Srinagar, Dec 31: The Ministry of Health and Family Welfare has imposed an immediate ban on the manufacture, sale, and distribution of all oral formulations of the painkiller nimesulide containing more than 100 mg in immediate-release dosage forms. The ministry stated that higher-dose oral nimesulide formulations “are likely to involve risk to human beings”.
The over-the-counter tablets and syrups commonly sold under brand names like Nimesulide, Nise, or generics have been banned by the union health ministry.
The decision was notified under Section 26A of the Drugs and Cosmetics Act, 1940 on 30 December and follows recommendations from the Drugs Technical Advisory Board (DTAB) and a detailed safety review by the Indian Council of Medical Research (ICMR). The ministry stated that higher-dose oral nimesulide formulations are likely to involve risk to human beings, particularly due to well-documented concerns over hepatotoxicity (liver damage). The ranges of potential damages include elevated liver enzymes and severe acute liver failure in rare cases. Safer alternative pain relievers and anti-inflammatory drugs are readily available, the notification has emphasised. Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) that has long been popular in India for treating many types of pain, fever, cramps and inflammation. It is usually prescribed 100 mg twice daily. As per reports, the drug has estimated Rs 500 crore in annual sales in India.However, its safety profile has drawn scrutiny for decades.