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Year : 2017  |  Volume : 8  |  Issue : 1  |  Page : 11-16

Regulatory environment for clinical research: Recent past and expected future

1 Department of Regulatory Affairs, Global Drug Development , Mumbai, India
2 Department of Medical, Novartis Limited, Mumbai, Maharashtra, India

Correspondence Address:
Amita Bhave
Novartis India Limited, Sandoz House, 5th Floor, Shivsagar Estate, Dr. Annie Besant Road, Worli, Mumbai - 400 018, Maharashtra
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Source of Support: None, Conflict of Interest: None

DOI: 10.4103/2229-3485.198551

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In the past few years, there have been numerous updates to policy and guidelines governing the conduct of clinical research in India. These measures were taken by regulators considering safety of Indian patients as the topmost priority although the overall regulatory environment became challenging. However, in the recent past, Indian regulations have evolved positively to favorably support clinical research in India while appropriately balancing patient safety as well. These regulatory changes are expected to bring newer innovative medicines to Indian patients at an earliest.

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