For the longest time I believed the "generic is generic" drug mantra and paid no attention to name brand or generic or who makes the generic. I took whatever the pharmacy gave me didn't think anything of it. I was happy to save a lot of money with generics when I could.

Last year a regular medication I take started getting refilled with different generic manufacturers randomly, after always getting the same kind for years. At least 4 different ones. Later in the year I felt really weird. Some days fine, some days not, and couldn't figure it out. Early this year while on a business trip overseas and wondering what was going on, I started searching on the internet about this medicine and found a bunch of people saying there is something wrong with the particular brand I was being given. They had similar symptoms, some pretty serious, like the medicine wasn't working at all. Some even claimed to have their Dr. test them to see if the drug was in their system only to come back negative.

The suspect brand "Accord" is made in India. I set those aside and started taking ones made by an Israeli company "Teva" since I had mixed them up in the bottle to have enough for the trip. Problem solved, felt normal, no issues. But they don't make them anymore, and almost all of the western companies are stopping production. After running out of that I found an old partial refill of the original stuff I was given for years, and it was fine, but it's not made anymore. Only solution my Dr. and I could come up with for the short term was to get a different form of the medicine that is still made by "Teva" but at much higher cost.

Then something similar happened with another medication - seemed not to be working. Manufacturer is "Aurobindo" which sounds latin, but also from India. I changed pharmacies to get more consistent refills from known-good manufacturers.

How can 3rd world countries make drugs and ship them to the US without the oversight of the FDA that heavily regulates pharmaceutical manufacturing in the US?

I know from experience that 3rd world manufacturers will make sure the "random" production samples they submit to certify quality and get source approved are usually cherry picked so they are all "good", and then when full production is authorized you get stuff that's all over the place. Everyone in my industry knows this. Hell, you better not buy bolts for high load joints from 3rd world countries because they will vary and you will never get stable bolt loads.

I don't have a lot of mediations, a regular one and a couple intermittent as needed, but I am having some issues this year that no Dr. can seem to figure out so they have prescribed some different things. And invariably if I check the manufacturer, every new thing a Dr. wants me to take is from a 3rd world manufacturer, and even at the new pharmacy they are getting 3rd world refills on stuff that used to be ok. I have told them I will only take certain manufacturers for a given prescription just to maintain some kind of consistency month to month. They are helping, but they can't control what is available from distributors.

It's all about keeping costs down, but at what cost?

Read this article for further information.
.
'Scary World' of Generic Drug Manufacturing, Revealed

The article is too long to post. Here is the link: https://www.medscape.com/viewarticle/914067

Which pharmacy is providing them to you?

I'd complain to them, loudly, at their corporate level.

I'd also file a complaint with your State Governments Pharmacy regulation board, as well as the FDA.

Avoid Indian and Chinese generics, if those are your only choice go Indian.

also watch out for Canadian too, US, Eurozone are preferred.

quote:

Originally posted by OKCGene:
Which pharmacy is providing them to you?

I'd complain to them, loudly, at their corporate level.

I'd also file a complaint with your State Governments Pharmacy regulation board, as well as the FDA.

Walgreens started subbing them in more than a year ago. Now CVS is. One prescription I have is expensive on insurance but a lot cheaper on the "Good RX" discount card. I checked all the local pharmacies - Walgreens, CVS, Kroeger, Meijer, Walmart, Target. Everything was Indian made except Teva (Isreali) at CVS/Target, and Meijer had a generic brand manufactured by the original name brand company (only in one mg dose size, other sizes varied).

Everyone is doing it because the 3rd world generics are FDA approved. Issue is how the FDA does the approvals, and how (if?) they monitor after the approval.

