedures, processes and equipment;
(b) requirements for qualification of personnel; and
(c) quality management system requirements.
The manufacturer shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
To the extent required for traceability, the manufacturer shall maintain documents and records of relevant purchasing information.
7.4.3 Verification of purchased product:
The manufacturer shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where the manufacturer intends to perform verification at the supplier‘s premises, the manufacturer shall state the intended verification arrangements and method of product release in the purchasing information. Records of the verification shall be maintained.
7.5 Production and service provision.-
7.5.1 Control of production and service provision:
7.5.1.1 General requirements:
The manufacturer shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable:-
(a) the availability of information that describes the characteristics of the product,
(b) the availability of documented procedures, documented requirements, work instructions; and reference materials and reference measurement procedures as necessary;
(c) the use of suitable equipment;
(d) the availability and use of monitoring and measuring devices;
(e) the implementation of monitoring and measurement;
(f) the implementation of release, delivery and post-delivery activities; and
(g) the implementation of defined operations for labeling and packaging.
The manufacturer shall establish and maintain a record for each batch of medical device or In-vitro Diagnostic devices that provides traceability and identifies the amount manufactured and amount approved for distribution. The batch record shall be verified and approved.
7.5.1.2 Control of production and service provision — Specific requirements
7.5.1.2.1 Cleanliness of product and contamination control:
The manufacturer shall establish documented requirements for cleanliness of product if:-
(a) product is cleaned by the manufacturer prior to sterilisation or its use; or
(b) product is supplied non-sterile to be subjected to a cleaning process prior to sterilisation or its use; or
(c) product is supplied to be used non-sterile and its cleanliness is of significance in use; or
(d) process agents are to be removed from product during manufacture.
If the product is cleaned in accordance with (a) or (b) above, the requirements content in clause 6.4 (a) and (b) do not apply prior to the cleaning process
7.5.1.2.2 Installation activities:
If appropriate, the manufacturer shall establish documented requirements which contain acceptance criteria for installing and verifying the installation of the medical device or In-vitro Diagnostic device.
If the agreed customer requirements allow installation to be performed other than by manufacturer or its authorised agent, the manufacturer shall provide documented requirements for installation and verification. Records of installation and verification performed by the manufacturer or its authorized agent shall be maintained.
7.5.1.3 Particular requirements for sterile medical devices:
The manufacturer shall maintain records of the process parameters for the sterilisation process which was used for each sterilisation batch. Sterilisation records shall be traceable to each production batch of medical device.
7.5.2 Validation of processes for production and service provision.-
7.5.2.1 General:
The manufacturer shall validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use. Validation shall demonstrate the ability of these processes to achieve planned results.
The manufacturer shall establish arrangements for these processes including, as applicable:-
(a) defined criteria for review and approval of the processes;
(b) approval of equipment and qualification of personnel
(c) use of specific methods and procedures,;
(d) requirements for records; and
(e) revalidation.
The manufacturer shall establish documented procedures for the validation of the application of computer software (and its changes to such software or its application) for production and service provision that affect the ability of the product conform to specified requirements. Such software applications shall be validated prior to initial use.
Records of validation shall be maintained.
7.5.2.2 Particular requirements for sterile medical devices:
The manufacturer shall establish documented procedures for the validation of sterilization processes. Sterilisation processes shall be validated prior to initial use. The records of validation of each sterilisation process shall be maintained.
7.5.3 Identification and traceability.-
7.5.3.1 Identification:
The manufacturer shall identify the product by suitable means throughout product realization, and shall establish documented procedures for such product identification. The manufacturer shall establish documented procedures to ensure that medical devices and In-vitro Diagnostics returned to the manufacturer are identified and distinguished from conforming product.
7.5.3.2 Traceability.-
7.5.3.2.1 General:
The manufacturer shall establish documented procedures for traceability. Such procedures shall define the extent of product traceability and the records required.
Where traceability is a requirement, the manufacturer shall control and record the unique identification of the product.
NOTE.- Configuration management is a means by which identification and traceability can be maintained.
7.5.3.2.2 Particular requirements for active implantable medical devices and implantable medical devices:
In defining the records required for traceability, the manufacturer shall include records of all components, materials and work environment conditions, if these could cause the medical device not to satisfy its specified requirements.
The manufacturer shall require that its agents or distributors maintain records of the distribution of active implantable medical devices and implantable medical devices to allow traceability and that such records are available for inspection. Records of the name and address of the shipping package consignee shall be maintained.
7.5.3.3 Status identification:
The manufacturer shall identify the product status with respect to monitoring and measurement requirements. The identification of product status shall be maintained throughout production, storage, implant, usage and installation of the product to ensure that only product that has passed the required inspections and tests (or released under an authorized concession) is dispatched, used or installed.
7.5.4 Customer property:
The manufacturer shall exercise care with customer property while it is under the manufacturer‘s control or being used by the manufacturer. The manufacturer shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained.
NOTE.- Customer property can include intellectual property or confidential health information.
7.5.5 Preservation of product:
The manufacturer shall establish documented procedures or documented work instructions for preserving the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product.
The manufacturer shall establish documented procedures or documented work instructions for the control of product with a limited shelf-life or requiring special storage conditions. Such special storage conditions shall be controlled and recorded.
7.6 Control of monitoring and measuring devices:
The manufacturer shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements.
The manufacturer shall establish documented procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
Where necessary to ensure valid results, measuring equipment shall be:-
(a) calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to Bureau of Indian Standards wherever available ; where no such standards exist, the basis used for calibration or verification shall be recorded;
(b) adjusted or re-adjusted as necessary;
(c) identified to enable the calibration status to be determined;
(d) safeguarded from adjustments that would invalidate the measurement result;
(e) protected from damage and deterioration during handling, maintenance and storage.
In addition, the manufacturer shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The manufacturer shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained.
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary.
8 Measurement, analysis and improvement.-
8.1 General:
The manufacturer shall plan and implement the monitoring, measurement, analysis and improvement processes needed:-
(a) to demonstrate conformity of the product;
(b) to ensure conformity of the quality management system; and
(c) to maintain the effectiveness of the quality management system.
This shall include determination of applicable methods, including statistical techniques, and the extent of their use.
Note.- If relevant Indian standards are not available, International standards are applicable. In case no Indian or International standards are available, validated testing process of the manufacturer is applicable.
8.2 Monitoring and measurement.-
8.2.1 Feedback:
As one of the measurements of the performance of the quality management system, the manufacturer shall monitor information relating to whether the manufacturer has met customer or regulatory requirements. The methods for obtaining and using this information shall be determined.
The manufacturer shall establish a documented procedure for a feedback system to provide early warning of quality problems and for input into the corrective and preventive action processes.
8.2.2 Internal audit:
The manufacturer shall conduct internal audits at planned intervals to determine whether the quality management system:-
a) conforms to the planned arrangements, to the requirements of this schedule and to the quality management system requirements established by the manufacturer, and
b) is effectively implemented and maintained.
An audit programme shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.
The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records shall be defined in a documented procedure. The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of the actions taken and the reporting of verification results.
8.2.3 Monitoring and measurement of processes:
The manufacturer shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product.
8.2.4 Monitoring and measurement of product.-
8.2.4.1 General requirements:
The manufacturer shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realisation process in accordance with the planned arrangements and documented procedures.
Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product. Product release shall not proceed until the planned arrangements have been satisfactorily completed.
8.2.4.2 Particular requirement for active implantable medical devices and implantable medical Devices wherever applicable:
The manufacturer shall record the identity of personnel performing any inspection or testing.
8.3 Control of nonconforming product
The manufacturer shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.
The manufacturer shall deal with nonconforming product by one or more of the following ways:
(a) by taking action to eliminate the detected nonconformity;
(b) by authorizing its use, release or acceptance under concession;
(c) by taking action to preclude its original intended use or application.
The manufacturer shall ensure that nonconforming product is accepted by concession only if regulatory requirements are met. Records of the identity of the person authorisng the concession shall be maintained.
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained.
When nonconforming product is corrected it shall be subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use has started, the manufacturer shall take action appropriate to the effects, or potential effects, of the non- conformity.
If product needs to be reworked (one or more times), the manufacturer shall document the rework process in a work instruction that has undergone the same authorisation and approval procedure as the original work instruction. Prior to authorisation and approval of the work instruction, a determination of any adverse effect of the rework upon product shall be made and documented.
8.4 Analysis of data:
The manufacturer shall establish documented procedures to determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate whether improvement of the effectiveness of the quality management system can be made.
This shall include data generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data shall provide information relating to:-
(a) feedback
(b) conformity to product requirements;
(c) characteristics and trends of processes and products including opportunities for preventive action; and
(d) suppliers.
Records of the results of the analysis of data shall be maintained.
8.5 Improvement.-
8.5.1 General:
The manufacturer shall identify and implement any changes necessary to ensure and maintain the continued suitability and effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
The manufacturer shall establish documented procedures for the issue and implementation of advisory notices. These procedures shall be capable of being implemented at any time. Records of all customer complaint investigations shall be maintained. If investigation determine that the activities outside the manufacturer‘s organisation contributed to the customer complaint, relevant information shall be exchanged between the organisations involved.
If any customer complaint is not followed by corrective or preventive action, the reason shall be recorded and approved. Manufacturer shall notify the adverse event to the regulatory authority and establish documented procedures for the same.
8.5.2 Corrective action:
The manufacturer shall take action to eliminate the cause of nonconformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the nonconformities encountered. A documented procedure shall be established to define requirements for:-
(a) reviewing nonconformities (including customer complaints);
(b) determining the causes of nonconformities;
(c) evaluating the need for action to ensure that nonconformities do not recur
(d) determining and implementing action needed, including, if appropriate, updating documentation;
(e) recording of the results of any investigation and of action taken; and
(f) reviewing the corrective action taken and its effectiveness.
8.5.3 Preventive action:
The manufacturer shall determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems. A documented procedure shall be established to define requirements for
(a) determining potential nonconformities and their causes,
(b) evaluating the need for action to prevent occurrence of nonconformities,
(c) determining and implementing action needed,
(d) recording of the results of any investigations and of action taken, and
(e) reviewing preventive action taken and its effectiveness.
Annexure ‘A‘
(refer para 4.2.1)
The manufacturer shall prepare a succinct document in the form of Device Master File containing specific information about the device manufacturing in the premises.
1.0 Executive Summary:
An executive summary shall be provided by the manufacturer and shall contain:
Introductory descriptive information on the medical device or In-vitro Diagnostics, the intended use and indication for use, Class of Device, novel features of the device (if any), shelf life of the device and a synopsis on the content of the dossier information regarding sterilisation of the device (whether it is sterile or non-sterile; if sterile, mode of sterilisation)
2.0 Device Description And Product Specification, Including Variants And Accessories:
2.1 Device Description
2.2 Product Specification
2.3 Reference to predicate and/or previous generations of the device
3.0 Labelling
4.0 Design And Manufacturing Information:
4.1 Device Design
4.2 Manufacturing Processes
5.0 Essential Principles (EP) Checklist
6.0 Risk Analysis And Control Summary
7.0 Product Verification And Validation:
7.1 Biocompatibility
7.2 Medicinal Substances
7.3 Biological Safety
7.4 Sterilisation
7.5 Software Verification and Validation
7.6 Animal Studies
7.7 Shelf Life/Stability Data
7.8 Clinical Evidence
7.9 Post Marketing Surveillance Data (Vigilance Reporting)
8. Additional information in case of the diagnostic kits:
Product dossier showing the:
8.1 The details of source antigen or antibody as the case may be and characterization of the same.
Process control of coating of antigen or antibody on the base material like Nitrocellulose paper, strips or cards or enzyme-linked immunosorbent assay (ELISA) wells etc.
Detailed composition of the kit and manufacturing flow chart process of the kit showing the specific flow diagram of individual components or source of the individual components.
8.2 Test protocol of the kit showing the specifications and method of testing. In house evaluation report of sensitivity, specificity and stability studies.
8.3 The detailed test report of all the components used/packed in the finished kit.
8.4 Pack size and labelling.
8.5 Product inserts.
Specific evaluation report, if done by any laboratory in India, showing the sensitivity and specificity of the kit.
Specific processing like safe handling, material control, area control, process control, and stability studies, storage at quarantine stage and finished stage, packaging should be highlighted in the product dossier.
Annexure `B`
(refer para 4.2.2)
The manufacturer shall prepare a succinct document in the form of Plant Master File containing specific information about the production and/or control of device manufacturing carried out at the premises. It shall contain the following information:
1. General Information:
(i) brief information on the site (including name and address), relation to other sites;
(ii) manufacturing activities;
(iii) any other operations carried out on the site
(iv) name and exact address of the site, including telephone, fax numbers, web site URL and e-mail address;
(v) type of medical devices handled on the site and information about specifically toxic or hazardous substances handled, mentioning the way they are handled and precautions taken;
(vi) short description of the site (size, location and immediate environment and other activities on the site);
(vii) number of employees engaged in Production, Quality Control, warehousing, and distribution;
(viii) use of outside scientific, analytical or other technical assistance in relation to the design, manufacture and testing;
(ix) short description of the quality management system of the company;
(x) devices details registered with foreign countries;
2. Personnel:
(i) organisation chart showing the arrangements for key personne;l
(ii) qualifications, experience and responsibilities of key personnel;
(iii) outline of arrangements for basic and in-service training and how records are maintained;
(iv) health requirements for personnel engaged in production
(v) personnel hygiene requirements, including clothing.
3. Premises and Facilities:
(i) layout of premises with indication of scale;
(ii) nature of construction, finishes/fixtures and fittings;
(iii) brief description of ventilation systems. More details should be given for critical areas with potential risks of airborne contamination (including schematic drawings of the systems). Classification of the rooms used for the manufacture of sterile products should be mentioned;
(iv) special areas for the handling of highly toxic, hazardous and sensitizing materials;
(v) brief description of water systems (schematic drawings of the systems are desirable) including sanitation;
(vi) maintenance (description of planned preventive maintenance programmes for premises and recording system);
4. Equipment:
(i) Brief description of major production and quality control laboratories equipment (a list of the equipment is required);
(ii) maintenance (description of planned preventive maintenance programmes and recording system);
(iii) qualification and calibration, including the recording system. Arrangements for computerized systems validation.
5. Sanitation:
Availability of written specifications and procedures for cleaning the manufacturing areas and equipments.
6. Production:
(i) Brief description of production operations using, wherever possible, flow sheets and charts specifying important parameters ;
(ii) arrangements for the handling of starting materials, packaging materials, bulk and finished products, including sampling, quarantine, release and storage;
(iii) arrangements for reprocessing or rework;
(iv) arrangements for the handling of rejected materials and products;
(v) brief description of general policy for process validation.
7. Quality Assurance:
Description of the Quality Assurance system and of the activities of the Quality Assurance Department. Procedures for the release of finished products.
8. Storage:
Policy on the storage of medical device.
9. Documentation:
Arrangements for the preparation, revision and distribution of necessary documentation, including storage of master documents.
10. Medical Device Complaints and Field Safety Corrective Action:
(i) Arrangements for the handling of complaints ;
(ii) Arrangements for the handling of field safety corrective action
11. Internal Audit:
Short Description of the internal audit system.
12. Contract Activities:
Description of the way in which the compliance of the contract acceptor is assessed.
Annexure ‘C‘
Environmental requirement for Notified medical devices and in-vitro diagnostics
| Name of Device |
Type of Operation |
ISO Class (At rest) |
| Cardiac stent/Drug Eluting Stent |
Primary Packing and Crimping |
5 |
| Washing, Ultrasonic cleaning &Drug coating |
7 |
| Assembly, Wrapping & Packaging |
8 |
| Laser cutting, Descaling, Annealing & Electro polishing |
9 |
| Heart Valves |
Valve Packing |
5 |
| Ultrasonic Cleaning & Visual Inspection |
7 |
| Frame & Disc Assembly |
7 |
| Intra Ocular Lenses |
Packing & Sealing |
5 |
| Final Inspection |
7 |
| Power Checking& Final Cleaning |
8 |
| Tumble Polishing & Lathe Cutting |
9 |
| Bone Cements |
Final Product Filling |
5 |
| Sieving & Calcinations |
7 |
| Powder Preparation, Granulation &Drying |
8 |
| Internal Prosthetic Replacement |
Packing |
5 |
| Product Preparation |
7 |
| Component Preparation |
8 |
| Orthopedic Implants |
Polishing &Cleaning & packaging (to be sterilized in factory premises) |
7 |
| Polishing , cleaning & packaging (Non Sterile- to be sterilized in Hospital) |
8 |
| Cutting, lathing |
9 |
| Catheters /Ablation Device / I V Cannulae / Scalp Vein Set/ Hypodermic Syringes/ Hypodermic Needles / Perfusion Sets |
Assembly, Coating, Wrapping & Packing |
7 |
| Component Preparation & Cleaning |
8 |
| Moulding |
9 |
| Condom |
Compounding |
Well ventilated area with minimum 5 micron filter |
| Moulding |
Well ventilated area with minimum 5 micron filter |
| Vulcanising |
Normal air |
| Packing |
Air conditioned |
| Intra Uterine Devices |
Moulding |
Well ventilated area with minimum 5 micron filter |
| Assembling |
7 |
| Packaging |
7 |
| Tubal ring |
Extrusion |
7 |
| Cutting and Assembly |
7 |
| Packaging |
7 |
| Blood bags |
Moulding/Extrusion of components |
8 |
| Assembly |
7 |
| Filing |
5 |
| Suture |
Extrusion |
9 |
| Assembly |
8 |
| Packing |
8 |
| Staplers |
Staple formation |
9 |
| Staple assembly523 |
8 |
| |
Staple final pack |
8 |
| Ligatures |
Extrusion |
9 |
| Cutting and assembly |
8 |
| Final Pack |
8 |
| Surgical dressings |
Weaving |
9 |
| Assembly and Gauzing |
9 |
| Final pack |
9 |
| In-vitro diagnostics Kit/Reagents |
Dry, Liquid Reagent Preparation |
Well Lighted and Ventilated controlled temperature & humidity as per process or product requirement |
| Coating of sheets etc. |
| Assembly and primary packing |
| Filling |
Well Lighted and Ventilated controlled temperature and humidity as per process or product requirement. Provision of Laminar hood if required, Clean Room class 8 or class 9 as per product/process requirement |
| Secondary Packing |
Well Lighted and Ventilated controlled temperature if required |
| Storage |
As per recommended storage condition of the product]. |
1[SCHEDULE N
[See Rule 64(1)]
LIST OF MINIMUM EQUIPMENT FOR THE EFFICIENT RUNNING OF A PHARMACY
1. Entrance. – The front of a pharmacy shall bear an inscription “Pharmacy” in front.
2. Premises. – The premises of a pharmacy shall be separated from rooms for private use. The premises shall be well built, dry, well lit and ventilated and, of sufficient dimensions to allow the goods in stock, especially medicaments and poisons to be kept in a clearly visible and appropriate manner. The areas of the section to be used as dispensing department shall be not less than 6 square meters for one pharmacist working therein with additional 2 square meters for each additional pharmacist. The height of the premises shall be at least 2.5 meters.
The floor of the pharmacy shall be smooth and washable. The walls shall be plastered or tiled or oil painted so as to maintain smooth, durable and washable surface devoid of holes, cracks and crevices.
A pharmacy shall be provided with ample supply of good quality water.
The dispensing department shall be separated by a barrier to prevent the admission of the public.
3. Furniture and apparatus. – The furniture and apparatus of a pharmacy shall be adopted to the uses for which they are intended and correspond to the size and requirements of the establishment.
Drugs, chemicals, and medicaments shall be kept in a room appropriate to their properties and in such special containers as will prevent any deterioration of the contents or of contents of containers kept near them. Drawers, glasses and other containers used for keeping medicaments shall be of suitable size and capable of being closed tightly to prevent the entry of dust.
Every container shall bear a label of appropriate size, easily readable with names of medicaments as given in the Pharmacopoeias.
A pharmacy shall be provided with a dispensing bench, the top of which shall be covered with washable and impervious material like stainless steel, laminated or plastic, etc.
A pharmacy shall be provided with a cupboard with lock and key for the storage of poisons and shall be clearly marked with the work ‘POISON‘ in red letters on a white background.
Containers of all concentrated solution shall bear special label or marked with the words “To be diluted”.
A Pharmacy shall be provided with the following minimum apparatus and books necessary for making of official preparations and prescriptions:-
__________
1.Subs. by S.O.2139 , dt. 12.8.1972.
__________
Apparatus:-
Balance, dispensing, sensitivity 30 mg.
Balance, counter, capacity 3 Kgm., sensitivity 1 gm.
Beakers, lipped, assorted sizes.
Bottles, prescription, ungraduated assorted sizes.
Corks assorted sizes and tapers.
Cork, extracter.
Evaporating dishes, porcelain. Filter paper.
Funnels, glass.
Litmas paper, blue and red.
Measure glasses cylindrical 10 ml, 25 ml, 100 ml and 500 ml.
Mortars and pestles, glass.
Mortars and pestles, wedgwood.
Ointment pots with bakelite or suitable caps.
Ointment slab, porcelain
Pipette graduated, 2 ml, 5 ml and 10 ml.
Ring, stand (retort) iron, complete with rings.
Rubber stamps and pad
Scissors
Spatulas, rubber or vulcanite Spatulas, stainless steel.
Spirit lamp
Glass stirring rods. Thermometer, 0oC to 200oC. Tripod stand.
Watch glasses.
Water bath.
Water distillation still in case Eye drops and Eye lotions are prepared.
Weights, Metric, 1 mg. to 100 gm.
Wire Gauze.
*Pill finisher, boxwood.
* Pill Machine.
* Pill Boxes.
* Suppository mould.
Books :
The Indian Pharmacopoeia (Current Edition).
National Formulary of Indian (Current Edition).
The Drugs and Cosmetics Act, 1940.
The Drugs and Cosmetics Rules, 1945.
The Pharmacy Act, 1948.
The Dangerous Drugs Act, 1930.
4. General provisions. – A pharmacy shall be conducted under the continuous personal supervision of a Registered Pharmacist whose name shall be displayed conspicuously in the premises.
The Pharmacist shall always put on clean white overalls.
The premises and fittings of the pharmacy shall be properly kept and everything shall be in good order and clean.
All records and registers shall be maintained in accordance with the laws in force.
Any container taken from the poison cupboard shall be replaced therein immediately after use and the cupboard locked. The keys of the poison cupboard shall be kept in the personal custody of the responsible person.
Medicaments when supplied shall have labels conforming to the provisions of laws in force.
Note:- The above requirements are subject to modifications at the discretion of the licensing authority, if he is of opinion that having regard to the nature of drugs dispensed, compounded or prepared by the licensee. It is necessary to relax the above requirements or to impose additional requirements in the circumstances of a particular case. The decision of the licensing authority in that regard shall be final.
* These items are to be provided only by those who intend to dispense pills or suppositories, as the case may be.]
1[SCHEDULE O
[See Rule 126]
STANDARD FOR DISINFECTANT FLUIDS
2[PART I
PROVISION APPLICABLE TO BLACK FLUIDS AND WHITE FLUIDS
The standards for disinfectants shall conform to the Indian Standards specification (IS 1061:1997) laid down from time to time by the Bureau of Indian Standards.]
________
1. Subs. by G.S.R. 1243, dared 19-09-1979, for Schedule O (w.e.f. 6-10-979). EARLIER Schedule O was added y Notification No. F.1-20/60-D, dated 24-01-1964.
2. Subs. by G.S.R. 735(E), dated 21-12-2005, for
________
“PART I
Provision applicable to Black Fluids and White Fluids
1.Classification – The disinfectants shall be classified as follows:-
(a) Black fluids
(b) White fluids
(A) Black fluids.– These shall be homogeneous dark brown solution of coal tar acid or similar acids derived from petroleum with or without hydrocarbon, and/or other phenolic compounds, and their derivatives and a suitable emulsifier.
(B) White fluids.– These shall be finely dispersed homogeneous white to off- white emulsion consisting of coal tar acids or similar acids derived from petroleum, with or without hydrocarbons, and/or other phenolic compounds, and their derivatives.
2. Gradation – Each of the above classes of disinfectant fluids shall be graded on the basis of the minimum requirements in respect of:
Rideal Walker (RW) Coefficient as follows:-
Grade Rideal Walker (RW) Coefficient (Minimum)
1. 18
2. 10
3. 5
3. Type – Each of the above grades of disinfectant fluids shall be stable in the range of temperature indicated against each type. –
Type Stable in the range of
(I) Normal 15o C to 45o C.
(II) Winter 5 o C to 30 o C
4. Requirements – All classes and grades of disinfectant fluids shall comply with the following requirements, namely:-
(1) Stability after dilution – When tested by the method described hereinafter the disinfectant fluid shall be miscible with artificial hard water (for Black fluids) or with artificial sea water (for White fluids) in all proportion from 1 per cent to 5 per cent by volume, to give emulsion which shall not break or show more than traces of separation of either top or bottom oil when kept for 6 hours at 15o C to 45o C for Type (I) (Normal) and 5o C to 30o C for Type (II) (Winter).
(2) Germicidal Value.– Rideal Walker Coefficient – Black fluids and White fluids shall be tested for determination of Rideal Walker Coefficient (R.W.Coefficient) by the method described hereinafter.
(3) Storage.– Disinfectant fluids of all classes shall be stored in mild steel, tinned mild steel or other suitable containers. These shall not be stored in containers made of galvanized iron.
(4) Labelling. -Subject to the other provisions in these rules, the label on the container shall state-
(i) the name of the product,
(ii) the name and full address of the manufacturer,
(iii) grade, type, R.W. Coefficient of product,
(iv) date of manufacture,
(v) quantity present in the container,
(vi) indications and mode of use, and
(vii) date up to which the product can be used.
5. Method of testing – (1) Preparation of sample – The sample of disinfectant fluid to be tested should be mixed thoroughly taking care that no air is beaten into the fluid immediately before withdrawing any portion for testing. The rest portion should be withdrawn from the middle of the sample.
(2) Method of resting stability after dilution. – (a) Preparation of Artificial Hard Water: 40 ml of I N Hydrochloric Acid (Analytical Reagent Quality) is neutralized with a slight excess of Calcium Carbonate and filtered. The filtrate is diluted to 1000 ml with distilled water, 10 parts of this solution is further diluted to 100 parts with distilled water.
(b) Preparation of Artificial Sea Water: 27G of Sodium Chloride (Analytical Reagent Quality) and 5 G of Magnesium Sulphate (Analytical Reagent Quality) are dissolved in distilled water and diluted to 1000 ml. The solution is filtered before use.
(c) Procedure: Take 1 ml and 5 ml portions of the sample in duplicate in 100 ml stoppered measuring cylinder (IS: 878 – 1956) by means of pipettes. Dilute the sample with artificial Hard water or Artificial Sea water (as the case may be) upto 10 ml mark. Mix thoroughly by inverting the cylinders 5 times. Keep the cylinders containing the diluted fluids for 6 hours at the extremes of the temperature range specified for the particular type. The sample complies with the test if the solution shows not more than a trace of separation at its top and bottom.
(3) Method of determination of Rideal Walker Coefficient (R.W.C)-
Apparatus – A loop, 4 mm in internal diameter is made at the end of 28 swg (0.376 mm) wire of platinum or platinum iridium alloy, 38 mm long from the loop to the holder. The loop is bent at such an angle to the length of the wire as will facilitate in removal vertically from the surface of the liquid while keeping the place of the loop horizontal.
Incubator – Set and maintained at 37o C ± 1o C
Pipettes – Standard graduated pipettes of capacity 10 ml; 5 ml and 1 ml
Dropping Pipette – Made of delivery 0.2 ml
Medication tubes – 5 sterile plugged rimless test tubes 125 mm x 22 mm (5 inch x ¾ inch) made of hard neutral glass.
Both tubes – About 2 dozens of the same description as medication tubes.
Standard measuring cylinders stopped and graduated—500 ml graduated in 10 ml–;one 100 ml graduated 1 ml– five. All apparatus must be scrupulously clean and sterile; immediately before use.
Reagents– (a) Broth.– Prepare a mixture of the following ingredients:
Meat extract (Microbiological grade) 20 g Peptone (Micro biological grade) 20g. Sodium Chloride (Regent Quality) 10 g Distilled Water- 1000 ml.
Dissolve the solids in distilled water. Add sufficient sodium hydroxide to neutralize the solution; then boil it to bring down phosphates and filter while hot. The broth thus prepared is then adjusted to pH 7.6 with normal Hydrochloric acid. The broth is then sterilized by autoclaving at 15 lbs pressure for 20 minutes. It is then filtered and placed in 5 ml quantities in sterilized broth tubes. The tubes of media thus prepared are sterilized by autoclaving at 15 lbs pressure for 10 minutes. The final pH of the medium should lie between 7.3 and 7.5. Further resterilization in bulk or in tubes is not permissible.
(b) Test Organism- Test organism used is Salmonella typhi (NCTC 786) of which suitable culture shall be obtained from the Director, Central Drugs Laboratory, Calcutta. This culture is maintained by weekly sub-culture on a nutrient agar slope (made by dissolving 2.5 per cent Agar Agar (Bacteriological grade) in broth prepared as above), incubating the sub- culture for 24 hours at 37O C and then storing in refrigerator at a temperature below 22o C. For the purpose of the test a little of the growth from the most recent sub-culture in nutrient agar slope is placed in tube of R.W. broth and incubated for 23 hours at 38o C. A standard loopful is then transferred to a second tube and incubated as before. This is done at least three times before a test is carried out. Sub-culturing in broth is limited to 14 days.
(c) Standard phenol: 5 per cent W/V solution in sterile distilled water of chemically pure phenol having a crystallizing point of not less than 40.5oC is prepared. Test dilutions are prepared from this stock solution containing 1 g of phenol in each 95, 100, 105, 115 ml of the solution made. These dilutions shall be used within a week of preparation.
(d) Test dilutions of Disinfectant (sample)- The sample is prepared as described under “Preparation of samples”. A test portion of 5 ml is withdrawn and discharged into about 480 ml of sterile distilled water in a 500 ml glass stoppered sterile measuring cylinder and the pipette is rinsed three times or more in the clear liquid. The whole is then made up to 500 ml with sterile distilled water, the cylinder is stoppered and the contents thoroughly mixed by inverting the cylinder several times. Suitable test dilutions in sterile distilled water are then immediately prepared from this stock solution.
Procedure: 5 ml of 4 chosen dilutions of the disinfectant are placed in 4 medication tubes which are then placed in a rack provided with water bath maintained at a constant temperature between 17o C and 19o C, with the strongest dilution on the left. The fifth medication tube containing 5 ml of the particular phenol dilution is placed on the right. When the content on the medication tubes and broth culture of the test organism have reached the temperature of the water bath, starting at Zero time, 0.2 ml of the culture is added to the left hand medication tube and the tube is shaken gently. After 30 seconds the next tube is inoculated similarly and the process is repeated with each successive tube at intervals of 30 seconds until the phenol control has been inoculated. Thirty seconds after this last addition (that is 2-1/2 minutes from zero) a loopful of the well-shaken content of the tube at the extreme left is withdrawn and placed in tube containing 5 ml of the broth medium. Thirty seconds after this similar operation is performed on the second medication tube. The procedure is repeated at an interval of 30 seconds with each of the 5 medication tubes working from left to right until 4 sets of cultures have been made i.e. at 2-1/2, 5, 7-1/2 and 10 minutes respectively after exposure. In each withdrawal care should be taken to ensure that the loop is removed vertically from the surface of the liquid with its plane horizontally and without touching the side of the test tubes. The loop shall be sterilized by flaming between each operation, care being taken that the loop is cooled before being again used. The inoculated broth tubes are incubated for not less than 48 hours and not more than 72 hours at 37o C when the tubes showing growth of the test organisms will be recognized by turbidity of the broth.
Calculation of Coefficient – The R.W. Coefficient is obtained by dividing that dilution of the disinfectant which shows life of test organism in 2-1/2 and 5 minutes but no life thereafter by that dilution of the phenol which gives the same response.A typical set of sample is given below:
Sample disinfectant Time of exposures in minutes
Dilutions 2½ 5 7½ 10
1:1000 − − − −
1:1100 + − − − R.W. Coefficient
1:1200 + + − . − = 1200 = 12
1:1300 + + − +
1:100 Pheno control + + − –
100
(+ = growth − = No growth)
PART II
Provisions applicable to other disinfectant fluids:
Disinfectant fluids which are made with chemicals other than those specified under Part I of this Schedule shall conform to the formula or list of ingredients shown on the label.
Labelling : Subject to the provisions of rules on labelling, the label of container shall state:
(i) the name of the product;
(ii) the name and full address of the manufacturer;
(iii) the full formula or list of ingredients of the preparation;
(iv) date of manufacture;
(v) date up to which the product can be used;
(vi) quantity present in the container; and
(vii) indications and mode of use.
Cautionary note:
Mercury compounds shall be strictly excluded from all grades.]
1[SCHEDULE P
[See Rule 96]
LIFE PERIOD OF DRUGS
| Sl. No. |
Name of the drug |
Period in months (unless otherwise specified) between date of manufacture and date of expiry which the labelled potency period of the drug shall not exceed under the conditions of storage specified in Column No.4 |
Condition of storage |
| 1 |
2 |
3 |
4 |
ANTIBIOTICS
| 1. |
Adramycin |
30 |
In a cool place |
| 2. |
Ampicillin |
36 |
In a cool place |
| 3. |
Ampicillin Capsules |
24 |
|
| 4. |
Ampicillin Dry Syrup |
24 |
|
| 5. |
Ampicillin Injection |
24 |
|
| 6. |
Ampicillin Sodium |
36 |
In a cool place |
| 7. |
Ampicillin Trihydrate |
30 |
In a cool place |
| 8. |
Amoxycillin Trihydrate |
36 |
In a cool place |
| 9 |
Amoxycillin Trihydrate Capsules |
24 |
|
| 10. |
Amoxycillin Trihydrate Dry Syrup |
18 |
|
| 11. |
Bacitracin |
18 |
In a cool place |
| 12. |
Bacitracin or Zinc Bacitracin Tablets |
12 |
|
| 13. |
Bacitracin Lozenges |
12 |
|
| 14. |
Carbenicillin Sodium Injection |
24 |
At temperature notExceeding 5°C |
| 15. |
Carbenicillin Sodium Powder |
24 |
At temperature notExceeding 5°C |
| 16. |
Cephalexin |
24 |
In a cool place |
| 17. |
Chloramphenicol |
60 |
In a cool place |
| 18. |
Chloramphenicol Capsules & Tablets |
48 |
|
| 19. |
Chloramphenicol Palmitate |
48 |
|
| 20. |
Chloramphenicol Palmitate Oral Suspension |
36 |
|
| 21. |
Chloramphenicol Eye drops |
24 |
|
| 22. |
Chloramphenicol Sodium Succinate Powder |
48 |
In a cool palace |
| 23. |
Chloramphenicol Sodium Succinate Injection |
36 |
In a cool place |
| 24 |
Chlortetracycline Hydrochloride |
60 |
In a cool place |
| 25. |
Chlortetracycline Hydrochloride Capsules |
60 |
|
| 26. |
Chlortetracycline Hydrochloride Tablets |
24 |
|
| 27. |
Chlortetracycline Hydrochloride Ointment |
24 |
|
| 28. |
Cloxacillin (Oral) |
36 |
In a cool place |
| 29. |
Cloxacillin Sodium (Injection Grade) |
36 |
In a cool place |
| 30. |
Colistin Sulphate |
60 |
Protected from light |
| 31. |
D-Cycloserine |
48 |
In a cool place |
| 32. |
Dimethyl Chlortetracycline Hydrochloride |
48 |
|
| 33. |
Dimethyl Chlortetracycline Hydrochloride Capsules |
36 |
|
| 34. |
Daunoblastin Injection. |
36 |
|
| 35. |
Doxycycline Hydrochloride |
48 |
In a cool place |
| 36. |
Doxcycline Monohydrate |
36 |
In a cool place |
| 37. |
Doxycyline Monohydrate for Oral Suspension. |
24 |
|
| 38. |
Doxycycline Monohydrate Capsules. |
36 |
|
| 39. |
Erythromycin Estolate |
36 |
In a cool place |
| 40. |
Erythromycin Ethylsuccinate |
60 |
In a cool place |
| 41. |
Erythromycin Oral Suspension |
36 |
|
| 42. |
Erythromycin Estolate for Oral Suspension |
36 |
|
| 43. |
Erythromycin Ethyl Succinate Tablet |
24 |
|
| 44. |
Erythromycin Estolate Tablets |
24 |
|
| 45. |
Erythromycin Stearate |
36 |
In a cool place |
| 46. |
Framycetin Sulphate |
48 |
In a well closed container with temperature not exceeding 30°C |
| 47. |
Framycetin Sulphate Eye drops |
24 |
In a well closed container with temperature not exceeding 30°C |
| 48. |
Framycetin Sulphate Ointment |
24 |
In a well closed container with temperature not exceeding 30°C |
| 49. |
Gentamycin Sulphate |
60 |
In a cool place. |
| 50. |
Gentamycin Sulphate Injection |
36 |
|
| 51. |
Gramicidin |
60 |
In a cool place |
| 52. |
Griseofulvin |
48 |
In a cool place |
| 53. |
Griseofulvin Tablets |
36 |
|
| 54. |
Kanamycin Sulphate Injection. |
24 |
|
| 55. |
Kanamycin Acid Sulphate Powder |
48 |
In a cool place |
| 56. |
Mitomycin C |
48 |
In a cool place |
| 57. |
Neomycin Sulphate. |
48 |
In a cool place |
| 58. |
Nystatin |
36 |
At temperature not exceeding 5°C |
| 59. |
Oleandomycin Phosphate sterile |
24 |
In a cool place |
| 60. |
Oleandomycin Phosphate non sterile |
36 |
In a cool place |
| 61. |
Oxytetracline Hydrochloride |
36 |
In a cool place |
| 62. |
Oxytetracycline Hydrochloride Capsules. |
36 |
|
| 63. |
Oxytetracycline Hydrochloride Tablets |
24 |
|
| 64. |
Oxytetracycline Hydrochloride Injection |
24 |
|
| 65. |
Oxytetracycline Hydrochloride Ointment |
36 |
|
| 66. |
Penicillin Crystalline |
36 |
In a cool place |
| 67. |
Penicillin Tablets |
18 |
In a cool place |
| 68. |
Procaine Penicillin G |
36 |
In a cool place |
| 69. |
Benzathin Penicillin G |
48 |
|
| 70. |
Potassium Phenoxy Methyl Penicillin |
48 |
In a cool place |
| 71. |
Potassium Phenoxy Methyl PenicillinTablets |
24 |
|
| 72. |
Polymixin B Sulphate |
48 |
In a cool place |
| 73. |
Polymixin B Sulphate Ointment or Powder |
24 |
In a cool place |
| 74. |
Rifampicin |
36 |
In a cool place |
| 1[75 |
Rifampicin Capsules |
36] |
|
| 76. |
Spramycin Base |
24 |
In a cool place |
| 77. |
Strepromycin Injection. |
36 |
|
| 78. |
Streptomycin Ointment |
24 |
|
| 79. |
Streptomycin Tablets |
24 |
|
| 80. |
Streptomycin Sulphate |
48 |
At temperature not exceeding 20oC |
| 81. |
Tetracycline Base |
24 |
In a cool place |
| 82. |
Tetracycline Hydrochloride |
36 |
In a cool place |
| 83. |
Tetracycline Hydrochloride Capsules |
36 |
|
| 84. |
Tetracycline Tablets |
24 |
|
| 85. |
Tyrothricin |
60 |
In a cool place. |
1. Subs. by G.S.R. 17(E) , dt. 7.1.1986 ( w.e.f. 7.1.1986 ).
VITAMINS
| 1. |
Vitamin A Injection |
24 |
|
| 2. |
Vitamin B1 Injection |
24 |
| 3. |
Thiamine Mononitrate Tablets |
36 |
| 4. |
Thiamine Hydrochloride |
48 |
In a well closed container, protected from light, in a cool place. |
| 5. |
Thiamine Mononitrate |
48 |
In a well closed container, protected from light, in a cool place. |
| 6. |
Riboflavin |
60 |
In a well closed container, protected from light, in a cool place. |
| 7. |
Riboflavin-5-Phosphate |
24 |
In a well closed container, protected from light, in a cool place. |
| 8. |
Riboflavin Tablets |
36 |
|
| 9. |
Vitamin B2 Injection |
24 |
|
| 10. |
Vitamin B6 |
60 |
In a well closed container, protected
from light, in a cool place. |
| 11. |
Vitamin B6 tablets |
36 |
|
| 12. |
Cyanacobalamin |
48 |
In a well closed container, protected from light, in a cool place. |
| 13. |
Hydroxycobalamin |
48 |
In a well closed container, protected from light, in a cool place. |
| 14. |
Vitamin B12 Injection |
36 |
|
| 15. |
Calcium Pantothenate |
36 |
In a well closed container, protected from light, in a cool place. |
| 16. |
Vitamin C Injection |
24 |
|
| 17. |
Calcium Pantothenate Tablets |
36 |
|
| 218. |
Vitamin C |
48 |
In a well closed container, protected from light, in a cool place. |
| 19. |
Vitamin D2 D3 |
36 |
In a well closed container, protected from light, in a cool place. |
| 20. |
Vitamin E or E-Acetate |
60 |
In a well closed container, protected from light, in a cool place. |
| 21. |
Folic Acid |
60 |
In a well closed container, protected from light, in a cool place. |
| 22. |
Folic Acid Tablets |
36 |
|
| 23. |
Vitamin K |
60 |
In a well closed container, protected from light, in a cool place. |
| 24. |
Vitamin K Injection |
36 |
|
| 25. |
Niacinamide |
60 |
In a well closed container, protected from light, in a cool place. |
| 26. |
Niacinamide Tablets |
36 |
|
| 27. |
D-Panthenol |
60 |
In a well closed container, protected from light, in a cool place. |
1. Subs. by G.S.R. 250(E), dt. 4.4.2002
2. Subs. by G.S.R. 626(E), dt. 14.10.1991
INSULIN PREPARATIONS
| 1. |
Globuline Zinc Insulin Injection |
24 |
At temperature between 2oC and 8oC, must not be allowed to freeze. |
| 2. |
Insulin Injection |
24 |
At temperature between 2oC and 8oC, must not be allowed to freeze. |
| 3. |
Insulin Zinc Suspension |
24 |
At temperature between 2oC and 8oC, must not be allowed to freeze. |
| 4. |
Isophane Insulin Injection. |
24 |
At temperature between 2oC and 8oC, must not be allowed to freeze. |
| 1[5. |
Human Insulin Injection |
30 |
At temperature between 2oC and 8oC, must not be allowed to freeze. |
NORMAL HUMAN PLASMA
| 1. |
Anti-Haemophillic Human Globulin |
12 |
In a cool place. |
| 2. |
Dried Plasma |
60 |
At a temperature not exceeding 25oC |
| 3. |
Dried Normal Human Serum Albumin |
60 |
At a temperature not exceeding 25oC |
| 4. |
Frozen Plasma |
60 |
In deep freeze |
| 5. |
Liquid Plasma |
24 |
In cold place |
| 6. |
Liquid Normal Human Serum Albumin. |
60 |
In cold place. |
| 2[7. |
Whole Human Blood- |
|
|
|
(a) Collected in ACD solution |
21days |
At temperature between 4oC and 6oC |
|
(b) Collection in CPDA solution. |
35days |
At temperature between 4oC and 6oC] |
1. Subs. by G.S.R. 626(E) , dt. 14.10.1991.
2. Subs. by G.S.R. 626(E) , dt. 14.10.1991.
SERA TOXIN AND TOXOID
| 1. |
Alum Precipitated Diphtheria Toxoid |
24 |
In cold place. |
| 2. |
Alum Precipitated Diphtheria and Tetanus toxoid and Pertusis vaccine combined |
18 |
In cold place. |
| 3. |
Alum Precipitated Tetanus Toxoid |
24 |
In a cold place. |
| 4. |
Aluminium Hydroxide Absorbed Diphtheria Toxoid |
24 |
In a cold place. |
| 5. |
Aluminium Hydroxide Absorbed Diphtheria Tetanus Toxoid and Pertussis Vaccine combined. |
18 |
In a cold place. |
| 6. |
Aluminium Phosphate Absorbed Diphtheria Toxoid. |
24 |
In a cold place. |
| 7. |
Aluminium Phosphate absorbed Diphtheria and Tetanus Toxoid |
24 |
In a cold place. |
| 8. |
Aluminium phosphate absorbed diphtheri Toxoid Tetanus Toxoid and |
18 |
In cold place |
| 9. |
Diagnostic Diphtheira Toxin (Schick Test) |
12 |
In cold place |
| 10. |
Cobra venom in solution |
3 |
Between 2oC and 5oC protected from light |
| 11. |
Diphtheria Toxoid |
24 |
In cold place |
| 12. |
Inactivted Diagnostic Diphtheria Toxin |
12 |
In cold place |
| 13. |
Liquid serum |
12 |
Between 2oC and 10oC preferable at the lower limit. |
| 14. |
Lyophilised anti-snake venom serum |
60 |
|
| 15. |
Lyophilised Schick test Toxin and control |
60 |
|
| 16. |
Old Tuberculin |
60 |
In cold place |
| 17. |
Thrombin (Bovine origin) |
36 |
In cold place |
| 1[18. |
Tetanus Toxoid |
36 |
In cold place] |
| 19. |
uberculin PPD |
60 |
In cold place |
OTHER VACCINES
| 1. |
Alum precipitatd pertussis Vaccine. |
18 |
In cold place |
| 2[2. |
BCG Vaccine |
48 |
In cold place |
| 3. |
Cholera Vaccine |
18 |
In cold place |
| 4. |
DHL Vaccine (for dog) |
12 |
In cold place |
| 5. |
Measles Vaccine |
24 |
In cold place |
| 6. |
Plague Vaccine |
36 |
In cold place |
| 7. |
Polio Vaccine |
24 |
When stored at minus 20oC |
| 6 |
When stored at Zero oC |
| 3 |
When stored at 4 oC |
| 8. |
Rabies vaccine |
6 |
In cold place |
| 9. |
Typhoid vaccine |
18 |
In cold place |
| 10. |
Typhoid and Para Typhoid Vaccine. |
18 |
In cold place |
| 11. |
Typhoid Para Typhoid A and B vaccine. |
18 |
In cold place |
| 12. |
Typhoid Para Typhoid A,B & C Vaccine |
18 |
In cold place |
| 13. |
Typhoid Para Typhoid A, B & C and Tetanus Vaccine. |
18 |
In cold place |
| 14. |
Typhus vaccine |
12 |
In cold place |
| 15. |
Yellow Fever Vaccine |
12 |
In cold place |
| 1[16. |
Anti-Rabies Vaccine (Cell Culture) |
24 |
In cold place |
1. Subs. by G.S.R. 26(E) , dt. 19.01.2006.
2. Subs. by G.S.R. 174(E) , dt. 16.03.2005.
ANTITOXIN
| (For serum extracted preparations) |
|
|
| 20% Excess potency |
12 |
In cold place |
| 30% Excess potency |
24 |
In cold place |
| 40% Excess potency |
36 |
In cold place |
| 50% Excess potency (for enzyme preparations) |
48 |
In cold place |
| 5% Excess potency |
12 |
In cold place |
| 10% Excess potency |
24 |
In cold place |
| 15% Excess potency |
36 |
In cold place |
| 20% Excess Potency |
48 |
In cold place |
MISCELLANEOUS DRUGS
| 2[1. Andrenaline for Injection |
12 |
[As prescribed in Indian Pharmacopoeia] |
| 2. Chorionic Gonadotrophin for Injection (Lyophilised) |
36 |
At temperature not exceeding 20oC |
| 3. Corticotrophin |
24 |
In cold place |
| 4. Corticotrophin Lyophilised |
36 |
In cold place |
| 5. Heparin Injection |
36 |
In a cool place |
| 6. Liquid Extract of Ergot |
12 |
In cold place |
| 7. Liver Extract Crude Injection |
24 |
In a cool place |
| 8. Oxytocin Injection |
24 |
In cold place |
| 9. Paraldehyde Injection |
6 |
In cool place protected from light. |
| 10. Pituitary Injection |
24 |
In cold place. |
| 11. Vasopressin Injection |
24 |
In cold place. |
Note : (1) The term “cool place” means place having a temperature between 10oC and 25oC.
(2) The term “cold place” means a place having a temperature not exceeding 8 oC.
(3) Capsules should be kept in a well-closed container at temperature not exceeding 30 o C.
(4) Wherever condition of storage is not specified in Column 4, it may be stored under normal room temperature.]
1. Ins. by G.S.R. 215(E) , dt. 19. 3. 1999.
2. Subs. by G.S.R. 174(E) , dt. 16. 3.2005.
1[SCHEDULE P1
[See Rule 109]
PACK SIZES OF DRUGS
| Name of the Drug |
Dosage form |
Pack size |
| 1 |
2 |
3 |
| Albendazole |
Suspension |
10ml |
| Atenolol |
Tablets |
14 |
| Anti-Haemmorhoidal Topicals |
Rectal Capsules |
20 |
| Aspirin (Low-dose) |
Tablets |
14 |
| Cholecalciferol or Ergocalciferol |
Granules |
1 gm. Sachet |
| Ciclopiroxolamine |
Vaginal Cream |
30 gms. |
| Catalin |
Ophthalmic drops |
15 ml |
| Famotidine |
Tablets |
14 |
| Glyceryl Trinitrate |
Spansules (Long Acting) |
25 |
| Isosorbide Dinitrate |
Spansules (Long Acting) |
25 |
| Isoniazide |
Syrup |
200 ml |
| Ipecacuanha |
Syrup |
10 ml |
| Oral Rehydration Salt (ORS) |
Powder |
Pouches to be reconstituted to one litre in one pack or in 5 unit dose sachets in one pack. |
| Piperazine |
Granules |
5 gm. |
|
Syrup |
30 ml |
| Pyrantel Pamoate |
Syrup |
8 ml or 10 ml |
| Potassium Chloride. |
Syrup |
60 ml and 200 ml. |
| Progestogen Qestrogen (Combinationsfor Oral Contraception) |
Tablets |
21 or 22 with or without placebo. |
| Roxatidine Acetate Hydrochloride |
Tablets |
14 |
| Vitamin A Oral Drops |
Drops |
7.5 ml.] |
| 2[Co-trimoxazole |
Suspension |
50 ml. |
| Haloperidol |
Oral Solution |
15 ml. |
| Loxapine |
Oral Liquid Concentrate |
15 ml.] |
1. Ins. by G.S.R. 796(E) , dt. 1.10.1992 (w. e. f. 1.1.1993).
2. Ins. by G.S.R. 753(E), dt. 4.11.1999.
1[SCHEDULE Q
(See rules 134 and 144)
2[PART I]
3[LIST OF DYES, COLOURS AND PIGMENTS PERMITTED TO BE USED IN COSMETICS AND SOAPS AS GIVEN UNDER IS : 4707
(PART I)-1988
(AS AMENDED BY THE BUREAU OF INDIAN STANDARDS)
| Common name of the colour |
Colour Index Number |
Chemical name of the colour |
| 1 |
2 |
3 |
| Guinea Green B |
42085 |
Monosodium salt of 4-(N-ethyl-p-sulfobenzylamino)– diphenylmethylone-(1-(N-ethyl-N-p-sulfoniumbenzyl)∆ 2,5- cyclohexadienimine). |
| Light Green SF Yellowish |
42095 |
Disodium salt of 4-[4-(N-ethyl-p-sulfobenzylamine)-phenyl)-4- sulphoniumphenyl) methylene]-2(-(N-ethyl-N-sulfobenzyl) ∆ 2,5-Cyclohexadienimine. |
| Tartrazine |
19140 |
Trisodium salt of 3-carboxy-5-hydroxy-1-p-sulfophenyl-4-psulfophenylazo-pyrazole. |
| Sunset yellow FCF |
15985 |
Disodium salt of 1-p-sulfophenylazo-2- naphthol-6-sulfonic acid |
| Ponceau 3R |
16155 |
Disodium salts of a mixture of 1-alkyl- phenylazo-2-napthol 3, 6-disulfonic acids. |
| Amarnath. |
16185 |
Trisodium salt of 1-(4-sulfo-1- napthylazo) 2-naphthol 3, 6-disulfonic acid. |
| Erythrosine. |
45430 |
Disodium salt of 9-0-carboxyphenyl-6- hydroxy 2,4,5, 7-tetraiodo-3- isoxanthone. |
| Ponceau SX. |
14700 |
Disodium salt of 2-(5 sulfo-2, 4-xylyl- azo)-1-naphthol-4-sulfonic acid. |
| Brilliant Blue FCF |
42090 |
Disodium salt of 4-(9-4-(N-ethyl-p-sulfobenzylamino)-phenyl)- 2-sulfonium phenyl)- methylene)-(1-(N-ethyl-N-p-sulfobenzyl)- ∆ 2, 5-cyclohexadienimine). |
| Indigocarmine. |
73015 |
Disodium salt of 5,5‘-indigotindisulfonic acid. |
| Wool Violet 5 BN (Acid- violet 6B) |
42640 |
Monosodium salt of 4-(N-ethyl-p-sulfobenzylamino)-phenyl)-(4-(N-ethyl-p-(sulfonium-benzylamine)-phenyl) methylene)-(N, Ndimethyl-∆ 2,5-cyclohexadienimine) |
| Light Green SF Yellowish |
42095 |
Calcium salt of 4-(4-(N-ethyl-p-sulfobenzyl) (minophenyl) (4- sulfonium-phenyl)methylene), (1-(N-ethyl-N-p-sulfobenzyl)-∆2,5-cyclohexadienimine). |
| Alizarin Cyanine Green F |
61570 |
Disodium salt of 1,4-bis (O-sulfo-p-toluino) anthraquinone. |
| Quinazarine Green SS |
61565 |
1,4-bis-(p-Toluino)-anthraquinone |
| Fast Green FCF |
42053 |
Disodium salt of 4-(4-(ethyl-p-sulfobenzylamino)-phenyl) (4-hydroxy-2 sulphoniumphenyl) methylene)-(1-N-ethyl-N-psulfobenzyl) ∆ 2, 5, cyclohexadienimine). |
| Acid Fast Green |
42100 |
Monosodium salt of 4-(4-N-ethyl-p-sulfobenzylomino) phenyl)-(o-chlorophenyl)-methylene)- 1-(N-ethyl-N- p-sulfonium benzyl- ∆ 2,5, cyclohexadienimine). |
| Pyranine Concentrated |
59040 |
Trisodium salt of 10-hydroxy-,3,5,8-pyrene-trisulfonic acid. |
| Quinoline Yellow WS |
47005 |
Disodium salt of disulfonic acid of 2-(2-Quinolyl)-1, 3-indandione. |
| Quinoline Yellow SS |
47000 |
2-(2-quinolyl)-1, 3 indandiene. |
| Poneceau 2 R |
16150 |
Disodium salt of 1-xylylazo-2-naphthol-3, 6-disulfonic acid. |
| Lithol Rubin B. |
15850 |
Monosodium salt of 4-(o-sulfo-p-tolylazo)3 hydroxy-2-naphthoic acid |
| Lithol Rubin BCA |
15850 |
Calcium salt of 4-(o-sulfo-p-tolylazo)-3-hydroxy-2-naphthoic acid |
| Lake Red D. |
15500 |
Monosodium salt of 1-0-carboxyphenylazo-2-naphthol. |
| Lake Red DBA |
15500 |
Barium salt of 1-o-carboxyphenylazo-2-naphthol. |
| Lake Red DCA. |
15500 |
Calcium salt of 1-o-carboxyphenylazo-2-naphthol. |
| Toney Red. |
26100 |
I-p-phenylazophenylazo-2-naphthol. |
| Oil Red OS. |
26125 |
I-Xylylazoxylylazo-2-napththol |
| Tetrabromofluorescein |
45380 |
2,4,5,7-Tetrabromo-3, 6-flurandiol. |
| Eosin TS |
45380 |
Disodium salt of 2,4,5,7-tetrabromo-9-0 carboxyphenyl-6-hyroxy-3-isoxanthone. |
| Eosin YSK. |
45380 |
Dipotassium salt of 2,4,5,7-tetrabromo-9-0 carboxyphenyl6-hyroxy-3-isoxanthone |
| Tetrachlorofluorescein NA |
45366 |
2,4,5,7- tetrachloro-S, 6-Fluorandiol |
| Tetrachlorofluorescein K. |
45366 |
Disodium salt of 9-0-carboxyphenyl-2,4,5,7-tetrachloro-6-hydroxy-3-isoxanthone. |
| Tetrachloro Tetrabromo fluorescein |
45410 |
2,4,5,7-Tetrabromo-12,13,14,15-tetrachloro-3, 6-fluorandiol. |
| Phloxine B |
45410 |
Disodium salt of 2,4,5,7-tetrabromo-9 (3,4,5,6-tetra chloroo-carboxyphenyl)-6-hydroxy-3-isoxanthone |
| Bluish Orange T.R. |
45457 |
1,4,5,8, 15-Pentabromo-2, 7-dicarboxy-3, 6-fluoran diol. |
| Helindone Pink CN. |
73360 |
5, 5-Dichloro-3, 3‘ dimethyl-thioindigo |
| Deep Maroon (Fanchon Maroon) |
15880 |
Calcium salt of 4-(I-sulfo-2-naphthylazo 3- hydroxy-2-naphthoic acid. |
| Toluidine Red. |
12120 |
1-(o-Nitro-p-tolylazo)-2-naphthol |
| Flaming Red. |
12085 |
I- (o-Chloro-p-nitrophenylazo)-2-naphthol |
| Deep Red (Maroon). |
12350 |
3-Hydroxy-N- (m-nitrophenyl)-4-(o-nitro-p-tolylazo)-2-naphthamide. |
| Alba Red. |
13058 |
o-(p,β,β-Dihydroxy-diethylamino)- phenylazo)-benzoic acid. |
| Orange G. |
16230 |
Disodium salt of 1-phenylazo-2-naphthol-6-8-disulfonic acid. |
| Orange II |
15510 |
Monosodium salt of 1-p-sulfophenylazo-2-naphthol. |
| Dichlorofluorescein |
45365 |
4,5-Dichloro-3, 6-fluorandiol. |
| Dichlorofluorescein. NA |
45365 |
Disodium salt of 9-o-carboxyphenyl-1-4,5- dichloro-6-hydroxy-3-isoxanthone |
| Diiodofluorescein. |
45425 |
4,5 –Diiodo-3, 6-fluorandiol |
| Erythrosine Yellowish NA. |
45425 |
Disodium salt of 9-o-carboxyphenyl-6- hydroxy-4, 5- diiodo-3-isoxanthone. |
| Erythrosine Yellowish K. |
45425 |
Dipotassium salt of 9-o-carboxyphenyl-6-hydroxy-4, 5-diiodo-3-isoxanthone. |
| Erythrosine Yellowish NH |
45425 |
Dipotassium salt of 9-o-carboxyphenyl-6-hydroxy-4, 5-diiodo-3-isoxanthone |
| Orange TR |
45456 |
4,5, 15-Tribromo 2, 7-dicarboxy-3, 6- fluorandiol. |
| Alizarin. |
58000 |
1,2- Anthraquinonediol. |
| Dibromodiiodofluorescein. 1[***] |
45371 |
4 ,5- Dibromo-2, 7-diiodo-3, 6-fluorandiol. |
| Alphazurine FG. |
42090 |
Diammonium salt of 4-(N-ethyl-p- sulfobenzyl amino)-phenyl)-(2-sulfoniumphenyl)-Methytlene)-(-(1 (N-ethyl-Np-sulfobenzyl) ∆ 2 ,5-cyclohexadienimine). |
| Allarin Astrol B. |
61530 |
Monosodium salt of 1-methylamino-4-(o-sulfo-p-toluino)-anthroquinone. |
| Indigo. |
73000 |
Indigotin. |
| Patent Blue NA. |
42052 |
Monosodium salt of 4-(4- (N-ethyl- benzyl-amino)-phenyl – (5-hydroxy-4-sulfo-2-sulfoniumphenyl-methylene)(N-ethylBenzyl- ∆ 2, 5-cyclohexadienimine). |
| Patent Blue CA. |
42052 |
Calcium salt of 4-(4- (N-ethyl- benzyl-amino)-phenyl)-(5 hydroxy-4-sulfo-2-sulfoniumphenyl, methylene)- (N-ethylN-benzyl- ∆ 2- 5-cyclohexadienimine). |
| Carbrantherene Blue |
69825 |
3, 3- Dichloroindanthrene |
| Napthol Blue Black |
20470 |
Disodium salt of 8-amino-7-p- nitrophenylazo 3-phenylazo-1- naphthol-3, 6-disulfonic acid |
| Alizurol purple SS |
60725 |
I-hydroxy-4-p-toluino-anthraquinone. |
| Acid Red 89 |
23910 |
—- |
| Acid Red 97 |
22890 |
—- |
| Acid Blue 1 |
42045 |
—- |
| Food Blue 3 |
42045 |
—- |
| Natural Orange |
75480 |
—- |
| Solvent Blues 4 |
44045 |
—- |
| Solvent Yellow 18 |
12740 |
—- |
| Food Yellow 12. |
12740 |
—- |
| 1[***] |
|
—- |
| Solvent Yellow 32. |
48045 |
—- |
| Fanchon Yellow (Hansa Yellow G). |
11680 |
(α) -(O-Nitro-p-tolylazo) accetoacetanilide |
1. Inserted by Notification F.-1-36/64 D, dated 17.8.1964.
2. Renumbered as Part I by G.S.R. 11(E) , dated 7.1.1991.
3. Substituted by G.S.R. 811(E) , dated 14.11.1994.
4. Omitted by G.S.R. 203(E), dated 18-03-2015.
2[Part II
LIST OF COLOURS PERMITTED TO BE USED IN SOAPS.
| Common name of the Colour |
Colour Inde No. |
Chemical name of the colour |
| Phthalocyanine Blue |
74160 |
(phthalocyninate (2–) copper |
| Iragalite Red CVPB Paste or Pigment Orange 5 |
12075 |
1-(2,4-dinithro phenylazo)-2-Naphthalenol. |
| Citrus Red No.2. |
12156 |
1-2(2,5-dimethoxy phenylazo) 2-naphthol |
| Rhodamine B 500 |
45170 |
3-ethochloride of 9-0 carboxy-ethenyl-6-diethylamino3-ethylamine-3-isoxanthene. |
| Aqueous Green Paste |
74260 |
Polychloro copper Phthalocyanine. |
| Pigment Yellow 3 |
11710 |
2-(4-Chloro-2-nitrophenyl)-azo-N-(-2-Chlorophenyl)-3- Oxobutamide. |
| Irgalite Carmine F-P Powder or Pigments Red 5. |
12490 |
N-(5-Chloro-2, 4-dimethoxy-phenyl)-4-(CS- diathylamine) Sulfonyl-2-methoxyphenyl)azo3-hydroxy-2-naphthalene carboxamide. |
| Monolite Red 4R HV Paste or Pigment Red 7 |
12420 |
N-(4-Chloro-2-methylphenyl-4-(-4-Chloro-2-methylphenyl) Azo 3-hydroxy-2-naphthalenol Carboxamide. |
| Oil Red No.1 or Solvent Red 24 or Oil Red 3R. /td>
| 26105 |
4-0-Tolylazo-Toluidine azo 2-naphthalenol.] |
*This list of colour for use in soaps is in addition to those colours already given in Schedule Q and are used for soaps.]
1. Omitted by G.S.R. 203(E) dated 18-03-2015
2. Ins. by G.S.R. 11(E) , dt. 7.1.1991.
1[SCHEDULE R
[See Rule 125]
STANDARDS FOR CONDOMS MADE OF RUBBER LATEX INTENDED FOR SINGLE USE AND OTHER MECHANICAL CONTRACEPTIVES
I- Condoms
1. Description – Condoms consist of cylindrical rubber sheaths with one end open. The open end shall terminate with an integral rim. The closed end may have a receptacle. They may be supplied rolled and shall be free from tackiness and shall be capable of being unrolled readily.
2. Materials – (1) Condoms shall be manufactured from good quality rubber latex and shall be free from embedded grit and shall be opaque or translucent prior to the application of dusting materials or lubricants.
(2) The rubber latex, colours used and any dusting materials or lubricants applied to the condoms shall neither contain nor liberate substances which are known to have toxic or other harmful effects under normal conditions of use. Any dusting material or lubricant or colour used shall not have deleterious effect on the condoms or be harmful to the users.
3. Procedure for sampling during production − (1) Specimens constituting the test samples shall be taken at random successively from each quantum of production that is, from the quantity produced from the same finished rubber latex and under the same processing and finishing conditions of manufacture and samples from each quantum shall be tested separately to ascertain conformity of quantum with the specified requirements in accordance with the tests described in this Schedule.
(2) (a) The number of samples drawn from each quantum shall be not less than 0.5 per cent of the number.
(b) The number of samples drawn from each quantum shall be tested for Burst Volume and Pressure Test and Water Leakage Test in accordance with the method prescribed in paras 9 and 10 of this Schedule. 75 per cent of the samples drawn will be tested for Water Leakage Test and 25 per cent will be tested for Burst Volume and Pressure Test.
(c) The number of test samples ‘N‘ and the number of rejected samples ‘R‘ from a sequence of production quanta shall be recorded in a register. The cumulative total of test samples ‘N‘ and the cumulative total of rejects ‘R‘ from the test shall be recorded and the condoms shall be deemed to comply with the requirements if the cumulative total of rejects ‘R‘ is not more than 2[0.0025N+3 x √0.0025N] for Water Leakage Test, and 2[0.015N+3 x√0.015N] for Burst Volume and Pressure Test.
(3) Each unit of 100 test samples shall be distributed for the various tests as follows:-
25 for Burst Volume Pressure Test, and;
75 for Water Leakage Test.
1 Subs. by G.S.R. 495(E) , dt. 9.6.1995.
2. Subs. by G.S.R. 353(E), dt. 26.4.2000.
(4) Where the number of test samples is a multiple of 100 the distribution scale mentioned above shall be prorated.
(5) If the cumulative total sample rejected exceeds the number of allowables at any point in the sequence of quanta, the quantum at which this occurs shall be liable to rejection. The assessment of quality of further production quanta shall include all previous test results starting from quantum number 1 and approval of production shall be in suspense until the condition required by the scheme is again fulfilled.
(6) At least one sample shall be taken at random from each production quantum not exceeding 10,000 condoms and shall satisfy all requirements regarding dimensions as specified in paragraph 8 of this Schedule.
4. Procedure for sampling and testing of finished products by a manufacturer –
A. Water Leakage Test.- (1) Statistical sampling for quality control assessment of the finished product in respect of Water Leakage Test shall be done in accordance with the plan set out in Annexure 1 to this Schedule.
(2) A test sample failing in the above test is to be considered as defective. If the cumulative total of rejects ‘R‘ is found to be equal to or greater than the number shown against
‘R‘ in Annexure-I, the batch or lot shall be declared as not of standard quality.
B. Bursting Volume and Pressure Test.- (1) Sample condoms shall be tested for Bursting Volume and Pressure Test. Statistical sampling for this test shall be done in accordance with the plan set out in Annexure III to this Schedule.
Condoms shall not leak or burst at a volume of less than that specified or at a pressure less than 1.0 kpa (gauge), when tested as per paragraph 9, both before and after oven conditioning as specified in Annexure V. Bursting Volume minimum limit in litres shall be equal to [mean condom width (mm)2] rounded to the nearest 0.5 litre.
151.8
(2) A test sample failing in the above test is to be considered defective. If the cumulative total of rejects ‘R‘ is found to be equal or greater than the number shown against
‘R‘ in Annexure III, the batch or lot shall be declared as not of standard quality.
C. Dimensions. – At least 2 samples drawn from the lot or batch shall satisfy the requirements regarding dimensions as specified in paragraph 8 of this Schedule.
5. Procedure for sampling and testing of condoms by a purchaser –
A. Water Leakage Test- (1) Statistical sampling of condoms by a purchaser for Water Leakage Test shall be done in accordance with the plan set out in Annexure II to this Schedule;
(2) A test sample failing in the above test is to be considered as defective. If the cumulative total of rejects ‘R‘ is found to be equal to or greater than the number shown against ‘R‘ in the Annexure-II, the batch or lot shall be declared as not of standard quality.
B. Bursting Volume and Pressure Test – Sample condoms shall be tested for Bursting Volume and Pressure Test. Statistical sampling for this test shall be done in accordance with the plan set out in Annexure III to this Schedule. If the cumulative total of rejects ‘R‘ is found to be equal to or greater that the number shown against ‘R‘ in Annexure III, the batch or lot shall be declared as not of standard quality.
Condom shall not leak or burst at a volume of less than that specified or at a pressure less than 1.0 kpa (gauge), when tested as specified in paragraph 9, both before and after oven conditioning as per specified in Annexure V. Bursting volume minimum limit in litres shall be equal to
[mean condom width (mm)2] rounded to the nearest 0.5 litre.
151.8
C. Dimensions. – At least two samples from the lot or batch shall satisfy the requirements regarding dimensions as specified in paragraph 8 of this Schedule.
6. Sampling plan for a Drugs Inspector – (1) Where an Inspector under the Act desires to take test samples from the premises of manufacturer or a distribution depot; twenty containers from each batch of production may be selected by him on a random basis and from each of the containers, five samples shall be taken. The hundred samples so selected shall be distributed for various tests as specified in paragraph 7 of this Schedule. In case the number of container is less than twenty, the number of samples to be taken from each container shall be proportionately increased.
(2) Where an Inspector under the Act desires to take samples from a sales premises, he shall take hundred samples from each batch of production in accordance with the procedure as specified in sub- paragraph (1).
7. Sampled condoms drawn under sub-paragraph.- (1) shall be distributed for various tests as follows:- Two samples for thickness, length and width;
Forty-five samples for Water Leakage Test;
Forty-five samples for Bursting Volume and Pressure Test; and Eight samples as reserve.
The samples shall be declared as not of standard quality, if, – (i) the number of condoms found defective in the Water Leakage Test exceeds one; (ii) the number of condoms found defective in Bursting Volume and Pressure Test exceeds two; (iii) samples fail to conform to the requirements of dimensions as specified in paragraph 8 of this Schedule.
8. Dimensions – (1) The length when unrolled (excluding test) shall be not less than –
(i) 170 mm.
(ii) 180 mm.
(2) The width of a condom which laid flat and measured at any point within 85 mm from the open end shall be,–
(i) 49 ± 2 mm for 170 mm length.
(ii) 53 ± 2 mm for 180 mm length.
(3) The single-wall thickness of a condom when measured at three points, one at 30 ± 2mm from the open end, 30 ± 5mm from the close end excluding the reservoir tip and at the mid distance between these two point shall be from 0.045 mm to 0.075 mm.
NOTE 1. – The single-wall thickness shall be determined with a suitable micrometer dial gauge graduated in intervals of 0.01 mm.
NOTE 2. – Condoms shall, prior to the measurement of thickness, have the dusting powder or the lubricant or both removed by means of water or Isopropanol.
9. Bursting Volume and Pressure Test – Determination of Bursting Volume and Pressure Test shall be done as specified in Annexure IV.
10. Water Leakage Test – Unroll the condom and fit the open end on a suitable mount, the condom thus being suspended open end upwards. Fill it with 300 ml water at room temperature and inspect it after a period of at least 1 minute for leakage up to 25.mm from the open end. If, because of distension of the condom the water does not extend to 25 mm from the open end, raise the closed end until the water level reaches this distance. After at least 1 minute, inspect the newly-wetted part of the condom for leakage. The condom shall be deemed to be defective if it bursts during test or shows any evidence of leakage or seepage of micro- droplets or does not hold 300 ml water.
11. Quantity of Lubricant – (1) The condoms shall be dressed with silicone lubricant. The quantity required on each individual condom should not be less than 200 mg and minimum viscosity shall be 200 centistokes.
(2) Lubricated condoms in individual foil packages shall be weighed on an Analytical Balance. Each condom shall be removed from its foil package and both condom and its foil package shall be washed in denatured ethanol or isopropanol, dried and then weighed again. All weights shall be recorded to the nearest milligram (mg.). Compliance with the requirement shall be determined by subtracting the weight of the washed and dried condom and its foil package from the weight of sample condom in individual foil package prior to the removal of lubricant. Washing and drying may be required upto a total of four times if the lubricant quantity is less than the required minimum.
(3) At least thirteen samples shall be drawn from the lot or batch and the samples shall satisfy the requirements regarding the quantity of lubricant.
12. Colour Fastness – Not less than ten samples taken at random from each batch of coloured condoms shall pass the following test for colour fastness, namely :-
Thoroughly wet inside and outside of the condom with distilled water. Make no attempt to remove any dusting material or lubricant. Wrap the wet condom in white absorbent paper so that the largest possible surface area of the condom is in contact with the paper and seal the whole in a suitable container to prevent loss of moisture. Allow the container and its contents to stand for 16 hours to 24 hours at room temperature. After removing the absorbent paper from the container, examine it visually in the natural daylight for any indication of staining. No part of the absorbent paper shall be stained. If there is any indication of staining of the absorbent paper by any colouring agent present in any of the condoms or any dusting material or lubricant, the entire batch shall be declared to be not of standard quality.
13. Labelling, packing and storage – (1) The condoms shall be individually wrapped and sealed in laminates containing at least eight microns of aluminium foil. The individual condom shall be packed in square (non-squeeze condition) / rectangular aluminium foil. The packing shall protect the condoms from contamination and mechanical damage. The smallest packing offered to the consumer shall bear a clear permanent marking with the following particulars, namely:-
(i) Manufacturer‘s name and address and the trade name of the condoms, if any;
(ii) Batch number;
(iii) Date of manufacture (Month and year only);
(iv) Date of expiry (Month and year only) which shall not be more than thirty-six months from the date of manufacture;
(v) The words “For single use only”
(2) The condoms shall be stored in a cool dry place away from heat and direct sunlight.
14. Integrity of individual package seals – Sample condoms in individual packages shall be placed in a sealed, transparent container (such as a laboratory Bell jar) and subjected to vacuum of 50± 10 kpa (gauge) for a period of one minute.
Condom packages that do not inflate or remain inflated for the period of the test shall be deemed non- compliers. In doubtful cases, the test may be repeated, and both the inflation and deflation of packages may be observed on application and removal of vacuum. An AQL of 2.5 per cent will be applied in assessing the results of this test. Thirty-two samples of condoms for a batch size less than 5 lakhs and fifty samples of condoms for batch size more than 5 lakhs shall be tested for integrity test of individual package seals and compliance limit or acceptance number shall be not more than two or three condoms respectively.
II- Other Mechanical Contraceptive
15. Standards for other mechanical contraceptive – Standards for ‘Copper T‘ and ‘Tubal Ring‘shall be as laid down in Annexure VI.
1[ANNEXURE I
[See Paragraph 4-A]
SAMPLING PLAN FOR QUALITY CONTROL OF CONDOMS AT MANUFACTURER’S LEVEL.
BATCH SIZE: 35,001 TO 1.5 LAKH
| Single Sampling Plan |
|
| Sample Size 200: |
AQL – 0.25
AC – 1
R – 2 |
1. Subs. by. G.S.R. 353(E) , for ” Annexures I to III” dt. 26-4-2000.
BATCH SIZE: 150001 TO 5 LAKHS
| Single Sampling Plan |
|
| Sample Size 315 : |
AQL – 0.25
AC – 2
R – 3 |
BATCH SIZE: OVER 5 LAKHS
| Single Sampling Plan |
|
| Sample Size 500: |
AQL – 0.25
AC – 3
R – 4 |
Note: AQL denotes Acceptance Quality Level;
AC denotes Acceptance Number i.e. the maximum allowable number of defectives for acceptance of the Batch; and
R denotes Rejection Number i.e., the minimum number of defectives for rejection of the Batch.
ANNEDURE II
[See Paragraph 5A]
SAMPLING PLAN FOR QUALITY CONTROL OF CONDOMS AT PURCHASER‘S LEVEL.
BATCH SIZE: 35,001 TO 1.5 LAKHS
| Single Sampling Plan |
|
| Sample Size 200: |
AQL – 0.25
AC – 1
R – 2 |
BATCH SIZE : 15,001 TO 5 LAKHS
| Single Sampling Plan |
|
| Sample Size 315: |
AQL – 0.25
AC – 2
R – 3 |
BATCH SIZE : OVER 5 LAKHS
| Single Sampling Plan |
|
| Sample Size 500: |
AQL – 0.25
AC – 3
R – 4 |
Note: AQL denotes Acceptance Quality Level;
AC denotes Acceptance Number i.e. the maximum allowable number of defectives for acceptance of the Batch; and
R denotes Rejection Number i.e., the minimum number of defectives for rejection of the Batch.
ANNEXURE III
[See Paragraph 4-B and 5-B]
SAMPLING PLAN FOR BURSTING VOLUME AND PRESSURE TEST.
BATCH SIZE: 35,001 TO 1.5 LAKH.
| Single Sampling Plan. |
|
| Sample Size 200: |
AQL – 1.5
AC – 7
R – 8 |
BATCH SIZE: 150001 LAKHS TO 5 LAKHS
| Single Sampling Plan. |
|
| Sample Size 315: |
AQL – 1.5
AC – 10
R – 11 |
BATCH SIZE: OVER 5 LAKHS
| Single Sampling Plan. |
|
| Sample Size 500: |
AQL – 1.5
AC – 14
R – 15 |
Note: AQL denotes Acceptance Quality Level;
AC denotes Acceptance Number i.e. the maximum allowable number of defectives for acceptance of the Batch; and
R denotes Rejection Number i.e., the minimum number of defectives for rejection of the Batch.]
