Regulator flags unauthorised mfg & sale of male infertility drug

New Delhi: India's drug regulatory authority has flagged concerns over the unauthorised manufacture and marketing of Enclomiphene, a drug used primarily to treat male infertility, directing all state and union territory drug controllers to immediately identify and act against companies selling the product without the mandatory approval.

The Central Drugs Standard Control Organisation (CDSCO) has asked states 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 under the Drugs and Cosmetics Act, 1940 including cancellation or suspension of manufacturing permissions wherever applicable, and ensure that such unapproved products aren't manufactured, sold, distributed, or marketed within their respective jurisdictions.

States have also been asked to furnish an action taken report to the regulator at the earliest, detailing manufacturers identified, regulatory action initiated, and the present status of compliance.


"Enclomiphene has seen growing interest in India in recent years, particularly as a treatment for secondary hypogonadism in men, a condition where the body does not produce enough testosterone," said an official.

CDSCO has found that certain manufacturers are making and marketing drug products containing Enclomiphene and its combinations without obtaining permission from the Central Licensing Authority, despite the drug falling under the definition of a "New Drug" under the New Drugs and Clinical Trials Rules, 2019.

"It has been brought to the notice of this 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," the circular said.