With the rise in demand for cosmetics products, the industry is also growing rapidly. From international companies coming to India to homegrown companies establishing themselves in the cosmetic market, the industry has come a long way. ‘BlueWeave Consulting’ is a leading strategic consulting and market research firm, and in its recent study, expects the Indian cosmetics market size to grow at a steady CAGR (compound annual growth rate) of 5.8% during the forecast period between 2023 and 2029.
The reason for such growth can be the hike in purchasing power, awareness, technology, innovative ideas of products, marketing strategies and to make human life easy. The cosmetic Industry has not only confined itself to social status or gender rather it has established itself as a want in every household after covid. In this article, we are going to talk about Cosmetovigilance In India’s Cosmetics Sector.
Cosmetovigilance: Compilation, Evaluation And Monitoring Of Cosmetic Products
Pharmacovigilance can be defined as the collection, detection, assessment, monitoring, and prevention of adverse reactions occurring with medications. Recently, the spectrum of the word vigilance has widened to include the safety of herbal products and cosmetic products as well. ‘Cosmetovigilance’ was introduced as a new term used for defining surveillance carried out by the industry to address the safety of cosmetic products.
The history of the word “cosmetovigilance” goes long back to 1976, in European Union, where it was held that cosmetic products should not harm the skin or cause any adverse reaction on the skin whenever applicable. It was also used in the literature in the year 1997 to refer to the monitoring of cosmetic product safety. Today, it is recognized globally as a concept of public health.
Cosmetovigilance is a very new and fresh topic in India. The objective of cosmetovigilance is an investigation of cosmetic products for the health of the public. Cosmetovigilance is developing as a durable regulatory science to protect public health and beauty. India is now the most populated country in the world and similarly has a huge market for the cosmetic industry. Dermatosis caused due to cosmetic products is common in India. There is a need for a proper vigilance system to guard the health of Indians. Cosmetovigilance can bring control and rule out hazardous ingredients in cosmetics products.
Cosmetic Regulation In India
In India, the cosmetic industry is governed under the Drugs and Cosmetics Act 1940, and the Drugs and Cosmetics Rules 1945. Section 3(aaa) of the act defines cosmetic as any article intended to be rubbed, poured, sprinkled, or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and includes any article intended for use as a component of cosmetic. Rule 145, 145D, 135, and 135A of rules 1945 prohibits the use and import of arsenic, lead-containing compounds, and mercury in cosmetic products. Rule 134-A prohibits the import of hexachlorophene containing cosmetics. Rule 134 specifies that cosmetic products should contain colour, dye, or pigment as per specified by schedule Q and the Bureau of Indian Standards.
The cosmetic industry is a vast industry, which categories cosmetic products into the following:
- Skin products which are further divided into subcategories products for skin care, cleansing, removal of body hair, body hair bleach, body odour corrective products, products for shaving pre or aftershave, products for makeup, perfume, products for sun, and self-tanning and others.
- Hair and scalp products are also further subcategories into cleansing and care products, products for hair colouring, hair styling products, and other products for hair and scalp care,
- Nail and cuticle products include nail varnish and remover, products for nail care and nail hardening, product for nail glue removal and other products for nail and cuticle care,
- Products for oral hygiene includes tooth care, tooth whiteners, mouthwash and breath spray and other products for oral hygiene.
For all cosmetic products, the standards are set by the Bureau of Indian Standards. When a product is made, it shall pass through a test set by the BIS, this test includes tests for arsenic and heavy metals, lead and mercury which are banned by the rules of Drug and Cosmetic Rules, 1945. Cosmetic products have adverse effects as well. A survey by local circles, with over 37,000 responses, reported that 34% of the households received counterfeit products and 15% of these had adverse effects of such cosmetics.
The central drugs standard control organization is the regulatory body responsible for overseeing the manufacture, import, and sale of cosmetics in India. All cosmetic products must be registered with the CDSCO. The registration process requires the submission of detailed information about the product including its formulation, labelling and packaging. Cosmetic products sold in India must comply with strict labelling requirements, including the use of standardized ingredient names and the inclusion of information such as manufacturing date, expiry date, and batch number.
The Advertisement for cosmetic products in India must comply with strict standards, including the prohibition of false or misleading claims and the requirement to provide accurate information about the product. The CDSCO carries out post-marketing surveillance of cosmetic products sold in India to ensure that they comply with regulatory standards. This includes the testing of products for safety and efficacy and the investigation of consumer complaints.
