印度药物警戒系统概述

Overview of Pharmacovigilance Systems in India

印度是世界上第4大药品市场,近年来印度不断借鉴西方先进的监管经验,改善其药品监管环境,药物警戒系统也逐渐受到印度政府的重视。本文从机构设置及职责、不良反应报告体系等方面对印度药物警戒法规进行简要介绍,提出建立药物警戒体系的重要性及相关措施。

India is the world＇s fourth largest pharmaceutical market, and it has been continuing to learn advanced supervisory experience from western countries in recent years to improve its drug regulatory environment, thus pharm- acovigilance system is gradually catching Indian government＇s attention. In this paper, institutions and its responsibilities, adverse reactions reporting system and other aspects of pharmacovigilance laws and regulations in India are briefly introduced, propose the importance of the establishment of pharmacovigilance system and some relevant measures.