
India to introduce more advanced testing for imported blood products to reduce infection risk
The ministry intends to introduce nucleic acid testing (NAT) to improve the screening of imported blood products for antibodies of the human immunodeficiency virus (HIV), the hepatitis B virus, the hepatitis C virus and other impurities, an official aware of the matter said.
The decision to shift to NAT has already been taken by the regulator, the Drug Controller General of India (DCGI), and the matter was discussed at the Drugs Technical Advisory Board meeting in April. The board is the highest statutory body responsible for advising the Central and state governments on technical matters related to the administration of the Drugs and Cosmetics Act, 1940.
Also Read | Banking on blood: Health ministry frames guidelines to curb paid donations, improve efficacy of transfusions
With the introduction of NAT, the conventional testing method known as ELISA, or enzyme-linked immunosorbent assay, will be done away with. ELISA, while a powerful tool, has several drawbacks, including the potential for false positive and negative results, apart from being time-consuming.
The Department of Pharmaceuticals and the National Institute of Biologicals (NIB) in Noida had issued an alert in October after the NIB found three imported blood products—Berirab-P (used in rabies injections), Hepabig (to prevent hepatitis B virus infection) and Tetglob (used for tetanus treatment)—to be of sub-standard quality.
When the Berirab-P and Hepabig samples were tested again at the National Institute of Virology in Pune using an advanced version of polymerase chain reaction, which is more sensitive than ELISA, they passed the test metrics. The set of Tetglob samples sent to a private laboratory that used ELISA were non-reactive.
Safety standards
Bharat Serums and Vaccines Ltd, now owned by Mankind Pharma, is the only company in the country that imports these lifesaving blood products.
Imported blood products are used for the treatment of critically ill patients or those who are suffering thalassemia and other blood-related disorders. These products are tested at government laboratories to ensure they meet safety and quality standards.
Also Read | India plans standard evaluation and quality protocols for HMPV' testing kits
'These are tested using conventional methods, but now the plan is to amend the rules to allow an advanced version of testing in line with international practices," the official said. 'NIB also proposed that an amendment may be considered to test blood products by NAT."
Queries sent to the health ministry, the Department of Pharmaceuticals and the Mankind Pharma spokesperson remained unanswered till press time.
'NAT testing gives accurate and quick results and nowadays it is highly used. NAT testing is used for tuberculosis and NAT testing was modified during the covid-19 pandemic to detect the coronavirus," a scientist from the Indian Council of Medical Research said, requesting anonymity. 'The ELISA test may sometimes give false results if the viral load in the sample is low. However, PCR and NAT give accurate results even if the viral load is low."
Also Read | ICMR and CDSCO develop framework for validation of pathogen identification and antimicrobial susceptibility testing
According to an assessment by the National Blood Transfusion Council, the apex policymaking body for issues pertaining to blood and plasma, the clinical requirement of blood in the country is about 14.5 million units per year. The volume of each unit of blood is about 450 ml.
In India, the import, manufacture, distribution and sale of drugs, cosmetics and notified medical devices are regulated by the Drugs and Cosmetics Act and the Drugs and Cosmetics Rules, 1945.

Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles


Time of India
2 days ago
- Time of India
Rapid test kits for Hepatitis B, Sickle cell anemia to be available at PHCs, government decides
NEW DELHI: In a big move to ensure timely detection of common diseases like Hepatitis B, sickle cell anemia and syphilis at primary level, the Indian Council of Medical Research (ICMR) has suggested that rapid diagnostic tests (RDTs) to diagnose them should be available at rural health centres. This includes the Ayushman Arogya Mandirs Sub-Centres and primary health centres. Sources said the move follows feedback received from national programs and other subject experts, who highlighted the growing importance of providing rapid diagnostic tools at primary health facilities for early detection and treatment. Many RDTs available in the market have not been included for the want of robust evidence. Officials said these tests can be reconsidered for inclusion in the National Essential Diagnostics List (NEDL) once the required data is comprehensively assessed and verified, the officials said. The ICMR, which is the apex health research agency, released the NEDL in 2019 to set basic standards for availability of diagnostic facilities at health facilities in the country. Recently, it has been updated to include RDTs and other requirements. For example, the 2019 NEDL had kept certain diagnostic tests under the "hub-and-spoke" model at primary health centres (PHCs). A hub and spoke model in a laboratory setting is a healthcare delivery strategy where a central, well-equipped "hub" laboratory provides specialized diagnostic services, while smaller, less equipped "spoke" laboratories handle routine and less complex testing, with samples often transferred between the two. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like No annual fees for life UnionBank Credit Card Apply Now Undo However, the updated equipment list which was released recently suggests these tests should be available at the PHCs itself. This will do away with the need for sample transfer to hubs thereby making it possible to diagnose and treat a wider array of conditions at the lower level, the ICMR says. The updated NEDL also addresses the issue of new nomenclature of healthcare facilities with Sub-Centres now referred to as Ayushman Arogya Mandirs. The revision of the National Essential Diagnostics List (NEDL) was undertaken through extensive engagement with a wide range of stakeholders. The process began with an open call on the ICMR website inviting suggestions on the existing Essential Diagnostics List. This was followed by four rounds of consultations to discuss the suggestions received with the relevant experts and stakeholders. Subsequently, the draft revised list was deliberated with representatives from State NHM and the Ministry of Health and Family Welfare. The final list incorporated the feedback and recommendations received in all consultations, officials said.


Indian Express
2 days ago
- Indian Express
ICMR recommends tests for TB, hepatitis at PHCs: How will this improve public health?
From rapid diagnostic tests for Hepatitis B, point-of-care tests for thalassaemia and sickle cell disease, to sample collection for molecular testing for tuberculosis (TB) at the sub-centre level — the Indian Council of Medical Research (ICMR), has updated its National List of Essential Diagnostics with the aim of bringing clinical testing closer to people. The National List of Essential Diagnostics — first released in 2019 — is a list of all the tests that must be available at different levels of health facilities, such as sub-centres, primary health centres or district hospitals. One of the key changes in the second iteration of the list is the inclusion of several rapid diagnostic and biochemical tests at lower levels of health centres, keeping in mind the expanding infrastructure over the years. The government's healthcare delivery mechanism provides primary care through sub-centres, primary healthcare centres (PHCs) and community healthcare centres (CHCs), secondary care through sub-district hospitals, tertiary care through district hospitals and super-speciality care through medical colleges. Why was the list revised? 'In the six years since the first list was released, there have been significant changes. Take, for example, the government investing in semi-auto analyzers at the PHC level. This means the tests can be performed at the PHC itself, instead of the samples being sent to a higher centre for analysis in a hub-and-spoke model,' said Dr Kamini Walia, senior scientist at ICMR, who was behind the compilation of the list. 'There have also been changes to the Indian Public Health Standards and the Integrated Public Health Laboratory Standards, so it was a good idea to revisit the list,' she added What are the new tests in the 2025 list compared to the one released six years ago? Several rapid diagnostic tests that have been added include those for sickle cell anaemia, thalassaemia, Hepatitis B and syphilis at the sub-centre level. Many of these are priority diseases for the government. The new list also recommends collecting samples for dengue testing at the sub-centre level. Over the years, the spread of the mosquito-borne disease has expanded to all states of the country, making it a bigger public health challenge. Many of the blood tests — such as those to check for blood glucose levels, liver enzymes, and cholesterol — which could not be performed at the primary health centre level earlier, are now recommended at that level, with