Pune-based MyLab is the first indigenous manufacturer to be approved for deploying its kits for COVID-19 testing.
“Congratulations to our Biotech innovators first make in India COVID 19 diagnostic kit,” Renu Swarup, Secretary, Department of Biotechnology, tweeted. Ms Swarup also leads the government’s Biotechnology Industry Research Assistance Council (BIRAC) that supports biotechnology companies, and MyLab was one of them.
While diagnostic tests for COVID-19 are largely reliant on foreign companies, several labs in India had applied to the National Institute of Virology, Pune, for getting their own kits vetted. Written guidelines by the Indian Council for Medical Research (ICMR) require that only diagnostic kits that have been approved by the United States Food and Drugs Administration or certified by the European Union be allowed to offer commercial tests for detecting SARS CoV-2. However, Director General of ICMR Dr. Balram Bhargava on Monday said this was no longer a requirement and even those approved by the NIV would be eligible for approval.
The Managing Director of Mylab Discovery Solutions, Hasmukh Rawal, told trade magazine BioSpectrum India: “With emphasis on ‘Make in India’ and support from local and Central governments, COVID- 19 kit has been made as per WHO/CDC guidelines. It was developed and evaluated in a record time”.
The support and the immediate action from regulatory bodies (CDSCO/FDA), evaluation centre of ICMR, NIV, BIRAC and the Central and State governments during this national emergency was commendable, he said.
Dr. Bhargava said at a press briefing on Monday, “For private labs, we have issued detailed guidelines and 12 lab chains have been registered and they have begun work. They have 15,000 collection centres across India and these labs will increase as and when they register.”
Under the ICMR network, 111 labs were functional and the government’s testing capacity was over 10,000 samples a day, he had said.