India bans high-dose oral nimesulide due to liver risks, effective Dec. 29, 2025.

India has banned the manufacture, sale, and distribution of oral nimesulide formulations exceeding 100 mg in immediate-release forms, effective December 29, 2025, citing risks of liver toxicity and serious adverse effects. The move, under Section 26A of the Drugs and Cosmetics Act, follows recommendations from the Drugs Technical Advisory Board and ICMR, emphasizing safer alternatives are available. The ban applies only to high-dose oral human use products, not all formulations, and builds on prior restrictions, including a 2011 pediatric ban and a 2025 veterinary prohibition. The government also proposed stricter rules for cough syrups after a WHO alert linked a batch to child deaths, aiming to regulate medicines by ingredient risk, not form.