INDIA’S COSMETIC REGULATION
The Drugs and Cosmetics Act 1940 and the Drug and Cosmetic Rules 1945 have regulated cosmetic products in India for years. According to the Drugs and Cosmetics Act 1940, a cosmetic is defined 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”.
The manufacture of cosmetics is regulated under a system of inspection and licensing by the State Licensing Authorities appointed by the respective State Governments. Import of cosmetics into India is regulated through a system of registration by the Central Drugs Standard Control Organization (CDSCO) under the provisions of the Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020. CDSCO is the main regulatory authority for the cosmetics industry.
If a product falls within the definition of cosmetic (under the 1940 Act), it is required to be registered along with pack size, variant(s) and manufacturing premises before it is imported into the country. If a cosmetic product is not registered under the existent rules, it cannot be imported to India. On the other hand, if a cosmetic product does not comply with the specifications set out and the standards of quality or safety, it cannot be imported or manufactured in India.
CLAIMS, LABEL AND INGREDIENTS
False or misleading claims (implicit or explicit) are not allowed in cosmetic products made available in the Indian market. Products that have been tested in animals cannot be imported to India. It is also not allowed to manufacture or import cosmetics that contain hexachlorophene, lead, arsenic and mercury compounds.
The name of the cosmetic, name and address of the manufacturer and the country where the product was manufactured, directions for safe use, batch number, manufacturing license number, among other details, need to be placed in the label of cosmetic products. There are special labelling requirements for hair products containing dyes, colours and pigments (e.g., para-phenylenediamine) and for toothpaste containing fluoride.
The requirements for the use of ingredients in cosmetic products are stipulated on the “Classification of Cosmetic Raw Materials and Adjuncts” issued by the Bureau of India Standards (BIS). Ingredients are classified into two categories: Generally Recognized As Safe (GRAS) and Generally Not Recognized As Safe (GNRAS).
A positive list of dyes, colours and pigments allowed in cosmetics is provided by BIS (GRAS class). It is prohibited to manufacture or import cosmetics that contain dyes, colours and pigments that are not specified by the BIS. For other ingredients, the BIS usually considers them to be part of the GRAS class. The BIS also publishes a negative list of raw material which shall not form part of the composition of cosmetic products, along with a list of substances which cosmetic products shall not contain except subject to restrictions and conditions laid down.
In December 2020, India released and implemented the ‘Cosmetic Rules 2020’, under the provisions of the Drugs and Cosmetics Act 1940. It lays down guidelines for importation, manufacture, registering, labelling, packaging, testing, sale and distribution of cosmetics. The rules consist of 72 rules, 13 schedules and 24 appendixes.
The concept of “new cosmetic” was introduced for the first time. According to the new regulation, the term ‘new cosmetic´ refers to “cosmetic which contains novel ingredient and has not been used anywhere in the world or is not recognized for use in cosmetics in any National and International literature”. A prior permission from the Central Licensing Authority (CLA) and submission of data about the products’ safety and efficacy is required when manufacturing or importing a new cosmetic.
The Cosmetic Rules 2020 has simplified application, reducing the duplication of regulatory processes and formalities for identical products and brands. Compliance with Good Manufacturing Practices (GMP) and other guidelines need to be self-declared by the applicant of the registration.
Products manufactured outside India need to comply with the Cosmetics Rules 2020 (formulation, label and claims) and need to be registered through the e-Governance portal (SUGAM). If the manufacture, sale or distribution of a product is prohibited in the country of origin, it cannot be imported to India.
Other changes have been implemented by the Cosmetic Rules 2020, but in order to ensure a smooth transition, all the licenses that were granted under the former Drugs and Cosmetics Rules 1945 will remain valid until they expire or for a period of 18 months (from the date of the beginning of the new regulation), whichever comes later.
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- Cosmetics. Central Drugs Standard Control Organization. Directorate General of Health Services. Ministry of Health &Family Welfare. Government of India. Available at: https://cdsco.gov.in/opencms/opencms/en/Cosmetics/cosmetics/
- India Cosmetic Regulation. Chemlinked. 2020. Available at: https://cosmetic.chemlinked.com/cosmepedia/india-cosmetic-regulation