The Central Drugs Standard Control Organization (CDSCO), on August 10, 2026, directed all State/UT Drugs Controllers to take action against the manufacture and marketing of unapproved drug products containing Enclomiphene and its combinations. CDSCO stated that such products fall within the definition of a “New Drug” under the New Drugs and Clinical Trials Rules, 2019, and that Enclomiphene and its combinations have not been approved by the Central Licensing Authority for manufacture and marketing in India.
Under Rule 19 read with Rule 2(1)(w) and Rule 80 of the New Drugs and Clinical Trials Rules, 2019, manufacture of a new drug for sale or distribution requires prior permission from the Central Licensing Authority, with an application in Form CT-21 and the prescribed fee under the Sixth Schedule. Accordingly, manufacture, sale, distribution or marketing of Enclomiphene-containing products without such approval would constitute non-compliance with the Rules and the Drugs and Cosmetics Act, 1940.
State/UT Drugs Controllers have been directed to identify manufacturers, marketers, distributors and retailers dealing with such products, initiate appropriate regulatory action, including suspension or cancellation of manufacturing permissions wherever applicable, and ensure that the unapproved products are not manufactured, sold, distributed or marketed. They have also been requested to submit an Action Taken Report detailing manufacturers identified, regulatory action initiated and compliance status.
[File No. ENFORC-12016(11)/2/2026-eoffice-34479]
