Daijiworld Media Network - New Delhi
New Delhi, Jun 22: In a significant leap for public health, scientists at the Indian Council of Medical Research (ICMR) have developed low-cost, made-in-India point-of-care (POC) diagnostic kits for genetic blood disorders such as Haemophilia A, von Willebrand Disease (VWD), and Sickle Cell Disease (SCD). These affordable and accessible kits are poised to transform diagnosis and treatment in rural and underserved regions across the country.
These inherited bleeding disorders often remain undiagnosed due to the high cost of testing and limited access to specialized healthcare facilities. India, with a substantial disease burden, particularly for Haemophilia A and SCD, has long faced challenges in early detection and care.
According to estimates, India may have over 136,000 Haemophilia A patients, yet only a small number are officially diagnosed and registered. Similarly, VWD prevalence is estimated at 1 in 12,000 in some areas, with studies suggesting it accounts for 10% of all inherited bleeding disorders. Sickle Cell Disease, notably prevalent among tribal populations (57%) and affecting 43% of non-tribal groups, continues to be a major concern.
Dr. Manisha Madkaikar, Director of the ICMR-Centre for Research, Management, and Control of Haemoglobinopathies (CRMCH) in Chandrapur, Maharashtra, highlighted the progress made:
“We now have multiple diagnostic tests made entirely in India. This is a moment of pride for our healthcare system.”
Developed by ICMR-National Institute of Immunohaematology (NIIH), the new POC kits for Haemophilia A and VWD can now be used even at Primary Health Centres (PHCs), drastically improving reach. Each test costs just Rs 582, a fraction of the traditional Rs 2,086 lab-based tests, and is expected to help uncover over 83,000 undiagnosed cases, potentially saving Rs 42 crore in public healthcare costs.
These diagnostic tools are being integrated into the national health program across states, bringing early detection to the local level.
“Affordable testing at PHCs will help us find and treat blood disorders early, improve patient outcomes, and dramatically cut costs,” said Dr. Madkaikar.
Globally, the innovation has also attracted attention. The World Federation for Hemophilia has expressed interest in procuring these India-made tests for use in other countries grappling with similar healthcare challenges.
On the Sickle Cell Disease front, ICMR-NIIH (Mumbai) and CRMCH (Chhattisgarh) have been designated as official nodal agencies for validating diagnostic kits. So far, 30 kits have been approved, ranging from simple finger-prick tests to sophisticated molecular and HPLC-based methods. These kits are central to India's National Sickle Cell Elimination Mission, which aims to screen over 7 crore people.
While the initial cost of SCD diagnostic kits stood at Rs 350 per test, ICMR's comprehensive evaluation pegged the optimal cost for mass screening at Rs 100 or less. Today, newly approved indigenous kits are priced at under Rs 50, drastically lowering the economic barrier to diagnosis.
“When the national mission began, we had only two imported point-of-care tests, each costing around Rs 350. Now, multiple Indian manufacturers are offering solubility, POC, and molecular tests—all affordable, effective, and made in India,” Madkaikar said.
This public health breakthrough not only supports India’s drive for self-reliance under Atmanirbhar Bharat but also marks a critical shift in the early diagnosis and management of genetic blood disorders—one that could serve as a model for low-resource settings globally.