For years, cosmetic products in India were governed by the Drugs and Cosmetics Act 1940 and the Drug and Cosmetics Rules 1945 (“1945 Rules”), which were primarily designed to manage pharmaceuticals and only few provisions concerning the control of cosmetics. India’s Ministry of Health and Family Welfare (MOHFW) had earlier planned to sort out cosmetic-related provisions from the 1945 Rules to develop a separate and updated cosmetic regulation for effective compliance management. In November 2018, a draft Cosmetics Rules 2018 was issued for public consultation.
On December 15, 2020, the MOHFW officially released the finalized regulation-Cosmetics Rules 2020 (“2020 Rules”) under the provisions of the Drugs and Cosmetics Act 1940 with immediate effect.1 The 2020 Rules, consisting of 72 rules, 13 schedules, and 24 appendixes, lays down the regulatory requirements for the manufacture, testing, labeling, import, registration, distribution, and sale of cosmetics in India.
Highlights of the 2020 Rules
The key points of the 2020 Rules are outlined below:
1. The concept of “new cosmetics” is introduced for the first time.
As per the 2020 Rules, a “new cosmetic” refers to a cosmetic that contains a novel 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 manufacture and import of a new cosmetic require prior approval from the Central Licensing Authority and submission of requisite data on product safety and effectiveness. Besides, the safety of new cosmetics shall be tested by the manufacturer in line with the IS 4011: 2018 Methods of Test for Safety Evaluation of Cosmetics.