Currently, many of these blood centres rely on rapid card tests, which are quick, disposable tests that check for infections using a small blood sample but with lower sensitivity than lab-based methods like ELISA, which uses enzymes and antibodies to precisely detect viruses and other disease-markers in blood.
The Centre’s move aims to standardize safety protocols and curb regulatory noncompliance in the backdrop of six children in Jharkhand contracting HIV (Human Immunodeficiency Virus) infections from contaminated blood transfusions at government hospitals last month. The new protocol requires all blood centres to adopt ELISA, the most effective standard for detecting transfusion-transmissible infections such as HIV, and Hepatitis B and C.
The document reviewed by Mint outlines a comprehensive proposal for ensuring timely renewal of blood centre licences and mandatory transfusion-transmissible infections testing via ELISA. This matter was discussed in a meeting last week of the Central Drugs Standard Control Organisation (CDSCO), which is headed by the Drugs Controller General of India.
The development assumes significance for India’s network of 4,153 licensed blood centres, which cater to an annual requirement of 14.6 million units. Besides testing upgrades, the CDSCO will enforce mandatory, regular inspections for all facilities, including government hospital-based centres. Additionally, the government has directed that licensing recommendations for charitable and voluntary organizations must strictly adhere to National Blood Transfusion Council (NBTC) norms.
The first of the two officials cited earlier said that these measures are intended to ensure facilities remain compliant with blood safety protocols. Regarding the granting of licences to charitable and voluntary organizations, the official said the guidelines laid down by the NBTC must now be strictly followed. “These steps are expected to create a more robust and safe blood transfusion system,” the official added.
Queries sent to the health ministry remained unanswered till press time.
Highlighting the urgency of these reforms, the document noted serious concerns regarding noncompliance with drug rules, particularly observed in recent incidents at hospital-based blood centres.
To address these gaps, all licensing authorities have been asked to ensure periodic inspections of every facility, including government centres, to verify strict compliance with the applicable rules.
“Special focus may be accorded to the testing of viral markers to ensure issue of safe blood,” the document states.
This shift is critical for India’s public health, as ELISA offers higher sensitivity, thereby significantly reducing the risk of “false negatives” and preventing contaminated blood from reaching vulnerable patients, such as those with thalassemia or trauma victims.
Dr R. Gangakhedkar, a former scientist at Indian Council of Medical Research (ICMR), said the ELISA test can detect infections in a window period better compared to the rapid tests. It can detect infection even where the viral loads are lower.
“This reduces the risk of passing transfusion-transmitted-infections such as HIV, Hepatitis B and C to those who receive the blood unit. Since doing rapid tests are cheaper and can be done quickly, the blood banks may use them instead of ELISA. Ensuring its compliance is vital through inclusion in audits will add value in the overall strategies to reduce transfusion-transmitted-infections,” he said.
Dr Anu Kundra, senior vice-president, lab operations, Agilus Diagnostics, said the government’s decision is a “timely and critical public-health intervention.”
She noted that ELISA is a World Health Organization-recommended, cost-effective method for large-scale screening, making it a robust step toward ensuring safer transfusions. However, she added a caveat regarding the technology’s limitations.
“It is important to note that ELISA cannot detect infections during the early window period. Globally, many advanced blood centres complement ELISA with nucleic acid amplification testing (NAAT) to improve early detection—though NAAT is significantly more expensive. Even so, the current move strengthens baseline safety and brings greater discipline and standardization to blood screening practices across India,” Dr Kundra explained.
“Noncompliance with blood safety protocols can have grave consequences, primarily the transmission of life-long infections like HIV, Hepatitis B and C, and syphilis,” warned Dr Kundra. She elaborated that even a single lapse in screening or handling can compromise blood integrity, placing recipients at irreversible risk. “Beyond individual harm, such failures undermine public trust and burden the healthcare system. Rigorous, standardised screening practices like mandatory ELISA testing are absolute necessities to ensure a safe blood transfusion ecosystem.”
The second official also pointed to e-RaktKosh, the health ministry’s digital system that links all blood banks on one platform to streamline and monitor their operations.
About the Author
