From the start, India’s response to the coronavirus pandemic has been handicapped by the lack of adequate testing. In fact, unlike other countries, it didn’t ramp up testing even after imposing a draconian nationwide lockdown in late March, although it was clear by then that aggressive testing was crucial to containing the spread of the virus.
India has tested just over 38 lakh samples for coronavirus so far, according to the Indian Council of Medical Research, the agency overseeing the country’s response to the pandemic. That’s 2,763 tests per million, among the lowest testing rates in the world. By April 30, over a month after the lockdown came into effect, India had tested about only 8,30,201 samples. Though the testing capacity has since been enhanced to over a lakh per day, it remains quite low compared to most major countries. And, to epidemiologists and community health experts, inadequate testing is one of the key reasons why coronavirus infections continue to rise sharply despite two months of the lockdown. As of noon on June 1, India had recorded 1,90,535 infections, with 5,394 deaths.
So, why did India fail to test aggressively?
Newslaundry found the authorities were slow to wake up to the need for wide testing and reluctant to share crucial information that would enable private labs to develop diagnostic kits of their own. They also bungled the procurement of antibody testing kits from China and the manufacture of ELISA kits, which are now being employed to study how far the virus has spread in the community.
India started testing for coronavirus in mid-January, at Pune’s National Institute of Virology. On January 30, Kerala reported the country’s . Yet, at the end of April, by when people had tested positive and at least 1,074 had died, just over , public and private, were authorised to test samples for coronavirus. The network has since been to 446 government and 195 private labs. Roping in private labs had sparked a controversy, though, as Newslaundry in April. The government was accused of arbitrarily allowing them to charge Rs 4,500 per RT-PCR test – the standard test for the novel coronavirus – making it unaffordable for the majority of the country’s population.
In March, as positive cases climbed steadily and it became clear that testing had to be scaled up, the ICMR started approving testing kits from private players. Dr Rajnikant Srivastava, the head of research management, policy, planning and biomedical communication at the ICMR, said the agency approved the use of kits certified by America’s Food and Drug Administration and the European Union’s Conformité Européene. These regulators assess the safety and efficacy of novel devices and certify them if proven satisfactory, he added.
Asked about India’s test development strategy in the initial days of the outbreak, Srivastava said the National Institute of Virology formulated the RT-PCR assay in January and provided it to the labs that were designated for coronavirus testing over the following months. Assay is an analysis done to determine the presence of a substance – in this case coronavirus – in a sample and its amount.
Then, on March 26, as the ICMR started approving FDA-certified kits, it invited domestic suppliers to submit kits for approval, which it promised would be fast-tracked. The agency eventually cleared RT-PCR kits from 20 Indian companies. By May 28, these companies were ready to provide up to five lakh RT-PCR kits per day, according to Dr Vinod Paul of the Niti Aayog who leads the government’s Covid Task Force. As they ramp up production further, Paul told a press briefing, these suppliers would not only meet domestic testing needs but even export their kits.
The suppliers, however, paint a less rosy picture. The domestic production of RT-PCR kits is still far from adequate, said a private supplier to the ICMR who asked not to be named for fear of reprisal. “One reason for the shortage of such kits is that they are being repackaged. Another reason is the kit requires 10 components which have to be outsourced from 10 different manufacturers,” the private supplier explained, adding that most Indian manufacturers get components from China or South Korea. “If one manufacturer doesn’t have a component, they go to another maker. This disturbs the quality control and leads to variations in kits.”
There was another problem. The kits were expensive and using them was tedious. They required trained technicians to use, as also labs with RNA extraction machines, meaning that the labs that could be roped in for testing were limited in number.
To address this, the ICMR its testing strategy on April 17, allowing the use of the antibody test – also known as the rapid test because, unlike the RT-PCR test, the result is available in a few hours – as a screening tool in hotspots, 170 of which would be identified across the country by April 25. As of today, 145 districts have been declared potential Covid hotspots. The rapid tests would be used for epidemiological studies and surveillance in these places, the ICMR said.
Accordingly, on April 16, the ICMR bought, through private firms at , rapid testing kits from the Chinese makers Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics. The kits turned out to be faulty, however, as Newslaundry reported, and several states refused to use them. The central government discontinued the use of the kits, and claimed it had not paid for them, even as the Chinese suppliers insisted that the products were approved by both the ICMR and the National Institute of Virology.
After this fiasco, the ICMR announced on May 8 that it had roped in HLL Infratech Services, a public sector undertaking, to oversee the procurement of 29 lakh RT-PCR kits. This was done to “streamline the procurement process further”, Srivastava said.
