The Central Drugs Standard Control Organisation (CDSCO) has directed all State and Union Territory Drugs Controllers to take regulatory action against the manufacture and marketing of unapproved drug products containing enclomiphene and its combinations.
The directive follows information received by the Directorate General of Health Services that certain manufacturers are producing and/or marketing drug products containing Enclomiphene and its combinations without obtaining the required permission from the Central Licensing Authority (CLA).
Under the New Drugs and Clinical Trials Rules, 2019, enclomiphene and its combinations fall within the definition of a “new drug” and therefore require prior approval from the CLA before they can be manufactured for sale or distribution.
“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,” CDSCO noted in a notice issued on Monday.
The regulator said enclomiphene and its combinations have not been approved by the CLA for manufacture and marketing in India. Accordingly, the manufacture, sale, distribution or marketing of such products without prior approval would constitute non-compliance with the New Drugs and Clinical Trials Rules, 2019, and the Drugs and Cosmetics Act, 1940.
The State and UT Drugs Controllers have been asked to immediately identify manufacturers, marketers, distributors and retailers dealing in such unapproved products and initiate appropriate regulatory action under the Drugs and Cosmetics Act and related rules.
The regulatory action may include suspension or cancellation of manufacturing permissions, wherever applicable. Authorities have also been directed to ensure that unapproved enclomiphene products are not manufactured, sold, distributed or marketed within their respective jurisdictions.
CDSCO has further asked the State and UT authorities to submit action-taken reports detailing the manufacturers identified, regulatory measures initiated and the current compliance status.
