Generic Drugs

[Ran2599dy]

I am using Walgreens Pharmacy for my drugs including my cancer drugs. All of my generic drugs are manufactured by companies located in India. i am bothered by Walgreens not notifying me where these drugs are manufactured. Are all generic drugs now coming from India and are they safe?

[Magnus1964]

I would think those drugs are safe. China I would question.

[Tall_Allen]

Even many brand name drugs are manufactured in India. The FDA must approve all drugs for safety and efficacy no matter where they are manufactured if they are sold in the US.

[dadzone43 in reply to Tall_Allen]

And you know full well the many failings of the FDA in surveillance of cleanliness and safety in India. We should send safe products but are not willing to pay the price for domestic production. It is all about the stockholders.

[Tall_Allen in reply to dadzone43]

What makes you think the surveillance of cleanliness and safety is any different for drugs manufactured in the US or India? The FDA holds all manufactured drugs sold in the US to the same testing procedures.

[dadzone43 in reply to Tall_Allen]

A recent cover story in Time documented laxity in the surveillance of drug manufactories in India. I have no reason to believe that the same slackness occurs in domestic manufactories. Regulatory agencies have been "gutted and denutted" quite deliberately by George W Bush and by Donald J Trump adminsitrations. When ideologues run agencies, the mission gets lost. When Congress gets bought out by Big Pharma, the mission gets lost. It will probably take either another thalidomide event or blood in the streets to get justice and cleanliness from the pharmaceutical industry.

[Tall_Allen in reply to dadzone43]

It is different when the drugs are manufactured for sale in the US. All drugs sold in the US undergo the same scrutiny. The FDA drug analysts are "source-blind" when they assess drug quality. You may be right that drug quality has suffered from underfunding of the FDA (I really don't know), but if it has, it is equally true whether the drug is manufactured in the US or india.

[dadzone43 in reply to Tall_Allen]

I understand what the regulations say. The article in Time simply demonstrated the lack of application of the regulations by the inspectors in India. Inspectors cheat and take bribes to look the other way, simply put.

[Tall_Allen in reply to dadzone43]

FDA has its labs in the US. It collects samples and analyzes them for purity for every drug it allows for sale in the US.

[j-o-h-n in reply to dadzone43]

There we go again.... blame Bush now Trump..... from a cover story in Time....the non partisan magazine....You should have read their expose about climate change and the tooth fairy.....Heaven help us....

Good Luck, Good Health and Good Humor.

j-o-h-n Wednesday 02/26/2020 7:02 PM EST

[dadzone43 in reply to j-o-h-n]

Really? Do you deny that Trump has excelled in "deregulation"? Do you deny that he has gone after agencies that he doesn't like (CDC, Justice. FDA) just because he can? I do not see Time as a flaming liberal, partisan publication. I guess you do?

[j-o-h-n in reply to dadzone43]

Woe is you..... Stay away from politics....doesn't belong here.....

Good Luck, Good Health and Good Humor.

j-o-h-n Thursday 02/27/2020 12:09 PM EST

[dentaltwin in reply to Tall_Allen]

It IS easier to surveil manufacturing in this country. My understanding is that the vast majority of generic meds (and not a few name-brand meds) are made abroad. Whether this impacts the overall quality of imported drugs I do not know, but there ARE concerns.

statnews.com/2019/10/29/dat...

[Tall_Allen in reply to dentaltwin]

It seems there are two different issues: One is plant inspections and batch records. The other is chemical analysis of the product, including impurities.

The FDA does the chemical analysis the same no matter where the product comes from.

"For example, the FDA labs tested 323 products from around the world – including more than 100 from India – to determine if foreign manufacturers had a higher incidence of product failure. All 323 samples met U.S. market quality standards using testing standards set by the United States Pharmacopeia (USP) or submitted in marketing applications."

fda.gov/news-events/press-a...

It is true that the FDA only analyzes a random sample of the batch, and if the batch records are falsified, it may not be a representative sample. But that should work in both directions if the FDA samples drugs from the shelf.

But, I wouldn't stop taking a drug sold in the US based on where it is manufactured. I would guess that nearly 100% of drugs sold in the US have at least some of their ingredients or reagents manufactured abroad. I guess that what is important to me is whether the pill contains only the pure chemical (+binders, buffers, etc.) and nothing more - that is what the lab analysis confirms.

[dentaltwin in reply to Tall_Allen]

Recent recalls of ARBs and PPIs contaminated with NDEA have not exactly made me feel warm and fuzzy about the inspection process. Yes it was caught--eventually.

[Tall_Allen in reply to dentaltwin]

I understand your fear. But what can you do about it? The manufacturing process may involve a hundred different chemicals, at least some of which were not made in the US, even if the final pill was put together in the US.

Thinking back to my organic chemistry days, for example. I once used some ethyl ether as an organic solvent for a Grignard reaction. Although the ether had not expired, was in a metal can, and had a "guaranteed" maximum peroxides, it blew up (fortunately, in the hood).

A drug manufacturing process may have dozens of steps, each with multiple reagents with varying actual purity (in spite of the label). Purification steps (like recrystallization from mixed solvents) may get rid of most impurities, but may introduce others. In the end, I always had to assess final purity using a gas chromatograph. If someone tries to cut corners, it will show up on the gas chromatograph - it's like a lie detector.

I wonder if those investigators you cited had limited their analysis to generics if the US numbers may have matched the India/China numbers. A brand name has the reputation of the manufacturer at stake, whereas the generics manufacturer is not concerned with branding. I guess we can insist on only brand name drugs, but some insurance won't cover it and the costs are prohibitive.

[dentaltwin in reply to Tall_Allen]

Didn't know you were a chem guy. My B.S. is in chemistry too. You're making me flash back to some not-terribly-pleasant memories. All I remember about Grignard is that it had something to do with magnesium.

Yeah, ether. I'm old enough that when I did my anesthesia rotation some of the general surgical patients had ether anesthesia--with the old copper kettle boilers in the OR. We were told the magnetic strips on the booties were to prevent sparks which could ignite the ether. Any patient getting ether would be blowing off fumes for 24 hours--I still remember the smell. Ah, good times.

No, I can't do a damned thing about contaminants, except when I hear about a recall bug my pharmacist to check lot numbers.

[dadzone43 in reply to Tall_Allen]

uspharmacist.com/article/fd...

[dmt1121]

While I would like to have great confidence in the FDA oversight process abroad, they are barely able to keep up in the US. There is nothing to be done about it and hopefully there is adequate oversight by someone!

[dadzone43]

Mostly " safe." India is a big manufacturer and so are other countries including Puerto Rico. The FDA whose mission it is to protect us has been lax in it's surveillance of manufacturing safety. You should ask Mr Trump about his laxity.

[leo2634]

My generic Zytiga comes from

Tel Aviv. By a company called Tevla.

[Hirsch]

I guess you could try buying Zytiga made by Janssen. It’s the original. Probably much more pricey. I used it till the generics arrived .

Generics work fine for me thank goodness