Kumar Pramod, Kaur Ismeet, Kalaiselvan Vivekanandan, Singh Abhishank
Indian Pharmacopoeia Commission, Ministry of Health and Family Welfare, Government of India Ghaziabad, Uttar Pradesh, India.
Indian J Anaesth. 2017 Jul;61(7):534-537. doi: 10.4103/ija.IJA_418_17.
Pharmacovigilance Programme of India (PvPI) was established to promote patient safety by the Ministry of Health and Family Welfare, Government of India in July 2010. It covers various medical hospitals/institutes and National Health Programmes across the country. India is coordinating with various national and international programmes to be a part of international drug monitoring and to monitor the risk-benefit profile of medicines. At present, India has contributed more than 200,000 adverse drug reactions (ADRs) to the database and can draw signals for regulatory decisions. To foster the culture of spontaneous reporting, India has launched paperless and simple modes of reporting ADRs such as Helpline and an Android application. This will help to create a national centre of excellence at par with global drug safety monitoring standards. With the increasing popularity of regional anaesthesia, adverse events may occur due to local anaesthetic drugs, techniques and adjuvants. Uncommon but clinically significant ADRs can be identified in a nationwide pharmacovigilance programme. Anaesthesiologists in India are encouraged to report local anaesthesia-related ADRs to the national pharmacovigilance database.
印度药物警戒计划（PvPI）于2010年7月由印度政府卫生与家庭福利部设立，旨在促进患者安全。它覆盖全国各类医疗医院/机构以及国家卫生计划。印度正与各种国家和国际计划进行协调，以成为国际药品监测的一部分，并监测药品的风险效益情况。目前，印度已向数据库提交了超过20万份药品不良反应（ADR）报告，并能够提取信号以供监管决策参考。为培养自发报告的文化，印度推出了无纸且简便的药品不良反应报告方式，如热线电话和一款安卓应用程序。这将有助于创建一个与全球药品安全监测标准相当的国家级卓越中心。随着区域麻醉的日益普及，局部麻醉药物、技术和佐剂可能会引发不良事件。在全国性的药物警戒计划中，可以识别出不常见但具有临床意义的药品不良反应。鼓励印度的麻醉医生向国家药物警戒数据库报告与局部麻醉相关的药品不良反应。
