This will help Central Drugs Standard Control Organisation (CDSCO) to take safety related regulatory decisions in blood safety. Through this reporting system, HvPI will help in identifying trends in adverse reactions and events, thereby to also form transfusion policy.
NIB is an autonomous institution under the Union health ministry which ensures quality of biologicals and vaccines in the country available through domestic manufacturers or imports.
Launched on December 10, 2012 by NIB, HvPI aims at raising awareness about blood transfusion hazards in blood banks across the country. HvPI has 333 centres as of today from the earlier 207 centres covering blood banks, medical colleges, government and private hospitals across the country.
Drugs Controller General of India (DCGI) had also sent a circular asking the state drug controllers (DCs) to direct all licensed blood banks for uplinking transfusion adverse reactions with NIB under the HvPI. There are 2650 licensed blood banks in the country which will be covered under the programme.
As a part of the programme, data in transfusion reaction reporting form (TRRF) from various centres is being collected through the software, Haemo-Vigil.
The reporting system deployed under HvPI is confidential, systems oriented and responsive. The identities of the patient, reporter and institution are never revealed to third party going by the clause for confidentiality. It is therefore independent of any authority. NIB/Indian Pharmacopoeia Commission (IPC) are the co-ordinating centres between the reporters and regulators.
HvPI ensures that traceability of events is done through proper documentation. This will lead to effective recommendations to be accepted and acted upon as also through defining systematic documentation process.
To recognise underlying systems causes with the help of a Haemovigilance Advisory Committee (HAC), reports are evaluated by experts who understand the clinical circumstances. Such information is also key to introduce required changes in the applicable policies, improve standards, systems, processes and assist in the formulation of guidelines.
Pharm.D @ SRIPMS-CBE-TN