CDSCO issues clarification on Regn Certificate issuance under Cosmetics Rules 2020

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The Central Drugs Standard Control Organization (CDSCO) has clarified vide CDSCO Notice dated 06-08-2021 that those who want to apply for the Registration Certificate for their existing cosmetic products under the new Cosmetics Rules 2020, may need to submit a “no change declaration statement.”

The clarification comes in the backdrop of the regulator receiving various concerns and reports of challenges from the stakeholders after the implementation of the separate rule, which was notified on December 15, 2020.

VG Somani DCGI
Dr. VG Somani, DCGI

“On commencement of these new cosmetic rules, this office has received various concerns and challenges faced by the stakeholders regarding application for grant of import registration certificates and subsequent endorsements,” said the notice issued by Dr V G Somani, Drugs Controller General (India) on August 6, 2021.

The validity of product endorsement granted under the existing RC in Form 43 as per the Drugs and Cosmetics Rules, 1945, will be effective from its date of issuance till the validity of parent RC in Form 43.

Currently option for endorsement in Form 43, the old RC, has been disabled for streamlining the process of implementation of Cosmetic Rules 2020 and further IT issues as informed by the CDAC Team.

“No Change Declaration Statement” with respect to composition, product label, specifications and test methods is required to be submitted for issuance of Registration Certificate or endorsement in Form COS-2 for products which are already registered in Form 43 in the erstwhile provisions of Drugs and Cosmetics Rules, 1945.

Further, an authorisation from manufacturer in specified format, information as per second schedule (Part 1) of the Rules and requisite fees for category, manufacturing sites and variants, as applicable is required to be submitted, added the CDSCO.

For additional pack size endorsements for already registered cosmetics products, the same No change declaration statement has to be submitted along with other details as mentioned for the issuance of the RC. For additional manufacturing site endorsement for already registered cosmetics products too, these documents need to be submitted.

The CDSCO also added that it is already processing the product/additional pack size/additional site endorsement applications for previously registered products having valid RC under Rule 72 of Cosmetics Rules, 2020 on the basis of the documents mentioned already.

The regulator has earlier also issued FAQs for the cosmetics manufacturers and importers, in order to alleviate their doubts that emerged in the wake of the implementation of the new rules. The new clarification comes as the latest in these FAQs, it added.

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