Abstract

This study investigates the regulatory framework for manufacturing and approving herbal products in South India, a region with increasing global demand for natural remedies. It focuses on understanding the specific guidelines and processes crucial for industry stakeholders and regulatory authorities. The research highlights the unique aspects of the South Indian regulatory environment, including botanical authenticity, safety assessments, labeling requirements, and the protection of traditional knowledge. The aim is to assist manufacturers, regulators, and policymakers in ensuring the quality, safety, and efficacy of herbal products. Methodologically, the study relies on document analysis, expert interviews, and case studies of approved herbal products. Its findings aim to enrich the understanding of herbal product regulation, promoting sustainable development and trade in this field. This research is a valuable asset for industry professionals, researchers, and policymakers in the herbal products sector. Keywords: Herbal products, regulatory framework, South India, traditional knowledge, safety assessments, authenticity. (160 words).

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