India, despite being number two in population (1380 million), was considered fortunate in Covid-19 as it had advantage of learning from the successes and failures of several countries and two months lead time to firm-up preparedness. Our bad luck- India’s fortune was short-lived, as it climbed the Covid-19 graph from 25th rank on March 25 to 10th on May 24. With stiff rise in daily detection to over 7000 (7%) Covid-19 infections in average 100000 samples tested daily. India is slated to reach 9th today, 5th position in 10 days bypassing Turkey, Germany, Italy, France and Spain, to remain below USA, Brazil, Russia and UK. Despite the widely accepted WHO diktat of March 16 that "We have a simple message to all countries - test, test, test", India is low in testing due to policies.At cumulative 33,62,136 tests as on today, India has done 2439 tests per million population; which is just 5% tests of those countries above us in numbers, barring Brazil. No, doubt, India has come a long way from 35 tests per million as on 24th March. The fear that the moment we escalate testing, we will be number one globally, may be keeping us back and that may be the reason tests are governed centrally.
Any infection like Covid-19 needs to be tackled with four Ts in a full cycle: Test-Trace-Track-Test. Mass-testing requires simpler tests. The only tests available in India are highly technical and costly tests- Reverse Transcriptase Polymerase Chain reaction (RT-PCR). Globally, available tests for Covid-19 are: molecular- PCR done on swab drawn from naso-pharynx or throat and serology tests - Enzyme Linked Immuno-sorbent Assay (ELISA). ELISA are Rapid Antibody Test done on whole blood or conventional ELISA that requires equipment and done on blood/serum samples, but none available for wider use.Prohibitive cost of Rs. 4500/-, stringent condition of personal examination by doctor and other restrictions imposed by the Govt. are impediments, eligible people face for tests. At public facilities they face inconvenience and most often denial of services. In fact as per Government of India order of March 21, cost per test of Rs.4500/- at large private laboratories, was based on preliminary PCR Rs.1500/- for suspect cases and confirmatory PCR Rs.3000/-. Largely people are unaware of this technical glitch in wording, but the government is and preferred to ignore. Govt. of India direction is reproduced from the link:
www.mohfw.gov.in/pdf/NotificationofICMguidelinesforCOVID19testinginprivatelaboratoriesiIndia.pdf
Our knowledge is –that although they only do a single PCR, they never revised the cost and thus private labs kept minting money in this Rs. 15-20 crore daily business with profit margin of over 300% that too during this unprecedented humanitarian crisis. Those labs have no time for processing other tests. Whereas majority of Covid-19 tests done in private labs are from public and private hospitals, besides some from mandatory tests on pregnant, dialysis, chemotherapy and pre-surgery patients who are defenseless. They are physically and economically inconvenienced in addition to being harassed with treatments getting deferred. As on May 25, ICMR evaluated 83 RT-PCR kits and found 35 to be satisfactory. Of these 20 are from Indian companies, including Pune’s My Labs that shot headlines for being first Indian test and that too below Rs.100 per test. While recommending target cost of Rs.4500/- per test the Health Ministry also stated “However, ICMR encourages free of subsidized testing in this hour of National Public Health Emergency”. Telangana state had fixed up Rs.2500/- per test from the very beginning, Tamil Nadu followed Telangana and pays 2500/- only, but Maharashtra state and Brihan-Mumbai Municipal Corporation (BMC) pay Rs.3500/- and private hospitals and individuals left to pay Rs.4500/- per test.In fact, this increases importance of Rapid test. The advantage being, if IgG is positive, that confirms immunity to Covid-19 in them. Till date, 23 antibody based rapid tests have been validated at National Institute of Virology (NIV) Pune and the Indian Council for Medical Research (ICMR) has licensed 14. Nine of these kits are manufactured in India. The target price per test was fixed at 600/- by the ICMR. The initial lot of Raid Test kits, have been imported from two Chinese companies; which ICMR blacklisted on April 27 due to inferior quality. That was also mired in controversy as well as corrupt practices in buying Rs.225 worth Chinese kit at Rs.600/- and is subject matter of larger investigation. We have not heard if any action was indeed taken against anyone on this large scale bungling. States of Jharkhand, Telangana and Delhi have widely used Korean rapid tests bought at Rs.337/-. Covid-19 is probably the only infection where the target price is fixed at high threshold and both target costs raises suspicion, as they could be halved.
What should be done?
1) The Union Health Ministry should publish list of approved tests weather they are PCR based or ELISA and allow states and private sector to negotiate cost, procure and use it.
2) Health Ministry should immediately withdraw their ambiguously worded circular dt. March 21; which lead to large-scale squandering and reissue fresh circular with clarity
3) Public and private hospitals should withheld payments to Private labs till they recalculate the rational cost of PCR and issue refund of excess amount charged, as this is not a time for huge profiteering. Private should also refund excess costs charged to all clients, they have their full details including Aadhar cards.
4) Allow Rapid and ELISA tests to be carried out in private and public settings with, though the results may not be part of statistics. All negative tests can be reported negative, positive tests can be referred to the approved centres for confirmation. This will ensure that the private sector medical profession can be an asset to the government. If emergency service provider, tests IgG positive, s/he can be redeployed in the services.
5) Escalate testing, including pool-testing and be ready for challenges than suppressing the test demands and facts. Make the private-public partnership a reality to fight Covid-19.