The expert panel on fixed dose combination (FDC), headed by the Drug Controller General of India (DCGI), 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 expert panel decided to recommend to the DTAB 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 will send its recommendations for final approval to the DTAB, which is the highest authority in the union health ministry on technical matters.
As per the decision taken in the meeting, the initial permission for these FDCs will be for one year only. These combination drugs should be allowed to be manufactured for prescription of specific indications and the label of these drugs should carry warnings against long term usage of the drugs. Besides, the industry has to submit within one year that this FDC is not having inferior safety profile than the FDC of NSAID with serratipeptidase.
This is the second meeting of the panel which was formed last year to resolve the vexed 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 controversial combination drugs.
With the decision on another 28 drugs on June 4 in the second meeting, the panel so far has taken decision on the controversial 76 combination drugs. Now, the panel has to decide on the fate of the remaining 80 drugs.