High dose Nimesulide oral formulations banned

The government has banned the manufacture, sale and distribution of all oral formulations of pain and fever medications, containing Nimesulide above 100 milligrams in immediate release dosage form, with immediate effect.

The drug was prohibited under Section 26A of the Drugs and Cosmetics Act, 1940 after consultation with the Drugs Technical Advisory Board.

“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,” a Health Ministry notification said.

Nimesulide, a non steroidal anti inflammatory drug, has been under global scrutiny for potential liver toxicity and other adverse effects, and the move aligns with efforts to tighten safety standards and phase out high risk medicines.

The ban is only applicable to high dose products for human use while allowing lower dose formulations and other therapeutic alternatives to remain available.

Pharmaceutical companies marketing Nimesulide brands must halt production and recall impacted batches, while analysts forecasted limited financial impact on large drugmakers because Nimesulide represents a small share of overall NSAID sales. However, they maintained that smaller firms with significant exposure could face revenue pressure.

India has previously used Section 26A to ban several fixed dose combinations and high risk drugs to safeguard public health.

The country has doubled down on domestic active pharmaceutical ingredient manufacturing with a total of Rs4,763.34 crore worth investment made in the three and a half years under the scheme for Promotion of Bulk Drug Parks, till September 2025.

The notable achievement is against an investment commitment of Rs 4,329.95 crore over the period of six years in greenfield projects, according to the government.