The vexed fixed dose combination (FDC) issue, which has been evading a solution for the last one year due to the divergent views of the government and the industry, appears to be heading for a solution as both sides have agreed to review all the 294 combinations and withdraw such combinations which are found irrational.

A consensus decision to this effect was taken at a formal government-industry meeting convened by DCGI on June 10 which was attended by representatives of all major pharma associations like IDMA, CIPI, OPPI, SPIC, IPA, etc. The government side was represented by DCGI Dr Surinder Singh and senior pharmacologist Dr YK Gupta. The meeting decided to have its next sitting on July 14.

The significance of the meeting lies in the fact that this is for the first time that the government has convened a meeting of all major pharma associations on the FDC issue. So far, the government has been meeting the representatives of individual associations separately. While the government has agreed to review all the 294 contentious combinations, the industry has also agreed to withdraw if any combination is found irrational.

According to government sources, the government has agreed to review even the banned and absurd category drugs and if any of them is found rational, it will be allowed to manufacture and market provided the industry proves its rationality. The government has asked the industry to come out with the rationality report of all the 294 combinations and the matter will be discussed threadbare in the July 14 meeting, which will be a crucial meeting.

Meanwhile, the industry has termed the meeting a good signal towards an amicable settlement on the vexed issue. Sources said that it was a well organised meeting and the government's approach towards the entire issue was positive. Now, it will purely be an issue of rationality and merit of a product. If a product is rational and even if it is in the banned list, it will be brought back to the market; sources said adding that it shows the positive attitude of the government. "It may ultimately lead to an out of court settlement on the issue by the end of August this year", sources said.