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Adverse drug reaction (ADR) notification drop box: an easy way to report ADRs

机译:药品不良反应(ADR)通知下拉框:报告ADR的简便方法

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摘要

In India we have a large drug consuming population.There is a plethora of counterfeit and substandard drugs , drugs belonging to alternative systems of medicine like ayurveda, unani, siddha, homeopathy and drugs which have been banned/withdrawn in other countries . Because of these factors, it is all the more important that a system of adverse drug reaction (ADR) reporting is established. In addition, without a proper ADR database, it is difficult to withdraw harmful drugs from the market.The enormity of the problem of ADR reporting and poor post marketing surveillance by pharmaceutical companies in India is well documented . India rates below 1% in terms of ADR reporting against the world rate of 5% .This clearly shows that the concept is still in its infancy here. To overcome this, the Ministry of Health & Family Welfare has initiated the National Pharmacovigilance Programme (NPP) which is co-ordinated by the Central Drugs Standard Control Organisation (CDSCO) in New Delhi. Under this programme 24 peripheral, five regional and two zonal Pharmacovigilance Centres are asked to work cohesively to improve ADR reporting in India .
机译:在印度,我们有大量的毒品消费人群。有大量的假冒伪劣药品,属于替代医学体系的药物,如印度草医学,乌尼(uniani),悉达(siddha),顺势疗法以及在其他国家/地区已被禁止/撤回的药物。由于这些因素,建立药物不良反应(ADR)报告系统就显得尤为重要。此外,如果没有适当的ADR数据库,很难将有害药物从市场上撤回.ADR报告问题的严重性以及印度制药公司对上市后的监管不力已得到充分证明。印度的ADR报告率低于1%,而全球的ADR报告率则为5%。这清楚地表明,此概念仍处于起步阶段。为了克服这个问题,卫生与家庭福利部已启动了国家药物警戒计划(NPP),该计划由新德里的中央药物标准控制组织(CDSCO)负责协调。根据该计划,要求24个外围,五个区域和两个区域药物警戒中心紧密合作,以改善印度的ADR报告。

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