The Central Drugs Standard Control Organisation (CDSCO) has directed state and Union Territory Drugs Controllers to identify and initiate regulatory action against manufacturers and sellers of enclomiphene and its combinations being produced or marketed without approval from the Central Licensing Authority (CLA). The direction follows information received by the Directorate General of Health Services that certain manufacturers were producing and marketing enclomiphene-containing products without the required permission from the CLA. According to the CDSCO communication, enclomiphene and its combinations have not been approved by the CLA for manufacture and marketing in India.

The products fall within the definition of a “New Drug” under the New Drugs and Clinical Trials Rules, 2019. The CDSCO has stated that the manufacture, sale, distribution or marketing of such products without prior…