ANNEXURE IV
(See Paragraph 9)
DETERMINATION OF BURSTING VOLUME AND PRESSURE
1. Principle – Inflation of constant length of the condom with air and recording the volume and pressure at the moment of bursting.
2. Apparatus – (1) Apparatus suitable for inflating the condom with clean air at a specified rate and provided with equipment for measuring volume and pressure.
(2) Suitable mount for fitting the condoms to the apparatus as shown in the figure annexed.
(3) Rod, 140 mm in length having a smooth sphere 20 mm in diameter at its top (see the figure) for hanging the unrolled condom when fixed to the apparatus.
3. Procedure – (1) Unroll the condom, hang it on the rod (2.3), affix to the mount (2.2) and inflate with air at a rate of 0.4 to 0.5 litre/sec. (24 to 30 litres/min.)
(2) Measure and note the bursting volume, in litres rounded to the nearest 0.5 litre and the bursting pressure, in kilopascals rounded to the nearest 0.1 kpa.
4. Test report – The test report shall include the following particulars:
(a) the identification of the sample;
(b) the bursting volume and bursting pressure of each tested condom;
(c) the date of testing.
ANNEXURE V
[See Paragraphs 4(B) and 5 (B)
OVEN CONDITIONING
1. Principle of the Method – The test consists in subjecting test samples to controlled deterioration by air at an elevated temperature and at atmospheric pressure after which burst volume and pressure limits are measured.
2. Apparatus – The air oven shall be of such a size that the total volume of the test samples does not exceed 10 per cent of the free air space of the oven. Provision shall be made for slow circulation of air in the oven of not less than three changes and not more than ten changes per hour. The temperature of the oven shall be thermostatically controlled so that the test samples are kept within ± 2o C of the specified ageing temperature. A thermometer shall be placed near the centre of the ageing test samples to record the actual ageing temperature.
Note:- Copper or copper alloys shall not be used for the material of construction of the oven prescribed.
3. Test sample – The foil laminations of individual packages should remain intact throughout all laboratory handling including over conditioning.
4. Temperature of the oven – Maintain the oven at 70 ± 2o C.
5. Duration of test – 96 hours.
6. Procedure – Condition the requisite number of unopened packages of rubber condoms in the oven at 70 ± 2o C for 96 hours. After heating, keep the packages at 23 ± 5o C for at least 12 hours but not more than 96 hours. Open the packages and examine conditioned condoms for tackiness, brittleness, or other signs of deterioration. Within 96 hours but not sooner than 12 hours after conditioning, do the bursting volume and pressure Test as described in this Schedule.
ANNEXURE VI
(See Paragraph 15)
1. Standards for Copper T (200B) (IS-12418) (part 4)-1991-UDC 615.477.87) – Contraceptive Device Copper T (200 B) shall conform to the Indian Standards laid down from time to time by the Bureau of Indian Standards.
2. Standards for Contraceptive Tubal Ring (IS 13009 : 1990-UDC 615.472.6 : 611.656) – Contraceptive Device Tubal Ring shall conform to the Indian Standards laid down from time to time by the Bureau of Indian Standards.]
1[SCHEDULE R1
(See Rules 109A, 109, 109C and 125A)
The medical devices shall conform to the Indian Standards laid down from time to time by the Bureau of Indian Standards. If there are no Bureau of Indian Standards then it shall conform to the International Standards, like International Organisation for Standardisation, or other International Pharmacopeia Standards and such other standards as may be specified for this purpose. In case national or international standards are not available, the device shall conform to the manufacturer‘s validated standards.]
2[SCHEDULE S
[See Rule 150-A]
STANDARDS FOR COSMETICS
Standards for cosmetics in finished form − The following cosmetics in finished form shall conform to the Indian Standards specifications laid down from time to time by the 3[Bureau of Indian Standards (BIS)].
1. Skin Powders.
2. Skin Powder for infants.
3. Tooth Powder.
4. Toothpaste.
5. Skin Creams.
6. Hair Oils.
7. Shampoo, Soap-based.
8. Shampoo, Synthetic-Detergent based.
9. Hair Creams.
10. Oxidation hair dyes, Liquid.
11. Cologne.]
4[12. Nail Polish (Nail Enamel).
13. After Shave Lotion.
14. Pomades and Brilliantines.
15. Depliatories Chemical.
16 Shaving Creams.
17. Cosmetic Pencils.
18. Lipstick.]
5[19. Toilet Soap.
20. Liquid Toilet Soap.
21. Baby Toilet Soap.
22. Shaving Soap.
23. Transparent Toilet Soap.]
1. Subs. by G.S.R. 690(E), dt. 25.9.2014.
2. Ins. by G.S.R. 510(E) , dt. 26.07.1982.
3. Subs. by G.S.R. 673(E), dt. 27.10.1993.
4. Ins. By G.S.R. 731(E) dated 23-08-1990
5. Ins. By G.S.R. 673(E) dated 27-10-1993
1[24. Lipsalve IS:10284.
25. Powder Hair Dye IS: 10350.
26. Bindi (Liquid) IS: 10998.
27. Kum Kum Powder IS: 10999.
28. Henna Powder IS: 11142.] 2[29. Bathing Bars IS: 13498: 1997 3[30. Sindoor IS: 14649: 1999
4[31. Liquid Foundation makeup IS 14318
4[32. Cold Wax Hair remover IS 15152
4[33. Face pack IS 15153
4[34. Kajal IS 15154
4[35. Oxidation Hair Dyes (Emulson Type) IS 15205 4[36. Cream Bleach IS 15608
1. Ins. by G.S.R. 553(E), dt. 20.7.1995.
2. Ins. by G.S.R. 592(E), dt.13.8.2008.
3. Ins. by G.S.R. 724(E), dt. 07.11.2013.
4. Ins. by G.S.R. 203(E), dt.18.03.2015.
5[SCHEDULE T
(See rule 157)
GOOD MANUFACTURING PRACTICES FOR AYURVEDIC, SIDDHA AND UNANI MEDICINES
The Good Manufacturing Practices (GMP) are prescribed as follows in Part I and Part II to ensure that:
(i) Raw materials used in the manufacture of drugs are authentic, of prescribed quality and are free from contamination.
(ii) The manufacturing process is as has been prescribed to maintain the standards.
(iii) Adequate quality control measures are adopted.
(iv) The manufactured drug which is released for sale is of acceptable quality.
(v) To achieve the objectives listed above, each licensee shall evolve methodology and procedures for following the prescribed process of manufacture of drugs which should be documented as a manual and kept for reference and inspection. However, under IMCC Act 1970 registered Vaidyas, Siddhas and Hakeems who prepare medicines on their own to dispense to their patients and not selling such drugs in the market are exempted from the purview of G.M.P.
5. Subs. by G.S.R. 560(E), dt. 07.3.2003.
PART I
GOOD MANUFACTURING PRACTICES
1.1 Factory Premises:
The manufacturing plant should have adequate space for:-
(i) Receiving and storing raw material. (ii)Manufacturing process areas. (iii)Quality control section. (iv)Finished goods store.
(v) Office.
(vi) Rejected goods/drugs store.
1.1 General Requirements:
1.1(A) Location and surroundings – The factory building for manufacture of Ayurveda, Siddha and Unani medicines shall be so situated and shall have such construction as to avoid contamination from open sewerage, drain, public lavatory for any factory which produces disagreeable or obnoxious odour or fumes or excessive soot, dust and smoke.
1.1(B) Buildings – The buildings used for factory shall be such as to permit production of drugs under hygienic conditions and should be free from cobwebs and insects/rodents. It should have adequate provision of light and ventilation. The floor and the walls should not be damp or moist. The premises used for manufacturing, processing, packaging and labelling will be in conformity with the provisions of the Factory Act. It shall be located so as to be:
(I) Compatible with other manufacturing operations that may be carried out in the same or adjacent premises.
(II) Adequately provided with working space to allow orderly and logical placement of equipment and materials to avoid the risk of mix-up between different drugs or components thereof and control the possibility of cross contamination by other drugs or substances and avoid the risk of omission of any manufacturing or control step.
(III) Designed, constructed and maintained to prevent entry of insects and rodents. Interior surface (walls, floors and ceilings) shall be smooth and free from cracks and permit easy cleaning and disinfection. The walls of the room in which the manufacturing operations are carried out shall be impervious to and be capable of being kept clean. The flooring shall be smooth and even and shall be such as not to permit retention or accumulation of dust or waste products.
(IV) Provided with proper drainage system in the processing area. The sanitary fittings and electrical fixtures in the manufacturing area shall be proper and safe.
(V) Furnace/Bhatti section could be covered with tin roof and proper ventilation, but sufficient care should be taken to prevent flies and dust.
(VI) There should be fire safety measures and proper exits should be there.
(VII) Drying Space:-There should be separate space for drying of raw material, in process medicine or medicines which require drying before packing. This space will be protected from flies/ insects/dust etc., by proper flooring, wire- mash window, glass panels or other material.
1.1(C) Water Supply – The water used in manufacture shall be pure and of potable quality. Adequate provision of water for washing the premises shall be made.
1.1(D) Disposable of Waste – From the manufacturing section and laboratories the waste water and the residues which might be prejudicial to the workers or public health shall be disposed off.
1.1(E) Container‘s Cleaning – In factories where operations involving the use of containers such as glass bottles, vials and jars are conducted, there shall be adequate arrangements separated from the manufacturing operations for washing, cleaning and drying of such containers.
1.1(F) Stores – Storage should have proper ventilation and shall be free from dampness. It should provide independent adequate space for storage of different types of material, such as raw material, packaging material and finished products.
1.1. (F)(A) Raw Materials – All raw materials procured for manufacturing will be stored in the raw materials store. The manufacture based on the experience and the characteristics of the particular raw material used in Ayurveda, Siddha and Unani system shall decide the use of appropriate containers which would protect the quality of raw materials as well as prevent it from damage due to dampness, microbiological contamination or rodent and insect infestation, etc. If certain raw materials require such controlled environmental conditions, the raw materials stores may be sub-divided with proper enclosures to provide such conditions by suitable cabinization. While designing such containers, cupboard or areas in the raw materials store, care may be taken to handle the following different categories of raw materials:-
1. Raw material of metallic origin.
2. Raw material of mineral origin.
3. Raw material from animal source.
4. Fresh herbs.
5. Dry herbs or plant parts
6. Excipients etc.
7. Volatile oils/perfumes and flavours
8. Plant concentrates/ extracts and exudates/resins.
Each container used for raw material storage shall be properly identified with the label which indicates name of the raw material, source of supply and will also clearly state the status of raw material such as ‘UNDER TEST‘ or ‘APPROVED‘ or ‘REJECTED‘. The labels shall further indicate the identity of the particular supply in the form of Batch No. or Lot No. and the date of receipt of the consignment.
All the raw materials shall be sampled and got tested either by the in-house Ayurvedic, Siddha and Unani experts (Quality control technical person) or by the laboratories approved by the Government and shall be used only on approval after verifying. The rejected raw material should be removed from other raw material store and should be kept in separate room. Procedure of ‘First in first out‘ should be adopted for raw materials wherever necessary. Records of the receipt, testing and approval or rejection and use of raw material shall be maintained.
1.1. (F)(B) Packaging Materials. – All packaging materials such as bottles, jars, capsules etc. shall be stored properly. All containers and closure shall be adequately cleaned and dried before packing the products.
1.1. (F)(C) Finished Goods Stores. – The finished goods transferred from the production area after proper packaging shall be stored in the finished goods stores within an area marked “Quarantine”. After the quality control laboratory and the experts have checked the correctness of finished goods with reference to its packing/labelling as well as the finished product quality as prescribed, then it will be moved to “Approved Finished Goods Stock” area. Only approved finished goods shall be dispatched as per marketing requirements. Distribution records shall be maintained as required.
If any Ayurvedic, Siddha and Unani drug needs special storage conditions, finished goods store shall provide necessary environmental requirements.
1.1(G) Working space. – The manufacturing area shall provide adequate space (manufacture and quality control) for orderly placement of equipment and material used in any of the operations for which these employed so as to facilitate easy and safe working and to minimize or to eliminate any risk of mix-up between different drugs, raw materials and to prevent the possibility of cross contamination of one drug by another drug that is manufactured, stored or handled in the same premises.
1.1(H) Health Clothing, Sanitation and Hygiene of Workers.- All workers employed in the Factory shall be free from contagious diseases. The clothing of the workers shall consist of proper uniform suitable to the nature of work and the climate and shall be clean. The uniform shall also include cloth or synthetic covering for hands, feet and head wherever required. Adequate facilities for personal cleanliness such as clean towels, soap and scrubbing brushes shall be provided. Separate provision shall be made for lavatories to be used by men and women, and such lavatories shall be located at places separated from the processing rooms. Workers will also be provided facilities for changing their clothes and to keep their personal belongings.
1.1. (I) Medical Services: The manufacturer shall also provide:-
(a) adequate facilities for first aid;
(b) medical examination of workers at the time of employment and periodical check up thereafter by a physician once a year, with particular attention being devoted to freedom from infections. Records thereof shall be maintained.
1.1(J) Machinery and Equipments – For carrying out manufacturing depending on the size of operation and the nature of product manufactured, suitable equipment either manually operated or operated semi-automatically (Electrical or steam based) or fully automatic machinery shall be made available. These may include machines for use in the process of manufacture such as crushing, grinding, powdering, boiling, mashing, burning, roasting, filtering, drying, filling, labelling and packing etc. to ensure ease in movement of workers and orderliness in operations a suitably adequate space will be ensured between two machines or rows of machines. These equipments have to be properly installed and maintained with proper cleaning. List of equipments and machinery recommended is indicated in Part II-A.
Proper Standard Operational Procedures (SOPs) for cleaning, maintaining and performance of every machine should be laid down.
1.1(K) Batch Manufacturing Records – The licensee shall maintain batch manufacturing record of each batch of Ayurvedic, Siddha and Unani drugs manufactured irrespective of the type of product manufactured (classical preparation or patent and proprietary medicines). Manufacturing records are required to provide an account of the list of raw materials and their quantities obtained from the store, tests conducted during the various stages of manufacture like taste, colour, physical characteristics and chemical tests as may be necessary or indicated in the approved books of Ayurveda, Siddha and Unani mentioned in the First Schedule of the Drugs and Cosmetics Act, 1940 (23 of 1940). These tests may include any in-house or pharmacopoeial test adopted by the manufacturer in the raw material or in the process material and in the finished product. These records shall be duly signed by Production and Quality Control Personnel respectively. Details of transfer of manufactured drug to the finished products store including dates and quantity of drugs transferred along with record of testing of the finished product, if any, and packaging, records shall be maintained. Only after the manufactured drugs have been verified and accepted quality shall be allowed to be cleared for sale.
It should be essential to maintain the record of date, manpower, machine and equipments used and to keep in process record of various shodhana, bhavana, burning and fire and specific grindings in terms of internal use.
1.1(L) Distribution Records – Records of sale and distribution of each batch of Ayurveda, Siddha and Unani Drugs shall be maintained in order to facilitate prompt and complete recall of the batch, if necessary.The duration of record keeping should be the date of expiry of the batch. Certain category of Ayurvedic, Siddha and Unani medicines like Bhasma, Rasa, Kupi-pakva, Parpati, Sindura, Karpu/Uppu/Puram, Kushta, Asava- arishta etc. do not have expiry date in contrast their efficacy increases with the passage of time. Hence, records need be maintained upto five years of the exhausting of stock.
1.1(M) Record of Market Complaints – Manufacturers shall maintain a register to record all reports of market complaints received regarding the products sold in the market. The manufacturer shall enter all data received on such market complaints, investigations carried out by the manufacturers regarding the complaint as well as any corrective action initiated to prevent recurrence of such market complaints shall also be recorded. Once in a period of six months the manufacturer shall submit the record of such complaints to the licensing authority. The Register shall also be available for inspection during any inspection of the premises.
Reports of any adverse reaction resulting from the use of Ayurvedic, Siddha and Unani drugs shall also be maintained in a separate register by each manufacturer. The manufacturer shall investigate any of the adverse reaction to find if the same is due to any defect in the product, and whether such reactions are already reported in the literature or it is a new observation.
1.1(N) Quality Control. – Every licensee is required to provide facility for quality control section in his own premises or through Government approved testing laboratory. The test shall be as per the Auurveda, Siddha and Unani pharmacopoeial standard. Where the tests are not available, the test should be performed according to the manufacturers‘ specification or other information available. The quality control section shall verify all the raw materials, monitor in-process quality checks and control the quality of finished product being released to finished goods store/warehouse. Preferably for such quality control there will be a separate expert. The quality control section shall have the following facilities:–
(1) There should be 150 sq. feet area for quality control section.
(2) For identification of raw drugs, reference books and reference samples should be maintained.
(3) Manufacturing record should be maintained for the various processes.
(4) To verify the finished products, controlled samples of finished products of each batch will be kept till the expiry date of product for 3 years.
(5) To supervise and monitor adequacy of conditions under which raw materials, semi- finished products and finished products are stored.
(6) Keep record in establishing shelf life and storage requirements for the drugs.
(7) Manufacturers who are manufacturing patent and proprietary Ayurveda, Siddha, and Unani medicines shall provide their own specification and control references in respect of such formulated drugs.
(8) The record of specific method and procedure of preparation, that is, “Bhavana”, “Mardana” and “Puta” and the record of every process carried out by the manufacturer shall be maintained.
(9) The standards for identity, purity and strength as given in respective pharmacopoeias of Ayurveda, Siddha and Unani systems of medicines published by Government of India shall be complied with.
(10) All raw materials will be monitored for fungal, bacterial contamination with a view to minimize such contamination.
(11) Quality control section will have a minimum of: –
1[(i) (a) Expert in Ayurveda or Sidha or Unani medicine who possesses a degree qualification recognized under Schedule II of Indian Medicine Central Council Act 1970;
(b) Chemist, who shall possess at least Bachelor Degree in Science or Pharmacy or Pharmacy (Ayurveda), awarded by a recognized University; and
(c) Botanist (Pharmacognosist), who shall possess at least Bachelor Degree in Science (Medical) or Pharmacy or Pharmacy (Ayurveda) awarded by a recognized University.]
(ii) The manufacturing unit shall have a quality control section as explained under Section 35 (ii). Alternatively, these quality control provisions will be met by getting testing etc., from a recognised laboratory for Ayurveda, Siddha and Unani drugs; under Rule 160-A of the Drugs and Cosmetics Act. The manufacturing company will maintain all the record of various tests got done from outside recognised laboratory.
(iii) List of equipments recommended is indicated in Part II C.
1.2. Requirement for Sterile Product:
(A) Manufacturing Areas: – For the manufacture of sterile Ayurvedic, Unani and Siddha drugs, separate enclosed areas specifically designed for the purpose shall be provided. These areas shall be provided with air locks for entry and shall be essentially dust free and ventilated with an air supply. For all areas where aseptic manufacture has to be carried out, air supply shall be filtered through bacteria retaining filters (HEPA Filters) and shall be at a pressure higher than in the adjacent areas. The filters shall be checked for performance on installation and periodically thereafter the record of checks shall be maintained. All the surfaces in sterile manufacturing areas shall be designed to facilitate cleaning and disinfection. For sterile manufacturing routine microbial counts of all Ayurvedic, Siddha and Unani drug manufacturing areas shall be carried out during operations. Results of such count shall be checked against established in-house standards and record maintained.
1. Subs. by G.S.R. 463(E) dated 08-07-2005.
Access to manufacturing areas shall be restricted to minimum number of authorized personnel. Special procedure to be followed for entering and leaving the manufacturing areas shall be written down and displayed.
For the manufacturing of Ayurvedic, Siddha and Unani drug that can be sterilized in their final containers, the design of the areas shall preclude the possibility of the products intended for sterilization being mixed with or taken to be products already sterilized. In case of terminally sterilized products, the design of the areas shall preclude the possibility of mix-up between non-sterile products.
(B) Precautions against contamination and mix:
(a) Carrying out manufacturing operations in a separate block of adequately isolated building or operating in an isolated enclosure within the building,
(b) Using appropriate pressure differential in the process area.
(c) Providing a suitable exhaust system.
(d) Designing laminar flow sterile air system for sterile products.
(e) The germicidal efficiency of UV lamps shall be checked and recorded indicating the burning hours or checked using intensity.
(f) Individual containers of liquids and ophthalmic solutions shall be examined against black-white background fitted with diffused light after filling to ensure freedom from contamination with foreign suspended matter.
(g) Expert technical staff approved by the Licensing Authority shall check and compare actual yield against theoretical yield before final distribution of the batch.
All process controls as required under master formula including room temperature, relative humidity, volume filled, leakage and clarity shall be checked and recorded.
PART II
A. LIST OF RECOMMENDED MACHINERY, EQUIPMENT AND MINIMUM MANUFACTURING PREMISES REQUIRED FOR THE MANUFACTURE OF VARIOUS CATEGORIES OF AYURVEDIC, SIDDHA SYSTEM OF MEDICINES
One machine indicated for one category of medicine could be used for the manufacturing of other category of medicine also. Similarly some of the manufacturing areas like powdering, furnace, packing of liquids and Avaleha, Paks, could also be shared for these items.
| Sl.No. |
Category of Medicine |
Minimum manufacturing space required |
Machinery/equipment recommended |
| (1) |
(2) |
(3) |
(4) |
|
|
1200 Square feet covered area with separate cabins or partitions for each activity. If Unani medicines are manufactured in same premises an additional area of 400 sq. feet will be required. |
|
| 1. |
Anjana/Pisti |
100 sq. feet. |
Karel/mechanized/motorized, karel. End runner/Ball-Mill Sieves/Shifter |
| 2. |
Churna / Nasya/ Manjan/Lepa/ Kwath Churn |
200 sq feet |
Grinder/disintegrator/Pulveriser/Powder mixer/sieves/shifter. |
| 3. |
Pills/Vati /Gutika Matirai and tablets |
100 sq. feet |
Ball Mill, Mass mixer/powder mixer, Granulator, drier, tablet compressing machine, pill/vati cutting machine, stainless steel trays/container for storage and sugar coating, polishing pan in case of sugar-coated tablets,mechanised chattoo (for mixing guggulu) where required. |
| 4. |
Kupi pakava/Ksara/ Parpati/LavanaBhasm a Satva/Sindura Karpu/ Uppu / Param |
150 sq. feet |
Bhatti, Karahi/Stainless steel Vessels/Patila Flask, Multani Matti/Plaster of Paris, Copper Rod, Earthern container, Gaj Put Bhatti, Mufflefurnace(Electrically operated) End/EdgeRunner, Exhaust Fan, Wooden/S.S.Spatula. |
| 5. |
Kajal |
100 sq. feet |
Earthern lamps for collection of Kajal, Triple Roller Mill, End Runner, Sieves, S.S.Patila, Filling/ packing and manufacturing room should be provided with exhaust fan and ultra violet lamps |
| 6. |
Capsules |
100 sq. feet |
Air Conditioner, De-humidifier, hygrometer, thermometer, Capsule filling machine and chemical balance. |
| 7. |
Ointment/Marham Pasai |
100sq. feet |
Tube filling machine, Crimping Machine/Ointment Mixer, End Runner/ Mill (Where required) S.S. Storage Container S.S.Patila. |
| 8. |
Pak/Avaleh/Khand/ Modak/Lakayam |
100 sq. feet |
Bhatti section fitted with exhaust fan and should be fly proof, Iron Kadahi/S.S. Patila and S.S. Storage container. |
| 9. |
Panak, Syrup / Pravahi Kwath Manapaku |
150 sq, feet |
Tincture press, exhaust fan fitted and fly proof, Bhatti section, Bottle washing machine, filter press / Gravity filter, liquid filling machine P.P. Capping Machine |
| 10. |
Asava / Arishta |
200 sq. ft. |
Same as mentioned above. Fermentation tanks, containers and distillation plant where necessary, Filter Press. |
| 11. |
Sura |
100 sq. ft. |
Same as mentioned above plus Distillation plant and Transfer pump. |
| 12. |
Ark Tinir |
100 sq. ft |
Maceration tank, Distillation plant, Liquid filling tank with tap / Gravity filter/Filter p ress, Visual inspection box |
| 13. |
Tail/Ghrit Ney |
100 sq. ft. |
Bhatti, Kadahi/S.S. Patila S.S.Storage Containers, Filtration equipment, filling tank with tap/Liquid filling machine. |
| 14. |
Aschyotan / Netra Malham Panir/Karn Bindu/Nasabindu |
100 sq. ft. |
Hot air oven electrically heated with thermostatic control, kettle gas or electrically heated with suitable mixing arrangements, collation mill, or ointment mill, tube filling equipment, mixing and storage tanks of stainless steel or of other suitable material sintered glass funnel, seitz filter or filter candle, liquid filling equipment, autoclave. |
| 15. |
Each manufacturing unit will have a separate area for Bhatti, furnace boilers, puta, etc. This will have proper ventilation, removal of smoke, prevention of flies, insets, dust etc. The furnace section could have tin roof |
200 sq. ft |
|
B. LIST OF MACHINERY, EQUIPMENT AND MINIMUM MANUFACTURING PREMISES REQUIRED FOR THE MANUFACTURE OF VARIOUS
CATEGORIES OF UNANI SYSTEM OF MEDICINES
One machine indicated for one category of medicine could be used for the manufacturing of other category of medicine also. Similarly some of the manufacturing areas like powdering, furnace, packing of liquids could also be shared for these items.
| Sl.No. |
Category of Medicine |
Minimum manufacturing space required |
Machinery/equipment recommended |
| (1) |
(2) |
(3) |
(4) |
|
|
1200 square feet covered area with separate cabins, partitions for each activity. If Ayurveda / Siddha medicines are also manufactured in same premises an additional area of 400 square feet will be required. |
|
| 1. |
Itrifal Tirya/majoon/ Laooq/Jawarish Khamiras |
100 sq. feet |
Grinder/ Pulveriser, Sieves, powder mixer (if required), S.S. Patilas, Bhatti and other accessories, plant mixer for Khamiras. |
| 2. |
Arq. |
100 sq. feet |
Distillation Plant (garembic) S.S. storage tank, Boiling Vessel, Gravity filter, Bottle filling machine, Bottle washing machine, Bottle drier |
| 3. |
Habb (Pills) and tablets. |
100 sq. feet |
Ball Mill, Mass Mixer/Powder mixer, Granulator drier, tablet compressing machine, pill/vati cutting machine, stainless steal trays/ container for storage and sugar coating, polishing pan in case of sugar-coated tablets, mechanized chattoo, (for mixing guggul) where required. |
| 4. |
Sufoof (Powder) |
200 sq. feet |
Grinder / pulveriser, Sieves, Trays, Scoops, Powder mixer (where required). |
| 5. |
Raughan (oils) (Crushing and boiling) |
100 sq. feet |
Oil Expeller, S.S. Patilas Oil filter bottle, Filling machine, Bottle drier, Bhatti. |
| 6. |
Shiyaf, Surma, Kajal |
100 sq. feet |
End runner, mixing S.S. Vessel.. |
| 7. |
Marham, Zimad (Ointment) |
100 sq. feet |
Kharal, Bhatti, End runner, Grinder, Pulveriser, Triple Roller Mill (if required) |
| 8. |
Qurs (Tab.) |
100 sq. feet |
Grinder/Pulveriser, Sieves, Powder mixer (where needed), Granulator, Drier, Tablet Compressing Machine, Die punches Trays, O.T. Apparatus, Balance with weights, Scoops, Sugar Coating Pan, polishing pan, Heater. |
| 9. |
Kushta |
100 sq. feet |
Bhatti, Kharal, Sil Batta, Earthen pots. |
| 10. |
Murabba |
100 sq. feet |
Aluminium Vessels 50-100kgs. Capacity, Gendna, Bhatti. |
| 11. |
Capsule |
100 sq. feet |
Pulveriser, Powder mixer (where needed), capsule filling machine, Air conditioner, Dehumidifier, Balance with weights, storage containers, glass. |
| 12. |
Sharbat and Joshanda |
100 sq. feet |
Tinctum Press, exhaust fan fitted, Bhatti section, Bottle washing machine, Filter Press Gravity filter, Liquid filling tank with tap/liquid filling machine, hot air oven electrically heated with thermostatic control, kettle. |
| 13. |
Qutoor-e- Chashm and Marham(Eye drops, eye ointment) |
100 sq. feet |
Hot air oven electrically heated with thermostatic control, kettle |
| 14. |
Each manufacturing unit will have a separate area for Bhatti, furnaces, boilers, putta,etc. This will have proper ventilation,removal of smoke, prevention of flies, insects, dust, etc. |
200 sq. feet |
|
C. LIST OF EQUIPMENT RECOMMENDED FOR IN-HOUSE QUALITY CONTROL SECTION
(Alternatively, unit can get testing done from the Government approved laboratory).
| (A) |
CHEMISTRY SECTION |
(B) |
PHARMACOGNOSY SECTION |
| 1. |
Alcohol Determination Apparatus (complete set) |
1. |
Microscope Binoculor. |
| 2. |
Volatile Oil Determination Apparatus. |
2. |
Dissecting Microscope. |
| 3. |
Boiling Point Determination Apparatus. |
3. |
Microtome |
| 4. |
Melting Point Determination Apparatus. |
4. |
Physical Balance |
| 5. |
Refractometer. |
5. |
Aluminium Slide Trays |
| 6. |
Polarimeter. |
6. |
Stage Micrometer. |
| 7. |
Viscometer. |
7. |
Camera Lucida (Prism and Mirror Type) |
| 8. |
Tablet Disintegration Apparatus. |
8. |
Chemicals, Glassware etc. |
| 9. |
Moisture Meter |
|
|
| 10. |
Muffle Furnace. |
|
|
| 11. |
Electronic Balance. |
|
|
| 12. |
Magnetic Stirrer. |
|
|
| 13. |
Hot Air Oven. |
|
|
| 14. |
Refrigerator. |
|
|
| 15. |
Glass/Steel Distillation Apparatus. |
|
|
| 16. |
LPG Gas Cylinders with Burners |
|
|
| 17. |
Water Bath (Temperature controlled.) |
|
|
| 18. |
Heating Mantles/ Hot Plates. |
|
|
| 19. |
TLC Apparatus with all accessories (Manual) |
|
|
| 20. |
Paper Chromatography apparatus with accessories |
|
|
| 21. |
Sieve size 10 to120 with Sieve shaker |
|
|
| 22. |
Centrifuge Machine. |
|
|
| 23. |
Dehumidifier. |
|
|
| 24. |
pH Meter. |
|
|
| 25. |
Limit Test Apparatus. |
|
|
1[D. SUPPLEMENTARY GUIDELINES FOR MANUFACTURING OF RASAUSHADHIES OR RASAMARUNTHUKAL AND KUSHTAJAT (HERBO- MINERAL-METALLIC COMPOUNDS) OF AYURVEDA, SIDDHA AND UNANI MEDICINES
These guidelines are intended to complement those provided above and should be read in conjunction with the parent guidelines. The supplementary guidelines are to provide general and minimum technical requirements for quality assurance and control in manufacturing Rasaushadhis or Rasamarunthukal and Kushtajat (Herbo-mineral-metallic formulations). These supplementary guidelines deal with Bhasmas, Sindura, Pishti, Kajjali, Khalviya Ras, Kupipakwa, Rasayan, Parpati, Potali Rasa, Satwa (of Metals and Minerals origin) Druti Parpam, Karpu, and Kushta etc. used in Ayurvedic, Siddha and Unani Systems of medicine.
The supplementary GMP guidelines for Rasaushadhi or Rasamarunthukal and Kushtajat are needed to establish the authenticity of raw drug, minerals and metals, in- process validation and quality control parameters to ensure that these formulations are processed and prepared in accordance with classical texts and for which safety measures are complied. Only those manufacturing units which have Good Manufacturing Practices for ASU drugs and supplementary certificate for Rasaushadhi or Rasamarunthukal and Kushtajat formulations shall be allowed to manufacture th e same. Supplementary Good Manufactur ing Pr actices Certificate for Rasaushadhies shall be issued by the State Licensing Authority only after thorough inspection by an expert team including Rasashastra experts nominated by the Department of AYUSH.
2. Manufacturing Process Areas :-
For the manufacture of Bhasma and Kupipakawa and Rasaushadhi preparations made from metals and minerals the following specific areas shall be provided, which should be completely segregated from the production area used for preparation of plants and animal by product based formulation to avoid cross contamination. The following exclusive areas the required for Rasaushadhies or Rasamarunthukal and Kushtajat:-
2.2 (a) Bhatti or Heating Device Section for Bhasma and Rasaushadhies :- 100 sq. feet for heating, burning, putta and any heat related work with proper ventilation, exhaust and chimney. This could be tin shed also.
1. Ins. By G.S.R. 157(E), dated 04-03-2009
(b) Grinding, Drying and Processing Section for Bhasma and Rasaushadhies:- 100 Sq. feet (Manual or Mechanical, oven etc.). Drying 1[Shall be] done in a space which is covered by glass or other transparent material to allow entry of sunrays on the material to keep for the purpose. If drying is being done in oven the temperature of the same may be selected specific temperature.
(c) Rashaushadi Related Store :-100 Sq. feet.
The size and dimensions of each Bhatti Section would be so designed to suit the batch size or quantity of materials to be processed, keeping in mind the processing is done as per the conditions of Drug and Cosmetics Act mentioned under Schedule I official books.
In addition to the fuels prescribed in the schedule books namely coal, fire wood, cow dung cakes etc., use of other heating devices e.g. electrical heating, oil or gas fired furnaces and others Shall be] employed so as to provide the required temperature as per the nature of material and object of heating. Depending on the formulation being manufactured, manufacturers may adopt aerobic or anaerobic process. Properly baked and clean earthen pots of other crucibles and glass containers of appropriate design shall be used.
The manufacturing area should be designed with special attention to process the products that generate toxic fumes like SO2, arsenic and mercury vapor, etc. When heating and boiling of the materials is necessary, suitable ventilation and air exhaust flow mechanism should be provided to prevent accumulation of unintended fumes and vapors. Such areas may be provided with properly designed chimneys or ducts fitted with exhaust system and suitable scrubbing system to remove fumes and smoke, so that safety of personnel and environment is taken care of.
Since processing of Rasaushadhis may introduce heavy metal contamination and cross contamination etc., therefore, cleaning of equipment is particularly important after every process by using appropriate cleaning agent which should not react with material of equipment and must be free from unwanted properties e.g. corrosiveness.
2.3 Records shall be maintained specially for temperatures attained during the entire process of Bhasmikaran, while employing different kinds of classical puta, furnaces using oil, gas or electricity. Appropriate temperature measuring instrument should be employed such as pyrometer and, pyrograph for manual reading or recording by heat sensors, connected to computer as the case may be.
In order to handle large quantities, appropriate technology like use of hand operated extruders for making chakrikas or pellets may be adopeted. However, such equipments made of aluminium or its alloys should not be used.
1. Subs. by G.S.R.Subs. by G.S.R.338(E), dated 15-04-2010.
Access to manufacturing areas shall be restricted to minimum number of authorized personnel only.
3. Quality Control :-
A. Inprocess Quality Control :-
The registers as indicated below should exclusively be maintained for ready reference :-
(a) Shodhan Register with following details :-
1. Sl No.
2. Batch No. and Size
3. Date, time and duration
4. Name of the Raw-material with Quality reference and quantity
5. Quantity of Shodhana Dravya
6. Book Reference followed
7. Methodology
(b) Bhavana and Putta Register with following details :-
1. Sl No.
2. Batch No.
3. Date, time
4. Name of the material and quantity of starting materials
5. Quantity of Nirvapya Dravya
6. Quantity of Bhavana Dravya
7. Date and time of Starting and completion of Bhavana or Mardana and duration
8. Type and Number of Puttas
9. Time and Date of completion of Puttas
10. Color and texture of the product or standards
11. Inprocess tests followed (Bhasma Pariksha and any other tests)
12. In case heating at a particular temperature is required, record of attainment of that temperature.
(c) Grinding Record Register:- (Finished Product / Intermediate procedure)
1. Sl. No.
2. Batch No.
3. Date and time
4. Name of the material and quantity
5. Name of the equipment (SS/granite)
6. Duration of grinding
7. Repeat the grinding if required (Number of repetition)
(d) Packing details:-
1. Name of Rasaushadhi
2. Type of Dosage Form (eg. Powder, pill, tablet etc)
3. Weight of Rasaushadhi in each unit
B. Product Quality Control:-
The specifications for finished Rasaushadhi are primarily intended to define the quality rather than to establish full characterization, and should focus on those characteristics found to be useful in ensuring the quality. Consistent quality for Rasaushadhi can only be assured if the starting material-metals and minerals are used of pharmacopoeial standards. In some cases more detailed information may be needed on aspects of their process. The manufacturer will ensure in-house standards for the uniform quality of product.
Quality testing will be carried out as per official Pharmaceutica or Schedule books for texts namely, color, taste, varitaratwa, Rekhapurnatwa, Laghutva, Nirdhumatwa, Dntagre Kachakacha, Niruttha, Apunarbhava and Nischandratwa.
The Particle size of the product should be tested by adopting microscope fitted with micrometer or particle size analyzer or any appropriate other techniques. Required physio- chemical characterization of the product should be undertaken by appropriate analytical equipment. The Standard Manufacturing Process of the product should be evolved/follow up. The disintegration time of pills-vati and tablets should also be recorded.
4. Product recalls:- Literature inserted inside the product package should indicate the name, address of the manufacturing unit 1[and] telephone number for reporting of any adverse drug reaction by physicians or patients. On receipt of such Adverse Drug Reaction report, it will be the responsibility of the manufacturer to ensure the recall of the product from the market.
Standard Operating Procedures (SOP) should be included for storage of recalled Rasaushadhies in a secure segregated area, complying with the requirements specified for storage till their final disposal.
5. Medical examination of the Employees:- Employees engaged in manufacturing should be medially examined periodically at least once a year for any adverse effect of the drug during manufacturing process for which necessary investigations 1[Shall be] carried out for ensuring that there is no effect of material on the vital organs of the employees. Annual examination reports of the employees shall be made available to statutory inspectors during Good Manufacturing Practices inspections.
6. Self-Inspection:- The release of Rasaushadhis should be under the control of a person who has been trained in the specific features of the processing and quality assurance of Rasaushadhis. Personnel dealing with the production and quality assurance of Rasaushadhis manufacturing section should have an adequate training in the specific subject of Rasaushadhis manufacturing. He will be at least a degree holder in Ayurvedic, Siddha / Unani medicines or B.Pharma degree holder in Ayurvedic / Siddha / Unani medicines.
1. Subs. by G.S.R. 338(E) dated 15-04-2010.
7. Dosage form of Rasaushadhis:- The Rasaushadhis may be made into an acceptable dosage forms such as churna, vati, guti, tablet or capsules etc. after adding suitable permissible fillers or binding agents as permissible under the Ayurvedic Pharmacopoeia of India or Indian pharmacopoeia as updated from time to time. In such cases the label must indicate the quantity of Ayurveda, Siddha and Unani medicines in one Tablet or Pill or Capsule in addition to the filler. The crystalline product may be grinded before packing in the individual dispensing size. All the Rasaushadhis or Rasamaruthukal or Kushtajat shall be packed in a dosage form which is ready for use for the consumer. Grinding and weighing of individual dose of potentially poisonous products will not be permissible in patient consumer pack. This arrangement may reduce the Adverse Drug Reaction of Rasaushadhi which takes place due to dose variation. However, for hospital bulk pack, it will not be applicable and label will clearly indicate the “Hospital pack.”
8. Area Specifications/ requirement for an applicant companies only to have GMP of Rasaushadhis or Rasamarunthukal and Kushtajat (Herbomineral/metallic compounds) of Ayurveda, Siddha and Unani medicines:-
1. Subs. by G.S.R. 338(E) dated 15-04-2010
| Sr. No. |
Category of Medicine / Manufacturing area |
Minimum Manufacturing space required (1500 sq. ft.) |
Machinery equipme recommended |
| 1. |
Pisti / grinding area for Bhasma, Pishti, Kushtajat |
100 sq. ft. |
Kharal/mechanized/motorized Kharal,End runner / Ball-Mill Sieves / Sifter. |
| 2. |
Powdering area for raw drugs of plant origin giving in Rasaushadhis (Herbo-metalic formulations) |
200 sq. ft. |
Grinder / Distintegrator /Pulverisor / Powder mixer / Sieves / Sifter |
| 3. |
Pills / Vati/ Gutika Matrica and tablets / Habb making area |
100 sq. ft. |
Ball Mills, Mass Mixer/Powder mixer, Granulator, drier, tablet compressing machine, pill/ vati cutting machine, stainless steel trays / container for storage and sugar coating, polishing pan in case of sugar coated tablets, mechanized chatoo, (for mixing of guggulu) where required. |
| 4. |
Kupi pakva / Ksara / Parpati / Lavana Bhasma Satva / Sindura Kapu / Uppa / Param / Qushta / Jawhar |
150 sq. ft. |
Bhatti, Karahi / stainless steel vessels /patila flask, Multani Matti / Plaster of Paris, Copper Rod, Earthen container, Gaj Put Bhatti, Muffle furnace (electrically operated) End / Edge Runner, Exhaust Fan, Wooden, S.S. Spatula. |
| 5. |
Receiving and storing raw material |
200 sq. ft. |
|
| 6 |
Quality Control Section |
150 sq. ft. |
|
| 7. |
Quarantine / observation |
50 sq. ft. |
|
| 8 |
Finished goods store |
150 sq. ft. |
|
| 9 |
Rejected goods store |
50 sq. ft. |
|
| 10. |
Bhatti-putta area |
200 sq. ft. |
|
| 11. |
Area for water and washing etc |
50 sq. ft. |
|
| 12. |
Office |
100 sq. ft. |
|
|
TOTAL |
1500 sq. ft. |
|
Note : The above requirements of machinery, equipments, space are made subject to the modification at the discretion of the Licensing Authority; if he is of the opinion that having regard to the nature and extent of the manufacturing operations it is necessary to relax or alter them in the circumstances in a particular case, 1[he may do so after recording reasons in writing]].
1. Added by G.S.R.463(E), dated 08-07-2005
1[Schedule TA
(See rule 157 A)
FORM FOR RECORD OF UTILIZATION OF RAW MATERIAL BY AYURVEDA OR SIDDHA OR UNANI LICENSED MANUFACTURING UNITS DURING THE FINANCIAL YEAR
Identification Particulars:
Manufacturing License No ……………………………..
Issued by…………………………………………………………
Name: ……………………………………..
Address: ………………………………….
State: ……………………………………… Pin Code: ………………………………………………………….
Telephone:……………………………….. Fax: ……………………………………………………………….
Email: …………………………….
1. Quantity of Medicinal Plants/Extracts/Essential Oils/Metals/Animal By-Products Minerals Used During 1st April, to 31st March of the preceeding year (For Productions at the identified facility)
(a) Herbs Used
| Common Name as in AFI/API* |
Plant’s Botanical Name |
Quantity Used/per annum (in Kgs.) |
Sources of Supply |
Part Used |
|
|
|
Traders/ Manufacturers |
Forest Collectors |
Cultivators |
Imported |
Total |
Whole plans |
Root |
Leaf |
Others |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
*Ayurvedic Formulary of India/Ayurvedic Pharmacopoeia of India
(b) Extracts Used
| Name of Extracts |
Quantity Used/per annum (in Kgs.) |
Sources of Supply |
| Common Name |
Biological/Chemical Name (if any) |
|
In-House |
Export Suppliers |
Importers |
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
* Ayurvedic Formulary of India/Ayurvedic Pharmacopoeia of India
(c) Metals/Minerals Used
| Name of Mineral |
Quantity Used/per annum (in Kgs.) |
Sources of Supply |
| Common Name |
Biological/Chemical Name (if any) |
|
Manufacturers Traders (Domestic) |
Importers |
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1. Ins. By G.S.R. 512 (E), dated 09-07-2008
(d) Animal By-Products Used
| Name of By-Product |
Quantity Used/per annum (in Kgs.) |
Sources of Supply |
| Common Name |
Biological/Chemical Name (if any) |
|
Manufacturers Traders (Domestic) |
Importers |
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2. Shortage of raw material(s)/inputs during the preceeding year.
Y N
If yes, please indicate name(s) of such raw material(s) by level of importance starting from most important to least important, reason for shortage [availability, quality or any other (please specify)]
| Name of Raw Materials |
Appro. Qty of shortage (in Kgs.) |
Reason |
| Name of the drug and part used as mentioned in official formulary / Pharmacopoeial/ Schedue I books |
Biological/ Chemical Name (if any) |
|
|
1[SCHEDULE U
(See rules 74, 74A, 74B, 78 and 78A)
I. PARTICULARS TO BE SHOWN IN MANUFACTURING RECORDS
A. SUBSTANCES, OTHER THAN PARENTERAL PREPARATIONS IN GENERAL.
1. Serial number
2. Name of the product
3. Reference of Master Formula Records.
4. Lot/Batch Size.
5. Lot/Batch Number.
6. Date of commencement of manufacture and date of completion of manufacture and assigned date of expiry.
7. Name of all ingredients, specifications quantities required for the lot/Batch size and quantities actually used. All weighings and measurements shall be carried out by a responsible person and initialled by him and shall be counter-checked and signed by the competent technical staff under whose personal supervision the ingredients are used for manufacture.
8. Control Numbers of raw materials used in the formulation.
9. Date, time and duration of mixing.
10. Details of environmental controls like room temperature, relative humidity. 11.Date of granulation, wherever applicable.
12. Theoretical weight and actual weight of granules/powder blend.
13. Records of in-processes controls (Periodically whenever necessary):
(a) Uniformity of mixing.
(b) Moisture content of granules/powder in case of Tablet/Capsules.
(c) pH of solution in case of liquid.
(d) Weight variation.
(e) Disintegration time.
1. Subs. by G.S.R. 735(E) dated 24-06-1988
(f) Hardness
(g) Friability test
(h) Leak test in case of strip packing.
(i) Filled volume of liquids.
(j) Quantity of tablets/capsules in the final container.
(k) Content of ointment in the filled containers.
14. Date of compression in case of Tablets/date of filling in case of capsules.
15. Date of sealing/coating /polishing in case of capsules/tablets wherever applicable.
16. Reference to analytical Report number stating the result of test and analysis.
17. Separate records of the disposal of the rejected batches and of batches withdrawn from the market.
18. The theoretical yield and actual productions yield and packing particulars indicating the size and quantity of finished packings.
19. Specimen of label/strip, carton with batch coding information like Batch Number, date of manufacture, date of expiry, retail price as applicable stamped thereon and inserts used in the finished packings.
20. Signature with date of competent technical staff responsible for the manufacture.
21. Counter-signature of the head of the testing units or other approved person-in-charge of testing for having verified the batch records and for having released and batch for sale and distribution, the quantity released and date of release.
22. Date of release of finished packings and quantity released for sale and distribution.
23. Quantity transferred to warehouse.
24. For Hypodermic tablets and ophthalmic preparations, which are required to be manufactured under aseptic conditions, records shall be maintained indicating the precautions taken during the process of manufacture to ensure that aseptic conditions are maintained.
B. PARENTERAL PREPARATIONS.
1. Serial number.
2. Name of the product.
3. Reference of the master formula record.
4. Batch /Lot size.
5. Batch No. and/or Lot No.
6. Date of commencement of manufacture and date of completion.
7. Names of all ingredients, specifications and quantity required for the Lot/Batch size and quantity actually used. All weighings and measurements shall be carried out by a responsible person and initialled by him and shall be countersigned by the technical staff under whose personal supervision the stock are issued and by another competent technical staff under whose supervision the ingredients are used for manufacture.
8. Control numbers of raw materials used in the formulation.
9. Date, time and duration of mixing.
10. Details of environmental controls like temperature, humidity, microbial count in the sterile working areas.
11. pH of the solution, wherever applicable.
12. Date and method of filtration.
13. Sterility test, reference on bulk batch wherever applicable.
14. Record of check on volume filled.
15. Date of filling.
16. Records of tests employed:-
(a) To ensure that sealed ampoules are leak proof
(b) To check the presence of foreign particles.
(c) Pyrogen test, wherever applicable
(d) Toxicity test, wherever applicable.
17. Records of checking of instruments and apparatus of sterilization (indicators).
18. Records of cleaning and sterilization of containers and closures, if necessary.
19. Records of sterilization in case of parenteral preparations which are heat sterilized including particulars of time, temperature and pressure employed. Such records should be marked to relate to the batch sterilized.
20. Number and size of containers filled and quantity rejected.
21. The theoretical yield and actual yield and the percentage yield thereof.
22. Reference to Analytical report numbers stating whether of standard quality or otherwise.
23. Specimen of labels, cartons, etc. with Batch coding information like batch number, date of manufacture, date of expiry, as applicable, stamped thereon, and inserts used in the finished packings.
24. Signature with date of the component technical staff responsible for manufacture.
25. Particulars regarding the precautions taken during the manufacture to ensure that aseptic conditions are maintained.
26. Countersignature of head of the testing unit or person in charge of testing for having verified the documents and for having released the product for sale and distribution, the quantity released and date of release.
27. Records for having transferred to warehouse giving packings and quantities.
28. Separate records of the disposal of the rejected batches and of all batches withdrawn from the market.
29. Records of reprocessing if any and particulars of reprocessing.
II. RECORDS OF RAW MATERIALS
Records in respect of each raw material shall be maintained indicating the date of receipt, invoice number, name and address of the manufacturer/supplier, batch number, quantity received, pack size, date of manufacture, date of expiry, if any, date of analysis and release/rejection by quality control, analytical report number with special remarks, if any, quantity issued, date of issue and the particulars of the name and batch numbers of products for the manufacture of which issued and the proper disposal of the stocks.
III. PARTICULARS TO BE RECORDED IN THE ANALYTICAL RECORDS
A. TABLETS AND CAPSULES.
1. Analytical report number.
2. Name of the sample.
3. Date of receipt of sample.
4. Batch/Lot number.
5. Protocols of tests applied.
(a) Description.
(b) Identification.
(c) Uniformity of weight.
(d) Uniformity of diameter (if applicable).
(e) Disintegration test (time in minutes).
(f) Any other tests.
(g) Results of Assay.
Note: Records regarding various tests applied (including readings and calculations) should be maintained and necessary reference to these records should be entered in Col. 5 above whenever necessary.
6. Signature of the Analyst.
7. Opinion and signature of the approved Analyst.
B. PARENTERAL PREPARATIONS.
1. Analytical report number.
2. Name of the sample.
3. Batch number.
4. Date of receipt of samples.
5. Number of containers filled.
6. Number of containers received.
7. Protocols of tests applied.
(a) Clarity.
(b) pH wherever applicable.
(c) Identification.
(d) Volume in container.
(e) Sterility –
(i) Bulk sample wherever applicable
(ii) container sample.
(f) Pyrogen test, wherever applicable.
(g) Toxicity test, wherever applicable.
(h) Any other tests.
(i) Results of Assay.
Note: Records regarding various tests applied (including readings and calculations) should be maintained and necessary reference to these records should be entered in Col. 7 above, wherever necessary.
8. Signature of the Analyst.
9. Opinion and signature of the approved Analyst.
PYROGEN TEST:
1. Test Report Number.
2. Name of the sample.
3. Batch Number.
4. Number of rabbits used.
5. Weight of each rabbit.
6. Normal temperature of each rabbit.
7. Mean initial temperature of each rabbit.
8. Dose and volume of solution injected into each rabbit and time of injection.
9. Temperature of each rabbit noted at suitable intervals.
10. Maximum temperature.
11. Response.
12. Summed response.
13. Signature of the Analyst.
14. Opinion and signature of the approved Analyst.
TOXICITY TEST
1. Test Report Number.
2. Name of the sample.
3. Batch Number.
4. Number of mice used and weight of each mouse.
5. Strength and volume of the drugs injected.
6. Date of injection.
7. Results and remarks.
8. Signature of Analyst.
9. Opinion and signature of the approved Analyst.
C. FOR OTHER DRUGS
1. Analytical report number.
2. Name of the sample.
3. Batch/Lot number.
4. Date of receipt of sample.
5. Protocol of tests applied.
(a) Description.
(b) Identification.
(c) Any other tests.
(d) Results of Assay.
Note: Particulars regarding various tests applied (including readings and calculations) shall be maintained and necessary reference to these records shall be entered in Column 5 above, wherever necessary.
6. Signature of Analyst.
7. Opinion and signature of the approved Analyst.
D. RAW MATERIALS
1. Serial number.
2. Name of the materials.
3. Name of the manufacturer/supplier.
4. Quantity received.
5. Invoice/Challan number and date.
6. Protocols of tests applied.
Note: Particulars regarding various tests applied (including readings and calculations) shall be maintained and necessary reference to these records shall be entered in Column 6 above, wherever necessary.
E. CONTAINER, PACKING MATERIALS ETC.
1. Serial number.
2. Name of the item.
3. Name of the manufacturer/supplier.
4. Quantity received.
5. Invoice/Challan number and date
6. Results of tests applied.
Note: Particulars regarding various tests applied shall be maintained and necessary reference to these records shall be entered in Column 6 above, wherever necessary
7. Remarks.
8. Signature of the examiner.
Notes: 1. The foregoing provisions represent the minimum requirements to be complied with by the licensee. The Licensing Authority may, however, direct the nature of records to be maintained by the licensee for such products as are not covered by the categories described above.
2. The Licensing Authority may permit the licensee to maintain records in such manner as are considered satisfactory, provided the basic requirements laid down above are complied with.
3. The Licensing Authority may at its discretion direct the licensee to maintain records for such additional particulars as it may consider necessary in the circumstances of a particular case.]
1[SCHEDULE U(I)
(See rules 142 and 142B)
I. PARTICULARS TO BE SHOWN IN THE MANUFACTURING RECORDS:
1. Serial number.
2. Name of the product.
3. Lot/Batch size.
4. Lot/Batch number.
5. Date of commencement of manufacture and date when manufacture was completed.
6. Names of all ingredients, quantities required for the lot/batch size, quantities actually used.
7. Control reference numbers in respect of raw materials used in formulation.
8. Reference to analytical report numbers.
9. Actual production and packing particulars indicating the size and quantity of finished packings.
10. Date of release of finished packing for distribution or sale.
11. Signature of the expert staff responsible for the manufacture.
II. RECORDS OF RAW MATERIALS:
Records in respect of each raw material shall be maintained indicating the quantity received, control reference number, the quantity issued from time to time, the names and batch numbers of the products for the manufacture of which the said quantity of raw material has been issued and the particulars relating to the proper disposal of the stocks.
Notes: (1) The Licensing Authority may permit the licensee to maintain records in such manner as is considered satisfactory, provided the basic requirements laid down above are complied with.
(2) The Licensing Authority may direct the licensee to maintain records for such additional particulars, as it may consider necessary in the circumstances of a particular case.]
2[SCHEDULE V
( See rule 124B)
STANDARDS FOR PATENT OR PROPRIETARY MEDICINES
3 [***]
4[2. Standards for patent or proprietary medicines, containing vitamins: Patent or proprietary medicines containing vitamins for prophylactic, therapeutic or paediatric use shall contain the vitamins in quantities not less than and not more than those specified below in single or in two divided daily doses, namely:- [see table below].
3 [***]
5[4. General Standards for Different Categories of Patent or Proprietary Medicines. – In the case of pharmaceutical products containing several active ingredients, the selection shall be such that the ingredients do not interact with one another and do not affect the safety and therapeutic efficacy of the product. The combination shall not also lead to analytical difficulties for the purpose of assaying the content of such ingredient separately. The substances added as additives shall be innocuous, shall not affect the safety or therapeutic efficacy of the active ingredients, and shall not affect the assays and identity tests in the amount present.]
1. Added by G.S.R. 1594, dt. 28-10-1976.
2. Added by G.S.R. 665, dt. 06-05-1977.
3. Omitted. G.S.R. 56(E) ,dt. 22.1.1992.
4. Added by G.S.R. No. 930 ,dt. 13-7-1978.
5. Ins. by. G.S.R. 792(E) ,dt. 17.9.1987.
Subject to the provisions of these rules, patent or proprietary medicines shall comply with the following standards, namely:-
1. Patent or proprietary medicines shall comply with the general requirements of the dosage form under which it falls as given in the Indian Pharmacopoeia. If the dosage form is not included in the Indian Pharmacopoeia, but is included in any other pharmacopoeia, prescribed for the purpose of the Second Schedule to the Act, it shall comply with the general requirements of the dosage of such pharmacopoeia. Without prejudice to the generality of the foregoing requirements, general requirements shall include compliance with colour consistency, clarity, stability, freedom from contamination with foreign matter or fungal growth, defects like chipping and capping of tablets, cracking of the coating, mottled appearance and other characteristic defects that can be perceived by visual inspection.
2. Without prejudice to the generality of the following paras, dosage forms of patent or proprietary medicines shall comply with the following requirements, namely:-
(a) Tablets: Medicines shall comply with requirements for tablets as laid down in the Indian Pharmacopoeia. The nature of coating shall be indicated on the label. Permitted colours may, however, be added and declared on the label. Nature of tablets, such as uncoated, sugar coated or film coated, shall be declared on the label.
1[***]
(b) Capsules : Medicines shall comply with the requirements for capsules laid down in the Indian Pharmacopoeia. However, the capsules shall be free from distortion or shape, dis- colouration and other physical defects like leakage of powder from joints, pinholes or cracks in the capsules;
(c) Liquid oral dosage forms: Emulsions and suspensions shall disperse uniformly on shaking. Homogeneous solutions shall contain no sediments. The volume of the product (net content) in the container shall be not less than the labelled volume. The limit for ethanol content of pharmaceutical products shall be not less than 90 per cent and not more than 110 per cent of the labelled contents.
(d) Injections: Medicines shall comply with the requirements for injections as laid down in the Indian Pharmacopoeia.
(e) Ointments: Medicines shall comply with the requirements for injections as laid down in the Indian Pharmacopoeia.
3. The content of active ingredients, other than vitamins, enzymes and antibiotics, in patent or proprietary medicines shall be not less than 90 per cent and not more than 110 per cent of the labelled content; however, for enzymes and vitamins, only for lower limit of 90 per cent shall apply. In all dry formulations containing antibiotics, the limit shall be 90 to 130 per cent of the labelled contents and in case of liquid antibiotic formulations, the limit shall be 90 to 140 per cent of labelled contents.
Fiducial limits for error for microbiological assay of antibiotics may be estimated depending upon the design of assay procedure. Methods, used for assaying active ingredients shall employ the same basic principles and shall use same organisms as given in the latest edition of the Indian Pharmacopoeia or shall follow any other methods as approved by the authority competent to grant licence to manufacture.
1. Omitted. by G.S.R. 59(E) ,dt. 22.1.1992.
4. All patent or proprietary medicines containing aspirin shall be subjected to “Free Salicylic Acid Test” and the limit of such acid shall be 0.75 per cent. Except in case of soluble type aspirin in which case the limit of such acid shall be 3 per cent.
5. Patent or proprietary medicine to be tested under the provisions of rule 121-A for pyrogen shall be tested by injecting into rabbits not less than the human dose of the medicine based on body weight of a 60 kg. human being. Methodology and limits shall be based on the method recorded in the Indian Pharmacopoeia. Dose selected shall be indicated in the protocol but the dose shall be not greater than 5 times the human dose based on body weight of 60 kg for man.
6. In injectable patent or proprietary medicines, the test for freedom from toxicity, shall be performed as described in the Indian Pharmacopoeia. Dose selected shall be indicated in the protocol but the dose shall not be less than five times the human dose based on body weight of 60 kg. human being.]
| Vitamin |
Unit |
Patent or proprietary Medicines containing Vitamins for prophylactic Use. |
Patent or proprietary medicines containing vitamins for therapeutic |
Patent or proprietary medicines containing vitamins for paediatric use. |
(in single dose or in two divided doses) per daily dose |
|
|
|
For adults |
For infants less than one year. |
For children above one year up to adults |
| 1 |
2 |
3 |
4 |
5 |
6 |
| Vitamin A. |
I.U |
Not less than 1600 and not more than 2,500 |
Not less than 5000 and not more than 10,000 |
Not less than 750 and not more than 3,000 |
Not less than 1500 and more than 5,000 |
| Vitamin D |
I.U. |
Not less than 100 and not more than 200. |
Not less than 400 and not more than 1,000 |
Not less than 200 and not more than 400. |
Not less than 100 and not more than 400. |
| Vitamin B1 |
mg . |
Not less than 1 and not more than 2. |
Not less than 4.5 and not more than 10. |
Not less than 0.5 and not more than 1. |
Not less than 1 and not more than 4.5. |
| Vitamin B2 |
mg . |
Not less than 1 and not more than 3. |
Not less than 5 and not more than 10 |
Not less than 0.5 and not more than 1.5. |
Not less than 1 and not more than 5. |
| Vitamin B6 |
mg. |
Not less than 0.5 and not more than 1.5. |
Not less than 1.5 and not more than 3. |
Not less than 0.5 and not more than 1.5. |
Not less than 1 and not more than 3. |
| Niacinamide |
mg. |
Not less than 15 and not more than 26. |
Not less than 45 and not more than 100. |
Not less than 5 and not more than 15 |
Not less than 10 and not more than 40. |
| d-Pantothenic acid or its salts and panthenol. |
mg. |
Not less than 1 and not more than 5. |
Not less than 5 and not more than 50. |
Not less than 1 and not more than 3. |
Not less than 2.5 and not more than 10. |
| Folic Acid more than 300 Vitamin B12 |
mcg..4A [mcg]. |
Not less than 50 and not more than 1,500. Not less than 0.5 and not more than 1.0 |
Not less than 1,000 and not more than 100. Not less than 5 and not more than 15. |
Not less than 25 and not not more than 500. Not less than 1 and not more than 3. |
Not less than 100 and Not less than 1 and not more than 5. |
| Vitamin C |
mg. |
Not less than 25 and not more than 50. |
Not less than 75 and not more than 150. |
Not less than 20 and not more than 40. |
Not less than 30 and not more than 80. |
| Vitamin E |
I.U. |
Not less than 5 and not more than 10. |
Not less than 15 and not more than 25. |
Not less than 2.5 and not more than 10. |
Not less than 5 and not more than 20. |
Notes: (1) Patent or proprietary medicines containing vitamins intended for prophylactic, therapeutic or paediatric use shall bear on the label the words “For Prophylactic Use” ” For Therapeutic Use,” or “For Paediatric Use” as the case may be. In the case of paediatric preparations the age of the infant or the child for whose use it is intended, shall be given in addition to the particulars required to be given under these rules.
(2)The above standards shall not apply to any preparation containing a single vitamin only and also to any preparation containing vitamins intended for parenteral use.
Provided, however, that in the case of patent or proprietary medicines containing vitamins which are intended for the treatment of certain specific conditions or diseases, the Licensing Authority specified in clause (b) of rule 21, may permit the addition of vitamins therein in relaxation of the limits specified above, if satisfactory evidence is produced in justification of such relaxation.
1. Subs. by G.S.R. dated 22-12-2009
1[***]
2[SCHEDULE X
[See Rules 23, 61, 75, 97 and 105A]
Amobarbital Glutethimide Pentobarbital
3[Ketamine hydrochloride] Amphetamine Meprobamate Phencyclidine
Barbital Methamphetamine Phenometrazine Cyclobarbital
4[***]
5[***]
Dexamphetamine Methylphenidate Secobarbital Ethclorvynol Methylphenobarbital
Note: 1. Any stereoisometric form of the substance specified in this Schedule, any salt of the substance and preparation containing such substances are also covered by this Schedule.
2. Preparations containing the above substances are also covered by this Schedule.
Provided, however, preparations containing Meprobamate 5[***] in combination with other drugs may be exempted by the Licensing Authority specified in clause (b) of rule 21, from the provisions of this Schedule, if satisfactory evidence is adduced that these preparations are not liable to be misused.]
1.Omitted by. G.S.R. 94(E) ,dt. 8.5. 2000
2 Ins. by G.S.R. 462(E) ,dt. 22.6.1982
3. Ins. by G.S.R. 724(E) ,dt. 07.11.2013
4. Omitted by G.S.R. 647(E) ,dt. 28.10.1998.
5.Omitted by. G.S.R. 673(E) ,dt. 27.10.1993.
1[SCHEDULE Y
(See rules 122A, 122B, 122D, 122DA, 122DAA and 122E)
REQUIREMENTS AND GUIDELINES FOR PERMISSION TO IMPORT AND / OR MANUFACTURE OF NEW DRUGS FOR SALE OR TO UNDERTAKE CLINICAL TRIALS
1. Application for permission.- (1) Application for permission to import or manufacture new drugs for sale or to undertake clinical trials shall be made in Form 44 accompanied with following data in accordance with the appendices, namely:-
(i) chemical and pharmaceutical information as prescribed in item 2 of Appendix I;
(ii) animal pharmacology data as prescribed in item 3 of Appendix I and Appendix IV;
(a) specific pharmacological actions as prescribed in item 3.2 of Appendix I, and demonstrating, therapeutic potential for humans shall be described according to the animal models and species used. Wherever possible, dose-response relationships and ED50s shall be submitted. Special studies conducted to elucidate mode of action shall also be described (Appendix IV);
(b) general pharmacological actions as prescribed in item 3.3 of Appendix I and item 1.2 of Appendix IV;
(c) pharmacokinetic data related to the absorption, distribution, metabolism and excretion of the test substance as prescribed in item 3.5 of Appendix I.
Wherever possible, the drug effects shall be corelated to the plasma drug concentrations;
(iii) animal toxicology data as prescribed in item 4 of Appendix I and Appendix III;
(iv) human Clinical Pharmacology Data as prescribed in items 5, 6 and 7 of Appendix I and as stated below:-
(a) for new drug substances discovered in India, clinical trials are required to be carried out in India right from Phase I and data should be submitted as required under items 1, 2, 3, 4, 5 (data, if any, from other countries), and 9 of Appendix I;
(b) for new drug substances discovered in countries other than India, Phase I data as required under items 1, 2, 3, 4, 5 (data from other countries) and 9 of Appendix I should be submitted along with the application. After submission of Phase I data generated outside India to the Licensing Authority, permission may be granted to repeat Phase I trials and/or to conduct Phase II trials and subsequently Phase III trials concurrently with other global trials for that drug. Phase III trials are required to be conducted in India before permission to market the drug in India is granted;
(c) the data required will depend upon the purpose of the new drug application . The number of study subjects and sites to be involved in the conduct of clinical trial will depend upon the nature and objective of the study. Permission to carry out these trials shall generally be given in stages, considering the data emerging from earlier Phase(s);
(d) application for permission to initiate specific phase of clinical trial should also accompany Investigator‘s brochure, proposed protocol (Appendix X), case record form, study subject‘s informed consent document(s) (Appendix V), investigator‘s undertaking (Appendix VII) and ethics committee clearance, if available (Appendix VIII);
1. Subs. G.S.R. 32(E), dt. 20.1.2005.
(e) reports of clinical studies submitted under items 5-8 of Appendix I should be in consonance with the format prescribed in Appendix II of this Schedule. The study report shall be certified by the Principal Investigator or, if no Principal Investigator is designated, then by each of the Investigators participating in the study. The certification should acknowledge the contents of the report, the accurate presentation of the study as undertaken, and express agreement with the conclusions. Each page should be numbered;
(v) regulatory status in other countries as prescribed in item 9.2 of Appendix I, including Information in respect of restrictions imposed, if any, on the use of the drug in other countries, e.g. dosage limits, exclusion of certain age groups, warning about adverse drug reactions,.etc. (item 9.2 of Appendix I). Likewise, if the drug has been withdrawn in any country by the manufacturer or by regulatory authorities, such information should also be furnished along with the reasons and their relevance, if any, to India. This information must continue to be submitted by the sponsor to the Licensing Authority during the course of marketing of the drug in India;
(vi) the full prescribing information should be submitted as part of the new drug application for marketing as prescribed in item 10 of Appendix I. The prescribing information (package insert) shall comprise the following sections: generic name; composition; dosage form/s, indications; dose and method of administration; use in special populations (such as pregnant women, lactating women, paediatric patients, geriatric patients etc.); contra-indications; warnings; precautions; drug interactions; undesirable effects; overdose; pharmacodynamic and pharmacokinetic properties; incompatibilities; shelf-life; packaging information; storage and handling instructions. All package inserts, promotional literature and patient education material subsequently produced are required to be consistent with the contents of the approved full prescribing information. The drafts of label and carton texts should comply with provisions of rules 96 and 97. After submission and approval by the Licensing Authority, no changes in the package insert shall be effected without such changes being approved by the Licensing Authority; and
(vii) complete testing protocol/s for quality control testing together with a complete impurity profile and release specifications for the product as prescribed in item 11 of Appendix I should be submitted as part of new drug application for marketing. Samples of the pure drug substance and finished product are to be submitted when desired by the regulatory authority.
(2) If the study drug is intended to be imported for the purposes of examination, test or analysis, the application for import of small quantities of drugs for such purpose should also be made in Form 12.
(3) For drugs indicated in life threatening / serious diseases or diseases of special relevance to the Indian health scenario, the toxicological and clinical data requirements may be abbreviated, deferred or omitted, as deemed appropriate by the Licensing Authority.
2. Clinical Trial:
(1) Approval for clinical trial
(i) Clinical trial on a new drug shall be initiated only after the permission has been granted by the Licensing Authority under rule 21 (b), and the approval obtained from the respective ethics committee (s). The Licensing Authority as defined shall be informed of the approval of the respective institutional ethics committee(s) as prescribed in Appendix VIII, and the trial initiated at each respective site only after obtaining such an approval for that site. The trial site(s) may accept the approval granted to the protocol by the ethics committee of another trial site or the approval granted by an independent ethics committee (constituted as per Appendix VIII), provided that the approving ethics committee(s) is/are willing to accept their responsibilities for the study at such trial site(s) and the trial site(s) is/are willing to accept such an arrangement and that the protocol version is same at all trial sites.
(ii) All trial Investigator(s) should possess appropriate qualifications, training and experience and should have access to such investigational and treatment facilities as are relevant to the proposed trial protocol. A qualified physician (or dentist, when appropriate) who is an investigator or a sub-investigator for the trial, should be responsible for all trial-related medical (or dental) decisions. Laboratories used for generating data for clinical trials should be compliant with Good Laboratory Practices. If services of a laboratory or a facilities outside the country are to be availed, its/their name(s), address(s) and specific services to be used should be stated in the protocol to avail Licensing Authority‘s permission to send clinical trial related samples to such laboratory(ies) and/or facility(ies). In all cases, information about laboratory(ies) / facilities to be used for the trial, if other than those at the investigation site(s), should be furnished to the Licensing Authority prior to initiation of trial at such site(s).
(iii) Protocol amendments if become necessary before initiation or during the course of a clinical trial, all such amendments should be notified to the Licensing Authority in writing along with the approval by the ethics committee which has granted the approval for the study. No deviations from or changes to the protocol should be implemented without prior written approval of the ethics committee and the Licensing Authority except when it is necessary to eliminate immediate hazards to the trial Subject(s) or when change(s) involve(s) only logistic or administrative aspects of the trial. All such exceptions must be immediately notified to the ethics committee as well as to the Licensing Authority. Administrative and/or logistic changes in the protocol should be notified to the Licensing Authority within 30 days.
(2) Responsibilities of Sponsor:
(i) The clinical trial Sponsor is responsible for implementing and maintaining quality assurance systems to ensure that the clinical trial is conducted and data generated, documented and reported in compliance with the protocol and Good Clinical Practice (GCP) Guidelines issued by the Central Drugs Standard Control Organization, Directorate General of Health Services, Government of India as well as with all applicable statutory provisions. Standard operating procedures should be documented to ensure compliance with GCP and applicable regulations.
(ii) Sponsors are required to submit a status report on the clinical trial to the Licensing Authority at the prescribed periodicity.
(iii) In case of studies prematurely discontinued for any reason including lack of commercial interest in pursuing the new drug application, a summary report should be submitted within 3 months. The summary report should provide a brief description of the study, the number of patients exposed to the drug, dose and duration of exposure, details of adverse drug reactions (Appendix XI), if any, and the reason for discontinuation of the study or non- pursuit of the new drug application;
1[(iv) Any report of the serious adverse event, after due analysis shall be forwarded by the
sponsor to the Licensing Authority as referred to in clause (b) of rule 21, the Chairman of the Ethics Committee and the head of the institution where the trial has been conducted, within fourteen days of the occurrence of the serious adverse event.]
2[(v) in case of injury or death occurring to the clinical trial subject, the Sponsor (whether a pharmaceutical company or an Institution) or his representative, whosoever, had obtained permission from the Licensing Authority for conduct of the clinical trial, shall make payment for medical management of the subject and also provide financial compensation for the clinical trial related injury or death in the manner as prescribed in Appendix XII;
2[(vi) the Sponsor (whether a pharmaceutical company or an Institution) or his representative, whosoever had obtained permission from the Licensing Authority for conduct of the clinical trial, shall submit details of compensation provided or paid for clinical trial related injury or death, to the Licensing Authority within thirty days of the receipt of the order of the Licensing Authority.]
1. Subs. by G.S.R. 889(E) dated 12-12-2014
2. Ins. By G.S.R. 53(E) dated 30-1-2013
1[(3)(i)] Responsibilities of the Investigator(s):
The Investigator(s) shall be responsible for the conduct of the trial according to the protocol and the GCP Guidelines and also for compliance as per the undertaking given in Appendix VII. Standard operating procedures are required to be documented by the investigators for the tasks performed by them. During and following a subject‘s participation in a trial, the investigator should ensure that adequate medical care is provided to the participant for any adverse events. Investigator(s) shall report all serious and unexpected adverse events to the 2[Licensing Authority defined under clause (b) of rule 21, the Sponsor or his repeesentative, whosoever had obtained permission from the Licensing Authority for conduct of the clinical trial, and the Ethics Committee that accorded approval to the study protocol, within twenty four hours of their occurance. 3[In case, the Investigator fails to report any serious adverse event within the stipulated period, he shall have to furnish the reason for the delay to the satisfaction of the Licensing Authority along with the report of the serious adverse event. The report of the serious adverse event, after due analysis, shall be forwarded by the Investigator to the Licensing Authority as referred to in clause (b) of rule 21, the Chairman of the Ethics Committee and the Head of the institution where the trial has been conducted within fourteen days of the occurrence of the serious adverse event.]].
4[(ii)The Investigator shall provide information to the clinical trial subject through informed consent process as provided in Appendix V about the essential elements of the clinical trial and the subject‘s right to claim compensation in case of trial related injury or death. He shall also inform the subject or his/her nominees(s) of their rights to contact the Sponsor or his representative whosoever had obtained permission from the Licensing Authority for conduct of the clinical trial for the purpose of making claims in the case of trial related injury or death.]
(4) Informed Consent:
(i) In all trials, a freely given, informed, written consent is required to be obtained from each study subject. The Investigator must provide information about the study verbally as well as using a patient information sheet, in a language that is non-technical and understandable by the study subject. The Subject‘s consent must be obtained in writing using an ‘Informed Consent Form‘. Both the patient information sheet as well as the Informed Consent Form should have been approved by the ethics committee and furnished to the Licensing Authority. Any changes in the informed consent documents should be approved by the ethics committee and submitted to the Licensing Authority before such changes are implemented.
(ii) Where a subject is not able to give informed consent (e.g. an unconscious person or a minor or those suffering from severe mental illness or disability), the same may be obtained from a legally acceptable representative (a legally acceptable representative is a person who is able to give consent for or authorize an intervention in the patient as provided by the law(s) of India). If the Subject or his/her legally acceptable representative is unable to read/write – an impartial witness should be present during the entire informed consent process who must append his/her signatures to the consent form.
(iii) A checklist of essential elements to be included in the study subject‘s informed consent document as well as a format for the Informed Consent Form for study Subjects is given in Appendix V.
1. Sub-para (3) renumbered as sub-para, (3)(i) thereof by G.S.R 53(E), dated 30-01-2013.
2. Subs. by G.S.R. 53(E), dated 30-01-2013.
3. Subs. by G.S.R. 889(E), dated 12-12-2014.
4. Ins. by G.S.R. 53(E), dated 30-01-2013.
(5) Responsibilities of the Ethics Committee:
(i) It is the responsibility of the ethics committee that reviews and accords its approval to a trial protocol to safeguard the rights, safety and well being of all trial subjects. The ethics committee should exercise particular care to protect the rights, safety and well being of all vulnerable subjects participating in the study, e.g., members of a group with hierarchical structure (e.g. prisoners, armed forces personnel, staff and students of medical, nursing and pharmacy academic institutions), patients with incurable diseases, umemployed or impoverished persons, patients in emergency situation, ethnic minority groups, homeless persons, nomads, refugees, minors or others incapable of personally giving consent. Ethics committee(s) should get document ‘standard operating procedures‘ and should maintain a record of its proceedings.
(ii) Ethics Committee(s) should make, at appropriate intervals, an ongoing review of the trials for which they review the protocol(s). Such a review may be based on the periodic study progress reports furnished by the investigators and/or monitoring and internal audit reports furnished by the Sponsor and/or by visiting the study sites.
(iii) In case an ethics committee revokes its approval accorded to a trial protocol, it must record the reasons for doing so and at once communicate such a decision to the Investigator as well as to the Licensing Authority.
1[(iv) In case of serious adverse event occurring to the clinical trial subject, the Ethics Committee shall forward its report on the serious adverse event, after due analysis, along with its opinion on the financial compensation, if any, to be paid by the Sponsor or his representative, whosoever had obtained permission from the Licensing Authority as referred to in clause (b) of rule 21 for conducting the clinical trial, to the Licensing Authority within thirty days of the occurrence of the serious adverse event.
