Recently, the pharma standard body ‘The Indian Pharmacopoeia Commission’ (IPC) issued safety concerns for the commonly used painkiller Meftal Spas. In its alert, IPC stated, “Healthcare professionals and consumers are advised to closely monitor the possibility of adverse drug reactions with the use of the drug.”
The IPC’s concerns over Meftal Spas, a medicine which is found on every Indian household’s kitchen shelves, have again brought the non-regulation of Over-the-counter (OTC) drugs into the limelight.
Over-the-counter medicines are also called non-prescription drugs and are defined as medicines that can be sold directly to people without a prescription. In India, the practice of self-medication is quite prevalent due to a plethora of reasons. These reasons include expensive healthcare which leads to inaccessible healthcare, low doctor-to-patient ratio, prevalence of home remedies and self-medication culture which has been in existence for generations. Therefore, the intake and consumption of OTCs are very common in our country and require strict regulation.
The Indian OTC market is estimated to be around $6.5 billion. However, at present, we do not have any law that explicitly regulates the sale of OTCs. There are some laws whose purview may include OTC drugs but the ambiguity persists. With a proper law, several societal, legal and medical issues can be resolved.
The Ahooja committee on OTC drugs constituted under the chairmanship of Narendra K Ahooja, Drugs Controller, Haryana stated that “Over-the-counter drug regulations are required for the following reasons:
- To reduce the treatment cost;
- To eliminate the problem of unregistered medical practitioners, who are neither qualifying as required under Rule 2 (ee) of Drug Rules nor have qualification as prescribed under the Indian Medical Council Act 1956 and the Central Council of Indian Medicine Act 1970;
- To provide primary healthcare facilities to all at the doorstep up to the village level;
- To empower registered pharmacists and to provide a legal base for pharmacists to perform their duties under the Pharmacy Act 1948 as provided under Chapter II Code of Pharmacy Ethics
- To eradicate the problem of irresponsible self-medication.”
Therefore, it is pertinent for us to explore the grey area of OTC medicines regulations which severely affects one’s right to health, an integral part of the right to life.
Under Section 7 of the D&C Act, a committee known as the Drugs Consultative Committee is to be constituted, whose sole function is to advise the government on policy matters for better regulation under this act.
In its 52nd meeting held in 2017, the committee recommended the creation of a separate class of drugs called OTC drugs. Furthermore, the subcommittee known as the Shankar Committee was established to prepare a list of OTC medicines. In its 55th meeting held in 2019, the Shankar committee submitted its report comprising recommendations for regulations for OTCs. Another sub-committee, the Ahooja Committee was also constituted in this meeting which examined the aforementioned report. The committee highlighted the urgent need for defining such regulations. Furthermore, in 2019, the 57th meeting was held which examined the recommendations given by the Ahooja committee. Subsequently, the DCC recommended that a suitable amendment should be made in Schedule K (exemptions and conditions for exemption from the provisions of Chapter IV of the D&C Act and the Rules made thereunder) of the D&C Rules to incorporate necessary provisions for OTC drugs.
Eventually, in 2023, the National Medical Commission notified the Regulations relating to the Professional Conduct of Registered Medical Practitioners. It notified a list of drugs which can be sold sans prescription.
Although deliberations have been going on among government, stakeholders and advisory and expert bodies, the moot question of OTC regulations persists.
LAWS GOVERNING OTC MEDICINES
DRUGS AND COSMETICS ACT, 1940 and DRUGS AND COSMETICS RULES, 1947
The act defines a drug as “all medicines for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals, including preparations applied on the human body to repel insects like mosquitoes” The definition, as evident, makes no classification of the drugs based on prescription.
However, by Schedules H, H (1), X and Schedule K of the Act, a vague attempt at differentiation has been made. Prescription drugs are those which are enlisted in Schedules H, H (1) and X. Although no specific schedule has been allotted to OTC medicines, Schedule K specifies those drugs sold by non-drug licensed stores or non-pharmacies. Common drugs such as Paracetamol and Aspirin tablets etc. fall under the latter category.
The act mentions several legal remedies in case of damage caused by the drugs. Though OTC medicines have not been expressly called out under the act, the provisions will nevertheless apply to them.
Section 16 of the Drugs and Cosmetics Act, 1945 provides that the drug must strictly comply with various tests as mentioned in the Second Schedule. Section 17 of the act defines ‘misbranded drugs.’ The section states that any drug which conceals the true nature of the drug or if not labelled in the prescribed manner or makes any false claim for the drug or misleads the consumer is said to be a misbranded drug.
Section 17(A) defines ‘adulterated drugs’ as any drug consisting of any contaminant and therefore, is injurious to health or a drug bearing a colour other than one which is prescribed. Section 17 B states that a drug is spurious if it is manufactured and sold under a name resembling another drug which tends to deceive the consumer by concealing the true character of the drug.
