The expert panel on fixed dose combination (FDC) drugs, headed by the Drug Controller General of India (DCGI), will hold its next meeting in the third week of this month. The meeting will decide the fate of 28 combinations falling in the category of gastro-intestinal drugs.
In fact, the meeting was scheduled to be held on August 8, but some members have asked the DCGI to postpone the meeting by some days citing unavoidable personal reasons. Now the meeting is most likely to be held in the third week of August, sources said.
This will be the third meeting of the panel which was formed last year to resolve the lingering FDC issue. 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.
The expert panel held its second meeting on June 4 and examined a total of 28 FDC drugs. The expert team, which included senior health ministry officials and medical experts from the industry, scrutinized the combination drugs having one NSAID (non-steroid anti-inflammatory drugs) and paracetamol with serratiopeptidase. Discussions were also held on the FDCs of NSAID with skeletal muscle relaxants.
After the in-depth examination, the panel in its second meeting decided to recommend to the DTAB, which is the highest authority in the union health ministry on technical matters, to allow the industry to manufacture these combination drugs with certain conditions that the industry should give further data within a year's time.
The panel so far has taken decision on the 76 contentious combination drugs. Now, the panel has to decide the fate of the remaining 80 drugs out of which 28 products will come up for expert scrutiny in the third meeting in the third week of August.