New Drugs and Clinical Trials (Draft Amendment) Rules, 2022.


The Ministry of Health and Family Welfare on 22nd November 2022, notified the New Drugs and Clinical Trials (Draft Amendment) Rules, 2022 and has invited objections and suggestions from the public which shall be addressed to the Under Secretary (Drugs), Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan, New Delhi – 110011 or emailed at within fifteen days.

The amendment is brought under the first schedule which deals with General Principles and Practices for clinical trial in which sub-para 3(1) (b) has been substituted as follows:

The general requirements of non-clinical studies have been specified in the Second Schedule. The Non-Clinical testing methods to assess the safety and efficacy of a new drug or investigational new drug may include the following:

  • Cell-based assay;
  •  Organ chips and micro physiological systems;
  • Sophisticated computer modelling;
  • Other human biology-based test methods;
  • Animal studies.

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