A lasting solution to the vexed Fixed Dose Combination (FDC) issue, which has been evading a solution for almost four years, does not appear to be on the cards as the expert panel, headed by DCGI, is adamant that the industry should come out with clinical trial details on each of the FDC products, even those products which were in the market for decades together.Industry sources said that the expert panel, which consisted of doctors from renowned hospitals, was not ready to even consider the drugs which were in the market for several years. Though the industry also took the help of several renowned doctors, that too specialists in each area, the panel simply refused to consider the pleas of these doctors and insisted on clinical trials for each of the FDC products, sources said.
After a long gap of more than one year, the expert panel on FDC held its meeting on April 19 and 20 this year to take a call on most of the remaining FDC drugs. In fact, the industry was optimistic on finding a lasting solution to the vexed issue during the two-day meeting, especially in the wake of DCGI Dr Surinder Singh's public announcement on January 7 this year in Mumbai that the long pending FDC issue would be resolved within one month. On that day, the DCGI was addressing the captains of Indian pharma industry on the occasion of the 49th annual day celebrations of the Indian Drug Manufacturers Association (IDMA) in Mumbai.But the insistence of the DCGI-headed expert panel on clinical trial for all the products has belied such a hope.Taking strong exception to the adamant attitude of the panel, industry sources said that if the DCGI wanted clinical trials for every product, the entire exercise of holding periodic meetings between the industry and the expert panel is a waste of time for one and all. “The industry has roped in several renowned doctors to present their case in the meetings. But, their views were not heeded by the panel,” the industry regretted. In fact, the industry is annoyed with the DCGI over his indifferent attitude in handling the entire FDC issue. There is resentment among the industry over the inordinate delay on the part of the DCGI in sending the list of FDCs, which have been accepted as 'good and rational' by the expert panel, to the State Licensing Authorities (SLAs) as the SLAs are directing the companies to approach DCGI office in Delhi for getting the license renewal of drugs which have been in the market for as long as 10 to 15 years. The expert panel on FDC had so far cleared more than 200 of the total 294 controversial combination drugs as 'good'. But, the DCGI is yet to officially communicate the same to the SLAs in writing, leaving the industry to approach the DCGI office for licenses.
