India bans Nimesulide oral tablets, syrups above 100 mg under Drugs Act: Here's why

Union Health Ministry has decided to ban the manufacture, sale and distribution of all oral formulations of pain and fever medications with immediate effect. The ban includes Nimesulide above 100 milligrams in immediate‑release dosage form. The drug was banned under Section 26A of the Drugs and Cosmetics Act, 1940, following consultation with the Drugs Technical Advisory Board.

In addition, the health ministry has also come up with a draft notification, announcing to removal of cough syrups from the list of over-the-counter medicines. The notification removes “syrups … for cough” from Schedule K — the list of medicines relieved from the requirement of a prescription by a registered medical practitioner. Meanwhile, Lozenges, pills or tablets for cough will remain on the list.

“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.

A non‑steroidal anti‑inflammatory drug, Nimesulide, has been under scrutiny across the globe for potential liver toxicity and other severe effects. The decision to prohibit aligns with efforts to tighten safety norms and phase out high‑risk medicines. The restriction applies only to high-dose Nimesulide products intended for human use, while lower-strength versions and alternative therapies will continue to be available.

The move is unlikely to hit large pharmaceutical companies

Drugmakers selling Nimesulide brands have been directed to stop production and recall affected batches. Analysts said the move is unlikely to significantly hit large pharmaceutical companies, as Nimesulide accounts for a small portion of overall NSAID sales. Smaller firms with heavier reliance on the drug, however, may face revenue pressure.

India has earlier invoked Section 26A to prohibit several fixed-dose combinations and high-risk medicines in the interest of public health. At the same time, the country has strengthened domestic API production, with investments totalling Rs 4,763.34 crore made over the past three and a half years under the Promotion of Bulk Drug Parks scheme, up to September 2025.

According to the government, the notable milestone is against an investment commitment of Rs 4,329.95 crore more than a period of six years in greenfield projects