New Delhi, December 31, 2025— The central government has imposed an immediate nationwide ban on the manufacture, sale and distribution of oral nimesulide tablets containing doses above 100 mg, citing serious concerns related to public health and patient safety. The decision, taken under Section 26A of the Drugs and Cosmetics Act, 1940, comes amid growing scrutiny over the safety profile of the widely used painkiller.
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 pose potential risks to human health. Nimesulide, a non-steroidal anti-inflammatory drug commonly prescribed for pain and inflammation, has been under global examination for its association with liver toxicity and other adverse effects.
The government said the move followed detailed consultations with the Drugs Technical Advisory Board and was taken in public interest to prevent exposure to higher-risk drug formulations, especially when safer alternatives are readily available in the market. Authorities clarified that the restriction applies with immediate effect across the country.
The notification further stated that the ban is limited to high-dose oral formulations and does not amount to a complete prohibition on nimesulide. Lower-dose versions that fall within approved safety limits, along with alternative pain relief medicines, will continue to be available for patients.
Officials noted that the decision aligns with international concerns and ongoing evaluations of the drug’s safety worldwide. The government reiterated that the step reflects its commitment to strengthening drug regulation, enhancing patient safety, and gradually phasing out formulations that carry a higher risk to public health.
