Indian pharma companies ready to do battle with government over FDCs

India’s Pharma Industry Challenging FDC Ruling

A selection of India’s biggest pharmaceutical firms are joining forces to challenge a new ruling by the Indian health ministry that effectively banned 329 Fixed Dose Combination drugs.

Fixed Dose Combination drugs combine two or more drugs to create a single tablet that the drugs industry maintains keeps costs low for the industry and the patient. There is an obvious benefit in having to swallow just one pill, compared to two, or more.

The government’s counter argument is that many of the drugs contained within the FDC are ineffective, thanks to growing resistance in patients, and some of the combinations can actually harm the patient. Cold remedies from Pfizer and Abbott, Corex and Phensedry respectively, are included on the banned list.

The ruling has been a long time coming and the government has ploughed significant time and resources into analyzing the individual FDCs. A committee was set up to look at the drugs back in 2014 and has inspected more than 6,000 drug combinations.

Are FDCs Hurting The Industry?

India stands accused of approving too many drugs. Some of the combinations are actually designed to treat different conditions, so there are nonsensical FDCs on the market. This was a concerted effort to make a stand to restore faith in the Indian pharmaceutical market.

The industry, though, feels that the changes have gone too far and there is talk of mutiny in the air as the leading players are pooling resources and mounting a strong challenge to the ruling. The reason is obvious: they stand to lose substantial amounts of money.

Research agency PharmaTrac claims that Abbott could lose up to Rs 485 crore (US$76,150,000), Macleods Pharma could lose Rs 370 crore (US$58 million) and Pfizer could lose a similar amount. These are massive numbers, the stakes are just too high, and the companies involved simply have to mount some form of challenge.

The government is clearly digging its heels in and is prepared to go to war with the drug companies over the FDCs, but it’s a battle that is sure to drag through the courts for months and years to come – and neither side looks ready to give ground.






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