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Pharmacovigilance plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effect in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reaction (ADR) can cause serious harm to patients. Today many pharmacovigilance centers are working for drug safety monitoring in this global pitch, however, at the turn of the millennium pharmacovigilance faces major challenges in aspect of better safety and monitoring of drug. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as premarketing including early stages of drug design, clinical trial, and post-marketing surveillance. Adverse events reported by PV system 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 electronically. Hence, PV helps to the patients get well and to manage optimally or ideally, avoid illness is a collective responsibility of industry, drug regulators, clinicians and other healthcare professionals to enhance their contribution to public health. This review summarized objectives and methodologies used in PV with critical overview of existing PV in India, challenges to overcome and future prospects with respect to Indian context.

In this review we will discuss about drug safety, worldwide pharmacovigilance centers and their role, benefits and challenges of pharmacovigilance and its future consideration in healthcare sectors. Hence, PV helps to the patients get well and to manage optimally or ideally, avoid illness is a collective responsibility of industry, drug regulators, clinicians and other healthcare professionals to enhance their contribution to public health. This review summarized objectives and methodologies used in PV with critical overview of existing PV in India, challenges to overcome and future prospects with respect to Indian context.

In this review we will discuss about drug safety, worldwide pharmacovigilance centers and their role, benefits and challenges of pharmacovigilance and its future consideration in healthcare

KEYWORDS: Adverse drug reaction; Clinical trials; Data mining; Indian Pharmacopoeia Commission; Pharmacogenomics; Pharmacovigilance (PV).