The DTAB sub-committee on fixed dose combination (FDC) drugs, which held its fourth meeting on February 24 at the DCGI office, cleared most of the products in the cardiovascular category. The committee, headed by the DCGI, had analysed a total of 17 FDC products falling under the category of cardiovascular and diabetes drugs.
The committee, consisting of Dr Y K Gupta chief pharmacologist at AIIMS and Dr Sanghavi of IDMA, analysed the FDC drugs in the cardiovascular category such as 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. While three items were rejected, two other items, clonidine+chlorthalidone, clopidogrel+aspirin+atorvastatin, were left to the scrutiny of cardiology specialists.
Though the committee was to take up some of the combination drugs in the diabetic category like gliclazide+chromium picolinate, metformin hydrochloride+mecobalamine, etc, due to time constraint, it was decided deferred for the next meeting, which is likely to be held in April.
This is after a gap of almost four months that the DTAB sub-committee on FDC is holding its meeting. The last meeting was held on October 30. So far, the panel has taken decision on 236 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.