India has approved the sale of 18 diagnostic kits made by private companies for coronavirus testing, a top official confirmed on Thursday. These include three kits which have been evaluated by the National Institute of Virology in Pune, and 15 kits which have obtained fast-track approvals based on licences and certificates obtained in other countries.

“We have issued approvals for 18 kits,” VG Somani, the Drug Controller General of India, told on phone. “These include both manufacturing and marketing [import] approvals.”

The approvals were fast-tracked, said Somani, given the need to rapidly scale up coronavirus testing in India. Until March 26 evening, 633 cases had tested positive in the country for Covid-19, the disease caused by the novel coronavirus. Experts believe this is an undercount given India had tested only 25,254 people till March 25.

While public health activists have urged the government to expand testing, they say the country needs to maintain transparency in its regulatory process for the diagnostic kits.

When asked for the list of the 18 kits that have been granted licenses for import and manufacture, Somani said it was available on the Central Drugs Standard Control Organisation’s website. But was unable to find it. Somani did not respond to further messages.

Malini Aisola, co-convenor of the All India Drug Action Network, said there should be public disclosure of the basis on which each test kit was granted a marketing licence in India. “We should know if it was on the basis of local evaluation or approval by a recognised foreign regulatory body,” she said.

A gap in the market

India’s coronavirus testing regime is supervised by the Indian Council of Medical Research, which functions under the health ministry. The early cases suspected in the country were tested at the National Institute of Virology in Pune, which was also tasked with preparing testing kits for use in other government labs in the country.

This centralisation was criticised for slowing down the testing process in the country.

As the number of Covid-19 cases in India rose, on March 17, the ICMR announced private labs would be roped into coronavirus testing. These labs, however, would need to buy their testing kits from the market.

The problem was that there was no approved kit in the market.

This is where the Central Drugs Standard Control Organisation enters the picture. Drugs and diagnostic kits cannot be sold in India without CDSCO approval.

To secure an import or manufacturing license from the CDSCO, diagnostic companies are required to get their products validated for efficacy. For this, they must get a test licence to gather data on the performance of their products, which is usually validated by national laboratories to maintain stringent norms.

Given the need to bring more coronavirus testing kits into the market urgently, however, this process was relaxed – similar to what has happened in other countries battling the pandemic – but there was a lack of clarity over the new rules.

This is why controversy broke out when a company based in Ahmedabad, CoSara Diagnostics, announced to its investors in a press release on March 19 that it “has become the first and only Indian company to receive a license from the Central Drugs Standards Control Organisation to manufacture” Covid-19 kits.

Somani, however, claimed CoSara had not been given any license to sell kits in the Indian market yet. The Economic Times reported that the company had misrepresented facts to its investors.

The controversy, however, served to draw more attention to the process for obtaining fast-track approvals for Covid-19 testing kits. What exactly is it?

Three tracks of approval

On March 19, the CDSCO released a public notice making two significant announcements. It said that companies with Covid-19 testing kits approved in any other country could approach the organisation for fast-track approvals. Second, it said that on a case-to-case basis, data requirement for clinical performance appraisal of the kits may be “abbreviated, deferred or waived” depending on “type and nature of the diagnostic kit, existing data on the product, and evidence of available clinical performance evaluation data.”

The public notice was put on the CDSCO website on March 19.

Asked what this meant, Somani said kits with approval from the Food and Drugs Administration of the United States, USFDA, or with European CE certification, would get an immediate license since their kits had already been subject to scrutiny from established regulators.

“Those with FDA or European CE approval can directly apply online to the DCGI with the necessary certification documents,” he said.

However, as Huffington Post reported on Wednesday, faced with the need to ramp up Covid-19 testing in the United States, the FDA has itself relaxed its regulatory protocol: it now grants approval to a company based on the tests run on just 30 samples, compared the industry norm of 200 samples. This raises questions on the faith placed by Indian regulators in FDA approvals.

In the case of kits approved in other countries which do not have FDA or European CE approval, Somani said an in-principle import or manufacturing license, as the case may be, would be issued but the data on their products will be analysed. “If we are not satisfied, the approval will be withdrawn,” he said.

This still leaves a third category of kits: those which do not have approvals from foreign regulators. The companies making such kits have been asked to get them evaluated by the National Institute of Virology. The decision to make NIV the sole validating agency came under criticism since it was already overburdened with the production and distribution of testing kits for government labs. On March 25, the ICMR announced that three more national institutes were being made available for validation of kits.

Until now, the NIV has tested 14 privately-made kits and recommended three kits made Atona Diagnostics, MyLab and Seegene for CDSCO licence. The ICMR released the data to explain why these kits had been recommended: they had shown 100% results while the others had not.

Results for 14 kits evaluated by NIV. Three were approved based on 100% concordance between among true positive and true negative samples.

The data released by ICMR has brought a measure of transparency to the regulatory process followed to grant licences to three testing kits that do not have foreign certification. But the process followed for granting Indian licences to 15 kits solely on the basis of foreign certification needs more scrutiny, said activists.

Aisola of the All India Drug Action Network said that in case the drug controller has exercised discretion in granting a waiver, then the rationale for the waiver should be provided.