Govt bans high‑dose Nimesulide oral formulations

December 31, 2025

New Delhi: The Central Government has banned the manufacture, sale, and distribution of all immediate-release oral medications containing more than 100 mg of nimesulide with immediate effect. This decision was taken under Section 26A of the Drugs and Cosmetics Act, 1940, following the advice of the Drugs Technical Advisory Board.

According to a Health Ministry notification, the use of nimesulide in high doses may pose a risk to human health, while safer alternatives are available. The non-steroidal anti-inflammatory drug (NSAID) nimesulide has been under scrutiny globally for liver toxicity and other side effects.

Instructions for pharmaceutical companies to halt production and recall batches
This ban will only apply to high-dose drugs for human use, while low-dose drugs will remain available. Companies manufacturing nimesulide-based brands have been instructed to halt production and recall affected batches. Experts believe that the impact on large pharmaceutical companies will be limited, but smaller companies that rely heavily on this drug may face revenue impacts.

The government has previously banned several high-risk drugs and fixed-dose combinations under public health protection.

Promoting domestic API manufacturing
Meanwhile, the government is focusing on strengthening active pharmaceutical ingredient (API) manufacturing in the country. Under the Bulk Drug Parks Promotion Scheme, a total investment of ₹4,763.34 crore has been made in the three and a half years until September 2025, exceeding the investment target of ₹4,329.95 crore in six years. The PLI scheme, with a budgeted amount of approximately ₹6,940 crore, aims to reduce import dependence for essential APIs and prevent supply bottlenecks.