logoThe People's Perspective on Medicine

Why We Have Lost Confidence in Generic Drugs: New Report Casts More Doubts on Imported Medicines

Gardiner Harris has written a powerful front-page story for the New York Times titled “Medicines Made in India Set Off Safety Worries” (Feb. 15, 2014). If anything, the headline downplays the seriousness of the problem. Here is the first sentence of the 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.”

We have been warning about drugs imported from abroad for more than a decade. That’s because readers of our syndicated newspaper column and visitors to our website have been telling us for years that there were problems with the generic medicines they were taking. At first we were skeptical of these protests, thinking there might be a psychosomatic component to some people’s bad experience. (We had long been big supporters of generic drug quality and the savings that can be gained by substituting generic for brand-name medications. It was hard to accept that we might have been overly enthusiastic.)

Eventually the sheer number of complaints and the compelling nature of the stories convinced us that there was something very wrong with the way the FDA approved and monitored generic drugs. The article by Mr. Harris confirms that there is indeed a scandal of immense proportions that has pretty much been ignored by physicians, pharmacists, patients, regulators and Congress. Here’s the straight and skinny.

India now supplies roughly 40% of the active pharmaceutical ingredients found in our prescription and over-the-counter medications. Until recently, the FDA was incapable of inspecting most of India’s manufacturing plants. It didn’t have the resources or the manpower. New legislation has allowed the FDA to accept money from the generic drug industry to speed drug approvals. Some of those funds also go to inspections. Last year the FDA visited 160 Indian manufacturing facilities, triple the number from four years ago.

In the process the FDA has uncovered fudged data, shoddy plants and questionable quality control in a number of facilities, including India’s largest drug maker, Ranbaxy. Just recently, the FDA banned all active pharmaceutical ingredients made at Ranbaxy’s Indian facilities from the U.S. market. This was one of the first large foreign generic drug makers to make a splash in the U.S., starting its exports to this market in 1998. Perhaps coincidentally, that was the year we began to receive enough complaints to make us start to question our trust in the FDA’s ability to guarantee generic quality. Here is just one example of the kind of story we were receiving from readers at that time:

“I have been treated for hypothyroidism for over thirty years, and have been on Synthroid 0.125 mg for the past ten. This year my doctor wrote the prescription for a generic at the same dose.

“By the fourth day on the generic, I felt as though I was on the end of a tightly coiled spring. I couldn’t sleep; I had a slight case of diarrhea; I was sweating more than usual and my heart felt as though it would pound out of my chest. When I finally realized all this might be due to the change in medication, I had the pharmacist give me Synthroid instead. Almost immediately I calmed down, my heart stopped pounding so hard and I was back to my normal self.” [published May 18, 1998]

We now know more about the flaws in the Indian drug regulatory system. The head of the Indian drug monitoring program is G. N. Singh. In response to a question about quality control he replied that:

“If I have to follow US standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those. We are not the US, the infrastructure and resources available there are much different from those in our country. Our priority is to make medicines available and affordable to all.”

If the goals of Indian regulation are availability and affordability over quality, then it is little wonder that the FDA officials are finding problems. It was alarming to read in Mr. Harris’s article that many generic drugs are under the supervision of state health departments in India rather than the national authority. He points out that:

“The making of medicines that have been on the market at least four years is overseen by state health departments, many of which are corrupt or lack the expertise to oversee a sophisticated industry.”

The other large supplier of generic ingredients and products to the U.S. and the world is China. The former head of China’s national drug regulatory authority was executed for corruption in 2007. He had taken office in 1998, the year we started hearing from our readers about increasing problems with generic medications. The FDA has historically had difficulty making unannounced inspections of drug manufacturing facilities in China. Here is what Gardiner Harris of The New York Times has to say about oversight there:

“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.”

Despite all these concerns, the FDA still maintains that generic drugs are “identical” to brand names and that “FDA requires generic drugs have the same high quality, strength, purity and stability as brand-name drugs.”

