On February 23, 2024, the Central Drugs Standard Control Organization (CDSCO) of India issued a Circular, requiring all registered cosmetics importers in the country to submit an annual statement detailing their imported products from the grant date of registration. This directive, effective immediately, aligns with the stipulations set forth in the Cosmetics Rules 2020.
The mandated information in the statement shall include the number of consignments or bill of entries of each consignment, the quantity and total cost of imported cosmetics per consignment, and warehouse details where the products are stored for further distribution and sale, etc.
Reasons for the Circular
As per the Cosmetics Rules 2020, cosmetics manufactured overseas and already registered under Rule 13 for import and sale in India can be imported by any individual or entity through the submission of an application in the Central Government's online portal in Form COS-4 “Application for issue of Import Registration Number for import of already registered cosmetics”, accompanied by a specific undertaking. Upon review of the application and submitted documents, the Central Licensing Authority may either grant Import Registration Number (IRN) in Form COS-4A “Import Registration Number to be issued for import of already registered cosmetics into India” or reject such application with recorded reasons within six months from the date of application.
The IRN, subject to suspension or cancellation in case of non-compliance, remains valid for three years from the date of issue. Importers possessing an IRN are obligated to adhere to all conditions associated with the IRN outlined in Form COS-4A, including providing an annual statement containing details of the cosmetics they have imported to the Central Licensing Authority.
Conditions of the Import Registration Number
This Import Registration Number shall be produced by the importer as and when required by the Licensing Authority or regulatory authority.
The importer shall inform to the Licensing Authority forthwith in the event of any administrative action taken namely, market withdrawal, deletion of product from the original Registration Certificate holder's or any regulatory restrictions of any cosmetics pertaining to this registration.
The importer shall provide the statement of details of cosmetics imported by them annually to the Central Licensing Authority.
The CDSCO's latest Circular is a response to the observed non-compliance that applicants importing cosmetics under Form COS-4A have failed to provide the requisite annual import details to the Central Licensing Authority. Importers are urged to promptly follow the reporting requirements to avoid potential regulatory consequences.
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