Context: Recently,The Indian Council for Medical Research (ICMR) has approved three other centres, alongside the National Institute of Virology (NIV), as agencies for approving diagnostic kits which give its approval to Mylab manufacturer.

• These are the National AIDS Research Institute, Pune; the National Institute of Cholera and Enteric Diseases, Kolkata; and the National Institute of Pathology, New Delhi, according to a notification issued by the ICMR.
• 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.

About Made in India COVID19 Test Kit

• India-based Mylab has discovered (Covid-19) diagnostic test kits, called reverse transcription polymerase chain reaction (RT-PCR) tests.
• It is the first indigenous manufacturer to be approved for deploying its kits for COVID-19 testing.
• RT-PCR kits can study 1000 samples from large labs and 200 from smaller labs.
• It is First 'Made in India' COVID19 Test Kit to diagnose COVID-19 gets the commercial approval from the Central Drugs Standard Control Organization (CDSCO).The approval is expected to help increase testing in the country.
• According to the developers, it would cost nearly one-fourth of the current procurement cost and is faster as it screens and detects the infection within 2.5 hours as compared with over 7 hours by others.

About 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.

About Central Drugs Standard Control Organization (CDSCO)

• It is the national regulatory body for Indian pharmaceuticals and medical devices.
• Within the CDSCO, the Drug Controller General of India (DCGI) regulates pharmaceutical and medical devices, under the gamut of Ministry of Health and Family Welfare.
• The DCGI is advised by the Drug Technical Advisory Board (DTAB) and the Drug Consultative Committee (DCC).
• It is divided into zonal offices which do pre-licensing and post-licensing inspections, post-market surveillance, and recalls when needed.
• Manufacturers who deal with the authority are required to name an Authorized Indian Representative (AIR) to represent them in all dealings with the CDSCO in India.