The DTAB sub-committee set up to decide the fate of the contentious fixed dose combinations (FDCs) will hold its twice-postponed third meeting on October 30 to deliberate on the combination drugs falling under the gastrointestinal category.
After the second meeting was held on June 4 to discuss on 28 FDCs belonging to the musculoskeletal system, the next meeting was scheduled to be held on August 8. But it was postponed as the members were pre-occupied with some other matters and the rescheduled meeting in the third week of August also did not take place.
The date for the next meeting has been fixed and was intimated to all the members. The meeting will in detail deliberate on 32 FDCs in the gastrointestinal category, and the clinical experts of the panel will also be present, along with the industry representatives, sources said.
In the previous meeting, the panel headed by DCGI had cleared almost all FDCs pertaining to the musculoskeletal system for further marketing on the grounds that the industry should provide satisfactory clinical trial data on them within a year’s time. The recommendations in this regard had been forwarded to the DTAB for approval.
The first meeting of the expert panel was held on January 23 and 24 this year in which a total of 48 FDC drugs were examined. The panel, 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, 2008 there was consensus among the industry and the government on as many as 138 combination drugs out of the total 294 contentious combination drugs.