Diagnostic companies are preparing to supply thousands of coronavirus test kits to India, but warn that it will take weeks to increase capacity due to a delay in government approvals.
Large parts of the country are under control and the number of cases is increasing, public health experts strongly criticize the government for not having tested enough to understand the scale of the epidemic.
The country has reported more than 400 cases of coronavirus on a population of 1.37 billion and maintains that there is no community transmission.
But India has one of the lowest test rates compared to Asian countries that have had more success in managing coronavirus outbreaks. As of March 22, fewer than 17,000 people have been tested – roughly equivalent to the daily capacity of South Korea.
“They’re flying blind,” said Manjunath Shankar, a Hyderabad-based public health consultant who was involved in the response of the United States Centers for Disease Control and Prevention to the Ebola epidemic in Africa. the West. “We have to catch as many positives as possible and isolate them as quickly as possible.”
Indian companies such as Trivitron Healthcare have already supplied hundreds of thousands of test kits to China, where the epidemic started in January, but New Delhi has not yet given the green light for its equipment.
The Indian subsidiary of the Swiss drug manufacturer Roche estimated that it would take weeks to clear the necessary regulatory hurdles and could increase supplies for a test that had already been authorized for emergency use in the United States.
Last week, New Delhi agreed to have private labs start testing samples and granted test licenses to a handful of companies to begin testing coronavirus test kits – one of the first steps towards marketing.
“First of all, we need to test more and I think they want to test more,” Kiran Mazumdar-Shaw, president and chief executive officer of Biocon, one of the country’s largest pharmaceutical companies, told the Financial Times.
Mazumdar-Shaw said private laboratories should start testing suspected coronavirus cases this week.
CoSara Diagnostics, the Utah-based Indian joint venture of Co-Diagnostics, which also had a test approved by the United States and the EU, applied for its Indian test license in February. Mohal Sarabhai, managing director of CoSara, estimated that it would not be until early April that the test kit would be ready for mass production in India if it were to be approved.
“The need of the hour is to do as many tests as possible,” said Sarabhai. “Once they say everything is fine and everything is fine, we can manufacture and distribute it to laboratories in India.”
President and CEO of Trivitron G.S.K. Velu said he is still waiting for his test kit to be cleared for testing, although his Chinese joint venture Labsystems Diagnostics Shandong has sold 500,000 of its kits in China.
“We have the capacity to manufacture between 500 and 75,000 per day,” said Velu, adding that he hoped his kit would soon be approved in India. “Next week is going to be very crucial.”
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