Read the article I linked. It addresses your questions. The following quote from the article:

On the FDA website there are links to warning letters and import alerts. There's another site that I like a lot called FDAzilla, which has all of the documents related to FDA inspections on it. If your patient is reacting badly to a drug made by company X, you could go into FDAzilla and look up the inspection record of that company. But for busy physicians, it's not so easy.

quote:

Originally posted by ZSMICHAEL:
Read the article I linked. It addresses your questions. The following quote from the article:

On the FDA website there are links to warning letters and import alerts. There's another site that I like a lot called FDAzilla, which has all of the documents related to FDA inspections on it. If your patient is reacting badly to a drug made by company X, you could go into FDAzilla and look up the inspection record of that company. But for busy physicians, it's not so easy.

I read the article and related ones. Had to register on the site - which I usually try avoid because of spam emails. Pretty scary what the inspectors have found in India...

quote:

I read the article and related ones. Had to register on the site - which I usually try avoid because of spam emails. Pretty scary what the inspectors have found in India...

^^^^^
Medscape should not bother you with spam. They may send you emails with new topics of interest but they are easily blocked. Yeah the India thing is concerning.

Many US companies have manufacturing plants in other countries. The FDA does do inspections on these as do the host country. So the products coming in have the same QA checks. Countries like Italy have stopped America based pharmas from receiving sedatives from their own Italian plants that were being used for executions.

Now the real kicker re: generics that few know. A generic drug is not necessarily bioequivalent to the branded drug. Pharmacists and doctors are usually not aware of the following information because most generic drugs do not have a dedicated sales force to push them. The FDA says, a generic drug has to be at least 80% bioequivalent to the branded drug. So one company may have a medicine you take that is 85% bioequivalent and the next time using a different manufacturer they give you the generic but this might be 80% bioequivalent and may have a different effect on how you feel.


I am making an assumption in your case you are not referring to some adverse event you have had with the drug but just your response to your medication as drug tolerance can occur and affect how much of a med you need to get the same result.

I have had this conversation with my physician in the past with meds I'm taking and he wasn't aware of the bioequivalence issue.

Remember, a pharma sales rep is required to disclose any adverse effects over 3% to the clinician. Selling a generic allows the rep, if there even is one, to say our drug lists the same adverse events as the branded drug, but we save you money. It is a conversation to start with your clinicians if you feel warranted.

Thanks for that information, AZSigs. I've wondered if generic drugs were truly the same as brand-name. Just from my experience with grocery store generics having different taste, texture, etc., I thought there might be something similar going on with the medicines and your post verifies my suspicion.

Do you know if this is true for the generic over-the-counter medicines as well - specifically the allergy meds.? Wal-Mart brands lists the same amount and type of active ingredients as Claritin and Allegra, but I wonder if there is something about these off-brands that reduce their efficacy?

An article from a few weeks ago discussed how drugs made in India and China were found to have cheaper ingredients in them. Many times the drug listed wasn't present, and at other times it was there at a different ratio mixed in with improper ingredients. They mentioned that while the FDA did inspections, they generally let the pharma company in advance that the inspection was happening.

One article:

"U.S. regulators have banned 11 drugs made at an Indian drug manufacturing plant from entering the United States over safety concerns.

Last Friday, the Food and Drug Administration issued an import warning to generic drugmaker Ranbaxy Pharmaceuticals over one of its factory's in Mohali in Punjab province. The agency said Monday its inspectors uncovered multiple violations at the factory last year, including failure to investigate manufacturing problems and failure to follow quality-control standards.
...

In May, the company's American subsidiary agreed to pay $500 million in fines and penalties for selling adulterated drugs and lying to federal regulators, the largest financial penalty against a generic drug company for violations of the Federal Food, Drug and Cosmetic Act, which prohibits the sale of impure drugs.

Some of the company's generic drugs "lacked necessary active ingredients due to poor quality control standards into interstate commerce," according to a statement from the New York State Attorney General's office.

In late 2012, another subsidiary, Ranbaxy Pharmaceuticals Inc., was forced to halt production of a generic version of the cholesterol drug Lipitorto investigate how tiny glass particles got into the ingredients used for dozens of batches that had to be recalled. It was Ranbaxy's second recall of the drug in three months."


