The Union Ministry of Health has banned 156 “irrational” fixed dose combination (FDC) medicines with an immediate effect. These banned medicines are commonly used antibiotics, painkillers, and multivitamins for the inital treatment of fever, headache, cough, etc.
The ban was announced through a gazette notification under the section 26A of the Drugs and Cosmetics Act, 1940, because of the health risks associated with these drugs. The production, marketing, and distribution of these drugs are now prohibited.
According to the notification, an expert committee and the Drugs Technical Advisory Board (DTAB) reviewed these medicines and concluded that there is no therapeutic justification for the ingredients in these FDCs. A well-known pain-relief medicine on this banned list is the combination of Aceclofenac 50 mg and Paracetamol 125 mg tablets. The government stated that the use of these FDCs could pose risks to humans, and safer alternatives are available.
Other banned combinations include Mefenamic acid + Paracetamol injection, Cetirizine HCl + Paracetamol + Phenylephrine HCl, Levocetirizine + Phenylephrine HCl + Paracetamol, Paracetamol + Chlorphenamine Maleate + Phenyl Propanolamine, and Camylofin Dihydrochloride 25 mg + Paracetamol 300 mg.
Fixed-dose combination (FDC) drugs, also known as “cocktail” drugs, contain more than one active ingredient in a single pill to treat multiple symptoms or conditions at the same time. While these drugs are designed to offer convenience and comprehensive treatment, they can also present significant health risks.
The ban on these 156 FDC medicines aims to reduce health risks and ensure safer, more effective treatments are available to patients.
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