For many years, cosmetics in India was regulated by the Medicines and Cosmetics Act, 1940 and the Medicines and Cosmetics Regulations, 1945 (Regulations 1945), which mainly dealt with the use of pharmaceuticals and only a few provisions, the Health and Welfare Service family (MOHFW) had previously planned to consider the provisions of the 1945 Rules relating to cosmetics to develop specific and up-to-date rules for cosmetics to effectively manage compliance. In November 2018, the draft 2018 Cosmetics Rules were submitted for public comment.
On December 15, 2020, MOHFW officially announced the final version of the 2022 Cosmetic Rules (the “2022 Rules”) under the provisions of the Medicines and Cosmetics Act of 1940, effective immediately.1 The 2022 Rules, consisting of 72 rules, 13 annexes and 24 annexes setting out the regulatory requirements for the production, testing, labelling, importation, registration, distribution and sale of cosmetics in India. Cosmetics Rules
Highlights of the 2022 Rules
The key points of the 2022 Rules are as follows:
- The concept of “new cosmetics” is introduced for the first time.
According to the 2022 regulation, “new cosmetics” refers to cosmetics containing a new ingredient that has not been used anywhere in the world or is not recognized for use in cosmetics in any national or international literature.1
The production and import of new cosmetics requires the prior approval of the Central Licensing Authority and the provision of the necessary data on the safety and efficacy of the product. In addition, the safety of new cosmetics must be certified by the manufacturer in accordance with IS 4011:2018 Test methods for evaluating the safety of cosmetics.
- Procedures for applying for a cosmetic license have been simplified.