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CDSCI asks SLAs to initiate action against unapproved enclomiphene production and sales
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Gireesh Babu, New Delhi
August 12 , 2026
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The Central Drugs Standard Control Organisation (CDSCO) has asked the state and Union Territory Drugs Controllers to track down and initiate regulatory action against manufacturing and sales of drug products containing enclomiphene and its combinations, without the approval of the central drugs regulatory authority.
Enclomiphene is used for the treatment as an ovulation stimulant among women, and also said to have its use in treatment of men with deficiency in testosterone. The CDSCO has in the past cracked down on units which sold the drug without approval from the Central Licensing Authority (CLA), according to reports.
The Enforcement and Intelligence Cell of CDSCO in a communication to all state and UT drugs controllers, said that it has been brought to the notice of the Directorate General of Health Services (DGHS), under which the CDSCO operates, that certain manufacturers are manufacturing and 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 provisions of the New Drugs and Clinical Trials Rules, 2019.
Enclomiphene and its combinations have not been approved by the CLA for manufacture and marketing in the country. Accordingly, any manufacture, sale, distribution, or marketing of such products without prior approval of the Authority shall be treated as non-compliance with the provisions of the New Drugs and Clinical Trials Rules, 2019, and the Drugs and Cosmetics Act, 1940, it said.
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. 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 CLA by submitting an application in Form CT-21, along with the prescribed fee specified in the Sixth Schedule.
In this backdrop, Dr Rajeev Singh Raghuvanshi, Drugs Controller General (India), said, "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 as per 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."
He also requested the state and UT Drugs Controllers to furnish the action taken report, including details of manufacturers identified, regulatory action initiated, and the present status of compliance, to the Directorate at the earliest.
According to pharmacy chain Apollo Pharmacy website, enclomiphene comes under the category of ovulation simulants, used to treat infertility in women without proper ovulation.
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