2[5(A). Serious Adverse Events:
(1) A serious adverse event is an untoward medical occurrence during clinical trial that is associated with death, in patient hospitalization (in case the study was being conducted on out- patient), prolongation of hospitalization (in case the study was being conducted on in-patient), persistent or significant disability or incapacity, a congenital anomaly or birth defect or is otherwise life threatening.
(2) The Investigator shall report all serious 3[***] adverse events to the Licensing Authority as defined under clause (b) of Rule 21, the Sponsor or his representative, whosoever had obtained permission from the Licensing Authority for conduct of the clinical trial and the Ethics Committee that accorded approval to the study protocol, within twenty four hours of their occurrence as per Appendix XI and the said Licensing Authority shall determine the cause of injury or death as per the procedure prescribed under Appendix XII and pass orders as deemed necessary. 4[In case, the Investigator fails to report any serious adverse event within the stipulated period, he shall have to furnish the reason for the delay to the satisfaction of the Licensing Authority along with the report of the serious adverse event.
1. Subs. by G.S.R. 889(E) dated 12-12-2014.
2. Ins. by G.S.R. 53(E) dated 30-01-2013.
3. The words “and unexpected”omitted by G.S.R. 889(E) dated 12-12-2014.
4. Ins. by G.S.R. 889 (E) dated 12-12-2014.
(6) Human Pharmacology (Phase I):
(i) The objective of studies in this Phase is the estimation of safety and tolerability with the initial administration of an investigational new drug into human(s). Studies in this Phase of development usually have non-therapeutic objectives and may be conducted in healthy volunteers subjects or certain types of patients. Drugs with significant potential toxicity e.g. cytotoxic drugs are usually studied in patients. Phase I trials should preferably be carried out by Investigators trained in clinical pharmacology with access to the necessary facilities to closely observe and monitor the Subjects.
(ii) Studies conducted in Phase I, usually intended to involve one or a combination of the following objectives:-
(a) Maximum tolerated dose: To determine the tolerability of the dose range expected to be needed for later clinical studies and to determine the nature of adverse reactions that can be expected. These studies include both single and multiple dose administration.
(b) Pharmacokinetics, i.e., characterization of a drug’s absorption, distribution, metabolism and excretion. Although these studies continue throughout the development plan, they should be performed to support formulation development and determine pharmacokinetic parameters in different age groups to support dosing recommendations.
(c) Pharmacodynamics: Depending on the drug and the endpoints studied, pharmacodynamic studies and studies relating to drug blood levels (pharmacokinetic/ pharmacodynamic studies) may be conducted in healthy volunteer Subjects or in patients with the target disease. If there are appropriate validated indicators of activity and potential efficacy, pharmacodynamic data obtained from patients may guide the dosage and dose regimen to be applied in later studies.
(d) Early Measurement of Drug Activity: Preliminary studies of activity or potential therapeutic benefit may be conducted in Phase I as a secondary objective. Such studies are generally performed in later Phases but may be appropriate when drug activity is readily measurable with a short duration of drug exposure in patients at this early stage.
(7) Therapeutic exploratory trials (Phase II):
(i) The primary objective of Phase II trials is to evaluate the effectiveness of a drug for a particular indication or indications in patients with the condition under study and to determine the common short-term side-effects and risks associated with the drug. Studies in Phase II should be conducted in a group of patients who are selected by relatively narrow criteria leading to a relatively homogeneous population. These studies should be closely monitored. An important goal for this Phase is to determine the dose(s) and regimen for Phase III trials. Doses used in Phase II are usually (but not always) less than the highest doses used in Phase I.
(ii) Additional objectives of Phase II studies can include evaluation of potential study endpoints, therapeutic regimens (including concomitant medications) and target populations (e.g. mild versus severe disease) for further studies in Phase II or III. These objectives may be served by exploratory analyses, examining subsets of data and by including multiple endpoints in trials.
(iii) If the application is for conduct of clinical trials as a part of multi-national clinical development of the drug, the number of sites and the patients as well as the justification for undertaking such trials in India shall be provided to the Licensing Authority.
(8) Therapeutic confirmatory trials (Phase III):
(i) Phase III studies have primary objective of demonstration or confirmation of therapeutic benefit(s). Studies in Phase III are designed to confirm the preliminary evidence accumulated in Phase II that a drug is safe and effective for use in the intended indication and recipient population. These studies should be intended to provide an adequate basis for marketing approval. Studies in Phase III may also further explore the dose-response relationships (relationships among dose, drug concentration in blood and clinical response), use of the drug in wider populations, in different stages of disease, or the safety and efficacy of the drug in combination with other drug(s).
(ii) For drugs intended to be administered for long periods, trials involving extended exposure to the drug are ordinarily conducted in Phase III, although they may be initiated in Phase II. These studies carried out in Phase III complete the information needed to support adequate instructions for use of the drug (prescribing information).
(iii) For new drugs approved outside India, Phase III studies need to be carried out primarily to generate evidence of efficacy and safety of the drug in Indian patients when used as recommended in the prescribing information. Prior to conduct of Phase III studies in Indian subjects, Licensing Authority may require pharmacokinetic studies to be undertaken to verify that the data generated in Indian population is in conformity with the data already generated abroad.
(iv) If the application is for the conduct of clinical trials as a part of multi-national clinical development of the drug, the number of sites and patients as well as the justification for undertaking such trials in India should be provided to the Licensing Authority along with the application.
(9) Post Marketing Trials (Phase IV):
Post Marketing trials are studies (other than routine surveillance) performed after drug approval and related to the approved indication(s). These trials go beyond the prior demonstration of the drug‘s safety, efficacy and dose definition. These trials may not be considered necessary at the time of new drug approval but may be required by the Licensing Authority for optimizing the drug’s use. They may be of any type but should have valid scientific objectives. Phase IV trials include additional drug-drug interaction(s), dose- response or safety studies and trials designed to support use under the approved indication(s), e.g. mortality/morbidity studies, epidemiological studies etc.
3. Studies in special populations:
Information supporting the use of the drug in children, pregnant women, nursing women, elderly patients, patients with renal or other organ systems failure, and those on specific concomitant medication is required to be submitted if relevant to the clinical profile of the drug and its anticipated usage pattern. Any claim sought to be made for the drug product that is not based on data submitted under preceding items of this Schedule should be supported by studies included under this item of the Schedule (Appendix I, item 8.3).
(1) Geriatrics:
Geriatric patients should be included in Phase III clinical trials (and in Phase II trials, at the Sponsor’s option) in meaningful numbers, if-
(a) the disease intended to be treated is characteristically a disease of aging; or
(b) the population to be treated is known to include substantial numbers of geriatric patients; or
(c) when there is specific reason to expect that conditions common in the elderly are likely to be encountered; or
(d) when the new drug is likely to alter the geriatric patient’s response (with regard to safety or efficacy) compared with that of the non-geriatric patient.
(2) Paediatrics:
(i) The timing of paediatric studies in the new drug development program will depend on the medicinal product, the type of disease being treated, safety considerations, and the efficacy and safety of available treatments. For a drug expected to be used in children, evaluations should be made in the appropriate age group. When clinical development is to include studies in children, it is usually appropriate to begin with older children before extending the trial to younger children and then infants.
(ii) If the new drug is for diseases predominantly or exclusively affecting paediatric patients, clinical trial data should be generated in the paediatric population except for initial safety and tolerability data, which will usually be obtained in adults unless such initial safety studies in adults would yield little useful information or expose them to inappropriate risk.
(iii) If the new drug is intended to treat serious or life-threatening diseases, occurring in both adults and paediatric patients, for which there are currently no or limited therapeutic options, paediatric population should be included in the clinical trials early, following assessment of initial safety data and reasonable evidence of potential benefit. In circumstances where this is not possible, lack of data should be justified in detail.
(iv) If the new drug has a potential for use in paediatric patients – Paediatric studies should be conducted. These studies may be initiated at various phases of clinical development or after post marketing survelliance in adults if a safety concern exists. In cases where there is limited paediatric data at the time of submission of application – more data in paediatric patients would be expected after marketing authorisation for use in children is granted.
(v) The paediatric studies should include –
(a) clinical trials,
(b) relative bioequivalence comparisons of the paediatric formulation with the adult formulation performed in adults, and
(c) definitive pharmacokinetic studies for dose selection across the age ranges of paediatric patients in whom the drug is likely to be used. These studies should be conducted in the paediatric patient population with the disease under study.
(vi) If the new drug is a major therapeutic advance for the paediatric population – the studies should begin early in the drug development , and this data should be submitted with the new drug application.
(vii) Paediatric Subjects are legally unable to provide written informed consent, and are dependent on their parent(s)/ legal guardian to assume responsibility for their participation in clinical studies. Written informed consent should be obtained from the parent/ legal guardian. However, all paediatric participants should be informed to the fullest extent possible about the study in a language and in terms that they are able to understand. Where appropriate, paediatric participants should additionally assent to enrol in the study. Mature minors and adolescents should personally sign and date a separately designed written assent form. Although a participant‘s wish to withdraw from a study must be respected, there may be circumstances in therapeutic studies for serious or life-threatening diseases in which, in the opinion of the Investigator and parent(s)/ legal guardian, the welfare of a pediatric patient would be jeopardized by his or her failing to participate in the study. In this situation, continued parental/ legal guardian consent should be sufficient to allow participation in the study.
(viii) For clinical trials conducted in the paediatric population, the reviewing ethics committee should include members who are knowledgeable about pediatric, ethical, clinical and psychosocial issues.
(3) Pregnant or nursing women:
(i) Pregnant or nursing women should be included in clinical trials only when the drug is intended for use by pregnant/nursing women or foetuses/nursing infants and where the data generated from women who are not pregnant or nursing, is not suitable.
(ii) For new drugs intended for use during pregnancy, follow-up data (pertaining to a period appropriate for that drug) on the pregnancy, foetus and child will be required. Where applicable, excretion of the drug or its metabolites into human milk should be examined and the infant should be monitored for predicted pharmacological effects of the drug.
1[(4) Post Marketing Surveillance:
(i) The applicant shall have a pharmacovigilance system in place for collecting, processing and forwarding the report to the licensing authority for information on adverse drug reactions emerging from the use of the drug manufactured or marketed by the applicant in the country.
(ia) The system shall be managed by qualified and trained personnel and the officer in- charge of collection and processing of data shall be a medical officer or a pharmacist trained in collection and analysis of adverse drug reaction reports.
(ib) Subsequent to approval of the product, new drug shall be closely monitored for its clinical safety once it is marketed.
(ic) The applicant shall furnish Periodic Safety Update Reports (PSURs) in order to-
(a) report all the relevant new information from appropriate sources;
(b) relate these data to patient exposure ;
(c) summarize the market authorization status in different countries and any significant variations related to safety; and
(d) indicate whether changes should be made to product information in order to optimize the use of the product.
(ii) Ordinarily all dosage forms and formulations as well as indications for new drugs should be covered in one PSUR. Within the single PSUR separate presentations of data for different dosage forms, indications or separate population need to be given.
(iii) All relevant clinical and non-clinical safety data should cover only the period of the report (interval data). The PSURs shall be submitted every six months for the first two years after approval of the drug is granted to the applicant. For subsequent two years – the PSURs need to be submitted annually.
Licensing authority may extend the total duration of submission of PSURs if it is considered necessary in the interest of public health. PSURs due for a period must be submitted within 30 calendar days of the last day of the reporting period.
However, all cases involving serious unexpected adverse reactions must be reported to the licensing authority within 15 days of initial receipt of the information by the applicant. If marketing of the new drug is delayed by the applicant after obtaining approval to market, such data will have to be provided on the deferred basis beginning from the time the new drug is marketed.
(iv) New studies specifically planned or conducted to examine a safety issue should be described in the PSURs.
1. Subs. by G.S.R. 287(E) dated 08-03-2016.
(v) A PSUR should be structured as follows:
(a) A title page stating: Periodic safety update report for the product, applicant‘s name, period covered by the report, date of approval of new drug, date of marketing of new drug and date of reporting;
(b) Introduction,
(c) Current worldwide market authorization status,
(d) Update of actions taken for safety reasons,
(e) Changes to reference safety information,
(f) Estimated patient exposure,
(g) Presentation of individual case histories,
(h) Studies,
(i) Other information,
(j) Overall safety evaluation,
(k) Conclusion,
(l) Appendix providing material relating to indications, dosing, pharmacology and other related information.
(5) Special studies: Bioavailability / Bioequivalence Studies:
(i) For drugs approved elsewhere in the world and absorbed systemically, bioequivalence with the reference formulation should be carried out wherever applicable. These studies should be conducted under the labelled conditions of administration. Data on the extent of systemic absorption may be required for formulations other than those designed for systemic absorption.
(ii) Evaluation of the effect of food on absorption following oral administration should be carried out. Data from dissolution studies should also be submitted for all solid oral dosage forms.
(iii) Dissolution and bioavailability data submitted with the new drug application must provide information that assures bioequivalence or establishes bioavailability and dosage correlations between the formulation(s) sought to be marketed and those used for clinical trials during clinical development of the product. (See items 8.1, 8.2 and 8.3 of Appendix I).
(iv) All bioavailability and bioequivalence studies should be conducted according to the Guidelines for Bioavailability and Bioequivalence studies as prescribed.
Note.- The data requirements stated in this Schedule are expected to provide adequate information to evaluate the efficacy, safety and therapeutic rationale of new drugs (as defined under rule 122-E) prior to the permission for sale. Depending upon the nature of new drugs and disease(s), additional information may be required by the Licensing Authority. The applicant shall certify the authencity of the data and documents submitted in support of an application for new drug. The Licensing Authority reserves the right to reject any data or any document(s) if such data or contents of such documents are found to be of doubtful integrity.
APPENDIX I
DATA TO BE SUBMITTED ALONG WITH THE APPLICATION TO CONDUCT CLINICAL TRIALS/IMPORT/MANUFACTURE OF NEW DRUGS FOR MARKETING IN THE COUNTRY
1. Introduction
A brief description of the drug and the therapeutic class to which it belongs.
2. Chemical and pharmaceutical information
2.1. Information on active ingredients
Drug information (Generic Name, Chemical Name or INN)
2.2. Physicochemical Data
(a) Chemical name and Structure Empirical formula
Molecular weight
(b) Physical properties Description Solubility Rotation
Partition coefficient Dissociation constant
2.3. Analytical Data
Elemental analysis
Mass spectrum
NMR spectra
IR spectra
UV spectra
Polymorphic identification
2.4. Complete monograph specification including Identification
Identity/quantification of impurities
Enantiomeric purity
Assay
2.5. Validations
Assay method
Impurity estimation method
Residual solvent/other volatile impurities (OVI) estimation method
2.6. Stability Studies (for details refer Appendix IX) Final release specification
Reference standard characterization Material safety data sheet
2.7. Data on Formulation
Dosage form Composition
Master manufacturing formula
Details of the formulation (including inactive ingredients) In process quality control check
Finished product specification Excipient compatibility study Validation of the analytical method
Comparative evaluation with international brand(s) or approved Indian brands, if applicable
Pack presentation Dissolution Assay
Impurities
Content uniformity pH
Force degradation study
Stability evaluation in market intended pack at proposed storage conditions Packing specifications
Process validation
When the application is for clinical trials only, the international non-proprietary name (INN) or generic name, drug category, dosage form and data supporting stability in the intended container-closure system for the duration of the clinical trial (information covered in item nos. 2.1, 2.3, 2.6, 2.7) are required.
3. Animal Pharmacology (for details refer Appendix IV)
3.1. Summary
3.2. Specific pharmacological actions
3.3. General pharmacological actions
3.4. Follow-up and Supplemental Safety Pharmacology Studies
3.5. Pharmacokinetics: absorption, distribution; metabolism; excretion
4. Animal Toxicology (for details refer Appendix III)
4.1. General Aspects
4.2. Systemic Toxicity Studies
4.3. Male Fertility Study
4.4. Female Reproduction and Developmental Toxicity Studies
4.5. Local toxicity
4.6. Allergenicity/Hypersensitivity
4.7. Genotoxicity
4.8. Carcinogenicity
1[Note.- Where the data on animal toxicity as per the specifications of Appendix III has been submitted and the same has been considered by the regulatory authority of the country which had earlier approved the drug, the animal toxicity studies shall not be required to be conducted in India except in cases where there are specific concerns recorded in writing.]
5. Human / Clinical pharmacology (Phase I)
5.1. Summary
5.2. Specific Pharmacological effects
5.3. General Pharmacological effects
5.4. Pharmacokinetics, absorption, distribution, metabolism, excretion
5.5. Pharmacodynamics / early measurement of drug activity
6. Therapeutic exploratory trials (Phase II)
6.1. Summary
6.2. Study report(s) as given in Appendix II
7. Therapeutic confirmatory trials (Phase III)
7.1. Summary
7.2. Individual study reports with listing of sites and Investigators.
8. Special studies
8.1. Summary
8.2. Bio-availability / Bio-equivalence.
8.3. Other studies e.g. geriatrics, paediatrics, pregnant or nursing women
1. Subs. by G.S.R. 313(E) dated 16-03-2016.
9. Regulatory status in other countries
9.1. Countries where the drug is
a. Marketed
b. Approved
c. Approved as IND
d. Withdrawn, if any, with reasons
9.2. Restrictions on use, if any, in countries where marketed /approved
9.3. Free sale certificate or certificate of analysis, as appropriate.
10. Prescribing information
10.1. Proposed full prescribing information
11. Samples and Testing Protocol/s
11.1. Samples of pure drug substance and finished product (an equivalent of 50 clinical doses, or more number of clinical doses if prescribed by the Licensing Authority), with testing protocol/s, full impurity profile and release specifications.
1[12. New Chemical Entity and Global Clinical Trial:
12.1 Assessment of risk versus benefit to the patients
12.2 Innovation vis-à-vis existing therapeutic option
12.3 Unmet medical need in the country.]
NOTES:
(1) All items may not be applicable to all drugs. For explanation, refer text of Schedule Y.
(2) For requirements of data to be submitted with application for clinical trials refer text of this Schedule.
APPENDIX IA
DATA REQUIRED TO BE SUBMITTED BY AN APPLICANT FOR GRANT OF PERMISSION TO IMPORT AND / OR MANUFACTURE A NEW DRUG ALREADY APPROVED IN THE COUNTRY
1. Introduction
A brief description of the drug and the therapeutic class
2. Chemical and pharmaceutical information
2.1. Chemical name, code name or number, if any; non-proprietary or generic name, if any, structure; physico-chemical properties
2.2. Dosage form and its composition
2.3. Test specifications
(a) active ingredients
(b) inactive ingredients
2.4 Tests for identification of the active ingredients and method of its assay
2.5 Outline of the method of manufacture of active ingredients
2.6 Stability data
1. Ins. by G.S.R. 826 (E), dt. 30-10-2015.
3. Marketing information
3.1 Proposed package insert / promotional literature
3.2 Draft specimen of the label and carton
4. Special studies conducted with approval of Licensing Authority
4.1 Bioavailability / Bioequivalence and comparative dissolution studies for oral dosage forms
4.2 Sub-acute animal toxicity studies for intravenous infusions and injectables.
1[APPENDIX I B
DATA TO BE SUBMITTED ALONG WITH APPLICATION TO CONDUCT CLINICAL TRIAL OR IMPORT OR MANUFACTURE OF A PHYTOPHARMACEUTICAL DRUG IN THE COUNTRY
PART – I
1. Data to be submitted by the applicant:
1.1. A brief description or summary of the phytopharmaceutical drug giving the botanical name of the plant (including vernacular or scriptural name, wherever applicable), formulation and route of administration, dosages, therapeutic class for which it is indicated and the claims to be made for the phytopharmaceutical product.
1.2. Published literature including information on plant or product or phytopharmaceutical drug, as a traditional medicine or as an ethno medicine and provide reference to books and other documents, regarding composition, process prescribed, dose or method of usage, proportion of the active ingredients in such traditional preparations per dose or per day‘s consumption and uses.
1.3. Information on any contraindications, side effects mentioned in traditional medicine or ethno medicine literature or reports on current usage of the formulation.
1.4. Published scientific reports in respect of safety and pharmacological studies relevant for the phytopharmaceutical drug intended to be marketed,-
(a) where the process and usages are similar or same to the product known in traditional medicine or ethno medicine; and
(b) where process or usage is different from that known in traditional medicine or ethno medicine.
1.5. Information on any contraindications, side effects mentioned or reported in any of the studies, information on side effects and adverse reactions reported during current usage of the phytopharmaceutical in the last three years, wherever applicable.
1.6. Present usage of the phytopharmaceutical drug, – to establish history of usages, provide details of the product, manufacturer, quantum sold, extent of exposure on human population and number of years for which the product is being sold.
2. Human or clinical pharmacology information:
2.1. Published scientific reports in respect of pharmacological studies including human studies or clinical studies or epidemiological studies, relevant for the phytopharmaceutical drug intended to be marketed,-
(a) where the process and usages are similar or same to the product known in traditional medicine or ethno medicine; and
(b) where process or usage is different from that known in traditional medicine or ethno medicine.
2.2. Pharmacodynamic information (if available).
2.3. Monographs, if any, published on the plant or product or extract or phytopharmaceutical. (Copies of all publications, along with english translation to be attached.)
1. Ins. by G.S.R. 918 (E), dt. 30-11-2015.
PART – II
Data generated by applicant
3. Identification, authentication and source of plant used for extraction and fractionation:
3.1. Taxonomical identity of the plant used as a source of the phytopharmaceutical drug giving botanical name of genus, species and family, followed by the authority citation (taxonomist‘s name who named the species), the variety or the cultivar (if any) needs to be mentioned.
3.2 Morphological and anatomical description giving diagnostic features and a photograph of the plant or plant part for further confirmation of identity and authenticity. (Furnish certificate of confirmation of botanical identity by a qualified taxonomist).
3.3 Natural habitat and geographical distribution of the plant and also mention whether the part of the plant used is renewable or destructive and the source whether cultivated or wild.
3.4 Season or time of collection.
3.5 Source of the plant including its geographical location and season or time of collection.
3.6 A statement indicating whether the species is any of the following, namely:-
(a) determined to be endangered or threatened under the Endangered Species Act or the Convention on International Trade in Endangered species (CITES) of wild Fauna and Flora;
(b) entitled to special protection under the Biological Diversity Act, 2002 (18 of 2003); (c) any known genotypic, chemotypic and ecotypic variability of species.
3.7. A list of grower or supplier (including names and addresses) and information on the following items for each grower or supplier, if available or identified already, including information of primary processing, namely:-
(a) harvest location;
(b) growth conditions;
(c) stage of plant growth at harvest;
(d) harvesting time;
(e) collection, washing, drying and storage conditions;
(f) handling, garbling and transportation;
(g) grinding, pulverising of the plant material; and
(h) sieving for getting uniform particle size of powdered plant material.
3.8. Quality specifications, namely:-
(a) foreign matter;
(b) total ash;
(c) acid insoluble ash;
(d) pesticide residue;
(e) heavy metal contamination;
(f) microbial load;
(g) chromatographic finger print profile with phytochemical reference marker;
(h) assay for bio-active or phytochemical compounds; and
(i) chromatographic fingerprint of a sample as per test method given under quality control of the phytopharmaceutical drug (photo documentation).
3.9 . An undertaking to supply specimen sample of plant duly labeled and photocopy of the certificate of identity confirmation issued by a qualified taxonomist along with drawings or photographs of the diagnostic morphological and histological features of the botanical raw material used for the confirmation of authenticity.
4. Process for extraction and subsequent fractionation and purification:
4.1. Quality specifications and test methods for starting material.
4.2. Steps involved in processing.
(a) details of solvent used, extractive values, solvent residue tests or limits, physico-chemical tests, microbial loads, heavy metal contaminants, chromatographic finger print profile with phytochemical reference markers, assay for active constituents or characteristic markers, if active constituents are not known;
(b) characterisation of final purified fraction;
(c) data on bio-active constituent of final purified fraction;
(d) information on any excipients or diluents or stabiliser or preservative used, if any.
4.3. Details of packaging of the purified and characterised final product, storage conditions and labeling.
5. Formulation of phytopharmaceutical drug applied for:
5.1. Details of the composition, proportion of the final purified fraction with defined markers of phytopharmaceutical drug per unit dose, name and proportions of all excipients, stabilisers and any other agent used and packaging materials.
5.2. Test for identification for the phytopharmaceutical drug.
5.3. Quality specifications for active and inactive phytopharmaceutical chromatographic finger print profile with phytochemical reference marker and assay of active constituent or characteristic chemical marker.
6. Manufacturing process of formulation:
6.1. The outline of the method of manufacture of the dosage form, along with environmental controls, in-process quality control tests and limits for acceptance.
6.2. Details of all packaging materials used, packing steps and description of the final packs.
6.3. Finished product‘s quality specifications, including tests specific for the dosage form, quality and chromatographic finger print profile with phytochemical reference marker and assay for active constituent or characteristic marker, if active constituents are not known.
7. Stability data:
7.1. Stability data of the phytopharmaceutical drug described at 4 above, stored at room temperature at 40 +/- 2 deg. C and humidity at 75%RH +/- 5%RH for 0, 1, 2, 3 and 6 months.
7.2 Stability data of the phytopharmaceutical drug in dosage form or formulation stored at room temperature at 40 +/- 2 deg. C and humidity at 75%RH +/- 5%RH for 0, 1, 2, 3 and 6 months, in the pack intended for marketing.
8. Safety and pharmacological information:
8.1. Data on safety and pharmacological studies to be provided.
8.2. Animal toxicity and safety data:
(a) 28 to 90 days repeat dose oral toxicity on two species of animals;
(b) In-vitro genotoxicity data (Ame‘s test and Chromosomal aberration test as per Schedule Y);
(c) dermal toxicity tests for topical use products;
(d) teratogenicity study (only if phytopharmaceutical drug is intended for use during pregnancy).
9. Human studies:
9.1. Clinical trials for phytopharmaceutical drugs to be conducted as per applicable rules and guidelines for new drugs.
9.2. For all phytopharmaceutical drugs data from phase I (to determine maximum tolerated dose and associated toxicities) and the protocols shall be submitted prior to performing the studies.
9.3. Data of results of dose finding studies performed and the protocols shall be submitted prior to performing the studies: Provided that in the case of phytopharmaceutical drug already marketed for more than five years or where there is adequate published evidence regarding the safety of the phytopharmaceutical drug, the studies may be abbreviated, modified or relaxed.
10. Confirmatory clinical trials:
10.1. Submit protocols for approval for any specific or special safety and efficacy study proposed specific to the phytopharmaceutical drug.
10.2. Submit proposed protocol for approval for human clinical studies appropriate to generate or validate safety and efficacy data for the phytopharmaceutical dosage form or product as per applicable rules and guidelines.
10.3. Submit information on how the quality of the formulation would be maintained during the above studies.
11. Regulatory status:
11.1. Status of the phytopharmaceutical drug marketed in any country under any category like functional food or dietary supplement or as traditional medicine or as an approved drug.
12. Marketing information:
12.1. Details of package insert or patient information sheet of the phytopharmaceutical drug to be marketed.
12.2. Draft of the text for label and carton.
13. Post marketing surveillance (PMS):
13.1. The applicant shall furnish periodic safety update reports every six months for the first two years after approval the drug is granted.
13.2. For subsequent two years the periodic safety update reports need to be submitted annually.
14. Any other relevant information:
Any other relevant information which the applicant considers that it will help in scientific evaluation of the application.]
APPENDIX II
STRUCTURE, CONTENTS AND FORMAT FOR CLINICAL STUDY REPORTS
1. Title Page:
This page should contain information about the title of the study, the protocol code, name of the investigational product tested, development Phase, indication studied, a brief description of the trial design, the start and end date of patient accrual and the names of the Sponsor and the participating Institutes (Investigators).
2. Study Synopsis (1 to 2 pages):
A brief overview of the study from the protocol development to the trial closure should be given here. This section will only summarize the important conclusions derived from the study.
3. Statement of compliance with the ‘Guidelines for Clinical Trials on Pharmaceutical Products in India :
GCP Guidelines‘ issued by the Central Drugs Standard Control Organization, Ministry of Health, Government of India.
4. List of Abbreviations and Definitions
5. Table of contents
6. Ethics Committee:
This section should document that the study was conducted in accordance with the ethical principles of Declaration of Helsinki. A detailed description of the Ethics Committee constitution and date(s) of approvals of trial documents for each of the participating sites should be provided. A declaration should state that EC notifications as per Good Clinical Practice Guidelines issued by Central Drugs Standard Control Organization and Ethical Guidelines for Biomedical Research on Human Subjects, issued by Indian Council of Medical Research have been followed.
7. Study Team:
Briefly describe the administrative structure of the study (Investigators, site staff, Sponsor/ designates, Central laboratory etc).
8. Introduction:
A brief description of the product development rationale should be given here.
9. Study Objective:
A statement describing the overall purpose of the study and the primary and secondary objectives to be achieved should be mentioned here.
10. Investigational Plan:
This section should describe the overall trial design, the Subject selection criteria, the treatment procedures, blinding / randomization techniques if any, allowed/ disallowed concomitant treatment, the efficacy and safety criteria assessed, the data quality assurance procedures and the statistical methods planned for the analysis of the data obtained.
11. Trial Subjects:
A clear accounting of all trial Subjects who entered the study will be given here. Mention should also be made of all cases that were dropouts or protocol deviations. Enumerate the patients screened, randomised, and prematurely discontinued. State reasons for premature discontinuation of therapy in each applicable case.
12. Efficacy evaluation
The results of evaluation of all the efficacy variables will be described in this section with appropriate tabular and graphical representation. A brief description of the demographic characteristics of the trial patients should also be provided along with a listing of patients and observations excluded from efficacy analysis.
13. Safety Evaluation:
This section should include the complete list
13.1 All serious adverse events, whether expected or unexpected and
13.2 unexpected advese events whether serious or not (compiled from data received as per Appendix XI).
The comparison of adverse events across study groups may be presented in a tabular or graphical form. This section should also give a brief narrative of all important events considered related to the investigational product.
14. Discussion and overall Conclusion:
Discussion of the important conclusions derived from the trial and scope for further development.
15. List of References:
16. Appendices:
List of Appendices to the Clinical Trial Report
(a) Protocol and amendments
(b) Specimen of Case Record Form
(c) Investigators‘ name(s) with contact addresses, phone, e-mail etc. (d) Patient data listings
(e) List of trial participants treated with investigational product
(f) Discontinued participants
(g) Protocol deviations
(h) CRFs of cases involving death and life threatening adverse event cases
(i) Publications from the trial
(j) Important publications referenced in the study
(k) Audit certificate, if available
(l) Investigator‘s certificate that he/she has read the report and that the report accurately describes the conduct and the results of the study.
APPENDIX III
ANIMAL TOXICOLOGY (NON-CLINICAL TOXICITY STUDIES)
1. General Principles:
Toxicity studies should comply with the norms of Good Laboratory Practice (GLP). Briefly, these studies should be performed by suitably trained and qualified staff employing properly calibrated and standardized equipment of adequate size and capacity. Studies should be done as per written protocols with modifications (if any) verifiable retrospectively. Standard operating procedures (SOPs) should be followed for all managerial and laboratory tasks related to these studies. Test substances and test systems (in-vitro or in-vivo) should be properly characterized and standardized. All documents belonging to each study, including its approved protocol, raw data, draft report, final report, and histology slides and paraffin tissue blocks should be preserved for a minimum of 5 years after marketing of the drug.
Toxicokinetic studies (generation of pharmacokinetic data either as an integral component of the conduct of non-clinical toxicity studies or in specially designed studies) should be conducted to assess the systemic exposure achieved in animals and its relationship to dose level and the time course of the toxicity study. Other objectives of toxicokinetic studies include obtaining data to relate the exposure achieved in toxicity studies to toxicological findings and contribute to the assessment of the relevance of these findings to clinical safety, to support the choice of species and treatment regimen in nonclinical toxicity studies and to provide information which, in conjunction with the toxicity findings, contributes to the design of subsequent non-clinical toxicity studies.
1.1 Systemic Toxicity Studies
1.1.1 Single-dose Toxicity Studies: These studies (see Appendix I item 4.2) should be carried out in 2 rodent species (mice and rats) using the same route as intended for humans. In addition, unless the intended route of administration in humans is only intravenous, at least one more route should be used in one of the species to ensure systemic absorption of the drug. This route should depend on the nature of the drug. A limit of 2g/kg (or 10 times the normal dose that is intended in humans, whichever is higher) is recommended for oral dosing. Animals should be observed for 14 days after the drug administration, and minimum lethal dose (MLD) and maximum tolerated dose (MTD) should be established. If possible, the target organ of toxicity should also be determined. Mortality should be observed for up to 7 days after parenteral administration and up to 14 days after oral administration. Symptoms, signs and mode of death should be reported, with appropriate macroscopic and microscopic findings where necessary. LD10 and LD50 should be reported preferably with 95 percent confidence limits. If LD50s cannot be determined, reasons for the same should be stated.
The dose causing severe toxic manifestations or death should be defined in the case of cytotoxic anticancer agents, and the post-dosing observation period should be up to 14 days. Mice should first be used for determination of MTD. Findings should then be confirmed in rat for establishing linear relationship between toxicity and body surface area. In case of nonlinearity, data of the more sensitive species should be used to determine the Phase I starting dose. Where rodents are known to be poor predictors of human toxicity (e.g., antifolates), or where the cytotoxic drug acts by a novel mechanism of action, MTD should be established in non-rodent species.
1.1.2 Repeated-dose Systemic Toxicity Studies: These studies (see Appendix I, item 4.2) should be carried out in at least two mammalian species, of which one should be a non- rodent. Dose ranging studies should precede the 14-, 28-, 90- or 180- day toxicity studies. Duration of the final systematic toxicity study will depend on the duration, therapeutic indication and scale of the proposed clinical trial (see item 1.8). If a species is known to metabolize the drug in the same way as humans, it should be preferred for toxicity studies.
In repeated-dose toxicity studies the drug should be administered 7 days a week by the route intended for clinical use. The number of animals required for these studies, i.e. the minimum number of animals on which data should be available, is shown in Item 1.9.
Wherever applicable, a control group of animals given the vehicle alone should be included, and three other groups should be given graded doses of the drug.
The highest dose should produce observable toxicity; the lowest dose should not cause observable toxicity, but should be comparable to the intended therapeutic dose in humans or a multiple of it . To make allowance for the sensitivity of the species the intermediate dose should cause some symptoms, but not gross toxicity or death, and should be placed logarithmically between the other two doses.
The parameters to be monitored and recorded in long-term toxicity studies should include behavioral, physiological, biochemical and microscopic observations. In case of parenteral drug administration, the sites of injection should be subjected to gross and microscopic examination. Initial and final electrocardiogram and fundus examination should be carried out in the non-rodent species.
In the case of cytotoxic anticancer agents dosing and study design should be in accordance with the proposed clinical schedule in terms of days of exposure and number of cycles. Two rodent species may be tested for initiating Phase I trials. A non-rodent species should be added if the drug has a novel mechanism of action, or if permission for Phase II, III or marketing is being sought.
For most compounds, it is expected that single dose tissue distribution studies with sufficient sensitivity and specificity will provide an adequate assessment of tissue distribution and the potential for accumulation. Thus, repeated dose tissue distribution studies should not be required uniformly for all compounds and should only be conducted when appropriate data cannot be derived from other sources. Repeated dose studies may be appropriate under certain circumstances based on the data from single dose tissue distribution studies, toxicity and toxicokinetic studies. The studies may be most appropriate for compounds which have an apparently long half life, incomplete elimination or unanticipated organ toxicity.
Notes:
(i) Single Dose Toxicity Study: Each group should contain at least 5 animals of either sex. At least four graded doses should be given. Animals should be exposed to the test substance in a single bolus or by continuous infusion or several doses within 24 hours. Animals should be observed for 14 days. Signs of intoxication, effect on body weight, gross pathological changes should be reported. It is desirable to include histo-pathology of grossly affected organs, if any.
(ii) Dose-ranging Study: Objectives of this study include the identification of target organ of toxicity and establishment of MTD for subsequent studies.
(a) Rodents: Study should be performed in one rodent species (preferably rat) by the proposed clinical route of administration. At least four graded doses including control should be given, and each dose group as well as the vehicle control should consist of a minimum of 5 animals of each sex. Animals should be exposed to the test substance daily for 10 consecutive days. Highest dose should be the maximum tolerated dose of single-dose study. Animals should be observed daily for signs of intoxication (general appearance, activity and behaviour etc), and periodically for the body weight and laboratory parameters. Gross examination of viscera and microscopic examination of affected organs should be done.
(b) Non-rodents: One male and one female are to be taken for ascending Phase MTD study. Dosing should start after initial recording of cage-side and laboratory parameters. Starting dose may be 3 to 5 times the extrapolated effective dose or MTD (whichever is less), and dose escalation in suitable steps should be done every third day after drawing the samples for laboratory parameters. Dose should be lowered appropriately when clinical or laboratory evidence of toxicity are observed. Administration of test substance should then continue for 10 days at the well-tolerated dose level following which, samples for laboratory parameters should be taken. Sacrifice, autopsy and microscopic examination of affected tissues should be performed as in the case of rodents.
(iii) 14-28 Day repeated-dose toxicity studies: One rodent (6-10/sex/group) and one non- rodent (2-3/sex/group) species are needed. Daily dosing by proposed clinical route at three dose levels should be done with highest dose having observable toxicity, mid- dose between high and low dose, and low dose. The doses should preferably be multiples of the effective dose and free from toxicity. Observation parameters should include cage- side observations, body weight changes, food/water intake, blood biochemistry, haematology, and gross and microscopic studies of all viscera and tissues.
(iv) 90-Day repeated-dose toxicity studies: One rodent (15-30/sex/group) and one non- rodent (4-6/sex/group) species are needed. Daily dosing by proposed clinical route at three graded dose levels should be done. In addition to the control a “high-dose-reversal” group and its control group should be also included. Parameters should include signs of intoxication (general appearance, activity and behaviour etc), body weight, food intake, blood biochemical parameters, haematological values, urine analysis, organ weights, gross and microscopic study of viscera and tissues. Half the animals in “reversal” groups (treated and control) should be sacrificed after 14 days of stopping the treatment. The remaining animals should be sacrificed after 28 days of stopping the treatment or after the recovery of signs and/or clinical pathological changes – whichever comes later, and evaluated for the parameters used for the main study.
(v) 180-Day repeated-dose toxicity studies: One rodent (15-30/sex/group) and one non- rodent (4-6/sex/group) species are needed. At least 4 groups, including control, should be taken. Daily dosing by proposed clinical route at three graded dose levels should be done. Parameters should include signs of intoxication, body weight, food intake, blood biochemistry, hematology, urine analysis, organ weights, gross and microscopic examination of organs and tissues.
1.2 Male Fertility Study
One rodent species (preferably rat) should be used. Dose selection should be done from the results of the previous 14 or 28-day toxicity study in rat. Three dose groups, the highest one showing minimal toxicity in systemic studies, and a control group should be taken. Each group should consist of 6 adult male animals. Animals should be treated with the test substance by the intended route of clinical use for minimum 28 days and maximum 70 days before they are paired with female animals of proven fertility in a ratio of 1:2 for mating.
Drug treatment of the male animals should continue during pairing. Pairing should be continued till the detection of vaginal plug or 10 days, whichever is earlier. Females getting thus pregnant should be examined for their fertility index after day 13 of gestation. All the male animals should be sacrificed at the end of the study. Weights of each testis and epididymis should be separately recorded. Sperms from one epididymis should be examined for their motility and morphology. The other epididymis and both testes should be examined for their histology.
1.3 Female Reproduction and Developmental Toxicity Studies
These studies (see Appendix I, item 4.4) need to be carried out for all drugs proposed to be studied or used in women of child bearing age. Segment I, II and III studies (see below) are to be performed in albino mice or rats, and segment II study should include albino rabbits also as a second test species.
On the occasion, when the test article is not compatible with the rabbit (e.g. antibiotics which are effective against gram positive, anaerobic organisms and protozoas) the Segment II data in the mouse may be substituted.
1.3.1 Female Fertility Study (Segment I):
The study should be done in one rodent species (rat preferred). The drug should be administered to both males and females, beginning a sufficient number of days (28 days in males and 14 days in females) before mating. Drug treatment should continue during mating and, subsequently, during the gestation period. Three graded doses should be used, the highest dose (usually the MTD obtained from previous systemic toxicity studies) should not affect general health of the parent animals. At least 15 males and 15 females should be used per dose group. Control and the treated groups should be of similar size. The route of administration should be the same as intended for therapeutic use Dams should be allowed to litter and their medication should be continued till the weaning of pups. Observations on body weight, food intake, clinical signs of intoxication, mating behaviour, progress of gestation/ parturition periods, length of gestation, parturition, post-partum health and gross pathology (and histopathology of affected organs) of dams should be recorded. The pups from both treated and control groups should be observed for general signs of intoxication, sex-wise distribution in different treatment groups, body weight, growth parameters, survival, gross examination, and autopsy. Histopathology of affected organs should be done.
1.3.2 Teratogenicity Study (Segment II):
One rodent (preferably rat) and one non-rodent (rabbit) species are to be used. The drug should be administered throughout the period of organogenesis, using three dose levels as described for segment I. The highest dose should cause minimum maternal toxicity and the lowest one should be proportional to the proposed dose for clinical use in humans or a multiple of it. The route of administration should be the same as intended for human therapeutic use.
The control and the treated groups should consist of at least 20 pregnant rats (or mice) and 12 rabbits, on each dose level. All foetuses should be subjected to gross examination, one of the foetuses should be examined for skeletal abnormalities and the other half for visceral abnormalities. Observation parameters should include: (Dams) signs of intoxication, effect on body weight, effect on food intake, examination of uterus, ovaries and uterine contents, number of corpora lutea, implantation sites, resorptions (if any); and for the foetuses, the total number, gender, body length, weight and gross/ visceral/ skeletal abnormalities, if any.
1.3.3 Perinatal Study (Segment III):
This study is specially recommended if the drug is to be given to pregnant or nursing mothers for long periods or where there are indications of possible adverse effects on foetal development. One rodent species (preferably rat) is needed. Dosing at levels comparable to multiples of human dose should be done by the intended clinical route. At least 4 groups (including control), each consisting of 15 dams should be used. The drug should be administered throughout the last trimester of pregnancy (from day 15 of gestation) and then the dose that causes low foetal loss should be continued throughout lactation and weaning. Dams should then be sacrificed and examined as described below.
One male and one female from each litter of F1 generation (total 15 males and 15 females in each group) should be selected at weaning and treated with vehicle or test substance (at the dose levels described above) throughout their periods of growth to sexual maturity, pairing, gestation, parturition and lactation. Mating performance and fertility of F1 generation should thus be evaluated to obtain the F2 generation whose growth parameters should be monitored till weaning. The criteria of evaluation should be the same as described earlier (3.4.1).
Animals should be sacrificed at the end of the study and the observation parameters should include (Dams) body weight, food intake, general signs of intoxication, progress of gestation/ parturition periods and gross pathology (if any); and for pups, the clinical signs, sex-wise distribution in dose groups, body weight, growth parameters, gross examination, survival and autopsy (if needed) and where necessary, histopathology.
1.4 Local toxicity
These studies (see Appendix I, item 4.5) are required when the new drug is proposed to be used by some special route (other than oral) in humans. The drug should be applied to an appropriate site (e.g., skin or vaginal mucous membrane) to determine local effects in a suitable species. Typical study designs for these studies should include three dose levels and untreated and/ or vehicle control, preferably use of 2 species, and increasing group size with increase in duration of treatment. Where dosing is restricted due to anatomical or humane reasons, or the drug concentration cannot be increased beyond a certain level due to the problems of solubility, pH or tonicity, a clear statement to this effect should be given. If the drug is absorbed from the site of application, appropriate systemic toxicity studies will also be required.
Notes:
(i) Dermal toxicity study: The study should be done in rabbit and rat. Daily topical (dermal) application of test substance in its clinical dosage form should be done. Test material should be applied on shaved skin covering not less than 10% of the total body surface area. Porous gauze dressing should be used to hold liquid material in place. Formulations with different concentrations (at least 3) of test substance, several fold higher than the clinical dosage form should be used. Period of application may vary from 7 to 90 days depending on the clinical duration of use. Where skin irritation is grossly visible in the initial studies, a recovery group should be included in the subsequent repeated-dose study. Local signs (erythema, oedema and eschar formation) as well as histological examination of sites of application should be used for evaluation of results.
(ii) Photo-allergy or dermal photo-toxicity: It should be tested by Armstrong/ Harber Test in guinea pig. This test should be done if the drug or a metabolite is related to an agent causing photosensitivity or the nature of action suggests such a potential (e.g., drugs to be used in treatment of leucoderma). Pretest in 8 animals should screen 4 concentrations (patch application for 2 hours ±15 min.) with and without UV exposure (10 J/cm2). Observations recorded at 24 and 48 hours should be used to ascertain highest nonirritant dose. Main test should be performed with 10 test animals and 5 controls. Induction with the dose selected from pretest should use 0.3 ml/patch for 2 hour ±15 min. followed by 10 J/cm2 of UV exposure. This should be repeated on day 0, 2,4,7,9 and 11 of the test. Animals should be challenged with the same concentration of test substance between day 20 to 24 of the test with a similar 2-hour application followed by exposure to 10 J/cm2 of UV light. Examination and grading of erythema and oedema formation at the challenge sites should be done 24 and 48 hours after the challenge. A positive control like musk ambrett or psoralin should be used.
(iii) Vaginal Toxicity Test: Study is to be done in rabbit or dog. Test substance should be applied topically (vaginal mucosa) in the form of pessary, cream or ointment. Six to ten animals per dose group should be taken. Higher concentrations or several daily applications of test substance should be done to achieve multiples of daily human dose. The minimum duration of drug treatment is 7 days (more according to clinical use), subject to a maximum of 30 days. Observation parameters should include swelling, closure of introitus and histopathology of vaginal wall.
(iv) Rectal Tolerance Test: For all preparations meant for rectal administration this test may be performed in rabbits or dogs. Six to ten animals per dose group should be taken. Formulation in volume comparable to human dose (or the maximum possible volume) should be applied once or several times daily, per rectally, to achieve administration of multiples of daily human dose. The minimum duration of application is 7 days (more according to clinical use), subject to a maximum of 30 days. Size of suppositories may be smaller, but the drug content should be several fold higher than the proposed human dose. Observation parameters should include clinical signs (sliding on backside), signs of pain, blood and/or mucus in faeces, condition of anal region/sphincter, gross and (if required) histological examination of rectal mucosa.
(v) Parenteral Drugs: For products meant for intravenous or intramuscular or subcutaneous or intradermal injection the sites of injection in systemic toxicity studies should be specially examined grossly and microscopically. If needed, reversibility of adverse effects may be determined on a case to case basis.
(vi) Ocular toxicity studies (for products meant for ocular instillation): These studies should be carried out in two species, one of which should be the albino rabbit which has a sufficiently large conjunctival sac. Direct delivery of drug onto the cornea in case of animals having small conjunctival sacs should be ensured. Liquids, ointments, gels or soft contact lenses (saturated with drug) should be used. Initial single dose application should be done to decide the exposure concentrations for repeated-dose studies and the need to include a recovery group. Duration of the final study will depend on the proposed length of human exposure subject to a maximum of 90 days. At least two different concentrations exceeding the human dose should be used for demonstrating the margin of safety. In acute studies, one eye should be used for drug administration and the other kept as control. A separate control group should be included in repeated-dose studies.
Slit-lamp examination should be done to detect the changes in cornea, iris and aqueous humor. Fluorescent dyes (sodium fluorescein, 0.25 to 1.0%) should be used for detecting the defects in surface epithelium of cornea and conjunctiva. Changes in intra-ocular tension should be monitored by a tonometer. Histological examination of eyes should be done at the end of the study after fixation in Davidson‘s or Zenker‘s fluid.
(vii) Inhalation toxicity studies: The studies are to be undertaken in one rodent and one non-rodent species using the formulation that is to be eventually proposed to be marketed. Acute, subacute and chronic toxicity studies should be performed according to the intended duration of human exposure. Standard systemic toxicity study designs (described above) should be used. Gases and vapours should be given in whole body exposure chambers; aerosols are to be given by nose-only method. Exposure time and concentrations of test substance (limit dose of 5mg/l) should be adjusted to ensure exposure at levels comparable to multiples of intended human exposure. Three dose groups and a control (plus vehicle control, if needed) are required. Duration of exposure may vary subject to a maximum of 6 hours per day and five days a week. Food and water should be withdrawn during the period of exposure to test substance.
Temperature, humidity and flow rate of exposure chamber should be recorded and reported. Evidence of exposure with test substance of particle size of 4 micron (especially for aerosols) with not less that 25% being 1 micron should be provided. Effects on respiratory rate, findings of bronchial lavage fluid examination, histological examination of respiratory passages and lung tissue should be included along with the regular parameters of systemic toxicity studies or assessment of margin of safety.
1.5 Allergenicity/ Hypersensitivity:
Standard tests include guinea pig maximization test (GPMT) and local lymph node assay (LLNA) in mouse. Any one of the two may be done.
Notes:
(i) Guinea Pig Maximization Test: The test is to be performed in two steps; first, determination of maximum nonirritant and minimum irritant doses, and second, the main test. The initial study will also have two components. To determine the intradermal induction dose, 4 dose levels should be tested by the same route in a batch of 4 male and 4 female animals (2 of each sex should be given Freund‘s adjuvant). The minimum irritant dose should be used for induction. Similarly, a topical minimum irritant dose should be determined for challenge. This should be established in 2 males and 2 females. A minimum of 6 male and 6 female animals per group should be used in the main study. One test and one control group should be used. It is preferable to have one more positive control group. Intradermal induction (day 1) coupled with topical challenge (day 21) should be done. If there is no response, re-challenge should be done 7-30 days after the primary challenge. Erythema and oedema (individual animal scores as well as maximization grading) should be used as evaluation criteria.
(ii) Local Lymph Node Assay: Mice used in this test should be of the same sex, either only males or only females. Drug treatment is to be given on ear skin. Three graded doses, the highest being maximum nonirritant dose plus vehicle control should be used. A minimum of 6 mice per group should be used. Test material should be applied on ear skin on three consecutive days and on day 5, the draining auricular lymph nodes should be dissected out 5 hours after i.v. H-thymidine or bromo-deoxy-uridine (BrdU). Increase in H- thymidine or BrdU incorporation should be used as the criterion for evaluation of results.
1.6 Genotoxicity
Genotoxic compounds, in the absence of other data, shall be presumed to be trans- species carcinogens, implying a hazard to humans. Such compounds need not be subjected to long-term carcinogenicity studies. However, if such a drug is intended to be administered for chronic illnesses or otherwise over a long period of time – a chronic toxicity study (up to one year) may be necessary to detect early tumorigenic effects.
Genotoxicity tests are in vitro and in vivo tests conducted to detect compounds which induce genetic damage directly or indirectly. These tests should enable a hazard identification with respect to damage to DNA and its fixation.
The following standard test battery is generally expected to be conducted:
(i) A test for gene mutation in bacteria.
(ii) An in vitro test with cytogenetic evaluation of chromosomal damage with mammalian cells or an in vitro mouse lymphoma tic assay.
(iii) An in vivo test for chromosomal damage using rodent haematopoietic cells. Other genotoxicity tests e.g. tests for measurement of DNA adducts, DNA strand
breaks, DNA repair or recombination serve as options in addition to the standard battery for further investigation of genotoxicity test results obtained in the standard battery. Only under extreme conditions in which one or more tests comprising the standard battery cannot be employed for technical reasons, alternative validated tests can serve as substitutes provided sufficient scientific justification should be provided to support the argument that a given standard battery test is not appropriate.
Both in-vitro and in-vivo studies should be done. In-vitro studies should include Ames‘ Salmonella assay and chromosomal aberrations (CA) in cultured cells. In-vivo studies should include micronucleus assay (MNA) or CA in rodent bone marrow. Data analysis of CA should include analysis of ‘gaps.‘
Cytotoxic anticancer agents: Genotoxicity data are not required before Phase I and II trials. But these studies should be completed before applying for Phase III trials.
Notes:
Ames‘ Test (Reverse mutation assay in Salmonella): S. typhimurium tester strains such as TA98, TA100, TA102, TA1535, TA97 or Escherichia coli WP2 uvrA or Escherichia coli WP2 uvrA (pKM101) should be used.
(i) In-vitro exposure (with and without metabolic activation, S9 mix) should be done at a minimum of 5 log dose levels. “Solvent” and “positive” control should be used. Positive control may include 9-amino-acridine, 2-nitrofluorine, sodium azide and mitomycin C, respectively, in the tester strains mentioned above. Each set should consist of at least three replicates. A 2.5 fold (or more) increase in number of revertants in comparison to spontaneous revertants would be considered positive.
(ii) In-vitro cytogenetic assay : The desired level of toxicity for in vitro cytogenetic tests using cell lines should be greater than 50% reduction in cell number or culture confluency. For lymphocyte cultures, an inhibition of mitotic index by greater than 50% is considered sufficient. It should be performed in CHO cells or on human lymphocyte in culture. In-vitro exposure (with and without metabolic activation, S9 mix) should be done using a minimum of 3 log doses. “Solvent” and “positive” control should be included. A positive control like Cyclophosphamide with metabolic activation and Mitomycin C for without metabolic activation should be used to give a reproducible and detectable increase clastogenic effect over the background which demonstrates the sensitivity of the test system. Each set should consist of at least three replicates. Increased number of aberrations in metaphase chromosomes should be used as the criteria for evaluation.
(iii) In-vivo micronucleus assay: One rodent species (preferably mouse) is needed. Route of administration of test substance should be the same as intended for humans. Five animals per sex per dose groups should be used. At least three dose levels, plus “solvent” and “positive” control should be tested. A positive control like mitomycin C or cyclophosphamide should be used. Dosing should be done on day 1 and 2 of study followed by sacrifice of animals 6 hours after the last injection. Bone marrow from both the femora should be taken out, flushed with fetal bovine serum (20 min.), pelletted and smeared on glass slides. Giemsa-MayGruenwald staining should be done and increased number of micronuclei in polychromatic erythrocytes (minimum 1000) should be used as the evaluation criteria.
(iv) In-vivo cytogenetic assay: One rodent species (preferably rat) is to be used. Route of administration of test substance should be the same as intended for humans. Five animals/sex/dose groups should be used. At least three dose levels, plus “solvent” and “positive” control should be tested. Positive control may include cyclophosphamide. Dosing should be done on day 1 followed by intra-peritoneal colchicine administration at 22 hours. Animals should be sacrificed 2 hours after colchicine administration. Bone marrow from both the femora should be taken out, flushed with hypotonic saline (20 min.), pelletted and resuspended in Carnoy‘s fluid. Once again the cells should be pelletted and dropped on clean glass slides with a Pasteur pipette. Giemsa staining should be done and increased number of aberrations in metaphase chromosomes (minimum 100) should be used as the evaluation criteria.
1.7 Carcinogenicity (see Appendix I, item 4.8)
Carcinogenicity studies should be performed for all drugs that are expected to be clinically used for more than 6 months as well as for drugs used frequently in an intermittent manner in the treatment of chronic or recurrent conditions. Carcinogenicity studies are also to be performed for drugs if there is concern about their carcinogenic potential emanating from previous demonstration of carcinogenic potential in the product class that is considered relevant to humans or where structure-activity relationship suggests carcinogenic risk or when there is evidence of preneoplastic lesions in repeated dose toxicity studies or when long-term tissue retention of parent compound or metabolite(s) results in local tissue reactions or other pathophysiological responses.
For pharmaceuticals developed to treat certain serious diseases, Licensing Authority may allow carcinogenicity testing to be conducted after marketing permission has been granted.
In instances where the life-expectancy in the indicated population is short (i.e., less than 2-3 years)- no long-term carcinogenicity studies may be required. In cases where the therapeutic agent for cancer is generally successful and life is significantly prolonged there may be later concerns regarding secondary cancers. When such drugs are intended for adjuvant therapy in tumour free patients or for prolonged use in non-cancer indications, carcinogenicity studies may be / are needed. Completed rodent carcinogenicity studies are not needed in advance of the conduct of large scale clinical trials, unless there is special concern for the patient population.
Carcinogenicity studies should be done in a rodent species (preferably rat). Mouse may be employed only with proper scientific justification. The selected strain of animals should not have a very high or very low incidence of spontaneous tumors.
At least three dose levels should be used. The highest dose should be sub-lethal, and it should not reduce the life span of animals by more than 10% of expected normal. The lowest dose should be comparable to the intended human therapeutic dose or a multiple of it, e.g. 2.5x; to make allowance for the sensitivity of the species. The intermediate dose to be placed logarithmically between the other two doses. An untreated control and (if indicated) a vehicle control group should be included. The drug should be administered 7 days a week for a fraction of the life span comparable to the fraction of human life span over which the drug is likely to be used therapeutically. Generally, the period of dosing should be 24 months for rats and 18 months for mice.
Observations should include macroscopic changes observed at autopsy and detailed histopathology of organs and tissues. Additional tests for carcinogenicity (short-term bioassays, neonatal mouse assay or tests employing transgenic animals) may also be done depending on their applicability on a case to case basis.
Note:
Each dose group and concurrent control group not intended to be sacrificed early should contain atleast 50 animals of each sex. A high dose sattelite group for evaluation of pathology other than neoplasia should contain 20 animals of each sex while the sattelite control group should contain 10 animals of each sex. Observation parameters should include signs of intoxication, effect on body weight, food intake, clinical chemistry parameters, hematology parameters, urine analysis, organ weights, gross pathology and detailed histopathology. Comprehensive descriptions of benign and malignant tumour development, time of their detection, site, dimensions, histological typing etc. should be given.
1.8 Animal toxicity requirements for clinical trials and marketing of a new drug.
Systemic Toxicity Studies
| Route of administration |
Duration of proposed human administration |
Human Phase(s) for which study is proposed to be conducted |
Long term toxicity requirements |
| 1[Oral or Parenteral or Transdermal |
Single dose or several doses in one day, Upto 1wk |
I,II,III |
2sp,2wks |
|
> 1 wk but upto 2wks |
I,II,III |
2sp;4wks |
|
Upto 2 wks |
Marketing permission |
2sp;4wks |
|
> 2 wk but upto 4wks |
I,II,III |
2 sp; equal to duration of human exposure |
|
|
Marketing permission |
2 sp; 12 wks |
|
> 4 wks but upto 12 wks |
I,II,III |
2 sp; equal to duration of human exposure |
|
|
Marketing permission |
2sp;24wks |
|
> 12 wks but upto 24 wks |
I,II,III |
2 sp; equal to duration of human exposure |
|
|
Marketing permission |
2 sp; Rodent 24 wks, non-rodent 36 wks |
|
> 24 wks |
I,II,III |
2 sp; Rodent 24 wks, non-rodent 36 wks |
|
|
Marketing permission |
2 sp; Rodent 24 wks, non-rodent 36 wks] |
| Inhalation (general anaesthetics, aerosols) |
Upto 2 wk |
I,II,III |
2sp;1mo; (Exposure time 3h/d, |
|
Upto 4wk |
I,II,III |
2sp;12wk,(Exposure time 6h/d, 5d/wk) |
|
> 1 4wk |
I,II,III |
2sp;24wk, (Exposure time 6h/d, 5d/wk) |
| Local Toxicity Studies Dermal |
Upto 2 wk |
I,II, |
1sp;4wk |
|
|
III |
2sp;4wk |
|
> 2 wk |
I,II,III |
2sp;12wk |
| Ocular or Otic or Nasal |
Upto 2 wk |
I,II |
1sp;4wk |
|
|
III |
2sp;4wk |
|
> 2 wk |
I,II,III |
2sp;12wk |
| Vaginal or Rectal |
Upto 2 wk |
I,II |
1sp;4wk |
|
|
III |
2sp;4wk |
|
> 2 wk |
I,II,III |
2sp;12wk |
1. Subs. by G.S.R. 287(E), dt. 08.3.2016.
Special Toxicity Studies Male Fertility Study:
• 1[Phase III in male volunteers/patients]
Female Reproduction and Developmental Toxicity Studies:
• Segment II studies in 2 species; Phase II, III involving female patients of child- bearing age.
• Segment I study; Phase III involving female patients of child-bearing age.
• Segment III study; Phase III for drugs to be given to pregnant or nursing mothers for long periods or where there are indications of possible adverse effects on foetal development.
Allergenicity/Hypersensitivity: Phase I, II, III – when there is a cause of concern or for parenteral drugs (including derrmal application).
Photo-allergy or dermal photo-toxicity:
• Phase I, II, III – if the drug or a metabolite is related to an agent causing photosensitivity or the nature of action suggests such a potential.
Genotoxicity:
• In-vitro studies – Phase I
• Both in-vitro and in-vivo – Phase II, III
Arcinogenicity:
• Phase III – when there is a cause for concern, or when the drug is to be used for more than 6 months.
Abbreviations: sp-species; mo-month; wk-week; d -day; h-hour; I, II, III – Phases of clinical trial;
Note:
1. Animal toxicity data generated in other countries may be accepted and may not be asked to be repeated/duplicated in India on a case to case basis depending upon the quality of data and the credentials of the laboratory(ies) where such data has been generated.
2. Requirements for fixed dose combinations are given in Appendix VI.
1.9 Number of animals required for repeated-dose toxicity studies
|
14-28 days |
84-182 days |
| Group |
Rodent (Rat) |
Non-rodent (Dog Monkey) or |
Rodent (Rat) |
Non-rodent (Dog Monkey) or |
|
M |
F |
M |
F |
M |
F |
M |
F |
| Control |
6-10 |
6-10 |
2-3 |
2-3 |
15-30 |
15-30 |
4-6 |
4-6 |
| Low dose |
6-10 |
6-10 |
2-3 |
2-3 |
15-30 |
15-30 |
4-6 |
4-6 |
| Intermediate dose |
6-10 |
6-10 |
2-3 |
2-3 |
15-30 |
15-30 |
4-6 |
4-6 |
| High dose |
6-10 |
6-10 |
2-3 |
2-3 |
15-30 |
15-30 |
4-6 |
4-6 |
1. Subs. by G.S.R. 287(E), dt. 08.3.2016.
2.0 Laboratory parameters to be included in toxicity studies.
Haematological parameters
| • Haemoglobin |
• Total RBC Count |
• Haematocrit |
• Reticulocyte Count |
| • Total WBC Count |
• Differential WBC Count |
• Platelet Count |
• Terminal Bone Marrow Examination |
| • ESR (Non- rodents only) |
• General Blood Picture: A special mention of abnormal and immature cells should be made. |
• Coagulation Parameters (Non-rodents only): Bleeding Time, Coagulation Time, Prothrombin Time,
Activated Partial Thromboplastin Time |
|
Urinalysis Parameters:
| • Colour |
• Appearance |
• Specific Gravity |
• 24-hour urinaryoutput |
| • Reaction (pH) |
• Albumin |
•Sugar |
• Acetone |
| • Bile pigments |
• Urobilinogen |
• Occult Blood |
• Microscopic examination of urinary sediment. |
Blood Biochemical Parameters
| • Glucose |
• Cholesterol |
• Triglycerides |
• HDL Cholesterol (Non- rodents only) |
| • LDL Cholesterol (Non-rodents only) |
• Bilirubin |
• SGPT (ALT) |
• SGOT (AST) |
| • Alkaline Phosphatase (ALP) |
• GGT (Non-rodents only) |
• Blood Urea Nitrogen |
• Ceatinine |
| • Total Proteins |
• Albumin |
• Globulin (Calculated values) |
•Sodium |
| • Potassium |
• Phosphorus |
• Calcium |
|
Gross and Microscopic Pathology
| • Brain*: Cerebrum, cerebellum, Midbrain |
• (Spinal Cord) |
• Eye |
• (Middle Ear) |
| • Thyroid |
• Parathyroid) |
• Spleen |
• Thymus |
| • Adrenal* |
• (Pancreas) |
• (Trachea) |
• Lung* |
| • Heart* |
• Aorta |
• Oesophagus |
• Stomach |
| • Duodenum |
• Jejunum |
• Terminal ileum |
• Colon |
| • (Rectum) |
• Liver* |
• Kidney* |
• Urinary bladder |
| • Epididymis |
• Testis* |
• Ovary |
• Uterus* |
| • Skin |
• Mammary |
• Mesenteric |
• Skeletal muscle gland lymph node |
* Organs marked with an asterisk should be weighed.
() Organs listed in parenthesis should be examined if indicated by the nature of the drug or observed effects.
Non-clinical toxicity testing and safety evaluation data of an IND needed for the conduct of different phases of clinical trials.
Note: Refer Appendix III (Points 1.1 through 1.7 and tables 1.8 and 1.9) for essential features of study designs of the non-clinical toxicity studies listed below.
For Phase I Clinical Trials
Systemic Toxicity studies
(i) Single dose toxicity studies
(ii) Dose Ranging Studies
(iii) Repeat-dose systemic toxicity studies of appropriate duration to support the duration of proposed human exposure.
Male fertility study
In-vitro genotoxicity tests
Relevant local toxicity studies with proposed route of clinical application (duration depending on proposed length of clinical exposure)
Allergenicity/Hypersensitivity tests (when there is a cause for concern or for parenteral drugs, including dermal application)
Photo-allergy or dermal photo-toxicity test (if the drug or a metabolite is related to an agent causing photosensitivity or the nature of action suggests such a potential)
For Phase II Clinical Trials
Provide a summary of all the non-clinical safety data (listed above) already submitted while obtaining the permissions for Phase I trial, with appropriate references.
In case of an application for directly starting a Phase II trial – complete details of the non- clinical safety data needed for obtaining the permission for Phase I trial, as per the list provided above must be submitted.
Repeat-dose systemic toxicity studies of appropriate duration to support the duration of proposed human exposure
In-vivo genotoxicity tests-
Segment II reproductive/developmental toxicity study (if female patients of child bearing age are going to be involved)
For Phase III Clinical Trials
Provide a summary of all the non-clinical safety data (listed above) already submitted while obtaining the permissions for Phase I and II trials, with appropriate references.
In case of an application for directly initiating a Phase III trial – complete details of the non-clinical safety data needed for obtaining the permissions for Phase I and II trials, as per the list provided above must be provided.
Repeat-dose systemic toxicity studies of appropriate duration to support the duration of proposed human exposure
Reproductive/developmental toxicity studies
Segment I (if female patients of child bearing age are going to be involved), and
Segment III (for drugs to be given to pregnant or nursing mothers or where there are indications of possible adverse effects on foetal development).
Carcinogenicity studies (when there is a cause for concern or when the drug is to be used for more than 6 months).
For Phase IV Clinical Trials
Provide a summary of all the non-clinical safety data (listed above) already submitted while obtaining the permissions for Phase I, II and III trials, with appropriate references.
In case an application is made for initiating the Phase IV trial, complete details of the non-clinical safety data needed for obtaining the permissions for Phase I, II and III trials, as per the list provided above must be submitted.
Application Of Good Laboratory Practices (GLP)
The animal studies be conducted in an accredited laboratory. Where the safety pharmacology studies are part of toxicology studies, these studies should also be conducted in an accredited laboratory.
APPENDIX IV
ANIMAL PHARMACOLOGY
1. General Principles
Specific and general pharmacological studies should be conducted to support use of therapeutics in humans. In the early stages of drug development enough information may not be available to rationally select study design for safety assessment. In such a situation, a general approach to safety pharmacology studies can be applied. Safety pharmacology studies are studies that investigate potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure within the therapeutic range or above.
1.1 Specific Pharmacological Actions
Specific pharmacological actions are those which demonstrate the therapeutic potential for humans.
The specific studies that should be conducted and their design will be different based on the individual properties and intended uses of investigational drug. Scientifically validated methods should be used. The use of new technologies and methodologies in accordance with sound scientific principles should be preferred.
1.2 General Pharmacological Actions
1.2.1 Essential Safety Pharmacology
Safety pharmacology studies need to be conducted to investigate the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure within the therapeutic range and above. These studies should be designed to identify undesirable pharmacodynamic properties of a substance that may have relevance to its human safety; to evaluate adverse pharmacodynamic and/or pathophysiological effects observed in toxicology and/or clinical studies; and to investigate the mechanism of the adverse pharmacodynamic effects observed and/or suspected.
The aim of the essential safety pharmacology is to study the effects of the test drug on vital functions. Vital organ systems such as cardiovascular, respiratory and central nervous systems should be studied. Essential safety pharmacology studies may be excluded or supplemented based on scientific rationale. Also, the exclusion of certain test(s) or exploration(s) of certain organs, systems or functions should be scientifically justified.
1.2.1.1 Cardiovascular System
Effects of the investigational drug should be studied on blood pressure, heart rate, and the electrocardiogram. If possible in vitro, in vivo and/or ex vivo methods including electrophysiology should also be considered.
1.2.1.2 Central Nervous System
Effects of the investigational drug should be studied on motor activity, behavioral changes, coordination, sensory and motor reflex responses and body temperature.
1.2.1.3 Respiratory System
Effects of the investigational drug on respiratory rate and other functions such as tidal volume and hemoglobin oxygen saturation should be studied.
1.3 Follow-up and Supplemental Safety Pharmacology Studies
In addition to the essential safety pharmacological studies, additional supplemental and follow-up safety pharmacology studies may need to be conducted as appropriate. These depend on the pharmacological properties or chemical class of the test substance, and the data generated from safety pharmacology studies, clinical trials, pharmacovigilance, experimental in vitro or in vivo studies, or from literature reports.
1.3.1 Follow-up Studies For Essential Safety Pharmacology
Follow-up studies provide additional information or a better understanding than that provided by the essential safety pharmacology.
1.3.1.1 Cardiovascular System
These include ventricular contractility, vascular resistance and the effects of chemical mediators, their agonists and antagonists on the cardiovascular system.
1.3.1.2 Central Nervous System
These include behavioral studies , learning and memory, electrophysiology studies , neurochemistry and ligand binding studies.
1.3.1.3 Respiratory System
These include airway resistance, compliance, pulmonary arterial pressure, blood gases and blood pH.
1.3.2 Supplemental Safety Pharmacology Studies
These studies are required to investigate the possible adverse pharmacological effects that are not assessed in the essential safety pharmacological studies and are a cause for concern.
1.3.2.1 Urinary System
These include urine volume, specific gravity, osmolality, pH, proteins, cytology and blood urea nitrogen, creatinine and plasma proteins estimation.
1.3.2.2 Autonomic Nervous System
These include binding to receptors relevant for the autonomic nervous system, and functional response to agonist or antagonist responses in vivo or in vitro, and effects of direct stimulation of autonomic nerves and their effects on cardiovascular responses.
1.3.2.3 Gastrointestinal System
These include studies on gastric secretion, gastric pH measurement, gastric mucosal examination, bile secretion, gastric emptying time in vivo and ileocaecal contraction in vitro.
1.3.2.4 Other Organ Systems
Effects of the investigational drug on organ systems not investigated elsewhere should be assessed when there is a cause for concern. For example dependency potential, skeletal muscle, immune and endocrine functions may be investigated.
1.4 Conditions Under Which Safety Pharmacology Studies Are Not Necessary
Safety pharmacology studies are usually not required for locally applied agents e.g. dermal or ocular, in cases when the pharmacology of the investigational drug is well known, and/or when systemic absorption from the site of application is low. Safety pharmacology testing is also not necessary, in the case of a new derivative having similar pharmacokinetics and pharmacodynamics.
1.5 Timing Of Safety Pharmacology Studies In Relation To Clinical Development
1.5.1 Prior To First Administration In Humans
The effects of an investigational drug on the vital functions listed in the essential safety pharmacology should be studied prior to first administration in humans. Any follow-up or supplemental studies identified, should be conducted if necessary, based on a cause for concern.
1.5.2 During Clinical Development
Additional investigations may be warranted to clarify observed or suspected adverse effects in animals and humans during clinical development
1.5.3 Before applying for marketing Approval
Follow-up and supplemental safety pharmacology studies should be assessed prior to approval unless not required, in which case this should be justified.
Available information from toxicology studies addressing safety pharmacology endpoints or information from clinical studies can replace such studies.
1.6 Application Of Good Laboratory Practices (GLP)
The animal studies be conducted in an accredited laboratory. Where the safety pharmacology studies are part of toxicology studies, these studies should also be conducted in an accredited laboratory.
APPENDIX V
INFORMED CONSENT
1. Checklist for study Subject‘s informed consent documents
1.1 Essential Elements:
1. Statement that the study involves research and explanation of the purpose of the research
2. Expected duration of the Subject’s participation.
3. Description of the procedures to be followed, including all invasive procedures and
4. Description of any reasonably foreseeable risks or discomforts to the Subject
5. Description of any benefits to the Subject or others reasonably expected from research. If no benefit is expected Subject should be made aware of this.
6. Disclosure of specific appropriate alternative procedures or therapies available to the Subject.
7. Statement describing the extent to which confidentiality of records identifying the Subject will be maintained and who will have access to Subject‘s medical records
8. Trial treatment schedule(s) and the probability for random assignment to each treatment (for randomized trials)
9. 1[Statement describing the financial compensation and medical management as under:
2[(a) In case of any injury occurring to the subject during the clinical trial, free medical management shall be given as long as required or till such time it is established that the injury is not related to the clinical trial, whichever is earlier.]
(b) In the event of a trial related injury or death, the Sponsor or his representative, whosoever has obtained permission from the Licensing Authority for conduct of the clinical trial, shall provide financial compensation for the injury or death].
10. An explanation about whom to contact for trial related queries, rights of Subjects and in the event of any injury
11. The anticipated prorated payment, if any, to the Subject for participating in the trial
12. Subject’s responsibilities on participation in the trial
13. Statement that participation is voluntary, that the subject can withdraw from the study at any time and that refusal to participate will not involve any penalty or loss of benefits to which the Subject is otherwise entitled.
3[14. Statement that there is a possibility of failure of investigational product to provide intended therapeutic effect.
15. Statement that in the case of placebo controlled trial, the placebo administered to the subjects shall not have any therapeutic effect.
16. Any other pertinent information.]
1.2 Additional elements, which may be required
(a) Statement of foreseeable circumstances under which the Subject’s participation may be terminated by the Investigator without the Subject’s consent.
(b) Additional costs to the Subject that may result from participation in the study.
(c) The consequences of a Subject‘s decision to withdraw from the research and procedures for orderly termination of participation by Subject.
(d) Statement that the Subject or Subject’s representative will be notified in a timely manner if significant new findings develop during the course of the research which may affect the Subject’s willingness to continue participation will be provided.
(e) A statement that the particular treatment or procedure may involve risks to the Subject (or to the embryo or fetus, if the Subject is or may become pregnant), which are currently unforeseeable
(f) Approximate number of Subjects enrolled in the study.
1. Subs. by G.S.R. 53(E), dt. 30-01-2013. 3. G.S.R. 611(E), dt. 31-7-2015.
2. Subs. by G.S.R. 889(E), dt. 12-12-2014.
2. Format of informed consent form for Subjects participating in a clinical trial
Informed Consent form to participate in a clinical trial
Study Title:
Study Number:
Subject‘s Initials: _________ Subject‘s Name:_____________
Date of Birth / Age: __________________
1[Address of the Subject
Qualification ________________
Occupation: Student/Self-Employed/ Service/Housewife/Others (Please tick as appropriate)
Annual Income of the subject __________
Name and address of the nominee(s) and his relation to the subject ________ (for the purpose of compensation in case of trial related death).]
Please initial box
(Subject)
(i) I confirm that I have read and understood the information sheet dated for the above study and have had the opportunity to ask questions. [ ]
(ii) I understand that my participation in the study is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected. [ ]
(iii) I understand that the Sponsor of the clinical trial, others working on the Sponsor‘s behalf, the Ethics Committee and the regulatory authorities will not need my permission to look at my health records both in respect of the current study and any further research that may be conducted in relation to it, even if I withdraw from the trial. I agree to this access. However, I understand that my identity will not be revealed in any information released to third parties or published.[ ]
(iv) I agree not to restrict the use of any data or results that arise from this study provided such a use is only for scientific purpose(s) [ ]
(v) I agree to take part in the above study. [ ]
Signature (or Thumb impression) of the Subject/Legally Acceptable Representative:
________
Date:____ / ____ / ____
Signatory‘s Name:________
Signature of the Investigator:________
Date:Study Investigator‘s Name:________
Signature of the Witness________
Date:____ /____ /____
Name of the Witness:________
1[Copy of the Patient Information Sheet and duly filled Informed Consent Form shall be handled over to the subject or his/her attendant.]
1. Ins. by G.S.R 53(E), dt. 30-01-2013
APPENDIX VI
FIXED DOSE COMBINATIONS (FDCs)
Fixed Dose Combinations refer to products containing one or more active ingredients used for a particular indication(s). FDCs can be divided into the following groups and data required for approval for marketing is described below:
(a) The first group of FDCs includes those in which one or more of the active ingredients is a new drug. For such FDCs to be approved for marketing data to be submitted will be similar to data required for any new drug (including clinical trials) [see rule 122E, item (a)].
(b)(i) The second group FDCs includes those in which active ingredients already approved/marketed individually are combined for the first time, for a particular claim and where the ingredients are likely to have significant interaction of a pharmacodynamic or pharmacokinetic nature [see rule 122E, item (c)]. If clinical trials have been carried out with the FDC in other countries, reports of such trials should be submitted. If the FDC is marketed abroad, the regulatory status in other countries should be stated. (see Appendix I, item 9).
(ii) For marketing permission, appropriate chemical and pharmaceutical data will be submitted. In case such a combination is not marketed anywhere in the world but these drugs are already in use concomitantly (not as an FDC but individually) for the said claim, marketing permission may be granted based on chemical and pharmaceutical data. Data showing the stability of the proposed dosage form will also have to be submitted.
