Transforming Blood Management Systems in Developing Countries Through Technological and Artificial Intelligence-Driven Innovations

Abstract

It is critical to ensure the safe and quality supply of blood among various stakeholders; however, this remains a significant challenge in today’s world, especially in developing countries. These countries face severe problems, including blood shortages, fragmented regulatory frameworks, and inconsistent quality control measures. To tackle these challenges, countries like India are trying to implement the use of artificial intelligence (AI) and its derivative platforms to transform blood collection, testing, storage, and distribution by enabling interoperability, real-time compliance monitoring, automated donor screening, optimized inventory management, and advanced component separation. The article argues that developing countries must adopt both regulatory reform and technological innovation to improve the current blood supply chain. Having a collaborative system wherein there is an interoperable relationship among various stakeholders, combined with an AI-driven blood management technology, would help ensure a reduction in blood wastage, improve patient safety, and the timely supply of high-quality blood products on a global scale.

Keywords

Blood Safety Regulation AI-Driven Blood Management Blood Management Software Artificial Intelligence in Healthcare Comparative Health Regulations

I. INTRODUCTION

Blood is a vital resource in modern health care, playing a crucial role in lifesaving procedures worldwide. As a crucial component for many medical procedures, especially for more serious illnesses requiring transfusions, blood is used to treat injuries, terminal illnesses like cancer, and complex surgeries, leading to consistently high demand. Globally, two significant issues require urgent attention: blood shortages and maintaining high-quality standards. Countries aim to address this through blood donation drives at blood banks and hospitals, but it is equally essential to ensure that all donated blood is rigorously tested and processed to ensure safety and quality. The primary argument of this article is that integrating technological advancements and artificial intelligence (AI) can help overcome both the shortage and quality concerns, especially in developing markets, by improving systems for blood collection, testing, and distribution. This global struggle to balance demand and safety has also prompted organizations such as the World Health Organization (WHO) to issue strict guidelines to ensure both an adequate supply and high-quality standards for blood.

Given the worldwide demand for high-quality blood, the WHO has issued guidelines requiring strict compliance by hospitals and blood banks. Despite these mandates requiring improvements to blood safety systems, developing countries have found it difficult to meet the strict requirements. According to the WHO, countries need about 3–5% of their total population to donate blood each year in order to meet their annual blood requirements.¹ Yet, more than 40% of the world’s nations are unable to achieve even a 1% donation rate.²

For instance, taking India as an example, despite having a well-developed health care system with a robust generic drug capacity, the country continues to struggle with persistent challenges, such as (a) shortages, (b) maintaining blood quality, and (c) wastage of blood units on account of late matching with recipients. Although India has made tremendous improvements in blood collection through the introduction of blood donation drives and policy changes in recent years, the country still faces a blood shortage. India requires an average of 14.6 million units of blood annually, but supply falls short by nearly 1 million units, resulting in critical gaps in emergency care.³

To understand why these challenges persist, it is important to examine the underlying structural issues. Several factors point toward struggles in maintaining a quality blood supply, with the chief among them being the absence of a centralized regulatory framework. Next, in India, the laws and guidelines governing blood safety and quality are fragmented between the central and state governments, making it difficult to enforce them uniformly. The scattered implementation of laws governing blood has increased India’s risk of adverse patient outcomes. Such adverse patient outcomes include organ damage and/or increased risk of contracting infectious diseases such as AIDS and SARS. These risks from impure blood are heightened particularly during emergency situations such as the COVID-19 pandemic, where timely and reliable blood management can be critical in saving human lives. To effectively address these shortcomings, India requires appropriate legal reforms and technological advancements to streamline blood management practices.

This article argues that technological advancements, such as blood management software, can play a vital role in facilitating sufficient integration among stakeholders, including donors, blood banks, and hospitals. This integration, in turn, can help address legal and regulatory fragmentation to ensure safe, efficient, and timely access to blood. To illustrate this, the article uses India as a case study, demonstrating how tech-driven solutions can strengthen blood quality management. Specifically, the article (A) outlines India’s existing legal framework and examines the challenges within the current system, (B) compares it with the U.S. legal and regulatory model, and (C) ultimately proposes the adoption of technological innovations to close gaps and enhance the safety and quality of blood.

A. Indian legal framework

Understanding India’s history of blood quality regulation reveals the key legal provisions shaping its current framework.

