The document discusses international guidelines for herbal drugs. The International Council for Harmonization (ICH) brings together regulatory bodies and the pharmaceutical industry to achieve greater harmonization of standards for safe, effective, and high-quality medicines worldwide. While ICH does not have separate guidelines for herbal drugs, development, testing, and clinical trials of herbal medicines follow ICH standards. The World Health Organization also provides information and guidelines regarding traditional and herbal medicines, as over 60% of the world's population uses some form of traditional medicine.

1. S.Selvadurai.,M.Pharm.,MBA.,
Associate Professor
Department of Pharmacognosy

4. QUALITY REFERES TO:

6. ICH is the
“International Council for
Harmonization of Technical
Requirement for Pharmaceuticals
for Human Use”

7. ROLE OF ICH Guidelines

8. ICH is non-Profit association started in 1990 to co-ordinate
regulatory bodies and Pharmaceutical Industry.
ICH brings together experts from all fields to discuss
scientific & technical aspects of drug registration
The mission behind ICH is to achieve greater harmonisation
worldwide for Safe, Effective & High quality medicines.
ICH brings uniformity throughout world & avoid confusion.
ICH does not give separate guidelines only for herbal drugs as such
Drug Development, Formulation, Analytical method development, Stability
testing, Clinical trials & other activity related to herbal dtugs are done
according to ICH guidelines.

10. It was established in 1948 for
international health matters & Public
Health
WHO has wide area & several functions
including provision of reliable
information & advice in the field of
Human health.
WHO deals with Diseases as well as
give guidelines for traditional & herbal
medicine.
According to WHO Survey, more than
60% of World population use one or
either form of traditional medicines.

11. • Gives a general IntroductionSection-I
• Discuss good agriculture practices for
medical plantsSection-II
Section – III
• Describes common technical aspects of good
agricultural practices for medical plants &
good collection practices for medicinal plants.
Section - IV
Section V
Discuss good collection practices for
medicinal plants
Considers other relevant issues

12. QUALITY EVALUATION OF
HERBAL DRUGS
Standardization & Quality Evaluation of Herbal drugs