DCGI tells unapproved FDC manufacturers to submit phase IV trial protocols

New Delhi: The pharmaceutical companies which are manufacturing the Fixed Dose Combinations (FDCs) without due approval from Drugs Controller General of India (DCGI)’s office have been now again asked to submit phase IV trial protocols of these combination drugs with main focus on safety of drugs.

Despite being asked to submit the same repeatedly, the companies have failed to submit the data so far. Earlier, the DCGI had issued notices on June 17, 2016, September 1, 2016 and March 1, 2017 asking for examination for safety and efficacy of FDCs licensed for manufacture for sale in the country without due approval from office of DCGI and to  submit phase IV trial protocol based on recommendations of Expert Committee on FDC.

Prior to that, on January 15, 2013, the DCGI had asked the manufacturers to prove the safety and efficacy of the FDCs approved before October 1, 2012 and made it clear that those FDCs approved by the State licencing authorities from October without the permission of the DCGI will be considered for ban.

The Committee opined that the FDCs for which the post marketing trials have been asked are those FDCs which appear to be rational, however safety in such FDCs is yet to be further ascertained.  Therefore the Committee recommended that the main focus and primary objective for conducting such trials in these FDCs could be safety and efficacy could be secondary objective. The study could be open label/double blind/comparative/single arm/crossover multi-centric trial depending upon the concerned FDC and its therapeutic indication and the number of subjects should be statistically significant.

The Committee further recommended that the scientific evaluation by validated parameters/methods should be included for assessing the safety and efficacy.   During the study, anticipated safety parameter should be defined clearly along with its monitoring mechanism.  The study sites should be geographically distributed.