GUWAHATI: The Centre banned 156 fixed-dose combination medicines, including antibiotics used for fever and colds, painkillers, and multivitamins on Thursday after the combinations were found to pose risks to human health.
Fixed-dose combination (FDC) drugs are medicines that contain a combination of two or more active pharmaceutical ingredients in a fixed ratio. They are also referred to as “cocktail” drugs.
Issuing a gazette notification prohibiting the manufacture, sale and distribution of these medicines under section 26 A of the Drugs and Cosmetics Act 1940, the Union Health Ministry said, “The matter was examined by an expert committee appointed by the central government and the Drugs Technical Advisory Board (DTAB), with both bodies recommending that there is no therapeutic justification for the ingredients contained in the said FDCs.”
The banned drugs include “Aceclofenac 50mg + Paracetamol 125mg tablet.” This is one of the popular combinations of pain-relieving medicines manufactured by top pharmaceutical companies.
The list also includes 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.
Additionally, the combination of Paracetamol, Tramadol, Taurine and Caffeine was also prohibited, as Tramadol is an opioid-based painkiller.
The ban, which was issued under Section 26A of the Drugs and Cosmetics Act, 1940, allows the government to prohibit the manufacture, sale, and distribution of drugs deemed harmful or unnecessary.
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According to DTAB, no form of regulation or restriction could justify the use of these FDCs in patients, leading to the decision for a complete prohibition in the interest of public health.
The list also includes certain products that many drug makers have already discontinued. In June 2023, 14 FDCs, which were part of those 344 drug combinations, were banned.
The notification further said that “the Central government is satisfied that it is necessary and expedient in the public interest to prohibit the manufacture, sale, and distribution for human use of the said drug in the country”.
