Dinesh S. Thakur Profile picture
Oct 6 30 tweets 13 min read
#longthread 👇

The @WHO issued a Medical Product Alert a couple of days back about DEG poisoning and death of over 60 children in Gambia.


This thread documents the persistent, callous, unaccountable and nonchalant attitude of every #publichealth


authority in the process, littered with intentional loopholes designed to offer plausible deniability.

@DrTedros @OfficeOf_MM @MoHFW_INDIA @CDSCO_INDIA_INF @KatherineEban @Rosemary100 @PeoplesPharmacy
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


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:
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.



The company was one of 39 companies blacklisted by Vietnam in 2014 for violation of Quality Control Regulation and Drug Regulation


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.
Imagine if it the database had information from the rest of the states and also the central drug labs
Speaking of Bihar …… Did you know that the state blacklisted this company in 2011?


And yes, it was a syrup!

Oh, and see Item 39 on this list:
Even Jammu and Kashmir has caught them red-handed with substandard products – again a syrup.

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
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.

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.
You can read more about the WHO CoPP’s (Certificate of Pharmaceutical Product) program here: who.int/teams/regulati…
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
this piece of paper? Look at entry 887 on this list:
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

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!
Here, read for yourself: dineshthakur.com/wp-content/upl…
The Indian Brand Equity Foundation (a trust run by the Ministry of Commerce) threatened to sue the authors for defamation at the time:

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:


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.
The @WHO does an evaluation of the competence of national regulatory authorities. It publishes a report with this assessment
It apparently rated the Indian regulatory authority with a maturity of 4

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
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. 🤔
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.


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More from @d_s_thakur

Aug 10
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Most of us have heard of 'Regulatory Capture' by the industry. But have you heard of 'Capture of Law Making Process' itself?

Fasten your seatbelts.
A sordid tale of how lobbying has almost succeeded in getting its masters a free pass from accountability
Remember this happened?

During the peak pandemic period, batches of a drug called Remdesivir manufactured by a Gujarat based pharma company were found to contain bacterial endotoxins which when administered to patients manifested in severe adverse
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Plausible Deniability. A long 🧵 👇


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
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
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Nov 9, 2021

Remember the claims made about Coronil?



Or the still unresolved questions about the way clinical studies for Covaxin were conducted in Bhopal?


Last week, we sent a petition to the Minister of @MoHFW_INDIA asking for the Clinical Trial Registry of India to be fixed once and for all. Here it is:


Much of the dysfunction in the way we conduct clinical studies can be traced back to the CTRI
Read 10 tweets
Jun 2, 2021
Longish thread 👇

This past week has seen much name calling and hyperventilation on TV debates between the representatives of the industry which practices evidence based medicine and the spokesperson who supposedly speaks on behalf of the Ayurvedic industry.

2/n Want to know why the administration is relegated to writing love-letters pleading "withdrawal" of "objectionable" comments?
@Preddy85 and I wrote about it here in the summer of last year:

Our regulation does NOT require the Ayush manufacturers to prove that their product has any therapeutic efficacy as is the case for drugs that are marketed by the pharmaceutical industry.

In fact, in 2018, the @moayush amended India’s Drugs & Cosmetics Rules, 1945
Read 10 tweets
Apr 23, 2021
Long thread…. Please bear with me

Can someone explain to me why there is no central TRIAGE of all positive cases in cities like Delhi? Let me explain what I mean
Last night, I participated in a @TwitterSpaces discussion organized by @PSampathkumarMD 1/n
2/n We had a gentleman who provides ambulance services in Delhi on the call. This question is based on what I learnt from him
Watching the tragedy unfold, the question we need is what can be done so that people who need help are not left waiting to get the care they need.
3/n Why do we make people run around pillar to post to look for beds?

Large cities like Delhi need to set up a central triage where a group of physicians evaluate every positive case and determine:
1.If the patient can be cared for at home with assistance
Read 10 tweets
Apr 21, 2021
This clip is a good example of why it is important to screen your panelists before putting them on. 1/n

Dr. Joshi says that he uses Remdesivir to treat moderate and severe disease; and makes broad statements like the drug is recommend by @US_FDA.
2/n Look up what *moderate* and *severe* mean in this context. The other panelist, Dr Parikh provides a history lesson on how this drug came to be used for treating Covid-19; how relevant that is to the question being discussed is anyone's guess.
3/n Remdesivir has a role in treating the disease in a narrow population demographic and at a very specific stage in disease progression. Here is the current clinical evidence: altnews.in/remdesivir-is-…

Clinicians like Dr Joshi dont seem to give very little weight to such evidence
Read 6 tweets

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