Monday, April 20, 2009

Pharma cos upset over delay in issuing minutes of DTAB meeting to SLAs

Mumbai- The drug manufacturers across the country are upset over the delay on the part of DCGI in issuing the minutes of the Drugs Technical Advisory Board (DTAB) meeting held early this year in which it has approved 44 out of the 294 controversial fixed dose combination (FDC) drugs. But even after months of the meeting, the DCGI is yet to issue the minutes of the meeting to the state licensing authorities (SLAs). The manufacturers are upset over the fact that inordinate delay in issuing a new directive to the SLAs are adversely affecting the industry, as they are not getting their licenses renewed by the SLAs in the absence of written communication from the DCGI office. In the absence of a formal letter, the SLAs are still following former DCGI Dr M Venkateswarlu's directive in October, 2007 in which the former DCGI had asked the SLAs to cancel the licenses of 294 contentious FDC drugs.It may be noted that the FDC issue is almost two years old and the drug manufacturers are annoyed over the SLAs continued refusal to renew licenses for their products in spite of the Madras High Court stay on the issue. In view of the court stay, the SLAs are not cancelling the already issued licenses and not withdrawing the products from the market, but their application for license renewal is returned asking the manufacturers to approach DCGI office in Delhi for new licenses which is very expensive. Part of the blame goes to the extremely slow pace at which the FDC issue is being handled by the new DCGI. There is apprehension among the manufacturers that if the present snail's pace continues, the FDC issue cannot be settled in the near future. Though the new DCGI, Dr Surinder Singh, after the initial dilly-dallying, has taken the initiative to resolve the vexed issue by calling a DCGI-industry meeting on July 14 last year, the delay in taking the follow-up action is irking the industry. Even though there was consensus on 138 of the total 294 contentious combination drugs way back in July last year, the DCGI did not issue any directive to the SLAs for allowing renewal of license of these combination drugs. The second DCGI-industry meeting held on October 1, 2008 decided to constitute an expert panel to screen the remaining 156 drugs. It was also decided in the meeting that the panel, headed by DCGI Dr Surinder Singh, will take up the FDCs in batches and finally report to the DTAB for final clearance. The first expert panel meeting was held on January 23 and 24. The panel, which examined 48 of the remaining 156 combination drugs, found most of them rational and referred to DTAB for final recommendations. The DTAB, which met on February 23, also found 44 drugs rational. Even though almost two months have passed, the DCGI is yet to issue any communications to the SLAs in this regard.

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