CDSCO bans 35 unapproved fixed-dose combination drugs to safeguard public health

India’s top drug regulatory authority, the Central Drugs Standard Control Organisation (CDSCO), has instructed all state and union territory drug controllers to immediately halt the manufacturing, sale and distribution of 35 unapproved Fixed-Dose Combination (FDC) drugs. These drugs include painkillers, nutritional supplements and anti-diabetic medicines. FDCs are pharmaceutical products that contain two or more active ingredients in a fixed proportion. 

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The directive follows a discovery that several FDC drugs were approved and marketed without proper safety and efficacy evaluations. This poses a significant risk to public health, as highlighted by Drugs Controller General of India (DCGI) Rajeev Raghuvanshi. In a letter to the drug controllers, he pointed out that these drugs were licensed without meeting the requirements of the New Drugs and Clinical Trials (NDCT) Rules, 2019 as laid out under the Drugs and Cosmetics Act, 1940. 

Manufacturers of the flagged drugs claimed they followed due process and were issued licenses by the respective state authorities. However, the DCGI emphasized that this has resulted in inconsistent enforcement of national drug safety regulations. As a corrective step, state drug controllers have been asked to reassess their approval procedures and strictly comply with legal provisions to avid similar lapses in the future.