The Drugs and Cosmetics Act, 1940 (“D&C Act”), classifies blood and blood components as “drugs.”⁴ As a result, blood is regulated by the Central Drugs Standard Control Organisation (CDSCO) and various state drug control agencies. Furthermore, Part XB of the D&C Act explains the requirements for the collection, storage, processing, and distribution of whole human blood and human blood components by blood banks, as well as for the manufacture of blood products. The Act also discusses the licensing requirements for blood banks to operate as entities for processing blood and blood components.⁵ Blood safety was first conceptualized in India in a 1996 Supreme Court judgment in Common Cause.⁶ The Court held blood banks and hospitals accountable and liable to patients for deficient blood or related services. The judgment laid the foundation for the establishment of National Blood Transfusion Council (NBTC) and State Blood Transfusion Council (SBTC). However, the primary limitation of NBTC is that they function as a policymaking and advisory body for blood services rather than a direct enforcement agency. Without the authority to enforce rules, its role is confined to framing and recommending policies, leaving implementation dependent on CDSCO.

Although the D&C Act has undergone several amendments addressing blood regulation, there is ample scope to improve India’s blood management regulatory framework to align with international standards. There is no doubt that India’s blood bank management system has improved significantly since the landmark Supreme Court judgment in 1996; however, several challenges remain to be addressed. Rural areas, some aptly termed “blood deserts,” continue to face acute challenges, as reflected in chronic blood shortages and transfusion delays compared with urban centers, ultimately compromising patient outcomes.⁷ Additionally, a low rate of voluntary blood donations due to limited awareness narrows the donor pool, thereby creating a blood supply shortage.

While these ongoing efforts are steps in the right direction, India can still improve its existing framework to match the heightened international standards. For example, with the introduction of e-RaktKosh, individuals can search for nearby blood banks and check the availability of blood and its components based on their geographic location by entering the required information. Similarly, on October 12, 2025, it was reported that the STBC in Maharashtra, one of the big states in India, had appointed a coordinator to monitor the distribution of excess blood across the state’s other districts.⁸ This move was aimed at reducing blood wastage and shortages and at monitoring, in real time, the balance between supply and demand for excess blood across the state of Maharashtra. At a time when India faces a nationwide blood shortage, this appointment in Maharashtra could serve as a catalyst for similar initiatives nationwide. A comparative examination of global blood management systems and their regulatory frameworks may help provide valuable insights to strengthen and harmonize India’s fragmented blood management system.

To provide context for these valuable insights, a comparative analysis between India and the United States, examined below, can help identify regulatory gaps that could address the system’s shortcomings in India. This analysis could demonstrate how establishing a centralized regulatory body, coupled with AI-driven technological innovations, could effectively address these gaps.

B. Legal framework in the United States

In the United States, the Food and Drug Administration (FDA) is responsible for regulating the quality of blood and blood products and ensuring the safety of patients who undergo blood transfusions. In particular, the FDA’s Center for Biologics Evaluation and Research (CBER) oversees the development, testing, and ensuring the safety, efficacy, and proper use of blood products throughout the country. CBER, in close alliance with the Public Health Service, performs critical duties, including establishing blood safety and technical standards and identifying potential dangers to the safety and use of blood products. CBER is entrusted with the duty of minimizing the risk of infectious diseases to the lowest level by thoroughly monitoring and reviewing these lifesaving blood products.

The FDA’s blood regulations are codified in Title 21 of the Code of Federal Regulations. It provides information regarding blood collection, processing, storage, and transportation of blood products. Part 606 of the Title discusses current good manufacturing practice requirements for blood and blood products.⁹ The objective is to have hospitals and blood banks comply with the required standards of care for various blood processing activities, including record management, reporting, labeling, equipment, facilities, personnel, and controls for production, processes, and laboratories. The primary objective of these good practices is to ensure the safety and quality of blood products. Following these practices helps reduce the risk of adverse outcomes, thereby ensuring the safety and efficacy of these blood products.

