Plausible Deniability. A long 🧵 👇
1/n
Over the last couple of days, scandalous news of the arrest of a Joint Drug Controller in @CDSCO_INDIA_INF has made waves. While much of the reporting is perfunctory until now, it helps to peel the onion and see how far the stench
1/n
Over the last couple of days, scandalous news of the arrest of a Joint Drug Controller in @CDSCO_INDIA_INF has made waves. While much of the reporting is perfunctory until now, it helps to peel the onion and see how far the stench
2/n
of corruption pervades the unholy nexus between the pharmaceutical industry and the DCGI’s office.
Lets start with a few facts, shall we:
A.“CBI officers claimed Bioinnovat Research Services Private Limited had been asked to get regulatory clearance for the Biocon
of corruption pervades the unholy nexus between the pharmaceutical industry and the DCGI’s office.
Lets start with a few facts, shall we:
A.“CBI officers claimed Bioinnovat Research Services Private Limited had been asked to get regulatory clearance for the Biocon
3/n
product. Bioinnovate, in turn, engaged Synergy Network to get the work done, the officers claimed.”
indianexpress.com/article/india/…
product. Bioinnovate, in turn, engaged Synergy Network to get the work done, the officers claimed.”
indianexpress.com/article/india/…
4/n
Isnt it interesting that a sponsor pharmaceutical company, in this case @Biocon, apparently engaged a third party “BioInnovat Research Pvt Ltd” to “get” regulatory clearance for their product. Why would any pharma company do that? Does it not employ people with expertise in
Isnt it interesting that a sponsor pharmaceutical company, in this case @Biocon, apparently engaged a third party “BioInnovat Research Pvt Ltd” to “get” regulatory clearance for their product. Why would any pharma company do that? Does it not employ people with expertise in
5/n
Regulatory Affairs who know how to work with the drug regulator?
For those of us who have dealt with US FDA or EMA know full well that communications with these regulatory agencies are only with a designated employee of the pharma company seeking market authorization.
Regulatory Affairs who know how to work with the drug regulator?
For those of us who have dealt with US FDA or EMA know full well that communications with these regulatory agencies are only with a designated employee of the pharma company seeking market authorization.
6/n
B.“The agency dug into her background to find that she had several pharmaceutical companies as her clientele. She allegedly delivered huge bribes through Dua and others to senior officers of CDSCO on different occasions for processing the files favourably on behalf
B.“The agency dug into her background to find that she had several pharmaceutical companies as her clientele. She allegedly delivered huge bribes through Dua and others to senior officers of CDSCO on different occasions for processing the files favourably on behalf
8/n
Hmm. So BioInnovat has “several pharma companies as its clientele? Let’s see who, shall we?
bioinnovat.com/clients/
Big names here. Not just Indian pharma companies, but MNCs too. Ever wonder why big pharma would need the services of “BioInnovat”?
Hmm. So BioInnovat has “several pharma companies as its clientele? Let’s see who, shall we?
bioinnovat.com/clients/
Big names here. Not just Indian pharma companies, but MNCs too. Ever wonder why big pharma would need the services of “BioInnovat”?
9/n
Do they not have people with expertise in clinical research and regulatory affairs? What do you think?
As they say, the existence of scores of “liaisons” whose only function is to liase with the DCGI’s office on behalf of “reputable” pharma companies
Do they not have people with expertise in clinical research and regulatory affairs? What do you think?
As they say, the existence of scores of “liaisons” whose only function is to liase with the DCGI’s office on behalf of “reputable” pharma companies
10/n
is not a bug but a feature of the system. BioInnovat is not an isolated “facilitator” or “consultant” that represent pharma companies, the fate of whose business is decided by these high-handed functionaries in the DCGI’s office.
is not a bug but a feature of the system. BioInnovat is not an isolated “facilitator” or “consultant” that represent pharma companies, the fate of whose business is decided by these high-handed functionaries in the DCGI’s office.
