The long-awaited meeting between the industry and the Drug Controller General of India (DCGI) over the issue of fixed dose combinations, on October 1, agreed to set up an expert panel to prepare the rationality of the remaining 156 FDCs. The panel headed by DCGI will take up the FDCs in batches and finally report to the DTAB for clearance.
The meetings of the panel, which has experts and two representatives of the industry, will start from November 28 to take up the case of 49 FDCs. But the final batch of FDCs will be scrutinized in August next year, thus to settle the vexed issue finally.
The meeting, attended by senior officials and experts including Dr YK Gupta on the government side and representatives of all major organisations including OPPI, IDMA, SPIC, FOPE and CIPI, also finalized a format in which the industry can also submit the rationality profile of these FDCs.
On the fate of other FDCs, apart from those 294 listed by the former DCGI, the manufacturers can seek approval from the DCGI office as new drugs and continue marketing, the meeting was informed.
The last meeting held on July 14, had reached consensus on as many as 138 combination drugs out of the total 294 FDCs last year listed by the former DCGI to be withdrawn from the markets.
The industry leaders who attended the meeting expressed concern on the long time frame that is now required to settle the issue once and for all. They also pointed out that some of State licensing authorities are refusing to renew licences of even other FDCs, not listed among the 294.