Unravelling framework for herbal product manufacturing and approval in south India

A. Rajini, D. Jothieswari, S. R. N, N. A. Narayana
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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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印度南部草药产品生产和审批框架的探索
本研究调查了南印度生产和批准草药产品的监管框架,该地区对天然疗法的全球需求日益增长。研究重点在于了解对行业利益相关者和监管机构至关重要的具体准则和流程。研究强调了南印度监管环境的独特之处,包括植物药的真实性、安全性评估、标签要求以及传统知识的保护。目的是帮助制造商、监管机构和政策制定者确保草药产品的质量、安全性和有效性。在方法上,该研究依赖于文件分析、专家访谈和已批准草药产品的案例研究。研究结果旨在丰富对草药产品监管的理解,促进该领域的可持续发展和贸易。这项研究对于草药产品行业的专业人士、研究人员和政策制定者来说是一笔宝贵的财富。关键词草药产品、监管框架、南印度、传统知识、安全评估、真实性。(160 个字)。
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