(iii) For any other such FDCs, clinical trials may be required. For obtaining permission to carry out clinical trials with such FDCs a summary of available pharmacological, toxicological and clinical data on the individual ingredients should be submitted, along with the rationale for combining them in the proposed ratio. In addition, acute toxicity data (LD 50) and pharmacological data should be submitted on the individual ingredients as well as their combination in the proposed ratio.
(c) The third group of FDCs includes those which are already marketed, but in which it is proposed either to change the ratio of active ingredients or to make a new therapeutic claim. For such FDCs, the appropriate rationale including published reports (if any) should be submitted to obtain marketing permission. Permission will be granted depending upon the nature of the claim and data submitted.
(d) The fourth group of FDC includes those whose individual active ingredients (or drugs from the same class) have been widely used in a particular indication(s) for years, their concomitant use is often necessary and no claim is proposed to be made other than convenience. It will have to be demonstrated that the proposed dosage form is stable and the ingredients are unlikely to have significant interaction of a pharmacodynamic or pharmacokinetic nature.
No additional animal or human data are generally required for these FDCs, and marketing permission may be granted if the FDC has an acceptable rationale.
APPENDIX VII
UNDERTAKING BY THE INVESTIGATOR
1. Full name, address and title of the Principal Investigator (or Investigator(s) when there is no Principal Investigator)
2. Name and address of the medical college, hospital or other facility where the clinical trial will be conducted: Education, training & experience that qualify the Investigator for the clinical trial (Attach details including Medical Council registration number, and / or any other statement(s) of qualification(s))
3. Name and address of all clinical laboratory facilities to be used in the study.
4. Name and address of the Ethics Committee that is responsible for approval and continuing review of the study.
5. Names of the other members of the research team (Co- or sub-Investigators) who will be assisting the Investigator in the conduct of the investigation (s).
6. Protocol Title and Study number (if any) of the clinical trial to be conducted by the Investigator.
7. Commitments:
(i) I have reviewed the clinical protocol and agree that it contains all the necessary information to conduct the study. I will not begin the study until all necessary Ethics Committee and regulatory approvals have been obtained.
(ii) I agree to conduct the study in accordance with the current protocol. I will not implement any deviation from or changes of the protocol without agreement by the Sponsor and prior review and documented approval / favorable opinion from the Ethics Committee of the amendment, except where necessary to eliminate an immediate hazard(s) to the trial Subjects or when the change(s) involved are only logistical or administrative in nature.
(iii) I agree to personally conduct and/or supervise the clinical trial at my site.
(iv) I agree to inform all Subjects, that the drugs are being used for investigational purposes and I will ensure that the requirements relating to obtaining informed consent and ethics committee review and approval specified in the GCP guidelines are met.
(v) I agree to report to the Sponsor all adverse experiences that occur in the course of the investigation(s) in accordance with the regulatory and GCP guidelines.
(vi) I have read and understood the information in the Investigator’s brochure, including the potential risks and side effects of the drug.
(vii) I agree to ensure that all associates, colleagues and employees assisting in the conduct of the study are suitably qualified and experienced and they have been informed about their obligations in meeting their commitments in the trial.
(viii) I agree to maintain adequate and accurate records and to make those records available for audit / inspection by the Sponsor, Ethics Committee, Licensing Authority or their authorized representatives, in accordance with regulatory and GCP provisions. I will fully cooperate with any study related audit conducted by regulatory officials or authorized representatives of the Sponsor.
(ix) I agree to promptly report to the Ethics Committee all changes in the clinical trial activities and all unanticipated problems involving risks to human Subjects or others.
(x) I agree to inform all unexpected serious adverse events to the Sponsor as well as the Ethics Committee within seven days of their occurence.
(xi) I will maintain confidentiality of the identification of all participating study patients and assure security and confidentiality of study data.
(xii) I agree to comply with all other requirements, guidelines and statutory obligations as applicable to clinical Investigators participating in clinical trials
8. Signature of Investigator with Date
APPENDIX VIII
ETHICS COMMITTEE
1[I. Requirements and guidelines for registration of Ethics Committee
1. Scope:
Ethics Committee shall review every clinical trial proposal and evaluate the possible risks to the subjects, expected benefits and adequacy of documentation for ensuring privacy, confidentiality and justice. In the case of any serious adverse event occurring to the clinical trial subjects during the clinical trial, the Ethics Committee shall analyze and forward its opinion as per procedures specified in APPENDIX XII of Schedule Y.
2. Composition of Ethics Committee:
(a) Ethics Committee shall consist of not less than seven members and one among its members, who is from outside the institute, shall be appointed as Chairman; one member as a Member Secretary and rest of the members shall be from Medical, Scientific, Non-medical and Non-scientific fields including lay public.
(b) The committee shall include at least one member whose primary area of interest or specialization is Non-scientific and at least one member who is independent of the institution. Besides, there should be appropriate gender representation on the Ethics Committee.
(c) The Ethics Committee can have as its members, individuals from other Institutions or Communities, if required.
(d) Members should be conversant with the provisions of clinical trials under this Schedule, Good Clinical Practice Guidelines for clinical trials in India and other regulatory requirements to safeguard the rights, safety and well- being of the trial subjects.
(e) For review of each protocol the quorum of Ethics Committee shall be at least five members with the following representations:
(i) Basic medical scientist (preferably one pharmacologist)
(ii) Clinician;
(iii) Legal expert;
(iv) Social scientist or representative of non-governmental voluntary agency or philosopher or ethicist or theologian or a similar person;
(v) Lay person from community.
(f) The members representing medical scientists and clinicians should have post graduate qualification and adequate experience in their respective fields and aware of their role and responsibilities as committee members.
(g) As far as possible, based on the requirement of research area such as HIV, Genetic disorder etc., specific patient group may also be represented in the Ethics Committee.
(h) There should be no conflict of interest. The members shall voluntarily withdraw from the Ethics Committee meeting while making a decision on an application which evokes a conflict of interest which may be indicated in writing to the Chairman prior to the review and be recorded so in the minutes. All members shall sign a declaration on conflict of interest.
(i) Subject experts or other experts may be invited to the meetings for their advice. But no such expert shall have voting rights.
3. Information required to be submitted by the applicant for registration of Ethics Committee:
(a) Name of the Ethics Committee
(b) Authority under which the Ethics Committee has been constituted, membership requirements, the term of reference, conditions of appointment and the quorum required.
1. Subs. by G.S.R. 72(E), dt. 8-2-2013.
(c) The procedure for resignation, replacement or removal of members.
(d) Address of the office of the Ethics Committee.
(e) Name, address, qualification, organizational title, telephone number, fax number, email, mailing address and brief profile of the Chairman.
(f) Names, qualifications, organizational title, telephone number, fax number, e-mail and mailing address of the members of the Ethics Committee. The information shall also in clude member ‘s specialty (pr imary, scientific or non -scientific), member ‘s affiliation with institutions and patient group representation, if any.
(g) Details of the supporting staff.
(h) In the case of Ethics Committees existing before the publication of the Drugs and Cosmetics (Third Amendment) Rules, 2013,-
(i) Type of clinical research reviewed by the committee (e.g. pharmaceuticals, devices, epidemiological, retrospective, herbals, etc.)
(ii) Documents reviewed for every clinical trial protocol including Informed Consent documents.
(iii) In for mation in respect of number of meetings of the committee and documentation of the minutes of meetings of these committees concerning clinical trials.
(iv) Information regarding review of serious adverse events reported during the conduct of the trial.
(i) The Standard Operating Procedures to be followed by the committee in general.
(j) Standard Operating Procedures to be followed by the committee for vulnerable population.
(k) Policy regarding training for new and existing committee members along with Standard Operating Procedures.
(l) Policy to monitor or prevent the conflict of interest along with Standard Operating Procedures.
(m) If the committee has been audited or inspected before, give details.
4. Maintenance of record:
All documentation and communication of an Ethics Committee are to be dated, filed and preserved according to the Standard Operating Procedures. Strict confidentiality shall be maintained during access and retrieval procedures. Records should be maintained for the following, namely:-
(a) The constitution and composition of the Ethics Committee; (b) The curriculum vitae of all the committee members;
(c) Standard Operating Procedures followed by the committee; (d) National and international guidelines;
(e) Copies of the protocol, data collection formats, Case Report Forms, Investigator‘s brochures, etc, submitted for review;
(f) All correspondence with committee members and Investigators regarding application, decision and follow up;
(g) Agenda of all Ethics Committee meetings;
(h) Minutes of all Ethics Committee meetings with signature of the Chairman; (i) Copies of decisions communicated to the applicants;
(j) Record of all notification issued for premature termination of a study with a summary of the reasons;
(k) Final report of the study including microfilms, compact disks or video-recordings. All records shall be safely maintained after the completion or termination of the study for not less than five years from the date of completion or termination of the trial (Both in hard and soft copies).
5. The Ethics Committee shall be open to inspection by the officers authorized by the Central Drugs Standard Control Organization, who may include an officer of the State Drug Control Authority concerned, to verify compliance to the requirements of Schedule Y, Good Clinical Practice guidelines and other applicable regulation for safeguarding the rights, safety and well-being of the trial subjects.]
III. Format for According Approval to clinical trial protocol by the Ethics Committee.]
To
Dr.
Dear Dr.
The Institutional Ethics Committee / Independent Ethics Committee (state name of the committee, as appropriate) reviewed and discussed your application to conduct the clinical trial entitled “……” on …….(date).
The following documents were reviewed:
(a) Trial Protocol (including protocol amendments), dated_________ Version no (s).
(b) Patient Information Sheet and Informed Consent Form (including updates if any) in English and/or vernacular language.
(c) Investigator‘s Brochure, dated_________ , Version no._________
(d) Proposed methods for patient accrual including advertisement (s) etc. proposed to be used for the purpose.
(e) Principal Investigator‘s current CV.
(f) Insurance Policy / Compensation for participation and for serious adverse events occurring during the study participation.
(g) Investigator‘s Agreement with the Sponsor.
(h) Investigator‘s Undertaking (Appendix VII).
The following members of the ethics committee were present at the meeting held on (date, time, place).
_________Chairman of the Ethics Committee
_________Member secretary of the Ethics Committee
_________Name of each member with designation
We approve the trial to be conducted in its presented form.
The Institutional Ethics Committee / Independent Ethics Committee expects to be informed about the progress of the study, any SAE occurring in the course of the study, any changes in the protocol and patient information/informed consent and asks to be provided a copy of the final report.
Yours sincerely,
Member Secretary, Ethics Committee.
APPENDIX IX
STABILITY TESTING OF NEW DRUGS
Stability testing is to be performed to provide evidence on how the quality of a drug substance or formulation varies with time under the influence of various environmental factors such as temperature, humidity and light, and to establish shelf life for the formulation and recommended storage conditions.
Stability studies should include testing of those attributes of the drug substance that are susceptible to change during storage and are likely to influence quality, safety, and/or efficacy. In case of formulations the testing should cover, as appropriate, the physical, chemical, biological, and microbiological attributes, preservative content (e.g., antioxidant, antimicrobial preservative), and functionality tests (e.g., for a dose delivery system).
Validated stability-indicating analytical procedures should be applied. For long term studies, frequency of testing should be sufficient to establish the stability profile of the drug substance.
In general, a drug substance should be evaluated under storage conditions that test its thermal stability and, if applicable, its sensitivity to moisture. The storage conditions and the length of studies chosen should be sufficient to cover storage, shipment and subsequent use.
Stress testing of the drug substance should be conducted to identify the likely degradation products, which in turn establish the degradation pathways, evaluate the intrinsic stability of the molecule and validate the stability indicating power of the analytical procedures used. The nature of the stress testing will depend on the individual drug substance and the type of formulation involved.
Stress testing may generally be carried out on a single batch of the drug substance. It should include the effect of temperatures ), humidity where appropriate, oxidation, and photolysis on the drug substance.
Data should be provided for (a) Photostability on at least one primary batch of the drug substance as well as the formulation, as the case may be and (b) the susceptibility of the drug substance to hydrolysis across a wide range of pH values when in solution or suspension.
Long-term testing should cover a minimum of 12 months‘ duration on at least three primary batches of the drug substance or the formulation at the time of submission and should be continued for a period of time sufficient to cover the proposed shelf life. Accelerated testing should cover a minimum of 6 months duration at the time of submission.
In case of drug substances, the batches should be manufactured to a minimum of pilot scale by the same synthetic route and using a method of manufacture that simulates the final process to be used for production batches. In case of formulations, two of the three batches should be at least pilot scale and the third one may be smaller. The manufacturing process(es) used for primary batches should simulate that to be applied to production batches and should provide products of the same quality and meeting the same specifications as that intended for marketing.
The stability studies for drug substances should be conducted either in the same container – closure system as proposed for storage and distribution or in a container – closure system that simulates the proposed final packaging. In case of formulations, the stability studies should be conducted in the final container – closure system proposed for marketing.
Stability Testing of new drug substances and formulations:
(i) Study conditions for drug substances and formulations intended to be stored under general conditions
Study Study conditions Duration of study
Long term 30°C ± 2°C/65% RH ± 5% RH 12 months
Accelerated 40°C ± 2°C/75% RH ± 5% RH 6 months
If at any time during 6 months‘ testing under the accelerated storage condition, such changes occur that cause the product to fail in complying with the prescribed standards, additional testing under an intermediate storage condition should be conducted and evaluated against significant change criteria.
(ii) Study conditions for drug substances and formulations intended to be stored in a refrigerator
Study Study conditions Duration of study
Long term 5°C ± 3°C 12 months
Accelerated 25°C ± 2°C/60% RH ± 5% RH 6 months
(iii) Study conditions for drug substances and formulations intended to be stored in a freezer
Study Study conditions Duration of study
Long term – 20°C ± 5°C 12 months
(iv) Drug substances intended for storage below -20°C shall be treated on a case-by- case basis.
(v) Stability testing of the formulation after constitution or dilution, if applicable, should be conducted to provide information for the labelling on the preparation, storage condition, and in-use period of the constituted or diluted product. This testing should be performed on the constituted or diluted product through the proposed in-use period.
APPENDIX X
CONTENTS OF THE PROPOSED PROTOCOL FOR CONDUCTING CLINICAL TRIALS
1. Title Page
(a) Full title of the clinical study,
(b) Protocol / Study number, and protocol version number with date
(c) The IND name/number of the investigational drug
(d) Complete name and address of the Sponsor and contract research organization if any
(e) List of the Investigators who are conducting the study, their respective institutional affiliations and site locations
(f) Name(s) of clinical laboratories and other departments and/or facilities participating in the study.
2. Table of Contents
A complete Table of Contents including a list of all Appendices.
1. Background and Introduction
(a) Preclinical experience.
(b) Clinical experience.
Previous clinical work with the new drug should be reviewed here and a description of how the current protocol extends existing data should be provided. If this is an entirely new indication, how this drug was considered for this should be discussed. Relevant information regarding pharmacological, toxicological and other biological properties of the drug/biologic/medical device, and previous efficacy and safety experience should be described.
2. Study Rationale
This section should describe a brief summary of the background information relevant to the study design and protocol methodology. The reasons for performing this study in the particular population included by the protocol should be provided.
3. Study Objective(s) (primary as well as secondray) and their logical relation to the study design.
4. Study Design
(a) Overview of the Study Design: Including a description of the type of study (i.e., double-blind, multicentre, placebo controlled, etc.), a detail of the specific treatment groups and number of study Subjects in each group and investigative site, Subject number assignment, and the type, sequence and duration of study periods.
(b) Flow chart of the study
(c) A brief description of the methods and procedures to be used during the study.
(d) Discussion of Study Design: This discussion details the rationale for the design chosen for this study.
5. Study Population: the number of Subjects required to be enrolled in the study at the investigative site and by all sites along with a brief description of the nature of the Subject population required is also mentioned.
6. Subject Eligibility
(a) Inclusion Criteria
(b) Exclusion Criteria
7. Study Assessments – plan, procedures and methods to be described in detail
8. Study Conduct stating the types of study activities that would be included in this section would be: medical history, type of physical examination, blood or urine testing, electrocardiogram (ECG), diagnostic testing such as pulmonary function tests, symptom measurement, dispensation and retrieval of medication, Subject cohort assignment, adverse event review, etc.
Each visit should be described separately as Visit 1, Visit 2, etc.
Discontinued Subjects: Describes the circumstances for Subject withdrawal, dropouts, or other reasons for discontinuation of Subjects . State how dropouts would be managed and if they would be replaced, describe the method of handling of protocol waivers, if any. The person(s) who approves all such waivers should be identified and the criteria used for specific waivers should be provided.
Describes how protocol violations will be treated, including conditions where the study will be terminated for non-compliance with the protocol.
9. Study Treatment
(a) Dosing schedule (dose, frequency, and duration of the experimental treatment) Describe the administration of placebos and/or dummy medications if they are part of the treatment plan. If applicable, concomitant drug(s), their doses, frequency, and duration of concomitant treatment should be stated.
(b) Study drug supplies and administration: A statement about who is going to provide the study medication and that the investigational drug formulation has been manufactured following all regulations Details of the product stability, storage requirements and dispensing requirements should be provided.
(c) Dose modification for study drug toxicity: Rules for changing the dose or stopping the study drug should be provided.
(d) Possible drug interactions.
(e) Concomitant therapy: The drugs that are permitted during the study and the conditions under which they may be used are detailed here. Describe the drugs that a Subject is not allowed to use during parts of or the entire study. If any washout periods for prohibited medications are needed prior to enrolment, these should be described here.
(f) Blinding procedures: A detailed description of the blinding procedure if the study employs a blind on the Investigator and/or the Subject.
(g) Unblinding procedures: If the study is blinded, the circumstances in which unblinding may be done and the mechanism to be used for unblinding should be given.
10. Adverse Events (See Appendix XI): Description of expected adverse events should be given.
Procedures used to evaluate an adverse event should be described.
11. Ethical Considerations: Give the summary of:
(a) Risk/benefit assessment:
(b) Ethics Committee review and communications.
(c) Informed consent process.
(d) Statement of Subject confidentiality including ownership of data and coding procedures.
12. Study Monitoring and Supervision: A description of study monitoring policies and procedures should be provided along with the proposed frequency of site monitoring visits, and who is expected to perform monitoring.
Case Record Form (CRF) completion requirements, including who gets which copies of the forms and any specifics required in filling out the forms CRF correction requirements, including who is authorized to make corrections on the CRF and how queries about study data are handled and how errors, if any, are to be corrected should be stated.
Investigator study files, including what needs to be stored following study completion should be described.
13. Investigational Product Management
(a) Give Investigational product description and packaging (stating all Ingredients and the formulation of the investigational drug and any placebos used in the study)
(b) The precise dosing required during the study.
(c) Method of packaging, labelling, and blinding of study substances.
(d) Method of assigning treatments to Subjects and the Subject identification code numbering system.
(e) Storage conditions for study substances.
(f) Investigational product accountability: Describe instructions for the receipt, storage, dispensation, and return of the investigational products to ensure a complete accounting of all investigational products received, dispensed, and returned/destroyed.
(g.) Describe policy and procedure for handling unused investigational products.
14. Data Analysis:
Provide details of the statistical approach to be followed including sample size, how the sample size was determined, including assumptions made in making this determination, efficacy endpoints (primary as well as secondary) and safety endpoints.
Statistical analysis: Give complete details of how the results will be analyzed and reported along with the description of statistical tests to be used to analyze the primary and secondary endpoints defined above. Describe the level of significance, statistical tests to be used, and the methods used for missing data; method of evaluation of the data for treatment failures, non-compliance, and Subject withdrawals; rationale and conditions for any interim analysis if planned.
Describe statistical considerations for Pharmacokinetic (PK) analysis, if applicable.
15. Undertaking by the Investigator (see Appendix VII).
16. Appendices: Provide a study synopsis, copies of the informed consent documents (patient information sheet, informed consent form etc.); CRF and other data collection forms; a summary of relevant pre-clinical safety information and any other documents referenced in the clinical protocol.
APPENDIX XI
Data Elements for reporting serious adverse events occuring in a clinical trial
1. Patient Details
Initials & other relevant identifier (hospital/OPD record number etc.)* Gender Age and/or date of birth
Weight
Height
2. Suspected Drug(s)
Generic name of the drug*.
Indication(s) for which suspect drug was prescribed or tested. Dosage form and strength. Daily dose and regimen (specify units – e.g., mg, ml, mg/kg).
Route of administration. Starting date and time of day.
Stopping date and time, or duration of treatment
3. Other Treatment(s)
Provide the same information for concomitant drugs (including non prescription/OTC drugs) and non-drug therapies, as for the suspected drug(s).
4. Details of Suspected Adverse Drug Reaction(s)
Full description of reaction(s) including body site and severity, as well as the criterion (or criteria) for regarding the report as serious. In addition to a description of the reported signs and symptoms, whenever possible, describe a specific diagnosis for the reaction.*
Start date (and time) of onset of reaction.
Stop date (and time) or duration of reaction. Dechallenge and rechallenge information.
Setting (e.g., hospital, out-patient clinic, home, nursing home).
5. Outcome
Information on recovery and any sequelae; results of specific tests and/or treatment that may have been conducted.
For a fatal outcome, cause of death and a comment on its possible relationship to the suspected reaction; any post-mortem findings.
Other information: anything relevant to facilitate assessment of the case, such as medical history including allergy, drug or alcohol abuse; family history; findings from special investigations etc.
6. Details about the Investigator*
Name Address
Telephone number Profession (speciality)
Date of reporting the event to Licensing Authority:
Date of reporting the event to Ethics Committee overseeing the site: Signature of the Investigator
Note: Information marked * must be provided.”]
1[APPENDIX XII
Compensation in case of injury or death during clinical trial
2[(1) In case of an injury occurring to the subject during the clinical trial, free medical management shall be given as long as required or till such time it is established that the injury is not related to the clinical trial, whichever is earlier.]
(2) In case the injury occurring to the trial subject is related to the clinical trial, such subject shall also be entitled for financial compensation as per order of the Licensing Authority defined under clause (b) of Rule 21 and the financial compensation will be over and above any expenses incurred on the medical management of the subject. 3[In case, there is no permanent injury, the quantum of compensation shall be commensurate with the nature of the non-permanent injury and loss of wages.]
(3) In the case of clinical trial related death of the subject, his/her nominee(s) would be entitled for financial compensation as per the order of the Licensing Authority defined under clause (b) of Rule 21, and the financial compensation will be over and above any expenses incurred on the medical management of the subject.
(4) The financial compensation for clinical trial related injury or death could be in the form of:-
(a) Payment for medical management;
(b) Financial compensation for trail related injury;
(c) Financial compensation to nominee(s) of the trial subject in case of death;
(d) Financial compensation for the child injured in–utero because of the participation of parent in clinical trial.
(5) The Sponsor or his representative, whosoever had obtained permission from the Licensing Authority for conduct of the clinical trial shall provide financial compensation, if the injury or death has occurred because of any or the following reasons, namely:-
(a) Adverse effect of investigational product(s);
(b) Any clinical trial procedures involved in the study;
(c) Violation of the approved protocol, scientific misconduct or negligence by the Sponsor or his representative or the Investigator;
(d) Failure of investigational product to provide intended therapeutic effect; where, the standard care, though available, was not provided to the subject as per the clinical trial protocol.
(e) Use of placebo in a placebo-controlled trial, where, the standard care, though available, was not provided to the subject as per the clinical trial protocol;
1. Ins. by G.S.R. 53(E), dt. 30.1.2013.
2. Subs. by G.S.R. 889(E), dt. 12.12.2014.
3. Ins. by G.S.R. 889(E), dt. 12.12.2014.
(f) Adverse effects due to concomitant medication excluding standard care, necessitated as part of approved protocol;
(g) Injury to the child in-utero because of the participation of parent in clinical trial.
(6) Procedure for payment of financial compensation.
(a) The Investigator shall report all serious 1[***] adverse events to the Licensing Authority as defined under clause (b) of Rule 21, the Sponsor or his representative whosoever had obtained permission from the Licensing Authority for conduct of the clinical trial and the Ethics Committee that accorded approval to the study protocol, within twenty four hours of their occurrence as per Appendix XI. 2[In case, the Investigator fails to report any serious adverse event within the stipulated period, he shall have to furnish the reason for the delay to the satisfaction of the Licensing Authority along with the report of the serious adverse event.]
(b) (i) The cases of serious adverse events of death shall be examined as under:
(A) An independent Expert Committee shall be constituted by the Licensing Authority as defined under Rule 21(b) to examine the cases and recommend to the Licensing Authority for the purpose of arriving at the cause of death and quantum of compensation in case of clinical trial related death.
(B) The Sponsor or his representative, whosoever had obtained permission from the Licensing Authority for conducting the clinical trial and the Investigator shall forward their reports on serious adverse event of death after due analysis to 3[***] the Licensing Authority as defined under Rule 21(b) and the head of the Institution where the trial has been conducted within 4[fourteen days] of occurrence of the serious adverse event of death.
(C) The Ethics Committee shall forward its report on serious adverse event of death after due analysis along with its opinion on the financial compensation, if any, to be paid by the Sponsor or his representative, whosoever had obtained permission from the Licensing Authority as defined under Rule 21(b) for conducting the clinical trial, 5[***] to the Licensing Authority within 6[thirty days] of the occurrence of the serious adverse event of death.
2[(CA) The Licensing Authority shall forward the report of the Investigator, Sponsor or his representative whosoever had obtained permission from the Licensing Authority for conducting clinical trial and the Ethics Committee to the Chairman of the Expert Committee.]
1. The word “and unexpected” omitted by G.S.R. 889(E), dt. 12.12.2014. 2. Ins. by G.S.R. 889(E), dt. 12.12.2014.
3. The word “Chairman of the Expert Committee with a copy of the report to” omitted by G.S.R. 889(E), dt. 12.12.2014.
4. Subs. by G.S.R. 889(E), dt. 12.12.2014.
5. The word “to the Chairman of the Expert Committee with a copy of the report” omitted by G.S.R. 889(E), dt. 12.12.2014.
6. Subs. by G.S.R. 889(E), dt. 12.12.2014.
(D) The Expert Committee shall examine the report of serious adverse event of death and give its recommendations to the Licensing Authority for the purpose of arriving at the cause of the adverse event with in 1[one hundred and five days of the occurrence of the adverse event,] and the expert committee while examining the event, may take into consideration, the reports of the Investigator, Sponsor or his representative whosoever had obtained permission from the Licensing Authority for conducting the clinical trial and the Ethics Committee.
(E) In the case of clinical trial related death, the Expert Committee shall also recommend the quantum of compensation to be paid by the Sponsor or his representative, whosoever had obtained permission from the Licensing Authority as defined under Rule 21(b) for conducting the clinical trial.
(F) The Licensing Authority shall consider the recommendations of the Expert Committee and shall determine the cause of death and pass orders as deemed necessary.
(G) In case of clinical trial related death, the Licensing Authority, after considering the recommendations of the Expert Committee, shall decide the quantum of compensation to be paid by the Sponsor or his representative, whosoever had obtained permission from the Licensing Authority for conducting the clinical trial and shall pass orders as deemed necessary within 1[one hundred and fifty days of the occurrence of the adverse event].
(ii) Cases of serious adverse events, other than deaths, shall be examined as under:
(A) The Sponsor or his representative, whosoever had obtained permission from the Licensing Authority for conducting the clinical trial, and the Investigator shall forward their reports on serious adverse event, after due analysis, to the Licensing Authority as defined under Rule 21(b), Chairman of the Ethics Committee and the head of the Institution where the trial has been conducted within 1[fourteen days] of occurrence of the serious adverse event.
(B) The Ethics Committee shall forward its report on the serious adverse event, after due analysis along with its opinion regarding the financial compensation, if any, to be paid by the Sponsor or his representative, whosoever had obtained permission from the Licensing Authority as defined under Rule 21(b) for conducting the clinical trial, to the Licensing Authority within 1[thirty days] of occurrence of the serious adverse event.
(C) The Licensing Authority shall determine the cause of injury and pass order as deemed necessary. The Licensing Authority shall have the option to constitute an independent Expert Committee, wherever considered necessary, to examine such serious adverse events of injury, which will recommend to the Licensing Authority for arriving at the cause considered necessary, to examine such serious adverse events of injury, which will recommend to the Licensing Authority for arriving at the cause of the injury and also the quantum of compensation in case of clinical trial related injury, to be paid by the Sponsor or his representative whosoever had obtained permission from the Licensing Authority as defined under Rule 21(b) for conducting the clinical trial.
(D) In case of clinical trial related injury, the Licensing Authority, shall decide the quantum of compensation to be paid by the Sponsor or his representative whosoever had obtained permission from the Licensing Authority for conducting the clinical trial and shall pass orders as deemed necessary within 1[one hundred and fifty days of the occurrence of the adverse event].
(c) The sponsor or his representative, whosoever had obtained permission from the Licensing Authority for conducting the clinical trial shall pay the compensation in case of clinical trial related injury or death as per the order of the Licensing Authority as defined under Rule 21(b) within thirty days of the receipt of such order.]
1. Subs. by G.S.R. 889(E), dt. 12.12.2014.
The Sick Industrial Companies (Special Provisions) Act 1985
ACT NO. 1 OF 1986
[8th January, 1986.]
An Act to make, in the public interest, special provisions with a view to securing the timely detection of sick and potentially sick companies owning industrial undertakings, the speedy determination by a Board of experts of the preventive, ameliorative, remedial and other measures which need to be taken with respect to such companies and the expeditious enforcement of the measures so determined and for matters connected therewith or incidental thereto.
BE it enacted by Parliament in the Thirty-sixth Year of the Republic of India as follows:—
CHAPTER I
PRELIMINARY
1. Short title, extent, commencement and application.— (1) This Act may be called the Sick Industrial Companies (Special Provisions) Act, 1985.
(2) It extends to the whole of India.
(3) It shall come into force on such date1 as the Central Government may, by notification in the Official Gazette, appoint and different dates may be appointed for different provisions of this Act and any reference in any provision of this Act to the commencement of this Act shall be construed as a reference to the commencement of that provision.
(4) It shall apply, in the first instance, to all the scheduled industries other than the scheduled industry relating to ships and other vessels drawn by power.
(5) The Central Government may, in consultation with the Reserve Bank of India, by notification, apply the provisions of this Act, on and from such date as may be specified in the notification, to the scheduled industry relating to ships and other vessels drawn by power.
2. Declaration.— It is hereby declared that this Act is for giving effect to the policy of the State towards securing the principles specified in clauses (b) and (c) of article 39 of the Constitution.
3. Definitions.— (1) In this Act, unless the context otherwise requires,—
(a) “Appellate Authority” means the Appellate Authority for Industrial and Financial Reconstruction constituted under section 5;
(b) “Board” means the Board for Industrial and Financial Reconstruction established under section 4;
(c) “Chairman” means the Chairman of the Board or, as the case may be, the Appellate Authority;
(d) “company” means a company as defined in section 3 of the Companies Act, 1956 (1 of 1956),
2***;
3[(da) “date of finalisation of the duly audited accounts” means the date on which the audited accounts of the company are adopted at the annual general meeting of the company;]
(e) “industrial company” means a company which owns one or more industrial undertakings;
1. 12th January, 1987, vide notification No. G.S.R. 24(E), dated 12th January, 1987 (except sections 15 to 34), see Gazette of India, Extraordinary, Part II, sec. 3 (i).
2. The words and figures “, but does not include a Government company as defined in section 617 of that Act” omitted by Act 57 of 1991, s. 2 (w.e.f. 28-12-1991).
3. Ins. by Act 12 of 1994, s. 2 (w.e.f. 1-2-1994).
(f) “industrial undertaking” means any undertaking pertaining to a scheduled industry carried on in one or more factories by any company but does not include—
(i) an ancillary industrial undertaking as defined in clause (aa) of section 3 of the Industries (Development and Regulation) Act, 1951 (65 of 1951); and
(ii) a small scale industrial undertaking as defined in clause (j) of the aforesaid section 3;
(g) “Member” means a Member of the Board or, as the case may be, the Appellate Authority and includes the Chairman thereof;
1[(ga) “net worth” means the sum total of the paid-up capital and free reserves.
Explanation.—For the purposes of this clause, “free reserves” means all reserves credited out of the profits and share premium account but does not include reserves credited out of re-evaluation of assets, write back of depreciation provisions and amalgamation;]
(h) “notification” means a notification published in the Official Gazette;
2[(i) “operating agency” means any public financial institution, State level institution, scheduled bank or any other person as may be specified by general or special order as its agency by the Board;]
(j) “prescribed” means prescribed by rules made under this Act;
3* * * * *
(l) “Reserve Bank” means the Reserve Bank of India constituted under section 3 of the Reserve Bank of India Act, 1934 (2 of 1934);
(m) “scheduled bank” means a bank for the time being included in the Second Schedule to the Reserve Bank of India Act, 1934 (2 of 1934);
(n) “scheduled industry” means any of the industries specified for the time being in the First Schedule to the Industries (Development and Regulation) Act, 1951 (65 of 1951);
4[(o) “sick industrial company” means an industrial company (being a company registered for not less than five years) which has at the end of any financial year accumulated losses equal to or exceeding its entire net worth.
Explanation.—For the removal of doubts, it is hereby declared that an industrial company existing immediately before the commencement of the Sick Industrial Companies (Special Provisions) Amendment Act, 1993 (12 of 1994), registered for not less than five years and having at the end of any financial year accumulated losses equal to or exceeding its entire net worth, shall be deemed to be a sick industrial company;]
(p) “State level institution” means any of the following institutions, namely:—
(i) State Financial Corporations established under section 3 or section 3A and institutions notified under section 46 of the State Financial Corporations Act, 1951 (63 of 1951);
(ii) State industrial development corporations registered under the Companies Act, 1956 (1 of 1956);
(iii) such other institutions, being companies and not being public financial institutions, engaged in the development or financing of industrial undertakings, as the Central Government may, by notification, specify:
Provided that no institution shall be so specified unless not less than fifty-one per cent. of the paid-up share capital thereof is held by any State Government or Governments or by any institution or institutions mentioned in sub-clauses (i) and (ii) or partly by one or more public financial institutions or institutions mentioned in sub-clauses (i) and (ii) and partly by one or more State Governments.
1. Ins. by Act 12 of 1994, s. 2 (w.e.f. 1-2-1994).
2. Subs. by s. 2, ibid., for clause (i) (w.e.f. 1-2-1994).
3. Clause (k) omitted by, s. 2, ibid. (w.e.f. 1-2-1994).
4. Subs. by s. 2, ibid, for clause (o) (w.e.f. 1-2-1994).
(2) (a) Words and expressions used and not defined in this Act shall have the meanings, if any, respectively assigned to them in the Companies Act, 1956 (1 of 1956).
(b) Words and expressions used but not defined either in this Act or in the Companies Act, 1956 (1 of 1956) shall have the meanings, if any, respectively assigned to them in the Industries (Development and Regulation) Act, 1951 (65 of 1951).
(3) Any reference in this Act to any other enactment or any provision thereof, shall, in relation to an area in which such enactment or such provision is not in force, be construed as a reference to the corresponding law or the relevant provision of the corresponding law, if any, in force in that area.
CHAPTER II
BOARD AND APPELLATE AUTHORITY FOR INDUSTRIAL AND FINANCIAL RECONSTRUCTION
4. Establishment of Board.— (1) With effect from such date as the Central Government may, by notification, appoint, there shall be established a Board to be known as the “Board for Industrial and Financial Reconstruction” to exercise the jurisdiction and powers and discharge the functions and duties conferred or imposed on the Board by or under this Act.
(2) The Board shall consist of a Chairman and not less than two and not more than fourteen other Members, to be appointed by the Central Government.
(3) The Chairman and other Members of the Board shall be persons who are or have been or are qualified to be High Court Judges, or persons of ability, integrity and standing who have special knowledge of, and professional experience of not less than fifteen years in science, technology, economics, banking industry, law, labour matters, industrial finance, industrial management, industrial reconstruction, administration, investment, accountancy, marketing or any other matter, the special knowledge of, or professional experience in which, would in the opinion of the Central Government be useful to the Board.
5. Constitution of Appellate Authority.— (1) The Central Government may, by notification, constitute, with effect from such date as may be specified therein, an appellate authority to be called the “Appellate Authority for Industrial and Financial Reconstruction” consisting of a Chairman and not more than three other Members, to be appointed by that Government, for hearing appeals against the orders of the Board under this Act.
(2) The Chairman shall be a person who is or has been a Judge of the Supreme Court or who is or has been a Judge of a High Court for not less than five years.
(3) A Member of the Appellate Authority shall be a person who is or has been a Judge of a High Court or who is or has been an officer not below the rank of a Secretary to the Government of India or who is or has been a Member of the Board for not less than three years.
6. Term of office, conditions of service, etc., of Chairman and other Members.— (1) Before appointing any person as the Chairman or other Member, the Central Government shall satisfy itself that the person does not and will not, have any such financial or other interest as is likely to affect prejudicially his functions as such Member.
(2) The Chairman and every other Member shall hold office for such period, not exceeding five years, as may be specified by the Central Government in the order of his appointment, but shall be eligible for reappointment:
Provided that no person shall hold office as the Chairman or other Member after he has attained the age of sixty-five years.
(3) Notwithstanding anything contained in sub-section (1), a Member may—
(a) by writing under his hand and addressed to the Central Government resign his office at any time;
(b) be removed from his office in accordance with the provisions of section 7.
(4) A vacancy caused by the resignation or removal of the Chairman or any other Member under sub-section (3) or otherwise shall be filled by fresh appointment.
(5) In the event of the occurrence of a vacancy in the office of the Chairman by reason of his death, resignation or otherwise, such one of the Members as the Central Government may, by notification, authorise in this behalf shall act as the Chairman till the date on which a new Chairman, appointed in accordance with the provisions of this Act to fill such vacancy, enters upon his office.
(6) When the Chairman is unable to discharge his functions owing to absence, illness or any other cause, such one of the Members as the Chairman may authorise in writing in this behalf, shall discharge the functions of the Chairman, till the date on which the Chairman resumes his duties.
(7) The salaries and allowances payable to and the other terms and conditions of service of the Chairman and other Members shall be such as may be prescribed:
Provided that neither the salary and allowances nor the other terms and conditions of service of the Chairman or any other Member shall be varied to his disadvantage after his appointment.
(8) The Chairman and every other Member shall, before entering upon his office, make a declaration of fidelity and secrecy in the form set out in the Schedule.
(9) The Chairman or any other Member ceasing to hold office as such shall not hold any appointment or be connected with the management or administration in any company in relation to which any matter has been the subject matter of consideration before the Board or, as the case may be, the Appellate Authority, for a period of five years from the date on which he ceases to hold such office.
7. Removal of Members from office in certain circumstances.— (1) The Central Government may remove from office any Member, who—
(a) has been adjudged as insolvent, or
(b) has been convicted of an offence which, in the opinion of the Central Government, involves moral turpitude, or
(c) has become physically or mentally incapable of acting as a Member, or
(d) has acquired such financial or other interest as is likely to affect prejudicially his functions as a Member, or
(e) has so abused his position as to render his continuance in office prejudicial to the public interest.
(2) Notwithstanding anything contained in sub-section (1), no Member shall be removed from his office on the ground specified in clause (d) or clause (e) of that sub-section unless the Supreme Court on a reference being made to it in this behalf by the Central Government, has, on an inquiry held by it in accordance with such procedure as it may specify in this behalf, reported that the Member ought, on such grounds, to be removed.
8. Secretary officers and other employees of Board or Appellate Authority.— (1) The Central Government shall appoint a Secretary to the Board and a Secretary (by whatever name called) to the Appellate Authority to exercise and perform, under the control of the Chairman, such powers and duties as may be prescribed or as may be specified by the Chairman.
1[(2) The Central Government may provide the Board and the Appellate Authority with such other officers and employees as may be necessary for the efficient performance of the functions of the Board and the Appellate Authority.]
(3) The salaries and allowances payable to and the conditions of service of the Secretary and other officers and employees of the Board and the Appellate Authority shall be such as may prescribed:
Provided that such Secretary, officer or other employee shall, before entering upon his duties, make a declaration of fidelity and secrecy in the form set out in the Schedule.
1. Subs. by Act 12 of 1994, s. 3, for sub-section (2) (w.e.f. 1-2-1994).
9. Salaries, etc., be defrayed out of the Consolidated Fund of India.— The salaries and allowances payable to the Members and the administrative expenses, including salaries, allowances and pension, payable to or in respect of the officers and other employees of the Board and the Appellate Authority shall be defrayed out of the Consolidated Fund of India.
10. Vacancies, etc., not to invalidate proceedings of Board and Appellate Authority.— No act or proceeding of the Board or, as the case may be, the Appellate Authority shall be questioned on the ground merely of the existence of any vacancy or defect in the constitution of the Board or the Appellate Authority or any defect in the appointment of a person acting as a Member of the Board or the Appellate Authority.
11. Members and staff of Board and Appellate Authority to be public servants.— The Chairman and other Members and the officers and other employees of the Board and the Appellate Authority shall be deemed to be public servants within the meaning of section 21 of the Indian Penal Code (45 of 1860).
12. Constitution of Benches of Board or Appellate Authority.— (1) The jurisdiction, powers and authority of the Board or the Appellate Authority may be exercised by Benches thereof.
(2) The Benches shall be constituted by the Chairman and each Bench shall consist of not less than two Members.
1[(3) If the members of a Bench differ in opinion on any point, the point shall be decided according to the opinion of the majority, if there is a majority, but if the Members are equally divided, they shall state the point or points on which they differ, and make a reference to the Chairman of the Board or, as the case may be, the Appellate Authority who shall either hear the point or points himself or refer the case for hearing on such point or points by one or more of the other Members and such point or points shall be decided according to the opinion of the majority of the Members who have heard the case including those who first heard it.]
13. Procedure of Board and Appellate Authority.— (1) Subject to the provisions of this Act, the Board or, as the case may be, the Appellate Authority, shall have powers to regulate—
(a) the procedure and conduct of the business;
(b) the procedure of the Benches, including the places at which the sittings of the Benches shall be held;
(c) the delegation to one or more Members of such powers or functions as the Board or, as the case may be, the Appellate Authority may specify.
(2) In particular and without prejudice to the generality of the foregoing provisions, the powers of the Board or, as the case may be, the Appellate Authority, shall include the power to determine the extent to which persons interested or claiming to be interested in the subject matter of any proceeding before it may be allowed to be present or to be heard, either by themselves or by their representatives or to cross-examine witnesses or otherwise to take part in the proceedings.
(3) The Board or the Appellate Authority shall, for the purposes of any inquiry or for any other purpose under this Act, have the same powers as are vested in a civil court under the Code of Civil Procedure, 1908 (5 of 1908) while trying suits in respect of the following matters, namely:—
(a) the summoning and enforcing the attendance of any witness and examining him on oath;
(b) the discovery and production of document or other material object producible as evidence;
(c) the reception of evidence on affidavit;
(d) the requisitioning of any public record from any court or office;
(e) the issuing of any commission for the examination of witnesses;
(f) any other matter which may be prescribed.
1. Subs. by Act 12 of 1994, s. 4 for sub-section (3) (w.e.f. 1-2-1994).
14. Proceedings before Board or Appellate Authority to be judicial proceedings.— The Board or the Appellate Authority shall be deemed to be a civil court for the purposes of section 195 and Chapter XXVI of the Code of Criminal Procedure, 1973 (2 of 1974) and every proceeding before the Board or the Appellate Authority shall be deemed to be a judicial proceeding within the meaning of sections 193 and 228 and for the purposes of section 196 of the Indian Penal Code (45 of 1860).
CHAPTER III
REFERENCES, INQUIRIES AND SCHEMES
15. Reference to Board.— (1) Where an industrial company has become a sick industrial company, the Board of Directors of the company, shall, within sixty days from the date of finalisation of the duly audited accounts of the company for the financial year as at the end of which the company has become a sick industrial company, make a reference to the Board for determination of the measures which shall be adopted with respect to the company:
Provided that if the Board of Directors had sufficient reasons even before such finalisation to form the opinion that the company had become a sick industrial company, the Board of Directors shall, within sixty days after it has formed such opinion, make a reference to the Board for the determination of the measures which shall be adopted with respect to the company:
1[Provided further that no reference shall be made to the Board for Industrial and Financial Reconstruction after the commencement of the Securitisation and Reconstruction of Financial Assets and Enforcement of Security Interest Act, 2002 (54 of 2002), where financial assets have been acquired by any securitisation company or reconstruction company under sub-section (1) of section 5 of that Act:
Provided also that on or after the commencement of the Securitisation and Reconstruction of Financial Assets and Enforcement of Security Interest Act, 2002 (54 of 2002), where a reference is pending before the Board for Industrial and Financial Reconstruction, such reference shall abate if the secured creditors, representing not less than three-fourth in value of the amount outstanding against financial assistance disbursed to the borrower of such secured creditors, have taken any measures to recover their secured debt under sub-section (4) of section 13 of that Act.]
(2) Without prejudice to the provisions of sub-section (1), the Central Government or the Reserve Bank or a State Government or a public financial institution or a State level institution or a scheduled bank may, if it has sufficient reasons to believe that any industrial company has become, for the purposes of this Act, a sick industrial company, make a reference in respect of such company to the Board for determination of the measures which may be adopted with respect to such company:
Provided that a reference shall not be made under this sub-section in respect of any industrial company by—
(a) the Government of any State unless all or any of the industrial undertakings belonging to such company are situated in such State;
(b) a public financial institution or a State level institution or a scheduled bank unless it has, by reason of any financial assistance or obligation rendered by it, or undertaken by it, with respect to, such company, an interest in such company.
16. Inquiry into working of sick industrial companies.— (1) The Board may make such inquiry as it may deem fit for determining whether any industrial company has become a sick industrial company—
(a) upon receipt of a reference with respect to such company under section 15; or
(b) upon information received with respect to such company or upon its own knowledge as to the financial condition of the company.
(2) The Board may, if it deems necessary or expedient so to do for the expeditious disposal of an inquiry under sub-section (1), require by order any operating agency to enquire into and make a report with respect to such matters as may be specified in the order.
1. Ins. by Act 54 of 2002, s. 41 and the Schedule (w.e.f. 21-6-2002).
(3) The Board or, as the case may be, the operating agency shall complete its inquiry as expeditiously as possible and endeavour shall be made to complete the inquiry within sixty days from the commencement of the inquiry.
1[Explanation.—For the purposes of this sub-section, an inquiry shall be deemed to have commenced upon the receipt by the Board of any reference or information or upon its own knowledge reduced to writing by the Board.]
(4) Where the Board deems it fit to make an inquiry or to cause an inquiry to be made into any industrial company under sub-section (1) or, as the case may be, under sub-section (2), 2[it may appoint] one or more persons to be a special director or special directors of the company for safeguarding the financial and other interests of the company 1[or in the public interest].
1[(4A) The Board may issue such directions to a special director appointed under sub-section (4) as it may deem necessary or expedient for proper discharge of his duties.]
(5) The appointment of a special director referred to in sub-section (4) shall be valid and effective notwithstanding anything to the contrary contained in the Companies Act, 1956 (1 of 1956), or in any other law for the time being in force or in the memorandum and articles of association or any other instrument relating to the industrial company, and any provision regarding share qualification, age limit, number of directorships, removal from office of directors and such like conditions contained in any such law or instrument aforesaid, shall not apply to any director appointed by the Board.
(6) Any special director appointed under sub-section (4) shall—
(a) hold office during the pleasure of the Board and may be removed or substituted by any person by order in writing by the Board;
(b) not incur any obligation or liability by reason only of his being a director or for anything done or omitted to be done in good faith in the discharge of his duties as a director or anything in relation thereto;
(c) not be liable to retirement by rotation and shall not be taken into account for computing the number of directors liable to such retirement;
1[(d) not be liable to be prosecuted under any law for any thing done or omitted to be done in good faith in the discharge of his duties in relation to the sick industrial company.]
17. Powers of Board to make suitable order on the completion of inquiry.— (1) If after making an inquiry under section 16, the Board is satisfied that a company has become a sick industrial company, the Board shall, after considering all the relevant facts and circumstances of the case, decide, as soon as may be by order in writing, whether it is practicable for the company to 3[make its net worth exceed the accumulated losses] within a reasonable time.
(2) If the Board decides under sub-section (1) that it is practicable for a sick industrial company to make its net worth positive within a reasonable time, the Board, shall, by order in writing and subject to such restrictions or conditions as may be specified in the order, give such time to the company as it may deem fit to 3[make its net worth exceed the accumulated losses].
(3) If the Board decides under sub-section (1) that it is not practicable for a sick industrial company to 3[make its net worth exceed the accumulated losses] within a reasonable time and that it is necessary or expedient in the public interest to adopt all or any of the measures specified in section 18 in relation to the said company it may, as soon as may be, by order in writing, direct any operating agency specified in the order to prepare, having regard to such guidelines as may be specified in the order, a scheme providing for such measures in relation to such company.
1. Ins. by Act 12 of 1994, s. 5 (w.e.f. 1-2-1994).
2. Subs. by s. 5, ibid., for “ it shall appoint” (w.e.f. 1-2-1994).
3. Subs. by s. 6, ibid., for “make its net worth positive” (w.e.f. 1-2-1994).
(4) The Board may,—
(a) if any of the restrictions or conditions specified in an order made under sub-section (2) are not complied with by the company concerned, 1[or if the company fails to revive in pursuance of the said order,] review such order on a reference in that behalf from any agency referred to in sub-section (2) of section 15 or on its own motion and pass a fresh order in respect of such company under sub-section (3);
(b) if the operating agency specified in an order made under sub-section (3) makes a submission in that behalf, review such order and modify the order in such manner as it may deem appropriate.
18. Preparation and sanction of schemes.— (1) Where an order is made under sub-section (3) of section 17 in relation to any sick industrial company, the operating agency specified in the order shall prepare, as expeditiously as possible and ordinarily within a period of ninety days from the date of such order, a scheme with respect to such company providing for any one or more of the following measures, namely:—
2[(a) the financial reconstruction of the sick industrial company;]
(b) the proper management of the sick industrial company by change in, or take over of, management of the sick industrial company;
3[(c) the amalgamation of—
(i) the sick industrial company with any other company, or
(ii) any other company with the sick industrial company;
(hereafter in this section, in the case of sub-clause (i), the other company, and in the case of sub-clause (ii), the sick industrial company, referred to as “transferee company”;]
(d) the sale or lease of a part or whole of any industrial undertaking of the sick industrial company;
4[(da) the rationalisation of managerial personnel, supervisory staff and workmen in accordance with law;]
(e) such other preventive, ameliorative and remedial measures as may be appropriate;
(f) such incidental, consequential or supplemental measures as may be necessary or expedient in connection with or for the purposes of the measures specified in clauses (a) to (e).
(2) The scheme referred to in sub-section (1) may provide for any one or more of the following, namely:—
(a) the constitution, name and registered office, the capital, assets, powers, rights, interests, authorities and privileges, duties and obligations of the sick industrial company or, as the case may be, of the 5[transferee company];
(b) the transfer to the 5[transferee company] of the business, properties, assets and liabilities of the sick industrial company on such terms and conditions as may be specified in the scheme;
(c) any change in the Board of Directors, or the appointment of a new Board of Directors, of the sick industrial company and the authority by whom, the manner in which and the other terms and conditions on which, such change or appointment shall be made and in the case of appointment of a new Board of Directors or of any director, the period for which such appointment shall be made;
(d) the alteration of the memorandum or articles of association of the sick industrial company or, as the case may be, of the 5[transferee company] for the purpose of altering the capital structure thereof or for such other purposes as may be necessary to give effect to the reconstruction or amalgamation;
1. Ins. by Act 12 of 1994, s. 6 (w.e.f. 1-2-1995).
2. Subs. by s. 7, ibid., for clause (a) (w.e.f. 1-2-1994).
3. Subs. by s. 7, ibid., for clause (c) (w.e.f. 1-2-1994).
4. Ins. by s. 7, ibid. (w.e.f. 1-2-1994).
5. Subs. by s. 7, ibid., for “transferee industrial company” (w.e.f. 1-2-1994).
(e) the continuation by, or against, the sick industrial company or, as the case may be, the 1[transferee company] of any action or other legal proceeding pending against the sick industrial company immediately before the date of the order made under sub-section (3) of section 17;
(f) the reduction of the interest or rights which the shareholders have in the sick industrial company to such extent as the Board considers necessary in the interests of the reconstruction, revival or rehabilitation of the sick industrial company or for the maintenance of the business of the sick industrial company;
(g) the allotment to the shareholders of the sick industrial company of shares in the sick industrial company or, as the case may be, in the 1[transferee company] and where any shareholder claims payment in cash and not allotment of shares, or where it is not possible to allot shares to any shareholder the payment of cash to those shareholders in full satisfaction of their claims—
(i) in respect of their interest in shares in the sick industrial company before its reconstruction or amalgamation; or
(ii) where such interest has been reduced under clause (f) in respect of their interest in shares as so reduced;
(h) any other terms and conditions for the reconstruction or amalgamation of the sick industrial company;
(i) sale of the industrial undertaking of the sick industrial company free from all encumbrances and all liabilities of the company or other such encumbrances and liabilities as may be specified, to any person, including a co-operative society formed by the employees of such undertaking and fixing of reserve price for such sale;
(j) lease of the industrial undertaking of the sick industrial company to any person, including a co-operative society formed by the employees of such undertaking;
(k) method of sale of the assets of the industrial undertaking of the sick industrial company such as by public auction or by inviting tenders or in any other manner as may be specified and for the manner of publicity therefor;
(l) transfer or issue of the shares in the sick industrial company at the face value or at the intrinsic value which may be at discount value or such other value as may be specified to any industrial company or any person including the executives and employees of the sick industrial company;
(m) such incidental, consequential and supplemental matters as may be necessary to secure that the reconstruction or amalgamation or other measures mentioned in the scheme are fully and effectively carried out.
(3) 2[(a) The scheme prepared by the operating agency shall be examined by the Board and a copy of the scheme with modification, if any, made by the Board shall be sent, in draft, to the sick industrial company and the operating agency and in the case of amalgamation, also to any other company concerned, and the Board shall publish or cause to be published the draft scheme in brief in such daily newspapers as the Board may consider necessary, for suggestions and objections, if any, within such period as the Board may specify;]
(b) The Board may make such modifications, if any, in the draft scheme as it may consider necessary in the light of the suggestions and objections received from the sick industrial company and the operating agency and also from the 1[transferee company] and 3[any other company] concerned in the amalgamation and from any shareholder or any creditors or employees of 4[such companies:]
1. Subs. by Act 12 of 1994, s. 7, for “transferee industrial company” (w.e.f. 1-2-1994).
2. Subs. by s. 7, ibid., for clause (a) (w.e.f. 1-2-1994).
3. Subs. by s. 7, ibid., for “any other industrial company” (w.e.f. 1-2-1994).
4. Subs. by s. 7, ibid., for “such industrial companies” (w.e.f. 1-2-1994).
Provided that where the scheme relates to amalgamation 1*** the said scheme shall be laid before 2[the company other than the sick industrial company] in the general meeting for the approval of the scheme by its shareholders and no such scheme shall be proceeded with unless it has been approved, with or without modification, by a special resolution passed by the shareholders of the 2[the company other than the sick industrial company].
(4) The scheme shall thereafter be sanctioned, as soon as may be, by the Board (hereinafter referred to as the „sanctioned scheme‟) and shall come into force on such date as the Board may specify in this behalf:
Provided that different dates may be specified for different provisions of the scheme.
(5) The Board may on the recommendations of the operating agency or otherwise, review any sanctioned scheme and make such modifications as it may deem fit or may by order in writing direct any operating agency specified in the order, having regard to such guidelines as may be specified in the order, to prepare a fresh scheme providing for such measures as the operating agency may consider necessary.
(6) When a fresh scheme is prepared under sub-section (5), the provisions of sub-sections (3) and (4) shall apply in relation thereto as they apply to in relation to a scheme prepared under sub-section (1).
3[(6A) Where a sanctioned scheme provides for the transfer of any property or liability of the sick industrial company in favour of any other company or person or where such scheme provides for the transfer of any property or liability of any other company or person in favour of the sick industrial company, then, by virtue of, and to the extent provided in, the scheme, on and from the date of coming into operation of the sanctioned scheme or any provision thereof, the property shall be transferred to, and vest in, and the liability shall become the liability of, such other company or person or, as the case may be, the sick industrial company.]
(7) The sanction accorded by the Board under sub-section (4) shall be conclusive evidence that all the requirements of this scheme relating to the reconstruction or amalgamation, or any other measure specified therein have been complied with and a copy of the sanctioned scheme certified in writing by an officer of the Board to be a true copy thereof, shall, in all legal proceedings (whether in appeal or otherwise) be admitted as evidence.
4[(8) On and from the date of the coming into operation of the sanctioned scheme or any provision thereof, the scheme or such provision shall be binding on the sick industrial company and the transferee company or, as the case may be, the other company and also on the shareholders, creditors and guarantors and employees of the said companies.]
(9) If any difficulty arises in giving effect to the provisions of the sanctioned scheme, the Board may, on the recommendation of the operating agency 3[or otherwise], by order to anything, not inconsistent with such provisions, which appears to it to be necessary or expedient for the purpose of removing the difficulty.
(10) The Board may, if it deems necessary or expedient so to do, by order in writing, direct any operating agency specified in the order to implement a sanctioned scheme with such terms and conditions and in relation to such sick industrial company as may be specified in the order.
(11) Where the whole of the undertaking of the sick industrial company is sold under a sanctioned scheme, the Board may distribute the sale proceeds to the parties entitled thereto in accordance with the provisions of section 529A and other provisions of the Companies Act, 1956 (1 of 1956).
3[(12) The Board may monitor periodically the implementation of the sanctioned scheme.]
1. The words “of the sick industrial company” omitted by Act 12 of 1994, s. 7 (w.e.f. 1-2-1994).
2. Subs. by s. 7, ibid., for the words “ transferee industrial company” (w.e.f. 1-2-1994).
3. Ins. by s. 7, ibid. (w.e.f. 1-2-1994).
4. Subs. by s. 7, ibid., for sub-section 8 (w.e.f. 1-2-1994).
19. Rehabilitation by giving financial assistance.— (1) Where the scheme relates to preventive, ameliorative, remedial and other measures with respect to any sick industrial company, the scheme may provide for financial assistance by way of loans, advances or guarantees or reliefs or concessions or sacrifices from the Central Government, a State Government, any scheduled bank or other bank, a public financial institution or State level institution or any institution or other authority (any Government, bank, institution or other authority required by a scheme to provide for such financial assistance being hereafter in this section referred to as the person required by the scheme to provide financial assistance) to the sick industrial company.
(2) Every scheme referred to in sub-section (1) shall be circulated to every person required by the scheme to provide financial assistance for his consent within a period of sixty days from the date of such circulation 1[or within such further period, not exceeding sixty days, as may be allowed by the Board, and if no consent is received within such period or further period, it shall be deemed that consent has been given].
(3) Where in respect of any scheme the consent referred to in sub-section (2) is given by every person required by the scheme to provide financial assistance, the Board may, as soon as may be, sanction the scheme and on and from the date of such sanction the scheme shall be binding on all concerned.
1[(3A) On the sanction of the scheme under sub-section (3), the financial institutions and the banks required to provide financial assistance shall designate by mutual agreement a financial institution and a bank from amongst themselves which shall be responsible to disburse financial assistance by way of loans or advances or guarantees or reliefs or concessions or sacrifices agreed to be provided or granted under the scheme on behalf of all financial institutions and banks concerned.
(3B) The financial institution and the bank designated under sub-section (3A) shall forthwith proceed to release the financial assistance to the sick industrial company in fulfilment of the requirement in this regard.]
(4) Where in respect of any scheme consent under sub-section (2) is not given by any person required by the scheme to provide financial assistance, the Board may adopt such other measures, including the winding up of the sick industrial company, as it may deem fit.
2[19A. Arrangement for continuing operations, etc., during inquiry.— (1) At any time before completion of the inquiry under section 16, the sick industrial company or the Central Government or the Reserve Bank or a State Government or a public financial institution or a State level institution or a scheduled bank or any other institution, bank or authority providing or intending to provide any financial assistance by way of loans or advances or guarantees or reliefs or concessions to the sick industrial company may make an application to the Board—
(a) agreeing to an arrangement for continuing the operations of the sick industrial company; or
(b) suggesting a scheme for the financial reconstruction of the sick industrial company.
(2) The Board may, within sixty days of the receipt of the application under sub-section (1), pass such orders thereon as it may deem fit.]
20. Winding up of sick industrial company.— 3[(1) Where the Board, after making inquiry under section 16 and after consideration of all the relevant facts and circumstances and after giving an opportunity of being heard to all concerned parties, is of opinion that the sick industrial company is not likely to make its net worth exceed the accumulated losses within a reasonable time while meeting all its financial obligations and that the company as a result thereof is not likely to become viable in future and that it is just and equitable that the company should be wound up, it may record and forward its opinion to the concerned High Court.]
1. Ins. by Act 12 of 1994, s. 8 (w.e.f. 1-2-1994)
2. Ins. by s. 9, ibid. (w.e.f. 1-2-1994)
3. Subs. by s. 10, ibid., for sub-section (1) (w.e.f. 1-2-1994)
(2) The High Court shall, on the basis of the opinion of the Board, order winding up of the sick industrial company and may proceed and cause to proceed with the winding up of the sick industrial company in accordance with the provisions of the Companies Act, 1956 (1 of 1956).
(3) For the purpose of winding up of the sick industrial company, the High Court may appoint any officer of the operating agency, if the operating agency gives its consent, as the liquidator of the sick industrial company and the officer so appointed shall for the purposes of the winding up of the sick industrial company be deemed to be, and have all the powers of, the official liquidator under the Companies Act, 1956 (1 of 1956).
(4) Notwithstanding anything contained in sub-section (2) or sub- section (3), the Board may cause to be sold the assets of the sick industrial company in such manner as it may deem fit and forward the sale proceeds to the High Court for orders for distribution in accordance with the provisions of section 529A, and other provisions of the Companies Act, 1956 (1 of 1956).
21. Operating agency to prepare complete inventory, etc.— Where,1[for the proper discharge of the functions of the Board under this Act], the circumstances so require, the Board may, through any operating agency, cause to be prepared—
(a) with respect to 2[a company], a complete inventory of—
(i) all assets and liabilities of whatever nature;
(ii) all books of account, registers, maps, plans, records, documents of title or ownership of property and all other documents of whatever nature relating thereto;
(b) a list of shareholders and a list of creditors showing separately in the list of creditors, the secured creditors and the unsecured creditors;
(c) a valuation report in respect of the shares and assets in order to arrive at the reserve price for the sale of a part or whole of the industrial undertaking of the company or for fixation of the lease rent or share exchange ratio;
(d) an estimate of reserve price, lease rent or share exchange ratio; and
(e) proforma accounts, where no up-to-date audited accounts, are available.
22. Suspension of legal proceedings, contracts, etc.— (1) Where in respect of an industrial company, an inquiry under section 16 is pending or any scheme referred to under section 17 is under preparation or consideration or a sanctioned scheme is under implementation or where an appeal under section 25 relating to an industrial company is pending, then, notwithstanding anything contained in the Companies Act, 1956 (1 of 1956) or any other law or the memorandum and articles of association of the industrial company or any other instrument having effect under the said Act or other law, no proceedings for the winding up of the industrial company or for execution, distress or the like against any of the properties of the industrial company or for the appointment of a receiver in respect thereof 3[and no suit for the recovery of money or for the enforcement of any security against the industrial company or of any guarantee in respect of any loans or advance granted to the industrial company] shall lie or be proceeded with further, except with the consent of the Board or, as the case may be, the Appellate Authority.
(2) Where the management of the sick industrial company is taken over or changed 3[in pursuance of any scheme sanctioned under section 18], notwithstanding anything contained in the Companies Act, 1956 (1 of 1956) or any other law or in the memorandum and articles of association of such company or any instrument having effect under the said Act or other law—
(a) it shall not be lawful for the shareholders of such company or any other person to nominate or appoint any person to be a director of the company;
1. Subs. by Act 12 of 1994, s. 11, for the words “in relation to an inquiry or scheme” (w.e.f. 1-2-1994).
2. Subs. by s. 11, ibid., for the words “ an industrial company” (w.e.f. 1-2-1994).
3. Ins. by s. 12, ibid. (w.e.f. 1-2-1994).
(b) no resolution passed at any meeting of the shareholders of such company shall be given effect to unless approved by the Board.
(3) 1[Where an inquiry under section 16 is pending or any scheme referred to in section 17 is under preparation or during the period] of consideration of any scheme under section 18 or where any such scheme is sanctioned thereunder, for due implementation of the scheme, the Board may by order declare with respect to the sick industrial company concerned that the operation of all or any of the contracts, assurances of property, agreements, settlements, awards, standing orders or other instruments in force, to which such sick industrial company is a party or which may be applicable to such sick industrial company immediately before the date of such order, shall remain suspended or that all or any of the rights, privileges, obligations and liabilities accruing or arising thereunder before the said date, shall remain suspended or shall be enforceable with such adaptations and in such manner as may be specified by the Board:
Provided that such declaration shall not be made for a period exceeding two years which may be extended by one year at a time so, however, that the total period shall not exceed seven years in the aggregate.
(4) Any declaration made under sub-section (3) with respect to a sick industrial company shall have effect notwithstanding anything contained in the Companies Act, 1956 (1 of 1956) or any other law, the memorandum and articles of association of the company or any instrument having effect under the said Act or other law or any agreement or any decree or order of a court, tribunal, officer or other authority or of any submission, settlement or standing order and accordingly,—
(a) any remedy for the enforcement of any right, privilege, obligation and liability suspended or modified by such declaration, and all proceedings relating thereto pending before any court, tribunal, officer or other authority shall remain stayed or be continued subject to such declaration; and
(b) on the declaration ceasing to have effect—
(i) any right, privilege, obligation or liability so remaining suspended or modified, shall become revived and enforceable as if the declaration had never been made; and
(ii) any proceeding so remaining stayed shall be proceeded with, subject to the provisions of any law which may then be in force, from the stage which had been reached when the proceedings became stayed.
(5) In computing the period of limitation for the enforcement of any right, privilege, obligation or liability, the period during which it or the remedy for the enforcement thereof remains suspended under this section shall be excluded.
2[22A. Direction not to dispose of assets.— The Board may, if it is of opinion that any direction is necessary in the interest of the sick industrial company or creditors or shareholders or in the public interest, by order in writing, direct the sick industrial company not to dispose of, except with the consent of the Board, any of its assets—
(a) during the period of preparation or consideration of the scheme under section 18; and
(b) during the period beginning with the recording of opinion by the Board for winding up of the company under sub-section (1) of section 20 and up to commencement of the proceedings relating to the winding up before the concerned High Court.]
1. Subs. by Act 12 of 1994, s. 12, for the words “ During the period” (w.e.f. 1-2-1994).
2. Ins. by s. 13, ibid. (w.e.f. 1-2-1994).
CHAPTER IV
PROCEEDINGS IN CASE OF POTENTIALLY SICK INDUSTRIAL COMPANIES, MISFEASANCE PROCEEDINGS, APPEALS AND MISCELLANEOUS
23. Loss of fifty per cent. net worth by industrial companies.— (1) If the accumulated losses of an industrial company, as at the end of any financial year (hereinafter referred to as the relevant financial year) have resulted in erosion of fifty per cent., or more of its peak net worth during the immediately 1[preceding four financial years]—
(a) the company shall, within a period of sixty days from the date (hereinafter referred to as the relevant date) of finalisation of the duly audited accounts of the company for the relevant financial year—
(i) report the fact of such erosion to the Board; and
(ii) hold a general meeting of the shareholders of the company for considering such erosion;
(b) the Board of directors shall, at least twenty-one days before the date on which the meeting under sub-clause (ii) of clause (a) is held, forward to every member of the company a report as to such erosion and the causes for such erosion;
(c) the company may, by ordinary resolution passed at the meeting held under clause (a) remove a director (being a director appointed by the members of the company) and fill the vacancy created by such removal, so far as may be, in accordance with the procedure provided in sub-sections (2) to (6) of section 284 of the Companies Act, 1956 (1 of 1956).
(2) A director removed under sub-section (1) shall not be entitled to any compensation or damages for termination of his appointment as director or of any appointment terminating with that as director.
(3) If default is made in complying with the provisions of this section, every director or other officer of the company who is in default shall be punishable with imprisonment which shall not be less than six months but which may extend to two years and with fine.
2[23A. Proceedings on report, etc., of loss of fifty per cent. net worth.— (1) Without prejudice to the provisions of clause (a) of sub- section (1) of section 23, the Central Government or the Reserve Bank or a State Government or a public financial institution or a State level institution or a scheduled bank may, if it has sufficient reasons to believe that the accumulated losses of any industrial company have resulted in erosion of fifty per cent. or more of its peak net worth during the immediately preceding four financial years, report the fact of such erosion to the Board.
(2) If the Board has, upon information received or upon its own knowledge, reason to believe that the accumulated losses of any industrial company have resulted in erosion of fifty per cent. or more of its peak net worth during the immediately preceding four financial years, it may call for such information from that company as it may deem fit.
(3) Where the Board is of the opinion that an industrial company referred to in sub-section (1) is not likely to make its net worth exceed its accumulated losses within a reasonable time while meeting all its financial obligations and that the company as a result thereof is not likely to become viable in future, it may require by order an operating agency to inquire into and make a report with respect to such matters as may by specified in the order.
(4) After consideration of the report of the operating agency the Board may publish or cause to be published a notice in such daily newspapers as the Board may consider necessary, for suggestions and objections, if any, within such period as the Board may specify, as to why the company should not be wound up.
1. Subs. by Act 12 of 1994, s. 14, for the words “preceding five financial years” (w.e.f. 1-2-1994).
2. Ins. by s. 15, ibid. (w.e.f. 1-2-1994).
(5) Where the Board, after consideration of the relevant facts and circumstances and after giving an opportunity of being heard to all concerned parties, is of the opinion that the industrial company is not likely to make its net worth exceed the accumulated losses within a reasonable time while meeting all its financial obligations and that the company as a result thereof, is not likely to become viable in future and that it is just and equitable that the company should be wound up, the Board may record and forward its opinion to the concerned High Court in relation to the company as if it were a sick industrial company and the provisions of sub-sections (2), (3) and (4) of section 20 shall apply accordingly.
23B. Power of Board to call for periodic information.— On receipt of a report under sub-clause (i) of clause (a) of sub-section (1) of section 23 or under sub-section (1) of section 23A or upon information or its own knowledge under sub-section (2) of section 23A, the Board may call for any periodic information from the company as to the steps taken by the company to make its net worth exceed the accumulated losses and the company shall furnish such information.]
24. Misfeasance proceedings.— (1) If, in the course of scrutiny or implementation of any scheme or proposal, it appears to the Board that any person who has taken part in the promotion, formation or management of the sick industrial company or its undertaking, including any past or present director, manager or officer or employee of the sick industrial company—
(a) has misapplied or retained, or become liable or accountable for, any money or property of the sick industrial company; or
(b) has been guilty of any misfeasance, malfeasance or non-feasance or breach of trust in relation to the sick industrial company, the Board may, by order, direct him to repay or restore the money or property or any part thereof, with or without interest, as it thinks just, or to contribute such sum to the assets of the sick industrial company or the other person entitled thereto by way of compensation in respect of the misapplication, retainer misfeasance or breach of trust, as the Board thinks just, and also report the matter to the Central Government for any other action which that Government may deem fit.
(2) If the Board is satisfied on the basis of the information and evidence in its possession with respect to any person who is or was a director or an officer or other employee of the sick industrial company, that such person by himself or along with other had diverted the funds or other property of such company for any purpose other than a bona fide purpose of the company or had managed the affairs of the company in a manner highly detrimental to the interests of the company, the Board shall, by order, direct the public financial institutions, scheduled banks and State level institutions not to provide, during a period of ten years from the date of the order, any financial assistance to such person or any firm of which such person is a partner or any company or other body corporate of which such person is a director (by whatever name called).
(3) No order shall be made by the Board under this section against any person unless such person has been given an opportunity for making his submissions.
(4) This section shall apply notwithstanding that the matter is one for which the person may be criminally liable.
25. Appeal.— (1) Any person aggrieved by an order of the Board made under this Act may, within forty-five days from the date on which a copy of the order is issued to him, prefer an appeal to the Appellate Authority:
Provided that the Appellate Authority may entertain any appeal after the said period of forty-five days but not after sixty days from the date aforesaid if it is satisfied that the appellant was prevented by sufficient cause from filing the appeal in time.
(2) On receipt of an appeal under sub-section (1), the Appellate Authority may, after giving an opportunity to the appellant to be heard, if he so desires, and after making such further inquiry as it deems fit, confirm, modify or set aside the order appealed against 1[or remand the matter to the Board for fresh consideration].
26. Bar of jurisdiction.— No order passed or proposal made under this Act shall be appealable except as provided therein and no civil court shall have jurisdiction in respect of any matter which the Appellate Authority or the Board is empowered by, or under, this Act to determine and no injunction shall be granted by any court or other authority in respect of any action taken or to be taken in pursuance of any power conferred by or under this Act.
27. Delegation of powers.— The Board may, by general or special order, delegate, subject to such conditions and limitations, if any, as may be specified in the order, to any Member or Secretary or other officer or employee of the Board or other person authorised by the Board to manage any industrial company or industrial undertaking or any operating agency, such powers and duties [except the powers and duties under sub-sections (2) and (4) of section 16, section 17, sub- sections (3) and (4) of section 19, sub-sections (1) and (4) of section 20, sub-section (3) of section 22 and section 24] under this Act as it may deem necessary.
28. Returns and information.— (1) The Board shall furnish from time to time to the Central Government such returns as the Central Government may require.
(2) The Board may, for the purpose of efficient discharge of its functions under this Act, collect from, or furnish to—
(a) the Central Government,
(b) the Reserve Bank,
(c) the scheduled bank or any other bank,
(d) the public financial institution, 2***
(e) the State-level institution, 3[or]
3[(f) the sick industrial company and, in case of amalgamation, the other company,] such information as it may consider useful for the purpose in such manner and within such time as it may think fit
29. Power to seek the assistance of Chief Metropolitan Magistrate and District Magistrate.— (1) The Board or any operating agency, on being directed by the Board, may, in order to take into custody or under its control all property, effects and actionable claims to which a sick industrial company is or appears to be entitled, request, in writing, the Chief Metropolitan Magistrate or the District Magistrate within whose jurisdiction any property, books of account or any other documents of such sick industrial company be situate or be found, to take possession thereof, and the Chief Metropolitan Magistrate or the District Magistrate, as the case may be, shall, on such request being made to him,—
(i) take possession of such property, books of account or other documents; and
(ii) cause the same to be entrusted to the Board or the operating agency.
(2) For the purpose of securing compliance with the provisions of sub-section (1), the Chief Metropolitan Magistrate or the District Magistrate may take or cause to be taken such steps and use or cause to be used such force as may, in his opinion, be necessary.
(3) No act of the Chief Metropolitan Magistrate or the District Magistrate done in pursuance of this section shall be called in question in any court or before any authority on any ground whatsoever.
1. Added by Act 12 of 1994, s. 16 (w.e.f. 1-2-1994).
2. The word “or” omitted by s. 17, ibid. (w.e.f. 1-2-1994).
3. Ins. by s. 17, ibid. (w.e.f. 1-2-1994).
30. Protection of action taken in good faith.— No suit or other legal proceeding shall lie against the Board or the Appellate Authority or the Chairman or any other Member, officer or other employee of the Board or the Appellate Authority, or operating agency or any other person authorised by the Board or the Appellate Authority to discharge any function under this Act for any loss or damage caused or likely to be caused by any action which is in good faith done or intended to be done in pursuance of this Act.
31. Saving of pending proceedings.— Where a receiver or an official liquidator has been appointed in any proceeding pending immediately before the commencement of this Act, in any High Court for winding up of an industrial company such proceeding shall not abate but continue in that High Court 1[and no proceeding in respect of such industrial company shall lie or be proceeded with further before the Board.]
32. Effect of the Act on other laws.— (1) The provisions of this Act and of any rules or schemes made thereunder shall have effect notwithstanding anything inconsistent therewith contained in any other law except the provisions of the Foreign Exchange Regulation Act, 1973 (46 of 1973) and the Urban Land (Ceiling and Regulation) Act, 1976 (33 of 1976) for the time being in force or in the Memorandum or Articles of Association of an industrial company or in any other instrument having effect by virtue of any law other than this Act.
(2) Where there has been under any scheme under this Act an amalgamation of a sick industrial company with another company, the provisions of section 72A of the Income-tax Act, 1961 (43 of 1961), shall, subject to the modifications that the power of the Central Government under that section may be exercised by the Board without any recommendation by the specified authority referred to in that section, apply in relation to such amalgamation as they apply in relation to the amalgamation of a company owning an industrial undertaking with another company.
2* * * * *
33. Penalty for certain offences.— (1) Whoever violates the provisions of this Act or any scheme, or any order of the Board, or the Appellate Authority and whoever makes a false statement or gives false evidence to the Board or the Appellate Authority, shall be punishable with simple imprisonment for a term which may extend to three years and shall also be liable to fine.
3[(2) No court shall take cognizance of any offence under sub-section (1) except on a complaint in writing of the Secretary or any such other officer of the Board or the Appellate Authority or any such officer of an operating agency as may be authorised in this behalf by the Board or the Appellate Authority.]
34. Offences by companies.— (1) Where any offence, punishable under this Act has been committed by a company, every person who, at the time the offence was committed was in charge of, and was responsible to, the company for the conduct of the business of the company, as well as the company, shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly:
Provided that nothing contained in this sub-section shall render any such person liable to any punishment, if he proves that the offence was committed without his knowledge or that he had exercised all due diligence to prevent the commission of such offence.
