Latest news with #NationalAccreditationBoardforTestingandCalibrationLaboratories
Hindustan Times
6 days ago
- Health
- Hindustan Times
Human cost of poor-quality testing in India
Ramesh, a 32-year-old construction worker, first visited his local clinic when he was having persistent cough and it refused to go away. For over two months, he had been suffering from coughing, recurring fever, and unexplained weight loss. The classic symptoms that should have raised red flags for tuberculosis (TB). But due to limited infrastructure and inadequate diagnostic support, his condition was misread as simple bronchitis. The technician, lacking proper training and resources, failed to spot early signs of TB. The doctor, relying on this flawed report, prescribed a general course of antibiotics and sent Ramesh home. Two more painful months passed. Ramesh's condition worsened. His cough began producing blood, and severe fatigue left him unable to work. This story reflects a deeper systemic failure of our country. Low-quality diagnostic services, often driven by under-resourced facilities, lack of quality checks, and poor training, lead to misdiagnosis, delayed treatment, worsening health, and higher health care costs. In situations like Ramesh's, the need is not for centralised, high-end laboratories but for accessible, quality-assured diagnostics at the point of care, especially for conditions like respiratory infections, diarrhoeal diseases, sexually transmitted infections (STDs), and chronic diseases like diabetes and kidney dysfunction. Many of these tests do not require the National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation. What's crucial is to ensure standardised quality control for every batch of diagnostics and robust supply chains so that tests are accurate, affordable, and always available where they are needed most. Most of the syndrome-based approaches such as fever, STDs where the diagnostic should be available at a point of care with a quality check. The cervical cancer diagnostics should be provided with appropriate quality checks, the same is with glucose levels, HB levels as well as basic diagnostics for lipids, kidney, liver tests. Point-of-care diagnostics for respiratory tract infections and diarrhoeal diseases must be made widely available, given the high mortality associated with these conditions. Just like medicines, every batch of diagnostic kits should undergo stringent quality checks and be supported by robust supply chain and storage systems. Currently, many government hospitals and public health facilities function without NABL accreditation. This underscores the need to build a parallel grassroots-level accreditation system, modeled along the lines of National Accreditation Board for Hospitals & Healthcare Providers (NABH), but adapted to rural realities. Such a system would ensure minimum quality benchmarks, especially for programme-related diagnostics and should be integrated into national health schemes including those under the Ayushman Bharat PM-JAY. The lack of structured quality control has allowed an influx of unreliable diagnostic tools in both public and private sectors. Each diagnostic batch, like medicines, must undergo quality verification before deployment. This is especially critical for widespread conditions like cervical cancer, glucose imbalance, anaemia (Hb levels), and liver/kidney dysfunction, where inaccurate results can lead to incorrect treatment or no treatment at all. To ensure sustained quality, regular training and upskilling of lab technicians must be mandated. Training should focus not only on basic test operations but also on ethical diagnostic practices, quality assurance, storage standards, and the correct use of surveillance tools, which should never be substituted for clinical diagnostics. According to the National Health Profile 2023, only 12% of primary health centers (PHCs) have diagnostic labs and many of those do not meet even basic standards. The result is a massive diagnostic gap in rural India, pushing patients toward unregulated, low-quality private labs. The consequences are severe: delayed or missed diagnoses, prolonged disease burden, high out-of-pocket costs, and ultimately, preventable deaths. While decentralised diagnostics are essential, India must also invest in national reference labs to support complex testing and surveillance. Establishing 50 NABL-accredited reference labs, each serving approximately 25 million people, would ensure comprehensive national coverage. These hubs should be equipped with Artificial Intelligence (AI)-assisted digital microscopy, real-time PCR machines, and cloud-based data systems for seamless health care integration. Public-private partnerships can be leveraged to train lab personnel at these reference centers, ensuring they are equipped with both theoretical knowledge and hands-on skills. Curriculum should emphasise AI tools, quality protocols, and patient-centric diagnostic delivery. Diagnostics are not just support tools; they are central to effective healthcare delivery. Without timely, accurate testing, even the best clinical decisions can fail. As India aspires toward Universal Health Coverage and a $ 5 trillion economy, strengthening diagnostic services, particularly at the last mile, is not optional. It's an urgent public health imperative. This article is authored NK Ganguly, former director general, Indian Council of Medical Research (ICMR).
