New Delhi, 31 December. The government has, with immediate effect, banned the manufacture, sale and distribution of all oral pain and fever medicines containing nimesulide in quantities more than 100 mg and which are immediate-release. This medicine is banned under Section 26A of the Drugs and Cosmetics Act, 1940. This decision was taken after taking advice from the Drugs Technical Advisory Board (DTAB).
The Health Ministry’s notification said that the use of medicines containing more than 100 mg of nimesulide can be dangerous for humans, and safer alternatives already exist. Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) and there have been concerns around the world about its potential for liver damage and other side effects.
This step has been taken in the direction of further tightening the safety of medicines and gradually removing risky medicines. This ban will apply only to high-dose medicines, which are made for humans. Low-dose medications and other treatment options will continue to be available. The notification states that pharmaceutical companies selling medicines containing Nimesulide will have to stop production and recall the affected batches in the market.
At the same time, analysts believe that it will not have much economic impact on big pharmaceutical companies, because the share of Nimesulide in total NSAID sales is low. However, small companies whose earnings are more dependent on this medicine may suffer losses. India has already used Section 26A to ban many dangerous drugs and fixed-dose combinations to protect people’s health.
According to the government, an investment of Rs 4,763.34 crore has been made under the Bulk Drug Park Scheme in the last three and a half years till September 2025, so that the production of raw materials of medicines can be increased in the country. The government said that this achievement has been achieved against the target of investment of Rs 4,329.95 crore in six years, which was set for new (greenfield) projects.
The PLI scheme for bulk drugs aims to avoid disruption in the supply of critical active pharmaceutical ingredients (APIs) used in essential medicines. This plan has been designed to reduce excessive dependence on any one country or source. The total budget of this scheme is Rs 6,940 crore.
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