The expert panel on FDC, constituted almost one year back headed by the DCGI to resolve the vexed fixed dose combination (FDC) issue, is moving at a snail's pace as it has failed to take a decision on more than half of the 156 combination drugs. The panel has so far taken decision only on 76 of the 156 contentious combination drugs.
The panel was constituted on October 1 last year to decide the fate of these 156 contentious FDC drugs which was proposed to be completed in around one year. But, the panel could meet only twice so far during the last one year of its existence. Now, the panel has to decide the fate of the remaining 80 drugs.
In fact the panel was to have its third meeting on August 8, but it was postponed due to the pre-occupancies of the members. Then it was to be held in the third week of August, that too could not materialise due to busy schedule of the DCGI. The third meeting was to decide the fate of 28 combinations falling in the category of gastro-intestinal drugs. Sources said that now the third meeting will be held somewhere in November after Diwali celebrations.
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.