BP 806 ET. QUALITY CONTROL AND STANDARDIZATION OF HERBALS (Theory)
Scope: In this subject the student learns about the various methods and guidelines for evaluation and standardization of herbs and herbal drugs. The subject also provides an opportunity for the student to learn cGMP, GAP and GLP in traditional system of medicines.
Objectives: Upon completion of the subject student shall be able to;
1. know WHO guidelines for quality control of herbal drugs
2. know Quality assurance in herbal drug industry
3. know the regulatory approval process and their registration in Indian and international markets
4. appreciate EU and ICH guidelines for quality control of herbal drugs
Unit I
Basic tests for drugs – Pharmaceutical substances, Medicinal plants materials and dosage forms
WHO guidelines for quality control of herbal drugs.
Evaluation of commercial crude drugs intended for use
Unit II
Quality assurance in herbal drug industry of cGMP, GAP, GMP and GLP in traditional system of medicine.
WHO Guidelines on current good manufacturing Practices (cGMP) for Herbal Medicines
WHO Guidelines on GACP for Medicinal Plants.
Unit III
EU and ICH guidelines for quality control of herbal drugs.
Research Guidelines for Evaluating the Safety and Efficacy of Herbal Medicines
Unit IV
Stability testing of herbal medicines.Application of various chromatographic techniques in standardization of herbal products.
Preparation of documents for new drug application and export registration
GMP requirements and Drugs & Cosmetics Act provisions.
Unit V
Regulatory requirements for herbal medicines.
WHO guidelines on safety monitoring of herbal medicines in pharmacovigilance systems
Comparison of various Herbal Pharmacopoeias.
Role of chemical and biological markers in standardization of herbal products.
Recommended Books: (Latest Editions
1. Pharmacognosy by Trease and Evans
2. Pharmacognosy by Kokate, Purohit and Gokhale
3. Rangari, V.D., Text book of Pharmacognosy and Phytochemistry Vol. I , Carrier
Pub., 2006.
4. Aggrawal, S.S., Herbal Drug Technology. Universities Press, 2002.
5. EMEA. Guidelines on Quality of Herbal Medicinal Products/Traditional Medicinal
Products,
6. Mukherjee, P.W. Quality Control of Herbal Drugs: An Approach to Evaluation of
Botanicals. Business Horizons Publishers, New Delhi, India, 2002.
7. Shinde M.V., Dhalwal K., Potdar K., Mahadik K. Application of quality control
principles to herbal drugs. International Journal of Phytomedicine 1(2009); p. 4-8.
8. WHO. Quality Control Methods for Medicinal Plant Materials, World Health
Organization, Geneva, 1998. WHO. Guidelines for the Appropriate Use of Herbal
Medicines. WHO Regional Publications, Western Pacific Series No 3, WHO
Regional office for the Western Pacific, Manila, 1998.
9. WHO. The International Pharmacopeia, Vol. 2: Quality Specifications, 3rd edn.
World Health Organization, Geneva, 1981.
10. WHO. Quality Control Methods for Medicinal Plant Materials. World Health
Organization, Geneva, 1999.
11. WHO. WHO Global Atlas of Traditional, Complementary and Alternative
Medicine. 2 vol. set. Vol. 1 contains text and Vol. 2, maps. World Health
Organization, Geneva, 2005.
12. WHO. Guidelines on Good Agricultural and Collection Practices (GACP) for
Medicinal Plants. World Health Organization, Geneva, 2004.
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