Centre Bans 156 Combination Medicines for Fever, Pain, Cold Relief; Calls Them Irrational, Harmful To Humans

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The government recently prohibited 156 fixed-dose combination (FDC) drugs, including common antibacterial medicines for fever, cold, allergies, and pain. These FDC drugs combine two or more active ingredients in a set ratio. The ban is based on concerns that these drugs pose risks to human health.

Expert Committee's Findings

An Expert Committee appointed by the Centre reviewed these FDCs and deemed them "irrational." The Drugs Technical Advisory Board (DTAB) also examined these combinations and found no therapeutic justification for their ingredients. The DTAB concluded that these FDCs could be harmful to humans.

The Union health ministry issued a gazette notification on August 12, listing the banned drugs. Among them is the 'Aceclofenac 50mg Paracetamol 125mg tablet,' a popular pain-relief medication produced by leading pharmaceutical companies. Other banned combinations include Mefenamic Acid Paracetamol Injection and Cetirizine HCl Paracetamol Phenylephrine HCl.

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.
Further, it prohibited the combination of Paracetamol, Tramadol, Taurine, and Caffeine; Tramadol being an opioid-based painkiller, mentions a report by PTI.

The notification also stated, "The Central government is satisfied that the use of the Fixed Dose Combination drug is likely to involve risk to human beings whereas safer alternatives to the said drug are available." It emphasized that prohibiting these drugs is necessary for public interest under section 26 A of the Drugs and Cosmetics Act 1940.

It said that the matter was examined by an Expert Committee appointed by the Centre which considered these FDCs as "irrational" and that the apex panel Drugs Technical Advisory Board (DTAB) also examined these FDCs and recommended that "there is no therapeutic justification for the ingredients contained in these FDCs".

Previous Bans And Legal Challenges

This isn't the first time such a ban has been implemented. In 2016, the government banned 344 drug combinations after an expert panel found they were sold without scientific backing. This decision faced legal challenges from manufacturers. In June 2023, another set of 14 FDCs from those initial 344 combinations was banned.

The notification further clarified that regulating or restricting these drugs for any patient use isn't justifiable. Therefore, only a complete prohibition under section 26A is recommended. Some products on this list had already been discontinued by several drug makers before this announcement.

Following DTAB's recommendations, the notification reiterated that it is necessary and expedient in public interest to prohibit the manufacture, sale, and distribution of these drugs in India.

This move aims to ensure public safety by removing potentially harmful medications from circulation while promoting safer alternatives.

Disclaimer: The information provided in this article is for general informational and educational purposes only and is not intended as a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or a qualified healthcare provider with any questions you may have regarding a medical condition.