After almost a year since its last meeting, the expert panel on Fixed Dose Combination (FDC) drugs, headed by Drug Controller General of India (DCGI), is yet to hold its next meeting to decide the fate of the remaining around 80-odd FDC drugs. The expert panel held its last meeting on February 24, 2010 and analysed 18 FDC products falling under the category of cardiovascular and diabetes drugs.
According to sources, even though the industry was expecting the fifth meeting on FDC immediately after the Diwali holidays in October last year, there was no intimation from the DCGI office so far about the meeting to resolve the issue which has been lingering for over more than three years, ever since the issue became controversial when former DCGI Dr M Venkateswarlu in June 2007 asked the state drug licensing authorities to withdraw licenses of 294 irrational combination drugs.
Sources said that the industry has already prepared the rationality data of around 15 FDC drugs falling under the category of dermatology and has been waiting for the invitation from the DCGI office for the meeting. The industry has been trying for an early meeting in this regard, but the DCGI is not showing much interest in the matter which is annoying the industry, sources said.
In fact, the industry is annoyed with the DCGI over his indifferent attitude in handling the entire FDC issue. There is resentment among the industry over the inordinate delay on the part of the DCGI in sending the list of FDCs, which have been accepted as ‘good and rational’ by the expert panel, to the State Licensing Authorities (SLAs) as the SLAs are directing the companies to approach DCGI office in Delhi for getting the license renewal of drugs which have been in the market for as long as 10 to 15 years.
The expert panel on FDC, headed by the DCGI and consisting of Dr Y K Gupta, chief pharmacologist at AIIMS and Dr Sanghavi of IDMA as members, had so far cleared more than 200 of the total 294 controversial combination drugs as ‘good’. But, the DCGI is yet to officially communicate the same to the SLAs in writing, leaving the industry to approach the DCGI office for licenses.
The panel held its first meeting on January 23, 2009 in which a total of 48 FDC drugs were examined. It held its second meeting on June 4, 2009 and examined a total of 28 FDC drugs. The panel held its third meeting on October 30, 2009 and decided the fate of 22 combinations falling in the category of gastro-intestinal drugs.