Setting up haemovigilance from the very first step. The Indian perspective

Abstract

Background and ObjectivesSetting up a national haemovigilance programme requires meticulous planning, and the following issues need to be addressed: whether reporting will be voluntary or mandatory, what is to be reported and by whom, reporting formats and resources to sustain the programme. With this in view, it was aimed to set up a national haemovigilance programme in India.Materials and MethodsThe Ministry of Health and Family Welfare, Govt. of India had launched the national Pharmacovigilance Programme (PvPI) in July 2010, with oversight by the Indian Pharmacopoeia Commission. Adverse Drug Reaction (ADR) Centres were set up in 90 medical institutes in the country, and trained staff was recruited for data collection and submission. After the successful establishment of PvPI, the haemovigilance programme was initiated as a collaborative venture between National Institute of Biologicals (NIB) and Indian Pharmacopoeia Commission with the coordinating centre at NIB. Five expert subgroups with defined responsibilities will analyse and collate data and make evidence‐based recommendations to the regulatory authorities for blood safety initiatives and their compliance.ResultsThe initial focus is on reporting the adverse reactions as defined by the Working Party of the International Society of Blood Transfusion, reporting is voluntary, and a Guidance Document and the TRRF have been made available to the medical institute blood banks. The reporting is online through software, ‘Haemo‐Vigil’. Reporting commenced from February 2013 and till date 731 reports of adverse reaction have been submitted.ConclusionA well‐structured programme of haemovigilance has been initiated in India.