The Union Health Ministry has banned the manufacture, sale and distribution of all oral formulations containing the popular painkiller nimesulide above 100 mg, citing serious risks to health. The decision was taken following a recommendation by ICMR, the apex health research body of India, according to the official notification

“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 stated that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution of the drug in the country for human use.

“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.

Cough syrups removed from OTC sales

The notification removes “syrups … for cough” from Schedule K — the list of medicines exempted from the requirement of a prescription by a registered medical practitioner, according to The Indian Express. Lozenges, pills or tablets for cough continue to remain on the list, the report said.

Earlier this year, at least 22 children died in Madhya Pradesh after consuming contaminated cough syrups. Similar news reports – of children deaths – came from Rajasthan at the same time.

The Drugs Consultative Committee (DCC) proposed deleting the exemption for cough syrups under Schedule K of the Drugs Rules, 1945, meaning they would require a doctor’s prescription.

‘Centre’s move on Nimesulide a patient-safety–driven’

The Union Health Ministry’s move on Nimesulide, meanwhile, has been welcomed by the medical fraternity as a “patient-safety–driven” step. “Nimesulide has long been associated with a risk of liver toxicity, especially when used in higher doses, for prolonged periods, or without medical supervision. Immediate-release high-dose formulations can cause sudden spikes in blood levels, increasing the risk of adverse effects such as liver injury, gastric irritation, and kidney stress,” Dr Tushar Tayal, associate Director, internal medicine, CK Birla hospital Gurgaon, said while speaking to financialexpress.com.

“This move does not mean all painkillers are unsafe, but it reinforces the need for rational prescribing and regulated dosing. Safer alternatives like paracetamol, when used correctly, or other NSAIDs under medical guidance, remain available. Importantly, this decision also sends a strong message against self-medication and over-the-counter misuse of potent drugs. Regulatory actions like these help align India’s drug safety standards with global best practices and ultimately protect public health,” he added.