Unapproved Infertility Drug Enclomiphene Under CDSCO Scanner, States Told to Take Action

New Delhi: The Central Drugs Standard Control Organization (CDSCO) has directed all State and Union Territory Drugs Controllers to immediately identify manufacturers, marketers, distributors and retailers involved in the manufacture or marketing of unapproved drug products containing Enclomiphene and its combinations, and initiate regulatory action against them.

The direction was issued by the Directorate General of Health Services, CDSCO’s Enforcement & Intelligence Cell, through a communication dated August 10, 2026, addressed to all State/UT Drugs Controllers. The communication, bearing F. No. ENFORC-12016(11)/2/2026-office-34479, specifically concerns the manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations.

According to CDSCO, it has come to the notice of the Directorate that certain manufacturers are manufacturing and/or marketing drug products containing Enclomiphene and its combinations without obtaining the requisite permission from the Central Licensing Authority (CLA), despite such products falling within the definition of a "New Drug" under the provisions of the New Drugs and Clinical Trials Rules, 2019.

CDSCO cited that as per Rule 2(1)(w) read with Rule 19 of the New Drugs and Clinical Trials Rules, 2019, no new drug shall be manufactured for sale or distribution unless it has been granted permission by the Central Licensing Authority.

Further, as per Rule 80 of the said Rules, any person intending to manufacture a new drug, whether as an Active Pharmaceutical Ingredient (API) or as a pharmaceutical formulation for sale or distribution, shall obtain prior permission from the Central Licensing Authority by submitting an application in Form CT-21, along with the prescribed fee specified in the Sixth Schedule.

The notice states, "It has been observed that Enclomiphene and its combinations have not been approved by the Central Licensing Authority for manufacture and marketing in the country."

In view of the regulatory position, CDSCO directs:

"All State/UT Drugs Controllers are requested to immediately identify manufacturers, marketers, distributors, and retailers dealing with drug products containing Enclomiphene and its combinations without the requisite approval of the Central Licensing Authority, initiate appropriate regulatory action asper the provisions of the Drugs and Cosmetics Act, 1940 and the Rules made thereunder, including cancellation or suspension of manufacturing permissions, wherever applicable, and ensure that such unapproved products are not manufactured, sold, distributed, or marketed within their respective jurisdictions."

"The action taken report, including details of manufacturers identified, regulatory action initiated, and the present status of compliance, may kindly be furnished to this Directorate at the earliest." the notice added.

To view the official notice, click the link below: