In a significant move aimed at safeguarding public health, the government has banned 156 fixed-dose combination (FDC) drugs, including common antibiotics for fevers, colds, and multivitamins, declaring them potentially harmful. The decision, announced on Thursday (Aug 22), follows recommendations from expert panels that found no therapeutic justification for these drug combinations.
FDC drugs, often referred to as “cocktail” medications, combine two or more active pharmaceutical ingredients in fixed ratios. While they are designed for convenience and efficacy, concerns have arisen over their safety and effectiveness.
The Union Health Ministry issued a gazette notification under Section 26A of the Drugs and Cosmetics Act, 1940, prohibiting the manufacture, sale, and distribution of these medicines. The notification stated, “The Central government is satisfied that the use of the FDC drug is likely to involve risk to human beings whereas safer alternatives to the said drug are available.”
The ban list includes widely used combinations such as Aceclofenac 50mg + Paracetamol 125mg tablet, Mefenamic Acid Paracetamol Injection, and various combinations involving Cetirizine, Levocetirizine, and Paracetamol. Notably, the opioid-based painkiller combination of Paracetamol, Tramadol, Taurine, and Caffeine has also been prohibited.
The expert committee and the Drug Technical Advisory Board (DTAB) evaluated the FDCs and concluded that these combinations lacked therapeutic justification and posed unnecessary risks to consumers. “The government believes it is crucial and beneficial to public welfare to prohibit the production, sale, and distribution of these drugs within the country for human consumption,” the notification emphasized.
This ban is part of a broader effort to regulate the use of FDC drugs in India. In 2016, the government banned 344 FDC drug combinations after an expert panel, established by the Supreme Court, recommended their discontinuation. Earlier this year, 14 more FDCs from that list were banned.
Many of the products on the current ban list have already been discontinued by drug manufacturers, highlighting the ongoing shift towards safer and more effective medications. This latest action underscores the government’s commitment to ensuring that only scientifically validated and safe drugs are available to the public.
