‘If your hospital's doctor prescribed recombinant factor, that's what patient should get': HC pull up govt
Eight months on, the Delhi government, on July 14, assured the HC that it will proactively ensure that adequate stock of recombinant factor injections are made available in the Capital's hospitals. It also directed the government 'to ensure that adequate numbers of haematologists are recruited and deployed in hospitals run by GNCTD to attend to the patients'.
Gandhi was diagnosed at AIIMS New Delhi with hemophilia when he was three years old – a cut during his mundan ceremony had resulted in incessant bleeding.
While crossing paths with others in a similar situation, his parents came to know of an NGO that ensures availability of fresh frozen plasma (FFP) for hemophilia patients, the prevalent therapy at the time. Over time, the more advanced therapy of recombinant factor, also known as Antihemophilic Factor (AHF), was introduced and made available as therapy for hemophilia patients in India.
Speaking to The Indian Express, Gandhi said, 'Between 2013 and 2019, government hospitals in Delhi were administering recombinant factor therapy. However, after 2019, we started seeing irregular availability of recombinant factor – held to be scientifically more efficacious than plasma… Many government hospitals started seeing plasma-derived factors being made available instead.'
'We would also suffer side effects of the plasma therapy, such as nausea and nose bleed. By 2023, we started witnessing an acute shortage of the recombinant factor therapy in Delhi's government hospitals. Twice a week, I would take a bus from Dhaula Kuan to Jaipur, which was offering a variety of recombinant factor therapies. While the recombinant factor therapy is easily available in tier 2 and 3 cities such as Jaipur and Haridwar, it is not available in the National Capital,' he added.
On July 14, the Delhi government, while admitting to have witnessed a supply shortage of the recombinant factor therapy, brought two experts to the HC – State Blood Cell officer Dr Seema Kapoor and Hemophilia in charge Dr Sunita Aggarwal at Lok Nayak Hospital. They impressed before Justice Datta that from their experience, they have seen 'no difference in efficacy between recombinant or plasma… techniques are so much developed that efficacy is same'.
Justice Datta, however, countered, 'I would generally accept what you have to say. But the court's concern is only one, when doctors prescribe recombinant, it should be available… if your hospital's doctor has prescribed recombinant factor, then that's what the patient should get… The court isn't competent to get into this but only thing is if recombinant is prescribed it should be available.'
The government then informed the HC that 'currently, there are adequate stocks of recombinant factor injections'. It went on to assure that 'proactive efforts shall continue to be made to ensure that there is adequate stock of recombinant factor injections in future as well'.
However, Gandhi – represented by advocate Amit Khanna –pointed at other systemic issues faced by hemophilia patients.
'Most government hospitals in Delhi do not have hemophilia daycare centres and there is no dignity in the way we are treated. Hematologists are not available, which is essential since they will be the ones deciding on the dose, in accordance to the patients' age, weight and other factors. Instead, this is being done by general medicine doctors.'
'At Lok Nayak Hospital, my doses were not given according to my weight. After being administered a dose, they would ask me to come again in 12 hours for the next one. Given our condition which already makes us weak and prone to fatigue, this is harassment…,' said Gandhi, who works in a Delhi-based tendering company.
Owing to hemophilia, which has caused internal bleeding over the years making his joints weak, Gandhi has 69% disability. He said that he was advised knee replacement surgery around five years ago but has been unable to consider the same in the absence of a steady supply of recombinant factor therapy.
'There have been instances where my knees got locked while crossing the road. Any surgery means I will require several doses of the recombinant factor… I have postponed the surgery as there is uncertainty over the availability of the drugs,' he added.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Time of India
6 hours ago
- Time of India
Bombay HC upholds Kirloskar Proprietary's rights on ‘Kirloskar' brand
In a major development in the trademark battle over the 'Kirloskar' brand, the Bombay High Court has upheld Kirloskar Proprietary Limited 's ( KPL ) rights as the registered proprietor of the mark, rejecting the claims of exclusive and perpetual ownership made by Sanjay Kirloskar-led Kirloskar Brothers Limited (KBL). The HC stayed the order of the Pune District Court that had temporarily restrained KPL from creating licensing rights , reaffirming that KPL has been the custodian of the 'Kirloskar' trademarks for over 50 years and is empowered to grant licenses to its member companies as per its Articles of Association. Explore courses from Top Institutes in Please select course: Select a Course Category Healthcare MCA Technology MBA Data Science Management healthcare Artificial Intelligence CXO Others Finance Public Policy PGDM Degree Data Science Digital Marketing Data Analytics Leadership Product Management Cybersecurity Operations Management Design Thinking others Project Management Skills you'll gain: Financial Analysis in Healthcare Financial Management & Investing Strategic Management in Healthcare Process Design & Analysis Duration: 12 Weeks Indian School of Business Certificate Program in Healthcare Management Starts on Jun 13, 2024 Get Details 'There is no material to support the contention of Kirloskar Brothers that it continued to be beneficial owner of the Kirloskar trademarks even after the assignment of the marks. The assignment and user agreements state to the contrary,' a division bench of Chief Justice and Justice M.S. Karnik ruled. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Cardiologist Reveals: The Simple Morning Habit for a Flatter Belly After 50! Lulutox Undo The court noted that the user agreements clearly state that the goodwill in the 'Kirloskar' marks vests with KPL, and that the permitted user (KBL) derives no ownership rights from usage. It further observed that there was no justification at this interim stage to restrain KPL from granting licenses, maintaining that the arrangement has been in place for the past five decades. The HC agreed with KPL's contention that the Pune court had erred in altering the status quo by restricting KPL's licensing rights. It also rejected documents submitted by KBL claiming perpetual ownership, saying they did not establish an exclusive or interminable right. Live Events The matter has been posted for further hearing on August 11.
The Hindu
2 days ago
- The Hindu
Issue guidelines within three months for safe collection, transport of medical samples, Delhi HC tells Centre
In a move that could significantly improve diagnostic accuracy and patient safety, the Delhi High Court has directed the Union government to notify long-pending minimum standards in the collection of medical samples or specimens by laboratories and collection centres, and guidelines to transport them, within the next three months. The order, if implemented, could help curb inaccuracy in test reports, especially when the samples are collected from the home of a patient, experts said. It could also reduce unsafe handling of biological specimens, and treatment errors caused by degraded samples, potentially saving lives, they added. Currently, India lacks specific regulations governing how medical samples, such as blood, urine, or swabs, are collected, stored, and transported to diagnostic laboratories. This regulatory gap has led to widespread inconsistencies, particularly with private labs and home sample collection services that operate without strict oversight. Wrong results 'Patients often assume their test results are scientifically reliable. But when samples are exposed to extreme heat or delayed in reaching the lab, the entire result can become invalid — without anyone realising it,' Dr. Rohit Jain, who had filed a public interest litigation (PIL) on the issue in 2019, said. 'Wrong results lead to wrong treatment. That's not just unethical — it's dangerous,' Dr. Jain said. The High Court, while hearing Dr. Jain's plea on July 18, recorded the Union Health Ministry's assurance that the draft minimum standards, which the Ministry said had already been approved by the Directorate General of Health Services (DGHS), were in advanced stages of being notified. The plea, filed through advocate Mrinmoi Chatterjee, stated that despite the directions of the Delhi HC in January 2023, no guidelines on minimum standards for sample collection had been formulated by the Centre. The Health Ministry, in its latest status report to the court, said the draft minimum standards were currently undergoing legal vetting by the Legislative Department of the Union Ministry of Law and Justice. The Ministry said four expert sub-committees had been formed with specialists in pathology, biochemistry, haematology, and microbiology to formulate 'minimum standards for sample collection and sample transport policy'. Once approved by the National Council for Clinical Establishments, after public consultation, the process of publishing the guidelines in the The Gazette of India would be initiated. The Ministry additionally said two guidelines issued by the Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV) during the COVID-19 pandemic were currently in place which, when read in conjunction with the draft minimum standards, offer comprehensive laboratory guidance in maintaining biosafety and ensuring quality specimen handling. But Dr. Jain remains sceptical. 'These draft standards have been stuck for two years. Meanwhile, nothing has changed on the ground,' he said. 'There are aggregators and collection agents who have no medical training, collecting samples from people's homes. They don't refrigerate them, don't process them in time, and no one is tracking how long it takes before the sample reaches the lab,' Dr. Jain said, when asked why private laboratories should self-regulate. According to him, there are well-established scientific windows within which samples must be analysed —sometimes within 30 to 60 minutes of collection. 'In Delhi's 45°C heat, a delay of even a few hours can completely distort test results. But the government has no binding standard for this. So why would private labs regulate themselves?' he said. The ICMR has issued specific guidelines for transporting specimens related to high-risk pathogens and samples for COVID-19, but those, he said, were limited in scope and not enforceable across all clinical establishments. 'Lab test results influence over 70% of treatment decisions globally. When they are wrong, they harm patients and erode trust in the medical system,' Dr. Jain added. 'There is no law specifically [for sample collection and transport], which is why this petition was filed. We want guidelines to be released by the government,' Alok Ahuja, former Professor of Pathology, National Accreditation Board for Testing and Calibration Laboratories, and National Accreditation Board for Hospitals and Healthcare Providers, told The Hindu. 'The quality of samples must be maintained and guidelines must be instituted. To have a law is the need of the hour,' he added. 'I am very happy that the court has been very positive to the demands of the pathologist that a law must be instituted,' Dr. Ahuja said.
Indian Express
2 days 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'.
