Cosmetic Registration and Licensing in India
What Is a Cosmetic?
As per Section 3(aaa) of the Drugs and Cosmetics Act, 1940, a cosmetic is defined as:
“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. This also includes any substance intended for use as a component of cosmetic products.”
Regulatory Authority
Cosmetic registration and licensing in India are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Ministry of Health and Family Welfare. The CDSCO ensures that all cosmetic products marketed in India comply with the safety, quality, and labeling standards specified in the Drugs and Cosmetics Act, 1940 and the Cosmetics Rules, 2020.
Process of Cosmetic Registration
For imported cosmetics, the registration process involves:
- Application Submission: An application for cosmetic import must be submitted through the online portal using Form COS-1. This can be done by:
- The manufacturer
- An authorized agent of the manufacturer
- An importer in India
- The manufacturer’s subsidiary in India
- Power of Attorney (PoA): The applicant must provide a PoA authorizing them to act on behalf of the foreign manufacturer.
- Dossier Submission: A detailed product dossier must be submitted, including:
- Product composition and specifications
- Manufacturing licenses
- Certificates of Free Sale (CFS)
- Safety data and test reports
- Good Manufacturing Practices (GMP): Compliance with GMP is mandatory, supported by the submission of Certificates of Analysis (COA) and microbiological test results.
Registration of New Cosmetics
For any new cosmetic product not previously approved in India, the applicant must obtain prior approval in Form COS-3 from the Central Licensing Authority, as per Chapter V of the Cosmetics Rules, before applying for import registration.
Domestic Manufacturing License
For cosmetics manufactured in India, a manufacturing license must be obtained from the State Licensing Authority (SLA). This ensures that the manufacturing facility complies with all regulatory and safety standards.
Who Can Import Cosmetics into India?
The following entities are eligible to apply for a cosmetic import registration certificate:
- The manufacturer
- Authorized agent of the manufacturer
- Authorized subsidiary of the manufacturer in India
- Any other authorized importer in India
What Is an Import Registration Certificate?
As per Rule 13 of the Cosmetics Rules, 2020, an Import Registration Certificate is a legal document issued by the Central Licensing Authority. It authorizes the registration and import of cosmetic products for use in India.
Documents Required for Import Registration
To obtain an Import Registration Certificate, the following documents must be submitted:
- Covering letter from the applicant
- Form 42 (Application form)
- Treasury Challan (Proof of fee payment)
- Power of Attorney (PoA)
- Schedule D (III)
- Original or copy of product labels
- Free Sale Certificate (FSC) / Marketing Authorization Letter / Manufacturing License
- Product specifications and testing protocols
- List of countries where the product is already registered or approved
- Pack insert (if applicable)
- Soft copies of all brand, product, and manufacturer information
Conclusion
Cosmetic registration and licensing through CDSCO ensure that all cosmetic products available in the Indian market are safe, high-quality, and compliant with regulatory norms. Adhering to these processes not only ensures legal compliance but also builds consumer trust and facilitates smooth market access for both Indian and international cosmetic brands.