Confusion marred the process for allowing private manufacture of COVID-19 testing kits

Vials used in coronavirus diagnostic test kits manufactured at a production facility in Berlin. In India, the health ministry has finally given the nod to private companies to manufacture testing kits. Krisztian Bocsi/Bloomberg / Getty Images
25 March, 2020

As India grapples with the COVID-19 outbreak, the health system is grappling with a shortage of testing kits. One of the most important ways to flatten the curve—an effort to slow down the rate at which people will contract the virus over a period of time, to help reduce the load on hospitals—is to expand and speed up the testing process and provide kits as soon as possible. The Indian government has been facing strong criticism for its low testing rates, despite the scale of its population and the alarming speed at which the virus is spreading. The medical establishment, led by the Indian Council of Medical Research and the ministry of health and family welfare, has finally given the nod to private companies to manufacture testing kits. While the decision has been welcomed by public-health experts, it is not clear why the government waited until now to allow this. The process itself has been slow and marred by confusion, owing particularly to two notifications issued by the ICMR.  

On 23 March, the ICMR issued a notification approving the kits of two companies for indigenous production, Altona Diagnostics, a German company and MyLab Discovery Solutions, a Pune-based company. Their kits—RealStar SARS-CoV-2- RT-PCR and Patho Detect MyLab, respectively—were found to have 100 percent concordance among true positives and true negatives, that is, the tests accurately represented whether the condition it was trying to detect was present or not. Kits from seven other companies were rejected because they did not generate 100 percent concordance. 

The ICMR notification said that it had established a fast-track mechanism for validation of testing kits that were not certified by the United States’ Food and Drug Administration or the European Union’s CE—a certification mark indicating that a product meets the health standards in practice within the  European Economic Area. In other words, kits manufactured by Indian companies now need only the certification of the National Institute of Virology, an ICMR institute in Pune. 

This cleared some of the confusion created by an earlier notification issued by the health ministry on 21 March detailing guidelines for private labs and testing kits, which said that commercial kits should have FDA approval or have the European CE certification. This came when large parts of the country started going into lockdown. The chairman and managing director of a medical-technology company that has also developed a COVID-19 testing kit, which is awaiting approval, told me that the FDA-CE clause was discriminatory to Indian firms. The managing director agreed to speak to me on the condition that I do not identify him or the company. “Why would the US FDA certify Indian kits?” he asked. “It is stupid. The whole classification of private testing is discriminatory and the [medical] associations are reaching out to the Prime Minister’s office.” 

The process until the second ICMR notification was that real time PCR testing kits—a polymerase chain-reaction test, which analyses small quantities of genetic material to enable detection—for COVID 19 were being procured by the NIV from the United States and distributed to testing laboratories around the country. As the guidelines for testing have now been relaxed by the ICMR, the country will need to ramp up production of testing kits.

Another guideline in the 21 March notification concerned the pricing of testing kits. It recommended capping the price for testing at private labs at Rs 4,500—including Rs 1,500 for screening and Rs 3,000 for a later confirmation test—while encouraging free or subsidised testing given “this hour of National public health emergency.” The upper limit for pricing, however, is unconscionably high, given that a majority of the Indian population will not be able to access it at that cost. “How many people in the country will be able to afford a Rs 4,500 test?” SP Kalantri, the director of the Mahatma Gandhi Institute of Medical Sciences, a non-profit hospital, asked me. “Just because they have a runny nose or a sore throat they are not going to go to a private lab. And this is just for one person. A family of four, imagine how much they will have to spend if everyone has the symptoms.”

There are examples of companies around the world that are offering COVID-19 testing kits at very low prices. For instance, Biomerica, an American Biomedical tech company, is offering a test costing ten dollars. Researchers at the Pasteur Institute in Senegal are aiming to make a diagnostic kit available at the cost of a dollar, albeit in three months. Closer home, scientists in Bangladesh have developed testing kits that will cost three dollars.

“The 4,500 price point is based on the cost that the government claims to be incurring, but there is no transparency on how the government arrived at this cost,” Malini Aisola, the co-convener of the All India Drug Action Network, told me. “It negates the very purpose of the public-health response and current strategy to expand testing. We want the government to make testing free, even in private labs.”

