A Comparative Study of Regulatory Requirements and Marketing Authorization of Herbal Medicines in INDIA, THE US, and EUROPE

Abstract

India’s formal oversight of herbal medicines is rooted in the Drugs & Cosmetics Act, 1940 (D&C Act) and rules, with dedicated provisions for Ayurveda, Siddha, and Unani (ASU) medicines. Schedule T (2000) codified GMP for ASU drugs, while Rule 158-B clarified evidence/experience requirements for ASU proprietary medicines. In 2015, the Government of India introduced phytopharmaceuticals via GSR 918(E), creating a modern “new drug” category (quality, nonclinical, clinical data assessed by CDSCO) distinct from classical ASU formulations. United States: In 1994, the Dietary Supplement Health and Education Act (DSHEA) established a distinct regulatory category for dietary supplements, under which most herbal products are marketed. Under DSHEA, FDA does not pre-approve supplements for safety/effectiveness; firms must follow labeling rules and are responsible for ensuring safety and quality. Manufacturing quality is governed by 21 CFR Part 111 (cGMP for dietary supplements), while structure/function claims require the 101.93 disclaimer and may not be disease claims. European Union: The EU established a harmonized framework under Directive 2001/83/EC (Community Code), later amended by Directive 2004/24/EC (the “Herbal Directive”) to create a simplified Traditional Herbal Medicinal Products (THMP) registration. THMP requires ≥30 years of medicinal use (including ≥15 years within the EU), evidence of safety and plausible efficacy, and is limited to non-injectable products intended for self-care; many dossiers rely on HMPC monographs and list entries. The study concludes that while regulatory divergence persists, convergence is both possible and desirable. The path forward lies in: Recognizing traditional knowledge alongside modern scientific evidence. Harmonizing GMP/GACP standards to secure global supply chains. Integrating PV systems into a shared platform. Leveraging digital innovations to streamline submissions and safety monitoring. In essence, a hybrid regulatory model combining cultural respect for traditional systems with modern scientific rigor represents the future of herbal medicine regulation worldwide.