Daijiworld Media Network - New Delhi
New Delhi, Dec 31: The central government has imposed an immediate ban on the manufacture, sale and distribution of all oral pain and fever medicines containing more than 100 milligrams of Nimesulide in immediate-release form, citing potential risks to human health.
The restriction has been enforced under Section 26A of the Drugs and Cosmetics Act, 1940, following consultations with the Drugs Technical Advisory Board. According to a Health Ministry notification, medical evidence indicates that high-dose Nimesulide formulations could pose safety risks, while safer treatment alternatives are readily available.
Nimesulide, a commonly used non-steroidal anti-inflammatory drug (NSAID), has faced international scrutiny over the years due to concerns related to liver toxicity and other adverse effects. The latest decision reflects the government’s continued push to strengthen drug safety regulations and eliminate medicines considered high-risk.
Officials clarified that the ban applies only to oral formulations exceeding the 100 mg dosage for human use. Lower-dose variants and other approved therapeutic options will continue to be permitted.
Drug manufacturers selling affected Nimesulide products have been instructed to immediately stop production and initiate recalls of existing stocks. Market analysts believe the overall financial impact on major pharmaceutical companies will be minimal, as Nimesulide contributes a relatively small portion of total NSAID sales. However, smaller firms with a heavier dependence on the drug may face revenue challenges.
India has previously invoked Section 26A to withdraw several fixed-dose combinations and unsafe medicines from the market as part of broader public health protection measures.
Meanwhile, the government continues to focus on strengthening domestic production of active pharmaceutical ingredients (APIs). Under the Promotion of Bulk Drug Parks scheme, investments worth Rs 4,763.34 crore have been made over the past three and a half years up to September 2025, exceeding the committed investment target for greenfield projects.
In addition, the Production Linked Incentive (PLI) scheme for bulk drugs, with a total outlay of Rs 6,940 crore, aims to reduce dependence on single-source imports and ensure uninterrupted supply of critical APIs used in essential medicines.