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:
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Previous |
Now |
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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:
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