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DCGI calls first meeting of expert panel on FDCs on Jan 23-24

Ramesh Shankar, MumbaiFriday, January 16, 2009, 08:00 Hrs  [IST]

The DCGI has called the first meeting of the expert panel on FDCs on January 23 and 24. The panel was constituted on October 1 last year to resolve the lingering fixed dose combination (FDC) issue. The first meeting, which will be attended by senior health ministry officials including the DCGI and representatives of industry associations, will decide the fate of 43 of the remaining 156 combination drugs. The meeting was first scheduled for January 16-17, but due to the preoccupation of the officials, it has been postponed to January 23 and 24. The two-day meeting will take up 43 of the remaining 156 combination drugs for examination. The industry will submit the rationality data of all these 43 combination drugs to the panel. The experts will examine one by one the data of these drugs in detail and will take a decision on it. In all, the expert panel, headed by the DCGI, has to take a final call on 156 combination drugs, most of which belong to the 'need further examination' category of the controversial 294 fixed dose combination drugs. In the first DCGI-industry meeting on FDC on July 14 last year, there was consensus among the industry and the government on as many as 138 combination drugs out of these 294 combination drugs. In the next meeting on October 1 last year, both the government and the industry agreed to set up an expert panel to prepare the rationality of the remaining 156 FDCs. It was also decided in the meeting that the panel, headed by DCGI Dr Surinder Singh, will take up the FDCs in batches and finally report to the DTAB for final clearance. Though the panel was proposed to have its first meeting on November 28, the meeting did not materialise so far due to the preoccupation of the officials, including the DCGI. The expert panel will meet periodically till a decision is taken on all the remaining 156 combination drugs to close the issue for ever. According to industry sources, the panel may take another year to finalise the matter. Meanwhile, the industry is ready with the rationality data of the 43 FDCs which will be taken up in the first meeting on January 23.

 
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