(2) Notwithstanding anything contained in sub-section (1), where any offence punishable under this Act has been committed by a company and it is proved that the offence has been committed with the consent or connivance of, or is attributable to any neglect on the part of, any director, manager, secretary or other officer of the company, such director, manager, secretary or other officer shall also be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly.
1. Added by Act 12 of 1994, s. 18 (w.e.f. 1-2-1994).
2.Omitted by s. 19, ibid. (w.e.f. 1-2-1994)
3. Subs. by s. 20, ibid., for sub-section (2) (w.e.f. 1-2-1994).
Explanation.—For the purposes of this section,—
(a) “company” means any body corporate and includes a firm or other association of individuals;
and
(b) “director”, in relation to a firm, means a partner in the firm.
35. Power to remove difficulties.— If any difficulty arises in giving effect to the provisions of this Act or the rules, schemes or orders made thereunder, the Central Government may, by notification, remove the difficulty:
Provided that no such notification shall be made by the Central Government after the expiry of a period of three years from the date on which this Act receives the assent of the President.
36. Power to make rules.— (1) The Central Government may, by notification, make rules for carrying out the provisions of this Act.
(2) In particular and without prejudice to the generality of the foregoing power, such rules may provide for all or any of the following matters, namely:—
(a) the salaries and allowances payable to and other terms and conditions of service of the Chairman and other Members under sub-section (7) of section 6;
(b) the powers which may be exercised and the duties which may be performed by the Secretary to the Board or the Appellate Authority under sub-section (1) of section 8;
(c) the restrictions and conditions subject to which officers and employees may be appointed to the Board or the Appellate Authority under sub-section (2) of section 8;
(d) the salaries and allowances and other conditions of service of the Secretary and other officers and employees of the Board or the Appellate Authority under sub-section (3) of section 8;
(e) the additional matters referred to in sub-section (3) of section 13;
(f) any other matter which is required to be, or may be, prescribed.
(3) Every rule made under this Act shall be laid, as soon as may be after it is made, before each House of Parliament, while it is in session, for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in making any modification in the rule or both Houses agree that the rule should not be made, the rule shall thereafter have effect only in such modified form or be of no effect, as the case may be; so, however, that any such modification or annulment shall be without prejudice to the validity of anything previously done under that rule.
THE SCHEDULE
(See sections 6 (8) and 8 (3)
DECLARATION OF FIDELITY AND SECRECY
I, , do hereby declare that I will faithfully, truly and to the best of my skill and ability, execute and perform the duties required of me as the Chairman/Member/Secretary/other officer or employee of the Board for the Industrial and Financial Reconstruction/the Appellate Authority for Industrial and Financial Reconstruction and which properly relate to the office or position held by me in or in relation to the said Board/Appellate Authority.
I further declare that I will not communicate or allow to be communicated to any person not legally entitled thereto any information relating to the affairs of the Board/Appellate Authority, nor will I allow any such person to inspect or have access to any books or documents belonging to or in possession of the Board/Appellate Authority or the business of any person having any dealing with the said Board/Appellate Authority.
Signature.
Signed before me.
The Companies (Amendment) Act 2002
No 1 of 2003 [31st December 2002]
An Act, further to amend the Companies Act, 1956
Be it enacted by Parliament in the Fifty-third Year of the Republic of India as follows:-
1. Short title and commencement
(1) This Act may be called the companies (Amendment) Act, 2002.
(2) It shall come into force on such date as the Central Government may, by notification in the Official Gazette, appoint.
2. Insertion of new Part IXA
In the Companies Act, 1956, after Part IX, the following Part shall be inserted namely: –
PART IXA
Chapter I
Producer Companies
581A. In this Part, unless the context otherwise requires
3. Definitions
(a) “active Member” means a member who fulfils the quantum and period of patronage of the Producer Company as may be required by the articles;
(b) “Chief Executive” means an individual appointed as such under Sub- section (1) of section 581 W;
(c) “limited return” means the maximum dividend as may be specified by the articles;
(d) “Member” means a person or Producer institution (whether incorporated or admitted as a Member of a Producer Company and who retains the qualification necessary for continuance as such;
(e) “inter-State cooperative society” means a multi-State cooperative society as defined in clause (p) of section 3 of the Multi-State Cooperative societies Act, 2002 (39 of 2002) and includes any cooperative society registered under any other law for the time being I force, which has, subsequent to its formation, extended any of its objects to more than one State by enlisting the participation of persons or by extending any of its activities outside the State, whether directly or indirectly or through an institution of which it is a constituent.
(f) “mutual assistance principles” means the principles set out in sub- section (2) of section 581G;
(g) “officer” includes any director or Chief Executive or Secretary or any person in accordance with whose directions or instructions part or whole of the business of the Producer Company is carried on;
(h) “patronage” means the use of services offered by the Producer Company to its Members by participation in its business activities;
(i) “patronage bonus” means payments made by a Producer Company out of its surplus income to the Members in proportion to their respective patronage;
(j) “primary produce” means-
(i) produce of farmers, arising from agriculture (including animal husbandry, horticulture, floriculture, pisciculture, viticulture, forestry, forest products, re-vegetation, bee raising and farming plantation products), or from any other primary activity or service which promotes the interest of the farmers or consumers; or
(ii) produce of persons engaged in handloom, handicraft and other cottage industries;
(iii) any product resulting from any of the above activities, including by-products of such products;
(iv) any product resulting from an ancillary activity that would assist or promote any of the aforesaid activities or anything ancillary thereto;
(v) any activity which is intended to increase the production of anything referred to in sub-clauses (i) to (iv) or improve the quality there of;
(k) “Producer” means any person engaged in any activity connected with or relatable to any primary produce;
(l) “Producer Company” means a body corporate having objects or activities specified in section 581B and registered as Producer Company under this Act;
(m) “Producer institution” means a Producer Company or any other institution having only producer or producers or Producer Company or Producer companies as its member whether incorporated or not having any of the objects referred to in section 581B and which agrees to make use of the services of the Producer Company or producer companies as provided in its articles.
(n) “withheld price” means part of the price due and payable for goods supplied by any Member to the Producer Company; and as withheld by the Producer Company for payment on a subsequent date.
Chapter II
Information of Producer Companies and other Matters
581B. Objects of Producer Company
(1) The objectives of the Producer Company shall relate to all or any of the following matters, namely:-
(a) production, harvesting, procurement, grading, pooling, handling, marketing, selling, export of primary produce of the Members or import of goods or services for their benefit:
provided that the Producer Company may carry on any of the activities specified in this clause either by itself or through other institution;
(b) processing including preserving, drying, distilling, brewing, vinting canning and packaging of produce of its members;
(c) manufacture, sale or supply of machinery, equipment or consumables mainly to its Members;
(d) providing education on the mutual assistance principles to its Members and others;
(e) rendering technical services, consultancy services, training research and development and all other activities for the promotion of the interests of its Members;
(f) generation, transmission and distribution of power, revitalisation of land and water resources, their use, conservation and communications relatable to primary produce;
(g) insurance of producers or their primary produce;
(h) promoting techniques of mutuality and mutual assistance;
(i) welfare measures or facilities for the benefit of members as may be decided by the Board.
(j) any other activity, ancillary or incidental to any of the activities referred to in clauses (a) to (i) or other activities which may promote the principles of mutuality and mutual assistance amongst the Members in any other manner;
(k) financing of procurement, processing, marketing or other activities specified in clauses (a) to (j) which include extending of credit facilities or any other financial services to its Members.
(2) Every Producer Company shall deal primarily with the produce of its active Members for carrying out any of its objects specified in this section.
581C. Formation of Producer Company and its registration
(1) Any ten or more individuals, each of them being a producer or any two or more producer institutions, or a combination of ten or more individuals and producer institutions, desirous of forming a Producer Company having its objects specified in section 581B and otherwise complying with the requirements of this Part and the provision of this Act in respect of registration, may form an incorporated Company as a Producer Company under this Act.
(2) If the Registrar is satisfied that all the requirements of this Act have been complied with in respect of registration and matters precedent and incidental thereto, he shall, within thirty days of the receipt of the documents required for registration, register the memorandum, the articles and other documents, if any, and issue a certificate of incorporation under this Act.
(3) A Producer Company so formed shall have the liability of its Members limited by the memorandum to the amount, if any, unpaid on the shares respectively held by them and be termed a company limited by shares.
(4) The Producer Company may reimburse to its promoters all other direct costs associated with the promotion and registration of the company including registration, legal fees, printing of a memorandum and articles and the payment thereof shall be subject to the approval at its first general meeting of the Members.
(5) On registration under sub-section (1), the Producer Company shall become a body corporate as if it is a private limited company to which the provisions contained in this Part apply, without, however, any limit to the number of Members thereof, and the Producer Company shall not, under any Circumstances, whatsoever, become or be deemed to become a public limited company under this Act.
581D. Membership and voting rights of Members of Producer Company
(1) (a) In a case where the membership consists solely of individual members, the voting rights shall be based on a single vote for every Member, irrespective of his shareholding or patronage of the Producer Company.
(b) In a case where the membership consists of producer institutions only, the voting rights of such Producer institutions shall be determined on the basis of their participation in the business of the Producer Company in the previous year, as may be specified by articles:
Provided that during the first year of registration of a Producer Company, the voting rights shall be determined on the basis of the shareholding by such Producer institutions.
(c) In a case where the membership consists of individuals and Producer institutions, the voting rights shall be computed on the basis of a single vote for every Member.
(2) The articles of any Producer Company may provide for the conditions, subject to which a Member may continue to retain his membership, and the manner in which voting rights shall be exercised by the Members.
(3) Notwithstanding anything contained in Sub-section (1) or sub- section (2), any Producer Company may, if so authorised by its articles, restrict the voting rights to active Members, in any special or general meeting.
(4) No person, who has any business interest which is in conflict with business of the producer shall become a Member of that Company.
(5) A Member, who acquires any business interest which is in conflict with the business of the Producer Company, shall cease to be a Member of that Company and be removed as a Member in accordance with articles.
581E. Benefits to Members
(1) Subject to provision made in articles, every Member shall initially receive only such value for the produce or products pooled and supplied as the Board of Producer Company may determine, and the withheld price may be disbursed later in cash or kind or by allotment of equity shares, in proportion to the produce supplied to the Producer Company during the financial year to such extent and in such manner and subject to such conditions as may be decided by the Board.
(2) Every Member shall, on the share capital contributed, receive only a limited return:
Provided that every such Member may be allotted bonus shares in accordance with the provisions contained in section 581ZJ.
(3) The surplus if any, remaining after making provision for payment of limited return and reserves referred to in section 581ZI, may be disbursed as patronage bonus, amongst the Members, in proportion to their participation in the business of the Producer Company, either in cash or by way of allotment of equity shares, or both, as may be decided by the Members at the general meeting.
581F. Memorandum of Producer Company
The memorandum of association of every Producer Company shall state-
(a) the name of the company with “Producer Company Limited “ as the last words of the name of such Company;
(b) the state in which the registered office of the Producer Company is to situate;
(c) the main objects of the Producer Company shall be one or more of the objects specified in section 581B;
(d) the names and addresses of the person who have subscribed to the memorandum;
(e) the amount of share capital with which the Producer Company is to be registered and division thereof into shares of a fixed amount;
(f) the names, address and occupations of the subscribers being producers, who shall act as the first directors in accordance with sub-section (2) of section 581J;
(g) that the liability of its members is limited;
(h) opposite to the subscribers name the number of shares each subscriber takes:
Provided that no subscriber shall take less than one share;
(i) in case the objects of the Producer Company are not confined to one State, the States to whose territories the objects extend.
581G. Articles of association
(1) There shall be presented, for registration to the Registrar of the State to which the registered office of the Producer Company is, stated by the memorandum of association, to be situate-
(a) memorandum of the Producer Company;
(b) its articles duly signed by the subscribes to the memorandum.
(2) The articles shall contain the following mutual assistance principles, namely:-
(a) the membership shall be voluntary and available, to all eligible persons who, can participate or avail of the facilities or services of the Producer Company, and are willing to accept the duties of membership;
(b) each Member shall, save as otherwise provided in this part, have only a single vote irrespective of the share holding;
(c) the Producer Company shall be administered by a Board consisting of persons elected or appointed as directors in the manner consistent with the provisions of this part and the board shall be accountable to the Members;
(d) save as provided in this part, there shall be limited return on share capital;
(e) the surplus arising out of the operations of the Producer Company shall be distributed in an equitable manner by-
(i) providing for the development of the business of the Producer Company;
(ii) providing for common facilities; and
(iii) distributing amongst the Members, as may be admissible in proportion to their respective participation in the business;
(f) provision shall be made for the education of Members, employees and others, on the principles of mutuality and techniques of mutual assistance;
(g) the Producer Company shall actively cooperate with other Producer Companies (and other organisation following similar principles) at local, national or international level so as to best serve the interest of their Members and the communities it purports to serve.
(3) Without prejudice to the generality of the foregoing provisions of sub-sections (1) and (2), the articles shall contain the following provisions, namely: –
(a) the qualifications for membership, the conditions for continuance or cancellation of membership and the terms, conditions and procedure for transfer of shares;
(b) the manner of ascertaining the patronage and voting right based on patronage;
(c) subject to the provisions contained in sub-section (1) of section 581N, the manner of constitution of the Board, its powers and duties, the minimum and maximum number of directors, manner of election and appointment of directors and retirement by rotation, qualification for being elected or continuance as such and the terms of office of the said directors, their powers and duties, conditions for election or co-option of directors, method of removal of directors and the filling up of vacancies on the Board, and the manner and the terms of appointment of the Chief Executive;
(d) the election of Chairman, term of office of directors and the Chairman, manner of voting at the general or special meetings of Members, procedure for voting, by directors at meetings of the Board, powers of the Chairman and the circumstances under which the Chairman may exercise a casting vote.
(e) The circumstances under which, and the manner in which, the withheld price is to be determined and distributed;
(f) The manner of disbursement of patronage bonus in cash or by issue of equity shares, or both;
(g) The contribution to be shared and related matters referred to in sub-section (2) of section 581ZI;
(h) The matters relating to issue of bonus shares out of general reserves as set out in section 581ZJ;
(i) The basis and manner of allotment of equity shares of the Producer Company in lieu of the whole or part of sale proceeds of produce or products supplied by the Members;
(j) The amount of reserves, sources from which funds may be raised limitation on raising of funds, restriction on the use of such funds and the extent of debt that may be contracted and the conditions thereof;
(k) The credit, loans or advances which may be granted to a Member and the conditions for the grant of the same;
(l) The right of any Member to obtain information relating to general business of the company;
(m) The basis and manner of distribution and disposal of funds available after meeting liabilities in the event of dissolution or liquidation of the Producer Company;
(n) The authorisation for division, amalgamation, merger, creation of subsidiaries and the entering into joint ventures and other matters connected therewith;
(o) Laying of the memorandum and articles of the Producer Company before a special general meeting to be held within ninety days of its registration;
(p) Any other provision, which the Members may, by special resolution recommended to be included in articles.
581H. Amendment of memorandum
(1) A Producer Company shall not alter the conditions contained in its memorandum except in the cases, by the mode and to the extent for which express provision is made in this Act.
(2) A Producer Company may, by special resolution, not in consistent with section 581B, alter its objects specified in its memorandum.
(3) A copy of the amended memorandum, together with a copy of the special resolution duly certified by two directors, shall be filed with the Registrar within thirty days from the date of adoption of any resolution referred to in sub-section (2):
Provided that in the case of transfer of the registered office of a Producer Company from the Jurisdiction of one Registrar to another, certified copies of the special resolution certified by two directors shall be filed with both the Registrars with in thirty days, and each Registrar shall record the same, and thereupon the Registrar from whose jurisdiction the office is transferred, shall forthwith forward to the other Registrar all documents relating to the Producer Company.
(4) The alteration of the provision of memorandum relating to the change of the place of its registered office from one State to another shall not take effect unless it is confirmed by the Company Law Board on Petition.
581-I. Amendment of articles
(1) Any amendment of the articles shall be proposed by not less than two-third of the elected directors or by not less than one-third of the Members of the Producer Company, and adopted by the Members by a special resolution.
(2) A copy of the amended articles together with the copy of the special resolution, both duly certified by two directors, shall be filed with the Registrar within thirty days from the date of its adoption.
581J. Option to inter-State cooperative societies to become Producer Companies
(1) Notwithstanding anything contained in sub-section (1) of section 581C, any inter-State cooperative society with objects not confined to one State may make an application to the Registrar for registration as Producer Company under this Part.
(2) Every application under sub-section (1) shall be accompanied by-
(a) a copy of the special resolution, of not less than two-third of total members of inter-State cooperative society, for its incorporation as a Producer Company under this Act;
(b) a statement showing-
(i) names and addresses or the occupation of the directors and Chief Executive, if any, by whatever name called, so such cooperative and
(ii) list of members of such inter-State cooperative society;
(c) a statement indicating that the inter-state cooperative society is engaged in any one or more of the objects specified in section 581B;
(d) A declaration by two or more directors of the inter-state cooperative society certifying that particulars given in clauses (a) to (c) are corrected.
(3) When an inter-state cooperative society is registered as a Producer Company, the words “Producer Company Limited” shall from part of its name with any word or expression to show its identify preceding it.
(4) On compliance with the requirements of sub-section (1) to (3), the Registrar shall, within a period of thirty days of the receipt of application, certify under his hand that the inter-state cooperative society applying for registration is registered and there by incorporated as a Producer Company under this Part.
(5) A cooperative society formed by producers, by Federation or Union of cooperative societies of producers or cooperatives of producers, registered under any law for the time being in force which has extended its objects outside the State, either directly or through a union or federation of cooperatives of which it is a constituent, as the case may be, and any federation or Unions of such cooperatives, which has so extended any of its objects or activities outside the State, shall be eligible to make an application under sub-section (1) and to obtain registration as a Producer Company under this part.
(6) The inter-state cooperative society shall, upon registration under sub-section (1), stand transformed into a Producer Company, and thereafter shall be governed by the provisions of this part to the exclusion of the law by which it was earlier governed, save in so far as anything done or omitted to be done before its registration as a Producer Company, and notwithstanding anything contained in any other law for the time being in force, no person shall have any claim against the cooperative institution or the company by reason of such conversion or transformation.
(7) Upon registration as Producer Company, the Registrar of Companies who registers the company shall forthwith intimate the Registrar with whom the erstwhile inter-state cooperative society was earlier registered for appropriate deletion of the society from its register.
581K. Effect of incorporation of Producer Company
Every shareholder of the inter-state cooperative society immediately before the date of registration of Producer Company (hereafter referred to as the transformation date) shall be deemed to be registered on and from that date as a shareholder of the Producer Company to the extent of the face value of the shares held by such shareholder.
581L. Vesting of undertaking in Producer Company
(1) All properties and assets, movable and immovable, of, or belonging to, the inter-state cooperative society as on the transformation date, shall vest in the Producer Company.
(2) All the rights, debts, liabilities, interests, privileges and obligation of the inter-state cooperatives society as on the transformation date shall stand transferred to, and be the rights, debts, liabilities, interests, privileges and obligation of, the Producer Company.
(3) Without prejudice to the provisions contained in sub-section (2), all debts, liabilities and obligation incurred, all contracts entered into and all matters and things engaged to be done by, with or for, the society as on the transformation date for or in connection with their purposes, shall be deemed to have been incurred, entered into, or engaged to be done by, with or for, the Producer Company.
(4) All sums of money due to inter-state cooperative society immediately before the transformation date, shall be deemed to be due to the Producer Company.
(5) Every organisation, which was being managed immediately before the transformation date by the inter-state cooperative society shall be managed by the Producer Company for such period, to such extent and in such manner as the circumstances may require.
(6) Every organisation which was getting financial, managerial or technical assistance from the inter-state cooperative society, immediately before the transformation date, may continue to be given financial, managerial or technical assistance, as the case may be, by the Producer Company, for such period, to such extent and in such manner as that company may deem fit.
(7) The amount representing the capital of the erstwhile inter-state cooperative society shall form part of the capital of the Producer Company.
(8) Any reference to the inter-state cooperative society in any law other than this Act or in any contract or other instrument shall be deemed to be reference to the Producer Company.
(9) If, on the transformation date, there is pending any suit, arbitration, appeal or other legal proceeding of whatever nature by or against the inter-state cooperative society, the same shall not abate, be discontinued or be in any way prejudicially affected by reason of the incorporation of the Producer Company under section 581C or transformation of the inter-state cooperative society as a Producer Company under section 581J, as the case may be, but the suit arbitration, appeal or other proceeding, may be continued, prosecuted and enforced by or against the Producer Company in the same manner and to the same extent as it would have, or may have been continued, prosecuted and enforced by or against the inter-state cooperative society as if the provisions contained in this Part had not come into force.
581M. Concession etc to be deemed to have been granted to Producer Company
With effected from the transformation date, all fiscal and other concessions, license, benefits, privileges and exemptions granted to the inter-state cooperative society in connection with the affairs and business of the inter-state cooperative society under any law for the time being in force shall be deemed to have been granted to the Producer Company.
581N. Provision in respect of officers and other employees of inter-State cooperative society
(1) Notwithstanding anything contained in section 581-O, all the directors in the inter-state cooperative society before the incorporation of the Producer Company shall continue in office for a period of one year from the transformation date and in accordance with the provisions of this Act.
(2) Every officer or other employee of the inter-state cooperative society (except a director of the Board, Chairman or Managing Director) serving in its employment immediately before the transformation date shall, in so far as such officer or other employee is employed in connection with the inter-state cooperative society which has vested in the Producer Company by virtue of this Act, become, as from the transformation date, an officer or, as the case may be, other employee of the Producer Company and shall hold his office or service therein by the same tenure, at the same remuneration, upon the same terms and conditions, with the same obligations and with the same rights and privileges as to leave, leave travel concession, welfare scheme, medical benefit scheme, insurance, provident fund, other funds, retirement, voluntary retirement, gratuity and other benefits as he would have held under the erstwhile inter-state cooperative society if its undertaking had not vested in the Producer Company and shall continue to do so as an officer or, as the case may be, other employee of the Producer Company
(3) Where an officer or other employee of the inter-state cooperative society opts under sub-section (2) not to be in employment or service of the Producer Company, such officer or other employee shall be deemed to have resigned.
(4) Notwithstanding anything contained in the Industrial Disputes Act, 1947 (14 of 1947) or in any other law for the time being in force, the transfer of the services of any officer or other employee of the inter- state cooperative society to the Producer Company shall not entitle such officer or other employee to any compensation under this Act or under any other law for the time being in force and no such claim shall be entertained by any court, tribunal or other authority.
(5) The officers and other employees who have retired before the transformation date from the service of the inter-state cooperative society and are entitled to any benefits, rights or privileges, shall be entitled to receive the same benefits, rights or privileges from the Producer Company.
(6) The trusts of the provident fund or the gratuity fund of the inter-state cooperative society and any other bodies created for the welfare of officer or employees shall continue to discharge functions in the Producer Company as was being done hitherto in the inter-state cooperative society and any tax exemption granted to the provident fund or the gratuity fund would continue to be applied to the Producer Company.
(7) Notwithstanding anything contained in this Act or any other law for the time being in force or in the regulations of the inter-state cooperative society, no director of the Board, Chairman, Managing Director or any other person entitled to manage the whole or substantial part of the business and affairs of the inter-state cooperative society shall be entitled to any compensation against the inter-state cooperative society or the Producer Company for the loss of office or for the premature termination of any contract of management entered into by him with the inter-state cooperative society.
Chapter III
Management of Producer Company
581-O. Number of directors
Every Producer Company shall have at least five and not more than fifteen directors:
Provided that in the case of an inter-state cooperative society incorporated as a Producer Company, such company may have more than fifteen directors for a period of one year from the date of its incorporation as a Producer Company.
581P. Appointment of directors
(1) Save as provided in section 581N, the Members who sign the memorandum and the articles may designate therein the Board of Directors (not less than five) who shall govern the affairs of the Producer Company until the directors are elected in accordance with the provisions of this section.
(2) The election of directors shall be conducted with in period of ninety days of the registration of the Producer Company:
Provided that in the case of an inter-state cooperative society which has been registered as a Producer Company under sub-section (4) of section 581J in which at least five directors [including the directors continuing in office under sub-section (1) of section 581N] hold office as such on the date of registration of such company, the provision of this sub-section shall have effect as if for the words “ninety days” the words three hundred and sixty five days” had been substituted.
(3) Every person shall hold office of a director for a period not less than one year but not exceeding five years as may be specified in the articles.
(4) Every director, who retires in accordance with the articles, shall be eligible for re-appointment as a director.
(5) Save as provided in sub-section (2), the directors of the board shall be elected or appointed by the Members in the annual general meeting.
(6) The Board may co-opt one or more expert directors or an additional director not exceeding one-fifth of the total number of directors or appoint any other person as additional director for such period as the Board may deem fit:
Provided that the expert directors shall not have the right to vote in the election of the Chairman but shall be eligible to be elected as Chairman, if so provided by its articles:
Provided further that the maximum period, for which the expert director or the additional director holds office, shall not exceed such period as may be specified in the articles
581Q. Vacation of office by directors
(1) The office of the director of a Producer Company shall become vacant if –
(a) he is convicted by a Court of any offence involving moral turpitude and sentenced in respect there of to imprisonment for not less than six months;
(b) the Producer Company, in which he is a director, has made a default in repayment of any advances or loans taken from any company or institution or any other person and such default continues for ninety days;
(c) ha has made a default in repayment of any advances or loans taken from the Producer Company in which he is a director;
(d) the Producer Company, in which he is a director-
(i) has not filed the annual accounts and annual return for any continuous three financial years commencing on or after the 1st day of April, 2002;or
(ii) has failed to, repay its deposit or withheld price or patronage bonus or interest thereon on due date, or pay dividend and such failure continues for one year or more;
(e) default is made in holding election for the office of director, in the Producer Company in which he is a director, in accordance with the provisions of this Act and articles;
(f) the annual general meeting or extraordinary general meeting of the Producer Company, in which he is a director, is not called in accordance with the provisions of this Act except due to natural calamity or such other reason.
(2) The provisions of sub-section (1) shall, as far as may be, apply to the director of a producer institution which is a member of a Producer Company.
581R. Powers and functions of Board
(1) Subject to the provisions of this Act and articles, the Board of directors of a Producer Company shall exercise all such powers and to do all such acts and things, as that company is authorised so to do.
(2) In particular and without prejudice to the generality of the foregoing powers, such powers may include all or any of the following matters, namely:-
(a) determination of the dividend payable;
(b) determination of the quantum of withheld price and recommend patronage to be approved at general meeting;
(c) admission of new Members;
(d) pursue and formulate the organisational policy, objectives, establish specific long-term and annual objectives, and approve corporate strategies and financial plans;
(e) appointment of Chief Executive and such other officers of the Producer Company, as may be specified in the articles;
(f) exercise superintendence, direction and control over Chief Executive and other officers appointed by it;
(g) cause proper books of account to be maintained; prepare annual accounts to be placed before the annual general meeting with the auditor’s report and the replies on qualifications, if any, made by the auditors;
(h) acquisition or disposal of property of the Producer Company in its ordinary course of its business;
(i) investment of the funds of the Producer Company in the ordinary course of its business;
(j) sanction any loan or advance, in connection with the business activities of the Producer Company to any Member, not being a director or his relative;
(k) take such other measures or do such other acts as may be required in this discharge of its functions or exercise of its powers.
(3) All the powers specified in sub-section (1) and (2) shall be exercised by the Board, by means of resolution passed at its meeting on behalf of the Producer Company.
Explanation – For the removal of doubts, it is hereby declared that a director or a group of directors, who do not constitute the Board, shall not exercise any of the powers exercisable by it.
581S. Matters to be transacted at general meeting.
(1) The Board of directors of a Producer Company shall exercise the following powers on behalf of that company, and it shall do so only by means of resolutions passed at the annual general meeting of its Members, namely:-
(a) approval of budget and adoption of annual accounts of the Producer Company;
(b) approval of patronage bonus;
(c) issue of bonus shares;
(d) declaration of limited return and decision on the distribution of patronage;
(e) specify the conditions and limits of loans that may be given by the board to any director ;and
(f) approval of any transaction of the nature as is to be reserved in the articles for approval by the Members.
581T. Liability of directors
(1) When the directors vote for a resolution, or approve by any other means, anything done in contravention of the provisions of this Act or any other law for the time being in force or articles, they shall be jointly and severally liable to make good any loss or damage suffered by the Producer Company.
(2) Without prejudice to the provisions contained in sub-section (1), the Producer Company shall have the right to recover from its director –
(a) where such director has made any profit as a result of the contravention specified in sub-section (1), an amount equal to the profit so made;
(b) where the Producer Company incurred a loss or damage as a result of the contravention specified in sub-section (1), an amount equal to that loss or damage;
(3) The liability imposed under this section shall be in addition to and not in derogation of a liability imposed on a director under this act or other law for the time being in force.
581U. Committee of director
(1) The Board may constitute such number of committees as it may deem fit for the purpose of assisting the Board in the efficient discharge of its functions:
Provided that the Board shall not delegate any of its powers or assign the powers of the Chief Executive, to any committee.
(2) A committee constituted under sub-section (1) may, with the approval of the Board, co-opt such number of persons as it deems fit as members of the committee:
Provided that the Chief Executive appointed under section 581W or a director of the Producer Company shall be a member of such committee.
(3) Every such committee shall function under the general superintendence, direction and control of the Board, for such duration, and in such manner as the Board may direct.
(4) The fee and allowances to be paid to the members of the committee shall be such as may be determined by the Board.
(5) The minutes of each meeting of the committee shall be placed before the Board at its next meeting.
581V. Meetings of Board and quorum
(1) A meeting of the Board shall be held not less than once in every three months and at least four such meetings shall be held in every year.
(2) Notice of every meeting of the Board of directors shall be given in writing to every director for the time being in India, and at his usual address in India to every other director.
(3) The Chief Executive shall give notice as aforesaid not less than seven days prior to the date of the meeting of the Board and if he fails to do so, he shall be punishable with fine which may extend to one thousand rupees:
Provided that a meeting of the Board may be called at the shorter notice and the reasons thereof shall be recorded in writing by the Board.
(4) The quorum for a meeting of the Board shall be one-third of the total strength of directors, subject to a minimum of three.
(5) Save as provided in the articles, directors including the co-opted director; may be paid such fees and allowances for attendance at the meetings of the Board, as may be decided by the Members in the general meeting.
581W. Chief Executive and his Functions
(1) Every Producer Company shall have a full time Chief Executive, by whatever name called, to be appointed by the Board from amongst persons other than Members.
(2) The Chief Executive shall be ex-officio director of the Board and such director shall not retire by rotation.
(3) Save as otherwise provided in articles, the qualifications, experience and the terms and conditions of service of the Chief Executive shall be such as may be determined by the Board.
(4) The Chief Executive shall be entrusted with substantial powers of management as the Board may determine.
(5) Without prejudices to the generality of sub-section (4), the Chief Executive may exercise the powers and discharge the functions, namely:-
(a) do administrative acts of a routine nature including managing the day-to-day affairs of the Producer Company.
(b) operate bank accounts or authorise any person, subject to the general or special approval of the Board in this behalf, to operate the bank account;
(c) make arrangements for safe custody of cash and other assets of the Producer Company;
(d) sign such documents as may be authorised by the Board, for and on behalf of the company;
(e) maintain proper books of account; prepare annual accounts and audit thereof; place the audited accounts before the Board and in the general meeting of the Members;
(f) furnish Members with periodic information to appraise them of the operation and functions of the Producer Company;
(g) make appointments to posts in accordance with the powers delegated to him by the Board;
(h) assist the Board in the formulation of goals, objectives, strategies, plans and policies;
(i) advise the Board with respect to legal and regulator matters concerning the proposed and on going activities and take necessary action in respect thereof;
(j) exercise the powers as may be necessary in the ordinary course of business;
(k) discharge such other functions, and exercise such other powers, as may be delegated by the Board.
(6) The Chief Executive shall manage the affairs of the Producer Company under the general superintendence, direction and control of the Board and be accountable for the performance of the Producer Company.
581X. Secretary of Producer Company
(1) Every Producer Company having an average annual turnover exceeding five crore rupees in each of three consecutive financial years shall have a whole-time secretary.
(2) No individual shall be appointed as whole-time secretary unless he possesses membership of the Institute of Company Secretaries of India constituted under the Company Act, 1980 (56 of 1980).
(3) If a Producer Company fails to comply with the provisions of sub- section (1), the company and every officer of the company who is in default, shall be punishable with fine which may extend to five hundred rupees for every day during which the default continues:
Provided that in any proceedings against a person in respect of an offence under this sub-section, it shall be a defense to prove that all reasonable efforts to comply with the provisions of sub-section (1) were taken or that the financial position of the company was such that it was beyond its capacity to engage a whole-time secretary.
581Y. Quorum
Unless the articles require a larger number, one-forth of the total membership shall constitute the quorum at a general meeting.
581Z. Voting rights
Save as otherwise provided in sub-sections (1) and (3) section 581D, every Member shall have one vote and in the case of equality of votes, the Chairman or the person presiding shall have a casting vote except in the case of election of the Chairman.
Chapter IV General Meetings
581ZA. Annual general meetings
(1) Every Producer Company shall in each year, hold, in addition to any other meetings, a general meeting, as its annual general meeting and shall specify the meeting as such in the notices calling it, and not more than fifteen months shall elapse between the date of one annual general meeting of a Producer Company and that of the next:
Provided that the Registrar may, for any special reason, permit extension of the time for holding any annual general meeting (not being the first annual general meeting) by a period not exceeding three months.
(2) A Producer Company shall hold its first annual general meeting within a period of ninety days from the date of its incorporation.
(3) The Members shall adopt the articles of the Producer Company and appoint directors of its Board in the annual general meeting.
(4) The notice calling the annual general meeting shall be accompanied by the following documents, namely:-
(a) the agenda of the annual general meeting;
(b) the minutes of the previous annual general meeting or the extra- ordinary general meeting;
(c) the names of candidates for election, if any, to the office of director indicating a statement of qualifications in respect of each candidate;
(d) the audited balance-sheet and profit and loss accounts of the Producer Company and its subsidiary, if any, together with a report of the Board of Directors of such Company with respect to-
(i) the state of affairs of the Producer Company;
(ii) the amount proposed to be carried to reserve;
(iii) the amount to be paid as limited return on share capital;
(iv) the amount proposed to be disbursed as patronage bonus;
(v) the material changes and commitments, if any, affecting the financial position of the Producer Company and its subsidiary, which have occurred in between the date of the date of the annual accounts of the Producer Company to which the balance-sheet relates and the date of the report of the Board;
(vi) any other matter of importance relating to energy conservation, environmental protection, expenditure or earnings in foreign exchanges;
(vii) any other matter which is required to be, or may be, specified by the Board;
(e) the next of the draft resolution for appointment of auditors;
(f) the text of any draft resolution proposing amendment to the memorandum or articles to be considered at the general meeting, along with the recommendations of the Board.
(5) The Board of directors shall, on the requisition made in writing, duly signed and setting out the matters for the consideration, made by one-third of the Members entitled to vote in any general meeting, proceed to call an extraordinary general meeting in accordance with the provisions contained in sections 169 to 186 of this Act.
(6) Every annual general meeting shall be called, for a time during business hours, on a day that is not public holiday and shall be held at the registered office of the Producer Company or at some other place within the city, town or village in which the registered office of the Company is situate.
(7) A general meeting of the Producer Company shall be called by giving not less than fourteen days prior notice in writing.
(8) The notice of the general meeting indicating the date, time and place of the meeting shall be sent to every Member and auditor of the Producer Company.
(9) Unless the articles of the Producer Company provide for a larger number, one-fourth of the total number of members of the Producer Company shall be the quorum for its annual general meeting.
(10) The proceedings of every annual general meeting along with the Directors’ Report, the audited balance-sheet and the profit and loss account shall be filed with the Registrar within sixty days of the date on which the annual general meeting is held, with an annual return along with the filing fees as applicable under the Act.
(11) In the case where a Producer Company is formed by Producer institutions, such institutions shall be represented in the general body through the Chairman or the Chief Executive thereof who shall be competent to act on its behalf:
Provided that a Producer institution shall not be represented if such institution makes a default or failure referred to in clauses (d) to (f) of sub-section (1) of section 581Q.
Chapter V
Share Capital and Members Rights
581ZB. Share capital
(1) The share capital of Producer Company shall consist of equity shares only.
(2) The shares held by a Member in a Producer Company shall as far as may be, be in proportion to the patronage of that company.
581ZC. Special user rights
(1) The producers, who are active Members may, if so provided in the articles, have special rights and the Producer Company may issue appropriate instruments to them in respect of such special rights.
(2) The instruments of the Producer Company issued under sub- section (1) shall, after obtaining approval of the Board in that behalf, be transferable to any other active Member of that Producer Company.
Explanation.- For the purposes of this section, the expression “special right” means any right relating to supply of additional produce by the active Member or any other right relating to his produce which may be conferred upon him by the Board.
581ZD. Transferability of shares and attendant rights
(1) Save as otherwise provided in sub-section (2) to (4), the shares of a Member of Producer Company shall not be transferable.
(2) A Member of a Producer Company may, after obtaining the previous approval of the Board, transfer the whole or part of his shares along with any special rights, to an active Member at par value.
(3) Every Member shall, within three months of his becoming a Member in the Producer Company, nominate, in the manner specified in articles, a person to whom his shares in the Producer Company shall vest in the event of his death.
(4) The nominee shall, on the death of the Member, become entitled to all the rights in the shares of the Producer Company and the Board of that Company shall transfer the shares of the deceased Member to his nominee:
Provided that in a case where such nominee is not a producer, the Board shall direct the surrender of shares together with special rights, if any, to the Producer Company at par value or such other value as may be determined by the Board.
(5) Where the Board of a Producer Company is satisfied that-
(a) any Member has ceased to be a primary producer; or
(b) any Member has failed to retain his qualifications to be a Member as specified in articles, the Board shall direct the surrender of shares together with special rights, if any, to the Producer Company at par value or such other value as may be determined by the Board:
Provided that the Board shall not direct such surrender of shares unless the member has been served with a written notice and given an opportunity of being heard.
Chapter VI
Finance, Accounts and Audit
581ZE. Books of account
(1) Every Producer Company shall keep at its registered office proper books of account with respect to-
(a) all sums of money received and expended by the Producer Company and matters in respect of which the receipts and expenditure take place;
(b) all sales and purchase of goods by the Producer Company;
(c) the instruments of liability executed by or on behalf of the Producer Company;
(d) the assets and liabilities of the Producer Company;
(e) in case of a Producer Company engaged in production, processing and manufacturing, the particulars relating to utilisation of materials or labour or other items of costs.
(2) The balance-sheet and profit and loss accounts of the Producer Company shall be prepared, as far as may be, in accordance with the provision contained in section 211.
581ZF Internal Audit
Every Producer Company shall have internal audit of its accounts carried out, at such interval and in such manner as may be specified in articles, by a chartered accountant as defined in clause (b) of sub- section (1) of section 2 of the institute of Chartered Accountants Act, 1949 (38 of 1949).
581ZG. Duties of Auditor under this part
Without prejudice to the provisions contained in section 227, the auditor shall report on the following additional matters relating to the Producer Company, namely:-
(a) the amount of debts due along with particulars or bad debts if any;
(b) the verification of cash balance and securities;
(c) the details of assets and liabilities;
(d) all transactions which appear to be contrary to the provisions of this part;
(e) the loans given by the Producer Company to the directors;
(f) the donations or subscriptions given by the Producer Company;
(g) any other matter as may be considered necessary by the auditor.
581ZH. Donations or subscription by Produce Company
A Producer Company may, by special resolution, make donation or subscription to any institution or individual for the purpose of –
(a) promoting the social and economic welfare of Producer Members or producer or general public; or
(b) promoting the mutual assistance principles:
Provided that the aggregate amount of all such donation and subscription in any financial year shall not exceed three percent of the net profit of the Producer Company in the financial year immediately preceding the financial year in which the donation or subscription was made:
Provided further that no Producer Company shall make directly or indirectly to any political party or for any political purpose to any person any contribution or subscription or make available any facilities including personnel or material.
581ZI. General and other reserves
(1) Every Producer Company shall maintain a general reserve in every financial year, in addition to any reserve maintained by it as may be specified in articles.
(2) In case where the Producer Company does not have sufficient funds in any financial year for transfer to maintain the reserves as may be specified in articles, the contribution to the reserve shall be shared amongst the Members in proportion to their patronage in the business of that company in that year.
581ZJ. Issue of bonus shares
Any Producer Company may, upon recommendation of the Board and passing resolution in the general meeting, issue bonus shares by capitalisation of amounts from general reserves referred to in section 581ZI in proportion to the shares held by the Members on the date on the issue of such shares.
Chapter VII
Loans to Members and Investments
581ZK Loan, etc to Members
The Board may, subject to the provision made in articles, provide financial assistance to the Members of the Producer Company by way of –
(a) credit facility, to any Member, in connection with the business of the Producer Company, for a period not exceeding six months;
(b) loans and advances, against security specified in articles to any Member, repayable within a period exceeding three months but not exceeding seven years from the date of the disbursement of such loan or advances:
Provided that any loan or advance to any director or his relative shall be granted only after the approval by the Members in the general meeting.
581ZL. Investment in other companies, formation of subsidiaries etc
(1) The general reserves of any Producer Company shall be invested to secure the highest returns available from approved securities, fixed deposits, units, bonds issued by the Government or cooperative or scheduled bank or in such other mode as may be prescribed.
(2) Any Producer Company may, for promotion of its objectives acquire the shares of another Producer Company.
(3) Any Producer Company may, subscribe to the share capital of, or enter into any agreement or other arrangement, whether by way of formation of its subsidiary company, joint venture or in any other manner with any body corporate, for the purpose of promoting the objects of the Producer Company by special resolution in this behalf.
(4) Any Producer Company, either by itself or together with its subsidiaries, any invest, by way of subscription, purchase or otherwise, shares in any other company, other then a Producer Company, specified under sub-section (2), or subscription of capital under sub-section (3), for an amount not exceeding thirty percent, of the aggregate of its paid-up capital and free reserves:
Provided that a Producer Company may by special resolution passed in its general meeting and with prior approval of the Central Government, invest in excess of the limits specified in this section.
(5) All investments by a Producer Company may be made if such investments are consistent with the objects of the Producer Company.
(6) The Board of a Producer Company may, with the previous approval of Member by a special resolution, dispose of any of its investments referred to in sub-section (3) and (4).
(7) Every Producer Company shall maintain a register containing particulars of all the investments, showing the names of the companies in which shares have been acquired, number and value of shares; the date of acquisition; and the manner and price at which any of the shares have been subsequently disposed of.
(8) The register referred to in sub-section (7) shall be kept at the registered office of the Producer Company and the same shall be open to inspection by any Member who take extracts therefrom.
Chapter VIII Penalties
581ZM. Penalty for contravention
(1) If any person, other than a Producer Company registered under this part, carries on business under any name which contains the words “Producer Company Limited “ he shall be punishable with fine which may extend to ten thousand rupees for every day during which such name has been used by him.
(2) If a director or an officer of a Producer Company, who willfully fails to furnish any information relating to the affairs of the Producer Company required by a Member or a person duly authorised in this behalf, he shall be liable to imprisonment for a term which extend to six months and with fine equivalent to five per cent of the turnover of that company during preceding financial year.
(3) If a director or officer of a Producer Company-
(a) makes a default in handing over the custody of books of account and other documents or property in his custody to the Producer Company of which he is a director or officer; or
(b) fails to convene annual general meeting or other general meetings, he shall be punishable with fine which may extend to one lakh rupees, and in the case of a continuing default or failure, with an additional fine which may extend to ten thousand rupees for every day during which such default or failure continues.
Chapter IX
Amalgamation, Merger or Division
581ZN Amalgamation, merger or division etc to form new Producer Companies
(1) A Producer Company may, by a resolution passed at its general meeting,-
(a) decide to transfer its assets and liabilities, in whole or in part, to any other Producer Company, which agrees to such transfer by a resolution passed at its general meeting, for any of the objects specified in section 581B.
(b) divide itself into two or more new Producer Companies.
(2) Any two or more Producer Companies may, by a resolution passed at any general or special meetings of its Members, decide to-
(a) amalgamate and form a new Producer Company; or
(b) merge one Producer Company (hereafter referred to as “merging company”) with another Producer Company (hereafter referred to as “merging company”)
(3) Every resolution of Producer Company under this section shall be passed at its general meeting by a majority of total Members, with right of vote not less than two-thirds of its Members present and voting and such resolution shall contain all particulars of the transfer of assets and liabilities, or division, amalgamation, or merger, as the case may be.
(4) Before passing a resolution under this section, the Producer Company shall give notice thereof in writing together with a copy of the proposed resolution to all the Members and creditors who may their consent.
(5) Notwithstanding anything contained in articles or in any contract to the contrary, any Member, or any creditor not consenting to the resolution shall, during the period of one month of the date of service of the notice on him, have the option,-
(a) in the case of any such Member, to transfer his shares with the approval of the Board to any active Member thereby ceasing to continue as a Member of that company; or
(b) in the case of a creditor, to withdraw his deposit or loan or advance, as the case may be.
(6) Any Member or a creditor, who does not exercise his option within the period specified in sub-section (5), shall be deemed to have consented to the resolution.
(7) A resolution passed by a Producer Company under this section shall not take effect until the expiry of one month or until the assent thereto of all the Members and creditors has been obtained, whichever is earlier.
(8) The resolution referred to in this section shall provide for-
(a) the regulation of conduct of the Producer Company’s affairs in the future;
(b) the purchase of shares or interest of any Member of the Producer Company by other Members or the Producer Company;
(c) in the case of purchase of shares of the Producer Company by another Producer Company, the consequent reduction of its share capital;
(d) termination, setting aside or modification of any agreement, howsoever arrived between the company on the one hand and the directors, secretaries and manager on the other hand, apart from such terms and conditions as may, in the opinion of the majority of shareholders, be just and equitable in the circumstances of the case;
(e) termination, setting aside or modification of any agreement between the Producer Company and any person not referred to in clause (d):
Provided that no such agreement shall be terminated, set aside or modified except after giving due notice to the party concerned:
Provided further that no such agreement shall be modified except after obtaining the consent of the party concerned;
(f) the setting aside of any transfer, delivery of goods, payment, execution or other act relating to property, made or done by or against the Producer Company within three months before the date of passing of the resolution, which would if made or done against any individual, be deemed in his insolvency to be a fraudulent preference;
(g) the transfer to the merged company of the whole or any part of the undertaking, property or liability of the Producer Company
(h) the allotment or appropriation by the merged company of any shares, debentures, policies, or other like interests in the merged Company;
(i) the continuation by or against the merged company of any legal proceedings pending by or against any Producer Company;
(j) the dissolution, without winding-up, of any Producer Company;
(k) the provision to be made for the Members or creditors who make dissent;
(l) the taxes if any, to be paid by the Producer Company;
(m) such incidental, consequential and supplemental matters as are necessary to secure that the division, amalgamation or merger shall be fully and effectively carried out.
(10) When a resolution passed by a Producer Company under this section takes effect, the resolution shall be a sufficient conveyance to vest the assets and liabilities in the transferee.
(10) The Producer Company shall make arrangement for meeting in full or otherwise satisfying all claims of the Members and creditors who exercise the option, within the period specified in the sub- section (5), not to continue as the Member or creditor, as the case may be.
(11) Where the whole of the assets and liabilities of a Producer Company are transferred to another Producer Company in accordance with the provisions of sub-section (9), or where there is merger under sub-section (2), the registration of the first mentioned Company or the merging company, as the case may be, shall stand cancelled and that Company shall be deemed to have been dissolved and shall cease to exist forth with as corporate body.
(12) Where two or more Producer Companies are amalgamated into a new Producer Company in accordance with the provisions of sub- section (2) and the Producer Company so formed is duly registered by the Registrar, the registration of each of the amalgamating companies shall stand cancelled forthwith on such registration and each of the Companies shall thereupon cease to exist as a corporate body.
(13) Where a Producer Company divides itself into two or more Producer Companies in accordance with the provisions of clause (b) of sub-section (1) and the new Producer Companies are registered in accordance with the provisions of sub-section (8), the registration of erstwhile Producer Company shall stand cancelled forthwith and that Company shall be deemed to have been dissolved and cease to exist as a corporate body.
(14) The amalgamation, merger or division of companies under the foregoing sub-sections shall not in any manner whatsoever affect the pre-existing rights or obligations and any legal proceedings
that might have been continued or commenced by or against any erstwhile company before the amalgamation, merger or division, may be continued or commenced by, or against, the concerned resulting company, or merged company, as the case may be.
(15) The Registrar shall strike off the names of every Producer Company deemed to have been dissolved under sub-sections
(11) to (14)
(16) Any member or creditor or employee aggrieved by the transfer of assets, division, amalgamation or merger may, with thirty days of the passing of the resolution, prefer an appeal to High Court.
(17) The High Court shall, after giving a reasonable opportunity to the person concerned, pass such orders thereon as it may deem fit.
(18) Where an appeal has been filed under sub-section (16), the transfer of assets, division, amalgamation or merger of the Producer Company shall be subject to the decision of the High Court.
Chapter X Resolution of Disputes
581ZO. Disputes
(1) Where any dispute relating to the formation, management or business of a Producer Company arises-
(a) amongst Members, former Members or persons claiming to be Members or nominees of deceased Members; or
(b) between a Member, former Member or a person claiming to be a Member, or nominee of deceased Member and the Producer Company, its Board of directors, office-bearers, or liquidator, past or present; or
(c) between the Producer Company or its Board, and any director, office-bearer or any former director, or nominee, heir or legal representative of any deceased director of the Producer Company, such dispute shall be settled by conciliation or by arbitration as provided under the arbitration and conciliation Act, 1996 (26 of 1996) as if the parties of the dispute have consented in writing for determination of such disputes by conciliation or by arbitration and the provisions of the said Act shall apply accordingly.
Explanation:- For the purpose of this section, a dispute shall include-
(a) a claim for any debt or other amount due;
(b) a claim surety against the principal debtor, where the Producer Company has recovered from the surety amount in respect of any debtor or other amount due to it from the principal debtor as a result of the default of the principle debtor whether such debt or amount due be admitted or not;
(c) a claim by Producer Company against a Member for failure to supply produce as required of him.
(d) A claim by a Member against the Producer Company for not taking goods supplied by him.
(2) If any question arises whether the dispute relates to formation, management or business of the Producer Company, the question shall be referred to the arbitrator, whose decision thereon shall be final.
Chapter XI Miscellaneous Provisions
581ZP. Strike off name of Producer Company
(1) Where a Producer Company fails to commence business within one year of its registration or ceases to transact business with the Members or if the Registrar is satisfied, after making such inquiry as he thinks fit, that the Producer Company is no longer carrying on any of its objects specified in section 581B, he shall make an order striking off the name of the Producer Company, which shall thereupon cease to exist forthwith:
Provided that no such order canceling the registration as aforesaid shall be passed until a notice to show cause has been given by the Registrar to the Producer Company with a copy to all its directors on the proposed action and reasonable opportunity to represent its case has been given.
(2) Where the Registrar has reasonable cause to believe that a Producer Company is not maintaining any of the mutual assistance principles specified, he shall strike its name off the register in accordance with the provisions contained in section 560 of this Act.
(3) Any member of a Producer Company, who is aggrieved by an order made under sub-section (1), may appeal to the company Law Board within sixty days of the order.
(4) Where an appeal is filed under sub-section (3), the order striking off the name shall not take effect until the appeal is disposed of.
581ZQ. Provisions of this Part to override other laws
The provision of this Part shall have effect notwithstanding anything inconsistent therewith contained in this Act or any other law for the time being in force or any instrument having effect by virtue of any such law; but the provisions of any such Act or law or instrument in so far as the same are not varied by, or are inconsistent with, the provisions of this Part shall apply to the Producer Company.
581ZR. Application of provisions relating to private companies
All the limitations, restrictions and provisions of this Act, other than those specified in this Part, applicable to a private company, shall, as far as may be, apply to a Producer Company, as if it is a private limited company under this Act in so far as they are not in conflict with the provisions of this part.
Chapter XII
Reconversion of Producer Company to Inter-State Cooperative Society
581ZS. Reconversion of Producer Company to inter-state cooperative society
(1) Any Producer Company, being an erstwhile inter-state cooperative society, formed and registered under this Part, may make an application-
(a) after passing a resolution in the general meeting by not less than two-third of its Members present and voting; or
(b) on request by its creditors representing three-fourth value of its total creditors.
to the High Court for its re-conversion to the inter-State cooperative society.
(2) The High Court shall, on the application made under sub-section (1), direct holding meeting of its Members or such creditors, as the case may be, to be conducted in such manner as it may direct.
(3) If a majority in number representing three-fourths in value of the creditors, or Members, as the case may be, presented and voting in person at the meeting conducted in pursuance of the directions of the High court under sub-section (2), agree for re-conversion, if sanctioned by the High Court, be binding on all the Members and all the creditors, as the case may be, and also on the company which is being converted:
provided that no order sanctioning re-conversion shall be made by the Court unless the Court is satisfied that the company or any other person by whom an application has been made under sub- section (1) has disclosed to the Court, by affidavit or otherwise, all material facts relating to the company, such as the latest financial position of the company, the latest auditor’s report on the accounts of the company, the pendency of any investigation proceedings in relation to the company under section 235 to 251, and the like.
(4) An order made by the Court under sub-section (3) shall have no effect until a certified copy of the order has been filed with the Registrar.
(5) A copy of every such order shall be annexed to every copy of the memorandum of the company issued after the certified copy of the order has been filed as aforesaid, or in the case of a company not having a memorandum, to every copy so issued of the instrument constituting or defining the constitution of the company.
(6) If default is made in complying with sub-section (4), the company, and every officer of the company who is in default, shall be punishable with fine which may extend to one hundred rupees, for each copy in respect of which default is made.
(7) The Court may, at any time after an application has been made to it under this section, stay the commencement or continuation of any suit or proceeding against the company on such terms as the Court thinks fit, until the application is finally disposed of.
(8) Every Producer Company which has been sanctioned re- conversion by the High Court, shall make an application, under the Multi-State Cooperative Societies Act, 2002 (39 of 2002) or any other law for the time being in force for its registration as multi-State cooperative society or cooperative society, as the case may be, within six months of sanction by the High Court and file a report thereof the High Court and the Registrar of companies and to the Registrar of the cooperative societies under which it has been registered as a multi-State cooperative society or cooperative society, as the case may be.
581ZT. Power to modify Act in its application to Producer Companies
(1) The Central Government may, by notification in the Official gazette, direct that any of the provisions of this Act (other than those contained in this Part) specified in the said notification-
(a) shall not apply to the Producer Companies or any class or category thereof; or
(b) Shall apply to the Producer Companies or any class or category thereof with such exception or adaptation as may be specified in the notification.
(2) A copy of every notification proposed to be issued under sub- section (1), shall be laid in draft before each House of Parliament, while it is in session, for a total period of thirty days which may be comprised in one session or in two or more successive sessions, and if, before the expiry of the session immediately following the session or the successive sessions aforesaid, both Houses agree in disapproving the issue of the notification or both Houses agree in making any modification in the notification, the notification shall not be issued or, as the case may be, shall be issued only in such modified form as may be agreed upon by both the Houses.
Ministry of Finance
(Department of Company Affairs)
Notification
No: SO 135(E) Date of issue: 5.2.2003 New Delhi
SO 135(E):- In exercise of the powers conferred by sub-section (2) of section 1 of the Companies (Amendment) Act, 2002 (1 of 2003), the Central Government hereby appoints the 6th day of February, 2003 as the date on which the provisions of the said Act shall come into force.
(F No: 1/1/2003-CL-V)
Rajiv Mehrishi Joint Secretary
Ministry of Finance
(Department of Company Affairs)
Notification
New Delhi, the 7th August, 2003
GSR 641(E) – In exercise of the powers conferred by clause (a) of Sub- section (1) of Section 642, read with Sub-section (1) of Section 581ZL of the Companies Act, 1956 the Central Government hereby makes the following rules, namely:-
1. Short title and commencement:- (1) These rules may be called the Producer Companies (General Reserves) Rules, 2003
2. Applicability:- These rules shall apply to a company formed and registered under section 581C of the Companies Act, 1956
3. Definition:- “cooperative society” means a society registered under any law relating to cooperative societies for the time being in force in any state.
4. Investment of general reserves:- A producer company formed and registered under Section 581C of the Companies Act, 1956, shall make investments from and out of its general reserves in the following manner, namely:-
(a) in approved securities, fixed deposits, units and bonds issued by the Central or State Governments or cooperative societies or scheduled bank;
(b) in a cooperative bank, State cooperative bank, cooperative land development bank or Central cooperative bank; or
(c) with any other scheduled bank;
(d) in any of the securities specified in Section 20 of the Indian Trusts Act, 1882; or
(e) in the shares or securities of any other multi-state cooperative society or any cooperative society; or
(f) in the shares, securities or assets of a public financial institutions specified under Section 4A of the Companies Act, 1956.
(F No: 1/1/2003-CL-V)
Rajiv Mehrishi Joint Secretary
Statements of objects and reasons
During the last decade, changes have t5aken place in the Indian economy, in the communication and transportation infrastructures, as well as in the method of commerce, banking and international trade. Liberalisation of the economy is in the process of changing the terms of trade between rural and urban, labour and industry, finance and commerce. Biotechnology, the information revolution, computerisation can all be used to raise the standard of living of the rural masses and ultimately link this economic with regional, national and global demand. Institutions are needed to link the rural economy with the emerging new opportunities. Rural producers are at a potential disadvantage given their generally limited assets, resources, education and access to advanced technology. In the present competitive scenario, if cooperative enterprises are to continue to serve rural producers, they require an alternative to the institutional form presently available under law.
2. Keeping all this in view, Government constituted a Committee consisting of experts led by Dr YK Alagh, Economist, former Union Minister to examine and make recommendations with regard to (a) framing a legislation which would enable incorporation of cooperatives as companies and conversion of existing cooperatives into companies and
(b) ensuring that the proposed legislation accommodates the unique elements of cooperative business within a regulatory framework similar to that of companies. The Committee had a series of meeting during which it interacted with, and received responses from various cooperatives, institutes and individuals.
3. On the basis of recommendations of the Committee, the present Bill has been prepared with the main objective of facilitating formation of cooperative business as companies and to convert existing business into companies. The salient features of the Bill are:
(i) To offer a statutory and regulatory framework that creates the potential for producer-owned enterprises to compete with other enterprises on a competitive footing. The Companies Act envisages and provides for various forms of Companies including
private limited, public limited, trusteeship companies and nidhis, each with specific and appropriate provisions applicable to them.
(ii) To provide for the formation and registration of producer companies, which include the mutual assistance and cooperative principles within the more liberal regulatory framework, afforded by the Company Law with suitable adaptations.
(iii) To provide an opportunity to cooperative institutions to voluntarily transform themselves into the new form of producer companies.
(iv) Under the Bill conversion of cooperatives to producer companies is purely voluntary.
(v) Member equity may not be publicly traded, but may only be transferred, with the approval of the Producer Company’s Board of Directors. Producer companies would not be vulnerable to the take over by multinationals or other companies.
(vi) The conversion option by cooperative society to Producer Company can be exercised only if two-thirds of the members of the concerned society vote in favour of a resolution to that effect.
(vii) The new form of company is designated as “producer company” to indicate that only certain categories of persons can participate in the ownership of such companies. The members of the Producer Company have necessarily to be “primary producers”, that is persons engaged in an activity connected with, or relatable to, primary produce.
(viii) The objects of a producer company have been defined to include, among other things, production, processing, manufacture and sale of primary produce as well as allied matters.
The Telangana Municipalities Act 2019
ACT No. 11 OF 2019.*
[9th October, 2018]
AN ACT TO CONSOLIDATE AND PROVIDE FOR THE CONSTITUTION OF MUNICIPALITIES (MUNICIPAL COUNCILS AND MUNICIPAL CORPORATIONS) OTHER THAN THE GREATER HYDERABAD MUNICIPAL CORPORATION IN THE STATE OF TELANGANA IN TERMS OF PART – IX A OF THE CONSTITUTION OF INDIA AND FOR MATTERS CONNECTED THEREWITH OR INCIDENTAL THERETO.
Be it enacted by the Legislature of the State in the Seventieth Year of the Republic of India as follows:-
CHAPTER – I
PRELIMINARY AND DEFINITIONS
1. Short title, extent, application and commencement.- (1) This Act may be called the Telangana Municipalities Act, 2019.
(2) It extends to the whole of the State of Telangana.
(3) It applies to the Municipal Councils and Municipal Corporations in the State and save as otherwise provided under this Act, it does not apply to the Greater Hyderabad Municipal Corporation (constituted under the Greater Hyderabad Municipal Corporation Act, 1955).
(4) It shall come into force on such date and in such areas as the State Government may, by notification in the Telangana Gazette appoint, and they may appoint different dates for different areas and for different provisions.
* Received the assent of the Governor on the 8th October, 2019.
2. Definitions.- In this Act, unless the context otherwise requires,-
(1) “Advertisement” means anything in writing or in print or by way of picture or effigy or representation to public through any device whether illuminated either wholly or part and further through any electronic or social media / medium, including any hoarding or structure used or adapted for the display of advertisement;
(2) “appointment” or “appoint” means and include temporary appointment and officiating appointment by the Government;
(3) “annual rental value” means the annual rental value of any building or land fixed in accordance with the provisions of this Act and the rules made thereunder;
(4) “booth capturing” includes, among other things, all or any of the following activities, namely:-
(i) seizure of a polling station or a place fixed for the poll by any person or persons making polling authorities surrender the ballot papers or voting machines and doing of any other act which affects the orderly conduct of elections;
(ii) taking possession of polling station or a place fixed for the poll by any person or persons and allowing only his or their own supporters to exercise their right to vote and prevent others from free exercise of their right to vote;
(iii) coercing or intimidating or threatening directly or indirectly any elector and preventing him from going to the polling station or a place fixed for the poll to cast his vote;
(iv) seizure of a place for counting of votes by any person or persons, making the counting authorities surrender the ballot papers or voting machines and the doing of anything which affects the orderly counting of votes;
(v) doing by any person in the service of Government, of all or any of the aforesaid activities or aiding or conniving at any such activity in the furtherance of the prospects of the election of a candidate.
(5) “building” means any permanent structure or otherwise constructed of any material for any purpose and includes multi storied complexes, gated communities, malls, high rise buildings, a house, out-house, shop, stable, latrine, shed, hut, wall and compound wall, or any part of such building either residential or non-residential;
(6) “building line” means a line which is in rear of the street alignment and to which the main wall of a building abutting on a street may lawfully extend;
(7) “capital value” means the capital value of any building or land fixed in accordance with the provisions of this Act and the rules made thereunder;
(8) “casual vacancy” means a vacancy arising otherwise than by efflux of time;
(9) “casual election” means an election held to fill a casual vacancy;
(10) “Carriage” means any wheeled vehicle with springs or other appliances acting as springs and includes any kind of bicycle, tricycle, rickshaw and palanquin but does not include any motor vehicle within the meaning of the Motor Vehicles Act, 1988;
(11) “Chairperson” and “Vice-Chairperson” means-
(i) in relation to a Municipal Corporation the Mayor and the Deputy Mayor respectively;
(ii) in relation to a Municipal Council, the Chairperson and Vice-Chairperson, respectively;
(12) “Chairperson” means the Chairperson of the Municipal Council and includes Mayor of Municipal Corporation as elected under section 20 of this Act, and the term Chairperson shall be construed as the Mayor wherever the context so requires with regard to the Municipal Corporation, unless otherwise provided;
(13) “Collector” means District Collector in charge of a District;
(14) “Commissioner” means the Commissioner of the Municipality or of Municipal Corporation, appointed by the Government under section 38 of this Act;
(15) “company” means a company as defined in the Companies Act, 2013, and includes any foreign company;
(16) “compound” means land, whether enclosed or not, which is the appurtenance of a building or the common appurtenance of several buildings;
(17) “contractor” means and includes any person or persons engaged by the Municipality for discharge of any duties or works or services under a contract as may be necessary;
(18) “corporation” means the Municipal Corporation constituted under section 3 of this Act;
(19) “council” means the Municipal Council constituted under section 3 of this Act;
(20) “cubical contents” means and includes all those parameters that are used with reference to the measurement of a building, the space contained within the external surface of its wall and roof and the upper surface of the floor of its lowest storey, or where the building consists of one storey only, the upper surface of its floor;
(21) “development” means the carrying out of any activity of construction or building, or other operations in, or over, or under land or water, or the making of any material changes or otherwise, in any building or land or any part thereof, or in the use of any building or land, and includes any repairs or redevelopment and layout and sub-division of any land; and “to develop” shall be construed accordingly;
(22) “development charge” means a charge levied for the purpose of any development activity;
(23) “Commissioner and Director of Municipal Administration” means an officer appointed by the Government under this Act, and includes an Additional Director, a Joint Director, Deputy Director, or any other officer of the Government authorized by it to perform the functions of the Commissioner and Director of Municipal Administration;
(24) “drain” includes a sewer, a house-drain, a drain of any other description, a tunnel, a culvert, a ditch, a channel or any other device for carrying of sullage, sewage, offensive matter, polluted water, rainwater or sub-soil water;
(25) “drainage” includes all liquid discharges except sewage;
(26) “election authority” means such officer or authority as may be appointed by the State Election Commission under this Act to exercise such powers, functions incidental therewith for the conduct of elections to the Municipalities;
(27) “election tribunal” means a Tribunal constituted for disposal of election petitions under section 233 of this Act;
(28) “energy conservation building code” means the energy code adopted by the Bureau of Energy Efficiency as revised from time to time, stipulating the minimum requirements for energy-efficient building design and construction;
(29) “factory” means any premises including the precincts thereof,-
(i) wherein any industrial or manufacturing process is carried on with the aid of steam, water, oil, gas, electrical or any other form of power which is mechanically transmitted, and it is not generated by human or animal agency; or
(ii) wherein twenty or more workers are working or were working and in any part of which a manufacturing process is being carried on without the aid of power or is ordinarily so carried on but does not include a mine subject to the operation of Mines Act, 1952 or a railway running shed or a hotel or restaurant or an eating house;
(30) “Finance Commission” or “State Finance Commission” means the Finance Commission constituted by the Governor under article 243-I of the Constitution of India;
(31) “filth” means,-
(i) night – soil and other contents of latrines, cesspools and drains;
(ii) dung and the refuse or useless or offensive material thrown out in consequence of any process of manufacture, industry or trade; and
(iii) putrid and putrefying substances;
(32) “financial year” means the year beginning on the first day of April or such other date as the Government may by notification appoint;
(33) “food” includes every article used for food or drink by man, other than drugs or water, and any article which ordinarily enters into, or is used in the composition or preparation of human food, and also includes confectionery, flavoring and coloring matters, spices and condiments;
(34) “garbage” means rubbish or waste, especially domestic or otherwise refuse;
(35) “Government” means the State Government of Telangana;
(36) “green cell” means a cell constituted at each Municipality to enhance greenery, plantation, parks and afforestation under envision Haritha Telangana or otherwise and to develop own nurseries and ensure supply of saplings and provide necessary care within the Municipal area;
(37) “height of building” means height measured from the road and in case of undulated terrain, height can be considered as average of the corresponding ground level.
The parapet wall, staircase headroom, lift room and water tank are excluded from the height of the building;
(38) “high-rise building” means and includes all buildings with 18 meters or more in height measured from the average level of the central line of street on which the site abuts, staircase rooms, lift rooms, chimneys, elevated tanks above the topmost floor and architectural features are excluded from the height of such building;
(39) “house” means a building or hut fit for human occupation, whether as a residence or otherwise, having a separate principal entrance from the common way, and includes any shop, workshop or warehouse or any building used for garaging or parking buses or as a bus-stand;
(40) “hut” means any building which is constructed principally of wood, mud, leaves, grass or thatch and includes any temporary structure of whatever size or any small building of whatever material made, which the council may declare to be a hut for the purposes of this Act;
(41) “industrial area local authority” means an authority created for industrial township as separate local authority by the Government of Telangana under the provisions of article 243-Q of Constitution of India;
(42) “infectious disease or communicable disease” means any disease, which may be transmitted from one person to another and declared as such by the Government through notification under this Act;
(43) “land” includes land which is being built upon or is built upon or covered with water, benefits to arise out of land, things attached to the earth or permanently fastened to anything attached to the earth and rights created by legislation over any street;
(44) “larger urban area” means a Municipal Corporation and classified as a larger urban area by the Governor by notification with reference to various factors as provided in article 243Q of the Constitution of India;
(45) “latrine” means and includes a place set apart for defecating or urinating or both and includes a closet of the dry or water-carriage type and urinal, any public convenient places such as rest rooms, washrooms, etc.;
(46) “license” means a license issued under this Act;
(47) “licensed technical personnel” is a Licensed Architect or Engineer or Town Planner or Structural Engineer or Surveyor or any other technical person as prescribed to plan, design and supervise for carrying out layout and building developmental activities, and also to issue certificate of supervision of such a development of land and building in municipal areas;
(48) “local area” means the entire area notified as Municipal area of the Municipality, and includes any town, village, hamlet, bazaar, station or other area or any group of the same in the immediate neighborhood of one another;
(49) “liquid waste management” means the creation, collection, and disposal of non-hazardous liquid materials to prevent discharge of pollutants to the storm water drain system or to watercourse and all such steps taken in this regard;
(50) “local authority” means any Municipality, Municipal Corporation, Zilla Praja Parishad, Mandal Praja Parishad, Gram Panchayat and Cantonment Board
(51) “Market” includes any place, by whatever name called, where persons assemble for the sale of vegetables, fruits, meat, fish, live stock, or any other article of food of a perishable nature, or any other article and declared and licensed by the municipality as a market;
(52) “master plan” means a comprehensive plan showing therein the existing and proposed locations and general layout of (a) arterial streets and transportation lines, (b) residential areas, (c) commercial areas, (d) industrial areas, (e) educational institutions, (f) public parks, playgrounds and other recreational places, (g) public and semi-public buildings, and (h) any other places put to any specified use or earmarked and proposed to be used for any of the purposes as mentioned in this definition and as provided under this Act;
(53) “Member” means elected members, ex-officio and co-opted members of the Municipality;
(54) “municipal officer” means and includes all the officers, employees and such other staff employed in the Municipality;
(55) “municipal property” means and includes municipal open spaces, auditoriums, parks, playgrounds, community halls, municipal roads, pavements, street lights, garbage, nalas, municipal drain, municipal market, municipal slaughter-house or water works and all such other structures, buildings, etc. belonging to and managed by the Municipality under this Act;
(56) “Municipalities” means institutions of self- government constituted under article 243Q of the Constitution of India and includes a Municipal Corporation and a Municipal Council as declared and notified under the provisions of this Act and the expression Municipality shall be construed as Municipal Council and Municipal Corporation wherever the context so requires and unless provided otherwise under this Act;
(57) “municipal fund” means the municipal fund referred to in section 106 of this Act;
(58) “nuisance” includes any act, omission, place or thing which causes or is likely to cause injury, danger, annoyance or offence to the sense of sight, smell or hearing or disturbance to rest or sleep or which is or may be dangerous to life or injurious to health or property of the public or the people in general who dwell or occupy in the vicinity or persons who may have occasion to use any public right;
(59) “notification” means a notification published either in the Telangana Gazette or as the case may be District Gazette concerned and the word ‘notified’ shall be construed accordingly;
(60) “non-revenue water” means water that has been produced and is “lost” before it reaches the customer or does not yield any revenue;
(61) “occupier” includes—
(i) any person for the time being paying or liable to pay to the owner the rent or any portion of the rent of the land or building or part of the same in respect of which the word is used; or
(ii) a rent-free occupant;
(62) “online service” means services of Municipality through electronic devices such as computer, computer network, computer resource and communication device or through any such other electronic device;
(63) “ordinary vacancy” means a vacancy occurring by efflux of time and “ordinary election” means an election held to fill an ordinary vacancy;
(64) “owner” means and includes—
(i) the person for the time being receiving or entitled to receive, whether on his own account or as agent, trustee, guardian, manager or receiver for another person or estate for any religious or charitable purposes, the rent or profits of the property in connection with which the word is used;
(ii) the person for the time being in charge of the animal or vehicle in connection with which the word is used;
(65) “population” means the population as ascertained at the latest census as published by the census authorities;
(66) “premises” means any land or building or part of a building or any hut or part of a hut, and includes —
(i) the garden, ground and outhouses, if any, appertaining thereto, and
(ii) any fittings or fixtures affixed to a building or part of a building or land or hut or part of a hut;
(67) “prescribed” means prescribed under the rules made under this Act;
(68) “private street” means any street, road, square, court, alley, passage or riding path, which is not a public street but does not include a pathway made by the owner of premises on his own land to secure access to, or the convenient use of, such premises;
(69) “public place” includes any path, garden or ground or any other place to which public have or are permitted to have access;
(70) “public street” means any street, road, square, court, alley, passage or riding path over which the public have a right of way whether a thoroughfare or not, and includes—
(i) the roadway over any public bridge or causeway;
(ii) the footway attached to any such street, public bridge or causeway; and
(iii) the drains attached to any such street, public bridge or causeway and the land, whether covered or not by any pavement, veranda, or other structure which lies on either side of the roadway upto the boundaries of the adjacent property whether that property is private property or property belonging to the Government;
(71) “public watercourse, springs, wells and tanks” include those used by the public to such an extent as to give a prescriptive right to such use;
(72) “qualifying date” means the first day of January of the year in relation to the preparation and publication of electoral roll under this Act.
(73) “re-construction of a building” includes—
(i) the re-erection, wholly or partially, of a building after more than one-half of its cubical contents have been taken down or burnt down or has fallen down whether at one time or not;
(ii) the re-erection, wholly or partially, of any building of which an outer wall has been taken down or burnt down or has fallen down to or within ten feet of the ground, adjoining the lowest storey of the building, and of any frame building which has so far been taken down or burnt down or has fallen down, so as to leave only the frame work of the lowest storey;
(iii) the conversion into a dwelling house or a place of public worship of any building not originally constructed for human habitation or for public worship as the case may be, or the conversion into more than one dwelling house of a building originally constructed as one dwelling house only or the conversion of a dwelling house into a factory, shop, office or warehouse;
(iv) the re-conversion into a dwelling house or a place of public worship or a factory of any building which has been discontinued as, or appropriated for any purpose other than a dwelling house or a place of public worship or a factory, as the case may be;
(74) “Regional Director” means the Regional Director- cum-Appellate Commissioner of Municipal Administration having jurisdiction over the Municipality concerned under this Act;
(75) “registered voter in the Municipality” means a person whose name appears in the electoral roll prepared and published under this Act;
(76) “residence” and “reside” means that a person is deemed to have his ordinary residence or to reside in any house, which includes a person using any portion thereof as a sleeping apartment; or a person merely absent to reside in any house but has a right or a liberty to return to such house at any time and has not abandoned his intention of returning;
(77) “Returning Officer” means an officer designated by the State Election Commission under this Act for conduct of elections to the offices under this Act;
(78) “rubbish” means dust, ash, broken brick, mortar, broken glass, and refuse of any kind which is not filth;
(79) “salary” means all pays or emoluments or payments and includes all allowances;
(80) “schedule” means the schedules annexed to this
Act;
(81) “Scheduled Castes” mean such castes, races or tribes or parts of or groups within such castes, races or tribes as are notified to be Scheduled Castes under article 341 of the Constitution of India in relation to the State of Telangana;
(82) “Scheduled Tribes” mean such tribes or tribal communities or parts of or groups within such tribes or tribal communities as are notified to be Scheduled Tribes under article 342 of the Constitution of India in relation to the State of Telangana;
(83) “segregation” means sorting and separate storage of various components of solid waste, namely biodegradable wastes, non-biodegradable wastes and domestic hazardous waste;
(84) “self-assessment” means the act or process of analyzing and evaluating oneself and in connection with which the word is used;
(85) “self-certification” means an official statement that a person make about himself, especially while applying for municipal services;
(86) “sewage” means night soil and other contents of water closets, latrines, privies, urinals, cesspools or drains, and polluted water from sinks, bathrooms, stables, cattle sheds and other like places and includes trade effluents and discharges from manufactories of all kinds;
(87) “self-declaration” means the act of declaring something that is stated or made known in an official or public way by the individual;
(88) “single window system” is a facility to process the applications for permission through online by streamlining the different processes and approvals, in order to act as a single point of contact for requesting various services, submission of documents and payment of fees as prescribed;
(89) “slaughter house” means any place used for the slaughter of cattle, sheep, goats, or pigs for the purpose of selling the flesh thereof as meat;
(90) “slum” means a highly populated urban residential area consisting of closely packed temporary structures like kutcha or semi-pucca houses without any basic amenities like roads, drains, water supply, street light or health facilities and occupied by below poverty line families;
(91) “special officer” means any officer of the Government appointed as such for exercising powers and discharging functions under provisions of this Act;
(92) “State Election Commission” means the State Election Commission constituted in pursuance of article 243-K of the Constitution of India;
(93) “street alignment” means a line dividing the lands comprised in and forming part of a street from the adjoining land;
(94) “smaller urban area” means a Municipality with reference to various factors as provided in article 243-Q of the Constitution of India;
(95) “solid waste management” means the process of generating, collecting and treating the solid waste or semi- solid domestic waste, sanitary waste, commercial waste, institutional waste, catering and market waste and other non-residential waste, street sweeping, silt removed or collected from the surface drains, horticulture waste, agriculture and dairy waste, treated bio-medical waste excluding industrial waste, bio-medical waste and e-waste, battery waste, radioactive waste generated in the area under the municipality;
(96) “State Government” means the Government of Telangana;
(97) “Transferable Development Right or TDR” means an award specifying the built up area an owner of a site or plot can sell or dispose or utilize elsewhere, in lieu of surrendering land free of cost which is required to be set apart or affected for public purpose as per the Master Plan or in road widening or covered in recreational use zone, etc.
and which was issued in the form of a certificate by Competent Authority;
(98) “Telangana State Industrial Project Approval and Self-Certification System (TS-iPASS)” means a body constituted under the Telangana State Industrial Project Approval and Self-Certification System (TS-iPASS) Act, 2014 meant for according clearances and approval for manufacturing proposals;
(99) “Urban Development Authority” means any Urban Development Authority constituted under the Telangana Urban Areas (Development) Act, 1975 and includes Hyderabad Metropolitan Development Authority constituted under Hyderabad Metropolitan Development Authority Act, 2008;
(100) “voting machines” means any machine or apparatus whether operated electronically or otherwise used for giving or recording of votes and any reference to a ballot box or ballot paper in this Act or the rules made thereunder shall, save as otherwise provided be construed as including a reference to such voting machine wherever such voting machine is used at any election;
(101) “Vice-Chairperson” means the Vice-Chairperson of the Municipal Council and includes Deputy Mayor of Municipal Corporation elected under section 20 of this Act, and the term Vice-Chairperson shall be construed as Deputy Mayor wherever the context so requires with regard to the Municipal Corporation, unless otherwise provided;
(102) “Ward Committee” means a Ward Committee constituted under section 17 and 30 of this Act;
(103) “waste” means solid waste or semi-solid domestic waste, sanitary waste, commercial waste, institutional waste, catering and market waste and other non-residential waste, street sweeping, silt removed or collected from the surface drains, horticulture waste, agriculture and dairy waste, industrial waste, bio-medical waste and e-waste, battery waste, radioactive waste generated in the area under the Municipality;
(104) “water connection” includes-
(i) any tank, cistern, hydrant, stand pipe, meter or tap situated on any private property and connected with a water main or pipe belonging to the Municipality; and
(ii) the water pipe connecting such tank, cistern, hydrant, stand pipe, meter or tap with such water main or pipe;
(105) “Watercourse” means and includes any river, stream or channel whether natural or artificial;
(106) “water for domestic purposes” shall include water for domestic requirement including drinking water purposes and shall not include water for any trade, manufacture or business or for building purposes, or for watering gardens or for fountains or for any ornamental or mechanical purposes;
(107) “year” means the financial year;
(108) The words and expressions used in this Act, but not defined shall have the meanings assigned to them in the relevant Acts.
