Key Points:
The Government of India has banned the manufacture, sale and distribution of oral Nimesulide doses above 100 mg. The decision was taken under Section 26A, citing health risks and availability of safer alternatives.
Nimesulide is widely used for pain, swelling and fever, but has faced global criticism for liver toxicity. The ban applies only to high-dose formulations, while lower doses and other medicines remain available.
Drug companies must stop production and recall affected batches immediately. Experts say big pharma firms will see little impact, but smaller companies dependent on Nimesulide may face losses.
The Government of India has banned the manufacture of Nimesulide, a painkiller medicine. In a Gazette Notification issued on Tuesday, December 29, 2025, the Union Ministry of Health and Family Welfare has banned the manufacture, sale and distribution of all oral formulations containing Nimesulide above 100 mg. The drug was prohibited under Section 26A of the Drugs and Cosmetics Act, 1940 after consultation with the Drugs Technical Advisory Board.
The Gazette Notification also mentioned: “The use of all oral formulations containing Nimesulide above 100 mg in immediate release dosage form is likely to involve risk to human beings, and safer alternatives are available…”.
Nimesulide is a medication that helps relieve pain, inflammation and swelling. It is mainly prescribed for pain caused by fever, menstrual cramps, osteoarthritis or other similar conditions. According to the IPC (Indian Pharmacopoeia Commission), this medicine helps people with joint problems like rheumatoid arthritis, pain after injuries or surgery, and sudden pain related to bones, ears, nose, throat, and dental problems. This drug belongs to the NSAID class (Non-steroidal anti-inflammatory drug).
Nimesulide has been criticised globally for causing adverse effects to the human body, such as potential liver toxicity. The move aligns with the government's efforts to tighten safety standards and phase out high‑risk medicines. However, the ban only applies to high-dosage products for human use, while lower-dosage formulations and other therapeutic alternatives remain available.
The move implies that pharmaceutical companies must immediately cease the manufacture of Nimesulide, and recall the impacted batches. Analysts have predicted that the move will not majorly impact large drugmakers financially, as Nimesulide forms only a small share of the larger overall NSAID sales. However, they have projected that it might hurt smaller firms with significant exposure.
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India has earlier used Section 26A to ban certain dangerous or risky medicines to protect people’s health. To become more self-reliant, the country is now focusing on making drug raw materials (APIs) within India.
Under the Bulk Drug Parks scheme, the government has seen investments worth ₹4,763.34 crore in the last three and a half years, up to September 2025. This is higher than the planned investment of ₹4,329.95 crore for six years.
The PLI scheme for Bulk Drugs, with a budget of ₹6,940 crore, aims to ensure a steady supply of important drug ingredients. It reduces India’s heavy dependence on a single country or source, so the supply of critical medicines is not disrupted.
With inputs from IANS
(GP)
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