Two other Ranbaxy factories are already under similar alerts from 2009."

Source: https://www.cbsnews.com/news/f...gs-from-entering-us/


From a New York Times article: "India, the second-largest exporter of over-the-counter and prescription drugs to the United States, is coming under increased scrutiny by American regulators for safety lapses, falsified drug test results and selling fake medicines...

Dr. Hamburg was met by Indian officials and executives who, shocked by recent F.D.A. export bans of generic versions of popular medicines — like the acne drug Accutane, the pain drug Neurontin and the antibiotic Cipro — that the F.D.A. determined were adulterated, suspect that she is just protecting a domestic industry from cheaper imports.

“If I have to follow U.S. standards in inspecting facilities supplying to the Indian market,” G. N. Singh, India’s top drug regulator, said in a recent interview with an Indian newspaper, “we will have to shut almost all of those.”

India’s drug industry is one of the country’s most important economic engines, exporting $15 billion in products annually, and some of its factories are world-class, virtually undistinguishable from their counterparts in the West. But others suffer from serious quality control problems. The World Health Organization estimated that one in five drugs made in India are fakes. A 2010 survey of New Delhi pharmacies found that 12 percent of sampled drugs were spurious.

In one recent example, counterfeit medicines at a pediatric hospital in Kashmir are now suspected of playing a role in hundreds of infant deaths there in recent years.

One widely used antibiotic was found to contain no active ingredient after being randomly tested in a government lab. The test was kept secret for nearly a year while 100,000 useless pills continued to be dispensed.

More tests of hospital medicines found dozens more that were substandard, including a crucial intravenous antibiotic used in sick infants.

“Some of the fake tablets were used by pregnant women in the post-surgical prevention of infections,” said Dr. M. Ishaq Geer, senior assistant professor of pharmacology at the University of Kashmir. “That’s very serious.”

Investigations of the deaths are continuing, but convictions of drug counterfeiters in India are extremely rare.
...
“China is the source of some of the largest counterfeit manufacturing operations that we find globally,” said John P. Clark, Pfizer’s chief security officer, who added that Chinese authorities were cooperative.

Using its new revenues, the F.D.A. tried to bolster its staff in China in February 2012. But the Chinese government has so far failed to provide the necessary visas despite an announced agreement in December 2013 during a visit by Vice President Joseph R. Biden Jr., said Erica Jefferson, an F.D.A. spokeswoman.

The United States has become so dependent on Chinese imports, however, that the F.D.A. may not be able to do much about the Chinese refusal. The crucial ingredients for nearly all antibiotics, steroids and many other lifesaving drugs are now made exclusively in China."

Source: https://www.nytimes.com/2014/0...-safety-worries.html

quote:

Originally posted by AZSigs:
I am making an assumption in your case you are not referring to some adverse event you have had with the drug but just your response to your medication as drug tolerance can occur and affect how much of a med you need to get the same result.

In my case the medication seemed to not work or have the opposite effect sometimes, some days I felt normal, other days I had symptoms like difficulty concentrating, flu like aches, vision issues. This seems to be consistent with withdrawl symptoms, so it's possible I had a bad batch with low bio-equivalence in at least some of the pills, and was experiencing inter-dose withdrawal. Looking at pharmacy records I was getting the Indian stuff for a few months before I noticed issues. Switching back to known well-tolerated effective "western" brands made me feel normal but neither of them is made anymore.

quote:

Originally posted by marksman41:
Thanks for that information, AZSigs. I've wondered if generic drugs were truly the same as brand-name. Just from my experience with grocery store generics having different taste, texture, etc., I thought there might be something similar going on with the medicines and your post verifies my suspicion.

