In a significant move to ensure public safety, the Indian government has banned 156 widely sold fixed-dose combination (FDC) drugs, including popular antibacterial medicines and pain relievers commonly used for fever, cold, and allergies. The ban, effective from August 12, was announced by the Union health ministry through a gazette notification, citing potential risks to human health.
FDC drugs, often referred to as "cocktail" drugs, contain two or more active pharmaceutical ingredients in a fixed ratio. Among the banned drugs is the well-known pain-relieving combination 'Aceclofenac 50mg Paracetamol 125mg tablet,' which is manufactured by several top pharmaceutical companies.
The list of banned combinations also includes Mefenamic Acid Paracetamol Injection, Cetirizine HCl Paracetamol Phenylephrine HCl, and other commonly used formulations. Notably, the combination of Paracetamol, Tramadol, Taurine, and Caffeine, which includes the opioid-based painkiller Tramadol, has also been prohibited.
The decision followed an examination by an Expert Committee appointed by the government, which deemed these FDCs as "irrational" and without therapeutic justification. The Drugs Technical Advisory Board (DTAB), India's apex drug panel, further supported the ban, stating that safer alternatives are available.