Co-Diagnostics, Inc., a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced that CoSara Diagnostics Pvt Ltd (“CoSara,” or the “JV”), its joint venture for manufacturing in India, has become the first and only Indian company to receive a license from the Central Drugs Standards Control Organisation (CDSCO) to manufacture RT-PCR COVID-19 test kits. The kits are expected to be sold in the Indian market, as well as for export to the surrounding regions.
CoSara has aligned itself with the “Make in India” initiative introduced in 2014 to transform India into a global design and manufacturing hub, and senior officials from the health department expedited the approval process for the license. The country took early measures to recall its citizens, drastically limit travel into the country and eventually close the country’s borders, which has also increased the demand for indigenous COVID-19 tests to serve India’s population of 1.3 billion.
The outbreak has been declared an epidemic in several states where provisions of the Epidemic Diseases Act have been invoked, and educational institutions and many commercial establishments have been shut down. Prime Minister Narendra Modi also recently called for enhanced testing facilities in an effort to contain the spread of the disease in a country where social isolation, as practiced in other areas, may prove difficult due to the high population density. According to economists, if the pandemic in India grows out-of-control, the consequences are likely to be even more severe than in Italy.
The COVID-19 test kits approved by the CDSCO were those originally designed by Co-Diagnostics, the first U.S. company to receive a CE marking for a COVID-19 diagnostic. “The high-quality tests built on our patented CoPrimer™ technology will have a positive impact on what is projected to be the largest healthcare market in the world,” said Dwight Egan, CEO of Co-Diagnostics. “Co-Diagnostics is honored that our joint venture has achieved such a significant milestone.”
Mohal Sarabhai, Director of CoSara, remarked “Presently there are 52 government-approved testing facilities and delivering the kits to those is the first target,” in addition to pursuing 60 accredited private labs to conduct COVID-19 tests. “Overall, our target market will be private as well as government labs.”