Herbal medicines occupy a distinctive regulatory space, governed by frameworks that are conceptually and legally separate from those applied to synthetic pharmaceutical drugs, reflecting both their traditional-use heritage and the practical reality that a whole-plant extract cannot always be regulated using the single-molecule paradigm developed for synthetic chemistry. This concluding phase examines the AYUSH and WHO regulatory pathways applicable to herbal drugs, the Good Manufacturing and Good Laboratory Practice frameworks governing their manufacture and testing, the CTD documentation required for submission, and the intellectual property and career landscape of the discipline.
The regulatory pathways, quality frameworks, and documentation requirements that govern herbal drug submission, together with intellectual property considerations and career opportunities in the field.
