Posted on 03/01/2025 6:50:03 AM PST by CondoleezzaProtege
“Where generic drugs are manufactured can make a significant difference.”
“The FDA assures the public that all generics patterned after the same original drug should be equivalently safe and effective, however, this is not necessarily the case when it comes to generic drugs made in India,” added another co-author, George Ball, associate professor of operations and decision technologies at Indiana University’s Kelley School of Business.
Generic drugs manufactured in India are linked to significantly more “severe adverse events” for patients who use them than equivalent drugs produced in the United States, a new study finds.
These adverse events included hospitalization, disability, and in a few cases, death. Researchers found that mature generic drugs, those that had been on the market for a relatively long time, were responsible for the finding.
The results show that all generic drugs are not equal, even though patients are often told that they are, said John Gray, co-author of the study and professor of operations at The Ohio State University’s Fisher College of Business.
“Drug manufacturing regulation, and therefore quality assurance practices, differ between emerging economies like India and advanced economies like the United States.”
“Overcoming this lack of transparency of drug manufacturing location is one of the major accomplishments of our study,” Gray said.
(Excerpt) Read more at news.osu.edu ...
Who funded this?
The number and concentration of chemical impurities is the difference. In addition, analytical methods used to determine concentration may be not adequate and vary from one manufacturing site to another.
I can vouch for that. I occasionally take a generic Lasix and I can take one and it will work immediately and strongly. Then sometimes I’ll take one and get nothing. Same bottle, different results.
I recently tried some Indian-made pills.
They didn’t work. Well, a little. But not sufficiently.
We deal with notified bodies every year at work.
There are specific guidelines laid down in standards from different organizations such ISO, ISTA, ASTM and the like.
With ASTM standards multiple laboratories in different locations determine if the tests are valid. So it shouldn’t matter if you manufacture in Switzerland or Swaziland.
You must conform to the standards.
If the company is not doing so it should be caught by auditors.
It sounds like both were not doing their jobs.
“ You must conform to the standards.”
Just go to Mexico or any other central or South American country. Pharmacies are open to the public, no doctor prescription is required. I’m sure all those cheap drugs are top quality generics!/S
“Oh, you want your prescription to actually WORK? Well, then, that’ll be $2,300 instead of $19. What? That’s too much? Sorry we can’t be of more help to you.” Had this conversation with a pharmacist a couple of years ago. Also, yesterday, I got a notice from my insurer explaining why they would not cover a drug prescribed by my doctor. A drug he had prescribed four years ago, and which worked like a dream— perfectly, and as expected. And which they covered a year ago. Now, they want me first try a bunch of other crap, and see if that works. Basically, experimenting on me. And this is First World living in the United States?
This is a weak study. No info given about the routes of administration of the generics. Was it all oral meds? Some injectables? What were the preexisting health conditions of those who had the adverse reactions? Were the drugs prescribed appropriately?. Did the patients take the meds as prescribed?
But it appears to be a decent sized signal. Bucking for a grant? Job security? American drug manufacturers trying to justify high reimbursement by government agencies?
DOGE dodging? Business professors researching this?
Many American companies use foreign manufacturers to make their drugs, so the distinction between the parent company and the manufacturer has to be made.
Needs further study. Sending crack FDA team...oh,boy.... Moe,Larry, and Curly,,,,
Maybe I’ve been lucky but so far no problems for me with any generics. But this is good information. Thanks.
That’s the question.
The research was led by members of the Ohio State faculty. It’s not that we need less generics, if anything we need MORE - but made in America or countries with high manufacturing standards: Israel, South Korea, France, and Germany come to mind. And affordably still at that!
You must conform to the standards.
If the company is not doing so it should be caught by auditors.
I hate when I get fake peyote too
Nah, this was nothing in the controlled-substance world. I’m 100% clean and sober, don’t touch anything like that. Well, Adderall, but I have a legitimate scrip for that.
The fake peyote won’t ruin your sobriety and has no contraindications with adderall. Though I did hear professional poker players crush it up and snort it to stay awake and focused during tournaments. The adderall I mean, not the fake peyote.
I have received inequivalent generics at least 3 times. There are quantifiable problems. The worst was manufactured by Torrent labs in India, but that doesn’t mean all Indian generics are bad. It’s especially insidious with antidepressants, which may take weeks to ramp up to determine efficacy, but a bad generic, admittedly less common than a good one, can’t be distinguished from simply needing another AD.
A couple times it was probably due to insufficient active ingredient, but at least once I had a debilitating side effect for many months.
I have taken one drug long term for many years. Just this last year it started making me sick so I stopped it and wasn’t sick. The brand had changed to Quallent and the order is processed by Express Scripts. Turns out Quallent is a branch of Cigna and didn’t actually make the drug. The drug is made by whatever low cost supplier to Quallent wins the bid at the time and we don’t actually know who made the drug. Cigna assures us they only use suppliers that have FDA approved drugs.
https://www.quallentpharmaceuticals.com/about-us
The audit is for things you have done or things you failed to do.
Typically you have third party testing done in a lab with proper certification (usually this means GLP).
I use an outside laboratory that’s ISTA certified for package testing. I use their data to write reports that auditors can read.
I think we did. They would have saved a boatload of money if they had just asked a group of random people about their experience with generics.
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