2 min read.Updated: 25 Mar 2020, 05:58 PM ISTLeroy Leo
The firm awaits formal clarification from the National Institute of Virology on whether its testing kit, which has received emergency use authorization from US FDA, will be exempt from a validation process in India
NEW DELHI: CoSara Diagnostics Pvt Ltd, the first Indian company to get a licence to produce Covid-19 testing kits from both Indian and US drug regulators, is ready to supply as many as 10,000 such diagnostic kits a day from the first week of April, director Mohal Sarabhai said.
“But before that I will also have 15,000 tests available for the market," Sarabhai said in an interview, adding that the company will also have an additional 5,000 tests imported from the US using its import licence.
CoSara Diagnostics is an Ahmedabad-based joint venture of US-based Co-Diagnostics Inc. and Sarabhai Group.
The supply of CoSara Diagnostics’ RT-PCR Covid-19 test kit, which was designed by Co-Diagnostics and would be manufactured in India by the JV firm, would help expand testing for novel coronavirus infections in India, where fewer than 19,000 people have been tested for the disease since the first case was detected in Kerala about two months ago.
The government has been criticized for failing to test enough people to establish whether a community contagion is already underway. The World Health Organization has declared the disease a pandemic and urged countries to increase testing to cover all suspected patients.
“It’s a PCR-based confirmatory test, similar to what Roche has. It is the same platform, except that mine is made in India and I’m claiming to get the result in two and a half hours," Sarabhai said.
Last week, testing kits of both CoSara and Roche Diagnostics received approval from the Central Drugs Standards Control Organization. The kit developed by Roche Diagnostics also has emergency use authorisation from the US Food and Drug Administration of the US (USFDA), and the company claims it can test as many as 4,128 samples a day. Roche claims results from its system are available in about three-and-a-half hours.
Sarabhai said he is awaiting formal clarification from the National Institute of Virology (NIV) in Pune on whether CoSara’s testing kit, which has received emergency use authorization from US FDA, will be exempt from a validation process in India.
The company will manufacture the kits at its plant in Ranoli near Vadodara. Sarabhai did not disclose the cost of the kit but said it would be “more affordable than the imported price". The company is in talks with half a dozen private firms to supply the kits.
Indian Council of Medical Research director general and health research secretary Balram Bhargava had said on Monday that NIV is fast-tracking the authorisation and validation process of testing kits.
“ICMR’s NIV Pune has fast-tracked the testing of kits and two kit manufacturers have already been approved," Bhargava had said at a press conference. He later said in an interview that a company that has received emergency use authorisation from the US FDA is not required to undergo validation process from NIV.
On Monday, two firms, Pune-based Mylab Discovery Solutions Pvt Ltd and Delhi-based altona Diagnostics India Pvt, Ltd, received commercial approval for their 'made in India' Covid-19 test kit.
ICMR has approved and recommended for commercial use in India only those test kits which show 100% error-free results.
Approval for more testing kit manufacturers is going hand in hand with the government’s move to include more private diagnostic chains such as SRL and Dr Lal Pathlabs for testing suspected Covid-19 patients.