Nimesulide banned: Centre blocks sale of oral painkiller above 100 mg immediate-release

The Government of India has banned the manufacture, sale, and distribution of oral formulations of nimesulide exceeding 100 mg in immediate-release form , citing potential health risks.

Nimesulide , a non-steroidal anti-inflammatory drug (NSAID), is commonly prescribed to treat fever, pain, and inflammation associated with conditions like arthritis or high-grade fever. While effective in these cases, medical experts warn that doses above 100 mg can lead to serious adverse effects , including liver injury, kidney damage, and gastritis .

The move follows a review by the Indian Council of Medical Research (ICMR) , which highlighted the risks of higher-dose oral formulations and recommended safer alternatives. The ban is enforced under Section 26A of the Drugs and Cosmetics Act, 1940 , after consultation with the Drugs Technical Advisory Board, making it effective immediately .

The prohibition applies only to oral formulations above 100 mg in immediate-release form . Other forms of the drug including oral doses below 100 mg, sustained or extended-release formulations, and non-oral forms such as topical gels, creams, and suppositories remain unaffected.

Medical experts have welcomed the decision. Dr S Chatterjee , Senior Consultant in Internal Medicine at Apollo Hospitals, said, “The ban is long overdue. Nimesulide was often used injudiciously for high-grade fever, ignoring its potential for liver and kidney damage. Safer alternatives are available.”