CHAPTER II
CONSTITUTION AND COMPOSITION OF MUNICIPALITIES
3. Constitution of Municipalities.- (Act 6 of 1965., Act 25 of 1994., Telangana Act 5 of 2018.) (1) The Municipality shall be a body corporate having perpetual succession and a common seal. It can sue or be sued in its corporate name, acquire, hold and transfer property, enter into contracts and do all things which are necessary, proper or expedient for which it is constituted.
(2) From the date of commencement of this Act, all the Municipalities constituted under the Telangana Municipalities Act, 1965 and the Municipal Corporations constituted under Telangana Municipal Corporations Act,1994 shall be deemed to have been constituted as Municipal Councils as specified in Schedule I and Municipal Corporations as specified in Schedule II under this Act, and the provisions of this Act shall apply to all such Municipalities constituted and deemed to have been constituted under this Act:
Provided that in cases where a Gram Panchayat is already notified as a Municipality under section 3-A of the Municipalities Act, 1965, the elected body of such Gram Panchayat shall continue to be in existence until its term expires and exercise all such powers under the provisions of the Telangana Panchayat Raj Act, 2018, and on such date of expiry, it shall be deemed to have been constituted as a Municipality under this Act.
(3) The State Legislature may, by way of amendment to this Act, modify or add or alter schedule I or II of this Act so as to,-
(a) form a new Municipality by separation of local area from any Municipality, or by uniting two or more local areas or part of areas, or by uniting any local area to a part of Municipality;
(b) include within a Municipality any local area;
(c) exclude from a Municipality, any area comprised therein;
(d) constitute any local area as a Municipality;
(e) alter the name of any Municipality;
(f) revise the boundary of municipal area;
(g) describe the boundaries of the Municipality;
(h) abolish a Municipality.
4. Power of Government over property of Municipalities.- (1) The Government may pass such orders as it may deem fit so as:-
(a) to the disposal of the property vested in a Municipality, which has ceased to exist, and the discharge of its liabilities; and
(b) to the disposal of any part of the property vested in a Municipality, which has ceased to exercise jurisdiction over any local area, and the discharge of the liabilities of the Municipality relating to such property, or arising from such local area;
(2) An order made under sub-section (1) of section (4) shall contain such supplemental, incidental and consequential provisions, as the Government may deem necessary, and, in particular, may direct;
(a) that any tax, fee or other sum due to the Municipality, or where a Municipality has ceased to exercise jurisdiction over any local area, such tax, fee, or other sum due to the Municipality, as relates to that area, shall be payable to such authorities, as may be specified in the order; and
(b) that appeals, petitions, or other applications, with reference to any such tax, fee or sum, which are pending on the date on which the Municipality ceased to exist or, as the case may be, on the date on which the Municipality ceased to exercise jurisdiction over the local area, shall be disposed of by such authorities, as may be specified in the order.
COMPOSITION OF MUNICIPALITIES
5. Composition of Municipality.- (1) In each Municipality, there shall be a Municipal Council or a Municipal Corporation having authority over the Municipality.
(2) The Municipal Council or the Municipal Corporation as the case may be, shall consist of such number of Ward Members elected in direct elections conducted to the Municipality, as specified in column No 4 of the Schedule-I and Schedule-II respectively.
(3) In addition to the elected members specified in sub- section (2), the following shall also be members in the Municipality:
(a) Member of the Legislative Assembly of the State, representing the constituency, of which a Municipality or a portion thereof forms part,
(b) Member of the House of People, representing the constituency of which a Municipality or a portion thereof forms part:
Provided that a Member of the Legislative Assembly, and a Member of the House of People, representing a constituency which comprises more than one Municipality, including a part of any Municipality, shall be the ex-officio member of one such Municipality, which he/she chooses within a period of thirty (30) days from the date of conduct of ordinary elections to the Municipality, or from the date of election as a Member of Legislative Assembly or of the House of People as the case may be, by notice, in writing, duly signed by him and delivered to the Commissioner of that Municipality:
Provided further that the intimation so delivered shall be final and irrevocable, and in default of such intimation within the aforesaid period, the District Election Authority shall decide the Municipality and inform the Member of Legislative Assembly or of the House of People as the case may be.
(c) Member of the Legislative Council of the State: Provided that a member-
(i) elected to the Legislative Council by the electorate of local authorities as provided in article 171 (3) (a) of the Constitution of India,
(ii) elected to the Legislative Council by the electorate consisting of graduates as provided in article 171 (3) (b) of the Constitution of India,
(iii) elected to the Legislative Council by the electorate consisting of the teachers as provided in article 171 (3) (c) of the Constitution of India,
(iv) elected to the Legislative Council by the members of the Legislative Assembly as provided in article 171 (3) (d) of the Constitution of India, and
(v) nominated by the Governor as provided in article 171 (3) (e) of the Constitution of India shall choose to be an ex-officio member of any one of the Municipalities in his jurisdiction within a period of thirty days from the date of conduct of ordinary elections to the Municipality, or from the date of election as a Member of Legislative Council, as the case may be, and deliver to the Commissioner of that Municipality, by notice, in writing, duly signed by him:
Provided further that the intimation so delivered shall be final and irrevocable, and in default of such intimation within the aforesaid period, the District Election Authority shall decide the Municipality and inform the Member of Legislative Council;
(d) Member of the Council of States:
Provided that a member of the Council of the State shall choose to be an ex-officio member of any one of the Municipalities in the State within a period of thirty days from the date of conduct of ordinary elections to the Municipality, or from the date of election as a Member of Council of State as the case may be, and deliver to the Commissioner of that Municipality, by notice, in writing, duly signed by him:
Provided further that the intimation so delivered shall be final and irrevocable, and in default of such intimation within the aforesaid period, the District Election Authority shall decide the Municipality and inform the Member of Council of States;
(e) The ex-officio members referred to in clauses (a), (b), (c) and (d) shall have the right to speak and take part in the proceedings of any meeting of the Municipalities within the jurisdiction, and shall have right to vote in the Municipality he / she has chosen.
(4) Two persons in the case of municipal council and three persons in case of Municipal Corporations having special knowledge or experience in municipal administration co-opted by the members specified in sub-sections (2) and (3), as prescribed and the persons should be the registered voters in the Municipality and they should possess the age not less than twenty one (21) years as on the date of notification and one amongst them shall be a woman.
(5) Two persons belonging to minority community co- opted by the members specified in sub-sections (2) and (3) as prescribed and the persons should be the registered voters in the Municipality and they should possess the age not less than twenty one (21) years as on the date of notification and one amongst them shall be a woman:
Provided that while co-opting members from minority community, preference shall be given to such members who are not represented in the municipality through direct elections:
Provided further that the members co-opted under sub- sections (4) and (5) shall have a right to participate in the meetings of the Municipality but shall have no right to vote.
(6) In the event of any member of the Municipality getting elected as a Member of the Legislature of the State or of Parliament or any other elected post, he shall submit his resignation as member of the Municipality or the newly elected post of Legislature of the State or of Parliament or any other elected post, within a period of 15 days from the date of such election. In the absence of such resignation he shall be deemed to have resigned from the office of member of the Municipality.
6. Division of Municipalities into wards for the purpose of election of members of the Municipal Council.- (1) All the seats in the Municipality shall be filled by persons chosen by direct election, and for this purpose, each municipality shall be divided into such number of wards as mentioned at sub-section (2) of section 5 on territorial basis as prescribed by notification in such a manner that all wards shall have, as far as practicable, equal number of voters and one member shall be elected from each ward, and,
(a) determine the wards in which the seats, if any, reserved under sub-section (1) of section 6 shall be set apart; and
(b) declare for whom such seats are reserved.
(2) All the electors of a ward shall be entitled to vote at an election to any seat in the ward, whether reserved or not.
(3) Where a notification issued under sub-section (1), results in material alteration of the existing division of a Municipality into wards, the Government may direct that the alteration shall take effect from the date of next ordinary elections.
(4) Where any local area within the jurisdiction of any other local authority is included in a Municipality under section 3, the local area shall be added to such adjoining ward or wards of the Municipality, as the Government may direct.
(5) When a new ward is formed, or when an existing ward is abolished, the Government may determine following the procedure under section 3(3) of this Act:-
(a) the ward which each elected member then on the Municipality shall be deemed to represent; and
(b) the ward or wards in which elections shall be held to fill the vacancies, if any, in the Municipality.
7. Reservation of seats.- (1) In every Municipality, out of the total strength of elected members determined under sub-section (2) of section 5 in the manner prescribed, seats shall be reserved-
(a) in favor of Scheduled Tribes and Scheduled Castes in proportion to their respective population of the Municipality, and
(b) in favor of Backward Classes:
Provided that, the total reservations shall not exceed 50 percent of the total number of seats of the municipality.
(2) (a) 50% of the total number of seats reserved for Scheduled Tribes, Scheduled Castes and Backward Classes under sub-section (1) shall be reserved for women belonging to the Scheduled Tribes, Scheduled Castes and Backward Classes respectively.
(b) 50% of the total number of seats under sub-section
(1) including the reservations made under clause (a) of sub- section (2) shall be reserved for women.
(3) The reservations referred to in sub-sections (1) and
(2) shall be made by rotation in the manner prescribed in the rules made under this Act and shall continue to remain for two consecutive terms commencing from the first ordinary elections held under this Act.
8. Oath of the members.- (1) Every person who is elected as a member shall, before taking his seat, make and subscribe at a meeting of the Municipality an oath or affirmation of his allegiance to the Constitution of India, before such authority and in such form as prescribed by the Government.
(2) Where a member fails to take the oath or affirmation prescribed in sub-section (1) within three months of the date on which his term of office commences, or at one of the first three meetings held from the said date whichever is later, ceases to hold his office and his seat shall be deemed to have become vacant.
9. Action by Commissioner and member after the member ceases office.- (1) Where a member ceases to hold office under section (8), the Commissioner shall report the same to the Council at its next meeting.
(2) If the member who failed to take an oath or affirmation under section (8) makes any application within thirty days of the date on which he has ceased to be a member, the council may grant him further time which shall not be more than three months for making the oath, and if he makes the oath within the extended time given by the Council, he shall continue to hold his office.
10. Term of office of members of Municipality.- (1) Save as otherwise provided in this Act, the term of office of elected members at ordinary elections shall be five years from the date of the first meeting of the Municipality, after the ordinary elections.
(2) An ex-officio member shall hold office so long as he continues to be the Member of the Legislative Assembly of the State or, as the case may be, of the House of the People, or of the Legislative Council or of the Council of the States.
(3) The process for election of elected members to any ordinary vacancies shall commence three months before the occurrence of such vacancy.
(4) A member elected at a direct election held after the occurrence of a vacancy, shall enter upon office forthwith, but shall hold office only as long as the member in whose place he is elected would have been entitled to hold office, if the vacancy had not occured.
11. Qualifications of candidates.- (1) Subject to the provisions of this Act, a person shall be qualified for election as a member only if his name appears on the electoral roll for the Municipality, and if he is not less than twenty-one (21) years of age.
(2) Any person who ceases to be a member shall, if qualified, under sub-section (1) and not otherwise disqualified, be eligible for re-election as such.
12. General disqualifications.- A person shall be disqualified for being chosen as, or for being, a member of a Municipality, if he is disqualified by or under any law for the time being in force, for the purpose of elections to the legislature of the State and others specified in Schedule IV.
13. Authority to decide questions of disqualification of members.- (1) Where any voter or local authority makes a complaint to the Commissioner that any person who is elected as a member has not qualified or has become disqualified under section 12, the Commissioner shall on such complaint or suo-moto shall enquire into such complaint after giving an opportunity and notice to the concerned member and pass order on merits of the complaint received and communicate the same to the concerned member either disqualifying the member or otherwise.
(2) In the event the concerned member is aggrieved by any such order, such member may approach by way of appeal before the District Court within a period of 30 days from the date of receipt of the order. The District Court shall after giving notice to the aggrieved appellant, dispose of the same within a period of three months. The District Court shall also have power to condone the delay on filing proper application and satisfying the sufficient cause. Pending disposal of the appeal, the member shall continue as such.
14. Special provision in the case of newly-constituted and reconstituted municipalities.- (1) Where a Municipality is constituted for the first time, the Government may appoint a Special Officer to exercise the powers, perform the functions and discharge the duties of the Council until the elected members assume the office and elects the Chairperson.
(2) The Special officer shall report to the State Election Commission for the conduct of elections to the Municipalities so that the elected members and the Chairperson come into office on such dates as may be specified by the Government by an order made in this behalf:
Provided that the Government may, from time to time, postpone the date within a period of six months so specified, if for any reason, the elections cannot be completed before such date.
(3) The provisions of sub-sections (1) and (2) shall, so far as may be, apply to all cases of reconstitution of municipalities, unless otherwise provided in this Act.
15. Vacancies of members.- (1) Every vacancy either by way of death, resignation or disqualification in the office of an elected member shall be reported by the Commissioner to the State Election Commission within fifteen (15) days from the date of occurrence of such vacancy and shall be filled within four
(4) months from that date.
(2) A member elected in a vacancy shall enter upon office forthwith, but shall hold office for the remaining period, in whose place he is elected.
(3) No election shall be held within six months before the date on which the term of office of its members expires by efflux of time.
16. Procedure when no member is elected.- (1) Where an election held under section 12 or section 15, and no member is elected, the State Election Commission in consultation with the State Government, may fix a fresh election date.
(2) The term of office of a member elected under this section shall expire at the time at which it would have expired, if he had been elected at the ordinary or casual election, as the case may be.
17. Appointment of Committees.- (1) In every Municipality, Ward Committees shall be constituted for every ward separately representing (i) youth,
(ii) women,(iii) senior citizens and (iv) other eminent people from the ward to consider and advise on the issues referred to them. Each of the committees may consist of 15 members.
(2) The duties, responsibilities and related matters of the committees shall be such as provided under sections 30 and 31 and as may be prescribed by the Government.
18. Acts of the Municipality not to be invalidated by defect in constitution and vacancy.- No act or order or proceedings of a Municipality or of any person acting as the Chairperson, Vice-Chairperson, or member shall be deemed to be invalid by reason only of a defect in the constitution of the Municipality or on the ground that the Chairperson, Vice-Chairperson or the member was not entitled to hold or continue in such office by reason of any disqualification or by reason of any irregularity or illegality in his election, or by reason of such act having been done during the period of any vacancy in the office of the Chairperson, Vice-Chairperson or member.
MUNICIPAL AUTHORITIES
19. Municipal Authorities.- Subject to the provisions of this Act, the municipal authority will be the Council.
20. Election of Chairperson and Vice-Chairperson.- (1) In terms of the rules prescribed under this Act, the elected members referred to in sub-section (2), and ex- officio members referred in clauses (a) (b) (c) of sub-section (3), of section 5 of this Act, shall elect one of its elected members to be its Chairperson and another to be its Vice- Chairperson in the case of Municipality; and to be its Mayor and another to be its Deputy Mayor in case of Municipal Corporation at the first meeting of the municipality, after elections. They will be elected by show of hands on party whip. If the Chairperson or Mayor and Vice-Chairperson or Deputy Mayor are not elected in such meeting, the fresh election shall be held on the consecutive day. The names of the persons so elected shall be published in the prescribed manner. Any vacancy in the said offices shall be filled in the same manner as a casual election, and the persons so elected in such vacancy shall enter upon office forthwith and holds office for the remaining period of the person in whose place he is elected.
(2) A member voting under sub-section (1) in disregard or disobedience of the party whip shall cease to hold office and the vacancy caused by such cessation shall be filled as a casual vacancy.
(3) The Chairperson or Mayor and the Vice-Chairperson or Deputy Mayor as the case may be, shall assume the office on his being declared as such, and hold office in accordance with the provisions of this Act, unless resigned or removed on any other reason in accordance with the provisions of the Act.
21. Resolution of disputes relating to cessation for disobedience of party whip.- Where a member ceases to hold office for disobedience of the party whip, he may apply to the District Court having jurisdiction over the area in which the Municipality is situated for a decision.
22. Oath of the office of the Chairperson or Mayor.- The Chairperson or Mayor before assuming office shall take the oath of secrecy in such form and administered by such officer, as may be prescribed.
23. Duties and Responsibilities of the Chairperson.- (1) The Chairperson shall be the Presiding Officer of the Municipal Council. The Chairperson shall get himself acquainted with the provisions of the Act within a period of three months on assumption of office and thereupon be responsible to,-
(a) convene the meeting of the Municipal Council once in a month and at such other times as requisitioned in writing by not less than 50% of total members of council;
(b) set the agenda for the council meeting;
(c) refer any resolution of the Council for its reconsideration which, in his opinion, is in excess of the powers of the Council or inconsistent with any law.
(2) The Chairperson shall also be responsible to,-
(a) maintain sanitation, water supply and proper street lights in the town;
(b) ensure door-to-door garbage collection from all residential and commercial establishments; and scientific process and disposal of municipal solid waste and liquid waste;
(c) constitute green cell and earmark 10% of funds in the budget and take up plantation and cause development of nurseries and species in the Municipality as decided by the District level committee headed by the District Collector and take up plantation in his / her ward and ensure survival of 85% of such plantations;
(d) development and maintenance of parks and protection of water bodies;
(e) protection of Government land and open spaces;
(f) take action for closure of annual accounts and audit of accounts every year;
(g) take action for removal of encroachments on municipal properties;
(h) take action to reduce non-revenue water and transmission loss of water and reduce usage of power bores, wherever not required;
(i) encourage construction of rain water harvesting structures and compliance with energy savings buildings including ECBC and cool roofings as prescribed;
(j) exercise the powers and perform the functions specifically conferred or imposed on him by this Act and rules made thereunder;
(k) sign the minutes of the council meeting immediately thereafter within 24 hours; and
(l) exercise any other power and perform any other function, as directed by Government from time to time.
24. Municipality wise “Green Action Plan”.- (1) A District Level Committee headed by the District Collector and consisting of District Forest Officer (Social Forestry) or equivalent level officer in charge of Haritha
Haaram and respective Commissioners shall draw up ward- wise and Municipality wise “green action plan” year wise for a period of 5 years which will clearly specify number of plants to be planted, keeping in mind the area, topography and availability of all possible spaces available for taking up plantations. The committee shall accordingly decide the size and location for setting up the municipality nursery which will be sufficient to meet the requirements of the municipality. The committee shall also decide the district specific plants and species to ensure maximum survival and growth of these plants. A campaign to propagate plantation involving all possible advertising means such as hoardings, cinema slides and other such means shall be taken up to keep up the momentum.
(2) The cost of maintaining the nursery and taking up plantations and their survival shall be met from the “Green Budget” earmarked in the municipality budget.
(3) The Chairperson or the Mayor and the Commissioner shall be responsible for setting up the nursery to take care of the requirements of the municipality. The nursery should be able to meet the year wise requirements of the municipality anytime for a period of 5 years and additional capacity to meet the requirements also by the households to take up plantations within their individual plot premises. These saplings will be provided free of cost.
(4) The Commissioner shall designate special officers for ward(s) so as to cover all the wards who will be responsible for taking up the plantation and ensuring their survival in accordance with the municipality wise action plan.
(5) The ward member shall be responsible for taking up the plantations in his or her ward as per the ‘municipal green action plan’ and ensuring their survival.
(6) It shall be the responsibility of the ward member and the special officer to ensure 85% survival of plants. Likewise, it shall be the responsibility of the Chairperson or the Mayor and the Commissioner to ensure proper upkeep and growth of nursery. The District Collector shall have the power to form flying squads and take up regular inspections of these plantations ward wise and the state of Nursery.
(7) In all such cases where the survival is less than 85% and or there is no or lackadaisical involvement of the ward member or the special officer resulting in poor survival of plants, the ward member shall be disqualified and removed and likewise, the special officer shall be removed from service by the District Collector for his or her failure to ensure 85% survival of plantations.
25. Function of Chairperson to incur contingent expenditure.- (1) The Chairperson may incur such contingent expenditure incidental to the municipal administration, as may be prescribed and report such expenditure incurred along with the reasons therefor to the Municipality at its next meeting:
Provided no such expenditure shall be incurred in the absence of the provision under the relevant head of account in the budget, or where such expenditure was expressly prohibited by the Municipality.
26. Emergency powers of the Chairperson.- No Chairperson shall direct the execution of any work or the doing of any act, which requires the sanction of the Municipal Council, unless it is done in consultation and with the approval of District Collector whenever there is such emergency which is necessary for the service or safety of the public, and may direct that the expense of such act shall be paid from the municipal fund and report the action taken to the Municipality at its next meeting:
Provided that:
(I) he shall not act in contravention of any resolution of the Municipal Council, prohibiting the execution of any particular act;
(II) he shall not direct the execution of any work to which the expenditure exceeds such an amount, as prescribed under the Rules, from time to time.
27. Delegation and devolution of functions of Chairperson.- The Chairperson may, by an order in writing, delegate any of his functions to the Vice-Chairperson, and any of his administrative functions to the Commissioner:
Provided that he shall not delegate any functions, which the Municipality expressly forbids him to delegate. The powers delegated shall be subject to the rules prescribed under the Rules.
28. Reservation of the office of the Chairperson.- (1) Out of the total number of offices of Chairpersons in the State, 50 percent of the seats shall be reserved for Scheduled Tribes, Scheduled Castes and Backward Classes, and the reservations for Scheduled Tribes and Scheduled Castes shall be made in proportion of the population of Scheduled Castes and Scheduled Tribes to total population of all the Municipal councils in the State and to Backward Classes, so that the total reservations shall not exceed more than 50 percent of the total number of the offices of the Chairperson.
(2) (a) 50% of the total number of offices of Chairperson reserved for Scheduled Tribes, Scheduled Castes and Backward Classes under sub- section (1) shall be reserved for women belonging to the Scheduled Tribes, Scheduled Castes, or the Backward Classes respectively, in the manner prescribed;
(b) 50% of the total number of offices, including the number of offices reserved for women belonging to the Scheduled Tribes, Scheduled Castes and Backward Classes under sub-section (2)(a) shall be reserved for women in the manner prescribed.
(3) The reservation referred in sub-sections (1), (2)(a) and (2)(b) shall be made by rotation to different Municipalities in the manner prescribed and shall remain for two consecutive terms, commencing from the first ordinary elections held under this Act.
29. Reservation of the office of the Mayor. (Act II of 1956.)- (1) Out of the total number of offices of Mayors in the State including the Mayor of Greater Hyderabad Municipal Corporation constituted under Greater Hyderabad Municipal Corporation Act,1955, fifty (50) percent of the seats shall be reserved for Scheduled Tribes, Scheduled Castes and Backward Classes, and the reservations for Scheduled Tribes and Scheduled Castes shall be made in proportion of the population of Scheduled Castes and Scheduled Tribes to total population of all the Corporations in the state and to Backward Classes, so that the total reservations shall not exceed more than 50 percent of the total number of the offices of the Mayors.
(2) (a) 50% of the total number of office of Mayors reserved for Scheduled Tribes, Scheduled Castes, and Backward Classes under sub-section (1) shall be reserved for women belonging to the Scheduled Tribes, Scheduled Castes or the Backward Classes respectively, in the manner prescribed;
(b) 50% of the total number of offices, including the number of offices reserved for women belonging to the Scheduled Tribes, Scheduled Castes and Backward Classes under sub-section (2)(a) shall be reserved for women in the manner prescribed.
(3) The reservation referred in sub-sections (1), (2)(a) and (2)(b) shall be made by rotation to different Corporations in the manner prescribed and shall remain for two consecutive terms, commencing from the first ordinary elections held under this Act.
30. Constitution of Ward Committees.- (1) There shall be constituted (4) four Ward Committees for each ward of the Municipality in the manner as prescribed under section 17.
(2) Each Ward Committee shall consist of a maximum of 15 members consisting of residents from the ward and from among the resident welfare associations, community based organizations, other such groups and individuals, by rotation annually and shall be entrusted with taking up issues pertaining to each of these groups pertaining to that ward.
(3) These ward committees shall meet once in a quarter and the salient issues raised by them pertaining to their ward be placed before the next council meeting.
31. Functions of the Ward Committee.- (1) The Ward Committee constituted in a ward, shall take up issues pertaining to each of the groups which the particular ward committee represents and among others will discuss on,-
(a) upkeep and maintenance of sanitation and solid waste management;
(b) tree plantations, Haritha Haram and survival of at least 85% plants;
(c) maintenance of water supply;
(d) maintenance of parks, playgrounds, public toilets and market places;
(e) facilitate collection of taxes, fees and other such dues to the municipality;
(f) unauthorised constructions and encroachments and taking it up with the authority to have them demolished;
(g) discourage use of plastics;
(h) encourage art and cultural activities, sports and games.
(2) The minutes of the meeting shall be drawn and placed in the next council meeting for discussion and the Municipal Commissioner shall be responsible for placing the minutes in the next council meeting.
32. Postponement of casual elections to the office of Chairperson, Vice- Chairperson and Members.- Notwithstanding anything in this Act, or the rules made thereunder, it shall be lawful for the Government to postpone, from time to time, by general or special order, and for reasons specified therein, any election to fill a vacancy to the office of Chairperson or Vice Chairperson or member of a municipality:
Provided that the total period of such postponement shall in no case exceed six months.
33. Cessation of the office of Chairperson and Vice-Chairperson.- The Chairperson or Vice Chairperson shall cease to hold office on his becoming disqualified or on his removal or on the expiry of his term or on his otherwise ceasing to be Chairperson and Vice-Chairperson; and the Member shall cease to hold office on the expiry of the term of office as a member or his otherwise ceasing to be a member.
34. Procedure when office of Chairperson is vacant.- (1) Where the office of the Chairperson falls vacant, the Vice-Chairperson shall perform the functions of the Chairperson until a new Chairperson is elected and assumes the office. Immediately on the occurrence of such vacancy, the Commissioner shall notify the vacancy to the State Election Commission to conduct elections for the vacancy of the office of the Chairperson.
(2) Where the office of the Chairperson is vacant and there is vacancy in the office of the Vice-Chairperson, or the Vice-Chairperson has been continuously absent from the jurisdiction for more than fifteen (15) days, or is incapacitated for any reason for more than fifteen (15) days, the person authorized by the Government or the District Collector, shall, notwithstanding anything in this Act or in the rules and notifications issued thereunder, exercise the powers and perform the functions of the Chairperson until a new Chairperson or Vice-Chairperson is elected, or the Vice- Chairperson returns to jurisdiction, or recovers from any such incapacity.
35. Notification of elections.- All elections of members, Chairperson, and Vice- Chairperson shall be notified, in the prescribed manner.
36. Resignation of Member, Chairperson and Vice-Chairperson.- (1) Any member, Chairperson or Vice-Chairperson may resign by submitting his resignation letter in writing to the Commissioner and such resignation shall be accepted by the District Collector after making due enquiry from such member, Chairperson and Vice-Chairperson, and after the expiry of three days.
(2) Such resignation shall take effect on the expiry of three working days from the date of such resignation, unless such a resignation is withdrawn within the said period of three working days, in writing to the Commissioner:
Provided that if any member, the Chairperson or the Vice-Chairperson is unable to deliver the letter of resignation to the Commissioner in person due to ill health or any other reasons, and delivered through post or through courier service, then such letter shall have to be attested by a Gazetted Officer and can be sent through a registered post and the period of such three days shall commence from the date of receipt of such a resignation.
37. Motion of no confidence in Chairperson and Vice-Chairperson.- A motion expressing want of confidence in the Chairperson and/or the Vice-Chairperson may be made by giving a written notice of intention to move the motion, in such form as specified under the Rules, signed by not less than one-half of the total number of members of the Municipality having right to vote, together with a copy of the proposed motion, to the District Collector concerned, in accordance with the procedure prescribed under the Rules:
Provided that no notice of motion under this section shall be made within three (3) years of the date of assumption of office by the person against whom the motion is sought to be moved:
Provided further that if the motion is not carried by two- thirds majority or if the meeting could not be held for want of a quorum, no notice of any subsequent motion expressing want of confidence in the same person shall be made until after the expiration of one year from the date of such first meeting.
38. Appointment of Commissioner.- (1) There shall be a Commissioner for a Municipality, appointed by the Government, who shall be the Chief Executive of the Municipality:
Provided that a person holding the office as the Commissioner of a Municipality prior to the commencement of this Act, shall be deemed to have been appointed by the Government as the Commissioner under this sub-section.
(2) The classification and methods, recruitment, conditions of service, pay and other allowances and disciplinary conduct of the officers, under sub-section (1), shall be subject to the rules made by the Government:
Provided that the conditions of service, pay and other allowances of a person holding office as the Commissioner, immediately before the commencement of this Act, shall not be varied to his disadvantage.
(3) The Government shall, from the Consolidated Fund of the State, pay the salaries, allowances, leave allowances, pension and contributions, if any, towards the provident fund, or provident-cum-pension fund of the officers appointed under sub-section (1).
39. Power to call for records.- The Commissioner shall produce all such documents which are in his/her custody for the examination by the Municipal Council as and when they are needed for public purpose.
40. Presidency of Municipality.- (1) Every meeting of the Municipal Council shall be presided over by the Chairperson, or in his absence, by the Vice-Chairperson, and in the absence of both the Chairperson and the Vice-Chairperson, if there is quorum, one of its members present may be chosen to preside for the meeting.
(2) The Chairperson shall preserve order and shall decide all points of order arising at or in connection with the meetings. There shall be no discussion on any point of order and the decision of the Chairperson, on any point of order shall, save as otherwise expressly provided in this Act, be final.
(3) If the conduct of a member in the meeting of the Council is not in order in the opinion of the Chairperson, he may direct such member to withdraw from the meeting of the Municipal Council for the day. But where a person ordered to withdraw, continues to remain in the meeting the Chairperson shall take steps to cause such member removed.
(4) In the case of grave disorder arising in any meeting, the Chairperson shall suspend the meeting for a period not exceeding three days.
(5) Where a member who disregards the authority of the chair or abuses the procedural rules, bye-laws or regulations of the Municipality by persistently and willfully obstructing the business thereof, the Chairperson if deems it necessary shall put the question that the member by naming him, be suspended from functioning, after affording reasonable opportunity of hearing the said member, for a period not exceeding three consecutive months, reckoned from the date of that meeting:
Provided that the Municipal Council may, at any time, resolve that such suspension be terminated. A member suspended under this sub-section shall forthwith withdraw from the precincts of the proceedings of the meeting.
Explanation: The Chairperson in this section includes the Vice-Chairperson, or any member presiding for the occasion.
41. Payment of honorarium and conveyance allowance to Chairperson and Vice-Chairperson and conveyance allowance to Members.- For any Municipality, payment of honorarium and conveyance allowance to the Chairperson and the Vice- Chairperson and conveyance allowance to every member shall be paid out of the Municipal fund, at such rates, as may be prescribed under the Rules.
42. Training for the Chairperson and Ward Members.- All ward members, Vice-Chairperson, Chairperson elected under this Act shall undergo training initially and on regular intervals, on department activities and functions of municipal institutions, on provisions of this Act and the rules made thereunder, in the manner prescribed.
ORGANIZATIONAL STRUCTURE OF MUNICIPALITY MUNICIPAL ESTABLISHMENT
43. Constitution of Telangana Common Municipal Service. (Act II of 1956., Act 1 of 1975., Act 8 of 2008.) (1) Notwithstanding anything contained in this Act or any other law in force, the Government as prescribed under the Rules may constitute a Common Municipal Service for the State for various cadres of the Officers and employees other than temporary employees of Municipalities including Greater Hyderabad Municipal Corporation constituted under Greater Hyderabad Municipal Corporation Act, 1955, Urban Development Authorities constituted under Telangana Urban Development Authorities Act, 1975 and Hyderabad Metropolitan Development Authority constituted under Hyderabad Metropolitan Development Authority Act, 2008.
(2) The Government shall have power to make rules to govern the classification, methods of recruitment, qualification, conditions of service, pay and allowances, trainings, discipline and conduct and other service conditions of the Common Municipal Service.
44. Power to transfer of officers and employees.- Notwithstanding anything contained in this Act or any other law for the time being in force, the Government shall have the power to transfer any officer or employee of any Municipality including Greater Hyderabad Municipal Corporation and any other Urban Development authorities including Hyderabad Metropolitan Development Authority:
Provided the Government may delegate this power to any authority in the State, if considered in each such case.
45. Appointment of officers and employees in the Municipality.- Government shall,-
(i) appoint any other officers to assist the Commissioner, to perform the functions relating to engineering, town planning, health, taxation, finance, audit, vigilance and any other functions under the Act, as may be prescribed;
(ii) appoint any category of employees in the Municipality other than those referred in clause (i) and may delegate powers to the authorities in the manner prescribed;
(iii) sanction posts considered necessary to run the administration in the Municipality from time to time, and while according such sanction, the Government may give due regard to the necessity and financial soundness of the Municipality;
(iv) fix cadre strength and staffing pattern in the Municipalities.
46. Government employees on Lien / Deputation to Municipality.- (1) If the Government is of the opinion that the services of particular class of state Government employees are required to perform the duties of the Municipality, shall place the services of such Government employee at the disposal of the Municipality and the Municipality shall pay the salary and other benefits as entitled to receive under the normal foreign service deputation Rules as prescribed.
(2) The Government is the competent authority for taking disciplinary action or in respect of employees of the Government on deputation / lien to Municipality under sub- section (1), and such action, if any, shall be in accordance with the provisions under the Act.
47. Code of Conduct of the elected representatives and the employees of the Municipality.- The Government may prescribe general code of conduct for the elected representatives and the employees of Municipality for the purpose of smooth functioning of day to day administration.
48. Control of District Collector and Municipal Commissioner over Officers and other employees and their liability.- (1) Subject to the provisions of this Act and the rules made thereunder for the time being in force, the Municipal Commissioner shall specify the duties of the officers and employees of the municipality and shall exercise supervision, control and shall initiate disciplinary actions over them in the manner prescribed.
(2) Every employee of the Municipality shall be personally liable for the loss, waste, misapplication of rules or orders or misappropriation of money or any other property. If such loss or waste or misapplication or misappropriation is a direct consequence of the neglect or misconduct in his/her capacity as employee of the Municipality, appropriate action for the same may be instituted against him or her including recovery of loss sustained by the Municipality.
(3) The District Collector, may suspend Municipal Commissioner or any other employees if in his/her opinion the said officer has failed to carry out the duties as entrusted under sections 52, 53, 54, 55, 57, 58 and 61 of this Act or for any other form of impropriety or dereliction of duties. In addition, the District Collector can also initiate disciplinary action against the said officer/s.
49. Essential Municipal Services.- The Government may prescribe rules for essential municipal services under this Act and no officer or employee temporary employee including outsourced contract personnel of the municipality shall,-
(a) absent himself from duty otherwise than on leave or permission duly granted and not subsequently cancelled; or
(b) willfully neglect or refuse to perform any of the duties assigned to him.
50. Salary and allowances of officers and employees.- Necessary provisions to this effect shall be carried out while preparing annual budget as part of obligatory expenditure under section 107.
DUTIES AND RESPONSIBILITIES OF MUNICIPALITY
51. Vesting of municipal administration.- Subject to the provisions of this Act, the administration of the Municipality shall vest in the Municipal Council for this purpose and the Municipal Council shall exercise such powers and perform such functions, other than those specifically conferred on the Chairperson or the Commissioner, as conferred under this Act and the rules made thereunder.
52. Duties and Responsibilities of the Municipality.- The Municipal Commissioner, on behalf of the Municipality, shall perform the following functions:-
(1) Any developmental activities or Urban planning, including town planning-
(a) preparation and implementation of master plan;
(b) planned development of new areas for human settlement;
(c) regulation of land use and construction of buildings;
(d) integration of the development plans and schemes of the municipal area with the district or urban development plan or metropolitan development plan, if any;
(e) measures for beautification of the municipal area such as setting up parks, green spaces, providing recreational areas, improving river banks and landscaping and other such measures;
(f) regulation of markets;
(g) survey of lands and buildings;
(h) preparation and maintaining up-to-date data of appropriate maps and records of lands on Geographical Information System platform.
(2) regulation of land use and construction of buildings-
(a) ensuring construction and development in accordance with the plan and land use pattern;
(b) regulation of unauthorized buildings.
(3) Construction and maintenance of roads, drains and bridges-
(a) improve or repair the same ensuring public safety or convenience;
(b) divert or close public roads;
(c) widen or expand roads ensuring traffic flow pattern.
(4) Water supply for domestic, industrial and commercial purposes:
Provided that individual tap connections, reduce non- revenue water, undertake water audit, and maintain GIS- based water network and asset data base.
All staff working in the municipality in the engineering wing whether borne in the cadre of municipality or on deputation from other departments shall directly report to the Commissioner and work under his or her direct superintendence.
(5) Public health, sanitation, conservancy and solid waste management-
(a) construction of individual household toilets, public toilets, community toilets and SHE toilets to make municipalities open defecation-free;
(b) sewerage and sewage treatment;
(c) faecal sludge and septage management;
(d) waste water treatment and recycling;
(e) prevention and control of infectious and communicable diseases;
(f) public vaccination;
(g) construction, maintenance and regulation of municipal markets and slaughterhouses;
(h) reclamation of unhealthy localities, removal of noxious vegetation and abatement of all nuisances;
(i) maintenance of all public tanks and regulating the excavation, repair and up-keep of all private tanks, wells and other sources of water-supply on such terms and conditions, as the municipality may deem proper;
(j) door-to-door garbage collection, promote segregation of waste at source, regular sweeping and cleaning of the streets and removal of sweepings therefrom, safe transportation of waste, scientific treatment and disposal with emphasis on recycling and upcycling, as per the rules prescribed from time to time;
(k) minimising usage of plastic and safe and scientific management of plastic waste and its disposal;
(l) safe management of construction and demolition
waste;
(m) regulate management of bio-medical waste and e-waste, as per the rules prescribed by the Government of India or State Government;
(n) promotion of measures for abatement of all forms of pollution, including air pollution;
(o) removal and disposal of excrement and other filthy matter, and of all ashes, refuse and rubbish;
(p) controlling unauthorized and illegal hoardings and other advertisements and take action against the concerned.
(6) Urban forestry and urban lung spaces, protection of environment and promotion of ecological aspects-
(a) construction and maintenance of parks, open spaces, gardens, and playgrounds;
(b) protection of environment including planting of trees in wards, open spaces, on road sides;
(c) reclamation of waste lands, promotion of social forestry and maintenance of open spaces;
(d) lake and water body protection and development;
(e) establishment and maintenance of nurseries and promotion of greenery.
(7) Slum improvement and up-gradation-
(a) improvement of notified and identified slums; and
(b) de-notification of developed slums.
(8) Night shelter for urban homeless.
(9) Provision of urban amenities and facilities such as community halls, sports complexes and bus shelters.
(10) Promotion of cultural, educational and aesthetic aspects
Promotion of cultural activities, including music, physical education, sports and theatres, and infrastructure therefor.
(11) Development of burial grounds, Vaikunta Dhamams and electric crematoriums and to arrange “vaikuntaratham” or a vehicle for transportation of the deceased to perform the final rites.
(12) Vital statistics including registration of births and deaths.
(13) Public amenities, including street lighting, parking spaces, bus stops and public conveniences-
(a) conversion of conventional street lights into energy-efficient lighting mode;
(b) development of road junctions, medians and parking spaces;
(c) establishment and maintenance of destitute homes, night shelters and shelters for exigencies;
(d) community welfare activities, campaigns for dissemination of information vital for public welfare;
(e) perform functions relating to public transport including encouraging environment friendly vehicles.
(14) Regulation and scientific management of slaughterhouses and tanneries.
(15) Use of Information Technology in service delivery and citizen centric services.
(16) Census-related functions.
(17) Perform any other function or responsibility as entrusted by the State Government from time to time.
53. Duties and Responsibilities of the Municipal Commissioner.- (1) The Commissioner shall be the Chief Executive of the Municipality and shall perform the functions as prescribed under section 52 of this Act and as entrusted by the State Government from time to time.
(2) The Commissioner shall be responsible for carrying out the instructions given by the Government from time to time, in relation to the provisions of this Act.
(3) The Commissioner may incur, in each case, contingent expenditure incidental to the administration of the Municipality as prescribed.
(4) The commissioner shall ensure that the municipality is kept clean from illegal and unauthorized hoardings and other such advertisement material which is put up without the proper authorization from the authority. Action shall be initiated against those putting up such unauthorized advertisement materials and also against the concerned municipal staff for their failure to prevent. These not only add to lack of general upkeep and sanitation but more importantly, are dangerous from human safety point of view in view of unscientific erection and instability.
(5) The Commissioner shall work under the overall control and superintendence of District Collector.
54. Responsibilities of various Functionaries of the Municipalities.- The functions referred to in section 53 shall be performed by the Municipal Commissioner through various employees of the Municipality. More specifically, all the engineering staff working in the municipality including those on deputation or from other departments shall work under the direct superintendence and control of the Commissioner. The Commissioner will be the disciplinary authority to initiate action against any of such engineering staff found neglecting his duties or for his failure to perform the duties as entrusted and in the manner prescribed.
55. Authority to contract.- The Commissioner shall be the authority to conclude and proceed with all contracts which have already been approved either by the Municipal Council or the Government, as the case may be subject to the rules made under this Act. The methodology of procurement of goods and services shall be standardized and will be based on a transparent process of procurement.
56. Duties and Responsibilities of Ward Member (Councilor or Corporator).- (1) Every ward member shall,-
(a) ensure proper sanitation, water supply, and street lights in his or her respective ward;
(b) ensure door-to-door garbage collection from all residential and commercial establishments and ensure in situ composting for wet waste and processing of dry waste at ward level;
(c) take up plantation in the ward in accordance with the District Action plan and ensure their survival to at least 85%;
(d) reduce non-revenue water, transmission loss of water, and reduce usage of power bores, wherever not required;
(e) safeguard and protect all the water sources, lakes or any other water bodies;
(f) perform all functions specifically conferred by this Act, or may be assigned by the Government from time to time; and
(g) undergo training on developmental activities in the administration of the Municipality.
(2) Any ward member, either suo-moto or representing any Ward Committee or on such other information, may call the attention of the Chairperson to any grievance or neglect or wastage of municipal property or to the needs of any locality or for any such other purposes any neglect in the execution of municipal work, or to the wants of any locality, and may suggest any improvements, which may appear desirable.
(3) Every ward member shall have the right to move resolution on any matter enumerated in sub-section (1) and sub-section (2) or any matter connected to the administration of the Municipality, subject to such rules, as may be prescribed under this Act.
(4) Any matter or subject as may be raised or submitted by any member for the purpose of consideration by the Municipal Council shall be considered and appropriate resolutions may be passed accordingly in due implementation of the suggestions forthcoming.
57. Transformation into Model Town.- The municipality shall strive to transform the town into a model town by preparing a perspective plan. The services required shall be performed by the Municipal Authorities and shall be delivered through online services.
58. E- Governance and Online Services.- (1) The Municipalities shall adopt e-governance system for citizen services on anytime anywhere basis for better, speedy, accountable and transparent administration.
(2) Municipal services may be delivered online for the convenience of citizens in a time bound manner as per the Citizens Charter prescribed under Schedule-III, if timeline is not adhered to, penalty as prescribed shall be recovered from the person responsible for the delay.
(3) Every municipality shall establish one or more Citizen Services Centre for the purpose of providing online services, and also for facilitating redressal of Citizen grievances.
CONDUCT OF BUSINESS
59. Rules and regulations for proceedings of the Municipal Council.- (1) The Municipal Council shall make regulations consistent with the provisions of this Act and as per the rules made thereunder.
(2) All decisions and resolutions of the Municipal Council shall be by simple majority of the members present and voting, subject to the availability of quorum.
(3) No other member other than the elected members including ex-officio and co-opted members, and officials or special invitees as required by the presiding officer shall participate in the meeting.
(4) The minutes of the proceedings shall be recorded by the Municipal Commissioner or officer authorized by the Municipal Commissioner for the purpose.
(5) The minutes of the council Meeting shall be drawn by the Municipal Commissioner or the officer authorised by him and shall be signed by the Chairperson or the mayor or any other Presiding Officer who chaired the council meeting soon after the meeting and not beyond one day. If Presiding Officer fails to sign, the Municipal Commissioner shall approve and sign the minutes within the next day. The minutes of such proceedings shall be placed before the Municipal Council for perusal in the next meeting. A copy of the same shall be sent to the district collector and to the authorities as prescribed by the Government. The Municipal Commissioner shall be responsible for any deviation or delay.
60. Member when to abstain from taking part in discussion and voting.- (1) No member shall vote or take part in discussion on any question in which he has personal or pecuniary interest of his own either directly or indirectly.
(2) The Chairperson may prohibit any member either from voting or taking part in the discussion of the council, if he has a reason to believe that the member has such interest, after recording reasons therefor. If the aggrieved member challenges the decision of the Chairperson, the presiding officer shall place the question before the Council, whose decision shall be final and binding on such member.
(3) Where a member present at the meeting believes that the Chairperson has a personal or pecuniary interest in any matter under discussion, and if a motion to that effect be carried, the Chairperson shall abstain himself from the meeting during discussion.
(4) The member concerned shall not be entitled to vote on the question referred to in sub-section (2) and the Chairperson shall not be entitled to vote on the motion referred to in sub-section (3).
DIRECTION AND CONTROL
61. Municipality to submit annual administration report.- Every Municipality shall submit to the Government, a report on the administration of the municipality during the preceding year and the annual action plan for the ensuing year not later than one month from the start of each financial year, in such form and in such manner as may be prescribed.
62. Power of the Government to transfer control of Endowments and Inams to Municipality. (Act 35 of 1974.)- (1) The Government by notification, make over the management and superintendence of any charitable endowment, or any other properties vested with the Government, under the relevant laws, in respect of which powers and duties are attached to the Government, may be vested in the Municipality with its consent. All powers and duties, which are attached to the Government, in respect thereof, shall be attached to the Municipality, as if it had been specially named in the Telangana Escheats and Bona Vacantia Act, 1974 and the Municipality shall manage and superintendent such endowment or other properties.
(2) The Government may, by notification, resume the management and superintendence of any endowment or other properties made over to a Municipality under sub- section (1), and upon such resumption, all the powers and duties, attaching to the Municipality under sub-section (1) shall cease.
(3) The Government may assign to a Municipality, with its consent, a charitable Inam, resumed by the Government or any authority, provided that the net income from such Inam can be applied exclusively to any purpose to which the funds of such Municipality may be applied and may revoke any assignment so made.
(4) No order of resumption under sub-section (2) or of revocation under sub-section (3), shall be passed unless the Municipality has an opportunity of making its representation.
63. Acceptance of donation, endowment or trust by the Municipality.- The Municipality may accept any donation, endowment or trust for the furtherance of any purpose for which the municipal fund is constituted.
64. Subjects not provided for by this Act.- The Government may, subject to such conditions, as it may deem fit to impose, transfer to the Municipality, the management of any institution or the execution of any work not provided for by this Act:
Provided that the funds required for such management or execution, shall be placed at the disposal of the Municipality by the Government.
65. Government’s power to cancel or suspend resolutions of the Municipality.- (1) The Government may, either suo-moto or on representation by any member, the Chairperson or the Vice- Chairperson, the District Collector and the Commissioner, by order, in writing,-
(a) cancel any resolution passed, order issued, or license or permission granted; or
(b) prohibit the doing of any act, which is about to be done, or is being done, in pursuance or under the colour of this Act, if, in their opinion,-
(i) such resolution, order, license, permission or act has been passed, issued, granted or authorized is not in accordance with law; or
(ii) such resolution, order, license, permission or act is in excess of the powers conferred by this Act or any other enactment; or
(iii) the above acts mentioned in sub-clauses (i) and (ii) the continuance in force of such act or permissions is likely to cause financial loss to the Municipality, danger to life, health or safety to human life or is likely to lead to a riot or disturb public peace and tranquility or is against public interest:
Provided that the Government before taking action under this section on the grounds referred to in clauses (a) and (b), shall give the authority or person concerned an opportunity for explanation:
Provided further that nothing in this sub-section shall enable the Government to set aside any election that has been held.
(2) Where in the opinion of the District Collector, an immediate action is necessary on the grounds referred to sub-clause (iii) of clause (b) of sub-section (1), he or she may suspend the resolution, order, license, permission or act for such period as he thinks fit, pending the exercise of their power under sub-section (1).
66. Government or the District Collector’s power to suspend Chairperson or Vice-Chairperson or Member.- (1) The Government or the District Collector, may, either suo-motu or on a representation of Chairperson or Vice- Chairperson or Member or Commissioner or employee of a Municipality, by notification, suspend any Chairperson or Vice-Chairperson or Member who, in their opinion, willfully misbehaved or manhandled any other Member or officer or employee of the municipality, or destroyed the property of the municipality, or used unparliamentary language or abused his position in the course of meetings of the Municipality, or during the discharge of any duty vesting upon the Chairperson or Vice-Chairperson or Member or officer or employee, so as to lead to a situation in which the municipal administration cannot be carried on in accordance with the provisions of this Act, or the financial stability of the municipality is threatened, for a period not exceeding six months, pending investigation into the said charges and action thereon under the foregoing provisions of this section.
(2) The Government or the District Collector shall, before taking action under sub-section (1), give the Chairperson or the Vice-Chairperson or the Member concerned an opportunity for explanation, and the notification issued under the said sub-section shall contain a statement of the reasons for the action taken by the Government or the District Collector:
Provided that the Chairperson or the Vice-Chairperson or member aggrieved by the order of suspension passed under sub-section (1) within 30 days from the date of receipt of order or as the case may be the intimation, prefer an appeal to the Municipal Tribunal:
Provided further that a person suspended under this section shall not be entitled to exercise the powers and perform the functions attached to his office and shall not be entitled to attend the meetings of the Municipality, except a meeting held for the consideration of a no-confidence motion against the Chairperson or Vice-Chairperson.
(3) When the Office of Chairperson is vacant, the Vice- Chairperson shall exercise the powers and perform the functions of the Chairperson, until the Chairperson resumes duty, or a Chairperson is elected and assumes office. When the Office of Vice-Chairperson is also vacant, any elected member of the council shall be chosen as the Chairperson by other members for the period of such vacancy and he shall exercise the powers of Chairperson until the duly elected Chairperson or Vice-Chairperson resumes office.
67. Government’s power to remove Chairperson or Vice-Chairperson or Ward Members.- (1) The Government may, by notification and in the manner prescribed, remove any Chairperson or Vice- Chairperson who, in the opinion of the Government,-
(a) willfully omits or refuses to carry out or disobeys the provisions of this Act, or any rules, bye-laws, regulations or lawful orders issued thereunder, or abuses his position or the powers vested in him;
(b) failed in performing the functions or discharging the duties;
(c) omitted or refused to carry out the orders of Government or any authority, designated by the Government for the proper working of the municipality in accordance with the provisions of this Act;
(d) is guilty of misconduct in the discharge of his duties;
(e) is guilty of embezzlement of municipal fund;
(f) persistently defaulted in the performance of his functions and duties entrusted to him under the Act to the detriment of the functioning of the municipality, or has become incapable of such performance;
(g) fails to carry out the functions as required under sections 23, 24 and 57 of this Act.
(2) The Government may, by notification and in the manner prescribed, remove any ward member, if he or she fails to carryout the functions as required under sections 24, 56 and 57 of the Act.
(3) The Government shall, when they propose to remove the Chairperson or the Vice-Chairperson under sub- section (1) and the ward member under sub-section (2), give the Chairperson or Vice-Chairperson or ward member concerned, an opportunity for explanation, and the notification issued under the said sub-section shall contain a statement of the reasons of the Government for the action taken.
(4) Any person removed under sub-sections (1) and (2) from the office of Chairperson, or Vice-Chairperson or ward member shall not be eligible for election as a member for a period of six years from the date of the removal.
(5) The resultant vacancy shall be filled in as per the provisions.
68. Government’s power to dissolve the Municipality.- (1) If, in the opinion of the Government, the Municipality is not competent to perform, or persistently makes default in performing the duties imposed on it by or under this Act, or any other law for the time being in force, or exceeds or abuses its position or powers, or a situation exists in which the municipal administration cannot be carried on in accordance with the provisions of this Act, or the financial stability or credit of the Municipality is threatened, the Government may, by notification, direct that the Municipality be dissolved, with effect from a specified date, and reconstituted either immediately or with effect from another specified date, not later than six months from the date of dissolution; and the notification shall be laid before both Houses of the State Legislature.
(2) For purposes of reconstitution of dissolved Municipality under this section, the seats of all the elected members shall be deemed to be vacant. Before publishing a notification under sub-section (1), the Government shall communicate to the Municipality concerned, the grounds on which they propose to do so, fix a reasonable period for the Municipality to show cause against the proposal and consider its explanations or objections, if any, and the Chairperson, of the municipality concerned, shall also be given a reasonable opportunity of being heard.
(3) On the date fixed for the dissolution of the Municipality under sub-section (1), all its members, ex- officio members and co-opted members along with Chairperson, and Vice-Chairperson, shall forthwith be deemed to have vacated their offices as such.
(4) During the interval between the dissolution and the reconstitution of the Municipality, all or any of the powers and functions of the Municipality, its Chairperson, and of the Committees referred in this Act, may be exercised and performed, as far as may be, and to such extent as the Government may determine, by such person as the Government may appoint in that behalf as special officer, to exercise and perform any powers and duties under this Act.
(5) The members, ex-officio members and co-opted members of the reconstituted Municipality, shall enter upon their office on the date fixed for its reconstitution and the term of office of the elected members, ex-officio members and co-opted members shall continue only for the remainder of the period for which the dissolved municipality would have continued, had it not been dissolved.
(6) The Government may reconstitute the Municipality before expiry of the period notified under sub-section (1) or sub-section (2):
Provided that where the remainder of the period, for which the dissolved municipality would have continued, is less than six months, it shall not be necessary to hold any elections under this clause for constituting the municipality for such period.
(7) When the Municipality is dissolved under this section, the Government, until the date of the reconstitution thereof, and the reconstituted Municipality, thereafter, shall be entitled to all the assets and be subject to all the liabilities of the Municipality, as on the date of the dissolution and on the date of the reconstitution respectively.
69. Government’s or the District Collector’s power to give directions.- (1) Notwithstanding anything contained in this Act, it shall be competent for the Government and District Collector or any authority designated by the Government, to enforce implementation of the provisions of the Act and execution of resolutions, to issue such directions, as the government may consider necessary, to the Chairperson for the proper working of the municipality, or for the implementation of the resolutions thereof.
(2) The Chairperson shall implement the directions issued under sub-section (1) and shall not do anything in derogation to the aforesaid directions. The Chairperson, who contravenes the provisions of this section, shall be deemed to have omitted or refused to carry out the directions of the Government, Collector or any authority, designated by the Government, for the proper working of the municipality, and shall be liable for action under section 68 of this Act.
70. Appointment of Special Officer.- (1) Notwithstanding anything contained in this Act, where, in the opinion of the Government, it is not possible to hold elections to the municipalities, in accordance with the provisions of this Act, before the date of expiration of the term, and to bring the newly-elected members into office on the date of expiration of the term, as aforesaid, the Government may, by notification, appoint a Special Officer to exercise the powers, perform the duties, and discharge the functions of,-
(a) the Municipal Council and
(b) the Chairperson under the Act:
Provided that the Government may, from time to time, by notification in the Telangana Gazette and for reasons specified therein, extend the said period of appointment of Special Officer until the newly elected Municipality assume office.
(2) The Government shall cause elections to be held to the Municipality, so that the newly-elected members may come into office on such date, as may be specified by the Government in this behalf, by a notification, in the Telangana Gazette.
(3) The Special Officer shall exercise the powers, perform the functions and discharge the duties of the Municipal Council until the elected members come into office, of the Chairperson, until a Chairperson is elected.
71. The Government or the District Collector’s power to call for records etc.- The Government or the District Collector, at any time,-
(i) may enter on and inspect, or cause to be entered on and inspected, any immovable property or any work-in- progress under the control of any municipal authority in his District;
(ii) require the Chairperson or Commissioner,-
(a) to produce any extract from any proceedings, record, correspondence, plan or other document of the Council, or any Committee, constituted under this Act;
(b) to furnish any return, plan, estimate, statement of account, or statistics;
(c) to furnish or obtain any report; and
(d) the Chairperson or the Commissioner, as the case may be, shall furnish the same without unreasonable delay.
72. Government’s power to appoint officers to supervise Municipalities.- (1) The Government may appoint such officers, as may be required, for the purpose of inspecting or superintending the operations of the Municipalities constituted under this Act.
(2) (a) The Government may appoint such officers, as they may consider necessary, to assist them for the purpose of inspecting or superintending the operations of all or any of the municipalities constituted under this Act;
(b) In particular, and without prejudice to the generality of the foregoing provisions, the Government may appoint Regional Directors of Municipal Administration and define the territorial jurisdiction of each such officer, for the above purpose, in the manner prescribed.
(3) The cost of the officers and the members of the establishment, aforesaid, shall be paid from the Consolidated Fund of the State.
(4) The Regional Directors of Municipal Administration shall exercise such powers and perform such functions, as may be prescribed by the Government or as may be delegated to them, under this Act.
(5) The officers appointed under sub-section (1) and clauses (a) and (b) of sub-section (2) or any other officer or person, whom the Government may empower in this behalf, may enter on and inspect or cause to be entered on and inspected, any premises and execution of any work as may be prescribed,-
(a) any immovable property or any work-in-progress under the control of any municipality;
(b) any school, hospital, dispensary, vaccination station, choultry or other institution maintained by, or under the control of, any municipality, and any records, registers or other documents kept in such institution;
(c) the office of any municipality and any records, registers or other documents kept therein.
(6) The municipality, and its officers and employees, shall be bound to afford to the officers and persons aforesaid, such access, at all reasonable times, to municipal property or premises, and all documents as may, in the opinion of such officers or persons, subject to such rules as prescribed, are necessary to enable them to discharge their duties under this section.
(7) The officers and persons aforesaid shall, on their visit to the municipality, sign and record any remark deemed necessary on a register maintained for such officers in the prescribed proforma. He shall submit the inspection report with due findings and endorsement to the next higher officer. In case the higher authority, at a later date, finds any omission or irregularity committed by a municipality but not reported by the inspecting officer, the inspecting officer shall be liable for disciplinary action.
(8) The officers appointed under this section shall inspect all Municipalities in their jurisdiction at least once in three months.
(9) The inspection shall be conducted in accordance with the format, as may be prescribed,-
(a) covering all the responsibilities;
(b) quantifying the functions; and
(c) evolving the benchmarks for every function, as provided under the Act, in respect of the municipality.
(10) The annual inspection programme of an authority shall be approved by the next higher authority at the beginning of every financial year.
(11) The inspecting officers shall prepare a monthly advance tour programme and obtain the approval of the next higher authority.
(12) The inspecting officers shall also submit tour diaries to the next higher authorities, which shall be reviewed regularly and approved.
(13) The inspecting officers shall send inspection report to the municipality and submit a copy of the same to the next higher authority within one week of completion of inspection and seek a report from the Commissioner, who is bound to submit such report within a fortnight.
(14) On receipt of a report from the Commissioner, the same shall be submitted to the higher authority.
(15) The higher authority shall, in turn, submit a report to the Government, on the lapses pointed out by the inspecting officer and the report of the Commissioner. The Government shall take action on the lapses reported, if any, where the explanation is not satisfactory.
(16) Inspecting officers shall also make surprise inspections in addition to the programmed ones.
(17) Organising capacity building programmes to the municipal functionaries and elected representatives.
(18) The District Collector shall supervise and monitor the functioning of the municipalities and take all necessary actions as deemed appropriate for its smooth functioning.
73. Government or the District Collector Power to Require the Performance of Duties and Responsibilities.- If the Government or District Collector is of the opinion that,-
(a) any duty or responsibility imposed on any municipal authority, by or under this Act, has not been performed,
(b) adequate financial provision has not been made for the performance of any such duty the Government or the District Collector, may, by order, direct the municipal authority, within a period to be specified in the order, to make arrangements for the proper performance of the duty, or to make financial provision for performance of the duty, as the case may be:
Provided that unless, in the opinion of the Government or the District Collector, the immediate execution of such order is necessary, the Government or the District Collector shall, before making an order, under this section, give the municipal authority, an opportunity of showing cause as to why such order shall not be made.
74. Government’s or the District Collector’s power to take action in certain cases.- (1) The Government or District Collector may, from time to time, give such directions, not inconsistent with the provisions of the Act or the rules made thereunder, to the municipalities, as it may consider necessary for carrying out the purposes of this Act.
(2) If, at any time, it appears to the Government or District Collector that the Municipal Council, the Chairperson or the Vice-Chairperson, or the members or the Committees has made any default in performing any duty imposed by or under this Act or any other law for the time being in force, the Government may, by order in writing, fix a period for the performance of such duty.
(3) The Commissioner shall, so far as the funds to the credit of the municipality permit, be bound to comply with such order.
75. Government’s powers to undertake work for Municipality.- (1) The Government may, with the consent of the Municipality, undertake, on its behalf, the construction of water supply, drainage or other works, appoint persons to carry out construction of such works and direct that the expenses, including the pay of such persons, be paid from the municipal fund and thereafter, the provisions of sub- sections (3) and (4) of section 78 shall apply.
(2) The Government may, after consultation with the Municipality, constitute Planning Committee for any municipality, consisting of such members as may be appointed by them, for the purpose of preparing plans in respect of such developmental works, as may be approved by the Government and the Municipality for execution within the municipality; and the Municipality shall undertake all such works. The expenses incurred towards the Planning Committees, the preparation of plans and the execution of developmental works under this section shall be paid from the municipal fund.
76. District Collector’s power to enforce implementation of the provisions of the Act and execution of resolutions.- (1) If it appears to the District Collector that the Chairperson or the Commissioner has made default in carrying out any resolution of the Municipality, the Collector shall, after giving the Chairperson or the Commissioner, as the case may be, a reasonable opportunity of explanation, send a report on such resolution, together with the explanation, if any received, to the Government and, at the same time, forward a copy of the same to the Municipality.
(2) The Government shall, on receipt of the report of the Collector under sub-section (1), consider the same and, if necessary, take action under sub-section (1) of section 65.
77. Power of Government or the District Collector for the purposes of control.- (1) The Government or the District Collector may enter on and inspect, or cause to be entered on and inspected, any immovable property or any work-in-progress under the control of any municipal authority in his District.
(2) The Government or the District Collector may direct any Municipality, the Chairperson or the Commissioner within the jurisdiction of the District Collector,-
(a) to furnish any document in their possession, or under their control;
(b) to furnish any return, plan, estimate, statement, account or statistics;
(c) to furnish any information or report on any municipal matter;
(d) to record, in writing, any observations they, or he may think proper in regard to its, or his, proceedings or duties.
(3) The District Collector shall inspect one municipality a week to have a first-hand experience of its functioning, inspect ongoing works, review the performance of municipality and interact with citizens and undertake necessary action as deemed appropriate.
(4) The District Collector shall convene a monthly review meeting of all Municipalities and Municipal Corporations in the District with Municipal Commissioners and other Officers as deemed necessary.
78. Emergency powers of the District Collector.- (1) The District Collector may, in cases of emergency, direct or provide for the execution of any work or the doing of any act, which the Municipality is empowered to execute or do, and the immediate execution or the doing of which is, in his opinion, necessary for the safety of the public and may direct that the expenses incurred for executing such work or doing such act, as the emergency may require, shall be paid from the municipal fund.
(2) If the expenses are not so paid, the District Collector may make an order, directing the Commissioner having the custody of the municipal fund, to pay them in priority to any other charge against the fund.
(3) The Commissioner shall, so far as the funds to the credit of the Municipality admit, be bound to comply with such order.
(4) Every case in which the powers conferred by this section are exercised shall be forthwith reported to the Government by the District Collector, with the reasons in full, for the exercise of such powers; and a copy of the letter, shall, at the same time, be sent to the Municipality for information.
79. Responsibilities of officers acting for, or in default of, the Municipality and liability of municipal fund.- When the District Collector or a person appointed by the Government lawfully takes action on behalf, or in default, of the Municipality or the Commissioner under this Act, he / she shall have all such powers as are necessary for the purpose, and shall be entitled to the same protection under this Act as the municipal authority whose powers he / she is exercising, and compensation shall be recoverable from the municipal fund by any person suffering damage from the exercise of such power to the same extent as if the action has been taken by such municipal authority.
80. Power of the District Collector to suspend a resolution, order, etc.- If in the opinion of the District Collector, immediate action is necessary on any of the grounds referred to in section 65(1)(b), he may, in accordance with section 65(2), suspend the resolution, order, license, permission or act, as the case may be, and report to the Government, who may, thereupon, either rescind the Collector’s order or, after giving the authority or person concerned a reasonable opportunity of explanation, ratify the same, with or without modification permanently, or for such period as they think fit.
81. Establishment of State Institute of Urban Excellence.- The Government shall establish State Institute of Urban Excellence as an autonomous institution of Excellence specializing to take up training for elected representatives and municipal employees on regular basis. It will be the hub of urban excellence, specializing in the broad domains of urban development, management, governance, finance, poverty and policy. It shall aim at quality research, undertake training, consultancy services and policy reforms on urban sector issues. The manner of establishment and maintenance of the Center shall be such as may be decided by the Government.
>CHAPTER III MUNICIPAL REVENUE
82. Sources, power to levy and collect Taxes and user charges.- (1) Subject to the directions from the Government, the Municipality shall collect Revenues under this Act, or other sources or authorized by any law.
(2) The sources of Revenue shall be,-
(a) taxes or Cess or fees levied by the Municipality – Property Tax on land and buildings, any surcharge on mutation proceedings or for any other purpose;
(b) levy of user charges for civic services,–
(i) provision for water supply, drainage, sewerage, solid Waste Management etc.,
(ii) parking of different types of vehicles in different areas and for different periods; and
(iii) any other specific service rendered in pursuance of the provisions of this Act, at such rates as may be prescribed by the rules.
(c) levy of any cost or expenditure towards reimbursement for the purpose of demolition of unauthorized or dangerous structures or any such other activity or purpose.
83. Power to levy and collect fees and fines.- In exercise of the regulatory powers vested in Municipality under this Act or the rules or the regulations made thereunder, the Municipality under the directions of Government shall have the power to levy and collect the fees, cess and fines.
(1) Sanction of building plans and issue of occupancy certificates.
(2) Issue of municipal licenses for various non- residential uses of lands and buildings.
(3) Licensing of –
(a) Various categories of professionals such as plumbers and surveyors;
(b) Various activities such as sinking of tube-wells, sale of meat, fish or poultry, slaughter house or hawking of articles;
(c) Such other activities as require a license or permission under the provisions of this Act; and
(4) Issue of birth and death certificates.
84. Power to levy development charges.- The Municipality may levy development charges on any layouts, residential buildings or non-residential buildings as may be determined, from time to time, and subject to rules made under this Act.
85. Assessment and Collection of Taxes or fees or user charges.- (1) Assessment and Collection of Taxes or fees or user charges shall be in accordance with the provisions of this Act and subject to the rules made thereunder.
(2) The Municipality shall provide online services for items mentioned under section 82 and section 83 and shall also provide electronic or any other machines, which will enable to auto update of payments in online applications and also accounting application for the purpose of collection.
(3) On the constitution of a new Municipality or on merging of new areas in a Municipality, the levy of tax, shall come into effect from the date specified in the relevant notification.
86. Levy of Tax or fee under any law.- The Municipality may, if so authorized by any other law for the time being in force, levy and collect any tax, fee, cess or user charge, imposed under that law, or any dues payable under that law, in accordance with the provisions thereof, under specific directions from the Government.
87. Recovery of arrears of Municipal Revenue. (Act No.II of 1864.)- The Municipality is empowered to recover any arrears due towards any amount towards Municipal Revenue by following the procedure as contemplated for the recovery of land revenue under the provisions of the Telangana Revenue Recovery Act, 1864.
88. By whom Taxes payable.- Subject to the provisions of this Act, assessment of property tax shall be payable by the owner, or by the occupier of the building. The occupier from whom tax is collected on behalf of the owner shall be entitled to be reimbursed or deduct such amount from the rent from time to time becoming due from him to such person.
89. Notification of new taxes.- (1) When the Municipality determines to levy any tax for the first time or revising at a new rate, in accordance with the provisions of this Act, or rules and regulations made thereunder, the Commissioner shall forthwith publish in the prescribed manner the rate at which, the date from which and the period of levy, if any, for which such tax shall be levied.
(2) The Municipality subject to sub-section (1) shall publish a notice in the District Gazette, or in one newspaper in the vernacular language of the locality having wide circulation and on the notice board of the Municipal office and in such other conspicuous place.
90. Liability for loss, waste or misappropriation.- Any person or officer as entrusted by the Municipality with the collection of sums due to the Municipality, shall be liable for the loss, waste, miscalculation or misappropriation of any money or other property owned or vested in the Municipality, where such loss, waste, miscalculation or misappropriation is a direct consequence of his neglect or misconduct shall be subjected to any disciplinary action without prejudice to any civil or criminal proceedings.
91. Power to write-off irrecoverable taxes, etc.- Subject to compliance with the directives from the Government in this regard, the Municipality may write-off any tax, fee or other amount, due to it, under a contract or otherwise, or any sum payable in connection therewith, if, in its opinion, such tax, fee, amount or sum is irrecoverable.
92. Property Tax.- (1) Subject to sub-section (1) of section 85, the Municipality shall levy property tax at such unit rates duly taking into consideration the location and usage as notified under section 93 on all buildings and lands which are occupied within the Municipal area, unless exempted under this Act or any other law.
(2) While levying property tax, the amount of trade license fixed as per the Act, shall also be levied and collected along with the Property Tax for the properties where any trade is being carried on.
(3) Any resolution abolishing an existing tax or reducing the rate, shall not be carried into effect without any notice issued under section 93 of this Act.
(4) The government shall exempt any residential building occupied by the owner from the property tax where the area of the building is or less than 75 square yards, having ground or ground plus one floor. In all such cases, a nominal amount of Rs.100 per annum shall be paid by them towards property tax.
93. Method of assessment.- (1) The Property Tax on buildings shall be levied on the following basis, namely:-
(a) Capital value, or
(b) Annual rental value, or
(c) Such other basis as prescribed.
(2) Every building shall be assessed together with its site and other adjacent premises occupied as an appurtenance thereto.
(3) The method of assessment, complaints, serving of notice, collection and recovery shall be in the manner, as prescribed.
94. Self-assessment.- (1) The owner of a building for new construction or reconstruction, which is not assessed in the municipal records, may submit an online self-certification and ensure his property is assessed and pay the tax to the Municipality. The individual shall be responsible for furnishing correct information in the self-assessment.
(2) An audit at random will be undertaken for the self- assessments made under sub section (1) in respect of plot size/plinth area/floors/usage, as prescribed.
(3) In case, any variation is found during the Audit, the Commissioner shall correct the assessment and levy and collect the actual tax, along with one-time penalty of 25 times for incorrect certification and initiate penal action as prescribed under the rules.
(4) Penalty on unauthorized construction or usage: –
(a) Notwithstanding anything contained in this Act and the rules made thereunder, where a building is constructed or reconstructed, or some structures are raised unauthorizedly, it shall be competent to the assessing authority to levy property tax on such building or structure with a penalty, as specified in this Act, till such unauthorized construction is demolished or regularized without prejudice to any proceedings, and the penalty so payable shall deem to be the property tax due,-
(i) upto 10 percent of the violation of permissible setbacks, only in respect of floors permitted in a sanctioned plan: – 25 percent of property tax as penalty;
(ii) more than 10 percent violation of permissible setbacks, only in respect of floors permitted in a sanctioned plan: – 50 percent of property tax as penalty;
(iii) unauthorized floors over the permitted floors in a sanctioned plan: – 100 percent of property tax as penalty.
(iv) total unauthorized construction: – 100 percent of property tax as penalty.
(v) violation of usage: – 100 percent of property tax as penalty and revised rate based on the new usage thereafter.
(b) The levy and collection of penalty referred under sub-section (1) shall not be construed as regularization. Sub-section (1) does not apply to buildings where occupancy certificate is issued by the Municipality with penalty of such unauthorized construction.
(c) When penalty is levied on unauthorized construction / deviation, the information of such properties, shall be sent to or brought to the notice of the Town Planning Section of the Municipality so as to take action for demolition or regularization, as the case may be, under the provisions of this Act.
(d) The penalty leviable under sub-section (1) shall be determined and collected by such authority and in such manner as may be prescribed in accordance with this Act.
(e) Monthly lists:- For regular assessment of any lands or buildings covered under sub-section (1) and clause (i) of sub section (4) of this section, the Revenue staff of the Municipality or any officer authorized in that behalf, shall prepare and submit monthly lists to the Municipal Commissioner who shall assess all such properties in the list and bring into the tax record immediately. The Municipality shall submit the statement of monthly lists, to the Regional Director.
95. Vacancy remission.- (1) When any building or land or any premises which has been vacant for more than three months is eligible for vacancy remission of 50% of the Property Tax for the vacancy period.
(2) For the purpose of sub-section (1),
(a) premises shall be deemed to be vacant only if they are unoccupied and unproductive of rent;
(b) premises used or intended to be used for the purposes of any industry which is seasonal in character shall not be deemed to be vacant merely on account of their being unoccupied and unproductive of rent during such period or periods of the half year in which seasonal operations are normally suspended.
(3) Every demand for remission under sub-section (1) shall be made during the half year in respect of which the remission is sought.
(4) (a) No demand for such remission shall be entertained unless the owner of the building, land or premises or his agent has previously thereto delivered notice to the Municipal Commissioner within one month of the vacancy during that half year;
(b) no demand for such remission shall be entertained in case of a person who is in arrears of property tax;
(c) notice of the vacancy has to be issued to Municipal Commissioner, for every half year of vacancy;
(d) the Property tax for the vacancy period shall be paid on or before the due date, the vacancy remissions sanctioned will be credited to the property as advance.
96. Tax on demolished buildings.- When any building or part of building, over which property tax is due, is demolished the owner of such property shall be liable to pay tax to the Municipality and intimate the same.
97. Levy of property tax on Vacant Land.- (1) The Property tax shall be levied and collected on vacant land which are not used either for agricultural purposes, and are not occupied by, or adjacent and appurtenant to buildings, at the time of construction or registration as a one-time payment, subject to rates prescribed by the Government from time to time on capital value of the land by the Municipality.
(2) The land owner shall obtain no-due certificate with respect to vacant land tax before initiating any construction.
(3) From the date of commencement of this Act, the Commissioner shall make an inventory of all the vacant lands within six months in the Municipal area and levy tax in accordance with this Act.
(4) The Property tax is leviable in respect of a land which is otherwise capable of being built upon i.e. where construction is permissible.
(5) The levy of property tax on vacant land shall be exempted in respect of all lands/usages belonging to or under the control of the Government in Municipality.
98. Recovery of service charges from the properties of Union of India.- The Municipality shall levy service charges on properties of Union of India and its departments at the rate of 75%, 50% or 33 1/3% of property tax leviable, depending on the availability of municipal services at full or partial or nil services respectively and collect accordingly.
99. Power of the Commissioner or any authorized officer to call for information and to enter upon premises.- The Commissioner or any other person authorized by him on behalf of the Municipality may enter, inspect, survey and measure such buildings or lands after giving reasonable notice to the owner or occupier. During inspection of any premises, any Woman Officer of the Municipality, as authorized by the Commissioner, shall be accompanied. The Commissioner may call on the owner or occupier of any land or building to furnish such information as may be required and the owner or occupier thereof shall comply with it and make a true return to the best of his knowledge.
