title: Reporting of adverse events for marketed drugs: Need for strengthening safety database.
abstract: 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.
authors.affiliation: Department of Pediatric Research, KEM Hospital Research Centre, Pune, Maharashtra, India.
authors.forename: Aditi Anand
authors.initials: AA
authors.lastname: Apte
keywords: Adverse events; marketed drugs; pharmacovigilance