Over 340 'irrational' drugs to go off shelves soon; many more under scanner

To hit Rs 20-bn market; 944 more fixed-dosage combination drugs under scanner

The Centre is one step closer to banning 343 “irrational” fixed-dose combination (FDC) drugs that were potentially harmful to consumers. The market size of the banned drugs is estimated to be around Rs 20-22 billion and will impact the country’s top drugmakers.

Patient advocacy groups say more FDCs, worth Rs 200-250 billion, are under scanner. An FDC drug is one that contains two or more active ingredients in a fixed-dosage ratio.

In March 2016, the ministry of health and family welfare had implemented a ban on 349 FDCs based on recommendations of the Chandrakant Kokate committee that found these drug combinations to be irrational and posing health risks. In December, the Supreme Court referred the matter to the Drug Technical Advisory Board (DTAB) for a fresh review after drugmakers challenged the ban.

The DTAB, in a meeting held in New Delhi on Wednesday, re-inforced the ban on 343 of the 349 drugs. It, however, felt restricted use could be allowed for six FDCs. The DTAB would forward its report to the health ministry in the next 7-10 days, said a top government official.

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These FDCs roughly contribute to 1.8 per cent of the overall domestic drug market. The FDC segment is clocking a slower growth rate (4.7 per cent in June) compared to the rest of the domestic drug market (8.6 per cent). They cover around 6,000 brands mainly from firms like Abbott Healthcare, Mankind Pharma, Wockhardt, Alkem, Lupin, Glenmark, Sun Pharma, Eris Lifesciences and Ipca, among others

Abbott, perhaps, would take the largest hit. It has an exposure of around Rs 5.45 billion in these FDCs. An Abbott spokesperson said the company was awaiting communication from DTAB on the matter. Abbott is followed by Macleods Pharma (Rs 2.95 billion) and Mankind Pharma (Rs 1.34 billion), according to market research firm AIOCD AWACS.

Anticipating the ban, the companies were bracing up. Pfizer, for instance, has changed the formulation for its popular cough syrup Corex and launched it as Corex T. (more)