The Union Health Ministry has banned the manufacture, sale and distribution of all oral formulations containing the painkiller nimesulide above 100 mg in immediate-release dosage form, citing serious risks to human health, according to an official notification.
The decision was taken following a recommendation by the Indian Council of Medical Research (ICMR), the country’s apex health research body, and after consultation with the Drugs Technical Advisory Board.
The prohibition has been imposed under Section 26A of the Drugs and Cosmetics Act, 1940, and comes into effect immediately.
“The Central government is satisfied that the use of all oral formulations containing Nimesulide above 100 mg in immediate release dosage form is likely to involve risk to human beings and that safer alternatives to the said drug are available,” the notification issued on Monday said.
It further stated that the move was necessary in public interest.
“Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 and after consultation with the Drugs Technical Advisory Board, the Centre, hereby prohibits the manufacture, sale and distribution of the drug, with immediate effect,” the notification said.
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) commonly used for pain and fever relief. However, it has been under scrutiny globally for its potential to cause liver toxicity and other adverse effects.
Health Ministry officials said the latest ban is aimed at tightening drug safety standards, particularly when safer alternatives are available.
Concerns over the drug are not new in India. In 2011, the health ministry banned the use of nimesulide in children below 12 years of age, citing heightened risks. “Nimesulide formulations in children below 12 years of age – Nimesulide containing products are not permitted in many countries in children under 12 years of age. The drug has been considered to be hepatotoxic and children are considered more susceptible to hepatotoxicity,” the government had said at the time.
Several countries have already restricted or withdrawn nimesulide due to similar concerns.
In Europe, nations such as Finland, Spain, Ireland and Belgium pulled the drug from the market after reports linked it to serious liver damage, including cases of acute liver failure requiring transplants.
In 2007, the European Medicines Agency reviewed nimesulide and concluded that its risks outweighed its benefits for routine pain relief, leading to its suspension or severe restriction across much of the European Union.
Outside Europe, countries including Canada, Japan, the United States, Australia and the United Kingdom never approved nimesulide for human use, largely due to safety concerns identified during early evaluations, particularly the risk of rare but severe liver toxicity that could occur even with short-term use.
