Ranbaxy USA has just pleaded guilty to felony charges involving adulterated drugs made in India for the U.S. market. It is the largest drug safety settlement in history.

Despite continuous reassurances by the FDA that all generic drugs are identical to brand name counterparts, this guilty plea makes it clear that some generic drug manufacturers have been cutting corners. In the case of Ranbaxy, the company will pay a total of $500 million in fines and civil claims.

What did the company do wrong? Ranbaxy has admitted that some of the drugs it sold in the U.S. were adulterated. These medications were produced at its facilities in Paonta Sahib and Dewas in India. The company finally fessed up to inadequate quality control, incomplete testing records, inadequate stability programs and deviations from good manufacturing practice. In particular, batches of the anti-seizure drug gabapentin did not meet requirements, had unknown impurities and “would not maintain their expected shelf life.”

The FDA list of medications manufactured at the two substandard Indian facilities included:

  • Acyclovir
  • Amoxicillin
  • Amoxicillin and Clavulanate Potassium
  • Carbidopa and Levodopa
  • Cefaclor
  • Cefadroxil
  • Cefpodoxime Proxetil
  • Cefprozil
  • Cefuroxime Axetil
  • Cephalexin
  • Ciprofloxacin HCl
  • Clarithromycin
  • Fenofibrate
  • Fluconazole
  • Fosinopril Sodium
  • Fosinopril Sodium and Hydrochlorothiazide
  • Gabapentin
  • Ganciclovir Sodium *
  • Glimepiride
  • Isotretinoin
  • Loratadine (OTC)
  • Metformin HCl
  • Nefazodone HCl
  • Nitrofurantoin; Nitrofurantoin and Macrocrystalline
  • Ofloxacin
  • Pravastatin Sodium
  • Ranitidine
  • Terazosin HCl
  • Valacyclovir HCl
  • Zidovudine

Drugs from these facilities have not been allowed into the U.S. since September 16, 2008. That’s when the FDA slapped an injunction on the company to keep drugs from these two plants out of the U.S. until they comply fully with FDA standards.

On the one hand this may seem like good news. But we worry about other manufacturing plants in countries where FDA’s inspection capabilities are limited. A little known fact is that in countries like India and China, inspectors often must request government permission to visit manufacturing facilities. The drug or chemical companies know well in advance before inspectors arrive, so they can clean up their paperwork and premises in time for inspection.

Imagine restaurant inspectors telling the owners ahead of time about inspection dates. Public health policy recognizes that such an inspection would be meaningless. That’s why food inspectors and FDA investigators show up unannounced in the U.S. Shouldn’t the same be true abroad?

The FDA has admitted to us that it still does not have the resources to inspect most foreign plants. That means that the majority of generic drugs that are imported into the U.S. come from factories that have no official FDA oversight. If we are supposed to trust the FDA to verify that $4 generic drugs from India, China, Thailand, Brazil or Mexico are up to snuff, we need to be sure inspectors are making unannounced visits and looking carefully at the manufacturing process and the records to insure that there are no falsifications like those that occurred with Ranbaxy.

What has been your experience with generic medications? We would like to hear both the pros and cons of your experience.

Here are some generic drug stories from visitors to this website.

“I recently filled two prescriptions, gabapentin and tramadol, which had been the same prescription for months. It took me forever to find a combo of pills which allowed me to manage my pain comfortably, so I could go about my daily life.

“Now I get two different versions of my pills and ALL my comfort is GONE; I’m experiencing problems I’d not had since I’d found my perfect combo of meds.

“Well, the ‘different’ versions of these pills were from new manufacturers/suppliers. I looked them up online which was not an easy task. Both companies seem to have a focus on animal meds, and I am NOT IMPRESSED.

“Why are all sorts of companies being allowed to provide meds to people who rely on these meds for their quality of life?”

J.L.


“I also had trouble with a generic medicine. I use Keppra for neuropathic pain syndrome in my hands from carpal tunnel syndrome and surgery on both hands. My doctor had changed me to generic levetiracetam and I started having awful pains in my hands. I went to a doctor after a while because the pains were worse than when they originally started.

“The doctor changed me back to Keppra, and it took a couple of weeks before the pain eased up.

“I reported it to FDA and they commented to me that they never heard of the generic not working. But you have warned on your website about generic for Keppra not working. I love reading your column and it is very helpful. Thank you so much!”

