目的 介绍印度传统医学药物警戒体系及其实施成效, 为完善我国中药药物警戒体系提供参考.方法 通过查阅国内外文献, 运用文献研究法进行分析, 梳理印度传统医学药物警戒体系与实践过程.结果 印度具有两套独立的药物警戒体系, 即西方现代药物警戒体系及传统医学药物警戒体系.印度传统医学药物警戒体系组织构架完善, 具有法律法规保障, 各相关方职责明确, 具有印度传统医学特色, 可合理有效地保障印度传统药物的安全合理应用.结论 我国可借鉴印度传统医学药物警戒体系, 提高我国中药安全监测能力.%Objective To introduce the pharmacovigilance system in India and its implementation effect, and provide reference for the improvement of Chinese medicine pharmacovigilance system. Methods Through consulting the literature at home and abroad and using the literature research method, analyze and combine the pharmacovigilance system and practice process in India. Results There were two independent pharmacovigilance systems in India: Western medicine and Indian traditional medicine. Pharmacovigilance system of Indian traditional medicine was well-organized with complete and standard legal documents, clear obligation, simplified and reasonable procedures and public information, which effectively guarantees the safety of drugs throughout the life cycle. Conclusion We should learn from the pharmacovigilance system of Indian traditional medicine to improve our ability to monitor Chinese medicine.
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