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    Shireesha Siri
    The document provides updated guidance from the Indian Council of Medical Research (ICMR) on enhancing the availability of COVID-19 testing kits and solutions in India. It modifies an earlier advisory to exempt only tests approved by the US FDA, Japanese PMDA, Australian TGA, and WHO EUL from separate validation in India. All other globally approved tests will require validation. It also provides points for approval of home testing solutions, including requirements for data capture and compatibility with ICMR portals.

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    The document provides updated guidance from the Indian Council of Medical Research (ICMR) on enhancing the availability of COVID-19 testing kits and solutions in India. It modifies an earlier advisory to exempt only tests approved by the US FDA, Japanese PMDA, Australian TGA, and WHO EUL from separate validation in India. All other globally approved tests will require validation. It also provides points for approval of home testing solutions, including requirements for data capture and compatibility with ICMR portals.

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    The document provides updated guidance from the Indian Council of Medical Research (ICMR) on enhancing the availability of COVID-19 testing kits and solutions in India. It modifies an earlier advisory to exempt only tests approved by the US FDA, Japanese PMDA, Australian TGA, and WHO EUL from separate validation in India. All other globally approved tests will require validation. It also provides points for approval of home testing solutions, including requirements for data capture and compatibility with ICMR portals.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
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    31 views1 page

    Important

    Uploaded by

    Shireesha Siri
    The document provides updated guidance from the Indian Council of Medical Research (ICMR) on enhancing the availability of COVID-19 testing kits and solutions in India. It modifies an earlier advisory to exempt only tests approved by the US FDA, Japanese PMDA, Australian TGA, and WHO EUL from separate validation in India. All other globally approved tests will require validation. It also provides points for approval of home testing solutions, including requirements for data capture and compatibility with ICMR portals.

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    भारतीय आयुर्विज्ञान अनुसंधान पररषद

    स्वास््य अनुसंधान र्वभाग, स्वास््य और पररवार


    कल्याण मंत्रालय, भारत सरकार
    Indian Council of Medical Research
    Department of Health Research, Ministry of Health
    and Family Welfare, Government of India

    Date: 18/06/2021
    VERSION II
    Guidance to enhance availability of COVID-19 testing kits and newer innovative testing
    solutions in India:
     Real time RTPCR and Rapid Antigen Tests (RAT) are the mainstay of diagnosis of SARS-CoV-2 in India.
     ICMR had advised that real time RTPCR, RAT, home based testing solutions, antigen/antibody ELISA/CLIA and
    rapid antibody tests approved by European CE/IVD, Ministry of Food and Drug Safety, Korea, PMDA, Japan, TGA,
    Australia, Brazil ANVISA and WHO Emergency Use Listing (EUL) procedure may be exempted from validation in
    India and accorded marketing permission by DCGI on the basis of existing approvals (Advisory dated 27/04/2021).

     The advisory dated 27/04/2021 is now being modified in consultation with the Drug Controller General of India
    (DCGI). Earlier a sizeable number of different test kits, approved by certain external agencies listed above,
    could not meet the validation criteria laid down in India. However, such kits became eligible to enter the Indian
    market without any improvisation/ revalidation.
    In view of this, only SARS-CoV-2 RTPCR, RAT, Antigen/Antibody ELISA/CLIA and Rapid Antibody tests approved
    only by the following agencies will not require separate validation in India:

    1. United States Food and Drug Administration (USFDA), USA


    2. Pharmaceuticals and Medical Devices Agency (PMDA), Japan
    3. Therapeutic Goods Administration (TGA), Australia
    4. WHO Emergency Use Listing (EUL) procedure

    All test kits approved by any other global agency (besides those listed at 1-4) will be subject to validation in India.

    Points to be noted prior to approval of home-based testing solutions:

    - All home testing kits will be validated in India.


    - All manufacturers intending to market such tests in India must ensure the following:
    i. All material for sample collection, testing and disposal should be part of the kit per se.
    ii. The kit insert should include detailed instructions for usage, interpretation and disposal of the test kit.
    - All such tests must have an inbuilt system of data capture through mobile phone based softwares.
    - All manufacturers are advised to liaise with the data entry team of ICMR to ensure compatibility of data flow into
    the ICMR COVID-19 testing portal. Once the compatibility is ensured, DCGI may be approached for approval. The
    contact points at ICMR are:
     Dr Neetu Vijay: Email: drneetu.vijay@icmr.gov.in
     Mr Ajay Singh Dhama: Email: ajaysinghdhama@gmail.com
    - Manufacturers who do not have a system or are unable to synchronize data flow with ICMR, may not be
    considered for marketing permission under the category of home-based testing solutions and considered for
    approval under another appropriate category.

    This guidance is applicable for tests using nasopharyngeal, oropharyngeal, throat, nasal, oral, saliva, mouth rinse,
    gargle, blood and serum samples.

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