India Bans Oral Nimesulide Above 100 mg

In a significant regulatory move, the Union Health Ministry has banned all oral formulations of Nimesulide exceeding 100 mg. The decision, notified on December 31, 2025, cites potential health risks to humans and the availability of safer alternatives, reinforcing India’s tightening oversight of pharmaceutical safety.

Health Ministry Notification and Rationale

According to the notification, higher-dose oral formulations of Nimesulide pose a likely risk to public health, particularly due to concerns over liver toxicity. The drug, a nonsteroidal anti-inflammatory drug commonly prescribed to reduce fever and pain, has already been prohibited for use in children below 12 years of age and for veterinary purposes. The ministry stated that the latest ban followed consultations with the Drugs Technical Advisory Board, the apex advisory body on technical matters related to drugs in India.

Safety Concerns and Regulatory Background

Nimesulide has long been under regulatory scrutiny globally because of its hepatotoxic potential. While it continues to be used in limited adult indications in India, authorities have progressively narrowed its scope. The ban on oral formulations above 100 mg reflects a precautionary approach, especially as alternative antipyretic and analgesic drugs with better safety profiles are widely available in the market.

Impact on the Pharmaceutical Market

Industry estimates suggest that the overall Nimesulide segment, including fixed-dose combinations, is valued at around ₹500 crore. Several major pharmaceutical companies, including “Dr Reddy’s Laboratories”, “Cipla”, “Emcure” and “Alkem”, have brands containing the drug. Market analysts note that while few products above 100 mg are actively sold, the government’s move aims to eliminate even marginal risks associated with higher strengths.

Imporatnt Facts for Exams

• Nimesulide is a nonsteroidal anti-inflammatory drug with known liver toxicity risks.
• India has banned oral Nimesulide formulations above 100 mg.
• The drug is already prohibited for children below 12 years and veterinary use.
• The Drugs Technical Advisory Board advises the government on drug safety matters.

Policy Signal and Industry Response

Experts view the ban as a clear signal of the Centre’s intent to prioritise patient safety over commercial considerations. According to industry observers, higher-strength formulations may have had regulatory approval but limited sales. The prohibition ensures that no potentially harmful dosage remains legally available, even if it affects a small section of consumers, aligning India’s drug policy with a more risk-averse public health framework.