Health Ministry bans nimesulide oral formulations above 100 mg
India’s Union Health Ministry has imposed an immediate nationwide ban on all oral formulations of nimesulide exceeding 100 mg, citing risks to human health and the availability of safer alternatives. This decision follows recommendations from the Drugs Technical Advisory Board (DTAB) and data from the Indian Council of Medical Research (ICMR) highlighting liver toxicity concerns.
The prohibition, issued via a Gazette notification on December 29, 2025, under Section 26A of the Drugs and Cosmetics Act, 1940, covers manufacture, sale, and distribution of high-dose immediate-release oral nimesulide for human use. Lower doses (100 mg or below) and non-oral forms remain permitted.
Nimesulide, an NSAID used for pain and inflammation, has faced global scrutiny for hepatotoxicity and other adverse effects. Authorities determined higher oral doses pose unnecessary risks, especially with alternatives like paracetamol or ibuprofen available.
Prior actions included black-box warnings and restrictions on pediatric use, building on ICMR’s earlier April 2025 recommendations for tighter controls. The ban aligns with India’s efforts to enhance pharmaceutical safety standards.
