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Indian Express
an hour ago
- Indian Express
Why minimum standards for handling diagnostic samples are important
The Union Ministry of Health and Family Welfare (MoHFW) last week assured the Delhi High Court that it will soon notify minimum clinical standards for collection, handling, and transport of diagnostic samples. The MoHFW said that subject experts held 'detailed internal deliberations for formulating minimum standards' following which the draft minimum standards were finalised. The policy is currently being vetted by the legislative department of the Ministry of Law & Justice, the MoHFW told the court. Existing Indian Council of Medical Research (ICMR) guidelines on collection and handling of clinical samples are rudimentary and piecemeal. For instance, the Pune-based ICMR-National Institute of Virology (NIV) has specific 'Guidelines for collection, packaging and transport of specimens for testing for high risk viral pathogens', which include guidelines for handling samples containing Covid-19 virus. These guidelines, however, are not comprehensive: they only relate to handling of specific 'high risk' viruses. These are also not uniformly enforced owing to gaps in the law governing labs and sample collection centres, as well as its enforcement. Medical professionals have long been calling for reform; the MoHFW's soon-to-be-notified policy seeks to answer this call. Beyond lack of comprehensive clinical guidelines, experts have pointed to a couple of significant loopholes vis-à-vis the medical testing ecosystem. 🔴 First is the continued existence of standalone collection centres. In 2018, the Centre had notified that sample collection centres should be part of the main laboratories, and that the parent laboratories should be held accountable for their compliance of norms. But in the absence of clear-cut standards, standalone collection centres continue to be registered in various states, posing a fundamental problem when it comes to ensuring compliance with clinical standards. In November 2020, the National Accreditation Board for Testing and Calibration Laboratories (NABL) had flagged that 'there are mismatches in the declaration (of samples) made by (accredited) lab to NABL and the actual collection centres/facilities/sources of collection which are available on their websites or other documents'. At the time, it advised labs to declare all sample collection centres within 30 days, and cautioned that 'any sample collection not under the responsibility of the lab and not covered under its (quality) management system is non-compliant with the accreditation norms and liable to action by NABL.' The MoHFW's new policy will likely address this issue. 🔴 Experts have also called for revisiting current laws guiding 'who' can collect samples and issue reports. In 2019, pathologist Dr Rohit Jain moved the Delhi High Court, challenging the Clinical Establishments (Central Government) Amendment Rules 2018, specifically on minimum requirements for signatory authorities in diagnostic laboratories. He sought implementation of a 2017 order of the Supreme Court, which said that a lab report should be counter-signed only by a registered medical practitioner with a post graduate qualification in pathology. At the time, he also sought guidelines on minimum standards for medical diagnostic labs with regard to sample collection centres, sample transport, electronic signatures on pathological reports by authorised signatories, number of pathology labs a pathologist can visit in a day and on daily internal quality control. But the Centre's Clinical Establishment (Central Government) Amendment Rules 2020 did not address the issue, allowing 'unqualified and unregistered non-medical persons viz MSc/PhD were authorised to issue pathology reports without the signature/counter signature of a pathologist,' according to Jain. Jain challenged these amended rules, and in August 2021, also moved court highlighting an RT-PCR testing 'scam' during the Kumbh Mela in Haridwar that year where one lakh fake tests were reportedly conducted on devotees by unqualified intermediaries. 'The accused diagnostic labs in Delhi and Haryana were able to collect samples and conduct a huge number of tests where they have no sample collection centres at Uttarakhand. It is clear that a scam of such enormity has only been possible because of the lack of essential minimum standards on the issue of sample collection/sample collection centres and sample transport policy,' Jain had argued in his submission. In 2023, the Delhi High Court directed the Centre to consider Jain's plea as a representation and decide a solution in three months. In May 2023, the government held a meeting under the chairmanship of the Additional Director-General of Health Services, New Delhi, where Jain too was invited to make his representation. After the meeting, the government decided to constitute four sub-committees of experts — pathology, biochemistry, hematology and microbiology — to define standards of procedure (SOPs) for sample collection, collection centres and sample transport policy. When these guidelines were not notified even a year later, Jain in May 2024 moved the Delhi High Court again, accusing the government of wilful disobedience of the court's order. It is in this matter that the MoHFW has now assured the court that a policy will be notified at the earliest. Taking the ministry's submission on record, the court instructed that the standards be notified expeditiously, with a direction that the process 'may be accomplished within the next three months'.