I spoke to Gautam Wankhede, the medical director of MyLab Solutions, the company that has won the government’s approval to start manufacture of kits. “We have got all the evaluations done and are ready to go now,” he told me. “Our team is already working in our manufacturing unit in Lonavala and hopefully by the end of Tuesday we should have released our first batch of tested kits and approved kits as well.” On the capacity and the price his company would be offering he said, “In a couple of days we can go up to 15,000 tests a day, so one lakh tests a week. The government has given a price of Rs 4,500, we can give it at a third to a fourth of that depending on volumes, where the lab is based, et cetera.”

The fact that there is only one validation agency for the whole of India, has created difficulties for some firms. “Our kits are ready, but they are in Delhi,” the managing director of the medical-technology company, told me. “How do we send it to Pune in these conditions of lockdown? MyLabs is based in Pune, so it’s easy for them to send their kits to NIV. Everything going to NIV is impossible in today’s world, even if the kits can be sent by courier, which itself is difficult, and sending our scientist to Pune is almost impossible,” he said. When I asked Wankhede about this, he agreed that being based in Pune made it easier for his company. But having said that, we are also going to ship the kits to hospitals and labs starting tomorrow,” he said. “I would think under the essential services there is some relaxation for couriers.”

The process of certification for Indian testing kits, according to Wankhede, involves several steps. A company has to conduct in-house research and development before developing a kit. Then it needs to send an application for a testing license to the Central Drugs Standard Control Organisation. The kit is next evaluated at NIV, which checks it for quality and effectiveness before giving its recommendation. Finally, the report is sent to CDSCO, which grants the manufacturing license, which is what MyLab was granted.

Another company that is trying to develop a testing kit is Gujarat-based CoSaraDiagnostics. On 19 March, media reportsnoted that CoSara had become the first firm in India to get a license to make COVID testing kits. A review of publicly available documents and an interview with the company’s managing director suggested this is not the true picture. CoSara had received a testing licence, and not a manufacturing permit. The misunderstanding was based on an exchange filingthat Ambalal Sarabhai, the listed parent company of CoSara, had sent the Bombay Stock Exchange on 18 March. It read “CoSara Diagnostics Private Limited has received Test License from CDSCO to manufacture corona virus (COVID-19) diagnostic test kits.” The confusion was caused by the use of the word manufacture.

“We haven’t received a manufacturing licence yet,” Mohal Sarabhai, the managing director of CoSara, told me. “The test licence means you can produce the diagnostic tests and then supply to NIV so they can check if everything is ok.” Sarabhai is expecting the licence within a week, but is uncertain because of the various lockdowns. “We plan on manufacturing and we want to ramp up to 10,000 tests per day, but that will happen in April and it depends on the logistics,” he told me. “There is not a shortage, but there are delays. But because we have a US partner we are better placed. All commercial flights have been cancelled, so we have to use special courier planes.” Sarabhai declined to say how much his kit would cost, except for saying that it would be cheaper than imported kits. 

When I asked Sarabhai if the entire process, including the two notifications, had caused confusion, he replied, “This disease is novelby definition it is new. As a result a lot of things are rapidly changing. So there is confusion, but it is not only this, it is on so many fronts. Even the US is not being able to handle the outbreak.” 

According to the managing director of the medical-technology company, there “should have been agencies in ten different cities validating kits, both imported and manufactured” to speed up the process. “Otherwise they should allow green channel imports, like what China did,” he said. “We are making it complicated. The US itself does not have kits, why will they send  FDA-approved kits to us?” The managing director claimed that once he got the final approval, he would be able to sell his kit at between Rs 500–700. 

By the evening of 24 March, ICMR had reportedly tested 21,804 people—about sixteen tests per million people in the country. I spoke to Dr Vinod Paul—a member of NITI Aayog and the chairman of the government’s committee of health experts on COVID-19—about the government response. “We have them in the millions,” Paul said, when I asked him how many testing kits the ICMR has. “As the disease spreads, if it does, in case it does, we will look at it. Now the kits can come from anywhere, the door has been opened, because it is not just the testing capacity. If the government needs to buy, apart from Indian kits it can acquire globally.” Paul told me that the kits developed indigenously would be available at a “relatively low cost.” When I asked him about the fast track approval for private companies wanting to develop these testing kits, he replied, “It will be done in less than a day.”