Government bans 156 medications including antibiotics, painkillers and multivitamins
The list also includes some products that manufacturers had already stopped producing at the time of the survey.
The Union government has banned 156 medications in a major move under their policy by shutting down 156 FDCs, including some antibiotics for fever and colds, as well as many multivitamin products, due to concerns about possible adverse health effects. This decision, announced to the public on Thursday, 22nd August, is part of a broader initiative to safeguard public health from potential risks associated with these medications.
Fixed-dose combination (FDC), also called ‘cocktail’ drugs, are the products that contain more than a single active pharmaceutical substance in a predetermined proportion.
The Centre for Regulation in Biologies has recently published a notification in the official Gazette with that regard after invoking Section 26A of the Drugs and Cosmetics Act, 1940, which has effectively prohibited the manufacture, distribution, and sale of these drugs.
Government Bans 156 Medications Over Safety Concerns
The health ministry stated, “The matter was examined by an expert committee appointed by the central government and the DTAB, with both bodies recommending that there is no therapeutic justification for the ingredients contained in the said FDCs.”
Some of the barred formulations are Aceclofenac 50 mg with Paracetamol 125 mg, Mefenamic Acid with Paracetamol Injection, Cetirizine HCl with Paracetamol, and Phenylephrine HCl. The following are the other banned preparations here:Levocetirizine with Phenylephrine HCl & Paracetamol Paracetamol with Chlorpheniramine Maleate and Phenylpropanolamine; Camylofin Dihydrochloride 25 mg with Paracetamol 300 mg. The government has also prohibited the mixture that contains paracetamol, tramadol, taurine, and caffeine, and tramadol is an opioid-based pain reliever.
The notification said, “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.”
It further added, “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 list also includes some products that manufacturers had already stopped producing at the time of the survey. In June 2023, the government had to ban 14 of these fixed-dose combinations, which were part of the 344 drug mixtures of FDCs. This came after its 2016 decision to withdraw from circulation 344 combinations of drugs against the backdrop of recommendations from an expert committee that was formed by the then Supreme Court.
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