Wed Apr 16 11:43:30 UTC 2025: ## India Bans 35 Unapproved Combination Drugs
**New Delhi, April 16, 2025** – India’s Central Drugs Standard Control Organisation (CDSCO) has ordered a nationwide ban on the manufacture, sale, and distribution of 35 unapproved fixed-dose combination (FDC) drugs. These drugs, which include painkillers, nutritional supplements, and anti-diabetics, were found to have been licensed without proper evaluation of their safety and efficacy, posing a significant risk to public health.
The CDSCO’s directive, issued on April 11th by Drugs Controller General of India Dr. Rajeev Raghuvanshi, follows years of concern regarding the licensing of FDC drugs—combinations of two or more active pharmaceutical ingredients—without the necessary approvals. The regulator highlighted that the absence of safety and efficacy testing could lead to adverse drug reactions and other health hazards.
Manufacturers of the banned drugs argued that their licenses were granted by state-level authorities and claimed no rule violations. However, the CDSCO cited inconsistencies in enforcement of the Drugs and Cosmetics Act, 1940, and the New Drugs and Clinical Trial Rules, 2019, across the country.
The CDSCO has instructed all state and union territory drug controllers to review their approval processes for FDCs and ensure strict compliance with regulations. A list of the 35 banned FDCs, previously licensed but subsequently cancelled or voluntarily surrendered, has been provided for reference. The action underscores the CDSCO’s commitment to ensuring the safety and efficacy of all medications available in the Indian market.
First Piper 