Page 78 - NATIONAL INSTITUTES OF HEALTH (NIH) GUIDELINES FOR CONDUCTING RESEARCH IN MINISTRY OF HEALTH (MOH) INSTITUTIONS & FACILITIES 3RD EDITION 2021

13 Concomitant treatment(s) List the concomitant treatment(s)
C. DETAILS OF TEST ITEM
14 Details of test item
15 Data of test item
NRDHM HERBAL TEST ITEM FOR STUDIES Ver3.1 Mar2015
62 NIH Guidelines for Conducting Research in MOH, 2021
 Type of product (refer Attachment A)
 Ingredient(s)
o Single plant
o Combinations: name all ingredients
o Part(s) of plant(s) used
o Use of protected/ endangered species
 All reported claim(s)
 Intended use(s) for this study
 Type of preparation (Eg Fresh, Freeze dried,
Spray dried etc)
 Method of extraction (To name the method
used)
 Standardized extract (To name marker(s))
## Below are the minimal data required for all
test items including fresh product
 Summary of Product Characteristic
o (Invented) Name of medicinal product,
strength, pharmaceutical form. Eg: xx
10mg tablet.
o Description of pharmaceutical form
 Standardization of extract
 Analytical Method Validation
 Quality data: In-Process Quality Control (IPQC),
Finished Product Quality Control (FPQC)
 Stability data (Container closure system,
storage condition, proposed shelf-life)
## Below are the additional data for
manufactured test item
 Certificate of GMP
 Certificate of Analysis
 Description of Pharmaceutical Development
 Protocol of Analysis
 Standard labelling requirements
 Bioavailability/ bioequivalent study
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