India Clarifies Cosmetic Importation and Registration Guidelines

India’s Central Drugs Standard Control Organization just published a clarification of the cosmetic importation and registration guidelines on its official website. Clarifications specifically relate to topics like cruelty-free, certificate of Free Sale (CFS), Letter of Authorization (LOA) and renewal of registration certificates.

The details of the clarifications are:

1. Products not tested on animals: 

The Manufacturer i.e. either legal or actual brand owners of the products or their Indian subsidiaries can submit a one-time self-declaration that the products have not been tested on animals after 12.11.2014 along with an import registration dossier to CDSCO. Proof of submission can be used at port offices in future for clearing future consignments.

2. Free sale certificate from the responsible person instead of the actual manufacturer: 

Free sale certificate issued by National Regulatory Authority or other competent associations/organizations from the country of origin of the legal manufacturer in addition to the actual manufacturer from the country of origin can be considered.

3. Letter of Authorization (LOA) in case of third party manufacturing outside India: 

In cases where the brand owner is located in India and gets its products manufactured from sites located outside India a LOA can be considered in place of Power of Attorney (POA). The overseas manufacturer has to give acceptance of LOA and conditions on appostilled copy.

4. Import of Bulk cosmetics- Requirement of a certificate of Free Sale (CFS): 

Applicants can obtain Free Sale Certificate (FSC) either from the country of origin or any other major market where the same product is freely sold. Alternatively bulk importers could get the bulk cosmetics tested in India at a Government laboratory to obtain custom clearance.

5. For renewal of a Registration Certificate the following documents will be required:

• Power of Attorney (original)
• Necessary fees
• Duly filed and signed Form 42 along with the list of products to be renewed
• Certificate of free sale/Marketing Authorization letter/Manufacturing License, if any
• Copies of original RC and endorsement certificates that were granted earlier
• Undertaking/ Self-declaration stating that there are no changes in earlier shared information with respect to product details (like composition, test methods, specifications, label ( complying Rule 148 of D&C Rules 1945) etc., constitution of the firm and sourcing location / site of the products.

* Reference Link: Central Drugs Standard Control Organization