‘I undergo blood transfusion every 15 days, I am at risk of acquiring infections like hepatitis and HIV’ (2024)

Anubha Taneja Mukherjee was diagnosed with thalassemia major, a type of beta-thalassemia, when she was just three months old. She undergoes regular blood transfusion every 15 days and consequently. Consequently, she is at a high risk of acquiring transfusion-transmitted infections like hepatitis and HIV.

Thalassemia is an inherited blood disorder that results in lower levels of hemoglobin in the body. Low hemoglobin levels can lead to anemia, causing fatigue. Thalassemia comes in different forms, including alpha-thalassemia and beta-thalassemia, which can range from mild to severe. While mild cases may not require treatment, moderate to severe cases may involve frequent blood transfusions, chelation therapy to remove excess iron from the blood, or even stem cell transplantation for those with severe thalassemia.

“People with thalassemia, as well as other patients who need regular blood transfusions, face the additional risk of acquiring transfusion-transmitted infections like hepatitis and HIV. Therefore, receiving unsafe blood can subject individuals already dealing with a challenging chronic illness to another potentially untreatable condition, which could have been avoided by using safe blood,” Mukherjee told Financial Express.com.

Also Read

Hamas chief Ismail Haniyeh killed in Iran, group confirms

Major Setback for India:Crisis in Bangladesh

Bangladesh Prime Minister Sheikh Hasina resigns and flees amid ongoing protests: Reports

Singapore relaxes rules for foreign students to apply for permanent residency

See Also

NHS complaints: how does the system work and what can be achieved?Impatient? Why and How to Practice PatiencePastor Tammy - Breast CancerImpatient? Why and How to Practice Patience

During the COVID-19 pandemic, the accessibility of blood supply emerged as a significant challenge for individuals with thalassemia, especially during periods of lockdown. As a result, voluntary blood donations dropped significantly, leading patients to arrange their donors for each transfusion. Meanwhile, replacement blood donation became a customary practice. Eventually, Mukherjee decided to take matters into her own hands.

“…during COVID-19 pandemic, my goal was to ensure that individuals with thalassemia do not experience a lack of blood supply. Therefore, all of us at Thalassemia Patients Advocacy Group (TPAG) assembled a group of patient volunteers to oversee blood donations for transfusions in both government and private hospitals across India. This involved working closely with blood banks to meet donor needs, as well as arranging transportation and handling necessary documentation,” she told Financial Express.com.

Access to safe blood is not only important for thalassemia patients but it also plays a crucial role in reducing mortality rates, improving the quality of life for patients, and ensuring appropriate services in all healthcare facilities.

Blood transfusion saves lives and improves health, but many patients requiring transfusion do not have timely access to safe blood. According to the World Health Organization (WHO), there is a marked difference in the level of access to blood between low-and high-income countries.

What is the status of safe blood in India?

Safe Blood is blood collected from healthy blood donors who are free from blood-transmitted infections like HIV, Hepatitis B, Hepatitis C, syphilis, malaria and bacteria.

“Access to safe blood is a challenge in India because the blood testing process is not uniform in all blood centers. There is a risk of window period (period between the donor getting infected and the test results coming positive) transmission if blood is not tested with fourth generation kits. Also, voluntary blood donations are not actively done. People give blood more as replacement donation where they can hide their health history during donor screening,” Dr Seema Sinha, Director & HOD, Blood Bank, Fortis Hospital, Noida told Financial Express.com.

In India, access to safe blood faces significant hurdles because of various factors.

“Firstly, the country bears a considerable burden of infectious diseases such as HIV, hepatitis, and malaria, all of which can be transmitted through contaminated blood. The high prevalence of these infections poses a threat to transfusion recipients. Moreover, there are limitations in testing methods employed by blood banks. While advanced testing technologies exist, not all blood banks have access to them or consistently utilize them. This can lead to the possibility of undetected infections in donated blood, further compromising blood safety,” Rishubh Gupta, MD – Roche Diagnostics India told Financial Express.com.

