New Delhi— The central government has imposed an immediate ban on the manufacture, sale and distribution of oral nimesulide tablets containing doses higher than 100 mg, citing serious public health concerns. The decision has been taken under Section 26A of the Drugs and Cosmetics Act, 1940, with authorities stating that higher-dose formulations of the painkiller pose potential risks to human health and that safer alternatives are already available in the market.
According to an official notification issued by the health ministry, oral formulations of nimesulide exceeding the 100 mg limit, including immediate-release tablets, have been found to carry safety concerns. Nimesulide, a non-steroidal anti-inflammatory drug widely used as a painkiller, has been under global scrutiny for its association with liver toxicity and other adverse effects. The government said the move was made after detailed consultations with the Drugs Technical Advisory Board and was necessary in the interest of public safety.
The notification clarified that the ban applies across the country with immediate effect. However, lower-dose formulations that fall within approved safety limits, along with other safer alternatives, will continue to remain available for patients. The ministry emphasised that the restriction targets only high-dose oral formulations and is not a blanket ban on the drug itself.
Officials noted that the step aligns with international concerns and ongoing evaluations of nimesulide’s safety profile worldwide. The government said the decision reflects its commitment to strengthening drug safety standards and gradually phasing out formulations that carry higher health risks, while ensuring that effective and safer treatment options remain accessible to the public.