Time of India
4 hours ago
- Time of India
2,426 cr Covid fight bill hit state economy hard: Report
1 2 3 Visakhapatnam: The Covid-19 pandemic not only triggered a public health emergency but also imposed significant financial pressure on the Andhra Pradesh exchequer. Between 2019–20 and 2022–23, the state incurred an expenditure of 4,606 crore on various Covid-19 prevention and management measures, according to the CAG report. Andhra Pradesh was among the hardest-hit states, recording over 23 lakh cases—ranking fifth in the country in terms of case load. In response to the emerging crisis, the state ramped up healthcare infrastructure beginning February 2020. Key initiatives included setting up diagnostic labs, expanding testing capacity, procuring medicines and vaccines, strengthening oxygen supply networks, and mobilizing critical medical resources. Although public health is a state responsibility, the Union Ministry of Health and Family Welfare provided both technical and financial aid to assist states in managing the pandemic. The Centre introduced the Emergency Covid Response Package (ECRP) to curb transmission and mitigate impact. Under ECRP-I, funds released to Andhra Pradesh in FY 2020–21 were fully borne by the Centre. In 2021–22, the funding was shared between Centre and state in a 60:40 ratio. According to the CAG report, during the four-year period, Andhra Pradesh received a total allocation of 4,961.36 crore (both Central and state share) and spent 4,606 crore. Of this, the state govt on its part spent 2,426.47 crore. GoI's share amounted to 1,876.44 crore, of which 1,612.45 crore was utilised. From the state disaster response fund, 140.95 crore was used out of the allocated 187.87 crore. Meanwhile, 426.13 crore was spent from the district mineral fund, against an allocation of 534.41 crore. At the onset of the pandemic in Feb 2020, Andhra Pradesh had no Covid-19 testing infrastructure. The state responded swiftly by establishing 135 testing laboratories. Until these labs became operational, test samples had to be sent to other states for processing. During the second wave, the state expanded the number of Covid-19 treatment hospitals from 260 in the first wave to over 640. It also ramped up human resources, recruiting 17,300 doctors and support staff during the first wave, and an additional 18,000 medical personnel during the second wave. Notably, Andhra Pradesh became one of the few states in India to achieve 100% double-dose vaccination coverage among eligible population groups. In a major welfare initiative, Andhra Pradesh became the first state in the country to include Covid-19 treatment under its flagship Arogyasri health scheme (now renamed as NTR Vaidya Seva). This decision enabled over 1 lakh patients to receive free inpatient treatment at private hospitals across the state.


United News of India
5 hours ago
- United News of India
PM Modi, Maldivian President inaugurate MoD building in Male; India delivers two advanced portable hospital units
Male/New Delhi, July 25 (UNI) Prime Minister Narendra Modi and Maldivian President Mohamed Muizzu today jointly inaugurated the state-of-the-art Ministry of Defence (MoD) building of Maldives in Male. Overlooking the Indian Ocean, the eleven-storey building is a symbol of the strong and long-standing defence and security cooperation between the two countries, a statement said. The MoD building has been constructed with India's financial assistance and will contribute towards enhancing the capabilities of the defence and law enforcement authorities of Maldives. Following the inauguration of the Dhoshimeynaa Building, the two leaders viewed a model of the building, and learned about its functions and services. Construction of the building began on 19 February, 2014. The facility will primarily house the Coast Guard division of the Defence Ministry. India has also formally delivered two advanced portable hospital units to the Maldives, marking a significant enhancement of the island nation's emergency medical response capacity and reaffirming New Delhi's commitment to regional health cooperation. Referred to as 'Arogya Maitri Health Cubes', the modular platforms are regarded as the world's first fully transportable hospitals. Each unit includes an intensive care unit (ICU), operation theatre, blood diagnostic equipment, X-ray machine, and power generator, configured to provide critical care for up to 200 individuals over a 72-hour period. Engineered for maximum mobility, the systems can be deployed by helicopter to remote areas and achieve full operational readiness in just 12 minutes. Supplementary kits and medicines allow customisation for varied scenarios, supporting a range of emergency situations. Enhancing this capability is the BHISHM app, a digital tool designed to facilitate configuration and monitor equipment inventories. The Maldives Emergency Medical Service, operating under the Ministry of Health, will oversee the integration of the new facilities into Maldives' emergency response framework. India's assistance to the Maldivian health sector has long reflected a sustained and multifaceted approach. Support has extended to the training of medical personnel, development of urban and atoll-based health infrastructure, and provision of emergency resources, including the expedited supply of Covid-19 vaccines during the pandemic. UNI RN