After a gap of almost four months since its last meeting on October 30, the DTAB sub-committee on fixed dose combination (FDC) drugs, headed by Drug Controller General of India (DCGI) Dr Surinder Singh, will hold its next meeting on February 24 to analyse 18 FDC products falling under the category of cardiovascular and diabetes drugs.
Atenolol+hydrochlorothiazie+amiloride, atorvastatin+aspirin+ramipril, atorvastatin+mecobalamine+folic acid, atorvastatin+mecobalamine+folic acid+vitB6, atorvastatin+omega3 fatty acid, atorvastatin+ramipril, atorvastatin+ubidecarenone, clonidine+chlorthalidone, clopidogrel+aspirin+atorvastatin, propranolol+hydrallazine, etc are some of the FDC drugs in the cardiovascular category that will come up for discussion in the proposed meeting.
The combination drugs in the diabetic category that are to be discussed in the meeting include gliclazide+chromium picolinate, metformin hydrochloride+mecobalamine, etc.
This is the fourth meeting of the expert panel on FDC. So far, the panel on FDC headed by the DCGI has taken decision on 236 of the total 294 controversial combination drugs. The FDC drugs 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 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.
As the issue between the government and the industry lingered on, DCGI Dr Surinder Singh constituted an expert panel to resolve the issue amicably. The panel, which was constituted on October 1, 2008 was given the mandate to decide the fate of the remaining 156 combination drugs. In the first DCGI-industry meeting on FDC on July 14, 2008 there was consensus among the industry and the government on as many as 138 combination drugs out of the total 294 controversial combination drugs.
The first meeting of the expert panel was held on January 23 and 24 this year in which a total of 48 FDC drugs, were examined. The expert panel held its second meeting on June 4 and examined a total of 28 FDC drugs having one NSAID (non-steroid anti-inflammatory drugs) and paracetamol with serratiopeptidase. The panel held its third meeting on October 30 to decide the fate of around 30 combinations falling in the category of gastro-intestinal drugs. But the panel decided only on 22 combinations.