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Past, Present and Future of Pharmacovigilance in India
| Content Provider | Semantic Scholar |
|---|---|
| Author | Kumar, Aswin |
| Copyright Year | 2011 |
| Abstract | While major advancements in the discipline of pharmacovigilance have taken place in the West, not much has been achieved in India. However, with more clinical trials and clinical research activity being conducted in India, there is an immense need to understand and implement pharmacovigilance. Pharmacovigilance is the pharmacological science relating to the detection, assessment, understanding and prevention of adverse effects, particularly long-term and shortterm adverse effects of medicines. As a means of pooling existing data on adverse drug reactions (ADRs), the World Health Organization (WHO) Programme for International Drug Monitoring was started in 1968. Currently, 86 countries participate in the programme, which is coordinated by WHO together with its collaborating centre in Uppsala, Sweden. The origin of pharmacovigilance in India goes back to 1986, when a formal ADR monitoring system consisting of 12 regional centers, each covering a population of 50 million, was proposed for India. The National Pharmacovigilance Program established in January 2005, was to be overseen by the National Pharmacovigilance Advisory Committee based in the Central Drugs Standard Control Organization (CDSCO), New Delhi. This article gives a systematic review of the pharmacovigilance in India from its origin to the current scenario and also discusses the various strategies and proposals to build, maintain and implement a robust pharmacovigilance system for India in the coming years. marketing surveillance studies have now been adapted by major pharmaceutical companies in order to identify the risks associated with the medicinal product and effectively manage the risks by applying robust risk management plans throughout the lifecycle of the product. Signal detection and risk management has added a new dimension to the field of pharmacovigilance and as an evolving discipline, it requires ongoing refinement in order to increase its applicability and value to public health. While major advancementsin the discipline of pharmacovigilance have taken place in the West, not much has been achieved in India. However, with more clinical trials and clinical research activity being conducted in India, there is an immense need to understand the importance of pharmacovigilance and how it impacts the lifecycle of the product. This will enable integration of good pharmacovigilance practice in the processes and procedures to help ensure regulatory compliance and enhance clinical trial safety and post-marketing |
| Starting Page | 55 |
| Ending Page | 55 |
| Page Count | 1 |
| File Format | PDF HTM / HTML |
| DOI | 10.4103/0975-8453.83440 |
| Volume Number | 2 |
| Alternate Webpage(s) | http://www.sysrevpharm.org/sites/default/files/2-8.pdf |
| Alternate Webpage(s) | https://doi.org/10.4103/0975-8453.83440 |
| Language | English |
| Access Restriction | Open |
| Content Type | Text |
| Resource Type | Article |
