Government Bans Oral Nimesulide Formulations Above 100 Mg

In a significant regulatory move, the Union Health Ministry has prohibited the manufacture, sale, and distribution of all oral formulations of nimesulide above 100 mg immediate-release dosage for human use. The ban, announced on December 31, 2025, comes after extensive consultations with the Drugs Technical Advisory Board (DTAB) and recommendations from the Indian Council of Medical Research (ICMR).  

Nimesulide, a non-steroidal anti-inflammatory drug (NSAID) widely used for pain and fever management, has long been under scrutiny for its safety profile. Concerns about liver toxicity and adverse reactions prompted the government to act decisively, ensuring patient safety remains paramount. The notification under Section 26A of the Drugs and Cosmetics Act, 1940, makes the ban effective immediately across the country.  

Key Highlights  

• Union Health Ministry bans oral nimesulide formulations above 100 mg dosage  
• Decision taken under Section 26A of the Drugs and Cosmetics Act, 1940  
• ICMR recommended a complete ban citing safety concerns, especially liver toxicity  
• Drugs Technical Advisory Board supported the move after reviewing clinical data  
• Ban effective immediately, impacting manufacture, sale, and distribution nationwide  
• Nimesulide continues to be permitted in lower doses under strict regulation  

Industry experts note that while nimesulide remains available in lower doses, the ban on higher-strength oral formulations reflects India’s tightening regulatory stance on drug safety. The move is expected to push pharmaceutical companies to reformulate products and strengthen compliance with safety standards.  

The government’s decision underscores its commitment to public health, prioritizing patient safety over commercial interests. With this ban, India joins several countries that have restricted or withdrawn nimesulide due to safety concerns. The step is seen as part of a broader effort to ensure that medicines available in the market meet stringent safety and efficacy standards.  

Sources: NDTV, Economic Times, Business Standard