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Currently, many of these blood centers rely on rapid card tests, which are quick, disposable tests that screen for infection using a small blood sample but with lower sensitivity than laboratory-based methods such as ELISA, which uses enzymes and antibodies to accurately detect the virus and other disease-markers in the blood.
The Centre’s move aims to standardize safety protocols and curb regulatory non-compliance in the backdrop of six children in Jharkhand suffering from HIV (human immunodeficiency virus) infection from contaminated blood transfusions in government hospitals last month. The new protocol requires all blood centers to adopt the ELISA, which is the most effective standard for detecting transfusion-transmissible infections such as HIV and hepatitis B and C.
Document reviewed peppermint A comprehensive proposal has been outlined to ensure timely renewal of blood center licenses and mandatory transfusion-transmissible infection testing through ELISA. The matter was discussed last week at a meeting of the Central Drugs Standard Control Organization (CDSCO), which is chaired by the Drugs Controller General of India.
The development is significant for India’s network of 4,153 licensed blood centres, which cater to the annual requirement of 14.6 million units. In addition to testing upgrades, CDSCO will implement mandatory, regular inspections for all facilities, including government hospital-based centres. Additionally, the government has directed that the licensing recommendations for charitable and voluntary organizations will have to strictly adhere to the National Blood Transfusion Council (NBTC) norms.
The first of the two officials cited earlier said these measures are aimed at ensuring facilities remain compliant with blood safety protocols. Regarding licensing of charitable and voluntary organisations, the official said the guidelines laid down by NBTC should now be strictly followed. “These steps are expected to create a more robust and safer blood transfusion system,” the official said.
Questions sent to the Health Ministry remained unanswered till press time.
Highlighting the urgency of these reforms, the document notes serious concerns regarding non-compliance with medication regimens, particularly as seen in recent incidents at hospital-based blood centres.
To overcome these shortcomings, all licensing authorities have been asked to ensure periodic inspection of every facility, including government centres, to verify strict compliance with the applicable rules.
“Special attention may be given to testing for viral markers to ensure safe blood,” the document says.
This change is important for India’s public health, as the ELISA offers higher sensitivity, significantly reducing the risk of “false negatives” and preventing contaminated blood from reaching vulnerable patients such as thalassemia or trauma victims.
Dr. R., former scientist of the Indian Council of Medical Research (ICMR). Gangakhedkar said the Elisa test can detect infection in the window period better than rapid tests. It can detect infection even where the viral load is low.
“This reduces the risk of blood unit recipients contracting transfusion-transmitted infections such as HIV, hepatitis B and C. Since rapid tests are cheaper and can be done quickly, blood banks can use them instead of ELISA. It is important to ensure compliance with this through inclusion in audits will add value to overall strategies to reduce transfusion-transmitted infections,” he said.
Dr. Anu Kundra, senior vice president of lab operations at Agillus Diagnostics, said the government’s decision is a “timely and important public-health intervention.”
He said ELISA is a cost-effective, World Health Organization-recommended method for large-scale testing, making it a strong step towards ensuring safe transfusions. However, he added a caveat regarding the limitations of the technology.
“It is important to note that ELISA cannot detect infection during the early window period. Globally, many advanced blood centers supplement ELISA with nucleic acid amplification testing (NAAT) to improve early detection – although NAAT is significantly more expensive. Nevertheless, the current step strengthens baseline safety and brings greater discipline and standardization in blood screening practices across India,” Dr Kundra explained.
“Non-compliance with blood safety protocols can have serious consequences, primarily life-long transmission of infections such as HIV, hepatitis B and C and syphilis,” warned Dr Kundra. He elaborated that even a single lapse in screening or maintenance could compromise the integrity of the blood, putting recipients at irreversible risk. “Beyond individual harm, such failures undermine public trust and burden the health care system. Rigorous, standardized screening practices such as mandatory ELISA testing are absolute necessities to ensure a safe blood transfusion ecosystem.”
The second official also pointed to the health ministry’s digital system e-Raktakosh, which connects all blood banks on a single platform to streamline and monitor their operations.
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