The Centre has prohibited 156 fixed-dose combination (FDC) drugs, including certain antibacterial medications used for treating colds, allergies, fever, and pain, due to their potential health risks.
The Centre has banned 156 fixed-dose combination (FDC) drugs commonly used for treating fever, pain, cold, and allergies, citing potential risks to human health. FDCs are medications that combine two or more active ingredients in a fixed ratio, often referred to as “cocktail” drugs.
This decision follows an evaluation by an expert committee and the Drugs Technical Advisory Board (DTAB), which determined that these combinations, including some antibacterial medicines, lacked therapeutic justification and posed health risks.
The Union health ministry’s gazette notification, issued on August 12, includes well-known combinations such as ‘Aceclofenac 50mg + Paracetamol 125mg tablet’, Mefenamic Acid + Paracetamol Injection, Cetirizine HCl + Paracetamol + Phenylephrine HCl, Levocetirizine + Phenylephrine HCl + Paracetamol, Paracetamol + Chlorpheniramine Maleate + Phenyl Propanolamine, 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.
This prohibition is enforced under Section 26A of the Drugs and Cosmetics Act, 1940, which allows the government to ban drugs deemed harmful or unnecessary. The DTAB underscored that no regulatory measure could justify these FDCs’ use, leading to a full prohibition to safeguard public health.
According to the notification, the central government has determined that these FDCs are likely to pose risks to human health and that safer alternatives are available. An Expert Committee appointed by the Centre labeled these FDCs as “irrational,” and the DTAB agreed, finding no therapeutic justification for the ingredients in these combinations.
The notification notes that any form of regulation or restriction would be insufficient, thus mandating a complete ban under Section 26A. The decision aims to protect public health by prohibiting the manufacture, sale, and distribution of these drugs.
The list also includes products previously discontinued by various manufacturers. In 2016, the Centre banned 344 drug combinations after an expert panel found they lacked scientific backing. Despite legal challenges from manufacturers, the DTAB later reaffirmed that 328 of those combinations were “irrational” and should be banned. In June of the previous year, 14 FDCs from the original list were banned, with many of the recently prohibited drugs also appearing on that list.
