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10. WHO & ICH guidelines
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.
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10. WHO & ICH guidelines
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- 6. ICH is the “InternationalCouncil for Harmonization of Technical Requirement for Pharmaceuticals for Human Use”
- 7. ROLE OF ICHGuidelines
- 8. ICH is non-Profitassociation 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 establishedin 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 ageneral 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 HERBALDRUGS Standardization & Quality Evaluation of Herbal drugs