Open AccessReporting of adverse events for marketed drugs: Need for strengthening safety database
Author(s) -
Aditi Apte
Publication year - 2016
Publication title -
perspectives in clinical research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.649
H-Index - 8
eISSN - 2229-5488
pISSN - 2229-3485
DOI - 10.4103/2229-3485.184781
Subject(s) - pharmacovigilance , context (archaeology) , adverse effect , adverse event reporting system , medicine , perspective (graphical) , adverse drug event , clinical trial , patient safety , business , medical emergency , health care , pharmacology , political science , computer science , geography , archaeology , pathology , artificial intelligence , law
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.