Government bans manufacture, sale of oral painkiller nimesulide above 100mg
What's the story
The Union Health Ministry has prohibited the manufacture, sale, and distribution of all oral formulations containing nimesulide above 100 milligrams (mg) for human use. The decision was taken after concerns were raised over the drug's safety profile, especially its potential to cause liver damage. The Indian Council of Medical Research (ICMR) had earlier recommended a total ban on such formulations due to these risks.
Order
What notification said
"The Central government is satisfied that the use of all oral formulations containing Nimesulide above 100 mg in immediate release dosage form is likely to involve risk to human beings and that safer alternatives to the said drug are available," the notification issued on Monday read. "Now...after consultation with the Drugs Technical Advisory Board, the Centre, hereby prohibits the manufacture, sale and distribution of the drug, with immediate effect," the notification said.
Drug profile
Nimesulide's history and safety concerns
Nimesulide, a non-steroidal anti-inflammatory drug (NSAID), was launched in Italy in 1985 and approved in India in 1995. It is widely used to relieve pain and reduce fever. However, countries like the United States, the United Kingdom, Spain, Australia, Canada, Japan, and New Zealand have never approved it due to safety concerns. The ICMR report highlighted significant risks associated with nimesulide use in patients under 18 years of age and those over 60 years old.
Twitter Post
Notification by Health Ministry
The government has banned the manufacture of the painkiller nimesulide and has also prohibited the sale of all oral formulations of this popular painkiller containing more than 100 mg. pic.twitter.com/gfw1DYUlTi
— ANI (@ANI) December 31, 2025
Ban history
Previous bans and market impact
The drug was banned for pediatric use in 2011 after reports of severe hepatotoxicity in young patients. In January 2025, it was also banned for veterinary use. Despite these bans, the market for nimesulide formulations in India is worth ₹497 crore and has been growing at 11% over the past year. The Drug Technical Advisory Board (DTAB) had earlier suggested further review before recommending a complete ban on nimesulide.