Kathleen


 “I’ve been taking the brand name Wellbutrin XL 300mg for many years now.  I just recently ran out of my last bottle of the brand name.  When I went to refill it shortly before I was completely out, I found out my insurance company will no longer cover the brand name even with a prior authorization from the doctor.

“I tried the generic version in the past and found that it did not work.  I tried it at least 3 different times with the same results.  I figured I’d give the generic another shot, given the circumstances.  I decided to try it before I was completely out of the brand name so I could do some direct comparisons.

“I took the generic for 3 days.  It felt like I hadn’t taken anything except for the fact that I felt nauseated and dizzy for those 3 days.  I decided to switch back to the brand name on the 4th day and noticed a huge difference immediately.  Everything seemed to be working properly.  The nausea & dizziness were gone.

“I took the generic the next day just to make sure I wasn’t just sick those first 3 days.  Once again, it was like night and day compared to the brand name.  The nausea and dizziness came back and along with it, the symptoms of my depression.

“For the following two days, I took my last 2 brand name pills and found everything back to normal.  I am absolutely 100% convinced that the generic does not work.

“I’ve read numerous posts from patients describing the same kinds of problems with the generic, but it seems to be all of the manufacturers of the generic.  When I read the FDA’s statement about pulling one manufacturer’s version, Budeprion, completely off the market because they found it to be ineffective, I felt as if what I have been experiencing may not be a fluke.  In addition to that, they ordered that the other 4 manufacturers of the generic conduct studies to prove that their drug is in fact the bioequivalent to the brand name.

“What I do not understand is why they didn’t pull those 4 manufacturer’s versions off the market until they could be proven to be as effective?  After all, they would not be demanding for those studies to be submitted if they were sure that the drugs were as effective.  Also, why isn’t the FDA conducting its own independent study of each of the 4 manufacturer’s versions of this drug?

“This all seems crazy to me.  Isn’t the FDA supposed to be protecting us?  I am very frustrated because I cannot afford to pay for the brand name with no insurance coverage.  I’d like to know what options I have.  I can tell you after being completely off the medication for almost a month now, I am very concerned.  My depression seems to be worse than it has ever been.  I am even starting to have suicidal thoughts, which is very new to me.

“I’m so desperate that I’m even considering trying to find a Canadian pharmacy to get the brand name at a price I can afford.  This is certainly not what I want to do, but what other choices do I have?”

L.L.


Share your own story below in the comment section. Are you concerned about the ability of the FDA to oversee the generic supply chain? We have been told that the agency does not have adequate resources to do its job in this country, let alone overseas. If we are supposed to trust the FDA to verify that $4 generic drugs from India, China, Thailand, Brazil and Mexico are up to snuff, we need to see the data. Sadly, the FDA does not reveal this information.

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  1. Dedra Ross
    Elton , Louisiana
    Reply

    I have taking several of these medications….

  2. Doug
    Cary, NC
    Reply

    I found this web page because I was trying find out why there was a shortage of a specific generic drug that I have been taking, hydroxychloroquine. I recently refilled my usual prescription, and I was given pills that looked different. They also were softer in consistency (dissolved more easily). It only took about a day to discover that they did not work at all to control the pain of my arthritis. When I asked my pharmacist what the former generic brand was, he said it was Ranbaxy. The current generic that I am taking (the ineffective one) was made by Sandoz, I believe. Apparently, there is a shortage of supply of the main ingredient, and it affects all companies. Despite Ranbaxy’s troubles with other generics, I hope this one does not disappear off the shelves. Also, my experience shows that switching to other generics does not guarantee that the new generic drug will be effective.

  3. msc
    Reply

    I had exactly the same experience, and now insist on using brand name lexapro.

  4. carl K.
    Reply

    Is it possible to have a pill tested to determine whether it contains any of the drug it purports to contain, and, how much of that drug?

