DCGI working on policy guidelines on Fixed Dose Combinations
Joseph Alexander, New Delhi

The DCGI is understood to be framing a broad policy document on fixed dose combinations to have an amicable way to settle the issue of weeding out irrational combinations from the market, it is learnt. The drive to clean up the market of irrational products has rattled the pharmaceutical industry.

The directive to withdraw the listed combination drugs, which were not so far cleared by the national authority, placed the pharma firms on a collision course with court stays and loud protests. The new draft on combinations is expected to have clear guidelines on the matter.

According to highly placed sources, the DCGI is working on the document and it would clear the grey areas on the vexed issue to help the companies and the State authorities, who are still in the dark about the norms and under pressure from the pharma bodies. However, the details of the expected norms are yet to be known.

But, it is likely that the guidelines will spell out the role of State licencing authorities clearly in phasing out irrational combinations and would set some time frame for the act. It may also begin a welcome phase of assessing the magnitude of combination drugs in the market.

At the same time, experts say that there was no need for the companies to get panicky as `it is not the end of the road.' All FDCs were not irrational and developed countries like America still continued to approve the FDCs, said leading pharma consultant Khalid Khan.

``It is time for the industry also to set itself right by deciding to assess the efficacy of the combination drugs collectively or individually so that they remain in the market. We have large pool of resources and infrastructure to do the same. Industry also should know that they cannot pump in any FDC without adequate clinical trials. There is no cause for panic as the move is not targeted at all FDCs. The DCGI did not want to use the word of irrational too, as they are not yet proved to be unsafe. We should go for an amicable settlement, acknowledging our own responsibility,'' he pointed out.

After the DCGI issued the order, industry bodies like Indian Drugs Manufacturers Association have called for clear-cut guidelines and specific rules to legalise the safe FDCs in the market, instead of putting all the combination drugs under suspected eyes of the consumers. They have also asked for time to phase out the harmful combinations.

Besides, there were many other contentious areas like the powers of the State authorities with regard to issuing licence to FDCs. It is also learnt that the meetings of DCGI with the State controllers in different zones brought to light the complicated issues involved and the grey areas. This has prompted the DCGI to begin the exercise of framing a clear policy on FDCs to be relied upon for future too.

Source: www.pharmabiz.com
8th October 2007

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