AYUSH Guidelines and Regulatory Pathways

India's AYUSH regulatory framework recognises several distinct categories of herbal product, each subject to a different approval pathway and evidentiary requirement. Classical ASU medicines — formulations documented in recognised classical texts and official formularies such as the Ayurvedic Pharmacopoeia of India or the Ayurvedic Formulary of India — require no separate new-drug approval, provided they are manufactured in strict compliance with the Schedule T Good Manufacturing Practice requirements described below and correctly labelled under Rule 161 of the Drugs and Cosmetics Rules. Patent or proprietary ASU medicines, comprising new combinations not present in an official formulary, require state licensing authority approval, supported by composition justification drawn from classical pharmacological principles and, where a safety concern is identified, supplementary clinical data. New phytopharmaceutical drugs — a distinct regulatory category introduced under India's New Drugs and Clinical Trials Rules, 2019 — require full CDSCO review under the New Phytopharmaceutical Clinical Drug (NPCD) pathway, encompassing preclinical safety data generated under OECD toxicology guidelines and Phase II/III clinical trial data, submitted in a Common Technical Document format directly analogous to that used for synthetic new drug applications. Herbal products marketed as nutraceuticals or health supplements without therapeutic claims instead fall under the Food Safety and Standards Authority of India's Nutraceutical Regulations, a materially less onerous pathway that explicitly excludes any therapeutic labelling claim.