Modern system of medicine is based on sound experimental data, toxicity studies and human clinical studies. But Pharmacopoeia standards on raw material / finished products are not available. The lack of quality standards has resulted in mild to serious adverse effects ranging from hepatotoxicity to death. Hence, herbal ingredients require tools for determining identity, purity and quality and tools must be technically sufficient, rapid, and cost effective with GMP requirements. World health organization has set specific guidelines for the assessment of safety, efficacy, and quality of herbal medicines. Standardization of herbal drug is not an easy task as numerous factors influence the bio efficacy, reproducible therapeutic effect. To obtain quality oriented herbal product care should be taken right from the proper identification of plants, season, area of collection, their extraction and purification and rationalizing the combination in case of polyherbal drugs. Hence standardization is a tool in the quality control process, which is very much need for the herbal drug industries at local, regional, and global level.

Goals and Objectives

This course is designed to provide foundation knowledge of standardization of herbal drugs. Upon completion of the course, it is expected that the students will be able to (know, do, and appreciate)

• Different methods of standardization of herbal drugs
• Stability assessment of herbal drugs
• Safety assessment and toxicological studies of herbal preparations
• ICH guidelines for standardization and quality control of herbal drugs