The FDA, working alongside the Centers for Disease Control and Prevention (CDC), has broad authority to ensure that infected blood and blood products are not introduced into U.S. markets. The strict vetting process prevents the spread and transmission of communicable diseases (PHSA Sec. 264).¹⁰ In recent years, the FDA has tightened quality control measures to ensure the purity of blood products, such as requiring blood donors to disclose any risk of transmissible diseases to ensure a match with the right recipient. Blood banks and other entities are required to maintain lists of unqualified individuals in a database to prevent the collection of blood from them. Additionally, the FDA has also increased its supervisory measures over blood banks and other institutions through inspections every two years or less. The Association for the Advancement of Blood & Biotherapies works with the FDA, participating in the rulemaking process of blood quality regulations to ensure a safe blood supply.

The CBER has established a five-step blood protection safety mechanism, which ensures that patients receive the best quality of blood while undergoing transfusion procedures, such as:

Donor screening by providing educational materials for donors to disclose any potential risks they could possess while making donations.

Donor deferral lists are mandated by the FDA to minimize transmission of infectious diseases.

Blood donation testing is mandated, requiring blood banks to thoroughly test blood and blood components for infections that may result in adverse transfusion reactions.

Quarantine donated blood until all tests are completed, and it is cleared for transfusion.

The monitoring and investigating problems requirement focuses on post-donation safety and long-term monitoring of the blood supply. It requires a combination of tracing, notifying, quarantining, and reporting any infectious unit of donated blood, and ensuring that the FDA is notified of deviations in distributed products.

II. COORDINATION FRAMEWORK

A. Hospitals

Considering that blood and blood components are classified as drugs under the Federal Food, Drug, and Cosmetics Act, hospitals are subject to the same provisions regarding adulteration and misbranding that apply to their handling, storage, or distribution of blood. Blood would be considered adulterated if it has been prepared, packed, or held under unsanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.¹¹ The provision further states that if the facilities, equipment, or procedures used to make, process, package, or store a drug (blood) do not comply with current good manufacturing practices, the blood will not be considered safe, reliable, or consistent in quality, identity, or strength.¹² Furthermore, the Act also sanctions hospitals for misbranding blood and blood products if their labels are inaccurate, misleading, or omit key details such as blood type, expiration date, or test results. If hospitals relabel blood incorrectly or fail to identify it properly, they may violate this rule, and such violations could trigger FDA warning letters, fines, seizures of blood inventory, or even injunctions against a hospital’s blood bank operations.¹³

As mentioned above, hospitals are required to strictly adhere to current good manufacturing practices for blood and blood components used in blood transfusion services.¹⁴ Additional requirements in Section 640 establish standards for labeling, sterility, storage conditions, and quality control of specific components such as platelets and plasma. All these processes must be performed under the supervision of the same licensed facility. However, if two or more licensed facilities jointly request to work together, the Director of the CBER may approve a special arrangement, provided it continues to meet all safety and regulatory requirements.¹⁵ Hospitals must also maintain traceability, participate in donor “lookback” and recipient notification procedures when risks are identified, and report serious transfusion-related events to the FDA. Where hospitals also collect blood from donors, they are further governed by Section 630, which sets detailed eligibility and screening requirements.¹⁶ Collectively, these regulations ensure that hospitals not only use FDA-approved blood products but also manage, store, and transfuse them in compliance with federal safety and quality standards.

B. Blood banks

The United States has also integrated AI effectively into the stream of blood quality management in blood banks. For example, Carter BloodCare is a nonprofit organization based in Bedford, Texas, established in the 1950s, with the aim of providing a high-quality blood supply.

Each year, it is estimated to provide more than 440,000 units of blood and blood components to meet patients’ treatment requirements in Texas. Carter BloodCare’s services include collection, processing, specialized laboratory testing, storage, and distribution of blood and blood components.

In January of 2025, Carter BloodCare automated the separation of whole blood into various blood components, including red blood cells and plasma, by partnering with Terumo Blood and Cell Technologies (Terumo BCT) using its flagship AI-based software, Reveos™, and the Lumia™ Software Platform.¹⁷ Carter had already adopted Terumo BCT’s Trima Accel™ Automated Blood Collection System for apheresis, a process that collects the necessary blood components from whole blood, such as plasma or white blood cells, and returns the remaining blood to the donor, thus preventing wastage, which plagues other systems in countries like India. By integrating both Trima and Reveos into their inventory, Carter effectively leveraged technology to advance a futuristic vision of efficiency, innovation, and patient care. Carter has streamlined the supply process, making these lifesaving resources more accessible and using AI to meet the growing demand for diverse blood components.

