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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.

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


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


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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