On December 15 2020, the Ministry of Health and Family Welfare released a notification for cosmetic rules to successfully codify and upgrade the cosmetic rules about import, labelling, manufacturing, sale, and the distribution of the cosmetics to India, which were previously set under Drugs and Cosmetic rules 1945.
To make the change easy, the new rules for cosmetics in 2020, needs that each cosmetic license that is granted under the Drugs and Cosmetics Rules 1945, before the implementation of cosmetic rules 2020, should remain valid till its expiry date or a period of 18 months from the notification date of the cosmetic rules.
Within all salient features of the new cosmetic rules 2020, a clause has been added regarding New Cosmetics. As per the rules, new cosmetics are those which were introduced in the market recently, which was not provided in the cosmetic rules 1945. According to the new rule, a new cosmetic contains a new ingredient that has not been used earlier across the world. The new ingredients are also not recognized for utilization in any cosmetics either in national or in international literature.
As per the new rules, it has been made mandatory for all importers and manufacturers of the new cosmetic to generate an application and obtain approval from the central licensing authority before the new cosmetic is either manufactured or imported in India. The application should include all required data on safety as well as effectiveness. Furthermore, the manufacturer should also obey IS 4011:2018 standards to test the proposed new cosmetics’ safety and efficacy.
Regarding the process for registration and the import of cosmetics, it is almost the same under the proposed new rules. The manufacturers and importers have to apply with the new application forms and reduced fee, which comes as one of the vital incentives for the whole industry.
The new cosmetic rules 2020, prevent the import and manufacture of those cosmetics that do not obey any prescribed specifications of quality and safety. Thus, we can say that the new cosmetic rules have been streamlined, united, updated and in some cases clarified the regulatory needs and standards about import, distribution and manufacture of cosmetics in India.
The new rules have increased accountability for manufacturers and importers about the quality of cosmetic products. In the future digitization will also enhance efficiencies and will make the whole process of application less time-consuming.