The DTAB sub-committee on FDC, which held its third meeting on October 30 to decide the fate of around 30 combinations falling in the category of gastro-intestinal drugs, did not approve a single product as the expert panel asked the industry to come out with more scientific data to prove these products' safety and efficacy.
Among the 30 combinations falling in the category of gastro-intestinal drugs, the DTAB sub-committee took up only 10 products today for discussion. After prolonged deliberations, the panel rejected all the products and asked the industry to conduct clinical trials for getting the approval.
This is for the first time that the panel, which consists of experts in the field, has refused to give approval even to a single product. In the first meeting held on January 23 and 24 this year, the panel had approved a total of 48 FDC drugs. In the second meeting on June 4 this year, the panel had examined and approved a total of 28 FDC drugs, albeit with conditions.
The expert panel on FDC, headed by the DCGI, was constituted more than a year ago on October 1 to resolve the vexed fixed dose combination (FDC) issue. The panel has so far taken decision on 76 of the 156 contentious combination drugs. The panel has to decide the fate of the remaining 80 drugs.
The FDC drugs became controversial when former DCGI Dr M Venkateswarlu asked the state drug licensing authorities to withdraw licenses of the 294 FDC drugs for irrational combinations and the issue became a bone of contention between the industry and the DCGI. The industry then moved court and got stay order against the DCGI order from Madras High Court, which is yet to be vacated.
As the issue between the government and the industry lingered on, DCGI Dr Surinder Singh constituted an expert panel to resolve the issue amicably. The panel, which was constituted on October 1 last year in the second DCGI-industry meeting on FDC, was given the mandate to decide the fate of the remaining 156 combination drugs. In the first DCGI-industry meeting on FDC on July 14, there was a consensus among the industry and the government on as many as 138 combination drugs out of the total 294 controversial combination drugs.