Directorate General of Health Services, Central Drugs Standard Control Organization (Enforcement & Intelligence Cell), stated that certain manufacturers are manufacturing and/or marketing drug products containing Enclomiphene and its combinations without obtaining permission from the Central Licensing Authority (CLA). The communication states that such products fall within the definition of a “New Drug” under the New Drugs and Clinical Trials Rules, 2019.

The communication states that Enclomiphene and its combinations have not been approved by the Central Licensing Authority for manufacture and marketing in India. Manufacture, sale, distribution, or marketing of such products without prior approval of the Central Licensing Authority is stated to constitute non-compliance with the New Drugs and Clinical Trials Rules, 2019 and the Drugs and Cosmetics Act, 1940. All State/UT Drugs Controllers have been requested to identify manufacturers, marketers, distributors, and retailers dealing with such products without the requisite approval and initiate regulatory action under the Drugs and Cosmetics Act, 1940 and the Rules made thereunder, including cancellation or suspension of manufacturing permissions, wherever applicable. They have also been requested to ensure that such products are not manufactured, sold, distributed, or marketed within their respective jurisdictions. An action taken report covering identified manufacturers, regulatory action initiated, and compliance status is to be furnished to CDSCO.