Almost two and a half months after the first crucial DCGI-industry meeting held on July 14 to resolve the controversial fixed dose combination (FDC) issue which decided the fate of 138 of the 294 combination drugs, the DCGI has issued the minutes of the meeting. DCGI has broadly agreed the industry proposals discussed in the meeting.
The issuing of minutes of the meeting is significant as even though the DCGI took a verbal decision on 138 FDC drugs, the state authorities were cancelling the renewal letters for these drugs in the wake of no new directions from the DCGI in black and white. Now, the manufacturers of these drugs can approach the state authorities for renewing the licenses of these drugs.
According to sources, the DCGI did not make any changes on the proposals put forward by the industry in the meeting. The meeting decided to allow manufacturing and marketing of 28 combination drugs which got DCGI approval after the FDC drugs became an issue a year ago. The authorities also agreed in the meeting to approve 36 FDCs which came under the same molecule family which has been already cleared.
In the meeting, which examined in detail the safety and efficacy of each combination drug, the industry agreed to withdraw 28 FDCs from the market voluntarily. It was also found that as many as 31 drugs were duplicated in the list of 294 FDCs. Some 15 drugs which were banned and not available in the market were also crept in the list.
After finding a consensus solution to the 138 of the total 294 contentious combination drugs, the DCGI had asked the industry to submit the scientific data of the remaining 156 drugs to take a final decision on them. The second meeting on this issue was scheduled for October 1. But, the inordinate delay in issuing minutes of the meeting was affecting the industry, especially the small scale industries as they are not getting their licenses renewed by state licensing authorities (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 last year in which the former DCGI had asked the SLAs to cancel the licenses of 294 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.