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In India, all medicines are having a trade-off between the benefits and the potential for harm. Pharmacovigilance is a formal adverse drug reaction (ADR) monitoring system and case study reporting program, under the supervision of the drug controller of India. In 1998. India was joined the World Health Organization (WHO) program for International Drug Monitoring which was not successful. In 2005, India launched the Nation Programme of Pharmacovigilance which was renamed in 2010 as the Pharmacovigilance Programme pf India(PVPI). Pharmacovigilance plays important role in detection, assessment, understanding and prevention of ADRs. In Pharmacovigilance, Adverse events reported for potentially benefit to the community due to their proximity to both population and public health practitioners, in terms of language and knowledge, enables easy contact with reporters by for example by telephone, Email, text massages by mobile phones. PV helps to the patients to manage optimally, avoid illness is a collective responsibility of industry, drug regulators, clinicians and other healthcare professionals to enhance their contribution to public health. Traditionally, PV involved in mining spontaneous reports submitted to national surveillance systems but recently focus is shifting toward the use of data generated from platforms outside the conventional framework such as electronic medical records, biomedical literature, and patient-reported data in health forms. This review summarized objectives and methodologies used in Pharmacovigilance.

KEY WORDS: Pharmacovigilance, Adverse drug reactions, Clinical trials, PVPI, Case study report, etc.