Drugs and Clinical Trial (Amendment) Rules, 2023

Recently, the Union Government passed an amendment to the New Drugs and Clinical Trial Rules (2023).

  • The amendment authorises researchers to instead use non-animal and human-relevant methods, including technologies like 3D organoids, organs-on-chip, and advanced computational methods, to test the safety and efficacy of new drugs.

Drugs and Clinical Trials Rules, 2019

  • Aim: To promote clinical research in India and further the conduct of ethical and quality clinical trials in the country.
  • Clinical Trials: The rules reduced the time for approving applications to 30 days for drugs discovered in India or whose research and development has been done in India and are ....
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