Cosmetic Import Compliance: Under the 2020 Cosmetics Rules, for importing and selling cosmetics from overseas, an application must be filed via the Central Government’s online portal in Form COS-4, along with an undertaking. The process is somewhat similar to the MD-14 form used for medical device registrations, emphasizing the importance of proper documentation and adherence to CDSCO guidelines. Upon satisfaction with the application, the Central Licensing Authority, part of the Central Drugs Standard Control Organization (CDSCO), can issue an Import Registration Number (IRN) in Form COS-4A or deny it, stating reasons, within six months. The IRN is valid for three years unless earlier suspended or revoked.
On February 23, 2024, CDSCO issued Circular No. F. No. COS-1018(11)/5/2024-eoffice, mandating all cosmetic importers in India to provide annual reports on their imports through the SUGAM portal. . This new directive has been implemented in response to the regulator’s finding that annual details of imported cosmetics are not being submitted by importers as required. This information includes details such as Bill of Entries or Number of consignments, quantities imported in each consignment, total cost of the consignment, which warehouse the consignment is stored for sales, etc.
Consequences of Non-compliance: Failure to fulfill Cosmetic Import Compliance can lead to problems for importers, including the suspension or cancellation of the IRN. Importers are given the opportunity to present their case before any action is taken, ensuring a fair process. Nonetheless, adherence to these regulations is important for maintaining market access and avoiding regulatory penalties in India.
Conclusion:
The CDSCO’s February 2024 directive marks a significant step in strengthening the regulatory framework for cosmetic imports in India, emphasizing the need for transparency and compliance in the industry. Morulaa’s expertise in CDSCO regulatory approval and registration processes for both cosmetics and medical devices through the SUGAM portal ensures businesses can meet these new requirements efficiently. For more information on how Morulaa can help you adapt to these regulatory changes, reach out to us at [email protected] or Click Here to learn more.