Even after two months of its constitution, the expert panel, constituted to resolve the lingering fixed dose combination (FDC) issue, is yet to decide the fate of 49 FDC drugs. Though the panel, headed by DCGI and with representatives from the industry associations, was proposed to meet on November 28, the meeting did not materialise so far, thanks to the preoccupation of the officials.
According to sources, as of now there is no word from the DCGI on convening the meeting which will examine 49 FDC drugs as was decided in the last DCGI-industry meeting held on October 1. It was in the last meeting the government and the industry agreed to set up an expert panel to prepare the rationality of the remaining 156 FDCs. The panel headed by DCGI Dr Surinder Singh will take up the FDCs in batches and finally report to the DTAB for clearance.
Meanwhile, the industry is ready with the rationality data of the 49 FDCs which will be taken up in the next meeting. Eminent pharmacologist and chairman of IDMA medical sub-committee Dr RK Sanghavi, who is heading the screening committee to prepare the rationality profile of the controversial FDC drugs, said that rationality profile of the 49 FDC drugs are almost ready. "It is almost ready, we are working on it," he said.
An early solution to the FDC issue is crucial for thousands of drug manufacturers, especially the small manufacturers, as the state drug authorities are refusing to give license to the controversial 294 FDC drugs ever since the former DCGI Dr M Venkateshwarlu issued orders to withdraw these drugs from the market more than one and half year back.
Even though there was consensus among the industry and the government on as many as 138 combination drugs out of the total 294 FDCs, which was decided in the first DCGI-industry meeting held on July 14 this year, the state drug authorities are still not issuing licenses to these drugs as there is no directive to this effect from the DCGI so far.
Sources said that the DCGI may take a decision on the date of the expert panel meeting of FDC at the Drugs Consultative Committee (DCC) meeting which is scheduled for December 10.