A review of legal, regulatory, and policy aspects of blood transfusion services in India: Issues, challenges, and opportunities.

backgroundBlood transfusion services (BTS) in India have progressed significantly during the last three decades. However, there is still inequity in the availability and access to blood due to various demand and supply-side issues. Appropriate laws, regulations, policies, and guidelines are critical to ensure universal access to blood. AIMS AND

objectivesThis article aims to review the evolution and current status of legal, regulatory, and policy framework and analyses the issues, challenges, and opportunities for improvement of BTS in India.

methodsThis article is based on an extensive review of currently available literature and government documents.

resultsThe review highlights the gaps and challenges in terms of licensing, safety and quality, voluntary blood donations, the organization of BTS, access to services, and regulatory bodies. The findings emphasize the need for a coordinated response by either the National Blood Transfusion Council or a newly established autonomous "National Blood Authority" consisting of technical, administrative, and legal experts which must be exclusively responsible for regulating the BTS. As adherence to quality management systems in blood banks is not a mandatory requirement, it recommends a legal measure to ensure mandatory quality assurance in blood banks and storage centers. Towards ensuring efficiency and universal access to blood, this article recommends evidence-based criteria for establishing new blood banks to avoid skewed distribution of blood banks, component separation facilities, and blood storage centers.

conclusionThe review emphasizes the need for periodic reviews and updates of the legal, regulatory and policy framework, considering the rapid developments and technical advancements with increasingly complex systems and processes in transfusion medicine.