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

Background and Objectives Setting 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 I ndia. Materials and Methods The M inistry of H ealth and F amily W elfare, G ovt. of I ndia had launched the national P harmacovigilance P rogramme ( P v PI ) in J uly 2010, with oversight by the I ndian P harmacopoeia C ommission. Adverse D rug R eaction ( ADR ) C entres 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 P v PI , the haemovigilance programme was initiated as a collaborative venture between N ational I nstitute of B iologicals ( NIB ) and I ndian P harmacopoeia C ommission 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. Results The initial focus is on reporting the adverse reactions as defined by the W orking P arty of the I nternational S ociety of B lood T ransfusion, reporting is voluntary, and a G uidance D ocument and the TRRF have been made available to the medical institute blood banks. The reporting is online through software, ‘ H aemo‐Vigil’. Reporting commenced from F ebruary 2013 and till date 731 reports of adverse reaction have been submitted. Conclusion A well‐structured programme of haemovigilance has been initiated in I ndia.