A thread on why the rule pushing doctors to write only chemical names of drugs, and not brand names, is a bad idea. (1) Let's first understand the regulatory system for new drugs the world over. First step: A company develops a new antibiotic, say XYZ, to treat respiratory infections (2)

So, the @MoHFW_INDIA has put out a "clarification" in response to @d_s_thakur 's tweet on the Jan Vishwas bill yesterday. Here is his tweet: And here is the ministry's note to journalists. I want to discuss the ministry's note, because it is misleading (1) https://t.co/JzK4cODcN8

https://twitter.com/d_s_thakur/status/1684542189215395841?t=K82WCDvriklres0o02HgUg&s=08

One reason I want to discuss the ministry's note is that it paraphrases a misleading argument that the CDSCO and the Indian drug industry have used for years: that only "adulterated" and "spurious" can cause bodily harm, but that "Not of Standard Quality (NSQ)" drugs can't (2)

News thread: Remember Digital Vision, the Himachal Pradesh based company, whose cough syrup killed over 13 children in Jammu and Baddi, because it was contaminated with DEG? (1) The Himachal Pradesh Drug Control Department never filed a case against the company until 2 years later, claiming they didn't have enough evidence livemint.com/science/hp-reg… (2)

So twisted. Instead of holding Maiden Pharma accountable in the DEG poisoning, where children died, govt. strategy is to deny that happened. Instead, owner'll go to jail for substandard ranitidine, for which, historically, NO1 goes to jail in India tribuneindia.com/news/haryana/m… (1) What is this random application of the law? You want to protect Maiden Pharma and India's image on intl. stage - so you ignore adulteration, which has actually been prosecuted strictly, historically, even in India (2)

The other day, I spoke to a prominent Indian government spokesperson about the Gambian DEG issue. I wanted to know why the government was taking such an odd stance of denying the dangers of such a well-known contaminant. Discussion was supposed to be on record (1) I asked: why is government calling WHO's announcement presumptuous, when WHO found DEG in Maiden's cough syrup. Why hasn't government directly addressed that finding? Spokesperson says: Read the CDSCO letter from Somani. It has all details. It shows WHO claims were unfounded (2)

Today's thread: The case of the deworming drug albendazole (read more in my Indian Pharmacopoeia report, available here: thakur-foundation.org/project-impact…). This case shows how the lack of a dissolution test for certain drugs in the IP can hurt efficacy (1) Guidelines from an international consortium of regulators and drug manufacturers, called the International Conference for Harmonisation (ICH), say that standards for all solid oral dosage forms (tablets, capsules etc) ought to have dissolution tests (2)

So, a person just wrote to me after reading the Executive Summary of my IPC report, and argues that just because a liposomal amphotericin monograph is not present in IP 2022 and 2018 doesn't mean it isn't in IP, because a monograph was there in IP 2010 (1) Their claim: even if a monograph is not present in the current edition of IP 2022, if it is there in any preceding edition, including an edition as old as the 1950s, a manufacturer can still use it (2)

My report on the Indian Pharmacopoeia, & its impact on drug quality, for @thakurfdn , is out. It is accompanied by a very interesting review from Shirish Kulkarni, pharma consultant, who was with Sun, Lupin, Maharashtra FDA in his previous avatars thakur-foundation.org/project-impact… (1) I urge those who closely follow the pharma industry to read the entire report, *and* the review. For others, during the course of today, I will be doing a thread of key sections to focus on (2)

A thread on *why* my story says that Pune's National Institute of Virology played a troubling role in the release of the Kyasanur Forest Disease vaccine to people livemint.com/science/health… (1) NIV's scientists originally developed the vaccine in the 70s, which is why NIV later became the de-facto advisor to all subsequent manufacturers of KFD vaccine. From 1989-2000, the manufacturer was VDL, & from 2000, the manufacturer was the Bengaluru-based public firm, IAHVB (2)

This statement about "not having found any link between child deaths and Maiden syrups" needs to be interpreted with a lot of caution economictimes.indiatimes.com/industry/healt… (1) First, The Gambia did find a prima-facie link, which is why the WHO even issued the caution. Beyond this point, The Gambia needs to do a study, perhaps along these lines, to strengthen the link scielosp.org/pdf/bwho/v86n1… (2)

