After a long gap of more than one year, the sub-committee of the Drug Technical Advisory Board (DTAB) on the issue of long pending Fixed Dose Combination (FDC) issue will hold a two-day meeting on April 19 and 20 and take a call on most of the remaining FDC drugs.
The much-awaited meeting of the panel, headed by the Drug Controller General of India (DCGI) and having representatives of major pharma associations along with the experts in the field, will examine as many as 64 FDCs during the sessions spread across two days, though as many as 80 odd FDCs, out of the controversial 294 FDCs, were still remaining to be assessed.
The panel will examine the feasibility and decide on the fate of FDCs belonging to dermatological, nutritionals, CNS, anti-microbial, anti-diabetic, orthopaedics, cough and cold categories, according to the list of FDCs shortlisted for deliberations at the meeting, sources said.
“The next meeting of sub-committee is scheduled to be held on April 19, from 11 am to 5.30 pm and on April 20, from 2 pm to 5.30 pm for examining the issues relating to the list of 294 FDCs,” said the letter from DCGI.
The expert panel on the FDC held its last meeting on February 24, 2010 and analysed 18 FDC products falling under the category of cardiovascular and diabetes therapeutic areas. The industry associations have been pressing for the next meeting for long now, with the hope that the FDC issue could finally be solved. The DCGI himself had announced in January that the issue would be cleared shortly.
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.