Nimesulide Ban in India: Why the Government Banned High-Dose Versions of the Popular Painkiller

New Delhi, December 31: In a significant move to strengthen drug safety standards, the Union Ministry of Health and Family Welfare has issued a nationwide ban on specific formulations of the popular painkiller Nimesulide. Through a Gazette notification dated December 29, 2025, the government prohibited the manufacture, sale, and distribution of all oral formulations containing more than 100 mg of the drug in immediate-release form for human use.

This regulatory action follows a similar sweeping ban on Nimesulide for veterinary use exactly one year prior, highlighting a coordinated effort to phase out the drug due to severe health and environmental risks. Cigarette Price Likely to Be Hiked to INR 72 Under New Excise Bill; Potential Price Rise Leaves Internet Divided.

India Bans Popular Painkiller Nimesulide

Severe Health Risks and Liver Toxicity: Why India Banned Nimesulide

The primary driver behind the restriction is the drug's long-standing association with hepatotoxicity (liver damage). Nimesulide, a non-steroidal anti-inflammatory drug (NSAID), has been under regulatory scrutiny globally for decades. Medical experts have found that higher doses—specifically those exceeding 100 mg—pose a significant risk of acute liver failure, which can be fatal in severe cases.

The Health Ministry’s decision was based on recommendations from the Drugs Technical Advisory Board (DTAB) and a detailed review by the Indian Council of Medical Research (ICMR). Experts noted that while the drug is effective for short-term pain relief, the availability of safer alternatives makes the risk of high-dose Nimesulide unjustifiable in the public interest.

Protecting Vulnerable Populations

The new regulations particularly target the risks posed to specific demographic groups:

• The Elderly: Patients over 60 years of age show an increased frequency of adverse reactions, including gastrointestinal bleeding and renal complications.
• Children: While Nimesulide was already banned for pediatric use (children under 12) in India since 2011, the latest review underscored that adolescents (12–18 years) remain highly susceptible to its toxic effects.
• Maternal Health: The advisory board reiterated that the drug should not be administered to pregnant or lactating women due to potential developmental risks.

The Environmental Connection: Saving Vultures

The human-use restriction comes on the heels of the December 2024 ban on veterinary Nimesulide. Environmentalists and the Bombay Natural History Society (BNHS) had long lobbied for this change, presenting evidence that Nimesulide is lethal to India's vulture population.

When vultures consume the carcasses of cattle treated with the drug, they suffer from rapid kidney failure and visceral gout. This ecological impact prompted the government to move Nimesulide to the "prohibited" list for animals, mirroring earlier actions taken against Diclofenac. Cigarette-Style Health Warnings Labels for Samosas, Jalebis? Health Ministry Says Claim ‘Misleading, Incorrect’.

Global Regulations on Nimesulide

India’s move brings it closer to international safety standards. Nimesulide was never approved for use in the United States, United Kingdom, Canada, Australia, or Japan. Many European nations, including Finland and Spain, withdrew the drug in the early 2000s following reports of sudden liver failure in patients.

In India, where brands like Nise, Nicip, and Nimulid are common household names, the 100 mg immediate-release limit is expected to significantly alter the pain-management market. Pharmacists have been instructed to clear existing high-dose stocks, and the government has urged practitioners to prioritize safer NSAIDs like Paracetamol or Ibuprofen as first-line treatments.

(The above story first appeared on LatestLY on Dec 31, 2025 01:34 PM IST. For more news and updates on politics, world, sports, entertainment and lifestyle, log on to our website latestly.com).