Draft New Drugs & Clinical Trials Rules, 2018 were published on 01-02-2018 inviting public/stakeholder comments. In the light of certain provisions of the said draft Rules, WHO expressed apprehension that there was a possibility that sponsors may not conduct clinical trials in India.

Subsequent to the deliberations and meetings on the Draft Rules, the New Drugs and Clinical Trial Rules, 2019 were notified on 19-03-2019.

The Minister of State (Health and Family Welfare), Shri Ashwini Kumar Choubey stated this in a written reply in the Rajya Sabha here today.

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MV/LK