The Haemovigilance Programme of India (HvPI), which aims at improving the quality of blood transfusion chain to ensure the safety of donors and recipients, is facing hurdles as many blood banks and medical institutions across the country remain reluctant to enroll in it.

Blood banks, hospitals and medical institutions are expected to enroll in HvPI, which is an indispensable part of pharmacovigilance programme at the national level. However, according to sources, even after five years, only 900 out of around 3,000 licensed blood banks in the country are registered.

“The number of enrollments is limited as it is voluntary at present. The solution is to make it mandatory under Drugs and Cosmetics Act,” the source added.

National Institute of Biologicals (NIB) is the nodal agency implementing the HvPI. An autonomous institution under the ministry of health and family welfare, it acts as the national control laboratory for assuring the availability of good quality biological products. When asked about the need for a regulatory mechanism to make the programme more effective, an NIB official said “the institute is also working along similar lines.”

The average annual blood collection in India is around 7-8 million units. The availability of safe blood is crucial as the country is facing a shortage of blood and blood components.

Ensuring blood safety is just one aspect of the programme. Haemovigilance system is beneficial for surveillance of treatment with other human products such as cells, tissues and organs. It also focuses on donor selection and biological control, labile blood component processing, qualification, transport and conditioning and follow-up of transfused patient.

“The main characteristics of HvPI are developed in accordance with WHO guidelines for adverse event reporting. The reporting and learning systems are non-punitive and independent of public authority. So framing a regulatory mechanism may not be easy,” another official pointed out.

The activities of blood banks and the National Coordinating Centre at NIB are guided by a core group. The group has introduced a transfusion reaction reporting form and gives expert opinion on collection and analysis of haemovigilance. HaemoVigil, a software developed for reporting adverse reactions, also helps keep an eye on the data collected.

Official figures show that until January 2017, more than 2,000 transfusion reaction reports have been received by the HaemoVigil software at 71 centres. If all blood banks are enrolled, the adverse reaction count may rise substantially and more experts and supporting staff will be needed to review the reports. Moreover, blood bank medical officers, clinicians, nurses and technicians need to be sensitised with these adverse reactions to make sure that the project will achieve its stated goals.