The Drug Controller General of India (DCGI) has called the next meeting of the expert panel on fixed dose combination (FDC) on June 4. The meeting will decide the fate of another 28 FDC drugs.
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.
One of the members of the panel Dr RK Sanghavi said that the industry is busy preparing the rationality data of another 28 FDC drugs which will be submitted to the government in the next meeting of the expert panel on FDC on June 4. The industry is confident that it can prove the rationality of these FDC drugs which became controversial when former DCGI Dr M Venkateswarlu asked the state drug licensing authorities to withdraw licenses of the 294 FDC drugs for irrational combinations.
As the issue between the government and the industry lingered on, the DCGI constituted an expert panel to resolve the issue amicably. The panel, which was constituted on October, 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, there was consensus among the industry and the government on as many as 138 combination drugs out of the total 294 controversial combination drugs.
In the October 1 meeting, both the government and the industry agreed to set up an expert panel to prepare the rationality of the remaining 156 FDCs. It was also decided in the meeting that the panel, headed by DCGI Dr Surinder Singh, will take up the FDCs in batches and finally report to the DTAB for final clearance. In the first meeting, the panel examined the rationality data of 48 FDC drugs and was sent to the DTAB for its final nod. The DTAB also gave its nod to the 48 FDC drugs. With the approval to another 48 FDC drugs, the industry and the government have reached a decision on 186 of the total 294 controversial irrational FDC drugs which Dr Venkateswarlu wanted to remove from the market.