Cosmetic Regulatory Consultant Services India

India in December 2020 has come up with a new set of rules defining the manufacturing, import and sale of cosmetics in India. These rules are known as Cosmetics Rules, 2020. These rules have enhanced the regulatory requirements applicable to the cosmetics industry. These rules have gone step further in providing detailed clarifications regarding regulatory requirements and standards applicable to cosmetics manufacturers and importers in India which were lacking in the Drugs and Cosmetics Rules, 1945.

In the new rules, the Government of India has introduced the concept of 'New Cosmetic’ in similar lines with the concept of ‘New Drug’ as in the case of Drugs. The term 'New Cosmetic' as defined in Section 3(r) reads as 'a cosmetic which 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 Rules provide importers of new cosmetics to seek approval by making an application to CLSA in Form COS- 3 before registration of import of new cosmetics into India. The application shall contain the method of test or analysis to be employed for safety evaluation of new cosmetics as specified in the IS 4011: 2018 methods of test for safety evaluation of cosmetics, published by the 'Bureau of Indian Standards' as amended from time to time.

For overseas manufacturers and importers, we understand the difficulties and questions arising in the mind as they are venturing into an unknown land with no or little knowledge about the procedures and working culture. The new Cosmetics Rules 2020 has placed the liability of the quality of cosmetics on importers and manufacturers.

An application for registration of a cosmetic product intended to be imported into India shall be made either by the manufacturer itself or by its authorized agent or importer in India or by a subsidiary in India authorized by the manufacturer, through the online portal of the central government in a prescribed form (Form COS-1). Once satisfied, the CLSA can issue an import registration certificate in the prescribed form (i.e. Form COS-2) or may deny an application for reasons to be documented in writing within six months of the date of application and remain valid in perpetuity, subject to payment of the retention fee for the registration certificate before the completion of the period of five years from the date of issue, unless, it is suspended or cancelled by the relevant Indian governmental authority.

API First is a team of regulatory experts who are well versed with the nuances of the regulatory filing and subsequent approval processes of drugs in India as well as other regulatory countries. The team of experts have a vast experience with the drug approval process in India.