The indifferent attitude of the drug controller general of India (DCGI) in sending the list of fixed dose combination (FDC) drugs, which have been accepted as 'good' by the expert panel on FDC, to the state licensing authorities (SLAs) has put the pharma industry in a dilemma as they are not getting the drug licenses renewed from the SLAs.

According to sources, the pharmaceutical industry in the country, especially the small and medium players, are annoyed over the inordinate delay on the part of the DCGI in sending the list of 'good' FDCs to the 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 236 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. And the DCGI office has made it clear that clinical trials are mandatory for license renewal.

Interestingly, some of the old FDC drugs, which have been in the market for 10-15 years, have overnight become New Drugs as some of the big companies have done the BA/BE studies and have received the license from the DCGI office as new drugs. Since they have received the license as New Drugs, no company will receive license for the same drug for the next four years, industry sources said.

The FDC issue 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 the 294 FDC drugs for irrational combinations and since then the issue became a bone of contention between the industry and the DCGI.

Though the incumbent DCGI Dr Surinder Singh had resolved to end the issue amicably, it still remains a stalemate. To resolve the issue, the DCGI had constituted an expert panel on October 1, 2008 which has so far held four meetings in which the cases of total of 236 FDCs out of the total 294 contentious FDCs were resolved amicably. But, the delay in communicating the same to the SLAs has caused immense difficulties to the industry.