Two diagnostic tests for coronavirus ( COVID-19 ) — the first to be developed entirely in India — are currently being evaluated by the National Institute of Virology (NIV) in Pune, a senior official in the Department of Biotechnology told The Hindu .
“The NIV is in the process of checking if these work and, if good, can be deployed for large scale testing,” said Renu Swarup, Secretary, Department of Biotechnology. “Hopefully we should know of their suitability in the next two weeks,” Ms. Swarup added. On Tuesday, the government said it was readying guidelines for private diagnostic companies to develop tests to detect the SARS-CoV-2 virus , which is responsible for the disease. All companies — and the ICMR themselves — currently rely on multinational companies for their diagnostic test kits.
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To accelerate development of drugs and diagnostics, the government will be forming a Rapid Response Regulatory Framework to rapidly evaluate potential diagnostic kits and vaccines against COVID-19.
Currently these processes, led by the Drug Controller General of India and Review Committee on Genetic Manipulation, take from 30-45 days, and the proposed farmework aims to bring the approval cycle to 7 days.
“The government notification on this should be out soon but this is to accelerate the development of potential products made in India and aid the development of diagnostics and vaccines in India,” Ms. Swarup said in telephone interview.
The ICMR has maintained that India now has 120 facilities where tests can be undertaken and that barely 10% of the capacity was being utilised. Its own tests had so far revealed no evidence of community transmission — when the virus begins to spread rapidly in the country and it’s no longer possible to trace positive cases to those with a travel history to affected countries or links to their contacts. However, there have been reports of patients, showing symptoms of the disease, showing up at hospitals and testing centres and being turned away. Some private laboratories were already gearing up to offer tests and had prepared dedicated facilities, The Hindu reported on Monday.
