The Indian government has taken a significant step to prioritize public health by banning 156 fixed-dose combination (FDC) medicines. These drugs, which combine two or more active pharmaceutical ingredients in a fixed ratio, have been deemed ‘likely to involve risk to human beings,’ according to a gazette notification issued by the Union health ministry on Thursday.
The ban, enforced under Section 26A of the Drugs and Cosmetics Act 1940, targets a wide range of medications, including antibiotics used for fever and colds, painkillers, and multivitamins. The decision follows thorough examination by an expert committee appointed by the central government and the Drug Technical Advisory Board (DTAB). Both bodies concluded that there is no therapeutic justification for the ingredients present in these FDCs.
Among the banned combinations is the popular pain reliever ‘Aceclofenac 50mg + Paracetamol 125mg tablet,’ manufactured by leading pharmaceutical companies. Other notable entries on the list include 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 government has also prohibited the combination of Paracetamol, Tramadol, Taurine, and Caffeine, with Tramadol being an opioid-based painkiller.
The notification emphasizes that ‘safer alternatives’ are available for the banned FDCs, highlighting the government’s commitment to protecting public health. The Expert Committee deemed these FDCs ‘irrational,’ further solidifying the rationale behind the ban. The government’s action is described as necessary and expedient in the ‘public interest’ to prevent the manufacture, sale, and distribution of these medicines within India.
While the ban includes certain products already discontinued by manufacturers, it builds upon previous efforts to regulate FDCs. In June 2023, 14 FDCs were banned, and in 2016, a ban on 344 drug combinations was announced following recommendations from an expert panel established at the Supreme Court’s direction. This ongoing commitment to public health safety underscores the government’s dedication to ensuring that medicines available in India meet stringent safety and efficacy standards.
