title: Role of Pharmacovigilance in India: An overview.
abstract: Pharmacovigilance (PV) plays a key role in the healthcare system through assessment, monitoring and discovery of interactions amongst drugs and their effects in human. Pharmaceutical and biotechnological medicines are designed to cure, prevent or treat diseases; however, there are also risks particularly adverse drug reactions (ADRs) can cause serious harm to patients. Thus, for safety medication ADRs monitoring required for each medicine throughout its life cycle, during development of drug such as pre-marketing including early stages of drug design, clinical trials, and post-marketing surveillance. PV is concerns with the detection, assessment, understanding and prevention of ADRs. Pharmacogenetics and pharmacogenomics are an indispensable part of the clinical research. Variation in the human genome is a cause of variable response to drugs and susceptibility to diseases are determined, which is important for early drug discovery to PV. Moreover, PV has traditionally involved in mining spontaneous reports submitted to national surveillance systems. The research 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 forums. The emerging trend in PV is to link premarketing data with human safety information observed in the post-marketing phase. The PV system team obtains valuable additional information, building up the scientific data contained in the original report and making it more informative. This necessitates an utmost requirement for effective regulations of the drug approval process and conscious pre and post approval vigilance of the undesired effects, especially in India. 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.
authors.affiliation: Department of Biotechnology, Priyadarshini Institute of Engineering and Technology, Nagpur-440 019, India.
authors.forename: Sanvidhan G
authors.initials: SG
authors.lastname: Suke
authors.affiliation: Division of Pharmacovigilance, Accenture Services Pvt. Ltd. Bannerghatta main Road, Bangalore- 560 076, India .
authors.forename: Prabhat
authors.initials: P
authors.lastname: Kosta
authors.affiliation: Clinical Research & Medical Services, Fresenius Kabi Oncology Ltd, Gurgaon- 122 001, India.
authors.forename: Harsh
authors.initials: H
authors.lastname: Negi
keywords: Adverse drug reaction; Clinical trials; Data mining; Indian Pharmacopoeia Commission; Pharmacogenomics; Pharmacovigilance