REGULATORY GUIDELINES FOR ENSURING QUALITY AND SAFETY OF HERBAL FORMULATIONS: A NARRATIVE REVIEW
Dawan Kumar1, Uma1, Mohit Mangla2
1Research Scholar, 2Associate Professor
Department of Pharmacy, SOMAS, GD Goenka University, Gurugram, India
ABSTRACT: Herbal formulations constitute a major component of traditional and complementary healthcare systems worldwide and are increasingly integrated into modern therapeutic practice. Despite their extensive use, the intrinsic complexity and variability of herbal medicines pose significant challenges in ensuring consistent quality, safety, and efficacy. Unlike synthetic pharmaceuticals, herbal formulations are multi-component systems influenced by botanical source, geographical origin, cultivation conditions, harvesting practices, processing methods, and storage. These factors necessitate robust and scientifically sound standardization strategies supported by regulatory oversight. International and national regulatory bodies, including the World Health Organization (WHO), International Council for Harmonisation (ICH), United States Food and Drug Administration (FDA), India’s Central Drugs Standard Control Organization (CDSCO) & AYUSH System, have developed guidelines addressing various dimensions of herbal medicine regulation. Although these frameworks differ in scope, legal enforceability, and regulatory philosophy, they collectively establish a comprehensive quality assurance system for herbal formulations. This review critically examines and compares the WHO, ICH, FDA, and CDSCO/ AYUSH guidelines with respect to raw material control, manufacturing practices, analytical standardization, stability assessment, safety evaluation, and post-marketing surveillance. Emphasis is placed on the harmonization potential of these regulatory approaches and their implications for global acceptance of herbal medicines. The review also highlights existing regulatory gaps and future perspectives for strengthening evidence-based herbal drug development.
KEYWORDS: Herbal formulations, Regulatory guidelines, WHO, ICH, FDA, CDSCO, AYUSH
VOLUME 10 ISSUE 07 2026: 391 – 402