100. Property Tax when payable.- (1) The property tax shall be levied every half-year and shall, save as otherwise expressly provided in prescribed manner under the rules, be paid by the owner of the assessed premises within 30 days after the commencement of the half-year, duly ascertaining the tax payable from the website. The tax-payers shall be entitled for a rebate on property tax as prescribed under the rules, if there are no arrears and if the tax for the entire financial year is paid before 30th April of the year, notwithstanding the service of a bill or demand notice.
(2) The tax-payer if commits a default to pay the tax by the end of June and by the end of December for the first and second half year respectively, the municipality shall levy a simple interest at the rate of 2% per month The commissioner after giving a notice to the defaulted owner or occupier disconnect the services to the premises.
(3) An Additional rebate, as prescribed under the rules shall also be allowed in respect of properties which have undertaken both recycling of waste water and rain water harvesting structures and in respect of properties which have installed solar heating and lighting system according to rules prescribed thereunder.
(4) Whenever, tax is levied for the first time or there is an increase in tax, the Commissioner, shall serve Notice to the property owner, giving opportunity to submit grievance within (30) days of notice, if any. For the payment of tax every year, the Commissioner shall inform the public about requirement of payment of tax through multimedia in the beginning of every half-year and also send SMS alerts through registered mobile numbers and in such cases issue of notices can be dispensed with.
101. Revision petitions and appeals when and to whom to lie.- (1) Any person aggrieved by any tax fixed or assessed under this Act may file a revision petition before the Commissioner, within 60 days of notice. The Commissioner shall dispose of the revision petition within 30 days from the date of receipt of the revision petition:
Provided that the Commissioner may condone the delay in filing the revision petition subject to the satisfaction of sufficient cause.
(2) An appeal shall lie to the Regional Director against any orders passed by the Commissioner under sub-section
(1) within 30 days from the date of receipt of the order passed by the Commissioner:
Provided that the Regional Director may condone the delay in filing the appeal petition subject to the satisfaction of sufficient cause.
102. Power of Government to make rules under property taxation.- The Government shall make rules providing for,-
(a) the exemption of special classes of buildings from the tax;
(b) the manner of ascertaining the annual rental value or capital value of houses and the categories into which they fall for the purposes of taxation;
(c) the persons who shall be liable to pay the tax and giving notice of transfer of property; and
(d) the grant of vacancy and other remissions.
103. Power to correct the Assessment records.- (1) Where at any time, it appears that any person or property has been inadvertently omitted from the assessment records or inadequately or improperly assessed relating to any tax, a clerical or arithmetical error is committed in the records, the Commissioner will assess or reassess or rectify the errors, as the case may be:
Provided that no such assessment shall be made where it has the effect of an increase in the assessment unless reasonable opportunity to show cause against the proposed action is given to the person affected.
(2) Such assessment or reassessment or correction of records shall not relate to a period earlier than five and half- years immediately preceding the current half-year.
104. Change of entries of Record of Rights in Municipal records.- (1) Whenever the Record of Rights of any person, primarily liable to the payment of property tax is transferred, and the person to whom the same is transferred shall remit the amount as prescribed and the same shall be instantly transferred in the name of Transferee in the Property Tax record of the Municipality as per the rules prescribed.
(2) Whenever the transfer is affected through succession, court decree or any other reason, the person, whose title is transferred and the person to whom the title is transferred, shall give notice of such transfer to the Commissioner and in such cases, the Commissioner shall complete the transfer of property in the time limit as prescribed in Schedule III of this Act. For alteration of entries relating to Record of Rights in succession cases, no fee is required to be collected.
(3) The Commissioner may, by notice, direct the transferee or the person to whom the Record of Rights passes, to produce before him, all documents evidencing the transfer and the person shall produce the same.
(4) Every person, who makes a transfer without giving notice to the Commissioner, shall, in addition to any other liability which he incurs through such neglect, continue to be liable for the payment of property tax on the premises transferred, until he gives notice or until the transfer is recorded in the municipal registers, but nothing in this section shall be held to affect –
(a) the liability of the transferee for the payment of the said tax; or
(b) any claim of the Municipality under the provisions of this Act.
105. Constitution of Telangana State Property Tax Board.- The Government shall constitute Telangana State Property Tax Board to provide assistance and technical guidance to all Municipalities in the State for proper assessment of property tax on buildings and lands in their respective jurisdictions. The Constitution of the Board and its functions, powers shall be as prescribed by the Government.
105-A. Method of assessment of duty on transfer of property. (Central Act 2 of 1899.)- The duty on transfers of property shall be levied,-
(a) in the form of a surcharge on the duty imposed by the Indian Stamp Act, 1899, for the time being in the State, on every instrument of the descriptions specified below, in respect of the whole or part of the immovable property, as the case may be, situated within the limits of a municipality; and
(b) at such rate as may be fixed by the Government, not exceeding five per centum on the amount specified below against such instrument:
| Sl. No. |
Description of instrument |
Amount on which duty shall be levied |
| (1) |
(2) |
(3) |
| (i) |
Sale of immovable property |
The amount or value of the consideration for the sale, as set forth in the instrument or the market value of the property which is the subject matter of the sale whichever is higher |
| (ii) |
Exchange of immovable property |
The market value of the property of greater value, which is the subject matter of exchange |
| (iii) |
Gift of immovable property |
The market value of the property which is the subject matter of the gift |
| (iv) |
Mortgage with possession of immovable property |
The amount secured by the mortgage, as set forth in the instrument |
| (v) |
Lease for a term exceeding one hundred years or in perpetuity of immovable property |
An amount equal to one- sixth of the whole amount or value of the rents which would be paid or delivered in respect of the first fifty years of the lease as set forth in the instrument |
105-B. Provisions of the Indian Stamps Act, 1899, applicable on the introduction of duty on transfers of property. (Central Act 2 of 1899.)- On the introduction of the duty on transfers of property—
(a) section 27 of the Indian Stamp Act, 1899 shall be read as if it specifically requires the particulars to be set forth separately in respect of property situated within the limits of a municipality and outside such limits;
(b) section 64 of the same Act shall be read as if it referred to the Municipal Council and Municipal Corporation concerned as well as the Government.
105-C. Power to make rules regarding assessment and collection of duty on transfer of property.- The Government may make rules not inconsistent with this Act for regulating the collection of the duty on transfer of property, the payment thereof to the Municipal Councils and Municipal Corporations concerned and the deduction of any expenses incurred by the Government in the collection thereof.
FINANCE
106. Definition of Municipal Fund.- (1) All the moneys received by the Municipality shall constitute a fund, which shall be called the Municipal Fund, and shall be applied and disposed of, subject to the provisions of the Act or other laws as prescribed by the Government. The Municipal fund consists of,-
(a) all moneys received;
(b) all proceeds of the disposal of Municipal property;
(c) all rents on the Municipal property;
(d) taxes, cess, fees and fines collected;
(e) compensation on account of compounding offences;
(f) moneys received from Government or public bodies, or private individuals as Grant, donations, gift or deposit;
(g) interests and profits from banking transactions and any other transactions;
(h) loans, bonds etc., raised by the Municipality;
(i) accumulated fund in the Municipality standing to the credit before the commencement of this Act.
(2) All moneys payable to the credit of the municipal fund shall be received by the Commissioner and shall be forthwith paid into any Scheduled Commercial Bank to the credit of an account which shall be styled “the account of the municipal fund of the (said) Municipality” and all funds shall be kept under one single account.
(3) No payment shall be made by the Bank referred in sub-section (2), out of the Municipal Fund except on a cheque signed by the Commissioner or by the way of online fund transfer when authorized by the Commissioner.
(4) For the purpose of strengthening of municipal fund and for taking up developmental projects, the Municipality may consider to raise funds through issue of municipal bonds or borrow from other sources, as per the notification issued by the Government.
(5) The Municipality shall also take necessary steps to obtain credit rating once in every two years, as specified by the Government.
BUDGET
107. Budget estimate.- (1) Each Municipality is an extensive human settlement with high density of population, housing and having its complex requirements of planning, sanitation, water supply, transport and communication among others. Each of these towns undertake infrastructure works such as roads, drains, waste management and street lights to ensure a safe and healthy ambience for its citizens. It is thus important that budget for the municipality is planned in a systematic manner to take care of its obligatory requirements and developmental works so as to ensure a balanced overall healthy growth.
(2) In order to provide a robust growth impetus, the State Government shall provide a matching amount equal to the municipality wise devolution under the Finance Commission, over and above the own resources of the municipality. Any deficit in the matching grant contribution from the State Government shall be carried forward to the next year.
(3) In order to have a uniformity in the budget formation exercise and to ensure that there is an earmarked budget for all the essential functions of the municipality, the District Collector shall be a part of budget preparation exercise of the municipality and shall guide them in its preparation. He or she shall be present in the budget meeting of the municipality.
(4) The municipality shall prepare a budget showing the probable income and expenditure during the ensuing year. While preparing the annual budget for the municipality, the required budget for the following components, in addition to the meeting the salary expenses, must be provided first for,-
(a) Proper upkeep of sanitation and budget requirement towards the sanitation vehicles, tools and sanitation instruments;
(b) Budget to meet the power bill towards street lights maintenance and water supply – municipality shall ensure that these bills are cleared in time and at such periodicity.
(c) Loan repayments if any;
(d) 10% of the annual budget as the “Green Budget” to meet the requirements of plantations and nursery;
The above provisions (a), (b), (c) and (d) will be obligatory and will be treated as charged provisions in the budget.
(5) After meeting the obligatory provisions as mentioned above, earmarking one-third of the balance budget on critical infrastructure requirements and works in newly merged areas, underdeveloped areas and the localities inhabited predominantly by the weaker sections, minorities and slums.
(6) In addition to and after having met the provisioning as above, the budget shall provide for the following,-
(a) maintenance of parks, playgrounds and open spaces;
(b) construction and maintenance of “Vaikuntadhamams” (crematorium) and burial grounds;
(c) construction and maintenance of public toilets;
(d) at-least one integrated vegetarian and non- vegetarian model market for each town and an additional market for every additional 50000 population–model market design may be provided by the Commissioner and Director of Municipal Administration;
(e) construction and maintenance of modern slaughter houses;
(f) scientific management of dump yards and scientific waste including solid and liquid management.
(7) Ward wise works shall be taken up once the above requirements have been met with.
(8) A copy of the budget shall be submitted to the Government at least a fortnight before the end of the financial year for the ensuing year.
108. Revised Budget.- In the course of a financial year, the Municipality shall not mandate the budget with regard to its income or expenditure it proposes unless the consent of the Government or any agency specified therefor is obtained.
109. Preparation of Annual Accounts.- (1) The Commissioner shall prepare annual accounts by way of Double Entry Accrual Based Accounting System with such information and in such form and manner, as may be prescribed under the rules and submit the annual accounts for approval of the Municipal Council.
(2) The annual accounts shall be forwarded to the Director of State Audit and the audit shall be completed within such time, as prescribed under the rules.
110. Audit of Accounts. (Central Act 45 of 1860.)- (1) The Government shall prescribe the procedure for auditing of the annual accounts of the municipal fund and the auditors shall be deemed to be ‘public servants’ within the meaning of section 21 of the Indian Penal Code, 1860.
(2) The Municipality shall provide for pre-audit and internal audit of the regular accounts of the Municipality to the Municipal Council as per the rules prescribed under the Act.
(3) The Government may appoint any person to carry out a special audit on specific accounts or whole of the accounts of any period relating to Municipality and submit the special audit report to the Government.
111. Contribution to expenditure by other local authorities.- (1) If the expenditure incurred by the Government or by any other municipality to which this Act applies or by any other local authority in the State for any purpose authorized in the manner prescribed so as to benefit the inhabitants of a municipality, the Municipal Council may, with the sanction of the Government, make a contribution towards such expenditure.
(2) The Government may direct a council to show cause, within a month after receipt of the order containing the direction, why any contribution described in sub-section (1) should not be made.
(3) If the council fails to show cause within the said period to the satisfaction of the Government, the Government may direct it to make such contribution as they may specify and it shall be paid accordingly.
112. Guarantee of State Government of principal of, and interest on, the loans floated by Council in Municipality for the purposes of the Act.- (1) It is the prerogative of the Government to undertake guarantee for any project/s of the Municipality. In such cases and if considered, the principle of, and interest on the loans floated by a Municipality, subject to fulfillment of the conditions, certification of financial robustness, and ceiling of maximum limit, as may be fixed by the Government, shall carry the guarantee of the Government.
(2) The Government may increase the maximum amount of guarantee given.
(3) The Government may, after consulting the Municipality,-
(a) by notification, and
(b) by notice, of not less than 14 days, discontinue any guarantee given by them or restrict the maximum amount thereof or modify the conditions subject to which it is given, with effect from a specified date not being earlier than six months from the date of publication of the notification in the Telangana Gazette:
Provided that in cases where the maximum amount of the guarantee is to be restricted or the conditions subject to which the guarantee is given are to be modified, the notification and notice aforesaid shall set forth with sufficient clarity the scope and effect of the restriction or modifications.
113. Recovery of loans and advances made by the Government.- Notwithstanding anything in the Local Authorities Loans Act, 1914, or any other law similar thereto for the time being in force, the Government shall be entitled to recover in the manner provided by sub-section (2) of section 74 of this Act or by suit, any loan or advance made to any Council for any purpose to which the funds of the said Council may be applied under this Act.
113-A. Constitution of Finance Commission.- (1) There shall be constituted a Finance Commission once in every five years by the Governor on the recommendation made by the Government. The Finance Commission constituted prior to the commencement of this Act shall be deemed to have been constituted under this Act and shall be governed by the provisions of this Act.
(2) The Finance Commission shall consist of a Chairman and four other members of whom one shall be the Member Secretary. The Governor shall by order appoint on the recommendation of the Government the Chairman and other members of the Commission.
(3) The Government shall make available to the Finance Commission such staff as may be necessary for the discharge of the functions conferred on the Finance Commission.
(4) The Chairman of the Commission shall be selected from among persons who have had experience in public affairs and other members shall be selected from among persons who,-
(a) have special knowledge of the finances and accounts of Government; or
(b) have had wide experience in financial matters and in administration; or
(c) have special knowledge of economics.
(5) The qualification, disqualification of members, term of members, functions of the Commission, powers of the Commission shall be such as may be prescribed.
CHAPTER IV
STATUTORY FUNCTIONS AND RESPONSIBILITIES OF THE MUNICIPALITY WATER SUPPLY
114. Vesting of powers.- All the existing sources of potable drinking water supply in any form including tanks, water reservoirs, cisterns, pipelines, wells and all other such facilities in the municipality, existing at the commencement of this Act and added subsequently, shall vest in the Municipality.
115. Water Audit.- The Municipality shall,-
(a) conduct water Audit within its jurisdiction, and make all efforts to reduce the non-revenue water (NRW) to its minimum, and may further, initiate necessary steps to rationalize usage of drinking water by ensuring the availability of re-cycled water for non-potable purposes such as horticulture, construction activity and other such activities as may be prescribed;
(b) maintain complete survey maps, drawings and descriptions of water-supply mains, supply-pipes and connections thereto, from all premises in the municipal area along with inventory details and improvements carried out during the year.
116. Powers of the State Government in water supply.- (1) The Government may make rules governing the allocations, classifications of supply of water for residential and commercial purposes including shops, hotels, industrial undertakings and other such non-residential undertakings, and to determine the levy of charges for different categories.
(2) The Government may also direct the Municipality to supply water outside the municipality on such terms, if any.
(3) The Government may constitute an authority or a body or a water board for one or more Municipalities or other local authorities, for the construction and maintenance of water works for the supply of water to such Municipalities or Local Authorities, subject to such conditions as may be prescribed, and such Municipalities or local authorities shall be bound to take water from such authority so constituted.
117. Powers of the Municipality in water supply.- (1) The Municipality may lay or carry any water-main or service-main or any pipe or channel of any kind for the purpose of providing or carrying out or maintaining a system of water-supply on, across, under or over any street or public place, may at all times do all acts and things which may be necessary or expedient for repairing or maintaining any such pipe or channel, as the case may be, in an effective state for the purpose for which such pipe or channel, as the case may be, may be used or intended to be used.
(2) The Municipality may, by regulations,-
(a) specify the terms and conditions for provision of water meter to the owner or the occupier of any land or building;
(b) recover the consumption charges for supply of such water as recorded by such water meter; and
(c) take all such necessary steps as may be required for proper utilization of water and detection of any fraud in respect of such water meters as prescribed.
(3) The Commissioner or any person authorized by him/ her, may cause necessary action including disconnection of municipal water supply in any non-occupied premises, where it is detected that there is illegal drawal of water, or such premises is causing contamination of water supply lines, or is otherwise causing interference in the municipal water supply network in any manner; and may take penal action for such violations as prescribed. Any additional expenses due to damage caused by any of the above circumstances, or for the restoration of water supply, incurred by the Municipality shall be recovered from the persons causing such damage.
(4) The Commissioner or any person authorized by him/her, may cause disconnection of Municipal water supply to any premises for non-payment of outstanding dues to the municipality, by the owner or occupier, till such dues are paid by him:
Provided that the Municipality shall not be liable to pay any penalty or damages for disconnecting supply of water or for not supplying water, in the case of any drought, or other unavoidable circumstances.
118. Certain prohibitions to maintain water supply.- (1) No person shall,-
(a) trespass on any premises connected to and are used for water supply;
(b) allow water to be wasted, or allow the pipes, works or fittings, for the supply of water in his/ her premises to be out of repair causing thereby waste of water;
(c) draw off, divert, or take water from any waterworks belonging to, or under the control of, the municipality, or from any watercourse or stream by which such water is supplied;
(d) unlawfully break, obstruct or otherwise cause any damage to any public channel, tank, reservoir, cistern, well, fountain or stand pipe, or divert water or opens or removes any lock, cock or pipe belonging to water supply or under the management or control of the Municipality.
(2) The Municipality shall impose fine and / or initiate penal action as prescribed against anyone found violating under this section.
PUBLIC DRAINAGE AND SEWERAGE
119. Public drains to vest in the Municipality.- (1) All public drains, alongside or under public street, or located elsewhere, all sewerage collection works existing in the Municipality, whether constructed by the Municipality or by the Government or otherwise, and all works, materials and things appertaining thereto, situated in the Municipal area, shall vest in the Municipality.
(2) For the purpose of enlarging, deepening or otherwise repairing or maintaining any drain as aforesaid, so much of the sub-soil appertaining to the drain as may be necessary, shall be deemed to vest in the Municipality.
120. Responsibility of the Municipality for drains, storm water drains and other such works.- The Municipality shall,-
(a) provide and maintain a sufficient system of public drains in its jurisdiction;
(b) prepare a map for drains, storm water drains and sewerage network in its jurisdiction capturing all existing facilities, missing gaps and additional requirements therein, and give importance to missing gaps and additional requirements for their improvement while preparing annual budget;
(c) prepare an annual plan, and maintain the upkeep of all drains by undertaking the cleaning and de-silting drains regularly, and be ensured that the de-silted material is not mixed with municipal solid waste, and is processed separately as Soil Compost:
Provided that the Municipality shall have power to acquire land wherever required for construction of public drain, storm water drain, and long sewerage network in the Municipality.
121. Prohibitions regarding drains and sewage lines.- No person shall,–
(a) unlawfully obstruct the flow of or divert any drain or sewerage belonging to the Municipality;
(b) throw any material including plastic bags and containers, or any waste of animals, into any municipal drain or sewer;
(c) erect or rebuild any building or fence over any drainage, storm water drain, or sewerage-line in the Municipality; and
(d) discharge trade effluent into any municipal drain from such trade premises without approval of the Municipality in accordance with the regulations made thereunder, or any other law for the time being in force.
The Municipality shall impose fine and initiate penal action against anyone violating under this section.
HEALTH AND SANITATION
122. City Sanitation Plan.- The Municipality shall prepare a City Sanitation Plan, which, inter-alia, shall include, ward-wise and Municipality wise plan, for the collection, segregation, transfer and processing of waste, in a manner that 100% municipal Solid Waste is lifted on a daily basis.
123. The responsibility of individuals to segregate waste.- (1) It shall be the responsibility of every individual household or user, whether domestic or non-domestic, to segregate the solid waste at source, and hand-over such segregated waste to the Municipality.
(2) If any household or premises fail to comply with the sub-section (1), the local authority shall cause segregation of the same and collect the cost thereof from the occupant of the premises, as applicable.
124. The responsibility of Municipality to collect segregated waste.- (1) It shall be the responsibility of the Municipality or any agency authorized by it, to ensure collection of the solid-waste, in accordance to plans prepared by the Municipality, and by collecting requisite charges as prescribed.
(2) It shall be the responsibility of the elected member of the ward as well as the officer concerned, to ensure segregation of waste at source, and to ensure that the garbage is collected on a regular basis.
125. Making arrangements for collection of waste.- The Municipality shall make adequate arrangements for,–
(a) collection of segregated solid waste from all residential and non-residential premises, separately;
(b) regular sweeping and cleaning of the streets, and removal of waste material generated;
(c) removal of filth, and carcasses of animals from any premises;
(d) collection, safe-keep, transportation and disposal of Municipal solid waste in a manner, including the establishment of Dry Resource Collection Centers, as per the waste disposal rules and guidelines of the Government.
126. Responsibilities of the Management of the Gated Communities, Apartments, etc.- It shall be the duty and responsibility of Resident Welfare Associations (RWAs) and the associations managing gated communities, apartments, other residential, and non-residential building complexes, to segregate the garbage at source, to provide in their premises community bins, or any other facility as prescribed by the Municipality and to ensure that the garbage is lifted daily by paying user charges as prescribed.
127. Management of Dump yards. (1) It is the responsibility of the Municipality to process the entire municipal Solid Waste collected duly segregating and using scientific management including bio-mining, bio- processing or any other technology as prescribed by the Government or any of its agency.
(2) All existing dump sites will be processed in a scientific manner, either using scientific capping or other techniques, as specified in Central and State Government guidelines from time to time.
(3) The Municipality may identify the lands, which are at a reasonable distance from densely populated areas, for the purpose of setting up of the future dump sites. If such land for the purposes of this sub-section is not available with the Municipal Authorities, it shall be the duty of the District Collector to provide the municipal authorities with appropriate land from amongst land under his control.
128. Compost Yards.- The municipality shall,-
(a) encourage and strive to have number of compost yards wherever possible;
(b) make efforts to have in-situ composting in public places, including identified parks, apartments, commercial complexes, function halls and other such public places;
(c) ensure that the respective building associations install composting units within their premises.
129. Bio-Medical Waste.- It shall be mandatory for all nursing homes, hospitals, clinics, labs and Para-medical Hospitals to segregate their bio-medical waste and arrange for its collection and transportation to the designated facilities, in accordance with Biomedical Waste Rules framed by the State or by the Central Government or by any agency authorized on their behalf. The Municipal Commissioner, in consultation with the health and pollution control authorities, and under the superintendence of District Collector shall initiate necessary action against such violators.
130. Hazardous waste. (Central Act 29 of 1986.)- It shall be the duty of the Municipality, either on its own or through any other agency authorized by it in this behalf, to implement the provisions of the rules made by the Central and State Government in exercise of the powers conferred by the Environment (Protection) Act, 1986 to regulate the management, and handling of hazardous wastes to the extent such rules apply to the Municipality.
131. Food safety and standards. (Central Act 34 of 2006.)- It shall be mandatory for all hotels, restaurants, canteens, cafeterias, function halls, hostels, mess or any other establishment serving food to either the general public or to any captive population to ensure that the food served is strict compliance of Food Safety and Standards Act, 2006 and rules framed thereunder. The Commissioner in consultation with District Collector shall initiate necessary action against anyone found not following the required norms or having furnished false certification.
132. Construction and Demolition Waste.- (1) The Municipality may handle the Construction and Demolition Waste and identify suitable places for its disposal and processing.
(2) Wherever a processing facility for Construction and Demolition waste is created, the Municipality may engage an Operation and Maintenance partner to operate the facility in accordance with the rules in force.
(3) The onus, to get the Construction and Demolition waste collected is on the person generating, and such a person shall pay to the municipality for the cost of its disposal, in the manner prescribed.
(4) The Municipality shall have the powers to levy and collect penal charges from the individuals or institutions, causing or said to have caused un-safe, improper and unauthorized dumping, of Construction and Demolition waste in places other than the designated places, and at the rates prescribed.
133. Municipal Waste Management.- The Government may set up a specialized body corporate either stand alone or under the superintendence of Commissioner and Director of Municipal Administration to,-
(a) bring in focused institutional attention to scientific waste management including solid & liquid waste and construction and demolition waste and management of dump sites and proper disposal;
(b) take every action including utilizing the services of subject experts, raising of resources, use of appropriate technology, hand holding the municipalities, and take all such actions for any other purposes as deemed appropriate to achieve the objectives of waste management.
AVAILABILITY OF PUBLIC CONVENIENCE OR RESTROOMS
134. Public Convenience.- The Municipality shall cause, either directly or indirectly, provisions to have sufficient number of public convenience places and facilities, including restrooms, urinals, washrooms, child- feeding centers and shall have mechanisms in place for their regular maintenance and up keep.
135. Free access to public convenience facilities.- Non-residential premises which are accessible to the general public by nature of their trade or activity, shall compulsorily provide public convenience facilities for use by the general public. Such non-residential premises shall include, but not limited to, petrol bunks, restaurants, hotels, shopping malls, cinema halls, educational institutions, and any other such non-residential premises or any other such premises and categories as may be prescribed by Government. The Commissioner shall act against any violation of this section in the manner prescribed. All new construction in these categories shall carry this provision.
136. Provision of sufficient number of rest-rooms and toilets.- The Municipality and Municipal Commissioner, on suo- moto or based on the complaint received, shall cause the owner or the user of the particular building to provide, alter, upgrade, add rest rooms and toilets including urinals as the case may be, and shall take necessary action in case of noncompliance in the manner prescribed.
PUBLIC STREETS
137. Barring obstruction in the public road.- No person shall build any wall or erect any fence or cause any other obstruction or projection or make any encroachment in or over any public road, except as hereinafter provided,-
(a) no door, gate, extension of any structure whatsoever, or ground floor window, shall, be hung or be placed so as to open upon any public road, without a license from the authority;
(b) the Municipal Commissioner may require the owner or occupier of any building to remove or alter any projection, encroachment, or obstruction, situated against or in front of such building, and in or over any public road vested in the Municipality.
138. Temporary permissions in public places.- (1) The Municipal Commissioner upon receipt of any request for temporary permission, may grant a temporary license, for a period not exceeding 15 days, for erection of temporary shamiana or pandal, or any other structure on the public road or open land vested with the Municipality, duly ensuring that such erection does not cause any public inconvenience and traffic obstructions, and the temporary license so granted shall include such terms and conditions including timings and charges in the manner prescribed by the Municipality. Damages, if any, caused to the public street or to open space, etc., shall be duly recovered in the manner prescribed by Government.
(2) The Government may, by notification, restrict and place under such control as deemed appropriate for the exercise of powers under sub-section (1), by the Municipality.
139. Penal action for damage of roads.- (1) No person shall cause any damage to the roads, footpaths, road margins in any manner whatsoever. Any violation thereof shall attract appropriate action, including penal action. The amount as required to repair the said damage shall be recovered from the said person in the manner prescribed.
(2) No person shall plant any tree on any public road, or other property vesting in or belonging to the Municipality, except with the previous permission of the Municipal Commissioner, and on such conditions as may be imposed.
(3) No person shall fell, remove, destroy, lop or strip bark, leaves or fruits, from, or otherwise damage any tree vesting in or belonging to Municipality or Government, except with the previous permission from the Municipal Commissioner or competent authority, and on such conditions as the Municipality may impose.
140. Naming of the Public Street.- The Municipal Council shall give names to public streets and parks, play grounds or any municipal property with the approval of the State Government.
141. Acquisition of Land and Buildings for Improvement of Streets.- The Municipality may,-
(a) acquire any land, and buildings if any standing upon such land, required for the purpose of widening, diverting, opening, extending, or otherwise improving any public street in any manner deemed fit and necessary, or of creating any new public street;
(b) acquire any land for the purpose of creating public parking places, and may collect the parking charges for the providing such facility;
(c) pay such reasonable compensation as prescribed, to the owners of any land or buildings, which are acquired for, or affected by any such purposes.
142. Traffic Engineering Schemes.- Subject to the provisions of this Act, the Municipality may, either on its own or through any other agency authorized by it in this behalf, as and when necessary, having regard to the abutting land uses and traffic flow patterns, implement traffic engineering schemes to ensure public safety, convenience and expeditious movement of traffic, including pedestrian traffic.
143. Creating Infrastructure for Pedestrians and Bus Stops.- Subject to the provisions of this Act, the Municipality may, either on its own or through any other agency authorized by it in this behalf, from time to time, cause various items of street Infrastructure, including street furniture, rest places, fences, guard-rails, traffic lights, traffic signs, street markings, median strips, bus stops, and any other item to be installed or done, and shall cause them to be maintained so as to ensure public safety and convenience, and expeditious movement of traffic including pedestrian traffic and safe crossing of roads.
STREET LIGHTS
144. Street lights.- The Municipality shall,-
(a) take all necessary measures for lighting in a suitable manner at all public streets, parks, places of public congregation under its control and other such places, as prescribed; and
(b) procure, erect, maintain and replace such number of lamp-posts and other appurtenances, as may be necessary, for the said purpose.
145. Prohibition of removal of lamps and damages of poles, etc.- (1) No person shall, without lawful authority, take away or willfully or negligently break or damage, in any other manner whatsoever,-
(a) any lamp or any appurtenance of any lamp, or lamp post, in any public street or any public place;
(b) any electric wire for illuminating such lamp;
(c) any post, pole, standard, stays, strut, bracket or other contrivance for carrying, suspending or supporting any electric wire or lamp;
(d) or cause any obstruction by blocking the right of
way.
(2) No person shall willfully or negligently extinguish the light of any lamp set up in any public street or any public place.
(3) If any person willfully or through negligence or accident breaks or causes any damage to any of the things described in sub-section (1), he shall, in addition to any penalty and/or to the penal charges, to which he may be subjected under this Act or any other law in force, pay the expenses of repairing the damages so caused by him.
PUBLIC MARKETS
146. Public Market.- (1) The Municipality shall maintain public markets at locations, enabling maximum public convenience. The markets shall have sufficient ventilation, up-keep, cleanliness, lighting and separate market/sections for vegetarian and non-vegetarian produce.
(2) The Municipality may provide sufficient parking space, sanitation, hygiene, water supply facilities, and public convenience while constructing new public markets henceforth.
(3) The Municipal Commissioner may prohibit by public notice, or regulate by license, the sale or exposure for sale of any animals or articles in or upon any public road or place or part thereof.
147. Allotment of Municipal Shops.- (1) The Municipality shall allot shops on rental basis through public auction to the eligible persons duly collecting the rent, for a specified period with a provision to renewal with due increase in the rent, subject to fulfillment of conditions, as prescribed.
(2) The Municipality shall cause vacation of such shops for violation of allocation terms and conditions including non-payment of rent and non – keeping up shop premises in the manner prescribed or utilization for other purpose or sub-letting. No court shall have jurisdiction over any matter for which provision is made under this section.
148. Permission for private markets.- No person shall open a new private market or continue to keep open a private market, including a temporary market, without obtaining the requisite permission from the Municipality in the manner prescribed by the Government.
VAIKUNTADAMAM (CREMATORIUM) AND BURIAL GROUNDS
149. Vaikuntadamam (Crematorium) and Burial Grounds.- (1) In order to provide dignity and respect to the departed soul, the Municipality shall provide, maintain and upgrade at least one vaikuntadamam (crematorium) or burial ground, and have all modern facilities.
(2) The Municipality may also strive to upgrade all existing and registered smashanavatikas or burial grounds or Crematoriums.
(3) The Municipality shall arrange at least one Vaikunta Ratham (vehicle) or its equivalent for the transportation of the deceased, either with Municipal Fund or with the assistance of others.
(4) Every owner or person, having the control of any place used at the commencement of this Act, being used as a place for burying, cremating or otherwise disposing of the dead, shall, if such place was not already registered under any law applicable thereto, apply to the Municipality to have such place registered under this Act, failing which it shall be construed as an offence under section 268 of the Indian Penal Code.
(5) If it appears that there is no owner or person having the control of such place, the Municipality shall assume such control and register such place or may close it.
(6) No new place for the disposal of the dead, whether private or public, shall be opened, formed, constructed or used unless a license is obtained in the manner prescribed by the Municipality.
150. Maintenance of records of Vaikuntadamam (Crematoriums) and Burial Grounds.- (1) The Municipality shall maintain the record in which all the places registered, licensed or otherwise authorized under the section 149, and all such places so registered, licensed or authorized under the previous Acts and before the commencement of this Act, shall be recorded therein.
(2) A notice in the local language of the town, that such place has been registered, licensed or otherwise authorized as aforesaid, shall be conspicuously affixed on or near the entrance to such place.
(3) The person having control of a place for disposing-of the dead, shall maintain and provide information of every burial, cremation or other disposal of a corpse at such place and time, in such manner, to appropriate authority appointed by the Municipality.
151. Identification of alternative site for grave yards.- (1) The Municipality, if it is satisfied that any registered or licensed place for disposal of the deceased is or is likely to become dangerous to the health of persons residing near any burial ground, may identify alternative site for the said purpose within the given time-frame as prescribed.
(2) No person shall, in contravention of any notice under this section and after the expiration of the period specified in such notice, bury, burn or otherwise dispose of, or cause or permit to be buried, burnt or otherwise disposed of, any corpse at such place. Any violation of this sub-section is liable for punishment, as may be prescribed by the Government.
SLAUGHTER HOUSE
152. Slaughter Houses.- (1) Subject to such rules as may be made by the Government, every Municipality may designate places for use as public slaughter houses, and charge rents and fees for the places so designated.
(2) If such land for the purposes of the sub-section (1) is not available with the Municipal Authorities, it shall be the duty of the District Collector to provide the municipal authorities with appropriate land from amongst land under his control.
(3) The Municipality shall, in consultation with District Collector and Commissioner and Director of Municipal Administration shall make efforts to modernize all existing slaughter houses in a time bound manner.
(4) The municipality shall,-
(a) prohibit or regulate the slaughter, cutting up or skinning of animals specified in the rules, on all occasions not excepted therein at places other than public or licensed slaughter houses;
(b) license persons to slaughter animals for purposes of sale to the public; and
(c) cause regular inspection of slaughter-houses, and of the meat therein, and the payment of remuneration to the officers employed for such inspection.
(5) The Municipal Commissioner shall notify, in the manner prescribed, that no place within the limits of the town shall be used for anyone or more of the purposes specified in the rules made in this behalf without a license issued by the Municipality in the manner prescribed and accepted in accordance with the conditions specified in such license.
(6) Appeal against the rejection of license shall lie with the District Collector.
CONTROL OF INFECTIOUS DISEASES
153. Prevention of infectious diseases.- (1) It shall be the duty of the Municipality to take such measures as are necessary for preventing, or checking the spread of, any danger, or of any epidemic, or those caused by any animals therein in the Municipal area.
(2) The Municipality shall exercise its powers for prevention of infectious diseases in its jurisdiction in the manner prescribed by the Government.
154. Public health surveillance programmes.- The Municipality may take up public health surveillance programs or undertake epidemiological investigations or surveys of the people in the Municipal area in coordination with the Medical and Health Department as prescribed by the Government to determine the existence, prevalence or incidence, or to determine the likelihood of a possible outbreak of,-
(a) any infectious disease; or
(b) any other disease, declared by the Government.
155. Steps to be taken on out-break of infectious diseases.- (1) In the event of the prevalence or threatened out- break of any infectious disease in the municipal area, or of any unusual mortality therein, the Municipality shall in coordination with district administration and Medical and Health Department of the Government provide such staff, medicines, appliances, equipment and other things, that in the opinion of the Government, are necessary for the treatment of such infectious disease and preventing it from spreading.
(2) The Municipal Commissioner may inspect any place in which any dangerous disease is reported or suspected to exist, and shall take such measures, as he/she thinks fit to prevent the spread of such disease, under intimation to the Government.
156. Principles to control of infectious diseases.- The Municipality shall follow the advice and directions of Medical and Health Department of the Government and District Collector and shall initiate all necessary steps as required including sanitation, proper hygiene and other such measures as under its control to ensure control of infectious diseases.
157. Eradication of Mosquitoes and prevention of their breeding.- The Municipality shall take all adequate measures, including spray of anti-larva liquids or use of Gambusia fish or take any other measures, for control of mosquito growth, and to formulate and execute schemes to prevent mosquito breeding.
158. Trade License for carrying out trade.- The Municipality may publish a notification specifying conditions and required certificates including no objection certificates from the required agencies such as pollution control board, and in the prescribed manner for the purposes for conducting any trade in the Municipality. The request for the license along with required documents as prescribed shall be made online and issued accordingly. A fine of 25 times shall be levied in case it is found that self certification was done wrongly with malafide intention.
MANAGEMENT AND CONTROL OF ANIMALS
159. Management of domestic animals or pets.- The Municipality may take appropriate measures for proper management of animals in its jurisdiction so as,–
(a) to promote public education on pet ownership, and responsibilities of the owners;
(b) to take necessary steps for registration of pet animals and issue guidelines for their care and vaccination;
(c) to ensure that no person shall feed or permit any animal, which is kept by him/her for dairy purpose or which may be used for food, to be fed on filth;
(d) to ensure that no person shall keep any animal on his/her premises so as to cause nuisance or danger to any person in his/her neighborhood;
(e) to take action on the persons who are cruel against animals in any manner, as per the provisions of the Prevention of Cruelty to Animals Act, 1960.
160. Control of animals.- (1) The Municipality may take necessary measures to reduce stray animal population in the manner prescribed, and make arrangements so that un-licensed pigs, dogs or any other domestic animal are not left unattended, staying within the Municipality are to be handed over to the Animal Protection Committees or any other agency.
(2) Whoever keeps any pigs, dogs or any other domestic animal in any place within the municipal limits without permission or otherwise than in accordance with the terms thereof, shall be punished with fine as may be prescribed by the Government:
Provided that if there is a situation which leads to endangering of human life or outbreak of epidemic diseases, or a situation leading to such outbreak due to proliferation of stray dogs, pigs, or any other animal, the Commissioner shall take suitable action to restrain such animals in the manner as may be prescribed.
PROHIBITION OF NUISANCES
161. Prohibition of Nuisances.- (1) The Municipality shall take steps to remove, put down and abate all nuisances affecting public peace, tranquility, public safety, public health, morals and decency within its jurisdiction on public or private premises, and may proceed at law against any person committing any such nuisances for the abatement thereof and for damages.
(2) No person shall,-
(a) unauthorizedly affix upon any building, monument, post, wall, fence, tree or other public place, any bill, notice or other document, or
(b) deface, or write upon, or otherwise mark on any building, monument, post, wall, fence, tree or other public place, or
(c) litter the public places, streets, roads, parks, playgrounds and other such places, or
(d) carry rubbish, filth or other polluted and obnoxious matter along any route in contravention of any prohibition made in this behalf by the authority, or
(e) bury or cremate or otherwise dispose of any corpse at a place not licensed for the purpose, or
(f) disturb public peace or order in violation of sound pollution control, or
(g) cause pollution of air in violation of air pollution control order, if any, or
(h) cause obstruction to the movement of vehicular or pedestrian traffic without permission from the competent authority, or
(i) affix indecent or obscene pictures or printed or written matter or any poster, bill, notice or other paper or means of advertisement against or upon any street, building, wall, tree, board, fence or pole or writes upon, spoils, defaces or marks any such building, wall, tree, board, fence or place with chalk or paint or any other way whatsoever, or
(j) quarry, blast, cut timber or carry on building operations in such manner as to cause, or likely to cause danger to persons passing by, or dwelling or working in the neighborhood.
(3) Any person who fails to comply with any order under this sub-section shall be liable for fine in addition to penal action, as prescribed.
ENVIRONMENTAL MANAGEMENT
162. Control of pollution.- Subject to the provisions of any law relating to air, water or noise pollution, for the time being in force, and in accordance with any notification by the State Government in that behalf, the Municipality may function as a competent authority for the enforcement of such law:
Provided that recovery of charges and imposition of penalty, is levied on those persons who are directly responsible for causing pollution of any kind referred above as prescribed by the Government.
DISASTER MANAGEMENT
163. Management of disaster. (1) The municipality shall, as far as possible, in collaboration with the concerned authorities of the Central Government or the State Government, including the meteorological office, prepare environmental base maps on emergency and disaster management and impact area diagrams, and shall collect other relevant data and take necessary steps for erecting installations and other accessories required to mitigate the effects of any disaster.
(2) The Municipality may organize emergency operations, and promote public awareness in relation to disaster management.
(3) The Municipality may take adequate measures to implement the regulations, if any, made by the Government to mitigate the effects of disaster, and promote citizen awareness in this regard.
(4) The Municipality shall prepare a Fire-hazard Response and Mitigation Plan every year as prescribed by the State Government through consultative process.
(5) A fire and safety audit shall be carried out in places of public congregations including religious places, schools, cinema halls, commercial complexes and schools in the manner prescribed and the report shall be uploaded in public domain. The municipality shall give directions to the concerned to carry out rectifications wherever necessary and in the manner prescribed.
164. Ensuring safety of engineering staff and workers.- (1) The Municipality shall ensure the safety of the engineering staff, construction workers, and persons engaged in carrying out all engineering works, by ensuring that they are provided with safety equipment, and that they carry out works with safety norms as prescribed.
(2) This provision shall also apply to works which are carried out by contractors and other private agencies on behalf of municipalities, and such works also include sanitation, sewerage, water supply and waste management.
VITAL STATISTICS
165. Registration of births and deaths and their reporting.- (1) All Births and deaths registration in the municipality, subject to the provisions of the Registration of Births and Deaths Act, 1969, is compulsory and it shall be the responsibility of the Authority to ensure cent percent registration in the manner prescribed. The information will be captured, documented and be reported to the Government in the manner prescribed.
(2) The Municipal Commissioner or any other officer authorized shall be the Chief Registrar of Births and Deaths occurring in the Municipal area.
(3) The Municipal Commissioner shall appoint such number of persons to be Registrars of Births and Deaths as he deems necessary and shall define the respective areas which shall be under the charge of such Registrars.
(4) Details of all births and deaths shall be available in public domain and required certificate can be obtained in the manner prescribed.
166. Registration of name of child or of alteration of name.- When the birth of any child has been registered without a name, and when a name is given to it, or, the name, if any, by which it was registered, is to be altered, the parent or the guardian of such child or other person giving the name or proposing to alter the name may, within the time frame and in the manner as prescribed enter the name mentioned as having been given to the child or altered.
167. Correction of errors in registers of births or deaths.- (1) Any clerical error, which may, at any time, be discovered in a register of births or register of deaths, may be corrected by any person authorized in this behalf by the Municipal Commissioner.
(2) An error of fact or substance in any such register if occurred due to typing or clerical mistake, may be corrected by any person authorized as aforesaid by entry in the margin, without any alteration of the original entry, upon request by the concerned without insisting on any declaration by the Municipal Commissioner or the person requiring such error to be corrected.
(3) Correction or change of details, if any, from original application shall require a declaration (setting forth the nature of the error and the fact of the case) on oath made before a Magistrate, by the person required by this Act to give information concerning the birth or death with reference to which the error has been made or, in default of such person, by a person having knowledge of the case.
(4) Except as provided in sub-section (2), no alteration shall be made in any such register.
168. Information of births.- It shall be the duty of the father or the mother of every child born in the municipal area and, in default of the father or the mother, of any relative, of the child living in the same premises and, in default of such relative, of the person having charge of the child, to give, to the best of his or her knowledge and belief, to the Registrar of the area concerned within eight days after such birth, information containing such particulars as may be prescribed in this behalf.
169. Information regarding deaths.- It shall be the duty of the nearest relative present at the time of the death or in attendance during the last illness of any person dying in the municipal area and, in default of such relative, of any person present or in attendance at the time of the death and of the occupier of the premises in which, to his knowledge, the death took place and, in default of the person as aforesaid, of each inmate of such premises and of the caretaker or other person causing the corpse of the deceased person to be disposed of, to give, to the best of his knowledge and belief, to the Registrar of the area within which the death took place information containing such particulars as may be prescribed within twenty-four hours of such death:
Provided that,–
(a) if the cause of death is known to be a dangerous disease, the information as aforesaid shall be given within twelve hours of its occurrence, and
(b) if the death of any person occurs in a hospital or a nursing home or a maternity home, it shall be the duty of none but the medical officer or other officer-in-charge thereof to forward forthwith a report of such death in such form as the Chief Registrar may, from time to time, specify.
170. Duties of police in regard to unclaimed corpses.- It shall be the duty of the police to convey every unclaimed corpse to a registered burial or burning ground or other place for disposal of the dead or to a duly appointed mortuary and, thereafter, to inform the Registrar within whose jurisdiction such corpse was found.
CHAPTER V TOWN PLANNING
171. Planned Development.- (1) There shall be, in every Municipality, and in a defined time frame, a Master Plan comprising of a detailed planning scheme, land pooling scheme, local area plan having components of Water Supply Network Plan, Drainage and Sewerage Plan, Sanitation Plan, Urban green spaces Plan, and Traffic & Transport Plan as prescribed in the Telangana Town Planning Act, 1920 and the Telangana Urban Areas (Development) Act, 1975 and such a plan shall be the guiding principle for overall development of the town.
(2) For securing planned development of areas in Municipalities, a Detailed Planning Scheme or Local Area Plan shall be prepared for specific areas as identified and notified, and as prescribed in the Telangana Town Planning Act, 1920. Detailed Planning scheme shall be prepared in conformity with Master Plan or Indicative Land Use Plan, if any, and shall have ecologically sensitive areas earmarked, and shall have detailed Road Network Plan, Urban Green Spaces Plan, Drainage Plan, Water Trunk Lines, Rain Water Harvesting Structures and Solid Waste Management among the other as prescribed.
DEVELOPMENT OF LAND AND CONSTRUCTION OF BUILDING
172. Development of Land and Making of Layout.- (1) Any individual or developer intending to develop a layout shall duly providing infrastructure and other amenities within the timeframe as prescribed, and pay the layout fee, development charges and other fees, as prescribed apply for its approval online in a manner prescribed and get it approved.
(2) The layout owner shall reserve certain percentage of the land towards open space, parks, playgrounds, common parking place and social infrastructure for Solid Waste Management in the layout, as prescribed.
The common parking area shall be developed by the developer for the said purpose only.
(3) Certain percentage of plotted area, as prescribed, for an amount equivalent to carrying out infrastructure works, shall be mortgaged with the municipality and shall be released upon completion of all infrastructure and amenities and other works, as stipulated and certified in the manner prescribed.
(4) All the layout proposals shall comply and conform to the Master Plan and Detailed Planning Scheme or Local Area Plans regarding land use, road network and reservation of land for public purpose.
(5) The applications for Layouts will be processed through the Self-Certification System in accordance with the Layout rules, and as notified in the Master Plan or Detailed Planning Scheme or Local Area Plan, in the manner as prescribed. Once all requisite documents are submitted and required fee is paid through a web-based online system, the Tentative Layout Plan shall be approved within a period of 21 days and will be communicated online in order to carry out the infrastructure activities and provision of amenities in the defined time frame.
(6) There shall be a District Level Committee which will verify, in the manner prescribed, the actual development and implementation of the layout and whether it is in conformity with the tentative layout approval as given in sub- section (5).
(7) The Owner or Developer of the layout sanctioned, shall complete the infrastructure and amenities and other works within a period of two years from the date of approval of the Tentative Layout Plan.
(8) If the developer fails to execute the required works within the said time period, the Commissioner shall get the left-over works executed within a year from the time of default, and shall meet the expenses incurred for executing such works by selling mortgage plots for an equivalent value. In such an eventuality, the owner or developer shall be blacklisted in the manner as prescribed, and shall not be allowed to undertake any further layout development works in the entire State, either individually or in partnership or in any other manner.
(9) The Government may constitute a Layout Approval Committee for every district under the chairmanship of District collector with Superintendent Engineers or Executive Engineers of Roads and Buildings Department, Panchayati Raj Department and Irrigation Department to process the application for Approved Layout Plan, in the manner as prescribed.
(10) All Roads and Open Spaces, such as Parks, Open Spaces and Playgrounds, common parking area and other such open spaces as earmarked in a Layout, shall be registered, free of cost and free from all encumbrances, in the name of municipality, and shall vest with the Municipality. The Commissioner shall maintain a record of all such Open Spaces vested with the Municipality.
(11) Upon completion of the layout, the owner or developer, shall submit online application along with the Self Certification duly attested by Licensed Technical Personnel, in a manner as prescribed declaring that the development in the layout is as per norms. The developer shall also register all the roads and open spaces in the layout in favor of Municipality. This is a pre-condition to be eligible to get the final layout approval. Based on the Self Certification of completion and upon registering the open spaces including roads in favor of the municipality, the approved layout plan shall be processed and approved by the layout approval committee constituted under sub- section (9) and shall be issued online to the developer.
(12) The Municipal Commissioner, after the issue of the approved layout plan under sub-section (11) of this section, shall release the area mortgaged within 21 days in the manner as prescribed.
(13) The Developer or Occupiers of all Unapproved or Unauthorized Layouts, as on the date of commencement of this Act, shall apply to the Commissioner within a year and shall cause or carry out necessary development in the manner and within the specified time period as prescribed. Failure to comply this will make these layouts unauthorized, and the Commissioner shall provide any amenity, as required, on a cost basis.
(14) Any transaction involving land that is a part of the earmarked open space or set apart for public purpose, shall be illegal, and any owner or developer who sells or claims such land for any use shall be penalized and punished, in the manner prescribed, including imprisonment for a period not exceeding three (3) years.
(15) In case, the layout was obtained by making a false statement or misrepresentation of any material facts, the same shall be revoked as per the procedure as prescribed.
(16) No new plot or sub-division shall be registered by Registration Authority unless it is approved by the authority as per the provisions of this Act.
(17) The official concerned, who fails to take necessary action within the prescribed period, shall be liable for disciplinary action in the manner prescribed.
(18) Any person or developer who takes up unauthorized development of land without obtaining necessary permission, shall be liable either for punishment with imprisonment for a term which may extend to three years, or with fine which may extend to twenty five percent (25%) of the value of land in question as fixed by the Registration Department at the time of using the land.
(19) Government may constitute special task force at the District level to take action against unauthorized layouts in the manner as prescribed. The special task force at District level shall inspect the unauthorized layouts and take action against all such unauthorized layouts.
173. Integrated Townships.- (1) It is desirable that municipalities undertake appropriate measures to have planned growth in the municipality. One of the ways of systematic development is to encourage the self contained townships based on the “walk to work” concept wherein the distance between the work place and residence is minimized. This also will bring down pressure on roads and will also have more productive time available with people. The State shall promote comprehensive integrated townships prescribing minimum threshold area.
(2) The integrated townships will act as a hub containing residential, office space, commercial, entertainment and services, as prescribed and with planned infrastructure in place.
(3) A set of appropriate incentives aimed at encouraging builders or developers to develop such integrated townships may be provided by the Government.
174. Approval of Building Permissions. No piece of land shall be used as a site for the construction of a building, and no building shall be constructed or reconstructed, and no addition or alteration shall be made to an existing building without the self certification based declarations or the required approval in the manner prescribed, relating to the use of building sites or the construction or reconstruction of buildings:
Provided that the Government may exempt certain buildings from taking building permission under this section, as in the manner prescribed.
(1) For plot size upto 75 square yards (63 square meters), and the construction of ground or ground plus one floor, will not require any permission; the applicant however need to register online with a token amount of Rs.1 and duly self certifying to this effect regarding the size of the plot and floors; it shall also not require a completion certificate or occupancy certificate. Any plot bigger than 75 sq yards cannot be split for this purpose or this provision cannot be misused for taking up constructions in Government or prohibited or disputed land and action as prescribed shall be initiated for violations noticed.
(2) Plot size upto 500 square meters and height upto 10 meters: The permission applications for all the individual residential buildings having plot area of 500 square meters and less and building height of 10 meters as specified, shall be processed through an online based Self-Certification System in accordance with the Master Plan or Detailed Planning Scheme or Local Area Plan and the building rules and in the manner prescribed, and upon furnishing all required information details shall get instant online approval.
(3) The onus to ensure authenticity of self-certification and compliance with the self-certification lies with the applicant, who shall be held personally accountable and liable in case of false declaration and action shall be initiated against the said person, as prescribed.
(4) The owner or developer shall along with the building application form, submit an undertaking that in case of any actual construction made by him or her in violation of sanctioned plan, the Government or the Commissioner or the Agency authorized by him or her shall take-up the demolition without issuance of any notice. Further, the District level committee may verify the documents so submitted, and in case of any misrepresentation or false statement, the action shall be taken as prescribed.
(5) Citizens shall be encouraged to bring to the notice of municipality and district collector cases where unauthorized construction or construction in violation of or in excess of permissions, in a manner prescribed. The identity of such informers shall be kept confidential. All such cases shall be examined within a week from such information and appropriate action initiated. The informant shall be incentivized in all such cases where the information furnished by him is found to be correct.
(6) Plot size above 500 square meters and height above 10 meters:- There shall be a single window system in case of applications for building permission in plots of area above 500 square meters and height above 10 meters and all Commercial buildings, High Rise Buildings, Group Development Schemes, Group Housing, Apartment Complexes, Multiplexes, non residential buildings and other such constructions, which require multiple NOCs, one common application form shall be submitted through web based online system as prescribed.
(7) The online application has to be submitted with all requisite documents as prescribed. The online system shall not accept the application unless all such documents are submitted. Such documents upon submission shall be examined by the single window committee set up for this purpose and shortfalls or incompleteness or cases where further information or clarification is needed shall be communicated to the applicant within the 10 days from the date of applying, in a manner prescribed.
(8) In all other cases, the applications for building permissions accompanied by all valid and required documents, as required and prescribed, shall be sanctioned within 21 days and in the manner, as prescribed.
(9) If no order is issued on the building application within the time prescribed, then the approval will be deemed to have been issued, as prescribed. The official concerned shall be liable for disciplinary action, if there has been a delay in arriving at a decision within the time period.
(10) The permission issued under deemed clause can be revoked by the commissioner within 21 days from the date of deemed approval if it is found that deemed approval has been obtained by misrepresentation of the facts or false statements, and/or against the building rules, regulations and Master Plan land use provisions.
(11) While examining the prima facie title, Municipal Commissioner may consult District Collector or Revenue Authorities to ascertain Government interest if any.
(12) The Building Permission Fees and other Charges shall be paid by the applicant, online at rates as prescribed by the Government from time to time.
(13) The applicant shall commence the construction work within 6 months from the date of issue of the Building permission, and shall complete the same within 3 years in case of Non-High Rise Buildings and within 5 years in case of High-rise Buildings. He shall also upload the pictures of commencement of construction within 6 months online.
(14) If the construction or reconstruction of any building is not completed within the specified period, the permission shall stand lapsed and a fresh application shall have to be made, duly paying the charges, as prescribed.
(15) Mortgage of certain percentage: The applicant is required to handover 10% of built up area in the ground floor or first floor or second floor as the case may be to the municipality by way of mortgage, as prescribed, before release of permission. The individual residential buildings in plots upto 200 square meters with a height upto 7 meters are exempted from this section.
(16) The area so mortgaged will be released on submission of completion certificate and Occupancy Certificate as prescribed.
175. Occupancy Certificate. (1) In case of non-high rise buildings constructed in plots above 200 square meters and less than 500 square meters, the Occupancy Certificate will be issued through online based on the Self Certification submitted by the Owner or Builder in the prescribed proforma duly attested by the Licensed Technical Personnel, stating that the building has been constructed as per the sanctioned plan and as per rules and regulations in force.
(2) The onus to ensure authenticity of self-declaration and compliance with the Self-Certification lies on the Owner, Applicant and Licensed Technical Personnel, who shall all be held personally responsible and accountable in case of false declaration, and the Owner, Applicant and the Licensed Technical Personnel will be liable for punishment as indicated in section 177.
(3) In case of High rise buildings and buildings constructed in plots 500 square meters and above the applicant shall submit online Self Certification in the prescribed proforma duly attested by the Licensed Technical Personnel, that the building has been constructed as per the sanctioned plan and as per rules and regulations in force and based on the Self Certification, Occupancy Certificate and mortgage shall be issued within 15 days from the date of receipt of application.
176. Preconditions for Building Permissions.- (1) If the proposal for Building Permission is affected by any reservation of land for Public purpose such as Road, Park, Nala Widening, Recreational on any other public person, as per the sanctioned Master Plan/ Detailed Town Planning Scheme/ Local Area plan, the said portion of the land shall be surrendered to local body free of cost and the applicant shall be compensated by the equivalent built up area in the balance portion of the land or by Transferable Development Rights as prescribed.
(2) If the construction or reconstruction of any building is not completed within the specified period, the permission shall stand lapsed and a fresh application shall have to be made, duly paying revised charges, as prescribed.
(3) All buildings of all sizes should have on-site treatment systems (septic tank with soak away / twin leach pit / decentralized treatment system / faecal sludge and septage) or connected to sewerage system, wastewater treatment and recycling system, as prescribed.
(4) Energy Conservation Building Code or Green Building Code or any other Energy and Water conservation measures as deemed appropriate by the State Government, shall be made applicable to buildings, as prescribed, on plots above certain size and/or built-up area beyond a certain area, as prescribed by the Government.
(5) Certain number of trees shall be planted in the open area in the plot where building is being constructed, as prescribed.
(6) It shall be mandatory to provide for the requisite parking place, while constructing, depending upon the use of building. Parking in buildings, places of public convenience, commercial complexes, cinema halls and other such places, as notified from time to time, shall be provided free of charge to the users, as prescribed.
(7) All parking places except individual independent / residential buildings shall be provided with Electric Vehicle Charging infrastructure.
(8) No external roof, veranda, wall of a building shall be constructed or reconstructed of grass, leaves, mats or other inflammable materials, except with the permission of the Commissioner.
(9) The Commissioner may revoke the Building permission whenever it is found that it was obtained by making false statement or misrepresentation of any material fact or violation of rules, by duly following the procedures, as prescribed.
177. Penalty for misrepresentation of the facts.- The onus to ensure authenticity of self-declaration and compliance with the self-Certification lies with the owner, applicant and Licensed Technical Personnel. He/she will be held personally responsible and accountable in case of false declaration, the applicant and the Licensed Technical Personnel will be liable for punishment which includes imprisonment up-to three years, levy of penalty, demolition or taking over or sealing of the property without any notice besides cancelling the Licenses of License Technical Personnel (LTP) and forfeiting the mortgaged plots in case of layout or mortgaged built up area flats in case of buildings.
178. Enforcement.- (1) Government may constitute special task force at the district level to detect and monitor the unauthorized constructions and take timely enforcement action in the manner as prescribed.
(2) Upon detection of construction or reconstruction of any building which has been commenced without obtaining the permission of Commissioner or carried out or completed otherwise than in accordance with the sanctioned Master Plan or Detailed Town Planning Scheme or Local Area Plan or in breach of any of the provisions of this Act, or any rule or regulation or bye laws made under this Act, the Commissioner or the Agency authorized by him shall take up the demolition of the unlawfully executed work and recover the cost incurred for doing so, from the owner.
(3) The Registration Authority shall not register any Building or Structure or part of the Building without the production of sanctioned plan approved by the Municipality.
(4) The electricity and water supply connection shall be given to buildings which have obtained necessary authorization in the manner as prescribed.
(5) During the construction of the Building the owner or Builder shall upload the photographs at different stages of the construction as prescribed.
(6) Whenever a complaint or case is brought by any Citizen regarding the unauthorized construction or constructions in deviation to the sanctioned plan as mentioned in section 174(5), it shall be examined within a week from its receipt and necessary action initiated.
(7) The Commissioner shall stop the construction or reconstruction of any building that endangers human life, after obtaining the safety report and causing due diligence from the appropriate authorities, as prescribed.
(8) The Commissioner shall take action on unlawful building, as prescribed and shall issue orders to vacate or demolish building in certain circumstances, as prescribed.
179. Town Planning Building Tribunal.- (1) The State Government shall appoint municipal building tribunal or tribunals herein after referred to in the section as “the tribunal” to hear and decide appeals arising out of matters referred to and to adjudicate the offences relating to contravenes of the provisions of the Act relating to building regulations and land development in sections 172 to 193 of this Act, in accordance with such procedure and to realize such fees or fines in connection with such appeals as may be prescribed.
(2) The Tribunal shall consist of a chairperson and such number of the other members not exceeding five as the State Government may determine. The members shall consist of judicial members and technical members. The technical member shall be a person who is working in the cadre of Director of Town and Country Planning in Telangana Town Planning service.
(3) The Chairperson or a judicial member shall be a person who is or has been a District Judge.
(4) The Chairperson and other members of the Tribunal shall be appointed by the State Government for such period and on such terms and conditions as the State Government may determine and shall be paid from the revenue of the State Government in the manner as prescribed.
(5) The Tribunal shall have an establishment consisting of such officers and other employees appointed on such terms and conditions as may be prescribed and the expenses of the tribunal shall be paid from the revenue of the State Government.
(6) No court shall have jurisdiction in any matter for which provision is made in this chapter for appeal to the tribunal.
(7) The Tribunal shall consist of one person only who shall be a judicial officer not below the rank of Subordinate Judge.
(8) The Tribunal shall have the same powers as are vested in a Civil Court under the Code of Civil Procedure, 1908.
(9) Each Tribunal shall have jurisdiction over such area as the State Government may, by notification, from time to time, determine.
(10) The Tribunal may, with the previous sanction of the State Government appoint such officers and staff as it considers necessary for carrying on its business, and the remuneration and other conditions of service of such officers and staff shall be as prescribed.
180. Penalties.- (1) Penalty for unlawful Buildings,-
Notwithstanding anything contained in this Act, any person who, whether at his own instance or at the instance of any other person or anybody including a department of the Government, undertakes or carries out construction or development of any law in contravention of the statutory Master Plan or without permission, approval or sanction or in contravention of any condition subject to which such permission, approval or sanction has been granted shall be punished with imprisonment for a term which may extend to three years, or either fine which may extend to twenty five percent (25%) of the value of land or building including land in question as fixed by the Registration Department at the time of using the land or building:
Provided that the fine imposed shall, in no case be less than fifty per cent of the said amount besides demolition of the building and recovery of demolition cost from the owner of the building.
(2) Penalty for parking violations,-
In case of buildings where the area earmarked for parking is being put to other use, the municipal commissioner shall levy a penalty on the Owner or Developer, which may extend to twenty five percent (25%) of the value of land or building including land in question as fixed by the Registration Department at the time of using the land or building:
Provided that the fine imposed shall, in no case be less than fifty per cent of the said amount as prescribed.
181. Power to seal unauthorized constructions / development or premises embers of Municipality.- (1) It shall be lawful for the Local Authority at any time, before or after making an order for the removal or discontinuance of any unauthorized development of construction under section 178, to make an order directing the sealing of such development or property, or taking the assistance of the police, for the purpose of carrying out the provision of the Act.
(2) Where any development or property has been sealed, the Commissioner may, for the purpose of removing or discontinuing such development or property, order such seal to be removed.
(3) No person shall remove such seal except,-
(a) under an order made by the Municipal Commissioner; or
(b) under an order of the Appellate Tribunal on the appeal made in this behalf.
182. Dangerous Structures, Precautions in case of dangerous structures.- (1) If any structure appears to the Commissioner to be in a ruinous state and dangerous to the passersby or to the occupiers of neighboring structures, he may, by notice, require the owner or occupier to fence off, pull down or repair such structures so as to prevent any danger therefrom.
(2) If immediate action is necessary, the Commissioner shall himself, before giving such notice or before the period of such notice expires, fence off, pull down or repair such structures or fence off a part of any street or take such temporary measures as he thinks fit to prevent danger and the cost of doing so shall be recoverable from the owner or occupier.
(3) If, in the opinion of the Commissioner, the said structure is imminently dangerous to the inmates thereof, he shall order the immediate help of any police officer.
183. Construction of Buildings for Public Worship.- No site shall be used for the construction of a building intended for public worship, if the construction of a building thereon will hurt the religious feelings of any class of persons or is likely to disturb the law & order situation.
184. Building Permission for Industries and Factories.- The Commissioner shall dispose of the building application for construction or establishment of any factory, workshop, work place, as listed and as per the provisions of the Telangana State Industrial Project Approval and Self Certification System (TS- iPASS) Act, 2014, through online mode, as prescribed.
185. Removal of Encroachments on Streets.- (1) All streets and roads vested in, or to be vested in, or maintained by Municipality, shall be open to all persons.
(2) No door, gate, bar, ground floor window or any other projections shall be hung or placed so as to open outwards upon any street, or causing of obstruction of any sort by anyone will not be permitted.
(3) The Commissioner shall cause to remove or alter any such projection, encroachment or obstruction.
(4) No decision made or order passed or proceeding taken, by the Commissioner effecting removal of encroachments, shall be called in question before a civil court in any suit, application or other proceeding, and no injunction shall be granted by any court.
(5) The Commissioner shall evict certain persons from municipal properties with the support of Police or enforcement team, as prescribed.
(6) The Commissioner shall remove unauthorized advertisement hoardings erected, exhibited or fixed or retained upon or over any land streets, building, wall, or structure, and shall collect removal of such hoardings and other such means of advertisements.
(7) If any obstruction is caused in any street by fall of trees, structures or fences, the owner or occupier of the premises concerned shall remove within 12 hours of the occurrence of such fall or within such period as the Commissioner shall by notice, allow or clear the street of such obstructions.
186. Protection of Water Bodies, Green Spaces and Heritage Structures / Areas.- (1) Water bodies and green spaces located within the municipal area shall be protected in the manner, as prescribed.
(2) Heritage structures or Areas or Precincts notified under Telangana Heritage (Protection, Preservation, Conservation and Maintenance) Act, 2017 shall be protected, conserved and maintained in the manner as prescribed in the said Act.
187. Usage of Toilet Facilities.- Restaurants, hotels, hospitals, shopping complexes, and places of public congregation and other such buildings or institutions as prescribed shall allow usage of toilet facilities to general public, specially women, aged people and children, in the manner prescribed.
188. Code of Conduct for Licensed Technical Personnel.- The Commissioner shall ensure an enforceable Code of Conduct to regulate certified Architects or Engineers and Licensed Technical Personnel (LTP). The licenses of LTP shall be cancelled and their name shall be blacklisted in case of misrepresentation or false statement or certification of drawings made in violation of Zoning Regulations and Building Rules.
189. Plan for Bus Bays and Waiting Arenas.- The Commissioner shall take all steps to provide for bus bays and waiting arenas scientifically so that they do not cause traffic obstruction.
190. Safety of pedestrians.- The Commissioner shall initiate all necessary measures to cause ease and convenience for pedestrians including construction of footpaths, street furniture, rest places and shall work for the public safety for pedestrian especially those crossing the roads and for pedestrian safety. Necessary markings on roads at all such points to enable pedestrian crossing shall be done.
191. Safety of all existing structures.- (1) All existing commercial or institutional or school buildings or hostels or other such structures or places of public congregation, such as hotels, temples and religious places or hospitals or theatres or restaurants, shall self- certify their fire-safety and emergency exit plans within a year from the introduction of this Act, and shall install all necessary measures as required during this period to comply with the safety standard.
(2) Any building not certified or having failed to install fire safety or scientific exit plans shall be declared unsafe and the management will have to make alternate arrangements by vacating such structures. The Municipality shall have the right to declare such structures unsafe and take all necessary measures, as deemed appropriate, including closure or sealing and demolition, wherever necessary, to ensure public safety.
192. Naming of Streets and Numbering of Buildings.- (1) The Municipality shall give name or alter the name of public streets, in the manner prescribed, with the approval of the Government.
(2) The Commissioner shall cause a number to be affixed or painted to the side or outer door of any building to some place at the entrance of the premises, as prescribed.
(3) The Commissioner shall take up naming and numbering of streets and introduce digital unique property numbering system.
193. Informal Sector and Slum Development.- (1) The Commissioner shall regulate street vending activity for public convenience and for informal sector by earmarking places.
(2) The Commissioner shall identify all non-notified slums for notification for development and improvement as per the procedure prescribed by the Government from time to time.
(3) The Commissioner shall conduct a survey of the notified slums for de-notification, as prescribed by the Government from time to time.
CHAPTER-VI
STATE ELECTION COMMISSION AND CONDUCT OF ELECTIONS
194. State Election Commission.- (1) The preparation of electoral rolls for and the conduct of elections to all municipalities in the State shall be under the superintendence, direction and control of the State Election Commission.
(2) All elections to the Municipalities shall be held under the supervision and control of the State Election Commission and for this purpose, it shall have power to give such directions as it may deem necessary to the Commissioner and Director of Municipal Administration, District Collector, Commissioner of Municipality or any officer or servant of the Government and of the Municipalities so as to ensure efficient conduct of elections under this Act.
(3) For the purposes of this section, the Government shall provide the State Election Commission with such staff as may be necessary.
(4) On the request of the State Election Commission, the State Government shall place at the disposal of the Commission such staff of the State Government and Municipalities for the purpose of preparation of electoral rolls and conduct of elections under this Act.
(5) The State Election Commissioner may, subject to control and revision, delegate his powers to such officers, as he may deem necessary.
195. Election notification.- (1) The State Election Commission shall issue the Notification and Schedule for general election and elections for casual vacancies in all Municipalities and Municipal Corporations. The Schedule and the dates on which elections will be conducted, shall be decided, by the State Election Commission in concurrence with the State Government, which has to consider matters pertaining to law and order situation, internal security, security personnel, central armed police forces and the logistics of their deployment, availability of staff for election related duties, availability and procurement of election related material and premises for polling and counting, conduct of elections to other legislative and statutory bodies, natural calamities and seasonal conditions including drinking water situation and agricultural season, major fairs and festivals, education calendar and examinations in schools and colleges, likely onset of any epidemic diseases, operations relating to collection of vital statistics like census or any other enumeration, and matters involving public interest and any other administrative exigencies:
Provided that in cases of multiple phases, the schedule of each phase shall have a gap of not more than five days from each other.
(2) For the purpose of holding elections to fill ordinary or casual vacancies, the State Election Commission shall, by notification under sections 15 and 16, call upon such date or dates, as may be specified therein, the voters of the Municipalities, to elect ward member in accordance with the provisions of the Act, the rules and orders, if any, made thereunder.
(3) The notification shall specify the time schedule for various stages of the elections to fill the ordinary or casual vacancies, which shall be as follows from the date of election notice referred in sub-section (2):-
| (a) Nomination shall be filed |
Within a period of three days (including the day of notice) upto 5.00 p.m. (whether or not it is a holiday) |
| (b) Scrutiny of nominations shall be completed |
On the fourth day (whether or not it is a holiday) |
| (c) Appeal against rejection of nomination shall be filed, before the District Election Authority or Additional District Election Authority or Deputy District Election Authority as authorized by District Election Authority concerned. |
On the fifth day upto 5.00 p.m. (whether or not it is a holiday) |
| (d) Disposal of appeal against rejection of nomination by the District Election Authority concerned or Additional District Election Authority or Deputy District Election Authority as authorized by District Election Authority concerned. |
On the sixth day before 5.00 p.m. (whether or not it is a holiday) |
| (e) Withdrawal of candidatures shall be allowed. |
On the seventh day upto 3.00 p.m. (whether or not it is a holiday). |
| (f) Publication of final list of contesting candidates. |
On the seventh day itself, after the withdrawal of candidatures (whether or not it is a holiday). |
| (g) Polling shall be held, wherever necessary. |
On the fifteenth day (whether or not it is a holiday). |
| (h) Counting of votes and declaration of results. |
On the date and time appointed by the State Election Commission. |
(4) The Returning Officer appointed for the purpose of conducting elections to Municipality shall as per the above time schedule specified by the State Election Commission issue the election notice for election of the ward members of Municipality and the time schedule shall commence from that date.
(5) The State Election Commission shall issue the election notification for election of the Chairperson and Vice- Chairperson and the time schedule shall commence from that date.
195-A. Preparation and publication of electoral roll for a Municipality.- (1) The electoral roll for a municipality shall be prepared and published by the person authorised by the State Election Commissioner in such manner by reference to such qualifying date as may be prescribed and the electoral roll for a municipality shall come into force immediately upon its publication in accordance with the rules made by the Government in this behalf. The electoral roll for a municipality shall consist of such part of the electoral roll for the Assembly constituency published under the Representation of the People Act, 1950 as revised or amended under the said Act, up to the qualifying date as relates to a municipality or any portion thereof:
Provided that any amendment, transposition or deletion of any entries in the electoral roll, or any inclusion of names in the electoral roll of the Assembly Constituencies concerned, made by the Electoral Registration Officer under section 22 or section 23, as the case may be, of the Representation of the People Act, 1950, up to the date of election notification, for any election held under this Act, shall be carried out in the electoral roll of the municipality and any such names included shall be added to the part relating to the concerned ward.
Explanation:- Where in the case of any Assembly Constituency there is no district part of the electoral roll relating to the municipality, all persons whose names are entered in such roll under the registration area comprising the municipality and whose addresses as entered are situated in the municipality shall be entitled to be included in the electoral roll for the municipality prepared for the purposes of this Act.
(2) The electoral roll for a municipality,-
(a) shall be prepared and published in the prescribed manner by reference to the qualifying date,-
(i) before each ordinary election; and
(ii) before each casual election to fill a casual vacancy in the office of the Mayor/Chairperson or Member of the Municipality; and
(b) shall be prepared and published, in any year, in the prescribed manner, by reference to the qualifying date, if so, directed by the State Election Commission:
Provided that if the electoral roll is not prepared and published as aforesaid, the validity, or continued operation of the said electoral roll, shall not thereby be affected.
(3) When a municipality has been divided into Wards, the Electoral Roll for the Municipality shall be divided into separate lists for each ward.
(4) Where after the electoral roll for a municipality or any alteration thereto have been published under sub-section (2), the Municipality is divided into Wards for the first time or the division of the Municipality into wards is altered or the limits of the Municipality are varied, the person authorised by the State Election Commission in this behalf shall, as soon as may be after such division or alteration or variation, as the case may be, in order to give effect to the division of the Municipality into wards or to the alteration of the variation of the limits, as the case may be, authorise a re- arrangement and republication of the electoral roll for the Municipality or any part of such roll, in such manner as the State Election Commission may direct.
(5) The electoral roll published under sub-section (1) or as the case may be under sub-section (4) shall be the electoral roll for the municipality and it shall remain in force till a fresh electoral roll for the municipality is published under this Section.
(6) Every person whose name appears in that part of the electoral roll relating to a ward shall subject to the other provisions of this Act, be entitled to vote at any election which takes place in that ward while the electoral roll remains in force and no person whose name does not appear in such part of the electoral roll shall vote at any such election.
(7) No person shall vote at an election under this Act in more than one ward or more than once in the same ward and if he does so, all his votes shall be invalid.
Explanation:- In this section, the expression “Assembly Constituency” shall mean a constituency provided by law for the purpose of elections to the Telangana Legislative Assembly.
196. Voting Machines at elections. Notwithstanding anything contained in this Act or the rules made thereunder, the giving and recording of votes by voting machines in such manner as may be prescribed, may be adopted in such ward or seats as the State Election Commission may, having regard to the circumstances of each case, specify.
197. Symbols for elections under the Act.- The State Election Commission shall by notification, specify the symbols that may be chosen by candidates contesting any election under this Act and the restrictions to which their choice shall be subject:
Provided that the State Election Commission shall not in the case of elections to Municipalities allot to any contesting candidate any symbol reserved for a recognized political party or a registered political party. The State Election Commission shall allot symbols reserved for a recognized political party or a registered political party where any candidate is setup by such political party.
198. Voter identity cards.- With a view to prevent impersonation of electors, provision may be made by rules made under this Act, for the production before the Presiding Officer of a polling station by every such elector, of his identity card before the delivery of a ballot paper or ballot papers to him, the identity card of which has been supplied with a photograph attached thereto by the electoral registration officer under the Registration of Electors Rules, 1960 made under the Representation of the People Act, 1950.
199. Injunctions not to be granted in Election Proceedings.- No proceeding which is being or about to be taken under this Act for the preparation or publication of any electoral roll or for the conduct of any election shall be called in question in any Court, in any suit, or application, and no injunction shall be granted by any Court restraining any action in this regard.
200. Requisitioning of premises and vehicles for election purposes.- (1) If it appears to the State Election Commissioner that in connection with any election held under this Act,-
(a) any premises is/are needed for or likely to be needed for the purpose of being used as a polling station or for the storage of ballot boxes after a poll has been taken; or
(b) any vehicle is needed or is likely to be needed for the purpose of transport of personnel or ballot boxes to or from any polling station, or transport of members of the police force for maintaining law and order, during the conduct of such election, or transport of any officer or other person for performance of any duties in connection with such election, the State Election Commissioner may, by order in writing, requisition such premises or such vehicle, as the case may be, and may make such further orders as may appear to him to be necessary or expedient, in connection with the requisitioning:
Provided that no vehicle which is being lawfully used by a candidate or his agent for any purpose, connected with election of such candidate shall be requisitioned under this sub-section until the completion of the poll at such election.
(2) The requisition shall be effected by an order in writing addressed to the person deemed by the State Election Commissioner to be the owner or person in possession of the property and such order shall be served in the prescribed manner on the person to whom it is addressed.
(3) Whenever any premises is requisitioned under sub- section (1) the period of such requisition shall not be extended beyond the period for which such property is required for any of the purposes mentioned in that sub- section.
