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Submitted by PatientsEngage on 26 March 2019

The Ministry of Health & Family Welfare, Govt of India had notified the New Drugs and Clinical Trials Rules, 2019. These new rules will now apply to clinical research (drugs/vaccines etc) conducted in the country (both in industry and the academic space). These rules apply from 19th March 2019 (the date of the publication of the gazette notification) except chapter IV which will apply from 19th September 2019.  The new rules can be downloaded from 

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/…

Gazette Notifications are here https://cdsco.gov.in/opencms/opencms/en/Notifications/Gazette-Notificat…

 

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