Bad news for those of us ordering from India. This reminds me of Bryan Johnson’s abruptly ending his stay in India because of air pollution levels there. I wonder if it is these pollutants that are creating issues with the drugs.
The results do not mean that all drugs made in India are of poor quality, or that the US should stop buying generic drugs from foreign producers.
The data included other countries too, but the core finding was “generic drugs made in India, where a majority of emerging economy generic drugs are made, experience significantly more SAEs than equivalent generic drugs made in the US, where a majority of advanced economy generic drugs are made.”
What the results do suggest is that the FDA’s claims that generic drugs are interchangeable may not necessarily hold true in all cases. Generic drugs may have the same active ingredients, the same dosage form, and the same routes of administration, but that doesn’t mean they are made with the same best practices.
Manufacturing operations and supply chain activity could be impacting the quality of these meds, making it more likely that a patient experiences severe side effects.
“There are good manufacturers in India, there are bad manufacturers in the US, and we’re not advocating for ending offshore production of drugs or bashing India in any way,” says business analytics researcher John Gray from OSU.
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Yes - this is a big issue that has been known about for years, and why people here typically only buy medications from the major Pharma in India: Generally Good Indian Pharma Companies (though its still less than an ideal situation).
In the last few decades, the generic drug landscape in the US has shifted as foreign competition for a chunk of the market surges. Nationwide, generic drugs account for more than 90 percent of all dispensed prescriptions, and a lot of these now come from overseas.
In just a short space of time, India’s pharmaceutical industry has grown to supply nearly half of all the generic prescription drugs filed in the US, including those for hypertension, mental health, lipid regulation, nervous system disorders, and ulcers.
The FDA maintains these generic drugs are all interchangeable, but some research has warned that generic drugs are “not as safe as the FDA wants you to believe.”
see Katherine Eban’s book:
Past discussions:
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I remember hearing this on NPR years ago, and what’s remarkable is that the FDA still makes announced visits to overseas drug plants. Just show up unannounced like they do in the US, and that would reduce the safety risks. I guess I’m screwed because I can only afford generic.
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Probably impossible IMO. Customs, immigration and lots of others need to be involved. I’m sure the drug companies would be given a heads up either way.
But yeah, Katherine Eban’s book was an eye-opener. I generally prefer brand name, if they’re available. And it’s why I’m generally pretty sceptical of supplements, because no matter how bad these generic drugs might be, supplements can be a hell of a lot worse. Like, your EGCG coming from leaves covered in pesticides which sat on a warehouse floor getting covered with rat and cockroach droppings.
I think Glenmark is a major manufacturer of the generic sirolimus sold in the USA Today:
In a report detailing their findings, the inspectors wrote that Glenmark failed to resolve why some medicines weren’t dissolving properly, and they raised concerns about the factory’s manufacturing processes.
“Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product,” the inspectors wrote.
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