Via Financial Times

Diagnostics companies are gearing up to provide thousands of coronavirus testing kits to India but warn it will take weeks to scale up capacity because of a lag in government approvals.

Large parts of the country are under lockdown and the number of cases is surging, with public health experts sharply criticising the government for not testing enough to understand the scale of the outbreak

The country has reported more than 400 coronavirus cases out of a population of 1.37bn and maintains there is no community transmission.

But India has one of the lowest testing rates compared with Asia countries that have had greater success at managing coronavirus outbreaks. As of March 22, fewer than 17,000 people had been tested — a number roughly equivalent to South Korea’s daily capacity. 

“They are flying blind,” said Manjunath Shankar, a public health consultant based in Hyderabad who was involved in the US Centers for Disease Control and Prevention response to the Ebola outbreak in west Africa. “We need to catch as many positives as possible and isolate them as quickly as possible.”

Indian companies such as Trivitron Healthcare have already provided hundreds of thousands of test kits to China, where the outbreak started in January, but New Delhi has yet to greenlight its equipment. 

The Indian subsidiary of Swiss drugmaker Roche estimated it would be weeks before it cleared the necessary regulatory hurdles and could increase supplies of a test that had already been authorised for emergency use in the US. 

New Delhi last week gave its approval for private laboratories to begin testing samples and granted test licences to a handful of companies to start trials of coronavirus testing kits — one of the first steps towards commercialisation.

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“First and foremost we should test more and I think they want to test more,” Kiran Mazumdar-Shaw, chairperson and managing director of Biocon, one of the country’s largest pharmaceutical companies, told the Financial Times.

Ms Mazumdar-Shaw said private labs were expected to start testing suspected coronavirus cases this week. 

CoSara Diagnostics, the Indian joint venture of Utah-based Co-Diagnostics, which has also had a test approved by the US and the EU, applied for its Indian test licence in February. Mohal Sarabhai, managing director of CoSara, estimated it would not be until early April that the testing kit was ready for mass production in India, should it be approved.

“The need of the hour is to get as many tests as possible,” said Mr Sarabhai. “Once they say it’s fine and all good, then we can manufacture and distribute to labs in India.”

Trivitron chairman and managing director G.S.K. Velu said he was still waiting for his test kit to be cleared for trials, despite its Chinese joint venture Labsystems Diagnostics Shandong selling 500,000 of its kits in China.

“We have the capacity to manufacture between 500 to 75,000 per day,” said Mr Velu, adding he was hopeful his kit would be approved soon in India. “The next week is going to be very crucial.”

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