The Central Drugs Standard Control Organisation (CDSCO) has issued a new set of clarifications with regard to import and registration of cosmetics in addition to existing guidelines.

On undertaking regarding products not tested on animals, the manufacturer either legal or actual/brand owner of the products/Indian subsidiaries can submit a one-time self-declaration that the applied products have not been tested on animals on and after 12.11.2014 along with import registration dossiers to CDSCO. The acknowledgment copy for submission of this undertaking as received by the applicants from CDSCO can be produced at port offices in future for clearing their future consignments.

On free sale certificate from the responsible person instead of the actual manufacturer, the CDSCO has clarified that the free sale certificate issued by National Regulatory Authority or other competent associations/organisations from the country of the legal manufacturer in addition to the actual manufacturer from country of origin can be considered.

On the issue of Letter of Authorisation (LoA) in case of third party manufacturing outside India, the CDSCO has clarified that in the cases where the brand owner is located in India and gets its products manufactured from sites located outside India, an LoA can be considered in place of Power of Attorney (PoA).The overseas manufacturer has to give acceptance of LoA and conditions on apostilled copy.

Regarding the import of bulk cosmetics and the requirement of a Certificate of Free Sale (CFS), the CDSCO has given the clarification that the applicants can obtain 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.

In its clarification, the CDSCO further said that for renewal of registration certificate, a string of documents are required which include power of attorney in original; necessary fees; duly filled and signed Form 42 along with the list of products to be renewed; certificate of free sale/marketing authorisation letter/manufacturing license, if any; copies of original RC and endorsement certificates that were granted earlier; and 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.