If you are having some doubts about the FDA’s ability to guarantee quality in drugs from foreign manufacturing plants, you may want to get the rest of the story. Twelve years ago we interviewed key players at the Food and Drug Administration about these very issues. You can read what we discovered in our book, Best Choices from The People’s Pharmacy. More recently, we uncovered another scandal at the FDA involving the process for approving generic drugs. We document those problems in our book Top Screwups and also provide guidelines on how to use generic drugs more safely in our Guide to Saving Money on Medicine.

Share your own story below. If generic drugs have worked well for you, please let us know. We’re also interested in your experience with therapeutic failures or complications from generic medications.

Rate this article
star-fullstar-emptystar-fullstar-emptystar-fullstar-emptystar-fullstar-emptystar-fullstar-emptystar-fullstar-emptystar-fullstar-emptystar-fullstar-emptystar-fullstar-emptystar-fullstar-empty
4.2- 14 ratings
About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
Saving Money on Medicines
$2.99

This online guide offers in-depth information on how to safely buy prescription drugs from Canada, assess generic drugs, qualify for free medicine from drug companies, and more.

Saving Money on Medicines
Join over 150,000 Subscribers at The People's Pharmacy

We're empowering you to make wise decisions about your own health, by providing you with essential health information about both medical and alternative treatment options.

Showing
10
comments (103 total)
Comments
Add your comment

My husband is taking Norco 10/325 for pain. He took Amneal which worked so-so. Then he was given Aurobindo which did not work at all. I called CVS ,and it only carries Lupin which is another Indian company. My husband will be 79 in 2 weeks, and he is miserable. Anyone know any good generic company for Norco? CVS and our other drug store say they cannot get brand name.

Recently my prescription for Benazepril 5mg was filled with the Solco brand.
I completely lost my BP control.
Had been taking Teva brand with good control.
Solco meds are made in China. Draw your own conclusions.
I will not ever take any Solco meds again.

Sadly, most of the time, you will not know for quite some time that a drug is working or not; a generic like a statin drug will eventually show up in blood work….but how about a drug like celexa; you would not know for quite some time that it is not working. I question whether I might consider switching to the name brand! I will speak of this to my physician…I have been checking on line for some time now……and sorry to say do not feel confident with many generics.

This article makes it clear that the lack of quality standards and ethics by many generic manufacturers is strictly driven by profit. In turn, it also reflects the attitude of most pharmacy outlets, to provide the cheapest generics regardless of the manufacturer or patient safety. Last week my doctor prescribed an ace-inhibitor (generic). He did mention to be careful about the manufacturer due to recent recalls.

This generic ace inhibitor is being manufactured by 10 different drug companies, most are large respected drug companies with a safe history and no drug recalls. When I inquired about my prescription at my local pharmacy they told me it needed to be ordered from their warehouse. When I inquired about the manufacturer they replied there is only 2 they can order from, either LUPIN or AUROBINDO. (One of these generic manufacturers gave me side effects in the past). I then contacted several of the largest pharmacy chains and warehouse outlets and they only stocked the same 2 companies with the exception of BLUEPOINT pharm.

None of them claim they could provide me with either of the other 7 generics because they are not carried in their warehouse at this time. So I’m stuck with either having to settle with their limited choices or having to switch to another medication. The price of the brand drug is out of the question and not affordable.

The pharmacies appear to be sacrificing safety and well-being for cost effectiveness. These pills are likely inferior, cost pennies and batches are very likely to be recalled in the near future. One pharmacist told me, why worry, these pills are all the same and FDA approved. The good news according to the article is the proactive role the FDA has been taking to assure better manufacturing practices.

I came here to your website on a serious search. The lorazepam I was taking wasn’t working ..at all? I was sick from sudden withdrawal. I read the subscription bottle and found it was a generic I had never heard of. I looked them up and read everything about them. I called my CVS and told them the pill wasn’t working and that I was seriously ill. I told them the brand (USA) I had been taking and they gave it to me. Secondly, I was taking Lisinopril from Solco Healthcare and it wasn’t working at all. In fact after waiting a half hour and taking my blood pressure again it had gone up.

