Lens on unauthorised mfg & sale of infertility drug

New Delhi: India's drug regulatory body has raised alarms over the unauthorized production and sale of Enclomiphene, a medication primarily utilized for treating male infertility. The Central Drugs Standard Control Organisation (CDSCO) has instructed all state and union territory drug controllers to promptly identify and take action against entities selling the drug without the necessary approval.

The CDSCO has mandated state authorities to immediately pinpoint manufacturers, marketers, distributors, and retailers dealing in drug products containing Enclomiphene and its combinations that lack the required authorization from the Central Licensing Authority. These authorities are then required to initiate appropriate regulatory measures under the Drugs and Cosmetics Act, 1940, which may encompass the revocation or suspension of manufacturing licenses as deemed appropriate.

Furthermore, the CDSCO emphasizes the importance of ensuring that these unapproved products are not produced, sold, distributed, or marketed within their respective regions.

States are also obligated to submit an action taken report to the regulator as soon as possible. This report must include a comprehensive list of the manufacturers identified, the regulatory actions taken, and the current status of compliance. Enclomiphene has gained significant attention in India recently, particularly as a treatment for secondary hypogonadism in men, a condition characterized by insufficient testosterone production in the body, according to a CDSCO official.

The regulatory body has discovered that certain manufacturers are both manufacturing and marketing drug products containing Enclomiphene and its combinations without obtaining the necessary permission from the Central Licensing Authority, despite Enclomiphene being classified as a New Drug under the New Drugs and Clinical Trials Rules, 2019.