The inordinate delay in issuing formal minutes of the DCGI-Industry meeting held on July 14, in which a consensus was reached in the case of 138 combination drugs, is irking the manufacturers of 294 FDC drugs as the state authorities are cancelling the renewal letters for these drugs in the wake of no new directions from the DCGI.

Though it is more than a month after the DCGI and the industry have reached consensus on as many as 138 combination drugs in the July 14 meeting, the DCGI is yet to issue the minutes of the meeting to the state licensing authorities (SLAs). 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.

According to sources, even after repeated reminders in this regard by the industry, the DCGI has not so far issued the minutes of the July 14 meeting in which the authorities 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 the 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. And another15 drugs, banned earlier, continued to appear in the medical reference books in the country.

After finding a consensus about 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.

However, the industry sources said that 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. But there is no response from the DCGI", they lamented.