Do you know if this is true for the generic over-the-counter medicines as well - specifically the allergy meds.? Wal-Mart brands lists the same amount and type of active ingredients as Claritin and Allegra, but I wonder if there is something about these off-brands that reduce their efficacy?

I do not know about the OTC drugs and their generic offerings.

quote:

symptoms like difficulty concentrating, flu like aches, vision issues.

If you are taking a generic of Abilify (which I believe you mentioned the medicine Accord or Aripiprazole Accord) these symptoms are reported as possible side effects. While not adverse events, you still might talk with your MD about dosing.

I do wish you the best and your MD can work to tailor your dosing.

If you really want to have nightmares, read Bottle of Lies. My wife has read it and relayed to me a lot of the info.
There are lots of known horror stories, e.g. the Rambaxy one about generic Lipitor noted above.
Worse, the entire process including serious limitations to the accuracy of FDA inspections (no “drop-in” inspections as happen in the US); clear cases of fraudulent test results, etc.

Teva is an Israeli company, but their drugs are made in India and China. They may have better control of quality, but who knows?

Here’s the clincher: even brand name drugs get their component chemicals from India and China, and they can’t tell you where they came from.

I’m a retired physician with the very large Kaiser Permanente organization, an integrated system of medical groups, hospitals, pharmacies, and insurance. I trust their own bioavailability testing of the drugs they dispense better than that of big-box pharmacies like CVS or Walmart.

The cultures of industry in India and China do not encourage whistle-blowing, to put it mildly.

If I recall correctly Kaiser did not permit Pharma reps to detail the physicians. Thanks for the information above.

quote:

Originally posted by AZSigs:

quote:

symptoms like difficulty concentrating, flu like aches, vision issues.

If you are taking a generic of Abilify (which I believe you mentioned the medicine Accord or Aripiprazole Accord) these symptoms are reported as possible side effects. While not adverse events, you still might talk with your MD about dosing.

It's not Abilify. The brand is Accord, and I had no idea they were Indian made until I checked after noticing the negative affects, which are consistent with sudden withdrawal. It is possible that the alternative Teva version I am using now metabolizes different because it is not the same.

Goal is eliminating this med, not changing the dose. I decided this a while ago when I found I could not rely on a stable supply from a consistent manufacturer.

quote:

The cultures of industry in India and China do not encourage whistle-blowing, to put it mildly.

My job is manufacturing but on corporate side setting standards and advising all of my company's plants worldwide. Also starting new ones in emerging markets. I've spent a lot of time in China over the past 8 years and a few trips to India and I am very well aware of the cultural challenges. We've had our own internal issues with gaming of performance metrics. The silly part is "really good" metrics will pass, but "perfect" raises suspicions.

All I can say is I am glad the Teva medication was working for you. I work for Teva in the manufacturing dept. All of the big name generic companies have facilities in India, China, etc. It's the cost factor why they keep them running. If you want to see tough scrutiny, the European "FDA" makes the US FDA look like cub scouts!!! I have been through some of their inspections.

It's our fault, you know. We keep suing drug companies to blame them for all of societies woes. I often think that when a state sues blaming a company for rampant pill abuse, that company should simply say "see you" and not do business in that state any longer.

Eventually, we might wise up.

quote:

Originally posted by jljones:
It's our fault, you know. We keep suing drug companies to blame them for all of societies woes. I often think that when a state sues blaming a company for rampant pill abuse, that company should simply say "see you" and not do business in that state any longer.

Eventually, we might wise up.

The FDA also continues to raise the regulatory bar continuously for manufacturing plants. Some pharma co's have burned their manuf facility for a specific product to the ground and rebuilt to FDA standards only to have FDA make new standards that were too hard to meet. The co just shut down the plant and sold it. Several co's have stopped producing drugs because the cost to continually upgrade and make the drug wasn't economically feasible. Because of this America looks to Europe to fulfill some of their pharmaceutical needs. (Anesthetics, sedatives, paralytics)