Recent Changes to Clinical Trial Regulation in India: Focus on Serious Adverse Events, Compensation and Registration of Ethics Committees
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The Central Drugs Standard Control Organization (CDSCO) in India has recently made an amendment to schedule Y of the Drug and Cosmetic Act after reports of irregularities were reported by media and non-governmental organizations (NGOs) in the conduct of clinical trials. The major concerns raised were related to the reporting of serious adverse events (SAEs), compensation to study participants in case of death or injury, and responsibilities of different stakeholders involved in the clinical trials. Another concern was to regularize the Ethics Committees and make them accountable for the clinical trials they approved. Considering all of the above points, three amendments in schedule Y have been introduced, namely Rule 122 DAB (GSR No. 53E), Rule 122 DAC (GSR No. 63E) [Rule 122 DAC, Permission to conduct clinical trials: http://www.cdsco.nic.in/GSR%2063(E)%20dated01%20.02.2013.pdf, 2013] and Rule 122 DD (GSR No. 72E). These amendments are a testimony to the fact that a subject’s rights are paramount in India, and all the stakeholders now have added responsibilities and accountability. This article summarizes the critical points in these amendments and highlights the challenges they pose for all stakeholders in complying with them. We have also tried to address the grey areas of these amendments, which are still unanswered, and we are hopeful to get further clarification from the Licensing Authority soon.
KeywordsExpert Committee Financial Compensation Independent Ethic Committee Investigational Product License Authority
Drs Karwa, Arora and Agrawal have no conflicts of interest that are relevant to the contents of this article and no financial compensation was received for the preparation of the manuscript.
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