New Delhi: In a decisive move to protect public health, the Indian government has banned 156 fixed-dose combination (FDC) drugs commonly prescribed for ailments such as fever, pain, colds, and allergies. These drugs, which combine two or more active ingredients in a fixed ratio, were found to pose potential risks to human health and lacked sufficient therapeutic justification.
The Union Health Ministry’s recent gazette notification lists widely used combinations such as Aceclofenac 50mg + Paracetamol 125mg, Mefenamic Acid + Paracetamol Injection, and Cetirizine HCl + Paracetamol + Phenylephrine HCl among the prohibited drugs. The combination of Paracetamol, Tramadol, Taurine, and Caffeine was also banned due to concerns over Tramadol, an opioid-based painkiller.
This decision follows recommendations from the Drugs Technical Advisory Board (DTAB) and a government-appointed expert committee. Both bodies concluded that these FDCs lacked therapeutic value and posed undue risks to patients, calling for their removal from the market.
Invoking Section 26A of the Drugs and Cosmetics Act, 1940, the government moved to halt the production, sale, and distribution of these drugs, stating that safer alternatives were available. The DTAB emphasized that no form of regulation could make these FDCs safe for use, leading to the decision for an outright ban.
“The Central government is convinced that the use of these Fixed Dose Combination drugs poses risks to human beings, and safer alternatives exist,” the notification affirmed.
This action is part of a broader effort by the government to regulate unsafe medications. A similar ban in 2016 prohibited 344 drug combinations, and despite legal challenges from manufacturers, the DTAB later upheld the ban on 328 of those combinations, labeling them as “irrational.”