An increase in the health consciousness and to improve quality of life in recent years with some early drug recalls from marketed raising issues by regulatory authorities. The need of an hour insists to establish a grating of legal and humane aspects based Pharmacovigilance (PV) system. Adverse Drug Reactions (ADR) to be the 4th-6th largest cause of death in the USA and are estimated to cause 3-7% of all hospital admissions. PV is a continuous and ongoing process which allows assessing the safety of medicinal product through its life cycle. PV collects, records, codes Adverse Drug Events (ADEs)/ADRs analyses and assesses the reports, promotes the safe use of drugs, creates appropriate structures, and means of communication needed to perform its tasks. The PV in India is a need of an hour because, of increasing trend of outsourced clinical trials and new researches going on in clinical field. India joined the World Health Organization (WHO) Adverse Drug Reaction Monitoring Program based in Uppsala, Sweden. The National Pharmacovigilance Program established in January 2005, was to be overseen by the National Pharmacovigilance Advisory Committee (NPAC) based in the Central Drugs Standard Control Organization (CDSCO), New Delhi was to collate information from all over the country and send it to the Uppsala Monitoring centre in Sweden.
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