“Test, test, test” has been the WHO’s mantra to tackle the coronavirus pandemic. A recent epidemiological model developed by a consortium of over 400 Indian scientists also strongly supported this plan, showing that testing and quarantining may actually be more effective than a lockdown for controlling COVID-19. To make the matter even more difficult to manage, studies now indicate that up to 44% of infection transmission can happen in the pre-symptomatic stage. This means that not only do we need to test every symptomatic patient – we also need to test every asymptomatic contact and ideally even undertake random community sampling to get an idea of the extent of disease.
In fact, 53 of 167 journalists (mostly asymptomatic) recently tested positive for COVID-19, demonstrating that among people currently working and interacting with many others during the lockdown, almost a third may contract the disease.
Unfortunately, India is doing way less than what it needs to be doing with regards to testing – although the Indian Council of Medical Research (ICMR), India’s apex scientific medical body, believes otherwise. For example, it recently stated that India is actually doing pretty well, and carries out a much higher 24 tests per positive case, compared to 6.7 in Italy, 5.3 in US, and 3.4 in UK. This is a misleading metric to use. The adequacy of a country’s testing should be based on the number of tests carried out per person, and not on the number of tests per positive case.
Data from Worldometers.info, accessed at 12 pm on April 23, of the number of tests per person in India is shocking. India tests a measly 363 per million population, while the other countries mentioned above test between 8,000 and 25,000 per million. Someone might argue that comparing India with first-world nations is like comparing apples and oranges. Unfortunately, even if we look at other developing countries, India falls way short. In fact, India tests less per million than Pakistan for COVID-19!
What is the issue here? India has a large pharmaceutical industry and a decent health tech environment as well, a history of low-cost innovations for medical technology, a head-start of a few months since COVID-19 hit the world, and a five-week lockdown giving us more time to get things back on track. Why are we unable to ramp up testing compared to other countries? Are we not spending enough on kits, or are there no kits available in the market?
ICMR hasn’t provided clear answers to these questions, but a deeper probe demonstrates five big issues.
1. The first and biggest issue is ICMR’s attitude. We have to first acknowledge the problem in order to start finding a solution. However, ICMR genuinely seems to believe that we are testing enough, which is at odds both with both our Indian data and the WHO’s stand. Many believe that ICMR actually understands reality – but then makes these statements as there aren’t enough testing kits available. If so, a better approach would be to honestly accept the fact that we are testing very little, and explaining that we are rationing our kits.
2. The second issue is the extremely centralised decision-making of ICMR and the Pune-based National Institute of Virology (NIV) – both of which are research organisations with limited clinical activity and patient interaction. As a result, they lack the key clinical inputs needed to make the right decisions. Further, ICMR left out other apex institutes like the PGI Chandigarh, CMC Vellore, NIMHANS Bangalore, and AIIMS and physicians’ associations as well.
For example, during the H1N1 outbreak, institutes like NIMHANS used to validate kits as well, but not this time around despite this being a much larger public health emergency. And thanks to the lockdown, Indian companies needing to send their kits for validation to NIV Pune have faced several delays, with some simply unable to reach Pune. It is no surprise then that the first Indian company to get ICMR approval for its test, MyLab Solutions, was based in Pune. Thankfully, ICMR belatedly realised its folly and has now approved more centres to validate testing kits.
3. The third big issue is the process of validating testing kits, with significant bureaucracy and red-tapism along with a unique opacity when it comes to sharing data and quality control methods. Even after receiving ICMR’s approval, a company has to get an okay from the Drug Controller General of India, which can take up to a week. Clearly, we need to fast-track such applications as much as possible. Similarly, companies that send their kits for validation to ICMR don’t receive feedback on the accuracy of their kits; they receive a simple ‘pass’ or ‘fail’ sort of report. This gives them no room to improve. Tests validated by ICMR also have not performed well on the field, particularly the recent rapid-testing kits whose accuracy reportedly varied from 6% to 71%, and the use of which ICMR suspended for two days. Apart from the kits themselves, what techniques is ICMR using to validate the kits? How was a kit with 6% accuracy validated for use?
4. The fourth issue is India’s inexplicable unwillingness to involve private laboratories in the testing process to the fullest. The RT-PCR test to detecting COVID-19 is complicated and needs an elaborate laboratory setup º not an easy task in our limited public health infrastructure. Private laboratories also need some time to setup and standardise their testing protocols before they can ramp up testing. And yet, ICMR took a long time before it allowed private laboratories to start testing. Subsequently, some private hospitals started testing every patient admitted in their hospital for COVID-19, something outside the purview of ICMR guidelines at the time. A substantial proportion of asymptomatic positive patients were thus detected, preventing many healthcare workers from getting infected.
Accordingly, the government has now formally recommended that hospitals close to COVID-19 containment zones test everyone who is admitted. Unfortunately, ICMR still doesn’t allow private labs to perform the rapid antibody tests. Clearly, we need every possible entity we can use to ramp up testing, and this strange antipathy to private laboratories isn’t helping the cause.
5. Finally, the fifth issue is ICMR’s contradictory role in what its own research shows and what it prescribes for the public. For example, one study authored by ICMR’s own researchers (submitted to a journal on February 27) stated that even a 100% flawless airport screening could not have delayed the COVID-19 epidemic by more than three days due to the role of pre-symptomatic carriers. They also predicted between 200,000 and 10 million cases in Delhi alone based on different government interventions and viral infectivity models. And yet, ICMR refused to widen the scope of testing for a long time beyond February.
This discrepancy between what its own research demonstrates and how it acts is perhaps the biggest cause for worry. ICMR either doesn’t believe its own data and or it doesn’t wish to act on it either because of external factors or its perceived limitations of the Indian health system. Thankfully, India’s testing numbers have been on the rise over the last few days, and many more kits have been procured recently.
The fact remains that India’s medical research organisation really needs to pull up its socks, and begin by simply acknowledging what all experts and its own data are saying: we need to test more. Most importantly, ICMR needs to demonstrate the urgency required to accelerate testing to whatever extent is feasible during the lockdown and beyond, both in words and in action. This is doable simply by cutting out bureaucracy and being transparent about its testing protocols and results, so that our extremely capable companies get the support they need to help the country.
Dr Akshay Baheti is an assistant professor at a hospital in Mumbai. The views expressed here are the author’s own.