Current regulatory landscape on fast-track pathway for IVDs under COVID-19 heath emergency in India

Sella Senthil Marimuthu Gowthamarajan Kuppusamy Arun Radhakrishnan Jithenthiran Saravanan Indhumathi Thirugnanasambandham   

Open Access   

Published:  Jun 19, 2022


The novel coronavirus (2019-nCoV) pandemic’s global regulatory authorities are issuing provisional market authorization to current public health for timely detection of COVID-19 infections based on the analytical performance data, limited clinical performance data, and manufacturers’ declarations. Importers, local manufacturers, government procurement agencies, and other stakeholders should be made aware of the regulatory process for market authorization of COVID-19 in vitro diagnostic (IVD) kits in India. The objective is to study in detail about COVID-19 IVD guidelines. Concentrating on the recent updates in COVID-19 IVD guidelines, we analyze the necessity for India to become efficient in manufacturing SARS-CoV-2 IVDs. In India, Central Drugs Standard Control Organization (CDSCO) coordination with The Indian Council of Medical Research (ICMR) is committed to ensuring the rapid availability of diagnostic tests for COVID-19. To address the urgent need for timely detection of COVID-19 infection, it is important to scale-up the testing capacity to maximum possible levels according to the CDSCO interim licensing process. This has helped to timely expand the variety of quality diagnostic tests available in India. The regulatory tools described in this article are made based on a comparison of data available on the procedure, followed by other major countries under the health emergency without compromising on the quality of the product within the existing provisions given in the Drugs and Cosmetic Act and Medical Devices Rules 2017.

Keyword:     Provisional market authorization analytical performances data COVID-19 expedited review IVDs.


Marimuthu SS, Kuppusamy G, Radhakrishna A, Saravanan J, Thirugnanasambandham I. Current regulatory landscape on fast-track pathway for IVDs under COVID-19 heath emergency in India. J Appl Pharm Sci, 2022; 12(07):078–087.

Copyright: © The Author(s). This is an open-access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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