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The Hindu
5 days ago
- Business
- The Hindu
40 products, 3 firms blacklisted in two years by T.N. Medical Services Corporation
In two years, the Tamil Nadu Medical Services Corporation (TNMSC) has blacklisted 40 products - drugs and injections - and three firms primarily for failing to meet quality control norms. According to data from TNMSC, an organisation that was set up to streamline the procurement, storage and distribution of essential drugs for government hospitals, 22 products were blacklisted for quality failures during 2023-2024. During 2024-2025, 26 products were blacklisted, of which 22 were quality-related and four for non-execution of purchase orders. A total of 14 products were blacklisted so far in 2025, all related to quality failures. Firm-wise, TNMSC blacklisted five firms during 2023-2024 (two for non-execution of purchase orders and three on quality grounds. While two firms were blacklisted during 2024-2025, one was blacklisted so far this year on quality grounds. Also Read: Not business as usual: On upholding India's reputation for quality drugs Year Number of blacklisted firms Reasons Number of products blacklisted Reasons 2023-2024 5 2 for non execution of purchase orders; 3 on quality grounds 22 All related to quality failures 2024-2025 2 On quality grounds 26 22 quality related 4 non execution of purchase orders 2025 (till date) 1 On quality grounds 14 All related to quality failures How quality checks are performed Officials of TNMSC said that quality checks on medicines are conducted as per the relevant pharmacopoeia (such as Indian Pharmacopoeia, British Pharmacopoeia, United States Pharmacopoeia) at their entry level at warehouses through NABL (National Accreditation Board for Testing and Calibration Laboratories) accredited empanelled laboratories. In case of any adverse reports from empanelled laboratories, the same drugs are re-tested at government laboratories in the State - laboratories at Teynampet and Guindy. Presently, TNMSC has contracts with 12 laboratories situated all over the country. The top reason for blacklisting products is failure to meet quality standards, an official said. Blacklisting is done for products due to quality failure/non supply and for companies as a whole, for quality failures. According to blacklisting details on TNMSC's website, 'not of standard quality' is the major reason cited for blacklisting a particular drug. 'Purchase orders not executed' and 'substandard quality' are other reasons. In fact, one drug has been blacklisted for the 'presence of an iron piece inside the tablet'. For firms blacklisted from 2024, misbranded drugs is the main reason. Monitoring of warehouses TNMSC's warehouses are monitored through the centralised portal - Drug Distribution Management System - for stock receipt, sampling process, receipt of lab reports, distribution to medical institutions and its fund management. The shelf life expired drugs are disposed through biomedical waste management agencies approved by the T.N. Pollution Control Board once in a year, officials added. As far as equipment is concerned, TNMSC procures only equipment with standardisation certificates such as European CE/US FDA/equivalent Indian standards, they said.
Indian Express
5 days ago
- Health
- 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'.
Indian Express
6 days ago
- Health
- Indian Express
Diagnostic labs will soon have to follow standards for sample collection, transport: Here's why the Govt move is important
The Ministry of Health and Family Welfare is in the process of notifying the minimum clinical standards for handling and transport of diagnostic samples, with the policy currently undergoing legal vetting by the legislative department of the Ministry of Law & Justice. It gave this assurance at the Delhi High Court last week. That's because existing guidelines by the Indian Council of Medical Research (ICMR) on processes for collection, packaging and transport of clinical specimens to maximum containment (Biosafety Level 4) laboratories are rudimentary. The broad framework concerns sample collection such as wearing of PPEs, triple packaging and its supervision, discarding used consumables among others. The norms are no different for Covid-19 sample collection and transport, touching only upon its collection and labelling. In 2018, the government had notified that collection centres should be part of the main laboratories and that the parent laboratories should be held accountable for their compliance of norms. The notification had clarified that collection centres would not be registered separately but as a component of the main laboratory. However, in the absence of clear-cut standards, even adherence to this provision remains scarce, with registration of standalone collection centres in various states. In November 2020, amid Covid-19, the National Accreditation Board for Testing and Calibration Laboratories, a board under Quality Control of India (QCI), 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 had advised labs to declare all sample collection centres/facilities/sources in 30 days. It had further 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.' It had further advised all labs to review such arrangements to ensure these are in line with norms for accreditation. In 2019, pathologist Dr Rohit Jain moved the Delhi High Court, challenged the Clinical Establishments (Central Government) Amendment Rules 2018, especially on the aspect of minimum standards for signatory authority 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. In February 2020, the Centre notified the Clinical Establishment (Central