The Pune-based MyLab Discovery Solutions and Germany’s Altona Diagnostics have developed test kits for COVID-19 and also 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).
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The kits have 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. 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.