Something is wrong with generics these days. Solco’s website states to other companies to partner with them. Are the Chinese and India drugs manufactured to look like their generics? The lisinopril is so bad that I started researching where it was manufactured “supposedly”. I have also had problems with trifluoperazine generics not working. Should a person have to pop them like candy until they get some semblance of relief? We need an investigation in to how this is allowed to happen!

1. Just for the record–I tried the only generic nitroglycerin on the market–Dr. Riddy’s (the name is similar to that). It was awful. Sublingual (placed under the tongue) nitroglycerin is supposed to be gradually absorbed directly into the bloodstream. The generic stayed in the mouth and melted into the saliva, requiring it to be swallowed rather than absorbed. The exact opposite of what it is supposed to do!! It did not work and more than one pill needed to be taken to provide relief.

2. I have been prescribed generic antibiotics at places like Patient First in those capsule forms. The capsules were so poorly made that they came apart and began to dissolve as the drug was still on its way to the stomach and refluxed up through the esophagus and into the mouth along with the foul tasting drug.

3. Some of my blood pressure meds come in large, oval, solid tablets. When the non-generic is used, the tablets are coated for easy swallowing. The generics are not coated and have almost gotten lodged in my throat on the way down.

If generic drugs are poorly composed and don’t do the job as well as non-generics, what is the point in having them at all? We pay less money and suffer problems or we return to the non-generics. It is such a scam and I am really sick of it! Thank you for letting me post!

In August my Paxil was changed to Socol brand. Over the past 3.5 months my anger has increased to almost an uncontrollable level. Bouts of depression had returned with a fury.

Initially I did not put 2 & 2 together, until last week. The outbursts began appropriately 2 weeks after being on the Solco brand. I went in the Pharmacy today & demanded I be returned to the prior medication brand.

I am calling an attorney in the morning & am having the remaining medication. TESTED.

I was just looking and trying to find out about Lisinipril 40 mg my husband is taking because like you his BP was elevated and after taking the medication and waiting 45 minutes it had went up. It never went down after tripling the dosage. So again today with a new bottle we checked it prior to taking and it is still elevated. No effectiveness at all. Wtf is going on with the FDA? This is unacceptable.

I can’t take any generic blood pressure meds made by the foreign drug companies. Cipla, and CAMBRIA, I think they are made in India. I get to many sideeffects, one made in the US, no side effects, figure that out. What do those other drug companies put in or don’t put in their meds.

One of them have been investigated for diluting chemo drugs they sell to the US. Why is our country still buying meds from theses countries, is it a payback issue. Why are our prices going up for generics.

im on tramadol i was taking from the mylan pharm in india the white pill stamped m and t-7 only took 1 on 50 mg.then the doctor or my insurance switched to another brand 377 from another pharm in india.i have since it was switched an itching in the top of my head going on 2 years.nobody does anything about it. when i went on line and relaid this to the fda i told them what im going thru.i found what they put in the fillers to make the pill syn poppy,syn,codeine,lactose,ibf,miralax,anti depression to name a few .im trying to get off tramadol but cutting down to one instead of two amt 100 mg causes severe pain so i was told by the doctor to do.its like withdrawal .china,and india have been cited 2014,2016,2017 so people have to be careful with drugs in the generic form by these country because there very laxed .i have a form to fill out from the fda about what im going thru this tramadolis from the sun pharm in india most of these drugs come from there.i was very upset when i found out about the fillers which 4 of them i cant take.so just to let u know seeing we get all the drugs from india and china to our country and there multi billion dollar industries .so ck out your rx when generic are given because it could cause problems like i have for 2 years. tu

This happened to me- I took Wp thyroid which doesn’t have gluten fillers and the pharmacist switched it on me to Naturethyroid. My hair started to fall out and I got exhausted on it- I gained weight..all of this in one month. I went to Duane Reade and the pharmacist said it’s from the same list different brand. Big deal that he apologized, he didn’t notify me of the change and this set me back. Frustrating!!!

I have had problems a number of times with refills of Metoprolol! This is all so scary & infuriating! Honestly, it seems that even if you are clued-in & somewhat vigilant, you are probably taking something destructive to your health!

* Be nice, and don't over share. View comment policy^