Regulatory Compliance & Herbal Drug Submission
Objectives
- Describe the AYUSH regulatory pathways applicable to classical, proprietary, and new phytopharmaceutical drugs in India.
- Explain the WHO herbal medicine guideline framework and its relationship to national regulation.
- Outline the CTD Module 3 documentation requirements for herbal drug substances and products.
- Distinguish Good Manufacturing Practice and Good Laboratory Practice as applied to herbal manufacture and testing.
- Explain the role of intellectual property protection, including patents and geographical indications, in phytopharmaceutical research.
- Identify career pathways available to phytopharmacy graduates and describe the future trajectory of the discipline.