  5. Merle K.
    Reply

    I use a small independent pharmacy in my neighborhood, both to support a local business, and because I always figured I would get more individualized service there than at a chain drug store. As someone who is very sensitive to any changes in medications, I’ve come to learn the hard way that not all generics are created equal, and that not all generics are like their brand name counterparts.
    I don’t know if that’s bec. they’re not bioequivalent, or bec. different mfrs use different fillers, so the drug is not breaking down in the body in the same way. (Two examples for me are Ambien and Ambien CR.) That leaves those of us who find a particular generic ineffective or dangerous, forced to pay huge amounts for brand name drugs, through no fault of our own.
    Everything was fine for a very long time, until recently, when I began to notice that at times it was the pharmacy itself that switched generics on me. I was always able to get them to switch back immediately, but as a safeguard, began having my doctors write the name of the generic on the prescription for every drug I take, with DAW [dispense as written] noted as well.
    Recently I was shocked to find that I had been out and out lied to by the pharmacy itself. I was told that a generic I had taken for years was no longer available, no longer on the market, that they had looked into getting it for me from several middlemen, but many mfrs had left the field, and now there were only two generics available for that particular drug, instead of 13.
    After suffering through trying the two, the first of which was completely ineffective, I decided to research the question myself, because something just didn’t seem right.
    I Googled the generic maker, spoke to customer service, and learned that not only was the drug still on the market, but it was widely available. I confronted the pharmacy owner with the elaborate lie I was told. (My impression was that this all had something to do with a change in the price the independent pharmacy was being charged by the generic maker or the middle man.) I told the owner that if it was a question of money, I would pay the upcharge, but I couldn’t tolerate having my medications switched. I was then able to get the right generic back again.
    The lie cost me not only so many years of trust, but two months of physical misery (the drug was baclofen, an antispasmodic. It’s off patent, so there is no brand name version of it. The effective generic was made by Ivax, which was bought by Teva but is still sold as Ivax).
    Obviously, I was ready to switch all my prescriptions to a nearby chain drugstore, until the pharmacist at CVS told me not to, bec. the chain decides which generics to buy for all its stores, and if they switch companies, you’re just out of luck; they don’t do special-orders. He told me I was still better off with the independent pharmacy, using my leverage as a good customer to get what I needed. And a friend told me that she’d been told the same lie by a pharmacy in her area.
    So people, be vigilant. Be aware. Follow the money. Caveat emptor. You have to look out for yourself, bec. the patient is obviously the lowest form of life on the food chain. If the ins. company isn’t trying to restrict what you get for their bottom line, it looks like the pharmacists may now be doing that too. And the FDA is nowhere to be found.
    I now make sure to ask for a refill 5 days before it’s due, and double check which pills are in the bottle while I’m still in the store, regardless of what the label says. That way, if I have another problem, there is time to switch my Rx to another pharmacy. I’m going to research the other pharmacies in my area and find out what they carry, so I can be ready to switch, medication by medication, if I have to.

  6. VH
    Reply

    The generic of Biaxin was prescribed for a sinus infection. I kept becoming more ill. I knew from past experience that generics did not help me. When I realized that I had generic rather than brand, I called the pharmacy. They were able to get brand with the doctor’s concurrence.
    They did not have it on hand and I had to wait for two days. Medicare prescription plan will only cover generic. The brand cost a fortune. We are being forced to remain ill or pay astronomical amounts for drugs that are effective.
    Literally sick of it.

    • Susan
      Reply

      I became very ill, from Levothyroxine made by Mylan, so I requested another manufacturer and CVS still wanted to give me the medicine by Mylan. Then I was told to come back two days later, so if they still don’t give me a different manufacturer, I will try another pharmacy. This is so disturbing, because I think the Levothyroxine that made me sick was made in India or China.

  7. Dennis Hutton
    Reply

    Ranitidine I was told to take two 150mg tablets a day. I started having mental confusion. I dropped the dosage to one tablet a day. This seemed to be working, however I think the symptoms slowly got worse. I was so confused I could look at my schedule and still be a week off.
    I went to meetings a week early and I had just checked my calendar. I read where you cannot stop this type of medicine cold turkey. So I have cut the pill in half and the symptoms have reduced. I have been taking half a pill for over a month now and feel somewhat better.
    The reason for taking them was to reduce my stomach acid as a prevention method against ulcers. I also take coumadin, so I cannot afford a bleeding ulcer. The Ranitidine was the third prescription I have tried. The first two also created mental confusion. I am not sure how to proceed once I quit the Ranitidine.

