Page 79 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

D.EFFICACY CLAIMS SUBSTANTIATION
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16 Efficacy Claim with Traditional Sources of information (refer Attachment B)
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Knowledge ## The references could be any of the following:

1. Standard reference (Reference textbooks,
pharmacopoeia, monographs)
2. Recommendations on usage from
reference regulatory authorities or
reference organizations
3. Good quality scientific evidence from
human observational studies: Case report
/ studies / series
4. Report prepared by expert
committees/expert opinion (subject to
Authority approval)
5. Published scientific reviews and meta-
analysis
6. Documented/reported negative marker
(e.g. Traditionally used for abortion) or
adverse events
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y
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17 Efficacy claim with Pharmacological Primary pharmacodynamics. Study primary mode
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a

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studies (Preclinical studies) of action related to therapeutic activity – In vitro
and in vivo
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p
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)
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P
-
G
( (OECD-GLP Compliance) (Note:: All S Secondary p pharmacodynamics. Study the
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y
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a
non-clinical should be conducted in
OECD/GLP compliance laboratory. additional mode of action of compound.
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p
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x
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y
:
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k
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This requirement will be mandatory T Toxicokinetic and pharmacokinetic study:
in the very near future) i. Metabolic and plasma protein binding
data
ii. ADME
iii. Biochemical drug interaction
iv. Nonclinical characterization of human
metabolite(s)
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.

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S Safety pharmacology. Assessment on core battery
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(Central Nervous System, Respiratory system,
Cardiovascular System)

E. SAFETY DATA
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18 Safety Data Based On Toxicology G Genotoxicity
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Study 1. In vitro test
(OECD-GLP Compliance) i. Ames test / Bacteria reverse mutation
(Note: : All non-clinical should be assay

conducted in OECD/GLP compliance
laboratory. This requirement will be ii. Metaphase chromosome aberration
mandatory in the very near future) assay
iii. Mouse lymphoma L5178Y cell thymidine
kinase gene mutation assay (MLA)
NRDHM HERBAL TEST ITEM FOR STUDIES Ver3.1 Mar2015 3

NIH Guidelines for Conducting Research in MOH, 2021 63