The Centre is planning to make external quality audits and digital inventory tracking mandatory for blood banks across the country as part of proposed changes to strengthen the blood transfusion system.
The proposed reforms would bring existing voluntary quality measures under the Drugs Rules, making compliance a legal requirement for licensed blood banks. Officials said the changes are intended to improve quality monitoring, standardize practices and enhance traceability of blood and blood components.
One of the key proposals is to mandate participation in External Quality Assessment (EQA) programmes. These programmes involve periodic evaluation of laboratory performance through independent assessments of blood grouping, compatibility testing and screening for transfusion-transmitted infections.
The government is also considering mandatory registration of all blood banks on e-RaktKosh, the national digital blood bank management platform developed by the Ministry of Health and Family Welfare and C-DAC. The platform enables real-time monitoring of blood inventory and is expected to improve visibility of blood availability across facilities.
Officials said the proposed amendments are aimed at aligning India’s blood transfusion practices with internationally accepted quality standards while strengthening regulatory oversight.
According to experts, mandatory external quality assessments could help ensure consistent laboratory performance, while centralized digital inventory management may improve blood stock monitoring and facilitate distribution during shortages or emergencies.
India’s annual blood requirement is estimated at around 14.6 million units. Healthcare professionals have said that measures to improve quality assurance, inventory management and traceability could support safer and more efficient blood transfusion services.
The proposed regulatory changes are under consideration and are expected to be incorporated into the Drugs Rules after the necessary approvals. Once notified, compliance with the new requirements would become mandatory for licensed blood banks across the country.
