Like books and minds, a public health response in the midst of the steadily worsening novel coronavirus pandemic works best when it is open. 

It’s been almost a week since the Indian Council of Medical Research (ICMR), the apex biomedical body on Covid-19 management, approved test kits from private manufacturers to supply real-time PCR testing PCR testing PCR Test Polymerase Chain Reaction tests analyse sequences of genetic material—DNA or RNA. This test is used for detecting several types of diseases. . Meaningful testing, though, has still not happened. Many of the private labs that were approved subsequently didn’t begin testing until Saturday, 28 March. While the efforts look substantive on the ICMR website, on the ground, it’s more chaos, less testing.  

Kits are in short supply; some of them are failing; suppliers are jacking up prices; a few labs are even hoarding kits. Some local manufacturers are caught between the National Institute of Virology’s (NIV) insistence on 100% concordance and international regulators’ disregard for it. And so on. Wild confusion reigns supreme in the field. 

The reasons are many, but ICMR’s own lack of transparency and organisation have played a major role in the current morass. 

In the name of decentralisation, on 25 March, ICMR added three more government centres to validate and approve RT-PCR kits. Given that the country is under lockdown, there was little consideration for the geographical distribution of these centres. Apart from NIV, which is the nodal agency for all testing approvals, in Pune, the three new centres are in New Delhi, National Institute of Pathology; Kolkata, National Institute of Cholera and Enteric Diseases; and, one more in Pune, National Aids Research Institute. 

For all their competence and recognition as the biotech hubs biotech hubs The Ken The two Indian companies expanding the scope of Covid-19 testing Read more of India, Bangalore, Hyderabad, and Chennai have been assigned no centres for validation and approval of kits. Manufacturers of kits in southern India are having to send their kits to Pune by road because flights are cancelled. It’s social distancing gone crazy. 

Moreover, until Saturday, the three newly designated centres were not ready to evaluate kits because NIV, the only agency dealing with Covid-19-positive samples, has not been able to send them. Without samples, centres cannot evaluate kits.  

In short, three new centres but no new work was done for over three days. 

As for the kits, ICMR has listed 15 non-US FDA-approved kits which NIV has tested. (Kits that are approved by international regulators need not get evaluated by NIV.) Only kits that have 100% sensitivity (to detect 100% cases) and 100% specificity (to detect 100% negative cases) have been recommended.

AUTHOR

Seema Singh

Seema has over two decades of experience in journalism. Before starting The Ken, Seema wrote “Myth Breaker: Kiran Mazumdar-Shaw and the Story of Indian Biotech”, published by HarperCollins in May 2016. Prior to that, she was a senior editor and bureau chief for Bangalore with Forbes India, and before that she wrote for Mint. Seema has written for numerous international publications like IEEE-Spectrum, New Scientist, Cell and Newsweek. Seema is a Knight Science Journalism Fellow from the Massachusetts Institute of Technology and a MacArthur Foundation Research Grantee.

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