New Delhi, 31 December 2025: The government has taken a big decision regarding Nimesulide, a traditional medicine for pain and fever. The Central Government has banned the production, sale and distribution of all oral Nimesulide medicines in dosage more than 100 mg with immediate effect.
The ban was imposed under Section 26A of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board. The Health Ministry’s announcement states that the use of Nimesulide drugs in doses more than 100 mg poses a risk to human health and safer alternatives already exist.
Nimesulide is a non-steroidal anti-inflammatory drug that has raised global concerns about its side effects such as liver damage. This government move aims to strengthen drug safety and phase out high-risk drugs. The ban will only apply to nimesulide at doses above 100 mg for humans, while lower dose drugs and other alternatives will remain available. Pharmaceutical companies selling Nimesulide brand will now be forced to stop production and recall the affected batches.
Experts believe that this decision will not have much impact on big pharmaceutical companies, because the sale of nimesulide is a small part of the NSAID market. However, small companies whose income largely depends on this drug may suffer losses. India has previously banned many fixed-dose combinations and dangerous drugs under Section 26A to protect public health. The government is also focusing on promoting local production of active pharmaceutical ingredients (APIs). By September 2025, an investment of over ₹4,763 crore has been made under the Bulk Drug Park Scheme.
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