Last Updated on January 13, 2024 by The Health Master
The Union ministry of health and family welfare has issued a notification to enable the National Institute of Biologicals (NIB), Noida to conduct testing of more medical devices including the devices and kits to diagnose Covid-19.
The Ministry has notified an amendment to its notification issued in June, 2018, to expand the testing offered by the Institute.
The move also comes in the wake of the increasing number of Covid-19 cases and the regulatory measures taken in the field of medical devices at present.
In a notification issued on June 1, 2018, (vide notification No. S.O. 2237(E) dt. 01-06-2018) the Ministry has designated the following laboratories having facilities for carrying out test and evaluation of medical devices, as Central Medical Device Testing Laboratory:
- The National Institute of Biologicals, Noida,
- The Central Drugs Testing Laboratory, Chennai,
- The Central Drugs Laboratory, Kolkata,
- The Regional Drugs Testing Laboratory, Guwahati,
- The Central Drugs Testing Laboratory, Mumbai.
These laboratories were approved for the purposes of testing and evaluation, functioning as an appellate laboratory and to carry out any other functions as may be specifically assigned to it by the Central government, in relation to medical devices specified for each of these laboratories in the notification.
According to this notification, the NIB was designated to conduct tests on in-vitro diagnostics for human immunodeficiency virus, hepatitis B surface antigen and hepatitis C virus, blood grouping sera, glucose test strip, and fully automated analyser based glucose reagent.
The Ministry has now come out with an amendment to this notification, to add tests for medical devices related to syphilis, RT-PCR Kits for diagnosis of Covid-19, ribonucleic acid (RNA) extraction kits for diagnosis of Covid-19, viral transport medium (VTM) for diagnosis of Covid-19, RT-LAMP Kit for diagnosis of Covid-19, and Glucometer, apart from those devices which were already designated to the institute.
Established in the year of 1992, NIB is performing primary statutory function of Quality Control of Biologicals e.g. Insulin, erythropoietin, blood products, diagnostic kits such as for HIV, HBV, HCV, therapeutic monoclonal antibodies like trastuzumab and rituximab used in cancer treatment etc. in accordance with provisions of Drugs & Cosmetics Act 1940 and Rule 1945.
The Immunodiagnostic kit Laboratory of the Institute is a World Health Organisation (WHO) Collaborating Centre for Quality Control of HIV, HCV, HBsAg and Syphilis In-Vitro Diagnostic Assays and Support Cell for WHO Prequalification Programme for In-Vitro Diagnostics.
Institute is NABL accredited for the discipline of biological testing and chemical testing in biological products.
The Institute is notified of the Central Drugs Laboratory and Central Medical Device Testing Laboratory under the statutory provisions.
The biological products are tested as per statutory standards laid down in Indian Pharmacopoeia or relevant pharmacopoeia or International norms, in the NIB laboratories.
The laboratories are also accredited by NABL as per the scope defined. Some of the NIB scientists have also been notified as government analysts and medical device testing officers for biological products as per statutory norms, says NIB.
The Central Drugs Standard Control Organisation (CDSCO) has till the first half of March, 2023, approved a total of 30 Medical Devices Testing Laboratories in the country.
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