Updated: March 24, 2020 1:38:55 pm
The National Institute of Virology (NIV) in Pune has given clearance to two companies — Germany-based Altona Diagnostics and Pune-based MY LAB — to make test kits for coronavirus. This comes two days after ICMR issued guidelines for private testing of COVID19 restricting use of only USFDA or European CE certified kits at private labs, widening the guidelines and allowing kits manufactured domestically or outside the country, after validation from the NIV.
ICMR Monday said it has established a “fast-track mechanism” for validation of non-US FDA-European CE approved kits at NIV, Pune. The moves come in the backdrop of criticism from various quarters about restricting commercial kits only those approved by USFDA or European CE. Read in Malayalam
DG ICMR DR Balram Bhargava said on Monday: “We have issued guidelines for private labs; 12 laboratory chains have registered so far and between them, they have some 15,000 collection centers. Two kits have been approved after validation by NIV Pune. FDA approval is not mandatory. Approval byICMR will be enough.”
At present, 6.8 per million, India has the lowest testing rates for COVID-19, with limited testing facilities and expensive testing kits were the biggest concern for health officials. The search for indigenous test kits got a leg up when the Pune company’s kit became the first of the nine kits tested by Indian authorities to get approval.
On the clearance for the first made in India kits by Mylab Discovery Solutions Pvt Ltd, Dr Renu Swarup, Union Secretary, Biotechnology, expressed delight. “This is a great source of happiness for us and as the MD has said they can produce one lakh kits a week, which is very good news,” she told The Indian Express.
The ICMR move is likely to give a push to domestic manufacturers in the country and to vendors who are in talks to import kits that are being produced in China. Sources said that after India opened up testing for the private sector last week, there were already massive international flight restrictions in place and it was impossible for private labs to procure USFDA approved kits for testing.
“Many of them reached out to the government and explained the position. After some to and fro the matter was resolved in favour of relaxing the norms and allowing Indian kits that meet the standards, to be used,” sources said. Another source said it was also communicated to the government that NIV Pune has also been using Research Use Only (RUO) kits, for COVID19 tests, that are not USFDA approved.
In the RT PCR test, that being conducted for COVID 19, the amplified DNA of the suspected patient is tested against a positive control, and negative control, which is a sample that has tested negative for the virus. According to new guidelines, issued on Monday, the ICMR said the “test kits with 100 per cent concordance among true positive and true negative samples will be approved for commercial use in India.” This effectively means that the samples have to be 100 per cent concordance to the SARS-CoV-2 genome, the virus that causes COVID19; and 100 per cent concordance, is seen only in identical or twin samples.
ICMR released the results of nine non-US FDA-European CE out which only Altona Diagnostic’s RealStar SARS-CoV-2 RT-PCR kit and My LABS Patho Detect secured 100 per cent concordance among true positive and true negative samples and have been approved for commercial use. Among those who could not get validation was IIT Delhi; its kit SYBR Green-based one step QRT-PCR got 98% concordance among true positive and just 10 per cent concordance among true negative.
“We were the first company to develop the SARS kit in 2002. We have also developed the testing kits for H1N1, Ebola, and Zika. We developed the kits for COVID19 in February. At first, we got research use only kits for evaluation at NIV, Pune. In fact, even before the validation in India, we already have published the results in two journals in Germany and UK,” Tarun Jain, general manager, South Asia, Altona Diagnostic, told The Indian Express.
Asked if the NIV Pune has used the company’s RUO kits, for testing at the government labs, Jain, said, “Yes and no. We are in discussion with ICMR. They are in the process of importing a bigger quantity from us. But we have certain obligations in the European Union and Germany, keeping in view the global situation. We are looking for all possible ways to expand our manufacturing.”
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Meanwhile, the German company has not yet started taking advance orders from the private labs. “We are not entertaining orders as yet, as we still need to receive an import licence. Our estimate is that private labs will be testing around 2000-8000 tests per day. This number can exponentially grow. We are still evaluating all possible options. At this time, we cannot give any number (on the number kits the company will be importing).”
So far the Indian government has been relying on testing kits from Germany to diagnose coronavirus patients. However, the supply of foreign kits has been causing problems and grounded airlines could add to the concerns. This can change with the approval for made in India kits.
The testing kit by Mylab would cost nearly “one-fourth of the current procurement cost”. Company sources say the Mylab kit screens and detect the infection within “2.5 hours, compared to 7+ hours taken by current protocols. This means that laboratories will be able to do twice the number of reactions in the same time on one machine.”
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