Govt to add non clinical tests to assess efficacy, safety of new drug

New Delhi: Through a recent notification, the Ministry of Health and Family Welfare, Government of India has issued a draft of certain rules suggesting to include the non-clinical testing methods to assess the safety and efficacy of a new drug or investigational new drug.
The non-clinical testing techniques specified in the draft to assess the efficacy and safety of a new drug or investigational new drug include animal studies, organ chips, micro physiological systems, advanced computer modelling, and cell-based assays.
The New Drugs and Clinical Trials Rules, 2019, First Schedule, paragraph 3, subparagraph (1), clause (b) states, "The detailed requirements of non-clinical studies have been specified in the Second Schedule."
However, in the draft rules, the Ministry has proposed to add the non-clinical testing methods to assess the safety and efficacy of a new drug or investigational new drug in the New Drugs and Clinical Trials Rules, 2019, in First Schedule, in paragraph 3, in subparagraph (1), clause (b).
1. (1) These rules may be called the New Drugs and Clinical Trials (....Amendment) Rules, 2022.
(2) They shall come into force on the date of their final publication in the Official Gazette.
2. In the New Drugs and Clinical Trials Rules, 2019, in First Schedule, in paragraph 3, in subparagraph (1), clause (b) shall be substituted with the following, namely:—
"(b) 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:
(i) Cell-based assay;
(ii) Organ chips and micro physiological systems;
(iii) Sophisticated computer modeling;
(iv) Other human biology-based test methods;
(v) Animal studies.".
To view the Gazette Notification, click on the below link:
https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=OTI4Nw==
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