CDSCO orders crackdown on unapproved enclomiphene drugs

The Central Drugs Standard Control Organisation (CDSCO) has directed all state and Union territory drug controllers to ensure that medicines containing enclomiphene and its combinations are not manufactured, sold or distributed in India. Enclomiphene, a non-steroidal selective estrogen receptor modulator used for male infertility, has not been approved for manufacture or marketing in the country.

The directive follows reports that some manufacturers are producing and marketing these products without permission from the central licensing authority, violating the Drugs and Cosmetics Act, 1940, and the New Drugs and Clinical Trials Rules, 2019. State regulators must trace all entities involved, initiate regulatory action, and submit action-taken reports to the central directorate.

The move is part of a wider CDSCO crackdown on unapproved drugs, which includes reconciling national registries and targeting legacy state licences issued before central approval rules began in 1988. Public health experts warn that unapproved drugs may contain incorrect ingredients or dosages, posing safety risks to patients.