The Government of India has issued a gazette notification G.S.R. 426(E) dated 19th May 2010 making it mandatory to register all imported cosmetics. This amendment was notified in the gazette amending Rule 129 of Drugs & Cosmetics Rules. The amendment and the provisions as in the amendment came into force from 1st April, 2012.
After obtaining a Cosmetic Registration Certificate, The following changes require a fresh registration –
Following changes do not require a new/fresh registration and only notification or amendment may be obtained –
Change in the method of testing
Change in composition
Updating in packaging and labels (provided proper justification should be provided for the above changes)
Minor changes in the manufacturing process that will not affect the final product specifications
The timeline for response to a change in notification is about 90 working days. If applicant has applied for Registration Certificate and still not issued but in between a change has happened in constitution of either Indian Agent or the Manufacturer or, address of manufacturer a fresh application has to be submitted including the fees.
A one-time self-declaration that the products applied for registration has not been tested on animals on and after 12.11.2014 along with import registration dossiers should be submitted to the CDSCO by the manufacturer either legal or actual/brand owner of the products/Indian subsidiaries. For clearing of consignments, the acknowledgement copy as received by the applicants from CDSCO shall be submitted at the port offices.