Explanation:- For purposes of this section ‘premises’ means any land, building or part of a building and includes a hut, shed or other structure or any part thereof and ‘vehicle’ means any vehicle used or capable of being used for the purpose of road transport, whether propelled by mechanical power or otherwise.
201. Payment of compensation.- (1) Whenever in pursuance of section 200, the State Election Commissioner requisitions any premises, there shall be paid to the person interested compensation the amount of which shall be determined by taking into consideration the following factors, namely:-
(i) the rent payable in respect of the premises or if no rent is so payable, will be the rent payable for similar premises in the locality;
(ii) if in consequence of the requisition of the premises the person interested is compelled to change his residence or place of business, the reasonable expenses, if any, incidental to such change:
Provided that where any person interested being aggrieved by the amount of compensation so determined makes an application within the prescribed time to the State Election Commissioner for referring the matter to an arbitrator appointed by him, the amount of compensation to be paid shall be determined by this arbitrator:
Provided further that where there is any dispute as to the title to receive the compensation or as to the apportionment of the amount of compensation, it shall be referred by the State Election Commissioner to an arbitrator appointed by him for determination and decision of the arbitrator shall be final.
Explanation:- In this sub-section, the expression “person interested” means the person who was in actual possession of the premises requisitioned under section 200 immediately before the requisition or where no person was in such actual possession, the owner of such premises.
(2) Whenever in pursuance of section 200, the State Election Commissioner requisitions any vehicle, there shall be paid to the owner thereof compensation, the amount of which shall be determined by the State Election Commissioner on the basis of the fares or rates prevailing in the locality for the hire of such vehicle:
Provided that where the owner of such vehicle, being aggrieved by the amount of compensation so determined, makes an application within the prescribed time to the State Election Commissioner for referring the matter to an arbitrator appointed by him, the amount of compensation to be paid shall be determined by this arbitrator:
Provided further that where immediately before the requisitioning, the vehicle was by virtue of a hire purchase agreement, in the possession of a person, other than the owner, the amount determined under this sub-section as the total compensation payable in respect of the requisition shall be apportioned between that person and the owner in such manner as they may agree upon, and in default of agreement, in such manner as the arbitrator appointed by the State Election Commissioner in this behalf may decide.
202. Power to obtain information.- The State Election Commissioner may with a view to requisitioning any property under section 200 or determining the compensation payable under section 201 by order, require any person to furnish to such authority as may be specified in the order; such information in his possession relating to such property as may be specified.
203. Eviction from requisitioned premises.- (1) Any person remaining in possession of any requisitioned premises in contravention of any order made under section 200 may summarily be evicted from such premises by an officer empowered by the State Election Commissioner in this behalf.
(2) Any officer so empowered may, after giving to any woman not appearing in public, reasonable warning and facility to withdraw, remove or open any lock or bolt or break open any door of any building or do any other act necessary for effecting such eviction.
204. Penalty for contravention of any order regarding requisitioning.- If any person contravenes any order made under sections 200 to 203, he shall be punishable with imprisonment for a term, which may extend to one year or with fine or with both.
CORRUPT PRACTICES AND ELECTION OFFENCES
205. Corrupt practices.- The following shall be deemed to be corrupt practices for the purposes of this Act:-
(1) Bribery, that is to say,-
(i) any gift, offer or promise by a candidate or his agent or by any other person with the consent of a candidate or his election agent, of any gratification, to any person whomsoever, with the object, directly or indirectly of inducing,
(a) a person to stand or not to stand as or to withdraw or not to withdraw from being a candidate at an election; or
(b) an elector to vote or refrain from voting at an election, or as reward to,
(ii) a person for having so stood or not stood, or for having withdrawn or not having withdrawn his candidature; or
(iii) an elector for having voted or refrained from voting.
(2) The receipt of or agreement to receive, any gratification, whether as a motive or a reward,-
(a) by a person for standing or not standing as or for withdrawing or not withdrawing from being a candidate; or
(b) by any person whomsoever for himself or any other person for voting or refraining from voting or inducing or attempting to induce any elector to vote or refrain from voting, or any candidate to withdraw or not to withdraw his candidature.
Explanation:- For the purposes of this clause, the term “gratification” is not restricted to pecuniary gratification or gratifications estimable in money and it includes all forms of entertainment and all forms of employment for reward but it does not include the payment of any expenses bonafide incurred at, or for the purpose of any election and duly entered in the account of election expenses.
(3) Undue influence, that is to say, any direct or indirect interference or attempt to interfere on the part of the candidate or his agent, or of any person with the consent of the candidate or his election agent with the free exercise of any electoral right:
Provided that,-
(a) without prejudice to the generality of the provisions of this clause any such person as is referred to thereon, who,-
(i) threatens any candidate or any elector or any person in whom a candidate or an elector is interested, with injury of any kind including social ostracism and excommunication or expulsion from any caste or community; or
(ii) induces or attempts to induce a candidate or an elector to believe that he, or any person in whom he is interested will become or will be rendered an object of divine displeasure or spiritual censure, shall be deemed to interfere with the free exercise of the electoral right of such candidate or elector within the meaning of this clause;
(b) a declaration of public policy, or a promise of public action, or the mere exercise of a legal right without intent to interfere with an electoral right, shall not be deemed to be interference within the meaning of this clause.
(4) The appeal by a candidate or his agent or by any other person with the consent of a candidate or his election agent to vote or refrain from voting for any person on the ground of his religion, race, caste, community or language or the use of, or appeal to religious symbols or the use of, or appeal to national symbols of the prospects of the election of that candidate or for prejudicially affecting the election of any candidate:
Provided that no symbol allotted under this Act to a candidate shall be deemed to be a religious symbol or a national symbol for the purposes of this clause.
(5) The promotion of, or attempt to promote feelings of enmity or hatred between different classes of the citizens of India on grounds of religion, race, caste, community or language by a candidate or his agent or any other person with the consent of a candidate or his election agent for the furtherance of the prospects of the election of that candidate or of prejudicially affecting the election of any candidate.
(6) The publication by a candidate or his agent or by any other person, with the consent of a candidate or his election agent or any statement of fact which is false, in which he either believes to be false, or does not believe to be true in relation to the personal character or conduct of any candidate or in relation to the candidature, or withdrawal of any candidate, being a statement reasonably calculated to prejudice the prospects of that candidate’s election.
(7) The hiring or procuring, whether on payment or otherwise of any vehicle or vessel by a candidate or his agent or by any other person with the consent of a candidate or his election agent or the use of such vehicle or vessel for the free conveyance of any elector other than that the candidate himself, the members of his family or his agent to or from any polling station:
Provided that the hiring of a vehicle or vessel by an elector or by several electors at their joint costs for the purpose of conveying him or them to and from any such polling station or place fixed for the poll shall not be deemed to be a corrupt practice under this clause if the vehicle or vessel so hired is a vehicle or vessel not propelled by mechanical power:
Provided further that the use of any public transport vehicle or vessel by any elector at his own cost for the purpose of going to or coming from any such polling station or place fixed for the poll shall not be deemed to be a corrupt practice under this clause.
Explanation:- In this clause, the expression “vehicle” means any vehicle used or capable of being used for the purpose of road transport, whether propelled by mechanical power or otherwise and whether used for drawing other vehicles or otherwise.
(8) The incurring or authorizing of expenses in contravention of various provisions under this Act.
(9) The obtaining or procuring or abetting or attempting to obtain or procure by a candidate or his agent, or by any other person with the consent of a candidate or his election agent, any assistance (other than the giving of vote) for the furtherance of the prospects of that candidate’s election, from any person in the service of the State, Central Government, local authority or a corporation owned or controlled by the State or Central Government:
Provided that where any person, in the service of the State or Central Government or a local authority in the discharge or purported discharge of his official duty, makes any arrangements or provides any facilities or does any other act or thing, for or in relation to, any candidate or his agent or any other person acting with the consent of the candidate or his election agent (whether by reason of the office held by the candidate or for any other reason), such arrangements, facilities or acts or things shall not be deemed to be assistance for the furtherance of the prospects of that candidate’s election.
(10) Booth capturing by candidate or his agent or other person.
Explanation:-
(i) in this section the expression agent includes an election agent, a polling agent, and any person who is held to have acted as an agent in connection with election with the consent of the candidate,-
(a) a person shall be deemed to assist in the furtherance of the prospects of a candidate’s election, if he acts as an election agent of that candidate;
(b) for the purposes of clause (9) notwithstanding anything contained in any other law, the publication in the Telangana Gazette of the appointment, resignation, termination of service, dismissal or removal from service of a person in the service of the Government shall be conclusive proof;
(ii) of such appointment, resignation, termination of service, dismissal or removal from service, as the case may be; and
(iii) where the date of taking effect of such appointment, resignation, termination of service, dismissal or removal from service, as the case may be, is stated in such publication, also of the fact that such person was appointed with effect from the said date, or in the case of resignation, termination of service, such person ceased to be in such service with effect from the said date.
206. Impersonation at Elections.- Whoever at an election applies for a ballot paper or vote in the name of any other person, whether living or dead or in a fictitious name or who having voted once at such election applies at the same election for a ballot paper in his own name, and whoever abets, procures or attempts to procure the voting by any person in any such way shall be punished with imprisonment for a term which may extend to five years and with fine which may extend to five thousand rupees.
207. Offences by Companies.- (1) Where an offence under this Act has been committed by a company, every person who at the time the offence was committed, was in charge of and was responsible to the company for the conduct of the business of the company as well as the company shall be deemed to be guilty of the offence and shall be liable to be proceeded against and punished accordingly:
Provided that nothing contained in this sub-section shall render any such person liable to any punishment, if he proves that the offence was committed without his knowledge or that he had exercised all due diligence to prevent the commission of such offence.
(2) Notwithstanding anything contained in sub-section (1) where any offence under this Act has been committed by a company and it is proved that the offence has been committed with the consent or connivance or is attributable to any neglect on the part of any director, manager, secretary or other officer of the company shall be deemed to be guilty of that offence and shall be liable to be proceeded against and punished accordingly.
Explanation:- For the purposes of this section,-
(a) “company” means any body corporate and includes a firm or other association of individuals; and
(b) “director” in relation to a firm means a partner in the firm.
ELECTORAL OFFENCES
208. Promoting enmity between classes in connection with election.- Any person who in connection with an election under this Act promotes or attempts to promote on grounds of religion, race, caste, community or language, feelings of enemity or hatred between different classes of the citizens of India shall be punishable with imprisonment for a term which may extend to three years and with fine which may extend to three thousand rupees or with both.
209. Prohibition of public meetings before the date of poll.- (1) No person shall,-
(a) convene, hold, attend, join or address any public meeting or procession in connection with an election; or
(b) display to the public any election matter by means of cinematography, television or other similar apparatus; or
(c) propagate any election matter to the public by holding, or by arranging the holding of, any musical concert or any theatrical performance or any other entertainment or amusement with a view to attract the members of the public thereto, in any polling area during the period of forty-eight hours prior to the hour fixed for the conclusion of the poll for any election in that polling area.
(2) Any person who contravenes the provisions of sub- section (1) shall be punishable with imprisonment for a term which may extend to two years or with fine or with both.
(3) In this section, the expression “election matter” means any matter intended or calculated to influence or affect the result of election.
210. Disturbance at election meetings.- (1) Any person who at a public meeting to which this section applies, acts or incites others to act in a disorderly manner for the purpose of preventing the transaction of the business for which the meeting was called together, shall be punishable with imprisonment which may extend to six months or with fine which may extend to two thousand rupees or with both.
(2) An offence punishable under sub-section (1) shall be cognizable.
(3) This section applies to any public meeting of a political character held in any Municipality between the date of the issue of notification under this Act calling upon the voters to elect a ward member or members and the date on which such election is held.
(4) If any police officer reasonably suspects any person of committing an offence under sub-section (1), he may, if requested to do so by the presiding officer of the meeting require that person to declare to him immediately his name and address and, if that person refuses or fails so to declare his name and address or if the police officer reasonably suspects him of giving a false name or address, the police officer may arrest him without warrant.
211. Restrictions on the printing of pamphlets, posters, etc.- (1) No person shall print or publish or cause to be printed or published, any election pamphlet or poster which does not bear on its face the names and addresses of the printer and the publisher thereof.
(2) No person shall print or cause to be printed any election pamphlet or poster,-
(a) unless a declaration as to the identity of the publisher thereof, signed by him and attested by two persons to whom he is personally known, is delivered by him to the printer in duplicate; and
(b) unless, within a reasonable time after the printing of the document, one copy of the declaration is sent by the printer, together with one copy of the document,-
(i) where it is printed in the capital of the State, to the Election Authority; and
(ii) in any other case, to the District Magistrate of the district in which it is printed.
(3) For the purpose of this section,-
(a) any process for multiplying copies of a document other than copying it by hand, shall be deemed to be printing and the expression “printer” shall be construed accordingly; and
(b) “election pamphlet or poster” means any printed pamphlet, hand-bill or other document distributed for the purpose of promoting or prejudicing the election of a candidate or group of candidates or any placard or poster having reference to an election, but does not include any hand-bill, placard or poster merely announcing the date, time, place and other particulars of an election meeting or routine instructions to election agents or workers.
(4) Any person who contravenes any of the provisions of sub-section (1) or (2) shall be punishable with imprisonment for a term which may extend to six months or with fine which may extend to two thousand rupees or with both.
212. Maintenance of secrecy of voting.- (1) Every officer, clerk, agent or other person who performs any duty in connection with the recording or counting of votes at an election shall maintain, and aid in maintaining the secrecy of the voting and shall not (except for some purpose authorized by or under any law) communicate to any person any information calculated to violate such secrecy.
(2) Any person who contravenes provisions of sub- section (1), shall be punishable with imprisonment for a term which may extend to three months or with fine or with both.
213. Officers at elections not to act for candidates or to influence voting.- (1) No person who is a District Returning Officer or Returning Officer, or an Assistant Returning Officer or a Presiding Officer or Polling Officer, at an election, or an officer or clerk appointed by the Returning Officer or the Presiding Officer to perform any duty in connection with an election shall in the conduct or the management of the election do any act other than the giving of vote for the furtherance of the prospects of the election of a candidate.
(2) No such person as aforesaid, and no member of a police force, shall endeavor,-
(a) to persuade any person to give his vote at an election; or
(b) to dissuade any person from giving his vote at an election; or
(c) to influence the voting of any person at an election in any manner.
(3) Any person who contravenes the provisions of sub- section (1) or sub-section (2) shall be punishable with imprisonment which may extend to six months or with fine or with both.
214. Prohibition of canvassing in or near polling station.- (1) No person shall, on the date or dates on which a poll is taken at any polling station, commit any of the following acts within the polling station or in any public or private place within a distance of one hundred meters of the polling station, namely:-
(a) canvassing for votes; or
(b) soliciting the vote of any elector; or
(c) persuading any elector not to vote for any particular candidates; or
(d) persuading any elector not to vote at the election;
or
(e) exhibiting any notice or sign (other than an official notice) relating to the election.
(2) Any person who contravenes the provisions of sub- section (1) shall be punishable with fine which may extend to two hundred and fifty rupees.
215. Penalty for disorderly conduct in or near polling stations.- (1) No person shall, on the date or dates on which a poll is taken at any polling station,-
(a) use or operate within or at the entrance of the polling station, or in any public or private place in the neighborhood thereof, any apparatus for amplifying or reproducing the human voice, such as a megaphone or a loudspeaker, or
(b) shout or otherwise act in a disorderly manner within or at the entrance of the polling station or in any public or private place in the neighborhood thereof, so as to cause annoyance to any person visiting the polling station for the poll, or so as to interfere with the work of the officers and other persons on duty at the polling station.
(2) Any person who contravenes or willfully aids or abets the contravention of the provisions of sub-section (1), shall be punishable with imprisonment which may extend to three months or with fine or with both.
(3) If the Presiding Officer of a polling station has reason to believe that any person is committing or has committed an offence punishable under this section, he may direct any police officer to arrest such person, and thereupon the police officer shall arrest him.
(4) Any police officer may take such steps and use such force as may be reasonably necessary for preventing any contravention of the provisions of sub-section (1), and may seize any apparatus used for such contravention.
216. Penalty for misconduct at the polling station.- (1) Any person who during the hours fixed for the poll at any polling station misconducts himself or fails to obey the lawful directions of the Presiding Officer may be removed from the polling station by the Presiding Officer or by any police officer on duty or by any person authorized in this behalf by such Presiding Officer.
(2) The powers conferred by sub-section (1) shall not be exercised so as to prevent any elector who is otherwise entitled to vote at a polling station from having opportunity of voting at that station.
(3) If any person who has been so removed from polling station re-enters the polling station without the permission of the Presiding Officer, he shall be punishable with imprisonment for a term which may extend to three months or with fine or with both.
217. Penalty for failure to observe procedure for voting.- If an elector, to whom a ballot paper has been issued, refuses to observe the procedure prescribed for voting, the ballot paper issued to him shall be liable for cancellation.
218. Penalty for illegal hiring or procuring of conveyance at elections.- If any person is guilty of any such corrupt practices as specified in sub-section (7) of section 205 or in connection with an election he shall be punishable with imprisonment for a term, which may extend to three months and with fine, which may extend to three thousand rupees.
219. Breaches of official duty in connection with elections.- (1) If any person to whom this section applies is without reasonable cause guilty of any act or omission in breach of his official duty, he shall be punishable with fine which may extend to two thousand rupees.
(2) No suit or other legal proceedings shall lie against any such person for damages in respect of any such act or omission as aforesaid.
(3) The persons to whom this section applies are the District Returning Officer, Returning Officer, Assistant Returning Officer, Presiding Officer, Polling Officer and any other person appointed to perform any duty in connection with the receipt of nominations or withdrawal of candidatures or the recording or counting of votes at an election and the expression “official duty” shall for the purposes of this section be construed accordingly but shall not include duties imposed otherwise than by or under this Act.
220. Penalty for Government servants for acting as election agent, polling agent or counting agent.- If any person in the service of the State or Central Government or a local authority or a Corporation owned or controlled by the State or Central Government acts as an election agent or a polling agent or counting agent of a candidate at an election, he shall be punishable with imprisonment for a term which may extend to three months or with fine or with both.
221. Prohibition of going armed to or near a polling station.- (1) No person other than Police Officer and any other person appointed to maintain peace and order, at a polling station who is on duty at the polling station, shall, on a polling day, go armed with arms, as defined in the Arms Act, 1959, of any kind with the neighborhood of a polling station.
(2) If any person contravenes the provisions of sub- section (1), he shall be punishable with imprisonment for a term which may extend to two years or with fine or with both.
(3) An offence punishable under sub-section (2) shall be cognizable.
222. Removal of ballot papers or ballot boxes from polling stations to be an offence.- (1) Any person who at any election fraudulently takes or attempts to take a ballot paper or ballot box out of polling station or willfully aids or abets the doing of any such act shall be punishable with imprisonment for a term which may extend to five years and with fine which may extend upto five thousand rupees or with both.
(2) If the Presiding Officer of a polling station has reason to believe that any person is committing or has committed an offence punishable under sub-section (1), such officer may, before such person leaves the polling station, arrest or direct a police officer to arrest such person and such officer may cause him to be searched by the police:
Provided that when it is necessary to cause a woman to be searched, the search shall be made by another woman with strict regard to decency.
(3) Any ballot paper found upon the person arrested on search shall be made over for safe custody to a police officer by the Presiding Officer or when the search is made by a police officer, shall be kept by such officer in safe custody.
223. Offences of booth capturing.- (1) Whoever commits an offence of booth capturing shall be punishable with imprisonment for a term which shall not be less than one year but which may extend to three years and with fine, and where such offence is committed by a person in the service of the Government, he shall be punishable with imprisonment for a term which shall not be less than three years but which may extend to five years and with fine.
(2) For the purposes of this sub-section, an offence punishable under sub-section (1) shall be cognizable.
224. Liquor not to be sold, given or distributed on polling day.- (1) No spirituous, fermented or intoxicating liquors or other substances of a like nature shall be sold, given or distributed at a hotel, eating house, tavern, shop or any other place, public or private, within a polling area during the period of forty-eight hours prior to the hour fixed for the conclusion of the poll for any election in that polling area.
(2) Any person who contravenes the provisions of sub- section (1), shall be punishable with imprisonment for a term which may extend to six months or with fine which may extend to two thousand rupees or with both.
(3) Where a person is convicted of an offence under this section, the spirituous, fermented or intoxicating liquors or other substances of a like nature found in his possession shall be liable to confiscation and the same shall be disposed off in such manner as may be prescribed.
225. Other offences and penalties thereunder. (1) A person shall be guilty of an electoral offence if at any election he,-
(a) fraudulently defaces or fraudulently destroys any nomination paper; or
(b) fraudulently defaces or fraudulently destroys or removes any list, notice or other document affixed by or under the authority of a Returning Officer; or
(c) fraudulently defaces or fraudulently destroys any ballot paper or the official mark of any ballot paper or any declaration or identity or official envelope used in connection with voting by postal ballot; or
(d) without due authority supplies any ballot paper to any person or receives any ballot paper from any person or is in possession of any ballot paper; or
(e) fraudulently puts into any ballot box anything other than the ballot paper which he is authorized by law to put in; or
(f) without due authority destroys, takes, opens or otherwise interferes with any ballot box or ballot papers then in use for the purposes of the election; or
(g) fraudulently or without due authority, as the case may be, attempts to do any of the foregoing acts or willfully aids or abets the doing of any such acts.
(2) Any person guilty of an electoral offence under this section shall,-
(a) if he is a Returning Officer or an Assistant Returning Officer or a Presiding Officer at a polling station or any other officer or clerk employed on official duty in connection with the election, be punishable with imprisonment for a term which may extend to two years or with fine or with both;
(b) if he is any other person, be punishable with imprisonment for a term which may extend to six months or with fine or with both.
(3) For the purposes of this section, a person shall be deemed to be on official duty, if duty is to take part in the conduct of an election or part of an election including the counting of votes or to be responsible after an election for the used ballot papers and other documents in connection with such election, but the expression “official duty” shall not include any duty imposed otherwise than by or under this Act.
226. Penalty for offences not otherwise provided for.- Whoever does any act in contravention of any of the provisions of this Act or of any rule, notification or order made, issued or passed thereunder and not otherwise provided for in this Act shall, on conviction, be punishable with imprisonment which may extend to two years and with fine which may extend to two thousand rupees.
MISCELLANEOUS ELECTION MATTERS
227. Adjournment of poll in emergencies.- (1) If at an election, the proceedings at any polling station are interrupted or obstructed by any riot or open violence or if at an election it is not possible to take the poll at any polling station or such place on account of any natural calamity or any other sufficient cause, the Presiding Officer for such polling station shall announce an adjournment of the poll to a date to be notified later and he shall forthwith inform the Returning Officer concerned.
(2) Whenever a poll is adjourned under sub-section (1), the Returning Officer shall immediately report the circumstances to the District Election Authority and the State Election Commission, and shall, as soon as may be, with the previous approval of the State Election Commission, appoints the day on which the poll shall recommence and fix the hours during which, the poll will be taken and shall not count the votes cast at such election until such adjourned poll shall have been completed.
(3) In every such case as aforesaid, the Returning Officer shall notify in such manner as the State Election Commission may direct, the date and hours of polling fixed under sub-section (2).
228. Fresh poll in the case of destruction of ballot boxes.- (1) If at any election,-
(a) any ballot box or electronic voting machine used at a polling station is unlawfully taken out of the custody of the Presiding Officer or the Returning Officer or is accidentally or intentionally destroyed or lost or is damaged or tampered with, to such an extent, that the result of the poll at that polling station cannot be ascertained; or
(b) any voting machine develops a mechanical failure during the course of the recording of votes; or
(c) any such error, human or mechanical or irregularity in procedure as is likely to vitiate the poll is committed at a polling station, the Returning Officer shall forthwith report the matter to the State Election Commission.
(2) Thereupon the State Election Commission shall, after taking all material circumstances into account, either,-
(a) declare the poll at that polling station to be void, appoint a day and fix the hours for taking a fresh poll at the polling station and notify the day so appointed and the hours so fixed in such manner as it may deem fit; or
(b) if satisfied that the result of a fresh poll at that polling station will not, in any way affect the result of the election or that the mechanical failure of the voting machine or the error or irregularity in procedure is not material, issue such directions to the Returning Officer as it may deem proper for the proper conduct and completion of the election.
(3) The provisions of this Act and of any rules or orders made thereunder shall apply to every such fresh poll as they apply to the original poll.
229. Adjournment of poll or countermanding of election on the ground of booth capturing.- (1) If at any election,-
(a) booth capturing has taken place at a polling station or in such number of polling stations as is likely to affect the result of such election or that the result of the poll at that polling station cannot be ascertained; or
(b) booth capturing takes place in any place for counting of votes in such a manner that the result of the counting at that place cannot be ascertained, the Returning Officer shall forthwith report the matter to the State Election Commission.
(2) The State Election Commission shall on the receipt of a report from the Returning Officer under sub-section (1) and after taking all material circumstances into account, either,
(a) declare that the poll at that polling station be void, appoint a day, and fix the hours, for taking fresh poll at that polling station and notify the date so appointed and hours so fixed in such manner as he may deem fit, or
(b) if satisfied that in view of the large number of polling stations involved in booth capturing the result of the election is likely to be affected or that booth capturing had affected counting of votes in such manner as to affect the result of the election, countermand the election in that constituency.
230. Destruction, loss of ballot papers at the time of counting.- (1) If at any time before counting of votes is completed, any ballot papers used at a polling are unlawfully taken out of the custody of the Returning Officer or are accidentally or intentionally destroyed or lost or are damaged or tampered with, to such an extent that the result of the poll at that polling station cannot be ascertained, the Returning Officer shall forthwith report the matter to the State Election Commission.
(2) Thereupon, the State Election Commission shall, taking all material circumstances into account, either,
(a) direct that the counting of votes shall be stopped, declare the poll at that polling station to be void, appoint a day and fix the hours, for taking a fresh poll at that polling station and notify the date so appointed and hours so fixed in the manner as it may deem fit; or
(b) if satisfied that the result of a fresh poll at that station will not, in anyway, affect the result of the election, issue such directions to the Returning Officer as it may deem proper for the resumption and completion of the counting and for the further conduct and completion of the election in relation to which the votes have been counted.
(3) The provisions of this Act and of any rules or orders made thereunder shall apply to every such fresh poll as they apply to the original poll.
231. Electoral officers and staff deemed to be on deputation.- (1) Any officer or staff employed in connection with the preparation, revision and correction of the electoral rolls for, and the conduct of elections shall be deemed to be on deputation to the State Election Commission for the period during which they are so employed and such officers and staff shall during that period, be subject to the control, superintendence and discipline of the State Election Commission.
(2) The District Election Authority, Returning Officer, Assistant Returning Officer, Presiding Officer, Polling Officer and any other officer appointed under this Act, and any police officer designated for the time being by the Government for the conduct of any elections shall be deemed to be on deputation to the State Election Commission for the period commencing from the date of notification calling for such elections and ending with the date of declaration of the results of such elections and such officer shall, during that period, be subject to the control, superintendence and discipline of the State Election Commission.
232. Delegation of powers of the Commission.- The State Election Commission may, subject to such conditions and restrictions as the Government may, by general or special order, impose, by order in writing delegate to any officer or authority subordinate to him, either generally or as respects any particular matter or class of matters any of his powers under this Act.
233. Election petitions.- (1) No election held under this Act shall be called in question except by an election petition presented to the Election Tribunal.
(2) The Government may specify a court of District Judge to be an Election Tribunal to try the election petitions under this Act.
(3) The Tribunal shall deal with such petitions and proceedings in connection there with in the manner prescribed.
ELECTION EXPENSES
234. Application of chapter. This chapter shall apply to candidates of any election held under this Act.
235. Accounts of election expenses.- (1) Every candidate at any election held under this Act shall, either by himself or by his election agent, keep a separate and correct account of all expenditure incurred in connection with the election, between the date on which the candidate concerned has been nominated and the date of declaration of the result of the election, both dates inclusive hereinafter in this chapter referred to as “election expenses”.
Explanation I:- “Election expenses” for purpose of this Act shall mean all expenses in connection with the election,-
(a) incurred or authorized by the contesting candidate or by his election agent;
(b) incurred, by any association, or body of persons, or by any individual (other than the candidate or his election agent) aimed at promoting or procuring the election of the candidate concerned; and
(c) incurred by any political party, by which the candidate is set up, so as to promote or procure his election:
Provided that any expenses incurred by any political party as part of its general propaganda, (which is distinguishable from its election campaign for the promotion or procuring the election of a particular candidate), by words, either written or spoken or by signs or visible representations or by audio-visual devises or through print or electronic media or otherwise shall not constitute ‘election expenses’ for purposes of this Act.
Explanation II:- For the removal of doubts, it is hereby declared that any expenses incurred in respect of any arrangements made, facilities provided or any other act or thing done by any person in the service of the Government and belonging to any of the classes mentioned in sub- section (9) of section 204 in the discharge or purported discharge of his official duty as mentioned in the proviso to that clause shall not be deemed to be expenses in connection with the election incurred or authorized by a candidate or by his election agent for the purposes of this sub-section.
(2) The account of election expenses shall contain such particulars, as may by order, be specified by the State Election Commission.
(3) The total of the said expenses shall not exceed such amount, as may by order, be specified by the State Election Commission.
236. Lodging of account with the District Election Authority.- (1) Every contesting candidate at an election shall, within forty-five days from the date of declaration of the result of the election, lodge with the District Election Authority, an account of his election expenses, which shall be a true copy of the account kept by him or by his election agent under section 235.
(2) The District Election Authority shall submit the copies of election expenditure statements to the State Election Commission.
APPOINTMENT OF OBSERVERS
237. Appointment of observers. (1) The State Election Commission may nominate an observer who shall be an officer of the Government to watch the conduct of election or elections for such specified area or areas in the district and to perform such other functions as may be entrusted to him by the Commission in relation thereto.
(2) The observer nominated under sub-section (1) shall have the power to direct the Returning Officer for any of the seats for which he has been nominated, to stop the counting of votes at any time before the declaration of the result, or not to declare the result, if in the opinion of the observer, booth capturing has taken place at a large number of polling stations or at counting centers or any ballot papers used at a polling station are unlawfully taken out of the custody of the Returning Officer or are accidentally or intentionally destroyed or lost or are damaged or tampered with to such an extent that the result of the poll at that polling station cannot be ascertained.
(3) Where an observer has directed the Returning Officer under this section to stop counting of votes or not to declare the result, he shall forthwith report the matter to the Commission and thereupon the Commission shall, after taking all material circumstances into account, issue appropriate directions under section 229 or 230 in the matter of declaration of results.
(4) It shall be competent for the State Election Commission to appoint an Election Expenditure Observer for a group of seats or a Municipality or group of Municipalities so as to ensure that the provisions of sections 235 and 236 are strictly adhered to and in that behalf the Commission may issue such instructions as it deems fit, from time to time to such observers.
CHAPTER VII
SUBSIDIARY LEGISLATION
RULES, BYE-LAWS AND REGULATIONS
238. Power of Government to make rules.- (1) The Government may, by notification without prejudice to the generality of the foregoing power, make rules for carrying out any or all of the purposes of this Act.
(2) In making any rules, the Government may provide that a breach thereof shall be punishable with a fine, as prescribed.
(3) Every rule made under the Act shall immediately after it is made, be laid before each House of the Legislature of the State if it is in session, and if it is not in session, in the session immediately following for a total period of fourteen days which may be comprised in one session or in two successive sessions and if before the expiration of the session in which it is so laid or the session immediately following, the Legislature agrees in making any modification in the rule or in the annulment of the rule, the rule shall, from the date on which the modification or annulment is notified, have effect only in such modified form or shall stand annulled, as the case may be, so however that any such modification or annulment shall be without prejudice to the validity or anything previously done under the rule.
239. Power to amend Schedules.- (1) The State Legislature may add to, modify or cancel any Schedule.
(2) A copy of every notification proposed to be issued under sub-section (1) shall be laid in draft before each House of the State Legislature while it is in session for both the Houses to approve or make any modification or alteration or otherwise within a period of 30 days from the date of submission:
Provided that in the event of no communication from the Legislature being received within the time prescribed above, it shall be deemed that the proposed notification stands approved and the government shall issue the notification accordingly.
240. Power of the Council to Make Bye-laws.- The Municipal Council may make bye-laws, not inconsistent with this Act, or with any other law for the time being in force, to provide for all matters, expressly required or allowed by this Act, to be provided for by bye-law.
241. Power of Government to make rules in lieu of Bye-laws.- (1) If, in respect of any matters specified in section 240, the Municipality has failed to make any bye-laws, or if the bye-laws made by it are not, in the opinion of the Government, adequate, the Government may make rules providing for such matters, as they may think fit.
(2) The rules made under this section may add to, alter, or cancel any bye-laws made by the Municipal Council.
(3) If any provision of bye-laws made by the Municipal Council is repugnant to any provision of a rule made under this section, the rule shall prevail, and the bye-laws, to the extent it is repugnant, be void.
242. Power to give retrospective effect to certain Bye-laws.- Bye-laws with regard to the drainage of, and supply of water to, buildings and water-closets, earth-closets, privies, ash-pits and cess-pools in connection with buildings, and the keeping of water-closets supplied with sufficient water for flushing, may be made so as to affect buildings erected before passing of the bye-laws or this Act.
243. Conditions precedent to making Bye-laws.- The Municipal Council shall, before making or altering bye-laws, publish a draft of the proposed bye-laws and alterations, together with a notice specifying a date at or after which such draft will be taken into consideration, and shall, before making the bye-laws or alterations, receive and consider any objection or suggestion, which may be made in respect of such draft by any person interested therein, before the date so specified.
244. Penalty for breaches of Bye- laws.- In making bye-laws the Municipal Council may provide that a breach of the bye-laws shall be punishable with fine specifying the same, not inconsistent with any other provision or existing rules.
PUBLICATION OF RULES, BYE-LAWS AND REGULATIONS
245. Copies of Act, Rules and Bye- laws to be made available online.- Complete copies of the Act, bye-laws and the rules framed by the Government and the Municipal Authorities, shall be made available online in English or in the main language of the district.
PENALTIES
246. General provisions regarding penalties.- (1) Whoever acts as a Member knowing that under this Act or the rules made thereunder he is not entitled, or has ceased to be entitled, to hold such office shall, be punished with fine as prescribed and not less than ten thousand rupees for every such offence.
(2) Whoever acts as or exercises the functions of the Chairperson or Vice-Chairperson of a Municipal Council knowing that under this Act or the rules made thereunder he is not entitled, or has ceased to be entitled, to hold such office or to exercise such functions shall be punished with fine as prescribed and not less than rupees ten thousand for every such offence.
(3) If the Chairperson or Vice-Chairperson of a council fails to hand over any documents of, or any moneys or other properties vested in, or belonging to, the council which are in or have come into his possession or control, to his successor in office or other prescribed authority, in every case as soon as his term of office as Chairperson or Vice- Chairperson expires and in the case of the Vice-Chairperson also on demand by the Chairperson, such Chairperson or Vice-Chairperson shall be punished with fine as prescribed and not less than ten thousand for every such offence.
247. Penalty for acquisition of interest by any Municipal Officer of interest in contract or work.- If any Municipal Officer or employee knowingly acquires, directly or indirectly, by himself or by a co-sharer or servant, or near relative or any benamidar, any share or interest in any contract or employment with, by or on behalf of, the Municipal Council, he shall be deemed to have committed an offence under section 168 of the Indian Penal Code:
Provided that no person shall, by reason of being a shareholder in, or member of, any company, be held to be interested in any contract, entered into between such company and the Municipal Council, unless he is a director of such company.
248. Penalty for willful prevention of distraint.- Any person willfully preventing distraint or sufficient distraint of property, subject to distraint for any tax due from any person, shall be liable to a fine, not exceeding ten times the amount of the tax found to be due.
249. Wrongful restraint of Municipal Authority or Officer and his delegate.- Every person, who prevents the municipal authority or officer or any person, to whom the said authority or officer has lawfully delegated its or his powers of entering into or on any land or building, from exercising its or his lawful power of entering there into or thereon, shall be deemed to have committed an offence under section 341 of the Indian Penal Code.
250. Penalty for not giving information or giving false information.- If any person, who is required by the provisions of this Act, or by any notice, or other proceedings issued under this Act to furnish any information,-
(a) omits to furnish it, or
(b) knowingly furnishing false information,
such person shall be liable to pay fine of Rupees two thousand.
PROCEDURE AND MISCELLANEOUS LICENSES AND PERMISSIONS
251. General provisions regarding licenses and permissions.- (1) Every license and permission granted under this Act or any rule or bye-law made under this Act, shall specify the period if any for which, and the restrictions, limitations and conditions subject to which, the same is granted, and shall be signed by the Commissioner.
(2) Save as otherwise expressly provided in or prescribed under this Act, for every such license or permission, fees be charged on such units and at such rates as may be fixed by the Municipal Council.
(3) Every order of a municipal authority granting or refusing a license or permission shall be communicated to the person concerned.
(4) Every order of a municipal authority refusing, suspending, cancelling, modifying or revoking a license or permission shall be in writing and shall state the grounds on which it proceeds.
APPEALS
252. Appeals.- (1) Any person aggrieved by any notice issued by the Municipality under this Act may file an appeal before the Regional Director, within 60 days from the date of receipt of such notice. The Regional Director shall dispose the appeal within 30 days from the date of receipt of the appeal:
Provided that the Regional Director may condone the delay in filing the appeal subject to the satisfaction of showing sufficient cause.
(2) A review shall lie to the Government against any orders passed by the Regional Director under sub-section (1), within 30 days from the date of receipt of the order passed by the Regional Director:
Provided that the Government may condone the delay in filing the review petition subject to the satisfaction of showing sufficient cause for delay in filing the review petition.
POWER TO SUMMON
253. Power of persons conducting election and other enquiries.- All persons authorised by rule to conduct enquiries relating to elections and all inspecting or superintending officers holding any enquiries into matters falling within the scope of their duties shall have, for the purposes of such enquiries the same powers in regard to the issue of summons for the attendance of witnesses and the production of documents, as enumerated under the Civil Procedure Code, 1908.
254. Summons to attend and give evidence or produce documents.- The Commissioner, the Municipal Engineer or the Town Planning Officer may summon any person to appear before him, and to give evidence or produce documents in respect of any question relating to taxation, or inspection or registration, or to the grant of any licence or permission under the provisions of this Act.
NOTICES, Etc.
255. Form of notices and permissions.- All notices and permissions given, issued or granted, as the case may be, under the provisions of this Act shall be in writing, either in print or electronic form, and in such form as may be prescribed.
256. Signature on documents.- (1) Every license, permission, notice, bill, Schedule, summons or other document which is required by this Act or by any rule, bye-law or regulation made thereunder shall bear the signature of the Commissioner or of any Municipal Officer either in writing or in electronic form, and may bear a facsimile of the signature of the Commissioner or of such Municipal Officer, as the case may be, stamped thereon.
(2) Nothing in sub-section (1) shall be deemed to apply to a cheque drawn upon the municipal fund or to any deed of contract entered into by the Municipality.
257. Publication of bye-laws, notice, orders etc.- Every bye-law, order, notice or other document directed to be published under this Act shall be written in, or translated into, the main language of the district and deposited at the municipal office, and a copy shall be posted up in a conspicuous position at such office or through web based, and at such other places as the Municipality may direct, and a public proclamation shall be made throughout the Municipality by beat of drum that such copy has been so posted up and that the original is open to inspection at the municipal office.
258. Notice of prohibition or setting apart of places.- Whenever the Municipality has set apart any place for any purpose authorized by this Act or has prohibited the doing of anything in any place, the Commissioner shall forthwith cause to be put up a notice in Telugu, Urdu or English. Such notice shall specify the purpose for which such place has been set apart, or the act prohibited in such place.
259. Method of serving documents.- When any notice, or other documents is required by this Act or by any rule, bye-law, regulation or order made under it, is to be served on or sent to any person, the service or sending thereof may be affected in the manner prescribed.
RELATIONS OF OCCUPIER TO OWNER.
260. Recovery by occupier of sum leviable, from owner.- If the occupier of any building or land makes, on behalf of the owner thereof, any payment for which, under this Act, the owner but not the occupier is liable, such occupier shall be entitled to recover the same from the owner, and may deduct the same from the rent, then or thereafter, due by him to the owner.
261. Obstruction of owner by occupier.- (1) If the occupier of any building or land prevents the owner from carrying into effect in respect thereof any of the provisions of this Act, the Commissioner may by an order, require the said occupier to permit the owner, within eight
(8) days from the date of service of such order, to execute all such works as may be necessary.
(2) Such owner shall, for the period during which he is prevented as aforesaid, be exempt from any fine or penalty to which he might otherwise have become liable, by reason of default, in executing such works.
262. Execution of work by occupier in default of owner.- If the owner of any building or land fails to execute any work, which he is required to execute under the provisions of this Act or of any rule, bye-law, regulation or order made under it, the occupier of such building or land may, with the approval of the Commissioner execute the said work and shall be entitled to recover, from the owner, the reasonable expenses incurred in the execution thereof, and may deduct the amount thereof from the rent, then or thereafter, due by him to the owner.
POWERS OF ENTRY AND INSPECTION
263. Power of entry to inspect, survey or execute the work.- The Commissioner, or any person authorized by him, on this behalf may enter into or on any building or land, with or without assistants or workmen, in order to make any enquiry, inspection, test, examination, survey, measurement, or valuation, or for the purpose of lawfully placing or removing pipes or meters, or to execute any other work, which is authorized by the provisions of this Act or of any rule, bye-law, regulation or order made under it, or which it is necessary, for any of the purposes of this Act, or in pursuance of any of the said provisions, to make or execute any work in the manner prescribed.
POWER TO ENFORCE LICENSING PROVISIONS.
264. Consequences of failure to obtain licenses or of breach of the same.- If, under this Act or any rule, bye-law or regulation made under it, the license or permission of the Commissioner or other officer of the Municipality, or registration in the municipal office is necessary for the doing of any act, and if such act is done without such license or permission or registration, or in a manner not consistent with the terms of any such license or permission, then action shall be taken against the person responsible in the manner prescribed.
PAYMENT OF COMPENSATION BY AND TO THE MUNICIPALITY
265. Power of Municipality to pay compensation.- If in any case, not otherwise expressly provided for in this Act, the Commissioner may, with the approval of the Government pay compensation to any person who sustains damage by reason of the exercise by any municipal authority, officer or servant of any of the powers vested in them by this Act or any other law, or by any rule, bye-law or regulation made under it.
266. Recovery of sums due as taxes.- All costs, damages, penalties, compensation charges, fees, other than school fees, expenses, rents, contributions and other sums, which, under this Act or any other law or rules or bye-laws made thereunder or under any contract in respect of water supply or drainage, made in accordance with this Act, the rules or bye-laws, are due by any person to the Municipality, shall be deemed as a bill payable to the Municipality and shall be recovered as per the rules prescribed under this Act.
267. Limitation for recovery of dues.- Notwithstanding any provisions provided under any law for time being in force, no distraint shall be made, no suit shall be instituted, and no prosecution shall be commenced in respect of any sum due to the Municipality under this Act, after the expiration of a period of seven years from the date on which distraint might first have been made.
268. Persons empowered to prosecute. Central Act 2 of 1974.- Subject to the provisions of section 267, no person shall be tried for any offence against the provisions of this Act, or of any rule or bye-law made under it, unless the complaint is made by the Commissioner or by a person expressly authorized in this behalf by the Municipality to the Judicial First Class Magistrate who has jurisdiction over the Municipality. The Judicial First Class Magistrate shall take cognizance as per the provisions of the Code of Criminal Procedure, 1973, in regard to the powers of the Magistrates to take cognizance of offences upon complaint received from the Commissioner or the person authorized by him:
Provided that failure to take out a license, obtain permission or secure registration under this Act shall, for the purposes of this section, be deemed a continuing offence until the expiration of the period, if any, for which the license, permission or registration is required and if no period is specified, complaint may be made at any time within twelve months from the commencement of the offence.
269. Imprisonment in default of payment and application of costs etc.- (1) Any fine, costs, tax or other sum imposed or assessed by a Magistrate under this Act or under any rule or bye-law made under it shall be recoverable by such Magistrate under the Code of Criminal Procedure, 1973, as if it were a fine and the same shall, except in the case of a fine on recovery, be paid to the Municipality, to be applied to the purposes of this Act.
(2) In case any fine or costs imposed or assessed under this Act or under any rule or bye-law made thereunder, are not paid by the defaulter or offender, the Magistrate may order the offender to be imprisoned for a period of six months in default of such payment.
270. Payment of compensation for damage to municipal property.- If, on account of any act or omission, any person has been convicted of an offence against the provisions of this Act or against any rule or bye-law made thereunder and, by reason of such act or omission, damage has been caused to any property, owned by or vesting in the Municipality, the said person shall pay compensation for such damage, notwithstanding any punishment to which he may have been sentenced for the said offence. In such event, the amount of compensation payable by the said person shall be determined by the Magistrate before whom he was convicted of the said offence on application made to him for the purpose of, by the Commissioner, not later than three
(3) months from the date of conviction; and in default of payment of the amount of compensation so determined, it shall be recovered under a warrant from the said Magistrate, as if it were a fine imposed by the Magistrate on the person liable thereof.
LEGAL PROCEEDINGS.
271. Institution of suits against Municipal Authorities, Officers and Servants.- (1) Notwithstanding any provisions provided under any law for the time being in force, no suit for damages or compensation shall be instituted against the Municipality, any municipal authority, officer or servant, or any person acting under the direction of such Municipality, municipal authority, officer or servant, in respect of any act done in pursuance of execution or intended execution of this Act or any rule, bye-law, regulation or order made under it or in respect of any alleged neglect or default in the execution of this Act, or any rule, bye-law, regulation, or order made under it, until the expiration of three (3) months after a notice has been delivered or left at the municipal office or at the place of abode of such officer, servant or person, stating the cause of action, the relief sought, and the name and place of abode of the intending plaintiff and the plaint shall contain a statement that such notice has been so delivered or left.
(2) Where the defendant, in any such suit, is the Chairperson, the Commissioner or a municipal officer or employee, payment of the sum or any part of any sum, payable by him in, or in consequence of the suit, whether in respect of costs, charges, expenses, compensation for damages or otherwise, shall be met from the municipal fund.
272. Provisions regarding institution of civil and criminal actions and obtaining of legal advice.- The Commissioner may,-
(a) take, or withdraw from, proceedings against any person who commits-
(i) any offence against this Act, rules, bye-laws or regulations;
(ii) any offence, which affects or is likely to affect any property or interest of the Municipality or the due administration of this Act;
(iii) any nuisance whatsoever;
(b) compound any offence against this Act, the rules, bye-laws or regulations;
(c) take, withdraw from or compromise proceedings for the recovery of expenses or compensation claimed to be due to the Municipality;
(d) withdraw or compromise any claim against any person in respect of a penalty payable under a contract entered into with such person;
(e) defend any suit or other legal proceedings brought against the Municipality or against any municipal authority, officer or employee, in respect of anything done or omitted to be done, as aforesaid;
(f) compromise any claim, suit or legal proceedings brought against the Municipality or against any municipal authority, officer or employee, in respect of anything done or omitted to be done, as aforesaid;
(g) institute and prosecute any suit, or withdraw from or compromise any suit or claim, which has been instituted or made in the name of the Municipality or any other municipal authority officer or employee;
(h) obtain such legal advice and assistance as he may, from time to time, think it necessary or expedient to obtain, or as he may be desired by the Municipality to obtain, for any of the purposes mentioned in the foregoing clauses of this section, or for securing the lawful exercise or discharge of any power or duty vesting in or imposed upon, any municipal authority or officer or employee.
273. Power of election authority to defend himself, if sued.- The election authority may defend himself, if sued or joined as a party, in any proceeding relating to the preparation or publication of electoral rolls or the conduct of elections, as the case may be, and the expenses incurred by the election authority in so doing shall be payable from the municipal fund.
274. Injunctions not to be granted in election proceedings. – No court shall grant any temporary injunction, or make any interim order, restraining any proceeding, which is being or about to be taken under this Act, for the preparation or publication of electoral rolls or for the conduct of any elections.
275. Protection of persons acting under this Act against suits.- No suit shall be maintainable against the Government, the District Collector, the Revenue Divisional Officer or any Chairperson, Municipal Authority, officer or employee, or any person acting under the direction of any Chairperson, Municipal Authority, officer or employee, or of a Magistrate, in respect of anything done in good faith under this Act or any rule, bye-law, regulation or order made under it.
276. Liability for loss, waste or misappropriation.- (1) The Chairperson, the Member, the Commissioner, the Municipal Engineer, the Town Planning Officer and the Bill Collector or other employee of the Municipality, entrusted with the collection of sums due to the Municipality under this Act, shall be liable for the loss, waste or misappropriation of any money or other property, owned by or vested in the Municipality, if such loss, waste or misappropriation is a direct consequence of his neglect or misconduct, and a suit for compensation may be instituted against him by the Municipality, or by the Government.
(2) No such suit shall be instituted after three (3) years after the accrual of the cause of action.
277. Sanction for Prosecution of Chairperson, Commissioner or any other officer.- When the Chairperson, Ward Member, the Commissioner or any other officer is accused of any offence, alleged to have been committed by him, while acting or purporting to act in the discharge of his official duty, no court shall take cognizance of such offence, except with the previous sanction of the Government.
278. Assessment not to be questioned.- No assessment or demand made, and no charge imposed under the authority of this Act, shall be questioned or affected by reason of any clerical error or by reason of any mistake (a) in respect of the name, residence, place of business or occupation of any person, or (b) in the description of any property or thing, or (c) in respect of the amount assessed, demanded or charged, provided that the provisions of this Act have been, in substance and effect, complied with; and no proceedings under this Act shall, merely for defect in form, be quashed or set aside by any Court.
279. Injunctions not to be granted in respect of revisions or amendment of assessment books.- No court shall grant any interim or temporary injunction or make any interim orders restraining any proceeding, which is being or about to be taken under Rules, for the revision or amendment of the assessment books or restraining such revision or amendment from taking effect.
POLICE
280. Duties of Police Officers.- (1) It shall be the duty of every police officer,-
(a) to communicate, without delay, to the proper municipal officer, any information which he receives of the design to commit or of the commission of any offence under this Act or any rule, bye-law or regulation made under it; and
(b) to assist the Chairperson, the Commissioner or any municipal officer or employee reasonably demanding his aid for the lawful exercise of any power, vesting in the Chairperson or the Commissioner, or in such municipal officer or employee under this Act, or any such rule, bye-law or regulation.
(2) Any police officer who omits or refuses to perform any duty, imposed on him by this Act, shall be subject to disciplinary proceedings for dereliction of duties as provided under the Service Rules applicable to the police.
281. Power of police officers to arrest persons.- (1) If any police officer sees any person committing an offence against any of the provisions of this Act or of any rule or bye-law made under it, he shall, if the name and address of such person are unknown to him, and if the said person on demand declines to give his name and address, or gives a name and address which such officer has reason to believe to be false, arrest such person.
(2) No person arrested under sub-section (1) shall be detained in custody,-
(a) after his true name and address are ascertained, or
(b) without the order of a Magistrate for any longer time, not exceeding twenty-four (24) hours from the hour of arrest than is necessary for bringing him before a Magistrate.
282. Exercise of Powers of Police Officer by Municipal Officers or Employees. Act III of 1889.- The Government may empower any municipal officer or employee or any class of municipal officers or employees to exercise the powers of police officer for the purposes of this Act and of the Telangana Towns Nuisances Act, 1889.
MISCELLANEOUS
283. Application of Term of ‘Public Servant’ to Municipal Officers, Agents and Sub-Agents. Central Act 45 of 1860.- Every municipal officer or employee, every contractor or agent, for the collection of any municipal tax, fee or other sum due to the Municipality, and every person employed by any such contractor or agent for the collection of such tax, fee or sum, shall be deemed to be a public servant within the meaning of section 21 of the Indian Penal Code, 1860.
284. Prohibition against removal of mark.- No person shall remove any mark set up for the purpose of indicating any level or direction incidental to the execution of any work authorised by this Act or by any bye- law, rule or order made under it.
285. Prohibition against removal or obliteration of notice.- No person shall, without authority in that behalf, remove, destroy, deface or otherwise obliterate, any notice exhibited by, or under the orders of the Municipality or the Commissioner or other officer authorized by him on this behalf.
286. Prohibition against unauthorized dealings with public place or materials.- No person shall, without authority in that behalf, remove earth, sand or other material or deposit any matter or make any encroachment from, in, or on, any land vested in the Municipality, or river, estuary, canal, backwater or water course, not being private property or, in any way, obstruct the same.
287. Delegation of powers by the government.- (1) The Government may, by notification, delegate to any person or authority all or any of the powers vested in them by this Act, except the power to make rules and may in like manner, withdraw any powers so delegated.
(2) The exercise of any powers delegated under sub- section (1) shall be subject to such restrictions and conditions, as may be prescribed, or as may be specified in the notification, and also to control and revision by the Government.
288. Power to give directions.- The Government or the District Collector may, from time to time, give such directions not inconsistent with the provisions of this Act or the rules made thereunder to a Municipality, as it may consider necessary, for carrying out the purposes of this Act.
289. Adjudication of disputes between Local Authorities.- When a dispute exists between a Municipality and one or more than one local authority in regard to any matters arising under the provisions of this Act, or any other enactment and the Government are of the opinion that the local authorities concerned are unable to settle it amicably among themselves, the Government may take cognizance of the dispute and issue orders. Any such decision shall be binding on each of the local authorities concerned and shall not be liable to be questioned in any court of law.
290. Notified Areas.- The Government may, by notification, declare any local area to be a notified area or a Township or an integrated township, for the purpose of application of all or any of the provisions of this Act in the said notified area or a Township in the manner prescribed.
291. Power to transfer functions of municipalities to Telangana State Industrial Infrastructure Corporation and vice versa.- Notwithstanding anything contained in this Act, or in any other law for the time being in force, relating to the Municipalities or the Notified Area Committees, the Government may, in consultation with any Municipality or the Notified Area Committee, as the case may be, and also the Telangana State Industrial Infrastructure Corporation, by notification, and subject to such restrictions and conditions, including those relating to the remittance of such percentage of the property tax to a Municipality or to a Notified Area Committee and to such control and revision, as may be specified therein, direct that any power or function vested in the Municipality or the Notified Area Committee by or under this Act, shall be transferred to and exercised and performed by the Telangana State Industrial Infrastructure Corporation or any other agencies, as notified by the Government. The same holds vice versa.
292. Disclosure of information.- The Municipality shall maintain and publish all its records, quarterly, half-yearly and yearly intervals, duly categorized and indexed in a manner and form which facilitates the disclosure of such information to the public in such manner as prescribed.
293. Extension of provisions of law relating to municipalities or of rules thereunder, for mining settlement. Act XLIV of 1956.- (1) The Government may, at the request of the Mines Board of Health, constituted under Telangana Mining Settlements Act, 1956 or otherwise by notification, declare that any of the provisions of this Act, or of any rule made thereunder, including those relating to taxation, shall be extended to and be in force in the Mining Settlement or in any specified area therein.
(2) The provisions so notified shall be construed with such alterations not affecting the substance, as may be necessary or proper, for the purpose of adapting them to the Mining Settlement or any special area therein.
294. Vesting of public streets and appurtenances in the Municipality.- (1) All public streets in the Municipality with the pavements, stones and other materials thereof and all works, materials and other things provided for such streets, including public resources and spaces such as water bodies, etc., other than those managed by Central and State Government, sewers, drains, drainage works, tunnels and culverts, whether made at the cost of the municipal fund or otherwise, in, alongside or under any street, whether public or private, and all works, materials and things appertaining thereto, shall vest in the Municipality.
(2) Notwithstanding anything in sub-section (1), the Government may, after consultation with the Municipality, shall withdraw any such street, sewer, drain, drainage work, tunnel or culvert from the control of the Municipality and place at the control of any other department of Government, by notification.
295. Duty of Municipality in respect of public streets withdrawn from its control.- (1) Where the Municipality has withdrawn a public street and vested the same under the control of any other department of the Government, under sub-section (2) of section 294, it shall be the duty of the Municipality to provide, from the Municipal funds, any amenities as the Government may by general or special order, direct.
(2) From the date of the commencement of this Act, all vacant lands belonging to or under the control of the Government unless otherwise vested with any Government department / local body, shall subject to sub-sections (3) and (4) vest in the possession or under the control of the Municipality concerned for the purposes of this Act.
Explanation:- For the purpose of this section “vacant land” includes a poramboke, donka or kunta.
(3) The Municipality shall keep all such vacant lands free from encumbrances and shall restore the possession of such land to the Government for the public purpose, free of cost, or for purpose of alienation to any person or authority whenever required.
(4) The Municipality shall not construct or permit the construction of any building or structure on any such vacant land, or, use or permit the use of such vacant land for any permanent purpose, or alienate such vacant land to any third-party, unless prior permission is obtained from the Government. The Government may give permission only after obtaining the necessary information which deems fit in the circumstances of the case.
296. Collected sewage, construction waste, etc. to belong to Municipality.- All garbage, filth, sewage, construction and demolition waste and other collected material by or on behalf of a Municipality, shall belong to the Municipality.
297. Procedure for acquisition of immovable property required by the Municipality. Central Act 30 of 2013.- The municipal authority under this Act may acquire an immovable property subject to the provisions of the Right to Fair Compensation and Transparency in Land Acquisition, Rehabilitation and Resettlement Act, 2013 and any subsequent Act or notification thereupon as applicable in the State of Telangana, on payment of compensation and the property acquired shall vest in Municipality.
298. Special powers of the Government. The Government, if it deems fit and necessary in the interest of the functioning of Municipal Corporations and the Councils, may make special provisions with respect to one or more corporations or councils.
299. Repeal and savings. Act No. 6 of 1965. Act 25 of 1994.- (1) On and from the commencement of this Act, the Telangana Municipalities Act, 1965 and the Telangana Municipal Corporations Act, 1994 are repealed.
(2) On such repeal, the provisions of sections 8 and 18 of the Telangana General Clauses Act, 1891, shall apply, provided that on such repeal, rules or provisions existing are not inconsistent with this Act.
(3) Notwithstanding the repeal of the Acts referred in sub-section (1) the appointment, notification, order, scheme, form, notice, rule, or bye-law, made or issued, and license or permission granted under the Acts, shall, in so far as it is not inconsistent with the provisions of this Act, shall continue in force and be deemed to have been made, issued or granted under the provisions of this Act, unless it is lapsed or superseded by any appointment, notification, order, scheme, form, notice, rule or bye-law made or issued, and any license or permission granted under the said provisions.
(4) The members of any Council and Corporation holding office at the commencement of this Act shall be deemed to have been elected as members of that Council and Corporation under this Act, and subject to provisions of section 10, continue to hold office of members until the expiration of their term under the provisions which were applicable to them immediately before such commencement.
(5) Any division of the Municipality into wards, made or deemed to have been made under the Telangana Municipalities Act, 1965 or Telangana Municipal Corporations Act, 1994 and in force at the commencement of this Act, shall be deemed to be the division of the Municipality into wards made under this Act; and the members representing the wards shall, subject to the provisions under sub-section (4), be deemed to represent them on and from the commencement of this Act.
300. Remove of difficulties.- If any difficulty arises in giving effect to the provisions of this Act or as to the first constitution or re-constitution of any Municipal Council or Municipal Corporation after the commencement of this Act, the Government may, as occasion may require, may by an order published in the Telangana Gazette do anything which appears to them to be necessary for the purpose of removing the difficulty.
301. Repeal of Ordinance 6 of 2019.- The Telangana Municipalities Ordinance, 2019 is hereby repealed.
Schedule – I
(see sub-section (2) of section 3) LIST OF MUNICIPALITIES IN THE STATE
| Sl.No. |
Name of the District |
Name of the Municipality |
Number of Wards |
| (1) |
(2) |
(3) |
(4) |
| I |
JANGAON |
|
|
| 1 |
|
Jangaon |
30 |
| II |
WARANGAL RURAL |
|
|
| 2 |
|
Parkal |
22 |
| 3 |
|
Narsampet |
24 |
| 4 |
|
Wardhannapet |
12 |
| III |
MAHABUBABAD |
|
|
| 5 |
|
Mahabubabad |
36 |
| 6 |
|
Dornakal |
15 |
| 7 |
|
Maripeda |
15 |
| 8 |
|
Thorrur |
16 |
| IV |
JAYASHANKAR BHUPALAPALLY |
|
|
| 9 |
|
Bhupalpally |
30 |
| V |
KARIMNAGAR |
|
|
| 10 |
|
Jammikunta |
30 |
| 11 |
|
Huzurabad |
30 |
| 12 |
|
Choppandandi |
14 |
| 13 |
|
Kothapally |
12 |
| VI |
JAGTIAL |
|
|
| 14 |
|
Jagtial |
48 |
| 15 |
|
Korutla |
33 |
| 16 |
|
Metpalli |
26 |
| 17 |
|
Raikal |
12 |
| 18 |
|
Dharmapuri |
15 |
| VII |
RAJANNA- SIRCILLA |
|
|
| 19 |
|
Vemulavada |
28 |
| 20 |
|
Sircilla |
39 |
| VIII |
PEDDAPALLI |
|
|
| 21 |
|
Peddapalli |
36 |
| 22 |
|
Manthani |
13 |
| 23 |
|
Sulthanabad |
15 |
| IX |
KHAMMAM |
|
|
| 24 |
|
Sattupalli |
23 |
| 25 |
|
Madhira |
22 |
| 26 |
|
Wyra |
20 |
| X |
BHADRADRI KOTHAGUDEM |
|
|
| 27 |
|
Kothagudem |
36 |
| 28 |
|
Palvancha |
24 |
| 29 |
|
Yellandu |
24 |
| 30 |
|
Manuguru |
23 |
| XI |
ADILABAD |
|
|
| 31 |
|
Adilabad |
49 |
| XII |
NIRMAL |
|
|
| 32 |
|
Nirmal |
42 |
| 33 |
|
Bhainsa |
26 |
| 34 |
|
Khanapur |
12 |
| XIII |
KUMARAMBHEEM ASIFABAD |
|
|
| 35 |
|
Kagaznagar |
30 |
| XIV |
MANCHERIAL |
|
|
| 36 |
|
Mancherial |
36 |
| 37 |
|
Bellampally |
34 |
| 38 |
|
Mandamarri |
24 |
| 39 |
|
Naspur |
25 |
| 40 |
|
Chennur |
18 |
| 41 |
|
Kyathanpally |
22 |
| 42 |
|
Luxettipet |
15 |
| XV |
RANGA REDDY |
|
| 43 |
|
Pedda Amberpet |
24 |
| 44 |
|
Ibrahimpatnam |
24 |
| 45 |
|
Jalpally |
28 |
| 46 |
|
Shadnagar |
28 |
| 47 |
|
Shamshabad |
25 |
| 48 |
|
Turkayamjal |
24 |
| 49 |
|
Manikonda |
20 |
| 50 |
|
Narsingi |
18 |
| 51 |
|
Adibatla |
15 |
| 52 |
|
Shankarpally |
15 |
| 53 |
|
Thukkuguda |
15 |
| 54 |
|
Amangal |
15 |
| XVI |
VIKARABAD |
|
|
| 55 |
|
Tandur |
36 |
| 56 |
|
Vikarabad |
34 |
| 57 |
|
Parigi |
15 |
| 58 |
|
Kodangal |
12 |
| XVII |
MEDCHAL- MALKAJGIRI |
|
|
| 59 |
|
Medchal |
23 |
| 60 |
|
Dhammaiguda |
18 |
| 61 |
|
Nagaram |
20 |
| 62 |
|
Pocharam |
18 |
| 63 |
|
Ghatkesar |
18 |
| 64 |
|
Gundlapochampally |
15 |
| 65 |
|
Thumkunta |
16 |
| 66 |
|
Kompally |
18 |
| 67 |
|
Dundigal |
28 |
| XVIII |
NIZAMABAD |
|
|
| 68 |
|
Bodhan |
38 |
| 69 |
|
Armur |
36 |
| 70 |
|
Bheemgal |
12 |
| XIX |
KAMAREDDY |
|
| 71 |
|
Kamareddy |
49 |
| 72 |
|
Banswada |
19 |
| 73 |
|
Yellareddy |
12 |
| XX |
YADADRI BHUVANAGIRI |
|
|
| 74 |
|
Bhongir |
35 |
| 75 |
|
Mothkur |
12 |
| 76 |
|
Choutuppal |
20 |
| 77 |
|
Alair |
12 |
| 78 |
|
Pochampally |
13 |
| 79 |
|
Yadagirigutta |
12 |
| XXI |
SURYAPET |
|
|
| 80 |
|
Suryapet |
48 |
| 81 |
|
Kodada |
35 |
| 82 |
|
Huzurnagar |
28 |
| 83 |
|
Neredcherla |
15 |
| 84 |
|
Tirumalagiri |
15 |
| XXII |
NALGONDA |
|
|
| 85 |
|
Devarakonda |
20 |
| 86 |
|
Nalgonda |
48 |
| 87 |
|
Miryalguda |
48 |
| 88 |
|
Nakrekal |
20 |
| 89 |
|
Nandikonda |
12 |
| 90 |
|
Chityal |
12 |
| 91 |
|
Haliya |
12 |
| 92 |
|
Chandur |
10 |
| XXIII |
SIDDIPET |
|
|
| 93 |
|
Siddipet |
43 |
| 94 |
|
Gajwel |
20 |
| 95 |
|
Dubbaka |
20 |
| 96 |
|
Husnabad |
20 |
| 97 |
|
Cherial |
12 |
| XXIV |
SANGAREDDY |
|
|
| 98 |
|
Sangareddy |
38 |
| 99 |
|
Sadasivapet |
26 |
| 100 |
|
Zaheerabad |
37 |
| 101 |
|
Andol-Jogipet |
20 |
| 102 |
|
Narayankhed |
15 |
| 103 |
|
Bollaram |
22 |
| 104 |
|
Tellapur |
17 |
| 105 |
|
Ameenpur |
24 |
| XXV |
MEDAK |
|
|
| 106 |
|
Medak |
32 |
| 107 |
|
Thoopran |
16 |
| 108 |
|
Ramayapet |
12 |
| 109 |
|
Narsapur |
15 |
| XXVI |
MAHABUBNAGAR |
|
|
| 110 |
|
Mahabubnagar |
49 |
| 111 |
|
Jadcherla |
27 |
| 112 |
|
Boothpur |
10 |
| XXVII |
NARAYANPET |
|
|
| 113 |
|
Narayanapet |
24 |
| 114 |
|
Makthal |
16 |
| 115 |
|
Kosgi |
16 |
| XXVIII |
JOGULAMBA GADWAL |
|
|
| 116 |
|
Gadwal |
37 |
| 117 |
|
Ieeja |
20 |
| 118 |
|
Waddepalle |
10 |
| 119 |
|
Alampur |
10 |
| XXIX |
WANAPARTHY |
|
|
| 120 |
|
Wanaparthy |
33 |
| 121 |
|
Kothakota |
15 |
| 122 |
|
Pebbair |
12 |
| 123 |
|
Atmakur |
10 |
| 124 |
|
Amarchinta |
10 |
| XXX |
NAGARKURNOOL |
|
| 125 |
|
Nagarkurnool |
24 |
| 126 |
|
Kollapur |
20 |
| 127 |
|
Kalwakurthy |
22 |
| 128 |
|
Atchampet |
20 |
SCHEDULE-II
(see sub-section (2) of section 3)
| Sl.No. |
Name of the District |
Name of the Municipal Corporation |
Number of Wards |
| (1) |
(2) |
(3) |
(4) |
| 1 |
Warangal |
Greater Warangal Municipal Corporation |
66 |
| 2 |
Karimnagar |
Karimnagar |
60 |
| 3 |
Peddapalli |
Ramagundam |
50 |
| 4 |
Nizamabad |
Nizamabad |
60 |
| 5 |
Khammam |
Khammam |
60 |
| 6 |
Ranga Reddy |
Badangpet |
32 |
| 7 |
Ranga Reddy |
Bandlaguda Jagir |
22 |
| 8 |
Ranga Reddy |
Meerpet (by merging Meerpet and Jillelguda) |
46 |
| 9 |
|
Boduppal |
28 |
| 10 |
Medchal- Malkajgiri |
Peerzadiguda |
26 |
| 11 |
|
Jawaharnagar |
28 |
| 12 |
|
Nizampet |
33 |
SCHEDULE-III
| Sl. No. |
Name of the Municipal Service |
Documents required |
Time lines |
Officers involved in this process |
Approval by |
| (1) |
(2) |
(3) |
(4) |
(5) |
(6) |
| 1. |
Property Tax Property Tax Assessment of building |
Registered Document / Court Decree / Affidavit, Building Permission Number |
Instant |
Online |
|
| 2. |
Vacancy remission |
Assessment copy / proof of vacancy |
15 days |
Online |
Municipal Commis- sioner |
| 3. |
Revision Petition |
Application with Assessment Number details |
15 days |
Online |
Municipal Commissioner |
| 4. |
Appeal |
Application with Review Petition orders |
15 days |
Authori- zed person |
Regional Director concer- ned |
| 5. |
Certified Copy of Assessment Register |
Free download of assessment details |
| 6. |
Vacant Land Assessment |
Registered Document / Court Decree / Affidavit |
Instant |
Online |
|
| 7. |
Water Tap Connection |
Application |
14 days |
Online |
Mission Baghira- tha |
| 8. |
Trade License |
Application with self certification |
Instant |
Online |
|
| 9. |
Trade Renewal |
Application with self certification |
Instant |
Online |
|
| 10. |
Mutation |
On registration, application get auto transfer from Registration Department to Municipality and makes auto title transfer instantly. |
| 11. |
Sub- Division request |
Registered Document / Court Decree / Affidavit, Building Permission Number / Affidavit |
15 days |
Authori- zed person |
Municipal Commis- sioner |
| 12. |
Certified Copy of Building Permission |
Instant download from website |
Instant |
Authori- zed person |
|
| 13. |
Land use certificate as per master plan |
Application |
7 days |
Online |
Municipal Commis- sioner |
| 14. |
Birth Certificate |
Application |
Instant |
Online |
Municipal Commis- sioner |
| 15. |
Child name inclusion in Birth Certificate |
Application |
7 days |
Online |
Municipal Commis- sioner |
| 16. |
Name Correction in Birth Certificate |
Application, self declaration |
7 days |
Online |
Municipal Commis- sioner |
| 17. |
Non- availability of Birth Certificate |
Application, self declaration |
7 days |
Online |
Municipal Commis- sioner |
| 18. |
Death Certificate |
Application along with documents prescribed |
7 days |
Online |
Municipal Commis- sioner |
| 19. |
Name correction in Death Certificate |
Application, self declaration |
7 days |
Online |
Municipal Commis- sioner |
| 20. |
Non availability of Death Certificate |
Application, self declaration |
7 days |
Online |
Municipal Commis- sioner |
| 21. |
Sanitary Certificate for Educational Institutions |
Registration and Recognised Certificate from School Education Department and application |
7 days |
Authori- sed person |
Municipal Commis- sioner |
| 22. |
Any other services as prescribed by the Government. |
SCHEDULE-IV
(see section 12)
PROVISIONS WITH REGARD TO DISQUALIFICATION OF MEMBERS
1. Disqualification for Election or for Holding Office as a Member:
A person holding an office of profit under a Municipality, the Central Government or the State Government shall be disqualified for election or for holding office as member:
Provided that a person shall not be deemed to hold an office of profit under Municipality by reason, only that he is a Chairperson or member of a Municipality in the State.
2. Other Disqualifications of Candidates:
(1) A person who has been sentenced by a criminal court,-
(a) to imprisonment for an offence under the Protection of Civil Rights Act, 1955 (Central Act 22 of 1955);
(b) for any offence other than an offence of political character, or any offence not involving moral delinquency, such sentence not having been suspended, reversed or the offence pardoned, shall be disqualified for election as a member, while undergoing the sentence and for five years from the date of expiration thereof.
(2) A person shall be disqualified for election as a member, if such person is, on the date fixed for scrutiny of nomination for election,-
(a) of unsound mind and stands so declared by a competent court;
(b) an applicant to be adjudicated an insolvent or undischarged insolvent;
(c) interested in a subsisting lease or contract entered into with or any work being done for the Municipality, except as a shareholder, other than a Director, in a company:
Provided that a person shall not be deemed to have any interest in such contract or work by reason only of his having a share or interest in,-
(i) any sale or purchase of immovable property or any agreement for the same; or
(ii) any public loan raised by Municipality or any security for the payment of money only; or
(iii) any newspaper in which any advertisement relating to the affairs of the Municipality is inserted; or
(iv) the sale to the Municipality, of any articles, in which he regularly trades, or the purchase from the Municipality, of any articles, to a value in either case not exceeding five hundred (500) rupees, in the aggregate, in any year during the period of the contract or work;
(v) the occasional letting out on hire to the Municipality or hiring from the Municipality, of any article, for an amount not exceeding, in the aggregate, in any one year five hundred (500) rupees;
(d) an honorary Magistrate for the municipal town;
(e) already a member or Sarpanch of a Gram Panchayat or a member of a Mandal Praja Parishad or Zilla Praja Parishad constituted under the provisions of the Telangana Panchayat Raj Act, 2018 (Telangana Act 5 of 2018);
(f) already a member whose term of office, as such, will not expire before his fresh election can take effect, or has already been elected a member, whose term of office has not yet commenced;
Explanation: Nothing in this clause shall be construed as disqualifying a sitting member of a Municipality for re- election as member to that Municipality;
(g) the employee or employer or the official subordinate or official superior of a member holding office on the said date;
(h) in arrears of any kind due by him otherwise than in a fiduciary capacity to the Municipality upto and inclusive of the previous year, in respect of which a bill or notice has been duly served upon him, and the time, if any, specified therein for payment, has expired; or
(i) dismissed from service of the Central Government, the State Government, any Municipality or any local authority, for misconduct.
3. Disqualification for failure to lodge Account of Election Expenses:
If the State Election Commission is satisfied that a person,-
(a) has failed to lodge an account of election expenses within the time limit prescribed and, in the manner, required by or under this Act, and
(b) has no good reason or justification for the failure, the State Election Commission shall, after following the procedure prescribed, by order published in the Telangana Gazette, declare him,
(i) to be ineligible for a period of three (3) years from the date of the said order to contest any election held for any office under this Act; and
(ii) to have ceased to hold office, in case he is elected.
4. Disqualification of Members:
(1) Subject to the provisions of section 13, a member shall cease to hold his office, if he,-
(a) is sentenced by a criminal court to such punishment and for such offence, as is described in sub- paragraph (1) of Paragraph 2;
(b) is elected to a ward/office reserved for Scheduled Castes or Scheduled Tribes or Backward Classes, and subsequently the Community Certificate, on the basis of which he is elected is cancelled, under section 5 of the Telangana (Scheduled Castes, Scheduled Tribes and Backward Classes) Regulation of Issue of Community Certificates Act,1993 (Act 16 of 1993);
(c) becomes of unsound mind and stands so declared by a competent court;
(d) applies to be adjudicated, or is adjudicated, an insolvent;
(e) subject to the proviso to sub-paragraph (2)(c) of Paragraph 2, acquires any interest in any subsisting contract made with, or work being done for, the Municipality, except as a shareholder, other than a Director, in a company;
(f) is employed as a paid legal practitioner on behalf of the Municipality or legal practitioner against the Municipality;
(g) is appointed as an officer or servant under this Act, or as an honorary Magistrate for the municipal town;
(h) accepts employment under or becomes the official subordinate of any other member;
(i) ceases to reside for a period of more than six (6) months in the Municipality or within two kilometers from the outer limits there from;
(j) fails to pay arrears of any kind due by him, otherwise than in a fiduciary capacity, to the Municipality within three (3) months after a bill or notice has been served upon him under this Act, or where, in the case of any arrears, this Act does not require the service of any bill or notice, within three (3) months after a notice requiring payment of the arrears, which notice it shall be the duty of the Commissioner to serve at the earliest possible date, has been duly served upon him by the Commissioner;
(k) absents himself from the meetings of the Municipality for a period of three (3) consecutive months, reckoned from the date of the commencement of his term of office, or of the last meeting which he attended, or of his restoration to office as member under sub-paragraph (3), as the case may be, or if within the said period, less than three (3) ordinary meetings have been held absents himself from three consecutive ordinary meetings held after the said date:
Provided that in the case of a woman member, a period of not more than two (2) months at a time shall be excluded in reckoning the period of absence aforesaid if, for reasons of physical disability, due to advanced stage of pregnancy and of delivery, such member absents herself from meetings of the Municipality, after giving a written intimation to the Commissioner of the date from which she would be absent:
Provided further that no meeting from which a member absented himself shall be counted against him under this clause, if notice of that meeting was not duly served on him:
Provided also that nothing in this clause shall apply to an ex-officio member.
(2) Where a person ceases to be a member under sub- paragraph (1) (a) of Paragraph 4, he shall be restored to office for such portion of the period, for which he was elected, as may remain unexpired at the date of such restoration, if and when the sentence or order is annulled on appeal or revision, and any person elected to fill the vacancy in the interim shall, on such restoration, vacate office.
(3) Where a person ceases to be a member under sub- paragraph (1) (l) of Paragraph 4, the Commissioner shall, at once, intimate the fact, in writing, to such person and report the same to the Municipality at its next meeting. If such person applies for restoration to the Municipality on or before the date of its next meeting, or within fifteen (15) days of the receipt by him of such intimation; the Municipality may, at the meeting next after the receipt of such application, or suo moto, restore him to the office of the member:
Provided that a member shall not be so restored more than thrice during his term of office.
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