Centre Pulls High-Dose Nimesulide Off Shelves, Citing Safety Risks

India bans oral Nimesulide medicines above 100 mg in immediate-release form, citing health risks and availability of safer alternatives.

Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) that was first introduced in Italy in 1985.

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The Union government has ordered an immediate ban on the manufacture, sale and distribution of oral pain and fever medicines containing more than 100 milligrams of Nimesulide in immediate-release form. The decision, notified on December 29, 2025, has been taken under Section 26A of the Drugs and Cosmetics Act, 1940, following consultations with the Drugs Technical Advisory Board (DTAB).

The directive applies across India and requires pharmaceutical companies and distributors to withdraw affected formulations from the domestic market with immediate effect.

Why Govt Acted

According to the Health Ministry’s notification, higher-dose immediate-release formulations of Nimesulide pose potential health risks, particularly when safer therapeutic alternatives are already available, reported Business Standard. The government concluded that allowing these products to remain on the market was not justified in the interest of public health.

As a result, all oral formulations exceeding the 100 mg threshold—commonly tablets and similar preparations—are now prohibited. However, lower-dose versions of the drug and other non-Nimesulide pain relief and fever treatments will continue to be legally available.

A Drug Under Longstanding Scrutiny

Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) that was first introduced in Italy in 1985. Over the years, it has faced sustained scrutiny in several countries due to concerns related to liver toxicity and other adverse reactions. Despite global debates around its safety profile, India approved the drug for use in 1995, and it has since become a widely prescribed medication.

Industry estimates suggest that Nimesulide-based products generate around Rs 500 crore in annual sales in India, making the latest move significant for both manufacturers and healthcare providers.

DTAB’s Recommendations & What Comes Next

While some medical experts have previously called for a complete nationwide ban on Nimesulide, the DTAB stopped short of endorsing such a measure at this stage. Instead, the board recommended that the Indian Council of Medical Research (ICMR) conduct further studies to evaluate the drug’s safety in specific population groups, including children under 12 years of age, adolescents between 12 and 18, and elderly patients above 60.

Until those studies are completed, the DTAB agreed that restricting higher-dose immediate-release formulations was a necessary interim step. The government, in its notification, stated that the prohibition was essential “in the public interest,” underscoring the precautionary approach adopted by regulators.