In order to allow the National Institute of Biologicals (NIB), Noida to test more medical devices, including the tools and kits used to diagnose Covid-19, the Union Ministry of Health and Family Welfare has issued a notification. In order to increase the number of tests the Institute offers, the Ministry has published an update to the notification it first published in June 2018. The decision was made in response to both the current regulatory framework for medical devices and the rising number of Covid-19 instances.
The National Institute of Biologicals, the Central Drugs Testing Laboratory in Chennai, the Central Drugs Testing Laboratory in Kolkata, the Regional Drugs Testing Laboratory in Guwahati, and the Central Drugs Testing Laboratory in Mumbai have been designated by the Ministry as the Central Medical Device Testing Laboratory in a notification that was published on June 1, 2018. These laboratories received approval to conduct testing and evaluations, serve as an appellate laboratory, and perform any additional duties that the Central government may have specifically delegated to them in connection with the medical devices listed in the notification for each of these laboratories.
This notification said that the NIB was authorised to do tests on blood grouping sera, glucose test strips, and fully automated analyser based glucose reagent, as well as in-vitro diagnostics for human immunodeficiency virus, hepatitis B surface antigen, and hepatitis C virus. In addition to those devices that were already designated to the institute, the Ministry has now released an amendment to this notification that includes tests for medical devices related to syphilis, RT-PCR Kits for Covid-19 diagnosis, ribonucleic acid (RNA) extraction kits for Covid-19 diagnosis, viral transport medium (VTM) for Covid-19 diagnosis, RT-LAMP Kit for Covid-19 diagnosis, and Glucometer.
In accordance with the provisions of the Drugs & Cosmetics Act 1940 and Rule 1945, the National Institute of Biotechnology (NIB) was established in 1992 and is currently carrying out its primary statutory function of quality control of biologicals, such as insulin, erythropoietin, blood products, diagnostic kits for HIV, HBV, and HCV, therapeutic monoclonal antibodies like trastuzumab and rituximab used in the treatment of cancer, etc. The 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 are located in the Immunodiagnostic kit Laboratory of the Institute. For the fields of biological testing and chemical testing in biological products, the institute has NABL accreditation.
According to statutory requirements, the Central Drugs Laboratory and Central Medical Device Testing Laboratory must notify the Institute. In the NIB laboratories, the biological products are tested in accordance with the legal specifications outlined in the Indian Pharmacopoeia or the applicable pharmacopoeia or international norms. According to the established scope, the laboratories are also accredited by NABL. In accordance with regulatory requirements, several NIB scientists have also been appointed as government analysts and medical device testing officers for biological goods, according to NIB.
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