An amicable out-of-court solution to the vexed fixed dose combination (FDC) issue is on the horizon with the Drug Controller General of India (DCGI) Dr Surinder Singh holding a meeting with Confederation of Indian Pharmaceutical Industries (CIPI) on the issue. The meeting holds significance as it was CIPI which had moved Madras high court on the FDC issue which is yet to come up for hearing.
Though the meeting remained inconclusive, the DCGI has taken several initiatives to resolve the issue that has been hanging in balance for some time. As a first step, the DCGI has asked the industry associations to work out a list of FDC drugs that can be phased out from the market voluntarily. The next meeting is scheduled to be held in the first week of May and two members from each of the major associations will be asked to attend the meeting.
According to sources, the DCGI will ask all the major industry associations like OPPI, IPA, IDMA, CIPI, etc to submit a separate list of FDC drugs that the industry is willing to voluntarily remove from the market. In the first phase of the formula that is emerging from the DCGI office, all the FDC drugs that are common in the list of industry associations will be withdrawn from the market. For the remaining contentious products, the DCGI will seek the assistance of Pharmacoepia Commission chairman to decide the efficacy or otherwise of the product and will act accordingly.
However, the role of the DTAB, the highest technical body in the health ministry dealing with such matters, is not clear. Incidentally, the matter is pending with the DTAB as former DCGI Dr Venkateshwarlu had asked the DTAB to examine the contentious 294 FDC drugs. There are reports that the DTAB has prima facie found a large number of the 294 products illogical.
Meanwhile, the CIPI has already made a list of around 110 drugs (most of them belonging to the banned, absurd and rejected category) its members are willing to voluntarily withdraw from the market if the DCGI allows them to manufacture and market the rest of the contentious 294 FDC drugs.