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Coronavirus | Private firms await clarity on nod for testing kits

A technician prepares COVID-19 coronavirus patient samples for testing at a laboratory in New York's Long Island on March 11, 2020.

A technician prepares COVID-19 coronavirus patient samples for testing at a laboratory in New York's Long Island on March 11, 2020.   | Photo Credit: AP

Approval from the National Institute of Virology, Pune, is mandatory

Private diagnostic labs in India say they are awaiting clarity on offering diagnostic tests for COVID-19. Current written guidelines from the Indian Council for Medical Research (ICMR) specify that only test kits approved by the United States' Food and Drugs Administration or the European CE would be eligible for use in India.

Also read | Interactive map of confirmed coronavirus cases in India

All diagnostic kits must also be approved by the National Institute of Virology (NIV), Pune, the nodal organisation for confirming and reporting COVID-19 positive samples.

Domestic units sidelined

Some labs as well as indigenous makers of diagnostic kits fear being discriminated against because they don't have U.S. or European certification. “This is the time to promote Indian industry. We have good organisations that can provide tests at lower costs,” a senior official in a major diagnostic company in New Delhi, told The Hindu.

At a press briefing on Monday, ICMR chief Balram Bhargava said the U.S. and EU certification wasn’t mandatory and an approval by NIV was sufficient. “Already two manufacturers have been approved,” he added.

Bangalore-based diagnostics company, Molbio Diagnostics, which offers a point-of-care diagnostic kit for tuberculosis, is among those that has applied to the NIV for testing for COVID. Their device can be tweaked to detect several pathogens from the H1N1 to SARS COV2, they claim.

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“I expect that we would hear within a week. It’s inevitable that NIV be the final authority on what kits are acceptable,” said Molbio’s Chief Technology Officer Chandrashekhar Nair.

Urgent demand

With over 400 positive cases of novel coronavirus detected in India and estimates suggesting that the country would see a sharp rise in cases because of increased testing, a larger group of players are trying to enter the testing market. The tests, according to the current guidelines, shouldn't exceed ₹4,500 for the end-consumer. Currently the government spends the same amount for testing but tests those suspected for free.

Nearly 17,000 tests have been conducted since March.

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Printable version | Apr 8, 2020 8:58:22 AM | https://www.thehindu.com/news/national/coronavirus-private-firms-await-clarity-on-nod-for-testing-kits/article31144207.ece

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