Kalaiselvan Vivekanandan, Thota Prasad, Singh Gyanendra Nath
National Coordination Centre, Pharmacovigilance Programme of India, Pharmacopoeia Commission, Ministry of Health and Family Welfare, Ghaziabad, Uttar Pradesh, India.
Pharmacovigilance Programme of India, Pharmacopoeia Commission, Ministry of Health and Family Welfare, Ghaziabad, Uttar Pradesh, India.
Indian J Pharmacol. 2016 Nov-Dec;48(6):624-628. doi: 10.4103/0253-7613.194855.
Promoting safe use of medicines is a priority of Indian Pharmacopoeia Commission that functions as the National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI). One hundred and seventy-nine adverse drug reactions (ADRs) monitoring centers currently report ADRs to NCC. Current India contribution to global safety database reaches 3% and the completeness score is 0.93 out of 1. NCC is taking several measures to enhance patient safety including capacity building for monitoring, surveillance, collaboration with national health programs and other organizations to increase ADR reporting and to ensure that PvPI is a vital knowledge database for Indian regulators. The Central Drugs Standard Control Organization has notified important safety label changes on drugs such as carbamazepine and piperacillin + tazobactam in the year 2015, other drugs are under monitoring for regulatory interventions.
促进药品安全使用是印度药典委员会的一项优先任务，该委员会作为印度药物警戒计划（PvPI）的国家协调中心（NCC）发挥作用。目前，179个药品不良反应（ADR）监测中心向NCC报告药品不良反应。印度目前对全球安全数据库的贡献达到3%，完整性得分在满分1分中为0.93。NCC正在采取多项措施来提高患者安全性，包括监测能力建设、监督、与国家卫生计划及其他组织开展合作，以增加药品不良反应报告，并确保PvPI成为印度监管机构的重要知识数据库。中央药品标准控制组织在2015年已发布了关于卡马西平和哌拉西林+他唑巴坦等药物重要安全标签变更的通知，其他药物正在接受监测以便进行监管干预。