Government) Amendment Rules 2020, under which, according to Dr Jain, 'unqualified and unregistered non-medical persons viz MSc/PhD were authorised to issue pathology reports without the signature/counter signature of a pathologist.' Apart from challenging these amended rules, Dr Jain also moved court in August 2021, highlighting an RT-PCR testing scam in Kumbh Mela where reportedly about one lakh fake tests were conducted on devotees after intermediaries were given contracts. '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,' Dr Jain had argued in his submission. He had also highlighted that the accused labs were not registered under the Act either. In 2023, the Delhi High Court directed the Centre to consider Dr Jain's plea as a representation and decide within three months. In May 2023, the government held a meeting under the chairmanship of the Additional Director-General of Health Services, New Delhi, where Dr Jain too was invited to make his representation. They 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. However, these guidelines weren't notified. So a year later, in May 2024, Dr Jain moved the Delhi High Court again, accusing the government of wilful disobedience of the court's order. The Ministry of Health and Family Welfare has now told the Delhi High Court that it is in the process of notifying the minimum clinical standards for handling and transport of diagnostic samples, with the policy currently undergoing legal vetting by the Legislative Department of Ministry of Law and Justice. It also told the court that currently the guidelines of ICMR-National Institute of Virology (NIV) are in place, which include rules for collection, packaging and transport of specimens for testing for high-risk viral pathogens, as well as guidelines for collection, packaging and transport for the COVID-19 virus. According to MOHFW, the subject experts held 'detailed internal deliberations for formulating minimum standards for sample collection and sample transport policy,' following which the draft minimum standards were technically finalized and were also technically approved by the Director General of Health Services (DGHS). 'The minimum standards for sample collection centres, as approved by the NCCE, are in the advanced stages of being notified in the Gazette of India. The draft minimum standards for sample collection centres are currently under legal vetting by the Legislative Department of the Ministry of Law and Justice,' the MOHFW said in its submission. The National Council for Clinical Establishments (NNCE), a statutory body under the Clinical Establishments Act, is working with the aim of developing minimum standards and their periodic review. 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.'
Hans India
22-07-2025
- Business
- Hans India
UFlex Secures Indian Patent for Sustainable Waterborne Heat Seal Coating for Food and Consumer Goods Packaging
UFlex, India's largest multinational flexible packaging and solutions company, has been granted an Indian patent (No. 567989) for its latest innovation, 'Waterborne Heat Seal Coating Composition and a Process for its Preparation'. This coating has been developed as a sustainable alternative to traditional fossil-based plastic coatings, aligning with the growing demand for recyclable and environmentally responsible packaging. The coating is designed for heat-sealable applications, offering oil and grease resistance on kraft paper and suitable blister coatings for paper and paperboard. It is both eco-friendly and compliant with food contact regulations. This patented coating can be applied to various packaging materials, including food wraps, takeaway boxes, and blister packs for toys and personal care products. One of the key advantages of this innovation is its user-friendliness—it is a ready-to-use formulation which requires no dilution. It offers a low seal initiation temperature, excellent heat seal strength, and high hot tack strength, while meeting USFDA standards for food contact packaging. An innovative solution from UFlex's chemicals product portfolio, this development underscores the company's extensive expertise in packaging inks, water-based, solvent-less and solvent-based adhesives, and specialty UV/LED coatings. Its state-of-the-art R&D center, NABL (ISO/IEC 17025:2017), is accredited and recognised by the Department of Science and Technology, Government of India. UFlex's inks and adhesives business is focused on developing innovative solutions with sustainable technologies, customised products, food-safe and toluene-free compliant inks as per IS 15495:2020 and providing on-site support.
Time of India
05-07-2025
- Health
- Time of India
BHU's VRD lab gets NABL accreditation
Varanasi: The Viral Research and Diagnostic Laboratory (VRDL) at the Institute of Medical Sciences (IMS), Banaras Hindu University, was awarded NABL accreditation under ISO 15189:2012 standards for medical laboratories by the National Accreditation Board for Testing and Calibration Laboratories (NABL). Prof Gopal Nath, principal investigator, said that the laboratory conducted around 9 lakh tests during the Covid-19 pandemic and carried out around 8,000 tests of dengue, Covid, Japanese encephalitis, and others in the past one-and-a-half years. He credited the contribution of Prof Pradyot Prakash (Co-Principal Investigator), and the entire scientific and technical team, for this accomplishment. The team comprises Dr Sudhir Kumar Singh, Dr Alka Shukla, Dr Manoj Kumar, Dr Mayank Gangwar, Deepak Kumar, Sonam Rastogi, Digvijay Singh, Pankaj Kumar, Ashish R. Singh, and Ajay Kumar. Prof SN Sankhwar, director, Institute of Medical Sciences, expressed happiness over NABL accreditation. tnn
