Wednesday, June 3, 2020
Home Fact-Check Did Gujarat company 'CoSara' become 'the first and only' company to get ​license to...

Did Gujarat company ‘CoSara’ become ‘the first and only’ company to get ​license to make Covid-19 testing kits? Here are the facts

It is evident from the chronology of events that there was no favouritism or corruption in the process. Perhaps it would bode well for people to remember that in the time of the pandemic, spreading fake news can land one in jail for up to 6 months.

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Nupur J Sharma
Editor, OpIndia.com since October 2017

On the 12th of March, the World Health Organisation (WHO) announced that the Wuhan Coronavirus, also known as Covid-19, has a pandemic. The outbreak that originated in Wuhan, China has claimed 18,910 lives and has infected a total of 4,23,493 people worldwide. While the WHO and China were complicit in hiding the severity of this pandemic for well over two months as the virus spread in the entire world, India has managed to mostly contain the spread of Covid-19 with strict measures. Only yesterday, on the 24th of March 2020, Prime Minister Narendra Modi announced a total country-wide lockdown in a bid to control the spread of the virus. While countries across the globe are trying their best to contain the spread, India, with a population of 1.3 Billion, has been relatively successful so far with 512 active cases, 9 deaths, and 40 people cured and discharged.

The pertinent point to note here is that the Wuhan Coronavirus was thrust upon the world and the preparation to deal with this in terms of testing kits, quarantine facilities and what medicines are to be administered are being developed and figured as the world moves forward. In that fight too, India has done remarkably well with relatively limited resources. India became the fifth country in the world to successfully isolate the Covid-19 virus strain that will help in developing vaccines, cures and testing kits. The response time in containment was also lauded by WHO.

As India prepares to fight the long battle against the Wuhan Coronavirus, there are elements that have continued to play petty politics and spread fake news. Recently, a rumour was spread that a Gujarat based firm had become the first and only firm to get the license to develop testing kits for Covid-19. The rumour led to the usual politicking with vested interests alleging that the Gujarat firm was given preferential treatment because the management of the company is “close to politicians”. However, the facts, when seen without the lens of unbridled propaganda, tell a very different tale.

Saket Gokhale, a less-known individual who fancies himself as an activist tweeted a thread where he alleged that he had found evidence of “corruption and favouritism in a pandemic”.

Saket Gokhale alleged that on the 20th March, 18 firms got permission from the government of India to get their testing kits validated by National Institute of Virology. He then says that “Gujarat-based firm CoSara had already received an approval to start manufacturing Covid-19 test kits. This firm is a collaboration between a US-based company & an Ahmedabad-based firm”. In the same tweet, he admits that Co Sara has FDA approval.

Gokhale said that some of the 18 firms that were waiting for their kits to get validated said that their kits would be sold for Rs 400 – Rs 500, which would be cheaper than imported ones. It is after these tweets that the ill-informed allegations began.

Gokhale said that “Suddenly, on 21st March, the Health Ministry issued guidelines allowing private labs to conduct Covid-19 tests. The cost of these is capped at a whopping 4500 rupees. These guidelines have one caveat – ONLY testing kits approved by US FDA/European CE can be used. That means ONLY kits manufactured by Ahmedabad-based CoSara can be used for Covid-19 testing. So after allowing 18 firms to test their kits for production, the Modi govt. suddenly changed guidelines to favor ONLY 1 Ahmedabad company (whose testing kit cost is unknown)”.

He ended his allegations by saying “Why is a Gujarat-based firm being provided monopoly on Covid-19 testing kits by suddenly tweaking guidelines overnight? Why are 18 firms who can produce testing kits for very cheap prices being blocked by these sudden new guidelines? I’ve filed an RTI to get more info”.

