A test for thalassemia patients
For the past 5 years, 11-year-old Jai has been a regular visitor to his city’s government hospital. He was diagnosed with thalassemia when he was 6 years old and needs blood transfusions at regular intervals. Last month he fell ill after a blood transfusion and was rushed to the nearest hospital. After medical investigation, it was revealed that he had contracted the human immunodeficiency virus (HIV) through a blood transfusion. Such cases highlight the need to implement better screening and blood testing standards in India.
With around 42 million carriers of beta thalassemia and 10,000 new cases diagnosed every year, one in eight patients with thalassemia resides in India. The lifelong thalassemia treatment regime puts parents under enormous financial stress. As thalassemia patients require regular blood transfusions, they are always susceptible to transfusion-transmissible infections (TTIs). There has been an increase in cases of transfusion-related illnesses due to poor blood safety and lack of proper testing. According to data shared by the Centers for Disease Control and Prevention (CDC), one in 100 HIV-positive patients could be the victim of an infected blood transfusion in India. Although it is mandatory to screen all units of blood collected for hepatitis B virus (HBV), HIV and hepatitis C virus (HCV), syphilis and malaria by serological tests, there remains a risk of transmission of TTIs due to serological infections, hidden diseases and the emergence of new variants and viruses. Therefore, it is high time to bring structural reforms to the blood transfusion process by adding an extra layer of protection.
NAT test: a new benchmark for blood safety
Blood safety is an ever-evolving concept that needs to be updated as technology improves. There should be basic checks and standards to ensure the blood is safe and of good quality. The current test system, the enzyme immunoassay technique (ELISA), has a higher residual risk of transmitting infections due to a longer window period. Today, with advances in technology, we have a more effective test called Nucleic Acid Test (NAT) which detects viral infections by shortening the window period and plays a vital role in improving blood safety. . NAT testing can reduce the risk of ITT when performed in addition to ELISA. Although many countries have made the NAT test mandatory, it is still only a recommended test for screening ITT in India under the Medicines and Cosmetics Act 2022. However, this law does not talk about blood safety. NAT testing is confined to a few regions due to lack of awareness, infrastructure, and high cost.
Need for a rigorous regulatory framework
Blood is classified as a ‘drug’ under section 2(b) of the Medicines and Cosmetics Act 1940. This law and its rules provide the legal framework for regulating the operation of blood banks. The Supreme Court in 1996 issued several directives to ensure blood safety, which included the establishment of the National Blood Transfusion Council (NBTC) and National Blood Transfusion Councils (SBTC), mandating the granting of blood bank licenses, framing an immediate and long-term strategy. term plan for blood safety and the adoption of separate legislation to regulate blood processes. Although further guidance has been implemented, no action has been taken with respect to the implementation of a long-term plan for blood safety with separate legislation in place.
As the new Drugs, Medical Devices and Cosmetics Bill, 2022 takes the right approach in the direction of the government’s progressive initiatives in regards to online pharmacies, Ayush products, medical devices and trials clinics, he fails to mention one of the most important healthcare resources, blood.
A gift that saves lives
With India being the thalassemia capital of the world, the healthcare system is under increasing pressure to ensure safe and standardized blood transfusion services. Voluntary blood donation and the best screening methodologies such as NAT therefore assume a sense of urgency. Today, several large hospitals have incorporated NAT testing, while smaller banks still follow the traditional method. Through a collaborative approach between government, private stakeholders and NGOs, the provision of safe and timely blood to thalassemia patients may soon become a reality. For starters, it would be important to adopt safe blood practices, including voluntary blood donation and standardization of screening technology. However, it would be relevant to work towards a separate regulatory framework for blood transfusion services which not only appoints a single regulatory authority, but also gives it statutory powers.
Now is the time to outline India’s path to ensure blood safety for its people. As a step towards modernizing the regulatory architecture, India needs to constantly review its blood regulatory framework to reflect breakthroughs in TTIs and testing technology for their detection.
The opinions expressed above are those of the author.
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