Even as a deadlock like situation prevails on the vexed Fixed Dose Combination (FDC) issue with no expert committee meeting in sight in the near future to decide on the remaining 58 controversial FDC drugs, efforts are on to resolve the issue out of court and a meeting in this regard is expected to be held between the DCGI and industry soon, it is learnt.
According to sources, hectic efforts are going on, both at the DCGI level and at the industry level, to find a lasting ‘out of court’ solution to the issue which has been hanging fire since June 2007. The FDC drugs became controversial when former DCGI Dr M Venkateswarlu in June 2007 asked the state drug licensing authorities to withdraw licenses of the 294 FDC drugs for irrational combinations and the issue since then 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.
Sources said that both the industry and the DCGI are keen to resolve the issue amicably and both of them do not want to prolong the issue. Though the incumbent DCGI Dr Surinder Singh had taken initiative to resolve the issue, it still remains to be solved mainly due to the pending case in the Madras High Court. So, the DCGI wanted the industry to first withdraw the case from the Madras High Court.
But, even though the industry is also keen to end the dilemma over the issue, industry sources said that it may not withdraw the case unless and until the DCGI provides a clear picture on the issue. Industry sources said that it is ready to withdraw the irrational FDCs from the market, but it should be allowed to market the rational FDCs some of which have been in the market for several years. “We will go to the meeting with an open mind with a resolve to end the dilemma over the issue”, a senior industry leader closely involved in the issue, said.
There is apprehension among the industry over the fate of the FDC drugs as the DCGI so far did not issue any letter to the state drug authorities on the decisions taken by the expert panel on FDC. During the last two years, the expert panel on FDC, headed by the DCGI himself and consisting of Dr Y K Gupta, chief pharmacologist at AIIMS and Dr Sanghavi of IDMA as members, had cleared 236 of the total 294 controversial combination drugs as ‘good and rational’. But, the DCGI's inaction on the issue has irked the industry.
Besides, the matter was further confused by DCGI's recent action in which he had issued guidance for marketing approval of FDC drugs, classifying the FDCs into different categories and stating various requirements for each category of drugs. But, the industry is baffled over the fact that there is no mention of the status of the controversial 294 FDCs for which several expert panel meetings over a period of two years had held and a decision was already taken on 236 of these products.