As India looks to scale up its capability multifold to test suspected cases of novel corona virus (COVID-19) infections in the eventuality of a community outbreak, its current strategy of conducting diagnostic tests free of cost will come under immense strain.
The major stumbling block in the ongoing negotiations with private diagnostic laboratories and the Indian Council of Medical Research (ICMR) to offer COVID-19 tests through private networks in addition to the government facilities where it is done today will also be the ICMR clause that reliable test should be offered free of cost by private labs.
Industry sources say that that unless government finds a way to help private sector laboratories meet their cost, the collaboration may not work. Every COVID-19 test carried out by laboratories in the ICMR network and other government labs costs around Rs 4,500 (Rs 1,500 for the first step screening assay and Rs 3,000 for confirmatory assays) today. A similar test, using diagnostic kit supplied by the same company - ICMR tests are known to be carried out by using kits supplied by US firm Thermo Fisher Scientific - is likely to cost the same for private players too.
In addition to Thermo Fisher, Swiss firm Roche Diagnostics is also offering COVID-19 tests. Both the tests are known to have been cleared by the Indian drug regulator - Drugs Controller General of India.
Incidentally, a home grown company Trivitron Healthcare, claims to be just weeks away from developing a highly economical COVID-19 test kit. "The prototype is ready and we are doing the lab validation now. It will be sent for external non-clinical validation by next week, hopefully to National Institute of Virology," G S K Velu, CMD Trivitron, says.
According to him, post validation, it will take maximum three weeks to be ready for commercial launch. "It can then be sold to either government labs or private labs. We are targeting to see that a single test costs as low as Rs 500." the Trivitron CMD says.
Velu says his company's Chinese joint venture partner has already got its COVID-19 test kit approved in China and their support and expertise helped Trivitron develop its COVID-19 testing kit before any other Indian firm. "We can do up to 700,000 tests per day in our factory in Chennai. I mean those are number of the patient sample test kits that we can supply in a day. Volume will not be a problem".
As Indian players offer cost effective solutions, the question before ICMR will be to see which one it wants to choose, and whether it can get private diagnostic labs agree to carry out tests based on the platforms developed by Indian firms.
On March 17, ICMR issued guidelines for private sector laboratories intending to initiate COVID-19 testing. It said that laboratory test should be only offered when prescribed by a qualified physician as per ICMR guidance for testing.
Another condition was that since the guidance evolves periodically, the latest revised version should be followed by the laboratories. ICMR is also to share the standard operating procedures (SOPs) for laboratory testing and provide positive controls for establishing the test as soon as the concerned private laboratory has procured the primers, probes and reagents as per SOPs. Adoption of commercial kits for testing should be based on validations conducted by ICMR-National Institute of Virology (NIV), Pune, it said. The need for appropriate biosafety and biosecurity precautions while collecting samples from a suspect patient was stressed. The guideline also called for the creation of a disease specific separate collection site. The private testing laboratories will also have to ensure immediate/ real-time reporting to the state officials of IDSP (Integrated Disease Surveillance Program of Govt. of India) and ICMR for timely initiation of contact tracing and research activities, the guideline said. Labs seem to be willing to go by all other conditions except the first - that calls for free of cost tests.