bottles of medications with warning stickers and information

Over the last several years, dozens of Indian drug manufacturers have received warnings from the FDA about bad manufacturing practices. In one of the latest incidents, Indian pharma firm Wockhardt is accused of deleting data and hiding the results of tests that did not turn out as hoped. The company will not be allowed to ship products to the US until it remedies the situation to the FDA’s satisfaction.

Multiple Recalls from Indian Pharma Company:

Hundreds of millions of tablets and capsules have been recalled. They include blood pressure pills amlodipine and lisinopril, the sleeping pill zolpidem and an antibiotic called azithromycin.

Other Indian Pharma Outfits Are Also in Trouble:

IPCA and Aurobindo have also run into difficulties with the agency. IPCA received a warning letter that will prevent US sales of drugs made in several of its plants. Other Indian drug firms, Dr. Reddy’s Laboratories and Sun Pharmaceutical Industries, also got warnings from the FDA late last year. You can read more about that here, here and here.

In addition, Ranbaxy Laboratories, the largest of the Indian pharma companies, has had multiple run-ins with the agency. In 2008, Congress contemplated strengthening oversight when data emerged that the FDA had known about fabrication of data in new drug applications for many months. You can read about that here. The company has also had difficulties maintaining good manufacturing practices.

Since a majority of generic drugs sold in the US are manufactured by drug companies in India, the evidence of ongoing problems with data integrity and appropriate manufacturing standards is troubling. American consumers have no way of knowing whether the pills they are taking might be affected.

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  1. Elizabeth
    Florida
    Reply

    Well, If you go to drugs.com or medschat.com it’s obvious how many people have and are being affected by inferior, even dangerous generics. Actavis, Aurobidino, Mylan Mallinkrodt and even Watson have all been reported for many years now concerning serious health issues after using their various generics. I’m in Florida and have had problems with Actavis alaprazolam .5mg once daily, Aurobidino Adderall 20mg once daily . Two years ago I’d had it with the Adderall generics causing a rotation of issues depending on which brand I was given and even though my Dr wasn’t very sympathetic since it was the holidays he conceded to write a new prescription stating Brand only. I even brought the remaining pills with me. Recently,he put me on Tramadol for my Lupus, fibro and Chronic fatigue syndrome and over the last few days I took maybe 4 total versus 4 a day. I’ve been waking up with intense heartburn (unusual) and extremely depressed and anxious plus, feeling like my skin’s on fire! My eye’s have had pressure behind them and even my throat and tongue have been hot. Turns out it’s Mylan Tramadol and I’d not realized my alaprazolam was Actavis too. Even my dog’s and my Prednisone is Mylan ? Meanwhile I’d been having side effects that I’d not had previously on these medications so of course I thought it was all just me. I’ve been losing patches of hair that’s waist length so I thought it was the weight of it pulling on my scalp. ?

  2. Ann
    Reply

    I am taking Warfarin and have for many years, although in the beginning and for many years it was called Coumadin. I never had a problem with consistency then, but I do now.
    My family doctor told me he has several patients who have issues with Warfarin who didn’t have issues with Coumadin either. But now all there is available in Canada is Warfarin.
    I haven’t seen Warfarin mentioned here, but this article really makes me wonder. Do you have any information about this? Or does anyone else?
    Thank you.

  3. Barbara
    Seattle
    Reply

    I did a lot of homework before I ordered from an online pharmacy in Canada. My gastroenterologist had prescribed a drug that has been on the market for 19 years; however, the generic at Costco was $1140 for one month (which in itself seems like a rip-off). I’ve been ordering the same generic drug from an online pharmacy for several months now, and it’s only $59.59 a month! Unfortunately my drug coverage will not reimburse me for any part of my expense. I checked with them, and they’ll pay ~$800/mo and my out-of-pocket would be ~$400/mo. Seems so crazy! You’d think they’d be glad to be saving thousands of dollars over the year when my out-of-pocket is ~$720 for a whole year.

  4. Ellen
    Dallas, Texas
    Reply

    I don’t have a lot of confidence in the FDA either, but I do think that I will look into the “authorized generic” drugs listed by that agency. Generics made by companies other than the original maker have , however slight, a molecular difference from the original name brand drug.
    Please correct me if this is wrong, but I did get the information from people with a good knowledge of pharmacology.

  5. Carey
    Chicago
    Reply

    Could this cause shortages?

  6. John
    maryland
    Reply

    My Doctor worries about the supplements I take…saying you don’t know what is in them. I worry about the very potent drugs he prescribes….I don’t know what is in them

  7. Jim
    Reply

    We have too much regulation already. Is the FDA bound up with too
    many laws and regulations created by congress in the past years.
    We need a more Free Market approach to medicine and drugs.
    A laissez fairer approach would keep the patient in charge.
    We also have too many medical and drug lawsuits, this could be resolved by instituting a caveat emptor policy in the courts.
    The DSHEA act of 1994 set the regulations for vitamins and supplements , this act is working well, why not apply this law to drugs?

