Standardization & Quality Control

WHO and Pharmacopoeial Standards for Herbal Quality

Ultrasound-assisted extraction (UAE): principle, workflow, key parameters, advantages, suitability, and comparison with maceration
Figure. WHO and Pharmacopoeial Standards for Herbal Quality

A defined hierarchy of pharmacopoeial and WHO technical documents provides the internationally recognised reference standards against which herbal drug quality is assessed. The Indian Pharmacopoeia provides official, legally binding monographs for a substantial number of Ayurvedic, Unani, and Siddha raw materials and formulations, specifying identity, purity, and assay requirements directly enforceable under Indian drug law. The WHO Monographs on Selected Medicinal Plants, published across four volumes, provide internationally harmonised reference monographs covering botanical description, authentication criteria, chemical constituents, pharmacology, and safety data for a substantial catalogue of globally significant medicinal plants. The WHO Technical Report Series, including TRS 863 addressing quality control methods for herbal materials and TRS 929 addressing methodology for selecting traditional medicines for clinical research, provides the underlying technical guidance from which many national pharmacopoeial requirements, including those of the Indian Pharmacopoeia, are ultimately derived. Together, these documents establish the reference framework that harmonises herbal quality expectations across national regulatory systems and facilitates international trade and mutual recognition of herbal drug quality data.