DCGI asks FDC manufacturers with no approval to submit phase IV trial protocols to prove safety of drugs

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The Drugs Controller General of India (DCGI) has once again asked the pharmaceutical companies which are manufacturing the Fixed Dose Combinations (FDCs) without due approval from DCG1 office to submit phase IV trial protocols of these combination drugs with main focus on safety of drugs.

Earlier on January 15, 2013, taking a sterner view about the FDC issue, 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. As the companies failed to submit the data, the DCGI kept on extending the final date for submitting the same.

More recently, the DCGI 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.

As it has been observed that most of the companies are yet to submit phase IV trial protocols, the matter was once again taken up with the Expert Committee on FDC in order to facilitate the stakeholders for submission of these protocols.

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.

“It is therefore again requested that all the applicants who have not yet submitted post marketing phase IV trial protocols shall submit the same in line with Schedule Y of Drugs and Cosmetics Rules, 1945 taking into consideration all the points as mentioned above. This may be treated as regulatory reminder for further necessary action, the DCGI in his latest directive said.

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