semi-auto analyzers (machines for conducting chemical and biological analysis of samples with minimal human intervention) becoming available. What do the new tests mean for public health? The updated list, once implemented, will have significant public health implications. Experts point out that the list has been updated keeping in view the ambitious targets set for specific diseases. For instance, the government runs a national mission aimed at eliminating sickle cell anaemia by 2047 by screening people and making them aware of whether they are carriers of the faulty gene. The mission also focusses on quick and accurate diagnosis of the disease and providing quality care to patients. The government runs the National Viral Hepatitis Control Programme, which focusses on reducing cases and deaths due to the various hepatitis infections. How this is likely to enhance sample collection for critical diseases at the sub-centre level The 2025 list recommends collecting samples for molecular TB testing right from the sub-centre level. For sub-centres and primary health centres, it recommends collecting sputum samples and sending them to a higher centre. From the community health centre level onwards, it recommends performing these tests in-house. This has been made possible due to the penetration of cost-effective molecular testing machines even in smaller centres during the pandemic. The country's National TB Elimination Programme recommends that molecular diagnosis become the first line of testing, instead of the less sensitive microscopy. The burden of the pathogen has to be much higher for it to test positive using microscopy, meaning the use of molecular tests can detect many more cases, including asymptomatic ones. It can also determine if a person is resistant to commonly used medicines. . The list calls for samples for sophisticated tests — such as HbA1c, which shows average blood glucose levels over a period of three months — to be collected at the PHC level and sent to a higher centre. The government has been focusing on controlling and caring for people with lifestyle diseases such as diabetes, hypertension and cancer. At the CHC level, the new list has also added tests such as the TB skin test, which can detect the presence of the pathogen even in people who do not have an active infection. Dental X-rays have now been added at the CHC level. This is important, considering the government's goal of ensuring these tests are available at its centres. 'This list is important because it is implemented in the health centres under the Free Diagnostics Service Initiative, which ensures that these tests are available at all health centres and, in turn, reduces people's out-of-pocket expenditure on healthcare,' said Dr Walia. In addition, the 2025 list has also merged the diagnostic lists for sub-district hospitals and district hospitals. This is because sub-district hospitals are being upgraded to district hospitals, while district hospitals are being upgraded to the level of medical colleges across the country, Dr Walia explained.


Time of India
6 days ago
- Time of India
NAT should be mandatory at all blood banks: Experts
New Delhi: Diagnosed with thalassemia at the age of two, a 23-year-old woman depended on blood transfusions every three weeks to stay alive. But when she was hospitalised with dengue in Class VIII, doctors discovered something more alarming - she was diagnosed as HIV-positive. "I wasn't recovering. After several tests, they told me I was HIV-positive. I suspect it came from a transfusion. If the blood was properly tested, maybe this wouldn't have happened," she said. Now living with both thalassemia and HIV, she depends not only on regular transfusions, but also on antiretroviral treatment. The woman's testimony at the roundtable on "Ensuring Safe Blood for All: Strengthening Blood Safety Practices", organised by the Thalassemia Patients Advocacy Group (TPAG) at India International Centre on Thursday, brought into sharp focus the urgent need to fix India's entire blood safety ecosystem. Experts at the event called for comprehensive reforms - from mandatory nucleic acid testing ( NAT ) at all blood banks to boosting voluntary blood donation and patient participation in policymaking. NAT, which detects HIV, Hepatitis B and Hepatitis C during the early infection "window period", is far more effective than standard tests, but is not yet mandatory across India. "Safe blood is not just about testing - it begins at the source," said Dr Sangeeta Pathak, secretary general of Indian Society of Blood Transfusion & Immunohematology (ISBTI) and head of Transfusion Medicine at Max Saket. "Voluntary, non-remunerated blood donation is key. Sri Lanka has achieved 100% voluntary donation. Why not India?" She called on both professionals and the public to take ownership. "We must talk about it, promote it, and strengthen the culture of safe, voluntary blood donation." Anubha Taneja Mukherjee, member secretary, TPAG, reminded participants that blood safety is a matter of human rights. "This isn't just a technical issue. It's about dignity, equity, and the right to safe, life-saving interventions." Public health advocate Prof Bejon Kumar Misra emphasised the need for transparency and accountability. "Safety is non-negotiable. People have a right to know what is being done - and what's not. Communication is critical. We need strategies that ensure no patient falls through the cracks." P C Sen, senior Supreme Court advocate, reiterated the state's legal obligation to ensure access to pathogen-free blood .