Major pharma associations representing small and medium companies in the country have come together on the fixed dose combination (FDC) issue and have formed a committee to screen all the contentious 294 FDC drugs. The committee, headed by eminent pharmacologist and chairman of IDMA medical sub-committee Dr RK Sanghavi, will prepare a rationality profile of all 294 combinations and will be submitted to the DCGI for review.
This is a significant move by the pharma associations as this is for the first time that the associations are coming together to find a solution to the FDC issue which has been hanging fire for the last more than one year. So far, IDMA, CIPI, FOPE and SPIC have been expressing views separately and there have been no concerted efforts by the industry to find a solution to the vexed issue which is pending in the Madras High Court.
The associations' move comes after the DCGI Dr Surinder Singh's positive signal to solve the issue out of court by convening a formal government-industry meeting on June 10. This is for the first time that he has called a formal meeting of all the major pharma associations on the issue. In the meeting, the DCGI is learnt to have asked the industry to come out with the rationality of all the 294 drugs.
This is a major policy shift taken by Dr Surinder Singh from that of former DCGI Dr Venkateshwarlu on the issue. After dividing the 294 combinations into absurd, banned, rejected and need further examination categories, Dr Venkateshwarlu had asked the industry to withdraw all these drugs immediately and apply with the DCGI office for fresh license with supporting data. Now, the new DCGI has asked the industry to come out with the rationality of the drugs to continue them in the market.
According to sources, though the other members of the committee and other technicalities are yet to be decided, the Dr Sanghavi committee will have the tedious job of preparing the rationality of all the contentious 294 combinations including the banned, rejected and absurd category drugs.