Why were coronavirus testing kit approvals hidden from public view?

The novel coronavirus pandemic calls for exemplary public communication: governments must use simple, clear language to keep citizens informed about the risks they face, the actions they must take to protect themselves, the decisions it is making to keep them secure, as well as respond to their concerns and questions.

The Indian government has done badly on this front – most evident in the way it triggered panic-buying and a migrant exodus by announcing a 21-day lockdown abruptly, without telling people how it planned to sustain food supplies.

Another clear example of poor communication is the continuing confusion over coronavirus testing kits.

Last week, a private company Bione announced it had created a self-testing kit that allows users to do a finger-prick test at home to detect if they were infected with the virus. By the time the drug and diagnostics regulator clarified on Sunday that it had not approved this kit, the company had already sold its first batch.

This isn’t simply the case of a company’s violations escaping the eye of the regulator – the regulator itself created the ground for such commercial deceit by not releasing the list of licensed kits in the public domain.

On March 26, the Drug Controller General of India, VG Somani, told Scroll.in that 18 testing kits had been given import and manufacturing licences. When asked for the list of approved kits, he said it was available on the website of the Central Drugs Standards and Control Organisation which he heads. No such list was available. Scroll.in asked for the list again on March 30. This time, Somani said his staff was too busy to upload it on the site.

In the meantime, private labs conducting the tests reported shortages of kits: executives of two labs said they were only aware of four vendors whose kits had been evaluated and recommended for licences by the National Institute of Virology under the Indian Medical Council of Research. They did not know about other vendors who had been directly licenced by the drug regulator. State governments wanting to buy kits from the market, to supplement the supplies they got from the Centre, were also in the dark.

As a result, neither private labs nor state governments were able to make optimal buying decisions. Everybody competed for supplies from a limited pool of vendors.

Worse, with no public disclosure on the licenses, anxious Indians fell for the claims of a company that started selling home-based testing kits, despite not having a license.

After controversy erupted over the home-based testing kit on Sunday, the drug regulator was forced to respond. It said the kit did not have a license. It released two lists of licensed kits.

But even now the regulator has been economical with information.

The first list is of 25 licensed diagnostic kits that use the reverse transcription polymerase chain reaction method of testing for the presence of the coronavirus in the nasal or throat swabs of suspected patients. This method is time-consuming and requires more expertise but is the preferred one for diagnostics since it is more reliable.

The second list is of 29 rapid kits that look for antibodies in the blood as a signal of coronavirus infection. Faster than RT-PCR tests, they are easier to do, but run the risk of false negatives: an infected person may appear normal in the blood test. Yet, experts recommend that these serological tests be used as a preliminary step for screening communities and many state governments have already announced such plans.

However, this list is ambiguously worded, leaving doubt over whether these rapid testing kits have final approvals. It is also not clear whether these kits can be used by private labs.

Such opacity will set back India’s efforts to fight the epidemic.

Around the world, countries like South Korea and Germany that have made coronavirus tests freely and easily available have been more successful at containing the epidemic. India, by contrast, has created an unequal system where government labs conduct the test for free, but private labs are allowed to charge up to Rs 4,500 or US$60 per test, which is unaffordable for most citizens. With states like Uttar Pradesh severely restricting the scope of government tests, even seriously ill patients are slipping through the cracks in rural areas as Scroll.in reported.

The drug regulator’s lack of transparency might come as an unexpected equaliser, depriving even affluent Indians of accurate and timely tests.