A day after the Union health ministry announced Ahmedabad-based pharmaceutical company Zydus Cadila would mass produce Elisa kits developed by the Indian Council of Medical Research, it is not clear why the ministry chose this company over others as its commercial partner.
On Sunday, the ministry said scientists at the National Institute of Virology, a government laboratory in Pune that functions under the ICMR, had developed the “Covid Kavach” – an Elisa kit that detects the presence of novel coronavirus antibodies in blood samples. The same day it announced the technology had been transferred to Zydus Cadila.
“Zydus has proactively taken up the challenge to expedite the approvals and commercial production of the ELISA test kits so that they can be made available for use at the earliest,” the ministry said in a press release.
But several companies that make Elisa kits for the detection of other diseases claim that the ministry had not released any public advertisements or notices inviting bids or expressions of interest for the technology transfer license. Three companies told Scroll.in they came to know about the selection of Zydus Cadila through news reports on Monday.
In a press briefing on Monday, responding to a question on why Zydus Cadila had been selected, Lav Agarwal, joint secretary at the health ministry, said the decision was made on the basis of two parameters: capacity to produce at a “faster pace” and “wherewithal to do production in the first place”.
“Over a period of time, if need be, other companies will be roped in,” he said.
Agarwal, however, did not respond to another question: how many companies had applied for the licence?
Questions sent by Scroll.in to the health ministry and the ICMR asking for more clarity on the selection process and the terms of the licensing agreement went unanswered. This story will be updated if there is a response.
Multiple licences needed
Public health experts expressed scepticism about the agreement. The need for emergency supplies during a pandemic did not justify a technology transfer to one company, said T Sundararaman, former director of the National Health Systems Resource Centre, an advisory body of the Union Ministry of Health and Family Welfare. Companies with similar production capacities should have been invited to make a presentation or submit technical bids, he said.
“Granted that price cannot be a yardstick in the current situation since you can’t give quality specifications for a new product and that may lead to sub-standard quality,” Sundararaman said. “Therefore, [the government] should have done the transfer to multiple companies, one in each region at least, who meet the technical specifications to see who can really scale up.”
Besides, he added, “Even if they give the licence to other companies in the future, why give one company the first mover advantage and create a monopoly?”
Zydus Cadila did not respond to specific questions about the agreement with the government. A spokesperson of the company said: “We are happy to partner with ICMR in making Covid Kavach Elisa tests available on a large scale which we will be manufacturing and supplying to ICMR for surveillance purposes. In a public private partnership, we had earlier partnered with ICMR to be better equipped against infectious disease outbreaks, and help people, who are at high risk, particularly in distant, remote areas of the country.”
The importance of Elisa test
Elisa or enzyme-linked immunosorbent assay is a laboratory test that looks for disease-fighting antibodies. Like the rapid antibody test, it is serological in nature: it looks for antibodies in blood samples. But it is considered more sophisticated and reliable.
While rapid tests generate a yes or no binary result, Elisa provides a quantitative count of antibodies. However, it takes longer to generate results – a few hours – compared to rapid antibody tests which give results within half an hour.
While both tests are unreliable for diagnosis, they could be useful surveillance tools. Since the antibodies remain in the bloodstream for months, the tests can detect older cases of infection – something that molecular diagnostic tests which look for the virus in genetic material are unable to do.
Serological tests can map the spread of the disease even among asymptomatic cases. They can also help forecast the future graph of the disease and inform public health policy decisions, particularly related to easing lockdowns and restrictions on movement.
Given that India’s rapid antibody testing never quite took off, it is now largely reliant on Elisa tests for future surveillance exercises. On May 10, the ICMR and the National Centre for Disease Control announced plans to conduct a serological survey in select districts.
No other kit available
This is where the ICMR-NIV kits will come in handy – particularly, because no other coronavirus-testing Elisa kit is available in India.
Four companies have been granted a marketing license by the Drug Controller General of India to sell imported Elisa kits. Three of them have tie-ups with Chinese manufacturers that lack a registration certificate from China’s drug watchdog, the National Medical Product National Medical Products Administration. Without such a certification, exports are not cleared by China’s customs department.
The fourth Indian company has a collaboration with a German firm, which has expressed its inability to export kits since Germany needs them domestically.
No other company approached
With global supply chains disrupted by the pandemic, domestic production of Elisa kits is necessary, if India wants to use them for coronavirus surveillance.
The country, in fact, has an established pharmaceutical sector that produces Elisa kits for the detection of other diseases like HIV. “There are more than 50 diagnostic companies in India which have the capability to make Elisa kits, if there is a technology transfer,” said Jatin Mahajan, the managing director of J Mitra, one of India’s leading manufacturers of HIV Elisa kits.
And yet, the health ministry had decided to transfer the technology to just one company, Zydus Cadila. The decision had come as a surprise, multiple pharmaceutical executives told Scroll.in. They said they were unaware of any open tender floated by the government. Nor had the government contacted other companies with a track record of manufacturing Elisa kits, they said.
Mahajan said he learnt about NIV’s technology transfer to Zydus Cadila only through media reports. Veena Kohli, chief executive officer at Vanguard Diagnostics, which also manufactures Elisa kits, echoed this. “I read about it in the morning papers,” she said. “No one approached us.”
A third Indian manufacturer of Elisa kits, Tulip Diagnostics, said it had not seen any government notices inviting bids or expressions of interest for the technology transfer. The company was in the process of manufacturing its own Elisa kit. “We have the bandwidth for that,” said managing director Deepak Tripathi. “The government can decide what it wants to do with its own technology.”
However, other executives emphasised the need for the government to rope in other manufacturers beyond Zydus Cadila to scale up production of the ICMR-NIV kits. “During a pandemic like this, there should be four-five forces which should be manufacturing this product, particularly since there are so many companies with expertise in Elisa manufacturing,” said Kohli, advocating a multi-licensing regime for ICMR’s Elisa kits.
Mahajan seconded this view: “That way the cost will also go down as we will need to conduct a large number of tests going forward.”
Public health expert Sundararaman tended to agree. “You want to have multiple options in a public health crisis,” he said. “What if this one company runs into trouble when it starts manufacturing and is not actually able to deliver?”
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