indigenously-developed-testing-kits-for-covid-19

Recently, the test kits for COVID-19 developed by the Pune-based MyLab Discovery Solutions and Germany’s Altona Diagnostics have been approved by the Indian Council of Medical Research (ICMR).

  • The two companies have also received approval to mass manufacture the kits after they received commercial approval from the Central Drugs Standard Control Organisation (CDSCO).
  • Currently, the diagnostic kits to test people for COVID-19 are imported from the USA.

Key Points

  • Approval Conditions:

    • Earlier, the kits approved by the United States Food and Drugs Administration or certified by the European Union were allowed to offer commercial tests for detecting SARS CoV-2.
    • However, ICMR stated that it is no longer a requirement and even those approved by the National Institute of Virology (NIV) would be eligible for testing.
  • Feature of the Developed Testing Kit:

    • Quick Detection: The developed kit detects the infection within two and half hours compared to over seven hours taken by current protocol.
    • Accuracy: The ability to detect the early stage of detection and highest accuracy has been observed with the indigenously developed testing kit for COVID-19.
    • Affordable: For the government labs, these testing kits would cost nearly Rs 1,200 per test kit, which is about one-fourth of the current testing kit used by India.
  • Indigenously Developed:

    • The indigenously developed testing kits for COVID-19 by MyLabs have been manufactured as per World Health Organisation (WHO) /Centre for Disease Control (CDC) guidelines.
    • MyLabs discovery Solutions is the first indigenous manufacturer to be approved for deploying its kits for COVID-19 testing.
    • The approval from National Institute of Virology (NIV) to MyLabs is expected to provide major support to the ‘Make in India’ programme in the future.

Indian Council of Medical Research (ICMR)

  • Indian Council of Medical Research (ICMR) is the apex body in India for the formulation, coordination and promotion of biomedical research.
  • It was founded in 1911 with the name of Indian Research Fund Association (IRFA) and renamed as ICMR in 1949.
  • It is funded by the Government of India through the Department of Health Research, Ministry of Health & Family Welfare.

National Institute of Virology

  • The National Institute of Virology is one of the major Institutes of the Indian Council of Medical Research (ICMR).
  • It was established at Pune, Maharashtra in 1952 as Virus Research Centre (VRC) under the auspices of the ICMR and the Rockefeller Foundation (RF), USA.

Central Drugs Standard Control Organisation (CDSCO)

  • The CDSCO is the Central Drug Authority for discharging functions assigned to the Central Government under the Drugs and Cosmetics Act,1940.
  • Major Functions:
     
    • Regulatory control over the import of drugs, approval of new drugs and clinical trials.
    • Approval of certain licences as Central Licence Approving Authority.

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Source:TH