A posted on the ICMR’s website lays out the rules for the procurement: only Indian firms with an import licence from the Drug Controller General of India and three years of experience supplying medical equipment, including reagents and diagnostic kits, can bid; foreign companies must apply through an Indian firm; a fourth of the tendered amount will go to MSME firms, with five percent reserved for MSMEs owned by Scheduled Castes and Scheduled Tribes, and three percent for enterprises owned by women. The procurement will be financed by the World Bank, whose auditors would check the bidder’s documents if needed.
Several states such as Rajasthan, Bengal, Tamil Nadu, Andhra Pradesh, and Uttar Pradesh are buying RT-PCR and rapid testing kits on their own from companies approved by the ICMR. Newslaundry contacted officials in all these states to ask about their procurement policies for diagnostic kits. The story will be updated if a response is received.
Apart from RT-PCR and antibody tests, India is now using ELISA, a serological test, for coronavirus screening. ELISA too works by detecting antibodies produced by the body against the virus but it has far higher sensitivity and specificity than the rapid test, meaning that it’s more likely to find a positive case and more accurately. But the RT-PCR test remains the gold standard in coronavirus testing.
On May 10, the health ministry announced that Zydus Cadila, a pharma company in Ahmedabad, Gujarat, would mass produce the first indigenous ELISA kit, developed by the National Institute of Virology. The selection of Zydus Cadila sparked a controversy, with rival companies alleging that the health ministry hadn’t released public notices or ads inviting bids for the technology transfer licence in a deliberate move to favour the Ahmedabad firm.
The ICMR has since also a survey in 69 districts of 21 states where the ELISA test will be used to estimate the extent of coronavirus infection in India.
Srivastava said the ELISA test will be used solely for surveillance. “It will determine how much of the population is exposed to the novel coronavirus by detecting the presence of IgG antibodies. IgG antibodies start developing after 14 days of infection, and stay for a longer period,” he said. Since these antibodies are produced only 10-14 days after the infection, the ELISA test cannot detect recent infections, he added.
Traditionally, the test is used for HIV and is quite accurate. It is hoped the wide availability of the kit will help aggressively test the Indian population, especially as the lockdown is relaxed.
Suresh Vazirani, chairman of the Transasia Bio-Medicals, an Indian multinational that produces ELISA kits, said they began developing a testing kit soon after the outbreak. “More than 20 lakh people have used our kits across the world,” he said. “We are selling the kit in many countries.”
But not in India because the government has provided positive control samples to select companies such as Zydus Cadila. A positive control sample, taken from a Covid patient, is the non-infectious portion of the virus genome that is made synthetically to see if the testing kit is working as expected.
“We have developed a kit. To know if it works, we need positive control samples. Right now, there’s no way that the government is allowing it to happen,” Vazirani said. “They aren’t giving us any positive control samples or access to them. How then can Indian manufacturers test?”
His company received FDA approval for its ELISA kit in four days, Vazirani claimed, but was still awaiting clearance from the National Institute of Virology for more than 20 days.
Srivastava of the ICMR maintained that kits approved by the FDA weren’t required to be validated by his agency, but Vazirani said that wasn’t quite accurate. “That’s what they are saying but that is not what the government is doing. We applied to the Central Drugs Standard Control Organisation for marketing and import permission. They gave us the import permission, but we can’t market it until we get the NIV testing and approval done,” he explained. “I checked with other companies and it’s the same for all of them.”
India has the capacity to test aggressively but it is not being utilised properly, Vazirani argued. “Unless you test, you don’t know. If you don’t know, you can’t do anything,” he explained. “Fortunately, India has a lot of labs, a lot of manpower. So we must utilise it fully. Covid needs serious action. But the government is not doing enough testing. Private labs can do about two lakh tests a day, but are hardly getting around 20,000 samples. The government isn’t sending the samples, and it is not allowing people to do testing. They are controlling it.”
Zoya Brar, CEO of Core Diagnostics, a company which collects samples and tests them for coronavirus using RT-PCR, echoed the sentiment. Testing has been a challenge in India because of the shortage of facilities and the huge population.
“Although the government has already ramped up testing by procuring RT-PCR and other allied machines, the expansion is still insufficient to meet the demand of the nation,” she said. “Alternative methods need to be explored in addition to RT-PCR testing, including serological tests that take about two hours to process.”
Newslaundry contacted the health and family welfare ministry and the Central Drugs Standard Control Organisation to ask about the availability and regulation of diagnostic kits in the country. This report will be updated if a response is received.
This piece is part of a project supported by the Thakur Family Foundation. The Thakur Family Foundation has not exercised any editorial control over the contents of this research.
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