The pharmaceutical industry in the country has urged the Union Health Ministry to reconsider its order making clinical trials mandatory for all the fixed dose combination (FDC) drugs irrespective of the fact that many of them have been accepted as 'good' by the expert panel on FDC and which are in the market for more than 10 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. Though the committee has found these drugs rational and good, the drug authorities are still insisting on clinical trial data for all the FDC drugs. Incidentally, most of these drugs have been in the market for more than 10 years.
The industry pleads that the clinical trials on such old and beneficial FDC are not necessary. As clinical trials take two to three years and if the production of these FDC drugs are stopped pending clinical trials, many companies will lose the market which they have established over the years. Besides, the patients will also lose the benefit of such established products, the industry says.
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 the issue became a bone of contention between the industry and the DCGI.
Though the present DCGI Dr Surinder Singh had resolved to end the issue amicably, the stalemate continues. To resolve the issue, the DCGI had constituted an expert panel on October 1, 2008 which has so far held four meetings.
The first meeting of the expert panel was held on January 23 and 24, 2009 in which a total of 48 FDC drugs, were examined. The expert panel held its second meeting on June 4, 2009 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, 2009 to decide the fate of around 30 combinations falling in the category of gastro-intestinal drugs. But the panel decided only on 22 combinations.
The panel held its fourth meeting on February 24 and 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.
Earlier, 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.