Ministry of Health and Family Welfare

On 13-3-2023, the Ministry of Health and Family Welfare notified the New Drugs and Clinical Trials (Amendment) Rules, 2023 to amend the New Drugs and Clinical Trials Rules, 2019. The provisions came into force on 13-3-2023.

First Schedule, Para 3 (1) (b) relating to Development Methodology has been revised:

Previous

Now

The detailed requirements of non-clinical studies have been specified in the Second Schedule.

The general requirements of non- clinical studies are specified in the Second Schedule.

The following testing methods to assess the safety and efficacy of a new drug or investigational new drug now includes the following:

  1. Cell- based assay

  2. Organ chips and micro physiological systems

  3. Sophisticated computer modeling

  4. Other human biology-based test methods

  5. Animal Studies

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