Furthermore, Section 18 prohibits the manufacturer from manufacturing for sale or for distribution, selling, or stock or exhibiting or offering for sale any drug which is misbranded, spurious or not of standard quality.
Section 26(a) grants the central government the authority to regulate, restrict, or manufacture misbranded drugs. Any violation of Sections 17 and 18 of the Act is subject to penalty under Section 27.
Moreover, Rule 106 of the Drugs and Cosmetics Rules, 1945 framed under the parent D&C Act, provides that no drug shall convey that the drugs cause miscarriage in women and shall not purport to cure ailments specified in Schedule J. Schedule J contains over 50 diseases, disorders and conditions such as AIDS, genetic disorders, baldness, cataract, diabetes, improvement in height of children and adults, improvement in vision, myocardial infarction, obesity, spondylitis, stones in the gallbladder, varicose vein, etc.
CONSUMER PROTECTION ACT, 2019
In LDA v M.K. Gupta, the Supreme Court reiterated the intent of the CPA, 2019 and stated that “To begin with the preamble of the Consumer Protection Act,2019, which can afford useful assistance to ascertain the legislative intention, it was enacted, to provide for the protection of the interest of consumers.”
The rights of a consumer are defined under section 2(9) of the Consumer Protection Act, 2019 which include the right to be protected against the marketing of goods, which pose a danger to life; the right to be informed about the nature of such goods or services to protect the consumer against unfair trade practices etc.
Section 21(2) empowers the Central Authority to impose a penalty in respect of false or misleading advertisements which may extend to ten lakh rupees. Further, Section 89 punishes the manufacturer promoting a false or misleading advertisement with imprisonment for a term which may extend to two years and with a fine which may extend to ten lakh rupees. For every subsequent offence, the punishment provided is imprisonment for a term which may extend to five years and a fine which may extend to fifty lakh rupees.
- Causes injury not amounting to grievous hurt – imprisonment for a term which may extend to one year and with a fine which may extend to three lakh rupees
- Causes injury resulting in grievous hurt – imprisonment for a term which may extend to seven years and with a fine which may extend to five lakh rupees;
- Causes the death of a consumer, with imprisonment for a term which shall not be less than seven years, but may extend to imprisonment for life and with a fine which shall not be less than ten lakh rupees.
The aforementioned offences are cognizable and non-bailable in nature. Further, the license of the manufacturer can be suspended for up to 2 years, in case of first contravention. Further and subsequent conviction may lead to cancellation of such license.
Section 84 introduces the concept of product liability of the manufacturer. The section holds the manufacturer strictly liable in case of inadequate instructions concerning usage, specifications, warranties and warnings. On the other hand, S.86 imposes liability on a product seller who is not a manufacturer.
DRUGS AND MAGIC REMEDIES (OBJECTIONABLE ADVERTISEMENTS) ACT, 1954
In Hamdard Dawakhana and Ors. vs. Union of India , the apex court discussed the intent and scope of the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954. It was averred by the court that “The main purpose and true intent and aim, object and scope of the Act is to prevent self-medication or self-treatment and for that purpose advertisements commending certain drugs and medicines have been prohibited.”
According to Section 3 of the Act, no one is allowed to publish any advertisements for drugs that (a) cause miscarriages in women or (b) prevent women from becoming pregnant. (b) The preservation or enhancement of human sexual enjoyment capability. (c) Treating women’s menstrual problems. Furthermore, it is illegal to advertise pharmaceuticals for the diagnosis, treatment, mitigation, cure, or prevention of any condition listed in the Schedule.
Section 4 of the Act prohibits such drug advertisement where it directly or indirectly gives a false impression regarding the true character of the drug and misleads the consumers.
Further, Section 7 penalizes any act done in contravention of this law. In the case of the first conviction, imprisonment of the utmost six months, or fine, or both are imposed. Whereas in the case of a subsequent conviction, an imprisonment of utmost one year, or fine, or both are imposed.
The landscape of over-the-counter medicines in India appears shrouded in ambiguity, with no specific legislation addressing the intricate issues surrounding these products. While existing laws such as the Consumer Protection Act, of 2019, and the Drugs and Cosmetics Act may provide a foundation for regulation, the absence of a dedicated framework contributes to significant confusion among consumers, manufacturers, and healthcare professionals alike. The article contends that in a rapidly evolving healthcare environment, it is imperative to establish comprehensive and explicit laws governing over-the-counter medicines. Such legislation would not only ensure the safety and efficacy of these products but also foster transparency, consumer confidence, and responsible marketing practices.
This article is written and submitted by Vani Singh during her course of internship at B&B Associates LLP. Vani is a 2nd year year B.A. L.L.B (Hons.) student at NLU,Visakhapatnam.