Essentially, what Gokhale alleged was that on the 20th of March, the Government of India asked Indian companies to get their kits validated which would be cheaper than imported kits. However, on the 21st, the Guidelines issued by ICMR specifically said that only FDA approved kits could be used while on 19th, the Govt had already issued approval to CoSara to ‘start manufacturing Covid-19 test kits’, a company, which is politically connected and has FDA approval. He then alleged that because of these guidelines, ONLY Co-Sara kits would be used and essentially, the Modi government changed the guidelines AFTER giving permission to 18 firms for manufacturing only to favour one company, which Co-Sara.

It is important to note that Saket Gokhale made these allegations on the 23rd of March. The importance of the date will be apparent when we move forward with facts.

As is the nature of activism, the thread focussed on CoSara while ignoring several other developments that had taken place between the 18th of March and 24th of March. It also ignored several established norms that the ICMR will have to follow in the face of Coronavirus pandemic, which the world is dealing with as we go along.

Gokhale’s lie is rather crafty as he has not only lied, but completely missed certain vital facts as well.

On 20th March, 18 firms for permission to get their kits validated?

This is a lie. On the 20th of March 2020, 14 firms got permission to get their test kits validated, not 18. The 14 firms, in fact, included Roche Diagnostics, which is a Swiss firm, along with Indian firms. At least this was reported by the media on the 20th. On the 19th of March, CoSara published a press release that claimed that it had become the “first and only Indian company to receive a license from the Central Drugs Standards Control Organisation (CDSCO) to manufacture RT-PCR COVID-19 test kits”. In reality, CoSara did not get any special license that they made it out to be. Actually they already have a Coronavirus test kit which is approved FDA in USA, and that’s why their kit does not need any additional validation in India, and can start production right away. They didn’t need any NIV approval, and they were not issued any specific approval.

In fact, ICMR had also responded to Gokhale’s tweet clarifying that “Cosara falls under the US-FDA approved category. Therefore, no special approval was given”.

Roche, which was one of the companies that got the permission to test their kits and it was reported by the media that it got the ‘license’ on the 18th, is on record saying, “The test licence accorded to Roche Diagnostics India allows us to import select quantities of the Cobas SARS Cov-2 diagnostic test kits for product performance evaluation. Following successful completion of the evaluation, a decision from the authorities will enable us to commercialise the kits in India”.

Essentially, it is here itself that Gokhale’s entire lie comes crashing down, however, there are certain other truths that should be explained.

So where did the number 18 come from?

We could not find any media which says that 18 firms were waiting for results of their kits, all media reports said there were 14 firms. 18 was the number of private lab chains that got permission to conduct the Covid-19 tests as on 21st March. That some of them were developing their kits individually is a separate matter. Essentially, these 18 labs were given permission to conduct tests and send their results to the government. That some of these 18 firms were waiting for approval to make their kits available commercially, becomes a separate matter altogether.

By now the number of private laboratory chains approved for Wuhan Coronavirus has gone up to 22.

For example, Trivitron Healthcare is the first Indian private diagnostic firm to receive approval to conduct Covid-19 tests.

The chairman and managing director said the kits which will be manufactured indigenously will have a turnaround time (period between the test being conducted and receiving the report) of four to six hours.

“Depending on the PCR platform (the gold- standard testing platform for viruses), a lab can turn around 100 tests to 1,000 tests per day. We have a production capacity to conduct 5,00,000 to 7,00,000 tests per day in our Chennai facility if we operate in three shifts,” added Velu.

The kit validation is happening at NIV Pune.

The kits developed by the firms are planned to be sold to private diagnostic chains such as Dr Lal Path Labs, SRL Diagnostics and Metropolis Healthcare, among others. This was reported by News 18 on the 21st of March 2020.

Explanation

Essentially, India has been giving license to molecular diagnostic companies to simply get their Covid-19 test kits validated from the NIV (National Institute of Virology). First, the company has to show that its test kits work with no variance, then they receive approval for those tests. It is only after that they receive a license to sell their test kits to diagnostic laboratories.