  8. EL
    Reply

    I was diagnosed as a type 2 diabetic in 1990; Glucophage ER 500 mg bid was prescribed. My diabetes was in excellent control until metformin became available about three years later. My A1C was 6.0 or 6.1, and my FBS was in the 90s and low 100s until metformin replaced Glugophage. At that oint, both A1C and FBS increased and Actos was added. Medco is the service that the state of Texas uses for its retirees (I retired after 20 years of faculty employment at The University of Texas Health Science Center at San Antonio School of Nursing).
    Although both the A1C and FBS did not decrease, my physician insisted on keeping me on Actos. When Medco merged with Express Script, the metformin manufacturer changed to Sun(Caraco); I had not recorded the name of the previous manufacturer but I noted the change. I also noted that the present metfomin has a faint odor that reminds me of rotting meat. My next A1C was much higher – 7.3 – and my FBS was 143. My ophthalmologist saw for the first time evidence of diabetic retinopathy and lab work showed evidence of kidney damage.
    Although I knew that the penalty would be stiff for ordering a brand name when a generic is available, I asked my physician to order Glucophage and to specify DAW in the box for that purpose. After checking several pharmacies, including Costco, I realized that the Express Script charge of $153 plus change for a 90-day supply is significantly lower than I can find elsewhere, so I sent in the prescription and am waiting for it to arrive. Three months after I begin to take it I will have blood drawn for an A1C and FBS to see if there is a significant difference from the previous readings.

  9. Mona Jones
    Reply

    There is no pedigree on any drug. This was exposed on 60 Minutes some years ago. Even name brands have no pedigree. This means you cannot know their origin. Drug companies love it that you may come back to the name brands and pay more money. I hope to never have to take a drug in my life. I am drug free at 63. Most drugs are not cures they mask the symptoms and have so many side effects.

  10. Dave Hyde
    Reply

    Pushing customers to generic drugs: Just one more thing to thank the insurance health care industry for.

  11. SD
    Reply

    I have taken Valium for nearly 60 years, so know what it feels like. I use it for back pain. Recently my PA ordered it for me and signed generic OK. Well, it wasn’t OK! While playing cards, a friend asked me if felt all right. I replied that I felt sort of “out of it”–brain fog and sleepy. We stopped playing and I went home and to bed, but couldn’t sleep. The next time I took one (5mg) before lunch I could hardly keep my eyes open to eat–again went to bed but couldn’t sleep.
    My PA has now ordered the real thing, and I hope it’s coming soon, but my drug plan only allows 4 months of the drug. I can buy it locally at full price $135 for 30 tabs, and the generic was $3.91 (co-pay) for 90 tabs!! How’s that for a price??
    A few years ago I took Toprol XL and had very few A-Fib episodes. When switched to the generic, I had 7 episodes in 10 days! That was the end of that generic!
    I have taken the generic of other drugs with seemingly no problems.

  12. joe h
    Reply

    Yes they have us over a barrel, because most insurance and medicare will not pay for name brand. Companies continue to charge outrageous prices for name brand. Everybody forgets that cutting government sounds good but they don’t understand that good programs like FDA take hits in budgets too. Companies love to have less oversight.

  13. Mike
    Reply

    I take Metformin 1000 mg tabs made by Mylan which I note produces this in India… is there any relationship with Metformin HCL and/or with the Indian manufacturer that make my tabs “adulterated” also?

  14. cwr
    Reply

    I had been on brand Protonix for around 10 years, with good results. When the generic came out, my insurance no longer paid for the brand, so I tried the generic. Within 4 days I was having chest pains. My doctor then gave me Nexium, which the insurance paid for, and the chest pains disappeared after a few days.
    I think your programs and literature are the closest we come to actual truth about medication.
    CWR, R.Ph.

  15. Naomi Baxter
    Reply

    Thank you for the above. I always go for the less expensive variety of a drug but, forewarned is …………
    In future, I will revert ONLY to Canada if there is no reasonably priced
    American generic.
    Again, thanks for the information.

  16. kms
    Reply

    I have been taking generic versions of voltaren and Placquenil for many years. Recently I have been experiencing problems with hives. I have been able to trace the reaction to the Placquenil (Hydroxychloroquine sulfate). It is manufactured by Ranbaxy! when I checked with my Pharmacy to see if I could get it from a different manufacturer, I was told that I was the 4th person that day to call and report problems with generic drugs (they all seemed to be Ranbaxy).
    This has been within the last week, so it seems that the problems with Ranbaxy are far from over.

  17. T
    Reply

    I can only take the “blue” generic Paxil. The white pill version does not work (different manufacturer).

