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Industry specific-Medical Central Ministry of Health & Family Welfare Drugs and Cosmetics Act, 1940

MOHFW revises Development Methodology vide New Drugs and Clinical Trials (Amendment) Rules, 2023

09-Mar-2023 | G.S.R. 175(E)

The Department of Health and Family Welfare has notified the New Drugs and Clinical Trials (Amendment) Rules, 2023 to amend the New Drugs and Clinical Trial Rules, 2019, with the effect from 9th March, 2023. The highlight of the amendment is under first schedule, Para 3(1)(b) relating to Development Methodology has been revised: 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. i. Cell based assay ii. Organ chips and micro physiological systems iii. Sophisticated computer modelling iv. Other human biology-based test methods v. Animal studies Previously it was the detailed requirements of non-clinical studies have been specified in the Second schedule.

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