The Union Health Ministry has ordered a ban on the manufacture, sale and distribution of all oral nimesulide formulations containing more than 100 mg for human use, citing potential health risks linked to the drug.
The decision follows recommendations from the Indian Council of Medical Research, which flagged concerns over nimesulide’s safety profile, particularly its association with serious liver injury that can be fatal in some cases.
In an official notification issued late on December 30, the government said it was “satisfied that it is necessary and expedient in the public interest” to prohibit these formulations across the country.
India had earlier banned the use of nimesulide in children below 12 years after reports of severe liver toxicity among young patients, both in India and abroad. The drug was also barred for veterinary use in February this year.
The latest restriction comes after the ICMR highlighted that nimesulide shows poor safety outcomes even in adults and recommended that it should be prescribed only as a second-line treatment, to be used when safer first-line options fail.
Although some experts pushed for a complete nationwide ban, the Drug Technical Advisory Board (DTAB), which advises India’s top drug regulator, sought further evidence. It asked the ICMR to carry out a detailed review of nimesulide use among children under 12, adolescents aged 12–18, and elderly patients above 60 years before taking a final call.
Minutes from the DTAB’s 92nd meeting in April 2025 note that the board acknowledged nimesulide’s effectiveness in reducing fever and its short-term use. However, it agreed that immediate-release oral formulations exceeding 100 mg, such as tablets, should not be permitted.
First introduced in Italy in 1985, nimesulide is a non-steroidal anti-inflammatory drug (NSAID) used to treat pain and fever. India approved it in 1995, and the drug currently has an estimated market size of around ₹500 crore based on moving annual turnover.
Several countries, including the United States, the United Kingdom, Spain, Australia, Canada, Japan and New Zealand, have never approved nimesulide because of safety concerns.