In his efforts to break the prolonged impasse over the fixed dose combinations (FDC) issue, Drug Controller General of India (DCGI) Dr Surinder Singh, as part of a series of interactive meetings with different stake-holders, has convened a meeting of all the pharma associations on June 10.
With several organisations, over the past months through delegations and telephonic calls, expressing desire to present their views before the DCGI, the drug regulator has decided to hold a preliminary meeting on the FDC issue which is currently pending in the court. The representatives from CIPI, IDMA, SPIC, FIPE, IPA and OPPI are expected to attend the meeting. It is likely to be followed by a decisive meeting with all stakeholders on June 24 with a view to put a lid over the issue permanently, as the DCGI himself was in favour of an out-of-the-court settlement.
A spokesman of SPIC has confirmed to Pharmabiz that his association leaders would be meeting the DCGI and they were in the process of gathering views from the members. The association was of the view that some items on the banned FDC list have brought a bad name to the SSI sector as a whole.
When contacted, CIPI chairman T Jaishankar said he was yet to get a formal invitation in this regard, but would be available in Delhi on June 10 and was willing to meet the DCGI. CIPI had filed the case on the issue in Chennai High Court and won the stay over the implementation of the order to ban 294 combination drugs by former DCGI M Venkateshwarulu.
The June 10 meeting is going to be the first formal meeting by the new DCGI with the associations over the deadlocked issue after he took over in February. Hence, industry is pinning their hopes greatly to resolve it and get a breather from the authorities. The industry associations would present their views and stands on the matter in this preliminary meeting as the DCGI wants to evolve consensus among the associations. A final decision could thus be worked out in the next and final meeting with all stakeholders and the authorities.
It is also going to be crucial as the industry associations are invited for an interaction for the first time after a similar attempt by former DCGI in October not only failed but made things more complicated with the authorities and industry taking divergent positions and ultimately dragging it to the court.