New Delhi/Chennai: Eighteen companies, both Indian and otherwise, have got licences from the Drug Controller General of India (DGCI) to conduct Covid-19 diagnostic tests in the country.
Most of these firms have also sought approval from Indian Council of Medical Research (ICMR) for commercialisation of kits and are expecting a go-ahead within a month.
GSK Velu, chairman and managing director of Trivitron Healthcare, told News18, "Once we get approvals from the DCGI and National Institute of Virology (NIV), Pune, we will be able to sell these kits commercially for around Rs 500-700 per test in another three weeks."
Trivitron Healthcare is the first Indian private diagnostic firm to receive approval to conduct Covid-19 tests.
The chairman and managing director said the kits which will be manufactured indigenously will have a turnaround time (period between the test being conducted and receiving the report) of four to six hours.
"Depending on the PCR platform (the gold- standard testing platform for viruses), a lab can turn around 100 tests to 1,000 tests per day. We have a production capacity to conduct 5,00,000 to 7,00,000 tests per day in our Chennai facility if we operate in three shifts," added Velu.
The kit validation is happening at NIV Pune.
Another private firm, Roche Diagnostics India (the Indian subsidiary of Swiss multinational firm Roche) was the first to be accorded test licence for Cobas SARS CoV-2 diagnostic tests by the Central Drugs Standard Control Organisation (CDSCO).
Dr Shravan Subramanyam, managing director of Roche Diagnostics India, said his firm is awaiting approval from the authorities to commercialise the test kits.
"The test licence accorded to Roche Diagnostics India allows us to import select quantities of the Cobas SARS Cov-2 diagnostic test kits for product performance evaluation. Following successful completion of the evaluation, a decision from the authorities will enable us to commercialise the kits in India," he said.
Roche says its kit will give results in three hours.
The kits developed by the firms are planned to be sold to private diagnostic chains such as Dr Lal Path Labs, SRL Diagnostics and Metropolis Healthcare, among others, to start community testing to detect the virus that has claimed four lives and infected at least 223 people in India so far.
The confirmatory reports for coronavirus tests will be given much faster once the private laboratories start testing. Going forward, the lab reports could be handed over to patients within two-and-a-half hours to five hours instead of the present turnaround time of two-three days.
On Tuesday, the ICMR decided to rope in 51 private laboratories to conduct tests for the novel coronavirus.
Meanwhile, the government is also scaling up its own testing capacity to 121 laboratories across the country by the end of this week. This includes 72 labs that are currently operational under the ICMR network and 49 engaged with the Council of Scientific and Industrial Research, Defence Research and Development Organisation, Department of Biotechnology, and those at government medical colleges.
Pune-based private firm, Mylab Discovery Solutions, has also claimed to be developing domestically produced health kits.
“The kits will eliminate the requirement of two tests — screening and confirmatory testing. It will give the results within two-and-a-half hours of loading the samples on the machine,” said Mylab Discovery managing director Hasmukh Rawal. Mylab's kits can test 10,000 samples in a day.
The ICMR has also released a set of guidelines and standard operation procedure for private labs that may be engaged in testing for Covid-19.
These laboratories can only diagnose those who bear a prescription from a qualified physician. They are required to follow bio-safety precautions, while conducting the tests and have to keep the state authorities and Integrated Disease Surveillance Programme informed in case a patient tests positive for coronavirus.
The ICMR has also revised the testing criteria for COVID-19 under which an individual who had come in direct or close physical contact of laboratory-confirmed positive case, has a history of travel in the last 14 days to high-risk coronavirus-affected countries and develops symptoms like fever, cough and difficulty in breathing should immediately contact the health ministry's helpline for testing.