Current Situation In Cosmetic Industry In India
Lab testing of fairness creams, lipsticks, some lip balms and anti-aging products by the Centre for Science and Environment found to have mercury which is banned by the Drugs and Cosmetic Act of 1940. There has been a number of raids by different department, five godowns were seized after a raid by a crime branch found expired products in large quantity and the employees were altering the labels. There were also cases of fake products from companies like ‘Lakme’ and ‘Kylie Cosmetics’ being sold in Delhi. A raid by FDA in salons and beauty parlours seized cosmetic products which did not have licence numbers on the labels, and after testing the products found the high lead of lead, mercury and impurities.
Misbranding of products in India is also a very common issue which is another reason why people suffer from allergic reactions to products in India. Misbranded cosmetics are defined in the Drugs and Cosmetics Act 1940 and Drug and Cosmetics Rule 1945. A product is misbranded if it contains an unprescribed colour, inappropriate labelling, or contains false or misleading product information. Spurious or counterfeit cosmetic products whose name resembles another cosmetic brand. Spurious cosmetics in branded bottles are found to be sold to parlours and salons. Pregnancy and children below the age of 5 years using personal care products are also other major issue in India. Mama Earth, one of the leading unicorn brands, came into the personal care market because of the lack of safe baby products in India.
Cosmetic Regulations In USA And EU
In the United States of America, the cosmetic regulation is governed by two laws, the Federal Food, Drug and Cosmetic Act and the Fair Packaging and Labelling Act. The authority for cosmetic products in the US is Food and Drug Administrator. The products and ingredients do not need FDA approval, except for colour additives, which are similar to India. These acts prohibit the marketing of adulterated and misbranded cosmetic products. Adulterated cosmetic products are which contain any toxic or harmful material which may pose a threat under normal conditions of use and contaminated cosmetic products. Misbranding of products is when there are improperly labelled products and misleadingly packaged products.
Companies and individuals who manufacture or market cosmetics have a legal responsibility to ensure the safety and labelling of their products. The Voluntary Cosmetic Registration Program is a program which replaces FDA but only applies to cosmetic products being sold to consumers in the United States. It does not apply to cosmetic products intended solely for professional use, such as those found in beauty salons, spas, or skin care clinics.
Cosmetic products in the EU are regulated by (EC) 1223/2009, prior to marketing any cosmetic product, it is necessary to prepare a safety report and a responsible person is required to notify national authorities concerning any serious undesirable effects detected in their cosmetic product. The objective of having a responsible person is to keep technical information about the product for ten years. The European Union requires cosmetic products placed on the EU market to be safe, which means they must not cause harm to human health when used under normal or reasonably foreseeable conditions. Manufacturers are responsible for ensuring that cosmetic products comply with the law.
The Cosmetics Regulation’s cosmetovigilance system, which requires serious adverse effects to be reported to the Responsible Person and relevant authorities, ensures that the safety of cosmetic products placed on the EU market is monitored across Europe. When an undesirable effect occurs, the competent authority of the member state must notify the competent authorities of the other member states. Furthermore, if end users or health professionals report serious undesirable effects to the competent authority of the member, that competent authority must transmit the information to the competent authorities of other member states as well as the Responsible Person.
Way Forward For Cosmetic Industry In India
The Ministry of Health and Family Welfare released a draft of the Drugs, Medical Devices, and Cosmetics Bill in 2022 which seeks to replace the existing drug and cosmetic laws in India. The objective of this act is to strengthen the existing law by expanding the scope of an improved and comprehensive regulatory framework for medical devices, clinical trials and cosmetic products. The Act will govern the import, manufacture, distribution, and sale of drugs and cosmetics in India, with the primary goal of ensuring that the drugs and cosmetics sold to the public are safe and effective.
The act will be simplified, consolidated, improved, and in some cases clarified the regulatory requirements and standards pertaining to the import, manufacture, and distribution of cosmetics in India, providing the industry with a level of regulatory certainty that was lacking in the Drug and Cosmetic Rules. The act will increase importers’ and manufacturers’ accountability for the quality of cosmetic products. In the future, the digitization of the regulatory process is likely to increase efficiencies and make the application process less cumbersome and time-consuming for applicants.
The hype around vegan, clean, and natural cosmetic products entering the international market, is an age-old tradition of our ancestors. But still, consumers are fooled by incorrect labels and misinformation through advertisements and packaging. What India needs are awareness programs, more stringent strict regulations, and authorities to be implemented to safeguard public health.