Drug companies and health workers have been fighting on opposite sides of the fixed doze combination (FDC) case in the Delhi High Court. But they were unified on one thing. That the final judgment on this case would be appealed at a higher court.

And that indeed could be the road ahead, following the Delhi High Court judgment today quashing the Government's ban on 344 FDC medicines.

The judgement misses the larger issue of safety and efficacy of these drugs and the danger it poses to public health, said S Srinivasan with LOCOST and the All India Drug Action Network (AIDAN). Both organisations supported the Government's move at the Delhi HC. And they would appeal the latest judgment, he told Business Line.

An FDC involves a combination of two or more pills into a single drug or product. But the “therapeutic justification” of FDCs was called into question as doubts emerged on the rationale behind these combinations. Were they developed for scientific or commercial reasons?

In March this year, the Government banned 300-plus FDCs, following the Kokate committee report, and there was promise of the axe falling on more such drugs. In fact, in 2007, the Government had undertaken a similar exercise to sweep out irrational drugs from the market.

Below the radar approvals

This time around the Government was to focus on FDCs that were in a sense below the radar. Those that had found their way into the market with approvals only from the State authorities, when in fact approvals were required from the national regulator the Drug Controller General of India.

But the situation got tricky as the final hatchet on FDCs seemed to deviate from this thinking and drugs even with a central approval got hit. The issue further got mixed up with concerns over the abuse of products such as cough syrups.

Health advocacy groups maintain that Government is well within its rights to call back a drug it had approved on grounds of safety. But industry representatives counter that the Government was behaving in an unpredictable fashion, withdrawing products that it had approved in the first place. Therapeutic segments including respiratory, diabetic and pain came under the net, impacting companies including Pfizer, Sun Pharma, Abbott, Macleods, Ipca, Glenmark, Lupin etc.

Srinivasan pegs the total FDC market in India at Rs 40,000 crore, with irrational products contributing to half this. Data from the AIOCD (All India Organisation of Chemists and Druggists) pegged the FDC ban impact at about 3 percent of the Indian pharmaceutical market, or Rs 3000-odd crores.

Shake off the shadow

The unhappy fallout of this tug-of-war is that truly irrational combinations that need to be shown the door (as they have no scientific rationale), will now continue in the market place, until they get caught again in the Government's net at a later date.

But with companies like Pfizer pulling out their old formulation of cough syrup Corex and recasting it into a new avatar of respiratory products, industry-watchers expect similar actions from other companies as well to shake off the shadow of the FDC ban from themselves.

Speaking for the Indian Pharmaceutical Alliance, DG Shah said that the number of litigations between the pharmaceutical industry and various departments of the government should be a matter of concern to the political leadership. “It is a clear sign of break-down of meaningful communication between the two.”

The IPA position is clear, he added, “The decision should be based on medical science and must follow due process of law. Unfortunately, both these were found wanting in the FDC ban.”

The FDC standoff illustrates the increasing friction between the pharma industry and the Government, something the country could well do without, as it involves the health of its people.

jyothi.datta@thehindu.co.in

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