India Bans Manufacture and Sale of 35 Drugs

India Bans Manufacture and Sale of 35 Unapproved Fixed-Dose Combination Drugs

India’s regulatory authority, the Central Drugs Standard Control Organisation (CDSCO) has issued a directive to halt the manufacture, sale, and distribution of 35 unapproved fixed-dose combination (FDC) drugs, including painkillers, anti-diabetic medicines, and nutritional supplements. This includes drugs that were found to have been licensed without proper safety and efficacy evaluations, potentially putting public health at risk.

The banned drugs were previously approved by state drug controllers without the mandatory safety checks outlined in the Drugs and Cosmetics Act, 1940. These FDCs, which contain multiple active pharmaceutical ingredients in a fixed ratio, were flagged for lack of compliance with national regulations and standards.

As part of the crackdown, all state and union territory drug controllers have been instructed to review their approval processes to ensure adherence to safety guidelines. The CDSCO emphasized the need for strict enforcement of the 2019 NDCT Rules to prevent further risks to public health.

This action follows concerns raised by the Drugs Controller General of India, Rajeev Raghuvanshi, who highlighted that unregulated distribution of these drugs posed significant health threats.

India's move underscores its commitment to improving pharmaceutical safety standards and protecting consumers from potentially harmful medications.