Centre bans oral formulations containing nimesulide above 100 mg citing health risks

New Delhi: The Union Health Ministry has prohibited the manufacture, sale and distribution of all oral immediate-release formulations of the painkiller nimesulide containing more than 100 mg, citing concerns over risks to human health and the availability of safer alternatives. The ban, which takes effect immediately across the country, follows a review and recommendation by the Indian Council of Medical Research (ICMR) and consultations with the Drugs Technical Advisory Board.

In a gazette notification issued on Monday, the Centre said it was “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.” It added that it was necessary and expedient, in the public interest, to prohibit the manufacture, sale and distribution of such formulations for human use. The order has been issued under Section 26A of the Drugs and Cosmetics Act, 1940.

Nimesulide is a commonly prescribed non-steroidal anti-inflammatory drug used to treat pain, fever and inflammation. However, it has long been under regulatory scrutiny due to safety concerns, particularly its association with liver toxicity. The ICMR reviewed evidence on the drug’s effects in adults before making its recommendation, which was subsequently accepted by an expert committee under the apex drug regulator.

The World Health Organization has not included nimesulide in its Model List of Essential Medicines, reflecting caution in its global use. Regulatory authorities in several countries have either restricted or withdrawn the drug following reports of hepatic injury. In India, the Central Drugs Standard Control Organisation has periodically examined its risk-benefit profile.

Medical experts welcomed the latest decision. Dr S Chatterjee, Senior Consultant in Internal Medicine at Apollo Hospitals, said the ban was overdue. “Nimesulide was banned much earlier in quite a few countries. To ban nimesulide by the government is a welcome decision because it was being used rampantly and injudiciously to treat high-grade fever without realising the potential side effects of liver injury or damage. Also, kidney injury and gastritis,” he said.

Alongside the ban, the health ministry has issued a draft notification proposing to remove cough syrups from the list of over-the-counter medicines under Schedule K, which currently exempts certain drugs from prescription requirements. While syrups for cough are proposed to be removed from the exemption list, lozenges, pills and tablets for cough would continue to be available without prescription.

The draft move follows reports of at least 22 children dying in Madhya Pradesh after consuming contaminated cough syrups, as well as other incidents, including in Rajasthan, involving cough syrups not meant for young children. An expert committee under the drug regulator had earlier noted these incidents and proposed deleting the exemption for cough syrups. Stakeholders have been given 30 days to submit suggestions or objections before the proposal is finalised.

The ICMR has also laid down additional safeguards on nimesulide use, recommending it only as a second-line treatment when other drugs fail or cannot be prescribed. It advised against its use in pregnant and lactating women, those planning pregnancy, and patients with kidney or liver impairment, and cautioned against combining it with other drugs toxic to the liver or kidneys. The drug remains banned for children under 12 years.