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Earlier this week, @CDSCO_INDIA_INF finally relented and published the names of the manufacturers whose products were found to be "Not of Standard Quality" in central and state drug testing laboratories.

There is visible outrage this time, including official

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spokespersons trying to manufacture a fig leaf to cover this up.

Truth is, such failures are routine.

Earlier this year, it was disclosed in the legislature of Himachal Pradesh that more than 1,600 drugs failed testing in the state over the last three years

@Preddy85 and I write in @HindustanTimes today about the sordid history of Rule 170 and how @moayush removed it from the law while the SC was adjudicating the IMA's petition. 🧵👇

If you need a definition of regulatory capture, look no further.

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hindustantimes.com/opinion/transp… 2/n
Our regulations require @moayush products to NOT submit any data for four of the five parameters that apply to modern medicine @theliverdr

Controlling false claims in advertisement is the only lever we have against outright quackery

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Lots of discussion about what happened in the Court yesterday in the case of #LalaRamdev as to how and why his company repeatedly made false claims of cure.

He and his company is NOT alone. The true culprit is elsewhere. Let me illustrate

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Here is the link:
amazon.in/dp/B0CW9SDDX3?…

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Two members of the Himachal Legislative Assembly, Kewal Singh Pathania and Vipin Singh Parmar did us all a great favor.

They asked a question of the HP Ministry of Health to provide a list of all drugs that have failed testing in the last three years along

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with the names of their manufacturers.

For background, HP has the largest number of pharma manufacturing units in the country because of the 'tax holiday' provided for development of hilly regions.

This is the 1st time when we have this data from a state govt on record.

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The Govt. (@nppa_india) recently announced the creation of a committee to relook the issue of drug pricing in the country.

As usual the focus is going to be the Drug Price Control Order (DPCO) which is notified under the Essential Commodities Act, 1955:

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It is time to question the logic and rationale of regulating drug pricing through the DPCO, when India has one of the largest pharmaceutical industries in the world.

Why is market competition not bringing down prices of generic drugs in India? 🤔

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In a recent op-ed published by the @IndianExpress, a former health secretary no less, concludes her piece with this: “in the fight between IMA and ASU, the goodness of ASU treatment which has helped countless people, must not be lost.”

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Goodness of ASU treatment is what I will address in this 🧵 whether it really has “helped” countless people is a matter of conjecture.

One can argue that drinking alcohol “helps” countless people drown their sorrows, but then I am wiser for following the admonishing

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As we come to end of the year, I want to dedicate this thread to the tax-payer funded sentinel of pseudo-science in India, our esteemed @moayush

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In this thread, I will present analysis of our own clinical trial registry meta data by Ronak Borana to reinforce what the @theliverdr said in a recent piece to @SumiSukanya about the quality of evidence that the claims made by the manufacturers of the concoctions

So the DGFT issued a diktat that all cough syrup for export needed to be tested before shipped out because of the public fall out from the deaths of children.

And because we began testing these "for export" medicines, we found that over 50 failed tests for quality
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Does that not make you wonder what the quality of other medicines, not just cough syrups is that we export? 🤔

Here is an example. Sri Lanka did a retrospective review on withheld and recalled medicines between June 2018 and August 2021

bmchealthservres.biomedcentral.com/articles/10.11…

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There appears to be a panic in the higher echelons of the government after the recent mandatory testing requirement for exports revealed that cough syrups from 50 manufacturers failed quality testing in govt. labs:

economictimes.indiatimes.com/industry/healt… 2/n

If this is the situation with exports, you can only imagine the kind of cough syrups being sold in the Indian market.

Syrups sold in India are not subject to the same testing requirements in govt. labs.

We are staring at a huge #publichealth crisis in the short term.

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Here is another example of the why public deliberations are important when considering amendments to existing laws. Case in point is the Jan Vishwas Bill 2023.

You have read about the impact it will have on our drug quality by diluting penal provisons of the D&C 1/n 2/n
Act 1940. One of the supposed objectives of the JV Bill is supposedly to make it easier to do business, by removing cumbersome provisions of existing laws.

Does the Bill achieve this objective? Well, lets see.

Operation of pharmacies (yes, the corner Chemist shop) is

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The @WHO has said today that the risk from “contaminated” cough syrups continues to be real.

It has named nine countries where such medicine has been on sale and has estimated the official death count to be 300.

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So much has happened since early October 2022 when the @WHO issued its first medicines alert.

Many distractions from the real issue, denial of responsibility and washing our hands off this tragedy.

This thread attempts to recount the timeline with specific supporting

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Wonder how dysfunction in our drug regulatory system impacts you? 🤔

Here is a timely example.
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Source: cag.gov.in/en/audit-repor… 2/2
This recent CAG report (covering the period 2016-17 to 2020-21) says over 11 lac medicines in Mumbai, approx 3 lac medicines in Kolkata were dispensed to CGHS members that were found to be substandard.

Know anyone in your family who gets healthcare from CGHS?

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Methylprednisolone eye drops, manufactured by Gujarat based Indiana Ophthalmics is suspected of causing infections of the eye in more than 35 people in Sri Lanka.

thewire.in/health/cdcso-i…
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This is not the first instance of eye drops causing harm to patients; recall that a few months ago, Global Pharma, another Indian manufacturer was cited for similar issues in the USA

usatoday.com/story/news/hea…

@foxerinr @annaedney

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Last week the @epw_in published a book review of our book, ‘The Truth Pill’ by Anant Phadke – an activist who is mentioned by name in our book for being co-founder of All India Drug Action Network (AIDAN) and a trustee of LOCOST – a pharma manufacturing
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enterprise that has been convicted in India of manufacturing substandard drugs – the drugs in question were hypertension drugs and had less than 50% of the active ingredient mentioned on the label.

I don’t need to explain the dangerous consequences of such substandard drugs

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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

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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:

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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: