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Rediff.com » Business » Gujarat firm gets licence to make covid-19 test kits

Gujarat firm gets licence to make covid-

19 test kits
By Vinay Umarji March 22, 2020 09:38 IST

A joint venture of Synbiotics, a wholly owned subsidiary of Ambalal

Sarabhai Enterprises (ASE), and CoDiagnostics, CoSara Diagnostics is
the first and only Indian company so far to receive a licence from the
Central Drugs Standard Control Organisation (CDSCO) to manufacture
coronavirus diagnostic test kits. 

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Image used for reprsentational purpose. Photograph: Somnath Sen / ANI Photo.
Ahmedabad-based CoSara Diagnostics has become the first and only Indian
company so far to receive a licence from the Central Drugs Standard Control
Organisation (CDSCO) to manufacture coronavirus (Covid-19) diagnostic test kits. 

The company now plans to send sample batches to National Institute of Virology
(NIV), Pune, for validation, following which it would apply for a manufacturing
licence with the Gujarat government. 

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A joint venture of Synbiotics, a wholly owned subsidiary of Ambalal Sarabhai

Enterprises (ASE), and CoDiagnostics, CoSara Diagnostics is a Gujarat-based
molecular diagnostic company. 
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While it did not share the exact pricing of the kits, the company’s chief executive
officer and ASE’s managing director Mohal Sarabhai said the price would be lesser
Ad than the imported kits available in the country. Market sources peg the imported
tests’ price being capped at around Rs 1,000-1,200. 

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“We are not giving the price right now because it is still dependent on various
factors. It will be lower than whatever the imported prices are right now. Currently,
logistics costs are higher because the cost of materials needed for these kits is
increasing day-by-day due to huge global demand. The swing is too high for us to
come to a price point until we get the validation from NIV,” Sarabhai told Business
Standard. 

While its US partner CoDiagnostics will share its research and technology of
molecular diagnostics for testing Covid-19, among other diseases, the Indian partner
will manufacture the same at its facility in Ranoli, Vadodara. 

CoSara’s plant can churn out 10,000 diagnostic tests or kits per day. Moreover,
compared to diagnostic results currently taking around two days, the company’s
tests can deliver results in two and a half hours. 

“Our molecular diagnostics platform using the polymerase chain reaction (PCR)
Coronavirus: Parliament session likely to
technology can deliver results in two and a half hours. We already have
end today
manufacturing licence for molecular diagnostics to cover diseases like tuberculosis
(TB), Hepatitis B, Hepatitis C, human papillomavirus (HPV) and malaria which are
being manufactured from the Vadodara plant,” he added. 

With the NIV Pune’s validation likely to come in by next week, Sarabhai said the
company is ready to commence manufacturing of the diagnostic tests in a week or
two. 

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“We have already placed orders for the raw materials including primer and probes
right now from approved source in the US. These will be used to manufacture
diagnostic tests which are basically tubes with liquid reagents which when mixed
with patients’ samples can then detect whether the patient is infected or not using
the PCR technology,” Sarabhai added. 

The company will be supplying these tests to not only the government-run
laboratories, but also to private ones. Around 60 private labs accredited by the
National Accreditation Board for Laboratories can now test for Covid-19. Until
recently, only government-owned labs were allowed to carry out tests for the
infection. 

Meanwhile, Goa-based diagnostic firm Molbio Diagnostics, along with its subsidiary
Bigtec Labs, has also developed and commercialised Truenat, which is claimed to be
PIX: Deserted roads across India during the world’s first commercial point-of-care molecular diagnostics platform using the
Janata curfew PCR technology. 
 Molio's Truenat can diagnose 22 infectious diseases such as TB, H1N1 and dengue,
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and has a pipeline of additional 43 diseases including coronavirus and MERS.
Recently, India Business Excellence Fund-III, managed and advised by Motilal
Oswal Private Equity decided to invest up to Rs 240 crore in the venture.

Vinay Umarji in Ahmedabad

Source:

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