Centre Bans High-Dose Nimesulide Oral Drugs Citing Health Risks

The Centre has prohibited the manufacture, sale and distribution of oral formulations of nimesulide containing more than 100 mg, citing concerns over patient safety and the availability of safer alternatives. The ban has come into effect immediately across the country.

Nimesulide, a widely used non-steroidal anti-inflammatory drug (NSAID) prescribed for pain, fever and inflammation, has been under long-standing regulatory scrutiny due to safety concerns, particularly its association with liver toxicity. In a notification issued under Section 26A of the Drugs and Cosmetics Act, 1940, the government said high-dose oral preparations of the drug pose a risk to human health and their continued availability is not justified in public interest.

The decision was taken after consultation with the Drugs Technical Advisory Board (DTAB), the apex statutory body advising the government on technical matters related to drugs and cosmetics. The order ensures uniform implementation across all States and Union Territories.

Regulatory authorities have repeatedly flagged concerns over the risk–benefit profile of nimesulide. The World Health Organization has not included the drug in its Model List of Essential Medicines, reflecting global caution regarding its safety. Several countries have either restricted or withdrawn nimesulide following reports of drug-induced liver injury.

In India, the Central Drugs Standard Control Organisation (CDSCO) has reviewed the drug on multiple occasions. Medical experts have consistently pointed out that alternatives such as paracetamol and ibuprofen, when used at recommended doses, have a more established safety record, supported by evidence from bodies including the Indian Council of Medical Research.

Welcoming the government’s move, Dr. Vijay Kumar Agarwal, Director of Pulmonology and Critical Care at Yatharth Super Speciality Hospital, Faridabad, said high doses of nimesulide significantly increase the risk of serious adverse effects.

“Nimesulide has been repeatedly linked to drug-induced liver injury, including acute liver failure that may require emergency transplant or even lead to death. The risk rises with higher doses, prolonged use, dehydration, alcohol intake, pre-existing liver disease, and unsafe use alongside other medicines,” Dr. Agarwal said.

He stressed that if the drug is used at all, it should be strictly on a doctor’s advice, at the lowest effective dose. “Typically, it should not exceed 100 mg per dose, with a maximum of 200 mg per day, and only for the shortest possible duration. It should be avoided in patients with liver disease, heavy alcohol use, during pregnancy unless specifically advised, and in children, where many regulators have restricted its use,” he added.

Dr. Agarwal also pointed to other known risks associated with nimesulide and similar NSAIDs, including gastric irritation, ulcers and gastrointestinal bleeding, kidney injury — especially in elderly or dehydrated patients — fluid retention, worsening heart failure, asthma or bronchospasm in susceptible individuals, and allergic skin reactions. Rare but severe conditions such as Stevens–Johnson syndrome and toxic epidermal necrolysis have also been reported.

He noted that India has already acted against several fixed-dose combinations involving nimesulide, including combinations with diclofenac and paracetamol. “Such combinations can mask overdosing, increase gastrointestinal and renal risks, and compound liver stress, particularly when patients unknowingly consume paracetamol from multiple sources,” he said.

Dr. Agarwal cautioned that patients experiencing symptoms suggestive of toxicity should stop the drug immediately and seek medical attention. “Early evaluation and supportive care can be life-saving,” he said.

The ban on high-dose nimesulide oral formulations marks a further step by the government to strengthen drug safety oversight and reduce avoidable health risks, while encouraging the use of safer, well-studied alternatives for pain and fever management.