Abstract

REGULATORY REQUIREMENTS FOR MANUFACTURING AND APPROVAL OF HERBAL PRODUCTS IN INDIA AND G-8 COUNTRIES

B. Ashwini*, M. V. Nagabhushanam, Adilakshmi Ch and M. Beena Devi

Abstract

The regulatory requirements for the manufacturing and approval of herbal products in India and G-8 countries emphasize ensuring product safety, efficacy, and quality through distinct frameworks. In India, herbal products are regulated under the AYUSH Ministry, adhering to traditional medicine systems like Ayurveda, Unani, and Siddha, with requirements for GMP compliance, quality standards, and preclinical studies. Conversely, G-8 countries, including the US, EU member states, and others, classify herbal products as dietary supplements, traditional medicines, or pharmaceuticals, each requiring adherence to stringent guidelines such as the FDA or EMA standards. These include GMP certification, scientific validation of claims, and toxicological studies. Despite differences, the global market for herbal products is growing, necessitating manufacturers to navigate regulatory complexities to meet international compliance standards.

Keywords: Herbal products, G-8 countries, Ayurveda, Unani, and Siddha