The Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, Government of India, has directed all State and Union Territory (UT) Drugs Controllers to take action against the manufacture and marketing of drug products containing Enclomiphene and its combinations without approval from the Central Licensing Authority (CLA).
In a letter dated 10 August 2026, issued by the Enforcement & Intelligence Cell of CDSCO, the Directorate said it had been brought to its notice that certain manufacturers were manufacturing and/or marketing drug products containing Enclomiphene and its combinations without obtaining the requisite permission from the CLA, despite such products falling within the definition of a “New Drug” under the New Drugs and Clinical Trials Rules, 2019.
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 CLA.
Further, under Rule 80 of the 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, is required to obtain prior permission from the CLA by submitting an application in Form CT-21, along with the prescribed fee specified in the Sixth Schedule.
The Directorate said it had observed that Enclomiphene and its combinations had not been approved by the CLA for manufacture and marketing in the country.
Accordingly, it stated that any manufacture, sale, distribution or marketing of such products without prior approval from the CLA would be treated as non-compliance with the provisions of the New Drugs and Clinical Trials Rules, 2019, and the Drugs and Cosmetics Act, 1940.
The State and UT Drugs Controllers have been requested to immediately identify manufacturers, marketers, distributors and retailers dealing with drug products containing Enclomiphene and its combinations without the requisite approval from the CLA.
They have also been directed to initiate appropriate regulatory action under the provisions of the Drugs and Cosmetics Act, 1940 and the Rules made thereunder, including cancellation or suspension of manufacturing permissions, wherever applicable.
The Controllers have further been asked to ensure that such unapproved products are not manufactured, sold, distributed or marketed within their respective jurisdictions.
CDSCO has also sought an action taken report, including details of manufacturers identified, regulatory action initiated and the present status of compliance, at the earliest.