The contentious fixed dose combination (FDC) issue seems to be heading for a final settlement out of court, as the authorities are willing to go by the 'consensus' at the proposed crucial industry-DCGI meeting on July 14. At the same time, the DCGI will stick to a `rational and scientific' stand on 294 FDC drugs.

The meeting will take up the scientific view points from the industry, which has jointly set up a panel to screen each of the controversial FDCs. The industry is expected to come up with the rationality profiles of these drugs while the authorities are compiling the scientific data including the literature, views of academia and the end users on the same. Government side also will be ready with draft profiles to be discussed, sources said.

Based on the discussions and subject to the agreement between both the sides, a fresh categorisation would be held with three baskets. According to the suggestion by the Government, those FDCs which both the sides agree as irrational should be voluntarily withdrawn from the markets. Those which need to be examined would be put for further studies and would be kept pending till the completion of additional information generation, scientific research, gathering of evidence and if needed clinical trials. And the drugs, which the Government and the industry agree as 'rational', would be allowed to be manufactured and marketed.

The authorities were reportedly satisfied with the preliminary meeting on June 10, which was more of sensitising all stakeholders and breaking the ice between the warring sides on the vexed issue. They also hoped that the industry would come up with a `rational' judgement.

"The next meeting will give a clear and concrete picture and take a final stand on the issue, paving way for a settlement out of the court. The industry was also not given a chance so far to express their view points on the controversial FDC drugs,'' sources said.

Industry is likely to make some compromises on the issue and call off the year-long cold war. On other hand, the DCGI has made it clear that the government would go without any prejudices and take a totally fresh look at the issue, giving a major consolation to the pharma associations. However, at the end of the day, decision will be governed by the rationality of profiles being prepared by the panel headed by Dr R K Sanghavi for the industry and to what extent eminent pharmacologist Dr Y K Gupta along with DCGI Dr Surinder Singh will accept the same.