DTAB to set up panel to look at efficacy of FDCs


The Drugs Technical Advisory Board (DTAB) will set up an expert committee to decide the fate of 300 fixed dose combinations (FDCs) after complaints surfaced from the pharmaceutical industry.

According to a Mint report, the committee will look at the safety, efficacy and therapeutic justification of these drugs, before finally recommending any action in its 22 January meeting.

Drug makers claim that the government did not seek guidance of the bodies before banning FDCs.

The paper spoke to DTAB chairman Jagdish Prasad who said that many of these drugs should not have been banned in the first place.

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“We will constitute committees, which will consult all the stakeholders concerned, before taking a final call and submit the report to the government for action within six months. Patients’ safety is paramount to us and we will do our best to make sure that the safety is not compromised. Simultaneously, we have to ensure industry should not get severely impacted,” said Prasad.

In January last year, the government filed an appeal against a Delhi High Court notification issued on 10 March 2016 for 344 FDC drugs. The ban cited health risks and lack of therapeutic justification.

On 31 March, the Supreme court had stayed the proceedings in all high courts against the ban on 344 FDC drugs.

The apex court in December referred the matter of FDCs to DTAB so that they can re-examine whether these drugs should continue to be marketed.moneycontrol