Regulatory developments in the conduct of clinical trials in India

There has been a drop in clinical research in India following stringent conditions put in place by the Indian Supreme Court in 2013. The Court's orders came in the wake of irregularities highlighted in the conduct of clinical trials in the country. This paper highlights the steps taken by the I...

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Published inGlobal health, epidemiology and genomics Vol. 1; p. e4
Main Authors Roy Chaudhury, R., Mehta, D.
Format Journal Article
LanguageEnglish
Published Cambridge, UK Cambridge University Press 01.01.2016
Subjects
Perspective
Policy and Society
Central drugs standard control organisation
clinical trials
Indian regulatory framework
confidence-building measures
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Abstract There has been a drop in clinical research in India following stringent conditions put in place by the Indian Supreme Court in 2013. The Court's orders came in the wake of irregularities highlighted in the conduct of clinical trials in the country. This paper highlights the steps taken by the Indian regulator, the Central Drugs Standard Control Organisation to comply with these directions. These are of three kinds: strengthening regulatory institutions, protecting participant safety and creating regulatory certainty for sponsors and investigators. Examples include the large-scale training of Ethics Committees, framing detailed guidelines on compensation and audiovisual recording of the informed consent process, as well as reducing the time taken to process applications. It is expected that these measures will inspire confidence for the much-needed resumption of clinical research.
AbstractList There has been a drop in clinical research in India following stringent conditions put in place by the Indian Supreme Court in 2013. The Court's orders came in the wake of irregularities highlighted in the conduct of clinical trials in the country. This paper highlights the steps taken by the Indian regulator, the Central Drugs Standard Control Organisation to comply with these directions. These are of three kinds: strengthening regulatory institutions, protecting participant safety and creating regulatory certainty for sponsors and investigators. Examples include the large-scale training of Ethics Committees, framing detailed guidelines on compensation and audiovisual recording of the informed consent process, as well as reducing the time taken to process applications. It is expected that these measures will inspire confidence for the much-needed resumption of clinical research.
ArticleNumber e4
Author Roy Chaudhury, R.
Mehta, D.
AuthorAffiliation 2 Health and Environmental Law , Vidhi Centre for Legal Policy , New Delhi , India
1 Task Force for Research , Apollo Hospitals Educational and Research Foundation (AHERF) , New Delhi , India
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Keywords Central drugs standard control organisation
clinical trials
Indian regulatory framework
confidence-building measures
Language English
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