India Bans Oral Nimesulide Over 100mg Immediate-Release

India's Union Health Ministry has imposed an immediate ban on the manufacture, sale, and distribution of all oral formulations of the painkiller nimesulide exceeding 100 milligrams in immediate-release form, citing significant health risks to users. The decision, announced in a notification issued on Monday, affects a widely prescribed nonsteroidal anti-inflammatory drug commonly used for short-term relief of pain, inflammation, and fever.

The ban targets only immediate-release oral doses above 100 milligrams, leaving lower-strength formulations, sustained- or extended-release versions above that threshold, and non-oral forms such as topical gels, creams, or suppositories unaffected, according to a senior ministry official. The government acted under Section 26A of the Drugs and Cosmetics Act, 1940, following consultations with the Drugs Technical Advisory Board and a recommendation from the Indian Council of Medical Research, the country's premier health research body.

"The Central government is satisfied that the use of all oral formulations containing nimesulide above 100 milligrams in immediate release dosage form is likely to involve risk to human beings and that safer...