The Union ministry of health and family welfare (MoHFW) has banned all oral formulations of the painkiller nimesulide containing more than 100mg in immediate-release dosage form, citing risks to human health and the availability of safer alternatives.
In a notification issued on 29 December 2025, the ministry states that it is satisfied that the use of high-dose nimesulide formulations is 'likely to involve risk to human beings' and that it is necessary, in public interest, to prohibit its manufacture, sale and distribution across the country with immediate effect.
The ban has been imposed under Section 26A of the Drugs and Cosmetics Act, 1940, after consultation with the drugs technical advisory board (DTAB), the government’s highest technical advisory body on drug regulation.
The notification specifically applies to 'all oral formulations containing nimesulide above 100mg in immediate release dosage form' meant for human use. Lower-dose formulations are not covered by the prohibition.
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) commonly prescribed in India for pain, fever and inflammation. It has been on the Indian market since 1997 and has been sold under popular brand names such as Nice and Nimulid MD.
The decision marks the latest regulatory action against nimesulide in India, a drug that has faced sustained scrutiny over safety concerns for more than two decades.
In February 2011, the Union government banned the use of nimesulide in children below 12 years of age, following recommendations from an expert committee constituted by the DTAB. At the time, the government cited evidence that the drug was hepatotoxic, with children considered more susceptible to liver injury.
Nimesulide-containing products for paediatric use were already restricted or not permitted in several countries. The then health minister, Ghulam Nabi Azad, had told Parliament in March 2011 that regulatory decisions on drug bans are guided by risk-benefit assessments, disease patterns, dosage norms and the availability of safer substitutes.
Notably, nimesulide has never been licensed for use in countries such as the US, UK, Canada, Australia and New Zealand.
Experts have long pointed out that weak pharma-covigilance and prescribing practices contributed to the widespread use of nimesulide in India, despite international restrictions.
Until the launch of the Pharmacovigilance Programme of India (PvPI) in 2010, adverse drug reaction monitoring in the country was largely ineffective, even though the country had formally joined the WHO programme for international drug monitoring in 1997.
Compounding the problem, more than half of India’s population depends on drug stores not run by qualified pharmacists and on practitioners of alternative medicine systems who are not legally permitted to prescribe allopathic medicines in many states. This has historically made enforcement of drug restrictions uneven.
The regulatory tightening around nimesulide has not been limited to human use. In December 2024, the government extended a ban to veterinary formulations containing nimesulide or its combinations.
That decision followed scientific evidence linking nimesulide residues in animal carcasses to toxic nephropathy in vultures, contributing to large-scale vulture mortality. Research showed that the drug persists in carcasses and proves lethal to scavenger species, prompting authorities to act in the interest of animal welfare and biodiversity conservation.
The latest ban on high-dose nimesulide reflects a broader shift towards tighter drug safety oversight, with regulators increasingly relying on expert review, pharma-covigilance data and international evidence.
While nimesulide remains available in lower doses, the government’s move signals that formulations deemed to carry an unfavourable risk-benefit profile will face restrictions, particularly when safer alternatives exist.
For patients and prescribers, the ban underscores the need for caution in the use of NSAIDs and for adherence to approved dosages, as India’s drug regulator continues to recalibrate its approach to balancing access with safety.
