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Explainer: Where does India stand in its capacity to test for Covid-19?
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On Monday, the ICMR began approving private kits to bolster testing capacity.

 

Covid-19, the disease caused by the coronavirus, has killed nine people in India so far. The total number of confirmed cases stood at 468 at 9.30 pm on Monday.
 
Maharashtra and Kerala remained the states with the highest number of confirmed cases. According to the Ministry of Health and Family Welfare update at 6 pm on March 23, Maharashtra had 71 positive cases and Kerala 60. The state governments later revised these numbers to 97 and 94 positive cases respectively.
 
With state governments across the country putting in place severe restrictions on movement and services in anticipation of increase in the spread of the infection, India’s capacity to test people for the virus has taken centre stage.
 
How many samples have India tested as on Monday? What is the government doing to increase the testing capacity, which is crucial for slowing down the spread of the virus and medical intervention for the patients?
 
Here is what we know on Monday evening.
 
How many samples tested so far?
 
As at 10 am on March 23, Indian had tested 18,383 samples from 17,493 individuals, a statement from the Indian Council of Medical Research said. There were 415 confirmed cases detected from these. By Monday evening, this figure jumped to 433, as per figures on the Ministry of Health and Family Welfare website. No fresh data was released on samples tested in the evening.
 
How many labs can do the tests?
 
According to the ICMR, there are currently 118 approved government laboratories for testing. Of these 92 are already operational and 26 are in the process of getting ready to test.
 
This apart, the ICMR has approved 12 private laboratories in six states to test for Covid-19.
 
Here is a list of the approved government and private labs.
 
How many Indian companies can make testing kits?
 
Even after the government opened up tests in more labs, there are concerns over the limited supply of kits. Until last week, the only kits available in India were those made by the National Institute of Virology.
 
On Saturday, the health ministry released guidelines that said only private testing kits with the approval of United States Food and Drug Administration or the European CE certification would be allowed to be used in India for Covid-19 testing.
 
This surprised Indian manufacturers, who had been asking the government to approve their own testing kits so that it could be put to use immediately.
 
On Monday, the Times of India’s Rema Nagarajan reported how this process could impede the aim of expanding the testing process.
 
At the moment, there seems to be only one manufacturer in India with USFDA approval. The Times of India reported that Cosara Diagnostics, an Ahmadabad-based company, has a joint venture with an American manufacturer.
 
However, with mounting pressure to make testing available to more people, on Monday, the ICMR released a statement stating that it has established a fast track mechanism for approving commercial kits that do not have the USFDA or European CE certification. “Test kits with 100% concordance among true positive and true negative samples will be approved for commercial use in India,” the statement said.
 
Under this process, the institution analysed kits of nine different manufacturers, including one developed by the Indian Institute of Technology-Delhi. Of these, two kits developed by Altona Diagnostics and MY LAB have been approved.
 
The ICMR statement also said that USFDA and European CE approved kits can be used directly after due approval from Drug Controller General of India and with intimation to ICMR.

 

Does this mean private labs can now scale up tests?
 
Private diagnostic manufacturers Scroll.in spoke to said they welcomed the move to fast track approval of commercial testing kits. But they still sounded cautious.
 
According to the chairman of a Chennai-based diagnostic manufacturer, given the high number of cases anticipated in India, many more testing kits have to get to the market quickly to meet the demand.
 
The diagnostic equipment manufacturer said importing USFDA and European CE approved kits at the moment would be close to impossible as movement of cargo from United States and Europe has come to a grinding halt. Even those manufacturers with USFDA approval will find it difficult to import at this juncture, making approval for more domestic kits crucial.
 
“Surprisingly, the only place from where imports are even remotely possible now is China. But for this, the Union government has to establish a cargo network to get the kits,” the private manufacturer said. It would also need to officially validate and approve them.
 
The chairman said that the government has to communicate better. “The Ministry statement on Saturday that only USFDA and European CE approved kits will be allowed caused a lot of apprehension,” he said. This statement came even as companies had sent their kits to the National Institute of Virology, Pune for approval.
 
What happens to availability of kits for government labs?
 
Indians who can afford to pay Rs 4,500 – the maximum amount that private labs are allowed to charge for the test – might soon have more testing options.
 
But what happens to millions in India who cannot afford them? They are entirely dependent on government testing which is being done for free.
 
The Union government is yet to categorically state what is the current number of testing kits available and how many have been sent to each state already.
 
But clues of the existing scenario emerged from statements by public health officials.
 
The Lede reported that Tamil Nadu, which had nine confirmed cases as at 6 pm on Monday, had a stock of kits to test 500 samples. According to Tamil Nadu Health Secretary Beela Rajesh, the state at the moment has the capacity to test 60 samples a day, which works out to 420 samples a week.
 
Epidemiological experts across the world have reiterated the need for massive testing to flatten the rising curve of the disease. In an interview to Scroll.in, Jayaprakash Muliyil, one of India’s foremost epidemiologists, hoped that with domestic commercial kits now available, the government will expand testing.

 
 


 
 


 
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