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.&nbsp;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.&nbsp;“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.&nbsp;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.<h3>The move is unlikely to hit large pharmaceutical companies</h3>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.&nbsp;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.&nbsp;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&nbsp;

The 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.

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

The 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.

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

The Indian government has banned 14 fixed-dose combination drugs including nimesulide and paracetamol dispersible tablets and chlorpheniramine maleate and codeine syrup.

The Indian government has banned 14 fixed-dose combination drugs including nimesulide and paracetamol dispersible tablets and chlorpheniramine maleate and codeine syrup. Citing a notification from the Union Health Ministry, the news agency PTI reported on Saturday (June 3) that the government said there is "no therapeutic justification" for these medicines and that they may involve "risk" to people. Which drugs have been banned? The banned drugs include those for treating common infections cough and fever- combinations such as nimesulide + paracetamol dispersible tablets, chlorpheniramine maleate + codeine syrup, pholcodine + promethazine, amoxicillin + bromhexine and bromhexine + dextromethorphan + ammonium chloride + menthol, paracetamol + bromhexine+ phenylephrine + chlorpheniramine + guaiphenesin and salbutamol + bromhexine. The move comes after recommendations by an expert committee. The committee said there is "no therapeutic justification for this FDC (fixed dose combination) and the FDC may involve risk to human beings. Hence, in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under section 26 A of the Drugs and Cosmetics Act, 1940. In view of the above, any kind of regulation or restriction to allow for any use in patients is not justifiable," as per the notification. "And whereas, on the basis of the recommendations of the Expert Committee and the Drugs Technical Advisory Board, the Central Government is satisfied that it is necessary and expedient in public interest to regulate by way of prohibition the manufacture for sale, sale and distribution for human use of the said drug in the country," the notification added. What are FDC drugs? FDC are drugs which contain a combination of two or more active pharmaceutical ingredients (APIs) in a fixed ratio. Back in 2016, the central government announced the ban on 344 drug combinations after an expert panel said they were being sold to patients without scientific data and the order was challenged by the manufacturers in court. The currently banned 14 FDCs are a part of these 344 drug combinations. (With inputs from agencies) WATCH WION LIVE HERE You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

India bans 14 fixed-dose combination drugs including nimesulide and paracetamol: Report

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