New story: Many of you may know about the Kyasanur Forest Disease (Monkey Fever) which affects people in Karnataka+parts of Maharashtra, Goa, TN & Kerala. In October, the Karnataka govt suddenly stopped using a 33-year old vaccine against this disease livemint.com/science/health… (1) While the Karnataka government hasn't clarified publicly why it stopped using the vaccine, the actual reasons are as follows: 1) The CDSCO hasn't renewed licences to the manufacturer to make this vaccine for almost 21 years (2)

A lot of people are confused about *how* diethylene glycol can get into a cough syrup in the first place, when it is so deadly. A thread based on some of my reading while reporting on the Digital Vision case (1) First, diethylene glycol (DEG) is not supposed to be there in cough syrup or any medicine. It's not an excipient or a byproduct of manufacture either. Typically, it is some other excipient like propylene glycol or glycerin that is being *adulterated* with DEG (2)

Full panel discussion here: For clarity, I had said that a common punishment to manufacturers of substandard drugs is to suspend their license to manufacturer *that particular substandard product* (not all products) for few days (1)

https://twitter.com/ndtv/status/1578114655037558785

In other words, it's not a "stop manufacture". Say a company makes paracetamol tablet which has only 70% active ingredient, they lose license to make it for few days. It is only when product is adulterated/spurious/kills people, that regulators seek stronger punishments (2)

I sense that the "exact one-to-one causal relation of death" which the WHO has not yet provided CDSCO, is the argument our CDSCO will eventually hang its hat on to dodge culpability.

https://twitter.com/dawalelo/status/1578018541986807809

Is DEG toxic? Yes. Has it been conclusively linked to deaths before? Yes. Did cough syrup have large amounts of DEG? Yes. But there's no "exact one-to-one causal relation". This is the argument the HP regulator used to not file a chargesheet in Digital Vision case for >2 years.

Thread: Almost 3 yrs ago, with a grant from the
@thakurfdn, I started looking into the Q of whether Indian drug quality standards are systematically different from those imposed by the US and Europe. The outcome of that exercise is finally here science.thewire.in/india-drug-imp… (1) What are drug quality standards? They include stuff like: how much active ingredient should be in the drug? If the drug is a tablet, how fast should it dissolve in your body to release the active ingredient? And how much of impurities can be present in the drug? (2)

Developing countries like India have always had lower drug-quality standards than high-income ones. This is not a Covid specific phenomenon. And some of this was considered acceptable, temporarily, because it enabled access to medicine. (1) But this doesn't mean that developing-country regulators have a free-pass to do nothing about quality issues. There is *always* a risk-benefit assessment to be made, always a decision to be communicated to the public (2)

New story on the suspension of Covaxin exports after the WHO found GMP issues with Bharat Biotech's plant science.org/content/articl… (1) Some clarity on what exactly happened. The WHO did't physically inspect Bharat Biotech's plant pre-EUL. Instead, they relied on the CDSCO's and ANVISA's inspections. (2)

Thread on a Nov 2021 paper from CDC researchers on the very rare instances of multi-system inflammatory syndrome in adults (MIS-A) following SARS-COV-2 vaccination (Pfizer or Moderna's mRNA vaccines), and why the authors think the data is reassuring academic.oup.com/cid/advance-ar… (1/n) Context: As this October 2020 cases series shows, a spike in MIS-A cases began soon after the Covid-19 pandemic began (and *before* Covid vaccinations were introduced), suggesting that Covid-19 itself is triggering this illness cdc.gov/mmwr/volumes/6… (2)

New story: In May 2021, at the height of the second Covid wave in India, patients across multiple hospitals in five Indian states started falling sick after receiving batches of Cadila's remdesivir livemint.com/science/health… (1) Their symptoms: fever, chills and sudden drop in SPO2. The first two can be caused by a type of drug contaminant, called bacterial endotoxins (2)

Including the volunteer who died, after which your company/investigators sponsored by your company didn't even bother to visit the family, interview them, and give them an effing post mortem report. Nice way of thanking volunteers.

https://twitter.com/RachesElla/status/1465532729110507537

What a bunch of bull this guy speaks. It would have taken him and his team literally one day to tackle the Bhopal protocol violations, when the media made them aware of it. It was one day's work. Instead, they slept through the damn thing. Now he is thanking volunteers.