Even after the public announcement on January 7 this year by Drug Controller General of India (DCGI) Dr Surinder Singh that the long pending FDC issue will be resolved within one month, he is yet to convene the next meeting in this regard to decide the fate of  remaining 80-odd FDC drugs, leave alone resolving the issue.

Speaking to the captains of Indian pharma industry on the occasion of the 49th annual day celebrations of the Indian Drug Manufacturers Association (IDMA) in Mumbai on January 7, Dr Singh had publicly announced that the lingering FDC issue will be resolved within one month.

Almost three months have passed since that public assurance by the DCGI, but there is no talk of convening the next meeting of the expert panel to resolve the issue. The expert panel on Fixed Dose Combination (FDC) drugs, headed by DCGI held its last meeting on February 24, 2010 and analysed 18 FDC products falling under the category of cardiovascular and diabetes drugs. It is more than a year now, but the DCGI is yet to make any move to hold the next meeting to decide the fate of the remaining around 80-odd FDC drugs.

Even after several reminders to hold a meeting to resolve the issue, there has been no positive response from the DCGI so far, sources in the industry said.  
 
The FDC issue became controversial when the then 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.

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.