Indian Government Announces New Clinical Trials Rules; Emphasizing Patient Safety & Some Nationalism

Mar 26, 2019 | Clinical Trials, India, Regulations

clinical trial

India’s Economic Times reports  the Health Ministry notified New Drugs and Clinical Trials Rules, 2019 reducing the time for approving applications to 30 days for drugs manufactured in India and 90 days for those developed outside the country exhibiting a nationalist preference.  Moreover, the new rules purport “to ensure patient safety” tightening up informed consent requirements.  Follow the link to the article. For any organizations doing any business in India, this will ensure work with the counsel in India to understand the impact of the new rules.

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