21st March – Here is why ICMR said only FDA approved test kits could be used

On the 21st March, the ICMR (Indian Council for Medical Research) issued a notice where one of the clauses read that Commercial kits for real-time PCR based diagnosis for Covid-19 should be US FDA approved or European CE certified.

ICMR notification about Covid-19
ICMR notification about Covid-19

This circular was turned into a “scam” by Gokhale. But the fact is that, as on 21st March, the ICMR had insisted on USA FDA or European CE certification test kits for the 16 approved labs because till then, the Indian kits had not been validated and the validation results were not out. Contrary to what Gokhale might think, the validation process for PCR tests kits takes substantial time. As there were no kits validated by ICMR NIV, the only option was to start with manufacturing kits which were already validated by FDA or European CE, as these standards are considered reliable worldwide due to their stringent validation tests.

That Saket Gokhale completely lied and said that the 21st March circular would make ONLY CoSara eligible is again a lie. Any company with kits American or European validations can make kits. Either way, ICMR mentioned that their guidelines continue to change and it is evident that this requirement was imposed because Indian test kits had not gone through the process of validation yet and the results were awaited.

The 23rd of March – When Gokhale tweeted his lies, India approved two Indian test kits

If one recalls, the article had mentioned earlier that the fact that Gokhale had spread his lies on the 23rd of March should be kept in mind. Interestingly, it is on the 23rd of March 2020 that the ICMR released the validation results of 9 testing kits for Covid-19. Of the 9 test kits that were sent for the process of validation, 2 kits were approved for use in Government and Private labs because these kits were found to have 100% concordance among true positive and true negative samples.

In a press conference on 23rd March, Director General of ICMR, Balram Bhargava had categorically said that FDA or CE approval is not mandatory for test kits, and kits approved by ICMR NIV will also be allowed. He had also informed that the validation process of kits by NIV was being fast-tracked. This makes it clear that the condition of requiring FDA/CE validation for kits mentioned in the notification dated 21 was modified and now kits validated by NIV also can be produced.

The names of the two companies whose kits were approved were:

  1. Altono Diagnostics (German)
  2. My Lab (Indian)

Other than these two, other FDA / Euro CE approved kits could also be used.

On the 23rd, it was also reported that India had waived off the need for Drug Controller General of India’s approval for COVID-19 testing kits that are developed locally. The two companies whose diagnostic test kits had been validated by Indian Council of Medical Research (ICMR)’s National Institute of Virology began supplies on 23rd, government officials had informed at the press conference.

24th March – One more kit gets approved

On the 24th March, ICMR released a list of 14 kits that were tested for commercial use. It said that test kits with 100% concordance among true positive and true negative samples will be approved for commercial use in India

Other than Altono Diagnostics and My Lab that were approved on the 23rd, another kit, made by Seegene, was found to have 100% concordance and was thus approved by ICMR for commercial use.

The other companies whose test kits were tested were BGI, Krishgen Bio System, ABI, HIMEDIA, Huwel, IIT Delhi, Kilpest, Genesig and Roche. 3 kits of Roche were tested, but none of them produced 100% concordance.

This means that these three companies can now supply their kits. And as CoSara already has US FDA approval, they can manufacture the kits under that certification as per ICMR rules, but no specific permission was issued to the company as claimed by the company and others on social media. It means that any company having kits validated by FDA and EU CE can make kits in India without needing any separate approval, apart from companies which have kits validated by ICMR NIV.

In conclusion, as there were no company with kits validated by ICMR, only kits certified by American and European authorities were allowed to make their kits in India. But once the results of Indian validation tests started coming out, the kits that showed 100% concordance also got permission for manufacture.

It is thus evident that while Saket Gokhale gets ample traction on Social Media from folks who either don’t understand or don’t follow the developments closely, his assertions are based on selective facts and whole lies. It is evident from the chronology of events that there was no favouritism or corruption in the process. Perhaps it would bode well for people to remember that in the time of pandemic, spreading fake news can land one in jail for up to 6 months.

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Nupur J Sharma
Editor, OpIndia.com since October 2017

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