The Central Government has officially banned the manufacture, sale, and distribution of all oral formulations containing nimesulide above 100 mg in immediate-release dosage form for human use across India. The notification (S.O. 6091(E)) issued by the Ministry of Health and Family Welfare, exercising powers under Section 26A of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board (DTAB).
According to the notification, the government is satisfied that Oral nimesulide formulations above 100 mg are likely to pose a risk to human health, and Safer therapeutic alternatives are available for pain and inflammation management. Considering these factors, the government stated that prohibiting such high-dose formulations is “necessary and expedient in the public interest.”
Globally, nimesulide has faced significant regulatory restrictions. The drug is not approved for marketing in the United States, United Kingdom, Canada, Australia, or Japan. In the European Union, nimesulide is not uniformly approved; it has been withdrawn, suspended, or never authorised in several EU countries due to concerns over liver toxicity, following reviews by European regulatory authorities. While limited use with strict restrictions has existed in a few countries in the past, many developed markets have either discontinued its use or avoided approval altogether, opting for safer NSAID alternatives. India’s latest decision aligns its regulatory approach more closely with international safety practices.
Nimesulide, a non-steroidal anti-inflammatory drug (NSAID), has long been under regulatory scrutiny due to concerns related to hepatic (liver) toxicity, particularly at higher doses. India had earlier restricted its use in children below 12 years, and banned its use in veterinary formulations.
The ban applies to “All oral formulations containing nimesulide above 100 mg in immediate-release dosage form.” The prohibition comes into force with immediate effect, meaning manufacturers, distributors, and retailers must stop production and sale of such products forthwith.
This move is expected to improve patient safety, align prescribing practices with safer alternatives and require immediate compliance by pharmaceutical manufacturers and marketers. Industry stakeholders are advised to review product portfolios and ensure strict compliance with the notification to avoid regulatory action.
