On March 26, the Drug Controller General of India told @sruthisagar that 18 diagnostic kits have been given import and manufacturing licences.
The DCGI is the licensing body for drugs and diagnostics in the country.
scroll.in/article/957365…
The DCGI is the licensing body for drugs and diagnostics in the country.
scroll.in/article/957365…
These 18 approved kits are RT-PCR kits, not rapid antibody kits, the DCGI told @psychia90
To know the difference between them, read this excerpt from one of our stories: scroll.in/pulse/957726/c…
To know the difference between them, read this excerpt from one of our stories: scroll.in/pulse/957726/c…
We asked for the list of 18 licensed RT-PCR kits.
On March 26, DCGI said it was on the website. There was no list on the website.
Yesterday, March 30, we called him again and asked for the list. He said his staff has been extra busy and hasn't had the time to upload it.
On March 26, DCGI said it was on the website. There was no list on the website.
Yesterday, March 30, we called him again and asked for the list. He said his staff has been extra busy and hasn't had the time to upload it.
Now, all that's publicly available is a list of #Covid19 kits evaluated by NIV – as of March 28, 17 kits have been evaluated and four have been recommended licences by ICMR.
Note: These are kits that do not have foreign regulatory approvals.
icmr.nic.in/sites/default/…
Note: These are kits that do not have foreign regulatory approvals.
icmr.nic.in/sites/default/…
Kits with foreign approvals – USFDA, European CE, others – don't need Indian evaluation and are being given fast-track approvals, said DCGI.
On a case-to-case basis, data requirement for clinical performance appraisal of the kits may be “abbreviated, deferred or waived”.
On a case-to-case basis, data requirement for clinical performance appraisal of the kits may be “abbreviated, deferred or waived”.
While there is a need to speed up the regulatory process,
@malini_aisola of All India Drug Action Network pointed out that there should be public disclosure of the basis on which each test kit was granted a licence in India.
@malini_aisola of All India Drug Action Network pointed out that there should be public disclosure of the basis on which each test kit was granted a licence in India.
Forget such a disclosure, we don't even have the list of 18 licensed kits (or more, assuming the number has gone up since March 26) in the public domain!
Meanwhile, private labs that are offering the #Covid19 tests are reporting kit shortages. If there are at least 18 approved vendors in the market, why such a shortage?
We asked private labs if they had the full list of approved kit vendors. Dr Arvind Lal of DrPathLabs said he did not. His lab had ordered kits from two suppliers - Altona, MyLab -the first two NIV-approved kits. Supplies were delayed, he said.
It's not just private labs – even state governments don't have the list of the licensed kits!
Chhattisgarh ordered kits from an NIV-approved supplier but supplies are delayed. An official said they had no idea as many as 18 kits had been licensed by DCGI!
Chhattisgarh ordered kits from an NIV-approved supplier but supplies are delayed. An official said they had no idea as many as 18 kits had been licensed by DCGI!
Private labs don't know.
State governments don't know.
Why grant licenses to #Covid19 kit vendors and then make the list an official secret?
State governments don't know.
Why grant licenses to #Covid19 kit vendors and then make the list an official secret?
I would argue even those getting tested have the right to know which kit is being used by the lab they have gone to – and should be able to check whether it is among the kits licensed by the Drug Controller.
The DCGI must urgently release the list of licensed kits. NOW.
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The DCGI must urgently release the list of licensed kits. NOW.
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