Long Thread 👇

Recently, in a piece in the Economic Times, in context of the tragedy in The Gambia, @preddy85 and I discussed the importance of a recall law aimed at withdrawing adulterated or dangerous drugs from the market.
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An essential feature of this is the framing and formulating of a robust drug recall law.

While our government has a system in place for testing drug samples already on the market to assess their quality, there is no system today to mandatorily recall a drug that has

Longish Thread 👇

Recently, the Uttarakhand State Government issued a ban and subsequently revoked its order prohibiting Patanjali Ayurved from manufacturing five products to treat blood pressure, diabeties, glaucoma and other diseases.

hindustantimes.com/india-news/utt…

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This punitive action was the result of a complaint filed by @drbabukv alleging violations of the Drugs and Magic Remedies Act by Patanjali Ayurved.

telegraphindia.com/india/uttarakh…

Is this the first time Patanjali has been held responsible for misleading consumers?

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As @Preddy85 and I were about to begin the session for the launch of the #truthpill this past Saturday evening, like clockwork, we received an email from the @CDSCO_INDIA_INF with a menacing notice threatening

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“to exhaust every available recourse including all possible legal options to take action to dissuade us” from repeating certain comments we made in our interview published in the India Today Interview:
indiatoday.in/india/story/ki…

Short thread 👇 #truthpill

This entire journey started for @Preddy85 and me with this:

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Where this 👇 was the norm when asked for data/records:

Longish Thread 👇

Want to know what regulatory capture looks like? Read on...

One of the drugs that the Parliamentary Standing Committee in its 59th Report reviewed was the FDC of Flupentixol and Melitracen used to treat depression.
@Preddy85 @truthpill

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The PSC report is available here: casemindia.org/wp-content/upl…

This combination does not exist in any developed markets. The Parliamentary Standing Committee asked for a copy of the approval files from the @CDSCO_INDIA_INF.

This is what it said in its report:

This is the last thread for tonite on the #coughsyrup tragedy in The Gambia.

Earlier today, @chetanabelagere filed a report which has some very interesting findings:

thesouthfirst.com/health/maiden-…
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This 👇 is very interesting.

Quick follow up thread on the #coughsyrup tragedy in The Gambia.

The official line seems to be that we dont have to worry about adulterated cough syrup because the company is making this product just for its overseas customers.

Lets see if this holds water, shall we?
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Here is a snapshot of the company's catalog showing the line of cough syrups it manufactures:

Our book, 'The Truth Pill: The Myth of Drug Regulation in India' is available for purchase on Amazon starting today:

amazon.in/TRUTH-PILL-Myt…

Its a product of many years of research and over 400 RTI responses.

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#truthpill @Preddy85 @SimonSchusterIN 2/2

We wanted to provide our readers direct access to our research because there is only so much we could put into our book. To that end, we are announcing the launch of an accompanying website for #thetruthpill where all our research is curated.

thetruthpill.in

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

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

Longish Thread 👇

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
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Remember this happened?
livemint.com/science/health…

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

Plausible Deniability. A long 🧵 👇

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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

#longthread

Remember the claims made about Coronil?

science.thewire.in/the-sciences/h…

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

thequint.com/coronavirus/ex…

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.

1/n 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:
livemint.com/opinion/online…

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.

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.

This is a limited point about availability of efficacy data for vaccines under development in the context of the approval for CovidShield and Covaxin in India.

There have been many so-called experts on the idiotbox opining about apparent availability of P III data which 1/n 2/n apparently the SEC had access to based on which it "supposedly" approved Covaxin. Another argument that is prevalent is other regulators (US FDA and MHRA) also approved vaccines based on P II data alone. Let me give you a few facts so that you can make your own decision.

Thread 👇

One of the reasons *opinions* drive such conversations and impact #publichealth is the fickle nature of the Indian drug regulator @CDSCO_INDIA_INF. Allow me to explain.

Scientific method requires you to define the hypothesis and the outcome *prior* to the 1/n

https://twitter.com/PriyankaPulla/status/1346336950681124864

2/n experiment, not find ways to justify unpredicted changes either in experimental design, process or true outcomes. This is the realm of faith which manifests as *opinion*, which is anything but Scientific.

We have a history of the drug regulator changing its allegiance

#longthread

Disclaimer: This is a hypothetical story; a work of fiction. Any resemblance to actual events or locales or persons, living or dead, is entirely coincidental.

Long long go, in a land far far away, there was a country of *believers* called Country *A*. 1/n 2/n

People of Country A believed pretty much anything that was sold to them on the idiotbox and through a ritual called *nationalization*. As long as anything was framed in terms of this ritual, most believers bought it lock, stock and barrel.

Here is the petition that a few of us have sent to the Health Minister asking for more transparency: dineshthakur.com/wp-content/upl…

@PrabhaRaghavan reported on this here: indianexpress.com/article/india/… 2. First, we think all clinical trial data should be made public regardless of whether the drug succeeds or fails. This is a demand being made in most countries and several of them are making this information public.

Long thread 👇

One of the biggest issues with our drug supply in India is that there is a high probability that what we purchase at the chemist shop/local pharmacy has never been proven to be therapeutically effective. Want to know why? Read on 1/n 2/n How do you know if a particular drug is actually therapeutically effective against a disease target? Well, it has to go through a series of gates, checkpoints, where it is tested to see if it is therapeutically effective against a particular disease.

A few weeks ago, it was reported that the GoI was considering an overhaul of the drug approval process. On behalf of CASEM, I sent yet another petition to the @MoHFW_INDIA to setup a committee for a comprehensive relook of the stability testing requirements for generic drugs 1/n Here it is: casemindia.org/a-petition-to-…
Establishing stability is extremely important to ensure drug quality because most drugs are inherently unstable over the long run.
If there is even a slight error in the mfg. process, the drug will degrade because of heat/humidity/light 2/n