Almost two months after the first crucial DCGI-industry meeting held on July 14 to resolve the controversial fixed dose combination (FDC) issue which decided on the fate of 138 of the 294 combination drugs, the second meeting will be held soon as the DCGI office is preparing the minutes of the first meeting, it is learnt. The tentative date for the second meeting is September 11.
According to sources, a clear hint in this regard was given to the industry leaders by the DCGI office. Once the minutes of the first meeting will be ready, the second meeting will be held and the minutes of the first meeting will be distributed to the industry. The industry has been sending repeated reminders to the DCGI office to hold the second meeting to decide the fate of the remaining 156 combination drugs.
After finding a solution to the 138 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. Most of these drugs belonged to the 'need further examination' category and the industry is hopeful that maximum drugs will pass the DCGI test in the next meeting.
Meanwhile, industry sources said they are ready with the scientific data of the remaining 156 drugs and they have already informed the DCGI about it. "We have asked the DCGI to issue the minutes of the July 14 meeting and also to convene the second meeting to decide on the fate of the rest of the 156 combination drugs," they said.
The delay in finalising a solution to the complex issue is 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.