III. Improvements needed for blood quality management

The U.S. system serves as a strong example of how a robust regulatory and technological framework can facilitate effective blood management. Countries like India and other developing nations stand to benefit significantly by integrating well-structured regulatory systems similarly. Using India as an example, the following improvements could help elevate its current health care standards to meet international benchmarks. These recommendations are also broadly applicable to other developing markets and would greatly enhance the overall efficiency and reliability of their health care systems.

Limited Adoption of Digitization in Blood Banks: Interoperable systems are still limited and will only strengthen existing online platforms. Some blood banks still rely on manual processes or proprietary software that cannot be easily integrated with other systems, and these need to upgrade to an interoperable system. In April 2016, the Indian government launched e-RaktKosh, a centralized blood bank management system designed to improve blood bank operations.¹⁸ However, during its implementation phase, 7 key barriers were identified that prevented effective online participation on the e-RaktKosh portal, directly or indirectly.¹⁹ These barriers affected the platform’s performance and adherence. The barriers to digitization identified in India mirror those faced by health care systems in other developing countries. The main challenges stemmed from the lack of appropriately trained staff for the work. Insufficient training, particularly limited to a single staff member, was another issue. Additionally, regular training during the initial year of implementation was found to be lacking. Introducing an interoperable software will enable simultaneous collaborative online work, improve uniform training, and better address inadequate data entry resulting from manpower constraints, thereby significantly reducing long-term barriers.

Inadequate Infrastructure for Efficient Blood Donation Management: Many blood banks in India lack adequate infrastructure and resources to maintain an effective blood supply. This includes inadequate equipment for blood storage, a lack of interoperable systems that force manual management, and transportation and testing inadequacies that worsen when coupled. Oftentimes, the integrity of the blood supply was compromised, increasing the risk of spoilage due to inadequate infrastructure, some of which can be addressed through effective technologies. Having said that, integrating an interoperable system would lead to faster preparation of blood products for transfusion and a reduced risk of contamination. While limited resources and restricted access to efficient blood storage and management systems remain challenges to blood safety, these issues also present opportunities for innovation. Investing in advanced, specialized equipment to safely store and transport blood products at optimal temperatures can significantly strengthen the reliability and safety of blood supply chains in developing health care systems.

Wastage of Blood: Blood banks bear significant responsibility for maintaining a consistent blood supply; however, wastage poses a significant challenge to blood availability. The WHO reports that blood wastage is primarily attributed to deficiencies in inventory management, substandard manufacturing practices, insufficient storage, and transportation issues. Insufficient or unsafe blood supply for transfusion negatively affects the effectiveness of important health care services. While maintaining adequate blood component stocks in blood banks is essential, careful inventory management is crucial to minimizing wastage. Implementing a blood management software system would help address the critical issue of blood waste by establishing a well-organized, efficient channel for blood distribution.

Hemovigilance and Patient Safety Gaps: A robust data collection and reporting system is essential to maintaining a coordinated, efficient blood management program across health care systems in developing nations. Hemovigilance is a set of surveillance procedures covering the entire transfusion chain, from the donation and processing of blood and its components to their provision and transfusion to patients and their follow-up. It includes monitoring, reporting, investigating, and analyzing adverse events related to the donation, processing, and transfusion of blood, and taking actions to prevent their occurrence or recurrence.²⁰ Currently, there is no digital solution at the central and state levels to track blood bank operations and transfusion-related compliance. Several developing nations, including India, face similar challenges in establishing a unified hemovigilance network. Implementing an integrated digital hemovigilance system would not only strengthen regulatory oversight but also enhance transparency, safety, and accountability within national blood management programs.

Poor Connectivity in Rural Areas: Online blood bank management requires robust IT infrastructure and reliable connectivity, which may not be available in all areas of India. Interrupted data entry during camps or rural operations leads to incomplete donor registration, lost records, and delayed reporting to e-RaktKosh. A similar challenge has been observed in several African nations, such as Nigeria, where inconsistent internet access and limited digital infrastructure have hindered the effective rollout of national blood management systems.²¹ These examples highlight the importance of investing in stable digital networks and localized technological solutions to ensure seamless data integration and reporting across all regions.

