Govt bans 80 more irrational FDCs; Delhi High Court rejects pharma firms’ plea to vacate ban on diabetes drugs


Just days after the Delhi High Court’s rejection of pleas challenging the ban on fixed dose combination (FDC) drugs for treating type-II diabetes, the Union health ministry has banned 80 more FDC drugs including antibiotics and painkillers. According to a notification issued by the ministry on January 11, the drugs that are banned include antibiotics like Cefglobe OZ, Taxim -OZ, drugs used for treating bacterial and fungal infections such as Orflaz kit and Vaginobact, hypertension drugs Telipril H and Loram H and anti-anxiety drug Resta, which is a combination of paracetamol and alprazolam. A fixed-dose combination contains two or more drugs combined in a fixed ratio, available as a single dose. With the latest measure, the total number of banned FDCs stands at 405. Though a few more drugs were banned in September last year, they remain available on account of the legal challenge mounted by affected manufacturers. The FDCs are banned on the recommendation of the Drugs Technical Advisory Board, which examined their rationality and safety. Last week, while dismissing the pleas filed by eight manufacturers, the Delhi high court observed that there was no ground to interfere with the central government’s September 7, 2018, notification.

The Centre had banned the FDCs of metformin, pioglitazone and glimepiride of varying compositions. These FDCs are used for treatment of type-II diabetes mellitus and to improve the glycemic control. The pharma firms had challenged the Centre’s notification banning the manufacture, sale and distribution of 328 FDC drugs. The firms on whose pleas the order was passed are Unison Pharmaceuticals, Alkem Laboratories, East West Pharma, Intas Pharmaceuticals, Lupin, Micro Labs, Eris Lifesciences and Franco Indian Pharmaceuticals. Last year, while recommending continuation of the ban on 300-plus FDC drugs, an expert sub-committee of the DTAB made it clear that the use of those “irrational” drug cocktails would expose patients to unnecessary overuse risks and dosing mismatch that could result in toxicity. The sub-committee report was a huge victory for public health activists and patient advocacy groups who were fighting to root out these risky drug combinations. The health ministry banned these medications after a committee headed by Prof CK Kokate declared them unsafe. Drug makers challenged the ban in high courts across the country. In January this year, the ministry moved the apex court challenging a Delhi High Court order that quashed the ban. The DTAB panel was constituted in accordance with the top court’s order to re-examine the issue.

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