The Regulatory Landscape for Herbal Medicines

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. In India, Ayurvedic, Siddha, and Unani (ASU) drugs are governed by the Drugs and Cosmetics Act, 1940, and administered by the Ministry of AYUSH, while genuinely novel herbal products making specific therapeutic claims require an evidence-based regulatory dossier reviewed by India's Central Drugs Standard Control Organisation under a dedicated new-drug pathway. Internationally, herbal product submission follows World Health Organization guidance and, in specific jurisdictions, region-specific frameworks such as the European Medicines Agency's Committee on Herbal Medicinal Products (HMPC) or the United States FDA's botanical drug guidance, each of which formalises how traditional use evidence may be combined with modern safety and efficacy data to support regulatory approval.