India has banned high-dose Nimesulide tablets, citing serious public health concerns. The Union government has prohibited the manufacturing, sale, and distribution of oral Nimesulide formulations exceeding 100 mg per dose. The decision takes effect immediately across the country.
The Health Ministry issued the notification under Section 26A of the Drugs and Cosmetics Act, 1940. Officials said higher doses of Nimesulide pose potential risks to human health. The government also noted that safer alternatives are widely available in the market.
Nimesulide is a non-steroidal anti-inflammatory drug commonly used as a painkiller. Medical experts have raised concerns over its link to liver toxicity and other adverse effects. Several countries have already restricted or closely monitored its use.
The ministry said it consulted the Drugs Technical Advisory Board before taking the decision. Based on expert opinion, the board concluded that doses above 100 mg could be harmful. The ban applies to all oral forms, including immediate-release tablets.
Lower-dose formulations that meet safety standards will continue to remain available. The government said the move aims to protect patients and strengthen drug safety norms.
Health officials urged people not to self-medicate and to use painkillers only under medical advice. Authorities will monitor compliance to ensure strict enforcement of the ban.
