Opportunity and prospects of pharmacovigilance in India
10th Pharmacovigilance Congress
September 20-21, 2017 Charlotte, USA

Pavan Kumar Gautam

S N Medical College Agra, India

Scientific Tracks Abstracts: J Pharmacovigil

Abstract:

Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding, prevention, monitoring and discovery of interactions amongst drugs and their effects in human beings. A number of pharmaceutical and biotechnological medicines are designed to cure, prevent or treat the diseases; however, adverse drug reactions (ADRs) can impart serious implications to patient�??s health. 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. In current scenario PV is to link premarketing data with human safety information observed in the post-marketing phases. The PV system team collects valuable additional information, building up the scientific data contained in the original report and making it more informative. In Indian context, this necessitates paramount requirement for effective regulations of the drug approval process and conscious pre and post approval vigilance of the undesired effects. 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. Pharmacovigilance faces major challenges in aspect of better safety and monitoring of drugs, hundreds of PV centers are working for drug safety monitoring across India.

Biography :

Pavan Kumar Gautam is currently working as Professor and Head of Department of Pharmacy at S N Medical College Agra, India.