 "Govt bans sale, use of oral formulations of nimesulide for human use")
The Union Health Ministry has banned the manufacture, sale and distribution of all oral formulations containing the popular painkiller nimesulide above 100 milligrams (mg) for human use, citing health risks.
This follows a similar recommendation made in a report by the Indian Council of Medical Research (ICMR) amid concerns that the drug could cause liver damage, which could turn life-threatening in some patients.
“The Central Government is satisfied that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution of the said drug in the country for human use,” a government notification released late on December 30 stated.
India has already banned the use of nimesulide in children under 12 after receiving reports of severe hepatotoxicity in several young patients globally and locally. Its use was subsequently banned for veterinary purposes in February this year.
The additional caution on nimesulide use comes after the ICMR report highlighted a poor safety profile for the drug in adults, suggesting it be reserved only as a second-line treatment and used only after first-line options have been tried and found ineffective.
While some experts considered recommending an all-India ban on nimesulide, the Drug Technical Advisory Board (DTAB) under India’s apex drug regulator asked the ICMR to conduct a systematic review of its use in children under 12, those aged 12–18, and the 60-plus group before further deliberations.
“The DTAB opined that nimesulide is one of the effective drugs for reducing fever and used for short-term treatment,” according to the minutes of its 92nd meeting held in April 2025.
However, it agreed that all oral formulations of nimesulide above 100 mg in immediate-release dosage forms, such as tablets, should be prohibited.
Launched in Italy in 1985, nimesulide belongs to the class of non-steroidal anti-inflammatory drugs (NSAIDs), commonly used to relieve pain and reduce fever.
India approved nimesulide in 1995 and currently has a market of around Rs 500 crore on a moving annual turnover (MAT) basis, according to estimates.
In contrast, countries such as the United States, the United Kingdom, Spain, Australia, Canada, Japan and New Zealand have never approved the drug due to safety concerns.