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Perspect Clin Res. 2019 Jan-Mar;10(1):31-33. doi: 10.4103/picr.PICR_188_18.

Indian regulatory update April-October 2018.

Author information

1
Head Regulatory Affairs, Global Drug Development India, Novartis Healthcare Private Ltd., Mumbai, Maharashtra, India.
2
General Regulator Affairs Manager, Johnson and Johnson Private Limited, Mumbai, Maharashtra, India.

Abstract

This document provides updates in regulatory requirements regarding conduct of clinical trials in India.

KEYWORDS:

Central Drugs Standard Control Organization (CDSCO); D & C Rules; DCGI; Drugs Controller General of India; Drugs and Cosmetic Rules; gazettes; mendments; notice; order; regulations; revision; updates

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