Public Safety: Centre Bans High-Dose Nimesulide Oral Formulations; Standard 100mg Doses Still Allowed

The Union Health Ministry has officially banned the manufacture, sale, and distribution of Nimesulide oral formulations exceeding 100 mg in immediate-release form. This order was issued via a gazette notification on December 29, 2025, following recommendations from the Indian Council of Medical Research (ICMR) and the Drugs Technical Advisory Board (DTAB). The ban applies strictly to “high-dose” immediate-release tablets; it does not apply to the standard 100mg tablets, sustained-release (SR) formulations, or topical gels/creams.

Why It Was Banned: The primary reason cited for the ban is the risk of severe hepatotoxicity (liver damage) and liver failure associated with high doses of the drug. The government stated that safer alternatives are available for pain and fever management, making the risk of high-dose Nimesulide unjustifiable. The ICMR highlighted that the elderly and children are particularly vulnerable to adverse effects like gastrointestinal bleeding and renal toxicity.

History: This move tightens the net around Nimesulide, which has been under scrutiny for decades. The drug was already banned for children under 12 years in 2011 due to safety concerns. Earlier this year (January 2025), the government also banned all veterinary formulations of Nimesulide to protect the vulture population, as the drug was found to be toxic to scavengers feeding on treated cattle carcasses.