Nimesulide painkiller above 100 mg banned in India: What the Health Ministry’s order means for patients

The Union Health Ministry has banned the manufacture, sale and distribution of all oral nimesulide formulations above 100 mg, citing serious risks to human health

Health-drugs - 1

Citing serious risks to health, the Union Health Ministry informed the decision to ban the manufacture, sale and distribution of all oral formulations containing the popular painkiller nimesulide above 100 mg. 

Ministry of Health and Family Welfare, in a gazette notification, said that the move is in consultation with the Drugs Technical Advisory Board and has been banned under section 26A of the Drugs and Cosmetics Act, 1940.

It also mentioned that the use of all oral formulations containing nimesulide is likely to involve risk to human beings and that safer alternatives to the Nimesulide drug are available in the market.

Why is Nimesulide used?

Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) having analgesic and antipyretic effects that are primarily COX-2 selective. 

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This medication is primarily used to relieve pain, especially the pain caused by menstrual cramps and osteoarthritis in adults. 

As per information available on the official website of CARE Hospitals, long-term usage may harm the liver or result in significant side effects, including gastrointestinal bleeding or renal issues.

Apart from this, other side effects like sour stomach, dizziness, skin infection, diarrhoea and increased liver enzymes might be observed in individuals. 

The decision to restrict Nimesulide to lower doses is part of a broader initiative to enhance drug safety and ensure that medications prescribed to patients do not pose undue risks.

Meanwhile, on December 19, 2025, the Australian Technical Advisory Group on Immunisation (ATAGI) issued a public health advisory, informing travellers that counterfeit batches of the human rabies vaccine Abhayrab have been circulating in India since 2023. 

Strongly refuting the advisory, the vaccine manufacturer mentioned that it had proactively identified a packaging anomaly in one specific batch in January 2025, notified Indian regulators and law enforcement agencies, lodged a formal complaint, and worked closely with authorities to ensure swift action.