Additionally, regulatory issues contribute to the challenge, he explained. Despite the presence of regulatory bodies like the National Blood Transfusion Council (NBTC) and State Blood Transfusion Councils (SBTC), gaps in enforcement and compliance with blood safety regulations exist.

According to Gupta, infrastructure and resource limitations are also significant obstacles faced by many blood banks in India. “Inadequate infrastructure, equipment, and trained personnel hinder the quality of screening and storage processes, further compromising the safety of blood supplies. The decentralisation of blood transfusion services in India exacerbates these challenges. Fragmentation across states, cities, and even within the same city leads to variations in standards and practices,” he revealed.

Decentralisation also limits vital resources like manpower, infrastructure, and financial resources, hindering efforts to ensure the quality, safety, and efficacy of blood and blood products, Gupta emphasised.

To address these challenges and improve blood safety in India, there is a pressing need for modification and change in the blood transfusion service, he highlighted.

Why safe blood is important?

Patients who suffer from conditions like thalassemia need access to safe blood consistently, however, the situation is grim. “First and foremost, is the lack of safe blood; blood that is free of infections like hepatitis or HIV. Also, sometimes there is no availability of blood which leads to long waiting hours hampering our schedule,” she told Financial Express.com.

She also revealed that the factors that are contributing to making access to safe blood challenging in India include lack of voluntary blood donation, unavailability of proper infrastructure in blood banks, not mandating NAT testing as a standard procedure after blood donation along with delays in processing and distribution of blood due to inefficient logistics or lack of resources at blood banks.

Ensuring supply of the safest possible blood is not a matter of choice but critical as a citizen’s rights issue, according to Mukherjee.

“While current protocols mandate serological testing for TTIs in blood donations, there are limitations to this approach. Despite regulatory mandates, a study published in the Indian Journal of Hematology and Blood Transfusion in 2021 highlighted significant gaps in administrative and technical aspects across many blood banks in India. Approximately 66 per cent of blood banks reported deficiencies in adherence to quality management systems and practices,” Gupta told Financial Express.com.

The National AIDS Control Organization and the Drugs and Cosmetics Act in India made HIV, HBV, HCV, syphilis, and malaria serological tests mandatory for all blood donations. Serology testing, while essential, has its drawbacks, he revealed.

“It often fails to detect infections during the serological window period, when viral pathogens are still undetectable, despite the donor being infected. Additionally, serology testing may not identify certain variants or occult infections, such as occult hepatitis B infection (HBI), posing a risk to transfusion recipients. In India, prevalence of occult Hepatitis B infections is high and hence it is very essential that advanced screening technologies should be deployed to limit the spread of these transfusion-transmitted infections,” Gupta told Financial Express.com.

Role of Nucleic Acid Testing (NAT)

Nucleic Acid Amplification Testing (NAT) is a blood screening technique that detects transfusion-transmitted infections by targeting the DNA/RNA of pathogens. “Unlike traditional serology testing, NAT offers unparalleled sensitivity and early detection capabilities, making it an indispensable tool in ensuring access to safe blood. By complementing serology testing with NAT, blood banks can significantly enhance their ability to detect infections at an early stage, thereby minimizing the risk of transmitting TTIs to recipients,” Gupta told Financial Express.com.

According to Gupta, NAT’s high sensitivity allows for the detection of viral markers within a short window period, enabling prompt intervention and treatment. For example, NAT can detect HCV RNA within 5-8 days of infection, effectively bypassing the pre-seroconversion window period of 1-3 months associated with traditional serological tests.

“Furthermore, NAT’s ability to uncover infections such as occult hepatitis B and immunologically variant mutant viruses further strengthens its role in blood safety. These infections, often undetectable through serological tests due to the absence of specific antigens or antibodies, pose significant risks to transfusion recipients. By identifying these elusive infections, NAT ensures that no potential threat goes unnoticed, safeguarding the health and well-being of recipients,” he said.

