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.
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.
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.
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.
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
It has to be so cheap that the cost of offshoring and coordinating all that is dwarfed by the savings.
If I want to make a clone of the AstraZeneca COVID vaccine, 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 a 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-Harayana corridor and the Hyderabad-Pune corridor.
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.
"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...
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.
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.