11/n
This arms-length model affords what is called “plausible deniability” just in case something “untoward” happens, like it did this time. The sponsor can take a holier-than-thou attitude and say we have nothing to do with it and throw these facilitators/consultants
This arms-length model affords what is called “plausible deniability” just in case something “untoward” happens, like it did this time. The sponsor can take a holier-than-thou attitude and say we have nothing to do with it and throw these facilitators/consultants
12/n
under the bus. I suspect that is probably what will happen here.
Question is why do these consultants exist in the first place? Why does the @CDSCO not deal directly with the sponsor? That my friend is the million-dollar question.
under the bus. I suspect that is probably what will happen here.
Question is why do these consultants exist in the first place? Why does the @CDSCO not deal directly with the sponsor? That my friend is the million-dollar question.
13/n
These intermediaries exist primarily because the regulator “encourages” them. That is the only way a sponsor can get their studies approved. The pharma companies know that, and they are happy to use these “facilitators” because it affords them plausible deniability.
These intermediaries exist primarily because the regulator “encourages” them. That is the only way a sponsor can get their studies approved. The pharma companies know that, and they are happy to use these “facilitators” because it affords them plausible deniability.
14/n
C.He manipulated the minutes of the meeting of SEC held that day by changing some key words in the recommendations, giving “substantial wrongful gain” to the company, the agency alleged.
thequint.com/news/india/cbi…
C.He manipulated the minutes of the meeting of SEC held that day by changing some key words in the recommendations, giving “substantial wrongful gain” to the company, the agency alleged.
thequint.com/news/india/cbi…
15/n
"Information has also revealed that Dr. S. Eswara Reddy, JDC has manipulated the Minutes of the Meeting of SEC held on May 18, 2022 by changing the word 'Data' to 'Protocol' in the recommendations and thereby causing substantial wrongful gain to Biocon Biologics Limited,"
"Information has also revealed that Dr. S. Eswara Reddy, JDC has manipulated the Minutes of the Meeting of SEC held on May 18, 2022 by changing the word 'Data' to 'Protocol' in the recommendations and thereby causing substantial wrongful gain to Biocon Biologics Limited,"
17/n
If you think this is a one-off thing, let me remind you what the @CDSCO itself told us, albeit grudgingly (for two years until the night before our appeal before the CIC):
dineshthakur.com/wp-content/upl…
If you think this is a one-off thing, let me remind you what the @CDSCO itself told us, albeit grudgingly (for two years until the night before our appeal before the CIC):
dineshthakur.com/wp-content/upl…
18/n
This is how our drug regulator functions. It is opaque, unaccountable and its actions raise questions about its ability to regulate the industry which makes millions from poor unsuspecting patients.
This is how our drug regulator functions. It is opaque, unaccountable and its actions raise questions about its ability to regulate the industry which makes millions from poor unsuspecting patients.
19/n
BTW, recall that @malini and @das_seed had to fight tooth and nail to just get the names of the members of the SEC which approved Covaxin. Remember this?
BTW, recall that @malini and @das_seed had to fight tooth and nail to just get the names of the members of the SEC which approved Covaxin. Remember this?
https://twitter.com/malini_aisola/status/1421075004716851206?s=20&t=uEDZEC3jCC6yFi5VvyCnqA
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And this 👇
And this 👇
https://twitter.com/malini_aisola/status/1345437136858693634?s=20&t=YVNZ3tXA7J0ozIFMJsz97A
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And this 👇
And this 👇
https://twitter.com/malini_aisola/status/1397596938170560514?s=20&t=F8-Q_12fQ0faFXIqSBgWLw
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Now ask yourself why? Does that sound Kosher to you? Why would the @CDSCO_INDIA_INF not disclose the SEC minutes until they were publicly shamed to do that? What is the process by which these minutes are reviewed and approved by members of the SEC
Now ask yourself why? Does that sound Kosher to you? Why would the @CDSCO_INDIA_INF not disclose the SEC minutes until they were publicly shamed to do that? What is the process by which these minutes are reviewed and approved by members of the SEC
23/n
to make sure their decisions are accurately transcribed before making them formal?
Yeah, you. Who took Covaxin shots because it was #atmanirbhar!
Sounds like a pattern, doesn’t it? Yeah, I know, we are dealing with the “Best Regulator in the World”
to make sure their decisions are accurately transcribed before making them formal?
Yeah, you. Who took Covaxin shots because it was #atmanirbhar!
Sounds like a pattern, doesn’t it? Yeah, I know, we are dealing with the “Best Regulator in the World”
24/n
D.“The guidelines provide a framework for waiver of phase 3 clinical trials to be conducted in India based on a commitment to undertake a phase 4 trial, the design of which should be approved by the Central Licencing Authority.
D.“The guidelines provide a framework for waiver of phase 3 clinical trials to be conducted in India based on a commitment to undertake a phase 4 trial, the design of which should be approved by the Central Licencing Authority.
25/n
In line with the above regulations, Biocon Biologics presented a proposal for import and marketing of Insulin Aspart with a waiver of Phase 3 clinical trial in India. The Company presented a detailed proposal along with CMC, pre-clinical and clinical trial data,"
In line with the above regulations, Biocon Biologics presented a proposal for import and marketing of Insulin Aspart with a waiver of Phase 3 clinical trial in India. The Company presented a detailed proposal along with CMC, pre-clinical and clinical trial data,"
27/n
Hmm.. sounds legit, does it not? Well, there are two problems.
First, most pharma companies who promise to do Phase IV studies in India just don’t honor their commitments. And the @CDSCO does nothing to compel them:
scrip.pharmaintelligence.informa.com/SC123070/Why-P…
Hmm.. sounds legit, does it not? Well, there are two problems.
First, most pharma companies who promise to do Phase IV studies in India just don’t honor their commitments. And the @CDSCO does nothing to compel them:
scrip.pharmaintelligence.informa.com/SC123070/Why-P…
28/n
These sponsors make empty promises of conducting Phase IV studies to get their marketing authorizations and then conveniently forget them. It is not like the CDSCO ever follows up and penalizes them for not honoring their commitments.
These sponsors make empty promises of conducting Phase IV studies to get their marketing authorizations and then conveniently forget them. It is not like the CDSCO ever follows up and penalizes them for not honoring their commitments.
29/n
Second, the clinical and scientific reasons why one would waive a requirement for a pivotal phase III studies is complex. It cannot be a blanket yes or no. One has to clearly evaluate the basis on which such a waiver is requested.
Second, the clinical and scientific reasons why one would waive a requirement for a pivotal phase III studies is complex. It cannot be a blanket yes or no. One has to clearly evaluate the basis on which such a waiver is requested.
30/n
Waiver of local phase 3 studies has been a contentious issue for 10 years. It was first highlighted in the 59th Parliamentary Report on the functioning of the CDSCO.
casemindia.org/wp-content/upl…
Waiver of local phase 3 studies has been a contentious issue for 10 years. It was first highlighted in the 59th Parliamentary Report on the functioning of the CDSCO.
casemindia.org/wp-content/upl…
31/n
But you say we have a law that does that, right? Didn’t the sponsor say that they comply with the law of the land?
Good that you ask.
What role does the industry play in framing these laws? I wrote this years ago:
scroll.in/article/754277…
But you say we have a law that does that, right? Didn’t the sponsor say that they comply with the law of the land?
Good that you ask.
What role does the industry play in framing these laws? I wrote this years ago:
scroll.in/article/754277…
32/n
But what do I know. I am just a poor IT guy and not a research scientist:
But what do I know. I am just a poor IT guy and not a research scientist:
https://twitter.com/kiranshaw/status/1283597027830403074?s=20&t=lfkKiPxWi78BLKk3BlvfoA
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If you have stayed with me this long, here is an 'easter egg' for you. Bonus points for guessing who all are in this picture 👇
If you have stayed with me this long, here is an 'easter egg' for you. Bonus points for guessing who all are in this picture 👇
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