Haemovigilance Programme of India: Analysis of transfusion reactions reported from January 2013 to April 2016 and key recommendations for blood safety

A centralized hemovigilance program was launched in the country on December 10, 2012, to assure patient safety and promote public health through a well‐structured program for monitoring of adverse reactions associated with blood and blood product transfusions. The National Institute of Biologicals (NIB), Noida, is the National Co‐ordinating Centre. The Haemovigilance Programme of India (HvPI) was started under the broad ambit of Pharmacovigilance Programme of India. The key objectives outlined in the HvPI are (i) monitor transfusion reactions, (ii) create awareness among health‐care professionals, (iii) generate evidence‐based recommendat ions , (iv) advise the Central Drugs Standard Control Organization (CDSCO) for safety‐related regulatory decisions, (v) communicate findings to all key stakeholders, and (vi) create national and international linkages. A core group, a national executive committee, and a national advisory committee were constituted for operationalization of the programme. The Transfusion Reaction Reporting Form (TRRF), Guidance document, standardized definitions of transfusion reactions, and the Haemo‐Vigil software for online reporting of transfusion reactions were approved. Three expert panels were also constituted for report analysis and training purposes.[1,2]