After a long gap of more than eight months since its last meeting in February, the DTAB sub-committee on fixed dose combination (FDC) drugs, headed by Drug Controller General of India (DCGI) Dr Surinder Singh, is likely to hold its next meeting in the second week of November to analyse the remaining 58 controversial FDC drugs which were banned by former DCGI Dr Venkateshwarlu in 2007.
Sources said that though no exact date has been finalised yet, the next meeting in this series may be held immediately after the Diwali celebrations. The expert panel on FDC had held its fourth meeting on February 24 this year to analyse 18 FDC products falling under the category of cardiovascular and diabetes drugs.
The proposed next meeting will be the fifth meeting of the expert panel on FDC. During the last two years, the expert panel on FDC, headed by the DCGI himself and consisting of Dr Y K Gupta, chief pharmacologist at AIIMS and Dr Sanghavi of IDMA as members, had so far cleared 236 of the total 294 controversial combination drugs as 'good and rational'.
The FDC drugs became controversial when former DCGI Dr M Venkateswarlu in June 2007 asked the state drug licensing authorities to withdraw licenses of the 294 FDC drugs for irrational combinations and the issue became a bone of contention between the industry and the DCGI. The industry then moved court and got stay order against the DCGI order from Madras High Court, which is yet to be vacated.
As the issue between the government and the industry lingered on, DCGI Dr Surinder Singh constituted an expert panel to resolve the issue amicably. The panel, which was constituted on October 1, 2008 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.
The first meeting of the expert panel was held on January 23 and 24 last year in which a total of 48 FDC drugs were examined. The expert panel held its second meeting on June 4 and examined a total of 28 FDC drugs. The panel held its third meeting on October 30 last year and decided the fate of 22 combinations falling in the category of gastro-intestinal drugs.