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Government Bans 156 Fixed-Dose Combination Drugs Over Health Risks

India has banned 156 FDC drugs, including common pain relievers and cold medicines, citing health risks and lack of therapeutic justification 

23-08-2024
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The Indian government has issued a ban on 156 widely used fixed-dose combination (FDC) drugs, including popular medications for fever, cold, allergies, and pain, citing significant health risks. FDCs, which combine two or more active pharmaceutical ingredients in fixed ratios, are also known as "cocktail" drugs.

According to a notification from the Union Health Ministry dated August 12, the banned list includes the 'Aceclofenac 50mg Paracetamol 125mg tablet,' a common pain reliever produced by major pharmaceutical companies. Other banned combinations include Mefenamic Acid Paracetamol Injection, Cetirizine HCl Paracetamol Phenylephrine HCl, and Paracetamol Chlorpheniramine Maleate Phenyl Propanolamine, among others. The prohibition also covers combinations such as Paracetamol, Tramadol, Taurine, and Caffeine, with Tramadol being an opioid painkiller.

The government’s decision follows recommendations from an Expert Committee and the Drugs Technical Advisory Board (DTAB), which deemed these FDCs as "irrational" and lacking therapeutic justification. The notification asserts that these drugs pose potential risks to human health and that safer alternatives are available. As a result, the manufacture, sale, and distribution of these FDCs have been prohibited under Section 26 A of the Drugs and Cosmetics Act of 1940.

This recent ban builds on a 2016 decision where the government had initially prohibited 344 drug combinations after an expert panel found they lacked scientific validation. Some of these FDCs were among those recently banned again.

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