Abstract

REGULATORY PERSPECTIVE OF HERBAL MEDICINAL PRODUCTS

Deepak Kumar Vishwakarma* and Awan Kumar Pandey

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Abstract

Herbal medicinal products (HMPs) have received international acclaim based on their therapeutic value, natural origin, and long history in traditional medicine. Their regulation, however, is still complicated because of differences in quality, safety, and efficacy standards among countries. This paper offers an overview of the regulatory landscape of HMPs, with a focus on the main challenges and harmonization. It reviews regulations from prominent agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and World Health Organization (WHO), highlighting differences in classification, registration needs, and quality control processes. The importance of pharmacovigilance, Good Manufacturing Practices (GMP), and scientific verification in maintaining the safety and efficacy of HMPs is also discussed. The research identifies the necessity for a harmonized regulatory system throughout the world that will enable world trade, prevent harm to the consumer, and support evidence-based integration of the herbal medicine system into contemporary medical systems. The regulatory view of herbal medicinal products is multifaceted and differs from one region to another. Within the European Union, the Committee on Herbal Medicinal Products (HMPC) provides scientific opinions on herbal substances and herbal preparations as a definite point of reference for companies and national competent authorities.[1] Three main regulatory routes exist for placing a herbal medicinal product on the EU Market: traditional use registration, well-established use marketing authorization and full marketing authorization.[2] Each route entails its own requirements, such as safety and efficacy data, quality control, and labeling and packaging regulations. In the United States, the FDA oversees herbal medicinal products as dietary supplements, which are less stringently regulated than pharmaceutical medications.[3] Herbal medicinal products do, however, have to abide by good manufacturing practices (GMPs) and labeling requirements. In India, the legal regime for herbal drugs is ruled by the Drugs and Cosmetics Act, 1940, and Rules framed under it.[4] The Act mandates that herbal drugs be produced and marketed as per good manufacturing practices (GMPs) and labeling regulations. Generally, the regulatory approach to herbal medicinal products is complicated and diverse in different parts of the world. Manufacturers and marketers of herbal medicinal products should know the regulatory needs of their region and meet them to maintain the safety and efficacy of their products.

Keywords: Herbal medicinal products, regulation, quality control, pharmacovigilance, global harmonization, safety, efficacy, FDA, EMA, WHO.