title: Pharmacovigilance Programme of India: Recent developments and future perspectives.
abstract: Promoting safe use of medicines is a priority of Indian Pharmacopoeia Commission that functions as the National Coordination Center (NCC) for Pharmacovigilance Programme of India (PvPI). One hundred and seventy-nine adverse drug reactions (ADRs) monitoring centers currently report ADRs to NCC. Current India contribution to global safety database reaches 3% and the completeness score is 0.93 out of 1. NCC is taking several measures to enhance patient safety including capacity building for monitoring, surveillance, collaboration with national health programs and other organizations to increase ADR reporting and to ensure that PvPI is a vital knowledge database for Indian regulators. The Central Drugs Standard Control Organization has notified important safety label changes on drugs such as carbamazepine and piperacillin + tazobactam in the year 2015, other drugs are under monitoring for regulatory interventions.
authors.affiliation: National Coordination Centre, Pharmacovigilance Programme of India, Pharmacopoeia Commission, Ministry of Health and Family Welfare, Ghaziabad, Uttar Pradesh, India.
authors.forename: Vivekanandan
authors.initials: V
authors.lastname: Kalaiselvan
authors.affiliation: National Coordination Centre, Pharmacovigilance Programme of India, Pharmacopoeia Commission, Ministry of Health and Family Welfare, Ghaziabad, Uttar Pradesh, India.
authors.forename: Prasad
authors.initials: P
authors.lastname: Thota
authors.affiliation: Pharmacovigilance Programme of India, Pharmacopoeia Commission, Ministry of Health and Family Welfare, Ghaziabad, Uttar Pradesh, India.
authors.forename: Gyanendra Nath
authors.initials: GN
authors.lastname: Singh
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards / Q000639:trends*; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000517:prevention & control*; D005544:Forecasting; D006801:Humans; D007194:India / Q000453:epidemiology; D060735:Pharmacovigilance
keywords: Adverse drug reaction reporting; Pharmacovigilance Programme of India; patient safety