Government bans high-dose Nimesulide oral formulations over safety concerns

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The government has banned the manufacture, sale, and distribution of all oral formulations of pain and fever medications containing Nimesulide above 100 milligrams in immediate-release dosage form, citing risks to human health and the availability of safer alternatives.

The prohibition, announced through a notification dated December 29, 2025, takes effect immediately under Section 26A of the Drugs and Cosmetics Act, 1940, following consultation with the Drugs Technical Advisory Board.

"The use of all oral formulations containing Nimesulide above 100 mg in immediate release dosage form is likely to involve risk to human beings, and safer alternatives are available," the Health Ministry said in the notification.

Why it matters

Nimesulide, a non-steroidal anti-inflammatory drug (NSAID), has long been under scrutiny globally for potential liver toxicity and other adverse effects. India’s move aligns with its broader push to tighten safety standards and phase out high-risk medicines.

The ban applies to manufacture, sale, and distribution for human use, effectively removing these high-dose products from the domestic market. Lower-dose formulations and other therapeutic alternatives remain available.

Pharmaceutical companies marketing Nimesulide-based brands will need to halt production and recall affected batches. Analysts expect limited financial impact on large drugmakers, as Nimesulide accounts for a small share of overall NSAID sales, but smaller firms with significant exposure could face revenue pressure.

India has previously banned several fixed-dose combinations and high-risk drugs under Section 26A to safeguard public health. The latest move underscores the government’s commitment to stricter pharmacovigilance amid rising concerns over drug safety.