Beyond its immediate impact on TTI diagnosis, NAT offers long-term benefits by reducing treatment expenses and preventing the spread of infections. In India alone, estimates point towards an HBV carrier rate of 4.7 percent with an estimated carrier population of 56.5 million. Early detection and intervention not only save lives but also alleviate the economic burden associated with prolonged or untreated infections, he said.

How to improve access to safe blood in India?

Mukherjee highlights that it is crucial for the government to urgently evaluate the possibility of consolidating the regulatory framework for blood tender services under a unified legislation-Blood law.

“Discontinuation of blood to be a part of the Drugs and Cosmetics Act. The regulatory body should extend its focus beyond merely granting licenses to blood banks. The National Blood Transfusion Council (NBTC) should assume the role of regulating blood-related matters. To prevent the transmission of diseases such as HIV through blood, it is crucial to enforce high-quality standards like NAT. Additionally, the government should initiate a nationwide voluntary blood donation awareness campaign,” she told Financial Express.com.

According to Gupta, to improve access to safe blood in India at a policy and regulatory level, several key actions need to be taken:

• Enactment of Comprehensive Blood Legislation: Implement comprehensive blood legislation that mandates Nucleic Acid Testing (NAT) alongside traditional serological testing for all blood donations. NAT allows for earlier detection of transfusion-transmitted infections (TTIs) such as HIV, Hepatitis B (HBV), and Hepatitis C (HCV), significantly enhancing blood safety.
• Centralisation of NAT Testing: Establish centralised NAT testing facilities to ensure uniformity and efficiency in the screening process. Centralisation will help standardise testing procedures, reduce costs, and ensure high-quality testing across all regions. This approach will enhance the reliability and safety of the blood supply nationwide.
• Alignment with International Standards: Review and update the guidelines of the National Blood Transfusion Council (NBTC) to align with the World Health Organization (WHO) assessment criteria. This alignment will ensure that India’s blood transfusion services meet global best practices, improving the quality and safety of the blood supply.
• Incorporation of NBTC into the Regulatory Framework: Designate NBTC as the regulatory authority for blood transfusion services, granting it oversight and licensing authority in collaboration with the Central Drugs Standard Control Organization (CDSCO). This integration will streamline regulatory processes and ensure consistent adherence to safety standards nationwide.
• Promotion of Voluntary Blood Donation: Make the renewal of blood bank licenses contingent upon achieving a specified percentage of blood collection through voluntary donations. This policy will encourage community engagement and foster a culture of voluntary blood donation, addressing the persistent challenge of blood shortages and ensuring a stable and safe blood supply.
• Inclusive Policy Development: Involve patient bodies and civil society in the policy-making process. Fostering collaboration and incorporating diverse perspectives will lead to the development of comprehensive policies that effectively address the challenges faced by the blood transfusion system. This inclusive approach ensures that policies are responsive to the needs and concerns of all stakeholders.

“Recognising the need for enhanced blood safety measures, Roche introduced the concept of NAT centralised testing, revolutionizing the way blood banks screen for TTIs. This innovative approach operates on a hub and spoke model, where blood samples collected from smaller, remote blood banks in barcoded vacutainers are transferred to a centralized testing processing center. Here, the samples undergo screening through automated NAT PCR systems, ensuring rapid and accurate detection of TTIs,” he explained.

Roche has empowered 141 blood banks across India to deliver improved quality, safety, and efficacy in blood transfusion practices, with 66 sites equipped with NAT instruments and 75 satellite sites sending samples to these NAT sites, Gupta claimed.

“Roche’s efforts have already borne fruit, with successful implementations of the centralised testing concept in states like Odisha and Madhya Pradesh- provided tangible solutions to enhance the accessibility and quality of safe blood for patients in need,” he added.