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.
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.
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 than the imported kits available in the country. Market sources peg the imported tests’ price being capped at around Rs 1,000-1,200.
“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 100,000 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) technology can deliver results in two and a half hours. We already have 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.
“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 the world’s first commercial point-of-care molecular diagnostics platform using the PCR technology.
Molio's Truenat can diagnose 22 infectious diseases such as TB, H1N1 and dengue, 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.