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REVIEW ARTICLE
Year : 2016  |  Volume : 7  |  Issue : 3  |  Page : 111-114

Reporting of adverse events for marketed drugs: Need for strengthening safety database


Department of Pediatric Research, KEM Hospital Research Centre, Pune, Maharashtra, India

Correspondence Address:
Aditi Anand Apte
Department of Pediatric Research, KEM Hospital Research Centre, Rasta Peth, Pune - 411 011, Maharashtra
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/2229-3485.184781

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Pharmacovigilance is an evolving discipline in the Indian context. However, there is limited regulatory guidance for adverse event reporting outside the purview of clinical trials. There are number of deficiencies in the framework for adverse event reporting from the perspective of pharma industry, health-care professional and general public due to which adverse events for marketed drugs are highly underreported. This article discusses the need to strengthen national safety database by promoting and mandating reporting of adverse events by all the stakeholders.


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