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Guwahati, Aug 25: The central government has banned at least 156 Fixed Dose Combination (FDC) medicines due to safety concerns. The list includes commonly used drugs such as antibiotics for fever and colds, painkillers, multivitamins, and more.
The Union Health Ministry issued a gazette notification prohibiting the manufacture, sale, and distribution of these FDCs under Section 26A of the Drugs and Cosmetics Act, 1940.
The Drugs Technical Advisory Board (DTAB) has also examined the FDCs and recommended that "there is no therapeutic justification for the ingredients contained in this FDC. The FDC may involve risk to human beings. Hence in the larger public interest, it is necessary to prohibit the manufacture, sale or distribution of this FDC under Section 26A of Drugs and Cosmetics Act, 1940."
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 and Paracetamol 300 mg.
The FDC medicines contain a combination of two or more active pharmaceutical ingredients in a fixed ratio, and they are also referred to as “cocktail drugs”.
Reportedly, the centre has banned the Aceclofenac 50 mg Paracetamol 125 mg tablet, which is a commonly used combination of painkillers produced by leading pharmaceutical companies.
Additionally, the government also prohibited the combination of paracetamol, tramadol, taurine, and caffeine. Tramadol is an opioid-based painkiller.
“The drug combinations banned now include several products manufactured by drug majors including Sun Pharmaceuticals, Dr Reddy's Laboratories, Cipla, Alkem Laboratories, Mankind Pharma, Torrent Pharmaceuticals, Eris Lifesciences, among others, according to information available,” the notification mentioned.
