The Indian government has officially banned the manufacture, sale, and distribution of high-dose Nimesulide painkiller pills, specifically all oral formulations exceeding 100 mg in immediate-release form. The ban was enacted on December 29th and published in The Gazette of India. This decision follows concerns about potential health risks associated with the drug and the availability of safer alternatives.
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) widely used to treat pain, fever, and inflammation. It has been marketed in India under brand names such as Nimulid, Nimtex, Nicip and Nise. The ban applies specifically to oral formulations above 100 mg in immediate-release form, meaning lower-dose formulations remain unaffected.
The Ministry of Health and Family Welfare stated it was convinced that the continued use of higher-dose Nimesulide carried potential risks to human health, necessitating the prohibition in the public interest. The decision was made after consulting with the Drugs Technical Advisory Board (DTAB) and considering a recommendation from the Indian Council of Medical Research (ICMR). The government declared that safer alternatives to the drug were available. The order was issued under Section 26A of the Drugs and Cosmetics Act, 1940, preventing manufacturers, distributors, and sellers from producing or supplying the banned formulations.
Nimesulide has been under regulatory scrutiny for over a decade. In 2011, the central government had already prohibited the use of Nimesulide in children below 12 years due to concerns about liver toxicity. Earlier in January 2025, the government banned veterinary formulations of Nimesulide due to its toxicity to vultures. The Bombay Natural History Society found that vultures died within 24 hours of being administered the drug.
Medical experts have warned that prolonged use of Nimesulide may lead to elevated liver enzymes, liver toxicity, internal bleeding, clotting disorders, and severe kidney damage. These risks have prompted several countries, including Finland, Spain, Ireland, and Singapore, to withdraw the drug between 2002 and 2007. In 2008, the International Society of Drug Bulletins, a WHO-supported network, advocated for a global ban on Nimesulide, citing a higher risk of potentially fatal liver disorders without clear therapeutic advantages over other NSAIDs.
Dr. Rommel Tickoo, director of internal medicine at Max Hospital, Saket, welcomed the ban as a prudent and timely decision. While the ban aims to safeguard consumers, the Times of India has cautioned about potential enforcement challenges, especially in a market dominated by generic versions. However, industry bodies have pledged compliance, and health experts anticipate minimal supply disruptions due to the availability of alternative medications like paracetamol and ibuprofen.
