10. WHO & ICH guidelines

AS per PCI Syllabus

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 dtugsare done
according to ICH guidelines.

10. Itwasestablishedin1948for
internationalhealthmatters&Public
Health
WHOhaswidearea&severalfunctions
includingprovisionofreliable
information&adviceinthefieldof
Humanhealth.
WHOdealswithDiseasesaswellas
giveguidelinesfortraditional&herbal
medicine.
AccordingtoWHOSurvey,morethan
60%ofWorldpopulationuseoneor
eitherformoftraditionalmedicines.

11. •Gives a general IntroductionSection-I
•Discussgoodagriculturepracticesfor
medicalplantsSection-II
Section –III
•Describescommontechnicalaspectsofgood
agriculturalpracticesformedicalplants&
goodcollectionpracticesformedicinalplants.
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