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:
End notes for each chapter is categorized and the entire database is fully searchable.
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Our hope is that newsrooms, independent journalists, researchers and anyone who is interested in the topic of Drug Regulation in India can use this archive for their own research.
Over the years, we have sent many petitions to the @MoHFW_INDIA asking for transparency, accountability, comments on proposed amendments etc. These are part of our advocacy for a better regulated medicines supply chain in India.
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 – we found domestic trademark registrations for Kof-Total which likely means they are selling it in India:
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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
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
3/n events. Endotoxins are not supposed to be present in injectibles, the way to make sure your drugs are not contaminated is to run a series of tests prescribed in the Indian Pharmacopiea before you ship them the market. The Pharmacopiea sets the standards and tells us what
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
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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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product. Bioinnovate, in turn, engaged Synergy Network to get the work done, the officers claimed.” indianexpress.com/article/india/…
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: