The Ministry of Health and Family Welfare notified the Cosmetics Rules, 2020, on December 15, 2020, with an aim to separately codify and update the rules relating to import, manufacture, labelling, sale and distribution of cosmetics in India, which were earlier set out under the Drugs and Cosmetics Rules, 1945.
To ease the transition, the Cosmetics Rules, 2020, require that all licenses granted under the Drugs and Cosmetics Rules, 1945 prior to the commencement of the Cosmetics Rules, 2020, must continue to remain valid until the later of (i) their expiry date; or (ii) a period of 18 months from the date of notification of the Cosmetics Rules, 2020.
Some of the salient features of the Cosmetics Rules, 2020 are as mentioned below:
The Cosmetics Rules, 2020 (‘New Rules’) for the first time introduce the concept of a ‘new cosmetic’ (erstwhile not provided for under the Drugs and Cosmetics Rules, 1945 (‘DCR’)), which has been defined to mean ‘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’. The New Rules mandate importers / manufactures of a ‘new cosmetic’ to make an application and seek an approval from the Central Licensing Authority (‘CLA’) before such a ‘new cosmetic’ could be imported or manufactured in India. Such an application should be accompanied with requisite data on safety and effectiveness. Further, the manufacturer must comply with IS 4011:2018 standards for testing the safety of the ‘new cosmetic’.
Import and Registration of Cosmetics
• Most of the process of registration and import of cosmetics remains the same under the New Rules, albeit under new forms, and with significantly reduced statutory fees, which comes as a significant incentive for industry. • The New Rules also streamline applications - the importer can make a single license application and seek a single registration certificate for the import of one or more cosmetics manufactured by the same manufacturer in a single manufacturing unit, which also encompasses multiple factories functioning conjointly. • The New Rules provide that the import registration certificate must remain valid in perpetuity, subject to payment of retention fee before a period of five (5) years from the date of issue. • The New Rules also prohibit import of cosmetics in the following cases: i. The manufacture, sale or distribution of the cosmetic in question is prohibited in the country of origin; ii. The “Use Before or Use by date” is less than six (6) months from the date of import; iii. The cosmetic contains hexachlorophene; and iv. The cosmetic has been tested on animals after November 12, 2014.
Manufacture of Cosmetics for Sale or Distribution
Similar to import and registration of cosmetics, the process for obtaining a manufacturing, sale and distribution license is largely similar to that under the DCR, albeit with new forms and with reduced statutory fees. The New Rules require that a self declaration be furnished by the applicant confirming compliance with good manufacturing practices and other prescribed requirements. In case of manufacturing at more than one premises, separate licenses should be obtained for each premise. Similar to the import registration certificate, the manufacturing license/loan license must also remain valid in perpetuity, subject to payment of retention fee before a period of five (5) years from the date of issue.
Quality of Cosmetics and Recall
The New Rules prohibit the import and/or manufacture of cosmetics which do not comply with the prescribed specifications or other standards of quality and safety. Certain raw materials (as specified under Annex A of the Indian Standard IS: 4707 Part 2) have also been prohibited. An obligation has been introduced on the concerned manufacturer or his authorized agent to recall cosmetics from the market in the event the manufacturer or its authorized agent considers or has reasons to believe that such cosmetic is likely to pose a risk to the health of a user and therefore may be unsafe. The New Rules also mandate such a manufacturer/authorized agent to indicate reasons for recall as well as inform the State Licensing Authority or the CLA, as the case may be.
The New Rules have streamlined, consolidated, upgraded and in certain cases clarified the regulatory requirements and standards pertaining to import, manufacture, and distribution of cosmetics in India, introducing a certain degree of regulatory certainty for the industry, which was missing in the DCR. The New Rules enhance accountability for importers and manufacturers with respect to the quality of their cosmetic products. The digitization of the regulatory process going forward is also bound to increase efficiencies and make the application process less cumbersome and time consuming for applicants.