Unethical Brokers and Paid Donors: WHO policy mandates both national (or sometimes only regional) self-sufficiency and an absence of remuneration for both blood products and transplantable organs.²² In the Indian context, the National AIDS Control Organization (NACO) also provides guidelines similar to those of the WHO. As per NACO’s Ethical Blood Donation Guidelines and NBTC standards, only voluntary, non-remunerated blood donation is permitted.²³ However, challenges such as ensuring consistent donor verification and preventing unauthorized intermediaries can occasionally affect the integrity of blood supply systems, as seen in many developing health care systems. NDTV, one of India’s leading news networks, highlighted ongoing efforts to curb illegal blood markets and improve oversight in both public and private health care facilities. The report emphasized the goal of ensuring equitable access to safe, reliable blood products without compelling patients to engage in informal or unauthorized transactions for a basic medical necessity.²⁴

Lack of Quality Controls and Auditing: Blood banks are responsible for testing donated blood to detect infectious diseases before it is used. However, testing quality is often substandard due to inadequate infrastructure, insufficiently trained personnel, and limited real-time performance monitoring. The accuracy and sensitivity of testing methods can vary, and it is important for blood banks to utilize validated methods that have proven effectiveness in detecting potential infectious agents. Specialized equipment and high-quality reagents are necessary for blood testing and must be regularly maintained. If the equipment is outdated or poorly maintained, it can lead to inaccurate test results. Similarly, insufficient training can lead to errors and unreliable test results. To maintain high standards, blood banks should establish robust quality control and assurance programs to monitor the testing processes. Timeliness is crucial in blood testing to minimize the risk of transmitting infectious agents. Delays in testing can increase the risk to patients and reduce the effectiveness of blood products. Addressing these issues is essential for improving the quality and reliability of testing procedures in blood banks.

Addressing these challenges is a pressing need of the hour in developing countries. The WHO’s Pandemic Agreement and its framework on Maintaining a Safe and Adequate Blood Supply in the Context of COVID-19 underscore the importance of strengthening national capacities for safe blood management and transfusion services.²⁵ The pandemic exposed the vulnerability of blood supply systems in developing countries, where disruptions in operations led to decreased blood donations and reduced availability of collection and storage facilities, impeding an effective emergency response. To tackle this problem, a strong and well-organized blood bank management system is needed. A blood bank management system is a software application that is designed to manage the various aspects of a blood bank, including blood donor registration, blood donation, blood testing, blood storage, and blood transfusion. For example, private companies have worked on these systems, including in India. While systems like these are unique and evolving, they are designed to improve the efficiency of blood bank operations, enhance the quality of blood products, and ensure patient safety. With such a system, it would easily address most of the challenges faced by India’s current health care system. For example, EHR Logic, an Indian healthtech software company, is making strides in tackling these challenges by providing interoperability solutions and creating a secure, efficient health care information exchange platform.²⁶ The system enables seamless communication and collaboration among health care providers, patients, and payers, with the ultimate goal of improving public health. For instance, it would help transform traditional blood banks into a fully digitized system in which donor data, test results, stock movements, and compliance reporting are automatically captured via a cloud-based, AI-enabled system. Second, it would automate blood donation camp workflows through a user-friendly online platform. This would be made possible by QR-based donor self-registration, AI-based voice medical screening, and offline data entry that syncs automatically once connected, ensuring real-time accuracy. Last, an AI-driven system on a cloud-based platform would provide state and central regulators with real-time visibility into compliance scores, stock levels, and audit status. This would facilitate the automatic recording of every step in the audit trail and compliance standards, generating real-time reports for the NBTC and SBTCs, and reporting them to the e-RaktKosh portal at the same time. These are a few features currently working in the new software; more are likely to be added in the near future. By integrating such AI-driven features into their respective national health infrastructures, developing countries can not only strengthen the resilience and transparency of their blood supply systems but also ensure equitable and timely access to lifesaving transfusion services during both emergencies and routine care.

In conclusion, the current blood management systems in developing countries like India need to be redeveloped to be stronger and more robust, with technology and AI integrated at every step to streamline the process as much as possible. Taking the example of India, though it has made considerable strides in this matter through the establishment of NTBC and STBCs, and the introduction of online platforms such as e-RaktKosh, there are still gaps in the system that need to be addressed, including the need for a binding regulatory framework. With a centralized regulatory authority like the FDA in the United States and advanced AI-based systems across various parts of the blood supply chain, India and other developing countries can strengthen their blood supply chains, minimize waste, and enhance patient safety.