India has taken a significant step to safeguard public health by prohibiting the manufacture, sale, and distribution of all oral formulations of Nimesulide that exceed 100 milligrams (mg) in immediate-release form. This decision was officially announced by the Ministry of Health and Family Welfare (MoHFW) on December 29, 2025, highlighting serious concerns regarding the potential health risks associated with this medication.
Nimesulide is classified as a non-steroidal anti-inflammatory drug (NSAID) often prescribed for alleviating pain, reducing inflammation, and managing fever in adults. It is widely available in India under various brand names including Nimulid, Nicip, and Nimegesic, among others. However, the drug has a troubling history, particularly regarding its link to liver damage, which can range from mild enzyme alterations to severe liver failure. This type of damage, known as hepatic risk, raises significant safety alarms surrounding its use.
Interestingly, Nimesulide has never gained approval in the United States due to ongoing safety concerns, nor is it sanctioned for use in several other countries, such as Canada, Japan, and Australia. Although some European nations initially permitted its prescription, many later imposed restrictions or outright bans due to similar issues related to liver safety.
The recent ban aims to protect the health and safety of the public. The government's announcement clearly states that the use of higher-dose Nimesulide formulations poses a significant risk to human health, especially when safer alternatives are readily available. As articulated in the official notification: "Whereas 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 are available; and, whereas, the Central Government is satisfied that 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."
This prohibition takes effect immediately and specifically targets all oral formulations of Nimesulide that exceed the specified dosage in immediate-release form. The move follows recommendations from the Drugs Technical Advisory Board (DTAB) and is enacted under Section 26A of the Drugs and Cosmetics Act of 1940.
Additionally, it is worth noting that the Ministry of Health had previously banned Nimesulide for children under the age of 12, based on findings from an Expert Committee established by the DTAB, due to concerns about the drug's hepatotoxicity. "The drug has been considered to be hepatotoxic, and children are considered more susceptible to hepatotoxicity," the notification stated.
Earlier this year, in February, the Ministry also prohibited the use of Nimesulide and its formulations for animals, further emphasizing the drug’s contentious safety profile. While large pharmaceutical companies phased out high-dose Nimesulide formulations years ago, some smaller generic manufacturers and trade-led brands continued to offer these products. This prompted regulators to implement a comprehensive ban aimed at eliminating any remaining availability in the market.
It's important to clarify that this ban is specific to oral, immediate-release formulations of Nimesulide exceeding 100 mg and does not constitute a blanket prohibition on the drug itself. Patients currently using Nimesulide are advised against abruptly discontinuing their medication and should consult healthcare providers for suitable alternatives if necessary.
