The Drugs Technical Advisory Board (DTAB) has advised the Drugs Controller General of India to take legal opinion on the contentious issue of fixed dose combinations before issuing notification to accord final clearance to those FDCs cleared by the sub-committee on the matter.
The recent meeting of the highest advisory body accepted the report of its subcommittee, set up some time in 2007, to take a final call on the 294 combination drugs to take out of the market following a directive by the former DCGI.
According to its report, the total list included 43 combinations, which were banned in the country and 31 other combinations which were repetitions by virtue of having same ingredients, but cleared or approved as some other brands.
The subcommittee, in its report, also said 22 FDCs had been cleared already by the DCGI. Another 49 were found rational but needed to have further documentary support and examination. The DTAB was briefed about the deliberations so far on the issue of FDCs including the involvement of the industry. The subcommittee had included the findings of the expert panel set up jointly by the industry and the DCGI in its report given to the DTAB, sources said.
However, the DTAB has asked for further examination or another look at the 22 drugs which were cleared by the DCGI. The board has cleared most of the 49 drugs, which were not irrational but needed further examination. The DTAB has asked for further examination of five FDCs in that category involving Lactobacilliefdcs. The apex advisory body also urged the DCGI to speed up the process of examining the rationality of the remaining FDCs.
"We will take a look at those approved 22 FDCs again and except a few, all other combination drugs in the list of 49 got the approval from the DTAB. Since the original list had 31 duplications, the number virtually came down to 263. Out of them, 43 were banned while 22 were already approved and 49 were found to be rational. Thus a total of 145 FDCs were discussed. But we have to take legal opinion on the matter, especially about those already banned in the country, as the case is still pending before the Chennai High Court before issuing notification and hence it may take some time," DCGI Surinder Singh told Pharmabiz, clarifying on the matter.
Thus the issue of FDC is likely to take much more time for a final disposal. However, the DTAB has given the green signal to most of the deliberations between the industry and the DCGI to sort out the issue. The expert panel involving the industry representatives have recently cleared most of the 48 FDCs came for examination for rationality. The expert panel will continue to take the remaining FDCs one by one and analyse the supportive data and take a call on their fate. It would be then again referred to the DTAB for clearance.