DCGI Mandates Annual Reporting: Cosmetics Importers Required to Submit Import Details

CDSCO tightens imports of Cosmetics with the issuance of this Directive

The national drug regulator has issued a directive to registered cosmetics importers in the country, urging them to furnish an annual statement containing comprehensive details of imported cosmetics. This mandate aligns with the provisions outlined in the Cosmetics Rules, 2020, notified on December 15, 2020, under the Drugs and Cosmetics Act, 1940.

The Central Drugs Standard Control Office (CDSCO) is responsible for granting Import Registration Numbers (IRN) under Form COS – 4A, facilitating the import and sale of cosmetics already registered for distribution within India.

Highlighting the necessity for compliance, Dr. Rajeev Singh Raghuvanshi, Drugs Controller General (India), emphasized the imperative for importers operating under COS-4A to submit the annual statement detailing cosmetics imported into India from the date of IRN issuance.

The specified information to be provided encompasses various aspects including the number of consignments or bill of entries, imported quantity per consignment, total cost, and warehouse details for storage and subsequent distribution.

According to the Cosmetics Rules, 2020, cosmetics manufactured abroad and registered under Rule 13 for import and sale in India may be imported by submitting an application through the online portal of the Central Government in Form COS- 4, accompanied by a specific undertaking. Upon satisfactory review of the application and documents submitted, the Central Licensing Authority may grant IRN in Form COS-4A or reject the application within a stipulated timeframe.

The validity of IRN stands at three years from the date of issuance, unless suspended or cancelled due to non-compliance with the conditions specified in Form COS- 4A.

In instances of non-compliance, the Rules empower the Central Licensing Authority to issue written orders, following due process, to suspend or cancel the import registration number for a duration deemed appropriate.

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