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<p>Herbal medicine and phytopharmaceuticals are recognized and regulated differently across the world. In India, phytopharmaceuticals have appeared as a novel category of plant-based medicine. In accordance with regulatory requirements, phytopharmaceuticals are defined as “purified and standard fractions containing a minimum of four bioactive phytochemical compounds of an extract of a medicinal plant for therapeutic use.” Since the development of phytopharmaceuticals aligns with synthetic drugs, these drugs are well standardized and address the safety and consistent efficacy issues of herbal drugs. Given the scarcity of literature on the topic, a comprehensive review encompassing the various aspects of phytopharmaceutical development, current status, and future directions would be an invaluable resource for researchers worldwide. For this review, databases like SciFinder, PubMed, and Web of Science were thoroughly searched to retrieve published literature on the development and standardization of phytopharmaceuticals. The review provides a brief summary on global regulations and development of phytopharmaceuticals, the current status of drugs in clinical trials, and examples of phytopharmaceutical ingredients. There are enormous opportunities in phytopharmaceuticals due to the increasing demand for products that serve the dual purpose of therapeutic use and nutritional dietary supplementation. It is anticipated that phytopharmaceutical research will contribute significantly to the development of plant-based drugs, similar to the advancements seen in the modern medicines.</p> Graphical Abstract <p></p>

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Regulations, current development, and future prospects of phytopharmaceuticals, a new class of herbal medicines in India

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年5月13日

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  • Rohini Jadhav,
  • Joyeeta Das,
  • Soham Rajyaguru,
  • Sanjana Kyada,
  • Vaibhav Kale,
  • Parusu Kavya Teja,
  • Dechen Ongmu Bhutia,
  • Siddheshwar K Chauthe

摘要

Herbal medicine and phytopharmaceuticals are recognized and regulated differently across the world. In India, phytopharmaceuticals have appeared as a novel category of plant-based medicine. In accordance with regulatory requirements, phytopharmaceuticals are defined as “purified and standard fractions containing a minimum of four bioactive phytochemical compounds of an extract of a medicinal plant for therapeutic use.” Since the development of phytopharmaceuticals aligns with synthetic drugs, these drugs are well standardized and address the safety and consistent efficacy issues of herbal drugs. Given the scarcity of literature on the topic, a comprehensive review encompassing the various aspects of phytopharmaceutical development, current status, and future directions would be an invaluable resource for researchers worldwide. For this review, databases like SciFinder, PubMed, and Web of Science were thoroughly searched to retrieve published literature on the development and standardization of phytopharmaceuticals. The review provides a brief summary on global regulations and development of phytopharmaceuticals, the current status of drugs in clinical trials, and examples of phytopharmaceutical ingredients. There are enormous opportunities in phytopharmaceuticals due to the increasing demand for products that serve the dual purpose of therapeutic use and nutritional dietary supplementation. It is anticipated that phytopharmaceutical research will contribute significantly to the development of plant-based drugs, similar to the advancements seen in the modern medicines.

Graphical Abstract