Drug companies especially the small and medium scale units located in the non-tax free zones, are thinking of moving court once again on the issue of fixed dose combinations as the office of DCGI has failed to arrive at a final decision even after more than one and half years of raking up the issue.
This time the drug manufacturers are aggrieved over the state drug licensing authorities (SLAs) continued refusal to renew the licenses for the combination drugs for which licenses got expired.
The Madras High Court had granted stay on the FDC issue in November 2007. The court had stayed former DCGI Dr M Venkateshwarlu's controversial order on October 21, 2007 asking the SLAs to cancel the licenses given to the drug manufacturers for producing irrational combination drugs and also to withdraw the products from the market.
According to industry sources, the drug manufacturers in the non-tax free zones are annoyed over the SLAs continued refusal to renew licenses for their products in spite of the Madras High Court stay. 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.
Industry sources said that 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.
In the July 14 meeting, a consensus was reached in the case of 138 combination drugs. But, the DCGI did not send any order to the SLAs so far. In the absence of new directives from the DCGI, the SLAs are not accepting the renewal letters for the 294 contentious FDC drugs as they are still following the controversial order issued by Dr Venkateshwarlu in October 2007.
In the second DCGI-industry meeting on October 1, 2008, it was decided to constitute an expert panel to screen the remaining 156 drugs. After almost four months of its formation, the expert panel met recently and examined the rationality data of only 30 products provided by the industry. On this too, the panel decided to leave the issue to DTAB to take a final decision, leaving an impression among the manufacturers that the government is not serious to find an early solution to the issue.
Meanwhile, the slow progress on the issue is providing an uneven playing field to the drug manufacturers in the country, benefiting a section of companies. While the drug companies in the tax-holiday zones, who received licenses relatively recently, continue to manufacture these contentious drugs, others in the non-tax free zones whose licenses have expired are not getting the licenses renewed from the SLAs.