Breaking News: Health Ministry Bans Immediate-Release Nimesulide Oral Doses Above 100 mg

“The Central Government is satisfied that the use of all oral formulations containing Nimesulide above 100 mg in immediate release dosage form are likely to involve risk to human beings and that safer alternatives to the said drug is available," the notification stated.

Invoking public interest considerations, the government further observed, “It is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution of the said drug in the country for human use.”

Accordingly, exercising powers under Section 26A, the notification orders an immediate nationwide prohibition on, “All oral formulations containing Nimesulide above 100 mg in immediate release dosage form.”

Long-Standing Safety Concerns Around Nimesulide

Nimesulide, a non-steroidal anti-inflammatory drug (NSAID), has remained under regulatory scrutiny for years due to concerns over hepatic toxicity, particularly at higher doses and with prolonged use. While permitted in India with restrictions, several countries have either withdrawn or tightly regulated its use. The drug was approved in India in 1995 for pain, fever and inflammation, however, it has not been approved in countries like the US, UK, Canada, Australia, Japan or New Zealand because of safety concerns. It is marketed in India under several brand names such as Nise, Nimrest, Nimopen and Nicip, in 100 mg and 200 mg formulations.

The Medical Dialogues team had earlier reported that the Central Government had moved to tighten the use of nimesulide by mandating a prominent boxed warning on all product labels, cartons, package inserts and promotional material, following safety concerns flagged by regulatory and expert bodies. The move, based on deliberations by the Drugs Technical Advisory Board (DTAB) and review of ICMR data, sought to restrict nimesulide to second-line use, prohibit oral formulations above 100 mg, and clearly warn prescribers and patients about potential liver and kidney risks, particularly in vulnerable populations. Regulators had also noted that nimesulide is not approved in several major global markets due to safety concerns, underscoring the need for stricter labelling and controlled use in India.

Also Read: Box Warning, Dose Limit: India Set to Tighten Nimesulide Use

Nimesulide has remained under regulatory scrutiny for years due to persistent safety concerns. In 2011, the Health Ministry banned its paediatric use in children below 12 years of age, and more recently, in January 2025, the government prohibited the manufacture, sale and distribution of all nimesulide formulations for veterinary use.

Despite these restrictions, the Indian market for nimesulide formulations stands at Rs 497 crore and has grown by 11 per cent over the last 12 months, according to data from market research firm PharmaTrac, reports ET.

Now, with the latest notification, any manufacture or sale of oral nimesulide formulations exceeding 100 mg in immediate-release form would now constitute a statutory violation under the Drugs and Cosmetics Act, inviting regulatory and penal action.