  18. wanda
    Reply

    Yes I’ve had problems generic drug for cough medicine (Tussionex Pennkinetic SuSP). Now the drug store gave me generic my cost with insurance was 180 dollars. It didn’t work like the first bottle I had the year before for the same problem.
    I had whooping cough in 2008 so get a bad cough every year the same time in February.
    Anyway I took bottle back and told the guy this stuff doesn’t work like it is suppose to why? He looked and said it was generic this time. I told him I didn’t want generic. That I wasn’t asked and why was it 180 dollars for generic not the real stuff? He told me it was as good. I told no it didn’t work I took two doses and I was still coughing for over 4 hours straight with this. That the other non-generic stopped cough within minutes. He said hold on and left me to use the phone.
    Said he called the FDA about it and they said it might not work. He then gave me a smaller bottle (4oz) of the real stuff for the same 180 dollars.
    Guess what it worked within 15 minutes just like it hard for the 3 years before (had paid $210.00 the year before for it.) Yes you read right 210 dollars for 8oz. with insurance. Can you imagine without? Who can afford this. What upsets me is Mexico, Canada, and anywhere in Europe don’t pay this for the same drug just us Good old boys in USA. We foot the bill for the world on everything including our drugs.
    So some of these drugs that are generic don’t work and we the public still have to pay the high price sometimes. Where is the FDA in all of this?

  19. Janet S.
    Reply

    Yes, the brand names are often not the same and the gov’t Has to know it by now. I took ONE of the generic pills of Cardizem and felt like I was passing out and my heart was doing odd things. Luckily, my clinic is 5 min. away. I lay on a gurney there for over an hour until my heart was normal.
    I now take just the brand name. Sometimes the Gabapentin doesn’t work and sometimes it does- I don’t know from day to day if it’s a worsening of my neuropathy, age or the darn pills. Often, the Same manufacturer is making the generic Not to work as well- how is this allowed?

  20. HET
    Reply

    Forgot to mention that the Manufacturers should not be told when the FDA come by to inspect. This will catch them in the act when they are not doing what is expected of them.

  21. HET
    Reply

    I am so glad I found this information, although I have not had any problems with the Generic brands. This is a great website to have to learn by.
    So far I have not had any problems with Generic brand medication. I will keep this in mind for future Generic meds.
    Thank You.

  22. paulbyr
    Reply

    Our US government, HR primarily, doesn’t want to fund the FDA adequately, because of their large kickbacks from Pharma. Nor do they apparently want laws that would ALWAYS incarcerate these crooked high level managers (maybe for attempted murder?) in addition to fining the company.
    The expenses of our citizens as we try to get relief using bogus drugs is passed on, as additional doctor or hospital visit costs. often to the health insurance industry (BCBS and Medicare in my case) because we cannot get drugs that properly treat our “ailments”.
    I think it would be much cheaper to fund FDA properly so the medical costs we transfer to insurance can be reduced. Too bad the insurance companies don’t agree; I guess they would rather we take generic but ineffective drugs.

  23. msc
    Reply

    I had extreme difficulty with generic Lexapro, primarily extreme dizziness and fatigue. In the course of research, I learned that the Canadian requirements that a generic drug must meet are MUCH stricter than ours. I also learned that generics made in Israel are much more reliable than those made in some other countries. Fortunately my insurance company was willing to ok my returning to the brand name.

  24. K Hopkins
    Reply

    I try to prevent consuming any product made in countries that do not have similar health & sanitary standards as ours. How can I avoid taking medications made in these countries. My drug plan insists on generics I am not given a choice nor am I informed as to where the drug is made. How can consumers protect themselves ?

  25. Ann C.
    Reply

    As bad as the news is about Ranbaxy (and I’ve used two of their drugs in the list above with no negative effects), we must not condemn Indian generic manufacturers altogether. Without Cipla, I would be dead. The cost of Cipla’s meds for COPD shows clearly the indecent mark-up made by the US
    makers of brand name drugs compared to Cipla’s generic: for the equivalent
    of two month’s supply of US meds, I can purchase a year’s supply from
    Cipla. For a poor old lady on Medicare, this means I can breathe.

  26. E T
    Reply

    I have had to make Walgreens do a prescription over a few times for my husband, because they give you the generic first, I told them I do not want it, and learned you have to tell your doctor to write on the prescription NO GENERIC. I have always been suspicious of them and do not want them.
    Thanks for the confirmation.

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