Drug Controller General of India (DCGI) Dr Surinder Singh has said that he will resolve the vexed fixed dose combination (FDC) issue by March next year. Once he resolves the issue with the industry, the DCGI will move Madras High Court to vacate the stay on the controversial order of former DCGI Dr M Venkateshwarlu in 2007 in which he had asked the state drug controllers to withdraw licenses given by them to 294 controversial irrational combinations.
“I am trying to resolve the FDC issue once and for all by March next year”, DCGI Dr Dr Surinder Singh said. He said the next DTAB meeting is scheduled for some time in February and the issue will be resolved immediately after the DTAB meeting. At present, an expert panel headed by DCGI himself is examining the 294 controversial combination drugs in phases. Before the next DTAB meeting in February next year, all the 294 drugs will be reviewed and the findings will be submitted to the DTAB for final decision. DTAB is the highest authority in the union health ministry on technical matters on drugs.
Once the DCGI succeeds in getting the stay vacated on another equally controversial issue of COPP at Madras High Court on December 2, he will concentrate on vacating the stay on FDC which the court had granted to the pharma association CIPI in October 2007.
Almost two and half years down the line since the controversial FDC issue hit the headlines, the DCGI exuded confidence that he will be able to resolve the issue amicably with the industry. So far, the expert panel on FDC headed by the DCGI has taken decision on 236 of the total 294 combinations.
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 contentious combination drugs. The panel on FDC was constituted after that on October 1 last year and was given the mandate to decide the fate of the remaining 156 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.