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REVIEW ARTICLE
Year : 2018  |  Volume : 13  |  Issue : 1  |  Page : 51-55

Paradigm shift in clinical trial regulations in India


1 Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India
2 Department of Pediatrics, Medical College and Hospital, Kolkata, West Bengal, India

Correspondence Address:
Prof. Suparna Chatterjee
Department of Pharmacology, Institute of Postgraduate Medical Education and Research, 244 A. J. C. Bose Road, Kolkata - 700 020, West Bengal
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/injr.injr_110_17

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India has the potential to contribute meaningfully to global clinical drug development. A critical enabler to achieve this potential is a balanced, predictable, and scientifically robust regulation involving clinical studies. In the past few years, the country's regulatory milieu has witnessed a positive transformation to favour ethical conduct of clinical trials, while appropriately supporting patient safety. Numerous amendments to existing policies governing the conduct of clinical studies are predicted to bring a paradigm shift in the overall regulatory scenario. In such view, it is important for us as academicians, to be abreast of such changes. We, therefore, discuss major regulatory highlights involving clinical research in India.


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