The industry associations, which are working expeditiously to prepare the rationality profile of the remaining 156 fixed dose combination (FDC) drugs to submit it to the DCGI office for its approval, have started submitting the scientific data of these drugs to the DCGI office.
Industry sources said that work on preparing the scientific data of these remaining 156 FDCs is going on and the associations have started submitting the same to the DCGI office in batches. Major pharma associations representing small and medium companies had last month formed a committee under eminent pharmacologist and chairman of IDMA medical sub-committee Dr RK Sanghavi to screen all the contentious 294 FDC drugs.
The industry had submitted the data of the first list of FDCs to the DCGI in the crucial DCGI-industry meeting held on July 14 to sort out the contentious FDC issue that has witnessed crossing of swords between the industry and the authorities.
Ending year-long impasse over the issue, a consensus was reached on the future of 138 combination drugs between the industry and the DCGI in the July 14 meeting. Out of the 138 combinations, 28 FDCs which got DCGI approval after the FDC issue broke out last year was permitted for manufacturing and marketing. The rest were withdrawn from the market voluntarily by the industry.
The meeting decided to examine the remaining 156 FDCs based on the scientific and the industry was asked to prepare the data to support its demand to manufacture and market these products.
Confederation of Indian Pharma Industries (CIPI) chairman TS Jaishankar said that the industry is making all efforts to prepare the data by the end of August and is looking for a review meeting with the DCGI in the last of week of August to decide on the remaining 156 combination drugs.
He said the pending FDC-related cases in the Madras High Court will be withdrawn by the CIPI only after a consensus is reached between the DCGI and the industry on all the contentious 294 combination drugs and the DCGI releases an official letter in this regard.