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DCGI asks registered cosmetics importers to submit annual statement with import details
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Gireesh Babu, New Delhi
February 28 , 2024
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The national drug regulator has directed the registered importers of cosmetics in the country to provide an annual statement with details of imported cosmetics from the date of grant of registration as per the Cosmetics Rules, 2020.
The directive comes after the regulator observed that the details of cosmetics imported annually by such importers are not being provided to its office, as per the requirement.
Under the Cosmetics Rules, 2020 notified on December 15, 2020 under the Drugs and Cosmetics Act, 1940, the Central Drugs Standard Control Office (CDSCO) grants Import Registration Number (IRN) under Form COS - 4A for cosmetics which are already registered for import and sale into India as per the relevant rules.
As per the requirements of conditions of IRN under the Form, the importer shall provide the statement of details of cosmetics imported annually to the Central Licensing Authority.
Observing that such importers failed to provide the details, Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), said, "every applicant who is importing cosmetics under COS-4A hereby directed to provide the annual statement of details of cosmetics imported in India from the date of grant of IRN under COS-4A to this office."
The information to be submitted include details such as number of consignments or bill of entries of each consignment, imported quantity in each consignment, total cost of imported cosmetics in each consignment, warehouse details where those are stored for further distribution and sale, etc.
According to the Cosmetics Rules, 2020, a cosmetic manufactured in a foreign site and already registered under Rule 13 for import and sale in India, may be imported by any person or entity by making an application in the online portal of the Central Government in Form COS- 4 with a specific undertaking. The Central Licensing Authority, on being satisfied with the application and documents submitted, may grant IRN in Form COS-4A, or reject such application with reasons recorded in writing within a period of six months from the date of application.
The IRN has a validity of three years from the date of its issue, unless it is suspended or cancelled.
The Rules stated that if the importer fails to comply with any of the conditions of the IRN issued in Form COS- 4A, the Central Licensing Authority may, after giving him an opportunity to show cause, issue an order in writing with reasons mentioned, suspend or cancel the import registration number for such period as it thinks fit.
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