India Bans High-Dose Nimesulide Oral Formulations Over Safety Concerns

The Union health ministry has banned the manufacture, sale and distribution of all oral formulations containing more than 100 mg of nimesulide in immediate-release form for human use, citing public health risks. The decision follows recommendations from the Drugs Technical Advisory Board (DTAB), based on a safety review conducted by the Indian Council of Medical Research (ICMR).

In a notification issued on December 29, the ministry stated that higher-dose immediate-release nimesulide poses potential risks to patients and that safer therapeutic alternatives are available. Exercising powers under Section 26A of the Drugs and Cosmetics Act, 1940, the ban has been enforced with immediate effect.

DTAB advised that nimesulide should be used only as a second-line treatment in adults and not prescribed to pregnant or lactating women, those planning pregnancy, or patients with liver or kidney impairment. The board also supported restricting high-dose formulations while seeking further age-specific safety reviews. Nimesulide remains prohibited for veterinary use due to ecological and safety concerns.

31-12-2025