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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2/n βto exhaust every available recourse including all possible legal options to take action to dissuade usβ from repeating certain comments we made in our interview published in the India Today Interview: indiatoday.in/india/story/kiβ¦
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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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:
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Responding to this finding of the PSC, the @MoHFW_INDIA constituted a committee to investigate and report on this questionable drug approval under the leadership of Prof T M Mohapatra:
How did this firm generate six-month real time accelerated stability data when the inspection found no samples of the product in the stability chamber?
One of key requirements for product registration is for the manufacturer to show that its formulation is stable under
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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2/n Here is a snapshot of the company's catalog showing the line of cough syrups it manufactures:
3/n While they may not selling cough syrup under the names they exported it to the Gambia, they are likely selling cough-syrup in India.
Here are some of their products β we found domestic trademark registrations for Kof-Total which likely means they are selling it in India:
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.
All primary research for our book is available to journalists, reporters and anyone who is interested in studying this topic further can access it here:
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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