The Drug Controller General of India (DCGI) has asked the state drug controllers (DCs) across the country to direct all licensed blood banks for uplinking transfusion adverse reactions with National Institute of Biologicals (NIB) under the Haemovigilance Programme of India (HvPI).

The letter states that licensed blood banks may be instructed by the respective state drug controllers to obtain their user ID and password from NIB to uplink their adverse transfusion data through its Haemovigil software.

There are 2760 licensed blood banks in the country as of today.

After uplinking, data in transfusion reaction reporting form (TRRF) will be collected by NIB online through a software named Haemovigil indigenously developed by IT division of NIB. This will help Central Drugs Standard Control Organisation (CDSCO) to take safety related regulatory decisions in blood safety.

Having started with a budgetary allocation of Rs.29 crore under the 12th Five Year Plan in December 2010 by NIB, HvPI will also help generate evidence based recommendations through this transfusion related adverse reaction reporting mechanism covering licensed government blood banks across the country.
 
The recent order passed by the DCGI states, "As required by the Union health ministry with reference to letter from the director, National Institute of Biologicals (NIB), on the subject, all the state drug controllers are requested to instruct all licensed blood banks in their jurisdiction to uplink their transfusion adverse reactions record to Haemovigil software for onward transmission to national coordination centre (NCC)- NIB. The licensed blood banks may also be instructed to obtain their user ID and password from NIB to uplink their adverse transfusion data to Haemovigil software by sending an email to member secretary, HvPI at haemovigilance@nib.gov.in."

An NIB official explains that among the key attributes of the HvPI are that it is confidential, independent, offers expert analysis, systems oriented and responsive. The reporting system deployed is independent of any authority with NIB/Indian Pharmacopoeia Commission (IPC) being the co- ordinating centre between the reporters and regulators.