Though the DCGI and the industry representatives are likely to meet over the fixed dose combination (FDC) issue again this week, the row will be settled fully only by November after the meeting of the DTAB.
"We have written to the States for suggestions on the agenda for the DTAB and DCC meetings. We are still waiting for the feedback. The DTAB meeting may be held by November and it will take up the FDC issue for final settlement, among other topics," DCGI Dr Surinder Singh told Pharmabiz on the matter.
Though a crucial meeting between the industry and the authorities was held on July 14 and sorted out the issue by reaching consensus on 138 FDCs, the minutes of the said meeting were yet to be prepared so far, leaving the issue still at the same stage and the State licensing authorities continued to follow the direction in this regard by the former DCGI.
Dr Surinder Singh said the next meeting with the industry will finalise the minutes of the previous meeting as "it would be better to discuss the differences and reach a consensus among all the participants on the minutes of the meeting." The draft has been ready but was not sent to the participants of the meeting because of this, he added.
Then the sub-committee set up over the issue would then submit the recommendations to the DTAB which will take it up in the next meeting, likely to be held sometime in November, the DCGI informed. The next industry-DCGI meeting will also discuss on the remaining 156 FDCs, besides approving the minutes of the earlier meeting.
At the same time, because of lots of pressing engagements including the workshops and interactions with USFDA, WHO and scheduled trip by the DCGI to attend an international conference of regulatory authorities next week, the industry-DCGI meeting may not be held as scheduled on September 11. "We have tentatively fixed the date, but as lots of other things also happening simultaneously, the schedule is tight. Let's see, if we can hold it as per the plans," Dr Singh said.
The industry has been waiting for the minutes as the State licensing authorities continued to cancel the renewal letters for these FDCs with no fresh direction coming from the DCGI to change the status quo. Indications are that the manufacturers have to wait till the final clearance of the decisions taken at the joint meeting of the DCGI and the industry to see the reversal of the present status.