Indian Express
11-05-2025
- Science
- Indian Express
Padma Shri awardee scientist Dr Subbanna Ayyappan found dead in Karnataka's Mandya, suicide suspected
Padma Shri awardee and esteemed agriculture and fisheries scientist Dr Subbanna Ayyappan, who had been missing for a few days, was found dead in the Srirangapatna taluk of Karnataka's Mandya district Saturday evening. Dr Ayyappan, who lived with his wife in Visvesvaraya Nagar, Mysuru, had been reported missing since May 7. His family members filed a missing person complaint at the Vidyaranyapuram Police Station. The police said they were alerted by a resident who spotted a body floating near the Cauvery River. When the police arrived at the spot, they identified the deceased as Dr Ayyappan, and also found his two-wheeler near the riverbank. The police said the initial investigations suggest Dr Ayyappan, 69, may have died allegedly by suicide around three days ago, adding they are continuing their probe to confirm the cause of death. The body has been moved to K R Hospital in Mysuru for a postmortem examination. Srinidhi, Dr Ayyappan's relative and a practising advocate, said he often visited the Ramakrishna and Sai Ashrams for meditation and spiritual reflection. Born on December 10, 1955, in Chamarajanagar district's Yalandur, Dr Ayyappan had a distinguished academic journey, completing his Bachelor's and Master's degrees in Fisheries Science from Mangaluru, followed by a PhD from the University of Agricultural Sciences, Bengaluru. He held several top positions nationally and was instrumental in promoting India's Blue Revolution, significantly boosting aquaculture development. In 2022, the government recognised his contributions by awarding him the Padma Shri. At the time of his passing, he served as the chairperson of the National Accreditation Board for Testing and Calibration Laboratories (NABL).
New Indian Express
27-04-2025
- Health
- New Indian Express
Land identified for Tamil Nadu's first Medical Devices Testing Laboratory in Coimbatore
COIMBATORE: After around three months of no progress, the Coimbatore district administration has identified land for constructing the state's first Medical Devices Testing Laboratory at Kavundampalayam. Revenue department land, spanning around 1.28 acres, has been identified for the project. "A portion of the land (around 50 cents) has been earmarked to construct the Kavundampalayam police station while the rest would be allocated to the drug administration department. The joint committee comprising the district administration and the drug administration department, along with the health officials, visited the location at Jeeva Nagar in Kavundampalayam on Thursday and held a discussion about the possibilities of establishing the laboratory," said sources, adding that the land will be officially handed over to the drug administration department soon. Testing A and B category medical devices at government-owned laboratories are a part of the Medical Devices Rules, under the Drug and Cosmetics (D&C) Act, which came into force in January 2018. However, the drug administration department in Tamil Nadu has not performed any tests on medical devices due to the lack of a specialised laboratory in the state. Based on a request from the state government, the central government approved the plan to establish a well-equipped NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited laboratory for testing medical devices, including in-vitro diagnostics, at Coimbatore. In a Memorandum of Understanding (MoU) between the central and state governments under the Strengthening of State Drug Regulatory System scheme, Rs 29.67 crore was allocated for the project in mid-2024-25, in a fund sharing ratio of 60:40 by the centre and the state, respectively. Even though it was announced in December 2024, there was no progress. Recently, Health Minister Ma Subramanian announced the project during the discussion on demands for grants in the Assembly. On April 22, a TNIE report highlighted that the delay in allocating land had affected the progress of setting up the lab. District Collector Pavankumar G Giriyappanavar had also assured that the land identification process will be wrapped up at the earliest.
New Indian Express
22-04-2025
- Health
- New Indian Express
Delay in land allotment hits progress of TN's first medical devices testing lab
COIMBATORE: The state government is set to establish the first Medical Devices Testing Laboratory in Coimbatore district for Rs 29.67 crore. However, sources said the project is yet to commence due to delay in land identification process by the district administration. The Medical Devices Rules, under the Drug and Cosmetics (D&C) Act, came into effect in January 2018, bringing medical devices under the broader umbrella of the Act. It required manufacturers, importers and sellers to obtain necessary permissions for their activities. Testing medical devices at government-owned laboratories is also a part of the rules. However, the drug administration department in Tamil Nadu has not performed any tests on medical devices due to the lack of a specialised laboratory in the state. After long, the project was officially announced in December 2024. Health Minister Ma Subramanian officially announced the project during demands for grants, sources said. Based on the proposal from the Director of Drugs Control, Tamil Nadu, the central government approved the plan of establishing a well-equipped NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited laboratory for testing medical devices, including in-vitro diagnostics, exclusively in Coimbatore. In a Memorandum of Understanding (MoU) between the central and state government under the Strengthening of State Drug Regulatory System scheme, Rs 29.67 crore was allocated for the project in mid-2024-25, in a fund sharing ratio of 60:40 by the centre and the state, respectively. Sources said there has been no progress in setting up the laboratory. "Considering the importance of the standard of medical devices, the central government introduced separate rules to them, and this mandates proper testing at laboratories. Even after the rule came into force, it could not be followed as there is no proper lab facility. While the establishment of the laboratory is expected to play a major role in testing medical devices across the state, the ongoing delay in land identification has raised concerns that the allocated funds might be returned as they remain unused," said sources. "There are well-equipped laboratories for drugs in Chennai and Madurai. As we have medical device manufacturers in Coimbatore region, and it is also an industrial hub, we chose to establish the device testing laboratory here. This lab is to test class A and B category medical devices. We need around one acre, including 20,000 sqft for the laboratory. Once the Coimbatore district administration identifies the land, we can start work through the Public Works Department. We sent a letter to the Coimbatore district collector, and a communication through the health secretary. We hope to get the land allotment soon," said MN Sridhar, Director of Drugs Control. Coimbatore District Collector Pavankumar G Giriyappanavar said, "We have shortlisted few parcels of lands, and will finalise it at the earliest as we are in the final stage of confirming the land."
