Cosmetic Registration And Licensing

As per Section 3(aaa) of the Drugs and Cosmetics Act, 1940, Cosmetic means any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance and includes any article intended for use as a component of cosmetic.

Cosmetic registration and licensing under the Central Drugs Standard Control Organization (CDSCO) is a crucial process for any cosmetic product intended to be marketed in India. The CDSCO, under the Ministry of Health and Family Welfare, oversees the regulation of cosmetics, ensuring they meet safety, quality, and labelling standards as per the Drugs and Cosmetics Act, 1940, and the Cosmetics Rules, 2020.

The process begins with the submission of an application for registration of the cosmetic product intended to be imported into India made through the online portal of the Central Government in Form COS- 1 either by the manufacturer himself or by his authorised agent or the importer in India or by the subsidiary in India authorised by the manufacturer., accompanied by a Power of Attorney (PoA) that authorises the Indian agent to act on behalf of the foreign manufacturer. A comprehensive dossier must also be provided, which includes product details, formulation, safety data, manufacturing licences, and Certificates of Free Sale (CFS) from the country of origin. This dossier ensures that the product complies with both international and Indian standards.

In addition to product-specific information, the registration process requires adherence to Good Manufacturing Practices (GMP) and the submission of relevant certificates, such as the Certificate of Analysis (COA) and microbiological test reports, ensuring the product is safe for consumer use. For domestically manufactured cosmetics, a manufacturing licence must be obtained from the State Licensing Authority (SLA), ensuring that the production facility complies with prescribed standards.

In case of a new cosmetic, the applicant shall obtain prior permission in Form COS- 3 as provided in Chapter V from the Central Licensing Authority before registration of import of new cosmetic into India.

The registration and licensing process under CDSCO not only ensures that cosmetics entering the Indian market are safe and effective but also enhances consumer confidence. Compliance with these regulations is mandatory for all manufacturers and importers, ensuring the protection of public health and the promotion of high-quality cosmetic products in India.

Who can import cosmetics into India: The manufacturer himself/the Authorised Agent of the Manufacturer/the authorised subsidiary of the manufacturer in India/any other importer in India can be an applicant for grant of Import Registration Certificate for import of cosmetics products into India.

What is Import Registration Certificate: Import registration certificate means a certificate issued under rule 13 of New Cosmetics Rules, 2020 by the Central Licensing Authority for registration of cosmetics manufactured for import into and use in India.

The following documents are required to be submitted for grant of registration certificate: