#longthread 👇
The @WHO issued a Medical Product Alert a couple of days back about DEG poisoning and death of over 60 children in Gambia.
cdn.who.int/media/docs/def…
This thread documents the persistent, callous, unaccountable and nonchalant attitude of every #publichealth
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The @WHO issued a Medical Product Alert a couple of days back about DEG poisoning and death of over 60 children in Gambia.
cdn.who.int/media/docs/def…
This thread documents the persistent, callous, unaccountable and nonchalant attitude of every #publichealth
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authority in the process, littered with intentional loopholes designed to offer plausible deniability.
@DrTedros @OfficeOf_MM @MoHFW_INDIA @CDSCO_INDIA_INF @KatherineEban @Rosemary100 @PeoplesPharmacy
authority in the process, littered with intentional loopholes designed to offer plausible deniability.
@DrTedros @OfficeOf_MM @MoHFW_INDIA @CDSCO_INDIA_INF @KatherineEban @Rosemary100 @PeoplesPharmacy
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There are three key questions that need answers:
1.What is the track record of this company in making quality products for patients?
2.What role do national and state regulators play in ensuring quality of global medicinal products?
3.Does the COPP certification process
There are three key questions that need answers:
1.What is the track record of this company in making quality products for patients?
2.What role do national and state regulators play in ensuring quality of global medicinal products?
3.Does the COPP certification process
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work?
Does the @WHO pre-qualification process provide a shield to cover up incompetent and dysfunctional national regulators?
A central govt. drug inspector prosecuted the company in Sonipat, Haryana for quality violations under the Drugs & Cosmetics Act:
work?
Does the @WHO pre-qualification process provide a shield to cover up incompetent and dysfunctional national regulators?
A central govt. drug inspector prosecuted the company in Sonipat, Haryana for quality violations under the Drugs & Cosmetics Act:
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Here are the court documents associated with this case:
dineshthakur.com/wp-content/upl…
dineshthakur.com/wp-content/upl…
dineshthakur.com/wp-content/upl…
Here are the court documents associated with this case:
dineshthakur.com/wp-content/upl…
dineshthakur.com/wp-content/upl…
dineshthakur.com/wp-content/upl…
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Oh, BTW, did you know that way back in 2017, a Judicial First Class Magistrate Court in Kerala fined this company a King’s ransom of INR 1000 in a prosecution filed by a Drug Inspector in Kerala in 2005.
dineshthakur.com/wp-content/upl…
dineshthakur.com/wp-content/upl…
Oh, BTW, did you know that way back in 2017, a Judicial First Class Magistrate Court in Kerala fined this company a King’s ransom of INR 1000 in a prosecution filed by a Drug Inspector in Kerala in 2005.
dineshthakur.com/wp-content/upl…
dineshthakur.com/wp-content/upl…
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The company was one of 39 companies blacklisted by Vietnam in 2014 for violation of Quality Control Regulation and Drug Regulation
ibtimes.co.in/39-indian-drug…
The company was one of 39 companies blacklisted by Vietnam in 2014 for violation of Quality Control Regulation and Drug Regulation
ibtimes.co.in/39-indian-drug…
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And yes, we know two states have said that drugs made by this company were not of standard quality (Link to the XLN data). Mind you, this database XLN only contains testing data from three states, Gujarat, Maharashtra and Kerala.
And yes, we know two states have said that drugs made by this company were not of standard quality (Link to the XLN data). Mind you, this database XLN only contains testing data from three states, Gujarat, Maharashtra and Kerala.
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Imagine if it the database had information from the rest of the states and also the central drug labs
Imagine if it the database had information from the rest of the states and also the central drug labs
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Speaking of Bihar …… Did you know that the state blacklisted this company in 2011?
timesofindia.indiatimes.com/city/patna/two…
Speaking of Bihar …… Did you know that the state blacklisted this company in 2011?
timesofindia.indiatimes.com/city/patna/two…
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Oh, and see Item 39 on this list:
Even Jammu and Kashmir has caught them red-handed with substandard products – again a syrup.
dineshthakur.com/wp-content/upl…
Oh, and see Item 39 on this list:
Even Jammu and Kashmir has caught them red-handed with substandard products – again a syrup.
dineshthakur.com/wp-content/upl…
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Is that enough data to tell you how good this company’s track record is of making quality products? Or do you need more?
Now lets talk about the role of the National Regulator, the CDSCO, in enabling this company not just poisoning people in India but beyond our boundaries
Is that enough data to tell you how good this company’s track record is of making quality products? Or do you need more?
Now lets talk about the role of the National Regulator, the CDSCO, in enabling this company not just poisoning people in India but beyond our boundaries
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Usually the CDSCO simply passes the buck in these cases to the state drug controller who issues the manufacturing licence.
Except in this case Maiden Pharmaceuticals was certified by the CDSCO through the CoPP process.
Usually the CDSCO simply passes the buck in these cases to the state drug controller who issues the manufacturing licence.
Except in this case Maiden Pharmaceuticals was certified by the CDSCO through the CoPP process.
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The national drug regulator, @cdsco_ind_inf provides assurance via the CoPP (Certificate of Pharmaceutical Product) to buyers overseas that it has inspected and ensured that the exporting pharma company complies with WHO cGMP standards.
The national drug regulator, @cdsco_ind_inf provides assurance via the CoPP (Certificate of Pharmaceutical Product) to buyers overseas that it has inspected and ensured that the exporting pharma company complies with WHO cGMP standards.
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You can read more about the WHO CoPP’s (Certificate of Pharmaceutical Product) program here: who.int/teams/regulati…
You can read more about the WHO CoPP’s (Certificate of Pharmaceutical Product) program here: who.int/teams/regulati…
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A pharma manufacturer has to provide this certificate (and the certification is not worth the paper it is written on) to the buyer overseas.
Given the wonderful track record above of this company, does it not beg the question on what basis does the @CDSCO_INDIA_INF issue
A pharma manufacturer has to provide this certificate (and the certification is not worth the paper it is written on) to the buyer overseas.
Given the wonderful track record above of this company, does it not beg the question on what basis does the @CDSCO_INDIA_INF issue
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Will the @CDSCO_INDIA_INF respond and tell us on what basis did they give this company this certificate?
Don't hold your breath.
They wont.
Because they know, they are immune. I have been trying to shame them for a decade now.
Nothing works with them
Will the @CDSCO_INDIA_INF respond and tell us on what basis did they give this company this certificate?
Don't hold your breath.
They wont.
Because they know, they are immune. I have been trying to shame them for a decade now.
Nothing works with them
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BTW, did you know, that @profamirattaran et. al. published a paper back in 2015 on testing they conducted showing that Indian companies were more likely to sell poor quality products in Africa because they know it is poorly regulated!
BTW, did you know, that @profamirattaran et. al. published a paper back in 2015 on testing they conducted showing that Indian companies were more likely to sell poor quality products in Africa because they know it is poorly regulated!
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Here, read for yourself: dineshthakur.com/wp-content/upl…
Here, read for yourself: dineshthakur.com/wp-content/upl…
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The Indian Brand Equity Foundation (a trust run by the Ministry of Commerce) threatened to sue the authors for defamation at the time:
timesofindia.indiatimes.com/business/india…
The Indian Brand Equity Foundation (a trust run by the Ministry of Commerce) threatened to sue the authors for defamation at the time:
timesofindia.indiatimes.com/business/india…
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When a similar tragedy happened in Jammu in 2020, I sent a petition to @drharshvardhan, the then Minister of @MoHFW_INDIA asking for a transparent investigation so that systemic issues could be identified and rectified. Here it is:
casemindia.org/wp-content/upl…
When a similar tragedy happened in Jammu in 2020, I sent a petition to @drharshvardhan, the then Minister of @MoHFW_INDIA asking for a transparent investigation so that systemic issues could be identified and rectified. Here it is:
casemindia.org/wp-content/upl…
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Do you think the Minister or his Ministry even bother to acknowledge the petition, much less act on it?
I take that back, it is a rhetorical question.
By now, you should know I sound like a broken record.
Do you think the Minister or his Ministry even bother to acknowledge the petition, much less act on it?
I take that back, it is a rhetorical question.
By now, you should know I sound like a broken record.
26/n
The @WHO does an evaluation of the competence of national regulatory authorities. It publishes a report with this assessment
who.int/initiatives/wh…
The @WHO does an evaluation of the competence of national regulatory authorities. It publishes a report with this assessment
who.int/initiatives/wh…
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It apparently rated the Indian regulatory authority with a maturity of 4
pib.gov.in/newsite/PrintR…
It apparently rated the Indian regulatory authority with a maturity of 4
pib.gov.in/newsite/PrintR…
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But when I asked them to share their methodology and how they do this evaluation, I was told:
These reports are not publicly available . "Only the maturity level is announced."
The pre-qualifications process exists to inspire confidence in the purchasing nations that
But when I asked them to share their methodology and how they do this evaluation, I was told:
These reports are not publicly available . "Only the maturity level is announced."
The pre-qualifications process exists to inspire confidence in the purchasing nations that
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do not have adequate state capacity.
Given the data in this thread, do you honestly believe and accept the @WHO rating of 4 for the Indian Regulatory Agency?
Think about it for a minute. 🤔
do not have adequate state capacity.
Given the data in this thread, do you honestly believe and accept the @WHO rating of 4 for the Indian Regulatory Agency?
Think about it for a minute. 🤔
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If this thread resonates with you, I invite you to read my upcoming book with my co-author @PReddy85 on why drug regulation is a myth in India.
amzn.to/3rCk8eI
If this thread resonates with you, I invite you to read my upcoming book with my co-author @PReddy85 on why drug regulation is a myth in India.
amzn.to/3rCk8eI
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