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Comment by dmm | Hacker News Reader

If you're interested in the safety of generic drugs you should read "Bottle of Lies" by Katherine Eban. She presents a convincing argument that FDA regulators were/are unprepared for ensuring the safety of drugs from overseas manufacturers.

For example, in the US, drug makers are subject to surprise inspections but in India and China, manufacturers have weeks or MONTHS of warning. There was a program to station inspector in India and perform random inspections but it was cancelled. She argues because it was too effective, every plant inspected was found to have serious issues.

And it's not just ignorance of good manufacturing practices or a few bad actors. She shares the story of whistleblower Dinesh Thakur who revealed Ranbaxy executives committing safety-compromising fraud.

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I did an IT consulting gig at a western pharma company that specialises in generics. They develop the chemistry and the manufacturing process at the head office, and then pack up the factory and ship it to India or China for low-cost operation.

I overheard an emergency conference meeting about a batch that had gone bad. I can't remember the details, it overheated or something like that, certainly ruining some horrifically complicated organic chemistry process step.

The Indian chemical engineers were arguing for hours about how they could "save" the batch or "use it somehow" while the westerners were repeatedly telling them that there is no safe way to do that, and the only option was the throw it out and start from the beginning.

"Sir, we can fix it!"

"No, no, no! Throw it out!"

... for hours.

Their culture is just not compatible with certain modes of thinking, like "safety first". Saving face takes priority in their culture, even if that means kids might die because the drug batch was bad.

Why is it so much cheaper in India or China? Labor cost? No EPA?

It has to be so cheap that the cost of offshoring and coordinating all that is dwarfed by the savings.

IP Enforcement.

If I'm a European, Israeli, or Japanese conglomerate that wants to make a clone of Pfizer or Abbott compounds, I can't do that in the EU or US+Canada because I'd be sued for patent infringement.

On the other hand, India, Israel, and Japan don't recognize or enforce American patents for pharmacuticals.

After Israel and Japan became developed countries in the 80s-90s, it became expensive to manufacture within both, so the Pharma companies like Teva and Takeda began investing heavily in the Indian Pharma manufacturing base in the Himachal Pradesh-Chandigarh-Haryana-Uttarakhand corridor and the Hyderabad-Pune corridor.

Yeah, no.

If what you said was true, The Serum Institute of India wouldn't have licensed the Oxford-AZ vaccine. Same applies for drugs like Molnupiravir where local manufacturers licenced the drug from Merck.

Even if these manufacturers were able to get away with patent violations, they still wouldn't be able to export them to the biggest and richest markets.

The COVID vaccine was a bad example as it was manufacted on license from AstraZeneca, but the larger Indian market absolutely does this due to how the Indian Patent Act is structured.

"Section 3(d) of the Patents Act, 1970, explains that a new form of a known substance, new property / new use for a known substance and the mere use of a known process are not patentable and is not considered distinct from the known substance. Based on this principle, inventions using known substances are not patentable unless, for example, the alleged invention displays a significant increase in efficacy." [0]

Ranbaxy, Reddy Labs, and Sun Pharma all started thanks to this loophole, and it has been a massive blocker in any US-India Free Trade Agreement.

This is all open knowledge to all players in the India market [1]. It's not necessarily a bad thing btw - it's a major reason India's Pharma and Agrochemical R&D pipeline punches above its weight, but it has an impact on US-India relations, but for other regions such as the EU, Japan, or Developing countries it doesn't have much of an impact.

[0] https://www.aipla.org/list/innovate-articles/the-global-sign...

[1] https://www.nishithdesai.com/fileadmin/user_upload/pdfs/Pate...

Sure, the fact that the patent regime in India doesn't allow evergreening is common knowledge. But that is not what your original comment said.

We may need nearshore/onshore QC

That's how the FDA operates.

That's why the filing above was created by the FDA.

You'll have some level of surprise inspections in India, and another set when the batch is imported to the US or EU.

That is not how the FDA operates. For more than 2 decades, the FDA has basically given these overseas generic factories months of advanced notice of inspections. There are even former inspector who tried to whistleblower over how many times theyve caught those factories fabricating data and other circumstnaces and the FDA just buried the issue.

The real question, what in the world changed that made the FDA decide to suddenly cause the effective discontinuation of chemo as a treatment option for the US LOL

Its ok to subsidize banks in the US, but we can't subsidize manufacturing (like every other country) for some reason.

> Saving face takes priority in their culture

To an outsider it looks like saving face, but it really isn't - it's self preservation.

Asian business culture doesn't have the concept of "Blameless Post-mortems".

If a batch was mismanufactered, the GM at the plant would have heads roll because margins are so low.

> kids might die because the drug batch was bad.

You need to trade that off with 'kids might die because the drug batch was thrown out.'

In any supply and demand market, any supplier chucking out product means some buyer somewhere is priced out of the goods they would have bought.

If the faulty drugs were even 50% as effective as good drugs, then more lives were probably saved by shipping them. The problem is that there is no way to find those people who would have been priced out and offer them the maybe-50%-effective-maybe-deadly drugs.

Is your argument really "we should let people take dangerous and potentially deadly pharmaceuticals to reduce costs." Because I agree that would reduce cost by dropping demand.... Because the people taking them would be dead.

> If the faulty drugs were even 50% as effective as good drugs, then more lives were probably saved by shipping them. The problem is that there is no way to find those people who would have been priced out and offer them the maybe-50%-effective-maybe-deadly drugs.

Huh? You are assuming that they are effective at all and, even worse, let’s assume that it is 50% effective intended drug dose what the hell is in the other 50%?! Does it cause cancer or lead to other disease? Is it innocuous? Frequently contaminants are really not. Look up Chanticleer, Metformin, ranitidine just in the last couple of years.

These aren’t expired medications. They are ineffective at an overly generous best and likely dangerous.

These also aren’t street dealers where you are okay if 50% is coke and 50% is flour.

No pharma company is your friend. They can be useful, sure.

A bad batch of a drug or precursor does not conform to standards is no good in a safety-critical industry. We are looking at generic drugs, it's not like you have a batch of polyethylene from the pilot plant which does not conform to any standard, and you send it off to SE Asia for use in cheap plastic toys.

If by 'their culture' you mean the culture of market capitalism you might be right.

What do you think happens to batches of products that exceed certain pollutant treshholds in the US or the EU or anywhere else? They are destroyed?

No. They get diluted into other batches until they just meet the tresholds of the allowed percentages.

How do you find out where your bottle of generic pills was made?

It should have the plant name on the bottle or box itself generally.

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