The Indian government has issued a ban on 156 widely used fixed-dose combination (FDC) drugs, including popular antibacterial medications for fever, cold, allergies, and pain, due to concerns over their safety. The decision, announced in a gazette notification by the Union Health Ministry on August 12, highlights the risk these drugs pose to human health.
FDC drugs combine two or more active pharmaceutical ingredients in fixed ratios, often referred to as “cocktail” drugs. Among those banned are the ‘Aceclofenac 50mg + Paracetamol 125mg tablet,’ a common pain reliever produced by leading pharmaceutical companies. Other banned combinations include Mefenamic Acid + Paracetamol Injection, Cetirizine HCI + Paracetamol + Phenylephrine HCI, Levocetirizine + Phenylephrine HCI + Paracetamol, and Camylofin Dihydrochloride 25 mg + Paracetamol 300mg. The ban also covers the combination of Paracetamol, Tramadol, Taurine, and Caffeine, with Tramadol being an opioid-based painkiller.
The government’s decision follows a review by an Expert Committee, which deemed these FDCs “irrational,” and a recommendation from the Drugs Technical Advisory Board (DTAB) that there was no therapeutic justification for these drug combinations. The notification asserts that safer alternatives are available and that the banned FDCs may pose significant risks to human health.
This latest ban continues a pattern of regulatory action against FDCs. In 2016, the government banned 344 such drug combinations after an expert panel, convened by the Supreme Court, reported their use lacked scientific backing. In June 2023, 14 FDCs from this list were also banned, with many recent prohibitions related to these earlier decisions.