COSMETIC REGISTRATION
Certificate in India : COS-2
CDSCO import registration for drugs and cosmetics involves submitting specific documents to the Central Drugs Standard Control Organization (CDSCO) to ensure the product meets Indian regulatory standards before it can be imported.
CDSCO ‘Import Registration’, which involves
Regulatory Basis: Cosmetics Rules 2020
Under the Drugs & Cosmetics Rules, 1945 (amended by Cosmetics Rules, 2020), import of all cosmetic products — including skincare, haircare, makeup, fragrance, and personal hygiene items — requires formal registration with the Central Drugs Standard Control Organisation (CDSCO).
No cosmetic may be legally imported into India without completing this registration.
Who Can Apply?
- A registered Indian entity, such as an importer or an authorized Indian agent (including a subsidiary of the foreign manufacturer), must apply through Form COS 1
- Foreign manufacturers are not permitted to apply directly and must appoint a local authorized agent or agent subsidiary in India.
Application Forms & Fees
- Form COS 1: Application by importer/agent for registration
- Fee structure (approximate, based on category/site/variant):
- USD 1,000 per cosmetic category
- USD 500 per manufacturing site
- USD 50 per variant
- Foreign payment via electronic transfer to Bank of Baroda, New Delhi branch.
- Registration processing may take up to 180 days, though CDSCO typically aims for 90 days when complete documentation is provided.
The Registration Certificate Process is Outlined as Follows:
Form COS 2 :-
👍 After approval, Form COS 2 is issued as the Import Registration Certificate. 👍 It is generally valid for 3 years, renewable with retention fees. If renewed on time, there is no break in validity
Exemptions :-
🏐 You may not require CDSCO registration if importing cosmetics exclusively for: 👍 Export or repackaging for export 👍 Research & development (e.g. shelf-life testing), provided you obtain prior permission from CDSCO and declare no domestic sale 👍 Duty free amenity kits or hotel in house use with formal undertaking However, these exemptions cannot be sold in the Indian market
Required Documentation You will need:
The following documents are required for successful application for import registration certificate:
- Cover letter and authorization documents (Power of Attorney)
- Free Sale Certificate from the country of origin (duly authenticated)
- Product formulation details and ingredient list
- Testing protocols, CER, or safety data (e.g. heavy metals, microbiological limits)
- Non animal testing declaration
- Labelling mock ups that meet Indian labeling norms: include product name, RC number, importer/manufacturer details, batch number, M.L. no., expiry, net contents, ingredient list, usage instructions/warnings.
- Additional requirements may include proof of ISO 22716 GMP certification for the manufacturing unit, qualified personnel like a chemist/dermatologist on board, and compliance with BIS standards where applicable.