Ban on Nimesulide drugs
The government has banned the manufacture, sale and distribution of oral medicines containing more than 100 mg of nimesulide in pain and fever medicines with immediate effect.
This decision has been taken under Section 26A of the Drugs and Cosmetics Act, 1940. This step was taken following the advice of the Drugs Technical Advisory Board (DTAB).
The Health Ministry’s notification states that use of more than 100 mg of nimesulide can be hazardous to human health, and safer alternatives are already available.
Side Effects of Nimesulide
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) that has raised concerns globally due to its potential for liver damage and other side effects. This step has been taken towards tightening the safety of medicines and gradually phasing out risky medicines.
This ban will apply only to high-dose drugs, while low-dose drugs and other treatment options will continue.
Impact on pharmaceutical companies
The notification states that companies selling medicines containing Nimesulide will have to stop production and recall the affected batches present in the market.
Analysts believe the economic impact on large pharmaceutical companies will be minimal, as nimesulide’s share in total NSAID sales is small. However, smaller companies that are more dependent on this drug may suffer losses.
Government’s drug safety initiative
India has already used Section 26A to ban many dangerous drugs and fixed-dose combinations to protect people’s health.
The government said that an investment of Rs 4,763.34 crore has been made under the Bulk Drug Park Scheme till September 2025, with the aim of increasing the production of raw materials of medicines in the country.
Importance of PLI Scheme
The PLI scheme for bulk drugs aims to avoid disruption in the supply of critical Active Pharmaceutical Ingredients (APIs) used in essential medicines.
This scheme has been made to reduce excessive dependence on any one country or source, whose total budget is Rs 6,940 crore.
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