Hemovigilance: a momentous step to blood safety


  • Rasika S. Khobragade Deparment of Pharmacology, Government Medical College, Chandrapur, Maharashtra, India
  • Shrikant G. Paranjape Deparment of Pharmacology, Government Medical College, Chandrapur, Maharashtra, India
  • Jyoti B. Gadhade Department of Pharmacology, B. J. Government Medical College, Pune, Maharashtra, India
  • Ameet Premchand Department of Pathology, Government Medical College, Chandrapur, Maharashtra, India




Haemovigilance, Blood transfusion reactions, Adverse drug reactions, PVPI, Pharmacovigilance


Hemovigilance is a series of monitoring procedures that cover the entire transfusion chain, from blood and its component collection to recipient follow-up, collecting and collecting information about unexpected or adverse effects resulting from the therapeutic use of unstable blood products. It is designed to be evaluated, and to prevent their occurrence and recurrence. The Haemovigilance program in developed countries is associated with IHN and has voluntary reporting requirements. In France, Germany and Switzerland, the hemodynamic system is regulated by supervisors. It is one of the blood manufacturers in Japan, Singapore and South Africa. In the Netherlands and the United Kingdom within the Medical Society; in Canada, regulated by health authorities. Intensive blood exercise program to ensure patient safety and promote public health begins on December 10, 2012 in Phase 1 in collaboration with National Institute of Biological Sciences under MOHFW for the first time in India it was done. HvPI is responding very well, as most medical colleges and laboratories have already registered and are beginning to provide data on side effects. The HvPI Unit produces educational materials in the form of publishing the Haemovigilance newsletter, information, education and communication (IEC) literature, and conducts an academic CME and awareness program on Haemovigilance throughout the year in India. The provocation is to understand not only the feedback of the internet, but even the sociology of human networks. Guaranteeing the reliability, responsiveness, and feedback of each alert is also important. Blood products are an important area of PvPI for reporting and recording post-transfusion ADRs of blood / blood products. To work efficiently, a lean mechanism and proper coordination with standardized tools at all levels is needed.

Author Biographies

Rasika S. Khobragade, Deparment of Pharmacology, Government Medical College, Chandrapur, Maharashtra, India

Assistant Professor,
Department of Pharmacology,
Government Medical College, Chandrapur

Shrikant G. Paranjape, Deparment of Pharmacology, Government Medical College, Chandrapur, Maharashtra, India

Associate Professor,
Department of Pharmacology,
Government Medical College, Chandrapur


Haemovigilance Programme of India. Available at: https://nib.gov.in/haemovigilance.aspx. Accessed on 11th October 2021.

Gadhade JB, Hiray RS, Aherkar RY, Shah KU. Pharmacovigilance programme of India: revival of the renaissance. Int J Basic Clin Pharmacol. 2018;7:2281-5.

Faber JC. Haemovigilance procedure in transfusion medicine. Hematol J. 2004;5(3):S74-82.

Bhattacharya P, Marwaha N, Dhawan HK, Roy P, Sharma RR. Transfusion related adverse events at the tertiary care center in North India: An institutional haemovigilance effort. Asian Journal of Transfusion Science. 2011;5(2):164-70.

Noel L, Debeir J, Cosson A. The French haemovigilance system. Vox Sang. 1998;74(2):441-45.

Andreu G, Morel P, Forestier F, Debeir J, Rebibo D, Janvier G, et al. Haemovigilance network in France: organization and analysis of immediate transfusion incident reports from 1994 to 1998. Transfusion. 2002;42(10):1356-64.

Salmi R. Epidemiological support of hemovigilance. Transfus Clin Biol. 1994;6:421-4.

Faber JC. The European Blood Directive: A new era of blood regulation has begun. Transfus Med. 2004;14:257-73.

Watson R. EU tightens rules on blood safety. BMJ. 2005;331:800.

Quality and safety standards for human blood and blood components. Summaries of EU legislation. Available at: http://europa.eu/legislation_summaries/public health/threats_to_health/c11565_en.htm. Accessed on 25 September 2015.

Public Health Service (PHS) Biovigilance working group. Biovigilance in the United States: Efforts to bridge a critical gap in patient safety and donor health. 2009;16.

IPC-NIB guidance document for reporting serious adverse reactions in blood transfusion service. National Institute of Biologicals& Indian Pharmacopoeia Commission Collaboration. Available at: http://nib.gov.in/ haemovigilance.html. Accessed on 11 October 2021.

Mukherjee S, Maiti R. Haemovigilance: a current update in Indian perspective. Journal of clinical and diagnostic research: JCDR. 2016;10(11):EE05.

Bisht A, Marwaha N, Kaur R, Gupta D, Singh S. Haemovigilance Programme of India: Analysis of transfusion reactions reported from January 2013 to April 2016 and key recommendations for blood safety. Asian J Transfus Sci. 2018;12:1 7.

Bisht A, Singh S, Marwaha N. National blood donor vigilance programme: India. Asian J Transfus Sci. 2016;10:1 2.

Bisht. National blood donor vigilance programme of India, analysis of donor adverse reactions and key recommendations Asian Journal of Transfusion Science. 2021;15(1).

Prasad JP, Gopinath SV, Bisht A. Haemovigilance Newsletter. 2013;1:1-16.

Global Consultation on Haemovigilance. 20.22 November 2012, Dubai, United Arab Emirates. Jointly Organized by WHO HQ/Geneva, Sharjah Blood Transfusion and Research Center and the Government of the United Arab Emirates, in Collaboration with the International Haemovigilance Network and the International Society of Blood Transfusion. 2012. Available at: http://www.who.int/bloodsafety /haemovigilance/haemovigilance-report.pdf. Accessed on 20 September 2021.

Sharma G, Sadhna D, Kaushik KN. Haemovigilance: a system to improve safety in blood transfusion process. World J Pharm Pharm Sci. 2014;3:1889-98.

Van Wijngaarden JD, Scholten GR, van Wijk KP. Strategic analysis for health care organizations: the suitability of the SWOT? analysis. Int J Health Plann Manage. 2012;27:34-49.

Van den Burg PJ, Magnussen K. Ethical aspects of blood donors and the recipients of their blood. J Blood Transfus. 2012;2012.

Detmer DE, Steen EB, Dick RS, editors. The computer-based patient record: an essential technology for health care. National Academies Press. 1997.

Vasudev R, Sawhney V, Dogra M, Raina TR. Transfusion-related adverse reactions: From institutional haemovigilance effort to National Haemovigilance program. Asian Journal of Transfusion Science. 2016;10(1):31-6.




How to Cite

Khobragade, R. S., Paranjape, S. G., Gadhade, J. B., & Premchand, A. (2022). Hemovigilance: a momentous step to blood safety. International Journal of Basic & Clinical Pharmacology, 11(3), 267–270. https://doi.org/10.18203/2319-2003.ijbcp20221043



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