Centre Bans Manufacture, Sale of High-Dose Nimesulide Oral Formulations Over Health Risks

New Delhi: The Union government has prohibited the manufacture, sale and distribution of all oral formulations of the painkiller Nimesulide containing more than 100 mg in immediate-release dosage form, citing potential risks to human health.

The decision was notified by the Ministry of Health and Family Welfare through an extraordinary gazette notification issued on December 29, 2025. The ban has come into force with immediate effect following consultation with the Drugs Technical Advisory Board (DTAB).

According to the notification, the Central government was satisfied that the use of oral formulations containing Nimesulide above 100 mg is “likely to involve risk to human beings” and that safer alternatives to the drug are available.

In view of public interest and patient safety, the government deemed it necessary to prohibit such formulations under the provisions of Section 26A of the Drugs and Cosmetics Act, 1940. “All oral formulations containing Nimesulide above 100 mg in immediate-release dosage form” have been barred from manufacture, sale and distribution for human use, the notification stated.

In a separate but related move, the government has also proposed amendments to the Drugs Rules, 1945, under which the term “syrup” has been omitted from Schedule K in relation to certain drug categories.

The draft rules have been issued for public consultation, allowing stakeholders and citizens to submit objections or suggestions within 30 days from the date of publication in the Gazette of India. The ministry clarified that feedback on the draft amendments can be sent to the Under Secretary (Drugs), Ministry of Health and Family Welfare, or emailed to the designated official address.

Nimesulide, a non-steroidal anti-inflammatory drug (NSAID), has been widely used in India for pain relief and fever management. However, concerns over its safety profile-particularly at higher doses-have been raised over the years by health experts and regulatory bodies.

The latest ban reinforces the government’s stance on tightening drug regulation to ensure patient safety and curb the availability of formulations deemed unsafe for human use.

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