The crucial Drugs Technical Advisory Board (DTAB) meeting to consider all the recommendations made by the government-industry meetings held on October 1 last year and January 23-24 this year, will be held on February 23. The DTAB comprises renowned pharmacologists and the DCGI.
But, it is not yet clear whether the decision taken at the first government -industry meeting on July 14 last year will be left to the DTAB for consideration. In the first DCGI-industry meeting, there was consensus among the industry and the government on as many as 138 combination drugs out of these 294 combination drugs.
In the October 1 meeting, both the government and the industry had agreed to set up an expert panel to prepare the rationality of the remaining 156 FDCs. 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.
The result of the DTAB meeting is keenly watched by the industry, especially the small and medium enterprises as the DCGI has left to the DTAB, the highest decision-making authority in the Union health ministry on technical matters, to take a final call on the FDC issue.
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 state licensing authorities (SLAs) for allowing renewal of license of these combination drugs. Likewise, even though the expert panel had cleared another around 40 FDC, the DCGI did not issue any directive to the SLAs.
But, the inordinate delay in issuing a new directive is adversely affecting the industry, especially the small scale industries as they are not getting their licenses renewed by the SLAs in the absence of written communication from the DCGI office in this regard. In the absence of a formal letter, the SLAs are still following former DCGI Dr Venkateshwarlu's directive in October, 2007 in which the former DCGI had asked the SLAs to cancel the licenses of 294 contentious FDC drugs.
Besides, the slow progress in officially finalising a solution to the FDC issue is providing an uneven playing field to the drug manufacturers in the country, benefiting a section of companies. While the drug companies which have received licenses relatively recently continue to manufacture these contentious drugs after the Madras High Court stay, others whose licenses have expired are not getting the licenses renewed from the state drug authorities.