The pharma industry in the country has urged Drugs Controller General of India (DCGI) Dr GN Singh to notify the 140 fixed dose combination (FDC) drugs which have been approved as 'Not irrational' by the expert panel on FDC headed by the DCGI himself.

The industry, especially the small and medium players, is annoyed over the inordinate delay on the part of the DCGI in notifying the list of 140 'Not irrational' FDC drugs and sending it 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 these drugs which have been in the market for as long as 10 to 15 years. Sources said that the indifferent attitude of the DCGI in this regard put the pharma industry in a dilemma as they are not getting the drug licenses renewed from the SLAs.

The expert panel on FDC, which had so far examined 258 of the total 294 controversial combination drugs, has found 140 FDC drugs as not irrational, 61 not approved and 57 drugs as irrational drugs. A total of 36 drugs are yet to be examined by the panel which met last time on April 25 and 26 this year.  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 FDC issue has been lingering for over more than five years now, ever since the issue became controversial when 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 since then the issue became a bone of contention between the industry and the DCGI.

Though the next DCGI Dr Surinder Singh had resolved to end the issue amicably, it still remains a stalemate. To resolve the issue, Dr Surinder Singh had constituted an expert panel on October 1, 2008 which has so far held several meetings in which the cases of total of 258 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.