    • Jeffrey
      Massachusetts
      Reply

      This post makes absolutely zero sense. How is a layman consumer supposed to evaluate the efficacy and purity of a drug? This free market ideology applied to a complicated and dangerous world leads to ludicrous conclusions. Perhaps we should skip the traffic lights too and let the drivers decide.

    • Barbara
      Reply

      To Jim, Feb. 5th, 2016. We don’t have enforcement of regulations, that is the problem. The FDA is poorly funded and staffed. And also controlled by the drug manufacturers.
      Frankly, your comment about no help for the drug consumer makes no sense at all, unless you are a drug manufacturer and you want a free hand to harm people!
      Your term “free market” means big business is free to do as they please with no concern for harming customers. Most other countries don’t allow such dangerous conditions. What you propose is what is wrong with American capitalism.. make the money and blame the victim because he didn’t (and couldn’t) know the poor manufacturing practices of an unethical drug company. Shame on you!!!

  8. deloris
    MIlwaukee, WI
    Reply

    If one were to question the safety of another country’s products, he or she could be easily labeled anti-trade or xenophobic. But when it comes to pharmaceuticals, it can be a matter of life and death. It’s difficult to know just where generics are made and if the manufacturers’ production processes and conditions are safe. Many other countries don’t seem to know or care about safety inspections and have a history of widespread bribery and corruption. Our FDA is also so pro-corporation that we can no longer trust them to effectively intervene. Furthermore, the world-wide medical establishment makes matters worse by being so quick to prescribe the drugs, making it impossible for domestic manufacturers to keep up with demand. This is globalization at its absolute worst.

  9. A.X.
    Reply

    Good luck trying to get your insurance company to let you have a brand name if a generic is available! And trying to find out where your drug was manufactured is a major undertaking. Boxes usually give the distributor, or where the company’s headquartered, not where the drug is actually manufactured. Or where different ingredients in it come from.

  10. Penelope
    Florida
    Reply

    When we consider that the products in Canada have much more oversight, it’s hard to keep from thinking that as far as the FDA is concerned, it’s the ‘fox guarding the henhouse.’ Is that why they don’t want us to import drugs from Canada?

  11. Mary
    Buffalo, NY
    Reply

    Hell yes, I’m upset. I take lisinopril and I noticed a few months ago the pills changed shape. Not sure they are working as well as they used to! But what can anyone due about it?

  12. joe
    EDELSTEIN IL
    Reply

    Once I had a prescription refill from a company different from my usual one, when they didn’t seem to work right,I contacted the FDA. A few weeks later I received a letter that sounded like from the FDA, asking if I would send the remaining pills for testing. Thought it sounded fishy on further checking the FDA, lets the company , check their own complaints. Whoopie I sent a few and guess what they said no problems, kept some for in case FDA wanted some, never heard from the suckers,They let the fox check the henhouse. JOE H.

  13. E
    Fl
    Reply

    There should be a legal requirement for all drugs manufactured outside the USA to be labeled by country of origin and manufacturers name.
    This info should be put on every prescription container provided to every patient.
    That way patients will know where their meds come from and would allow patients to alert the FDA, etc., where bad drugs are made.

  14. Madeline
    Texas
    Reply

    After taking sumatriptan for a migraine, I ended up in the ER. After the second time I realized my new prescription was a new brand-Dr Reddy’s! I reported the incidents to the FDA and notified my pharmacy that I will no longer take any medication from Dr Reddy’s.

  15. Fran McDowell
    Washington pa
    Reply

    I can not figure out why in the world the US doesn’t develop drug manufacturing facilities here and why we depend on, in some cases, third world countries for something so crucial

  16. Jennifer
    Roanoke
    Reply

    There have been ongoing problems with manufacturing quality issues (and integrity concerns) in India and China, and increasing shortages in essential life-saving drugs that our doctors and hospitals are dealing with on a daily basis. Plus, when you consider the price gouging happening in the pharmaceutical industry, is it time to consider government production of essential, generic drugs? Or tighter controls over pharmaceutical companies? This is one of the most serious issues facing our country. It needs to be addressed in a way that makes needed quality drugs available and affordable to everyone who needs it.

  17. Grace
    Tx
    Reply

    I always look at the labels and research online any drugs before I buy OTC . I will not buy or take any drugs mfg. in India, China, or Mexico. The problem is that the bar code’s first 3 digits do not necessarily mean the country of origin. If I have a prescription, I use my phone to look it up before I leave the pharmacy. If it is one of those countries, then I ask for a refund. I also ask the pharmacist not to use any drugs from those countries, when I drop off the Rx. You can check the codes at snopes.com by searching for bar codes by country of origin. I will not buy any vitamins or supplements unless they are USP certified.

  18. Jeffrey
    Massachusetts
    Reply

    Why take a chance? With a little bit of internet research, I found that the generics I was taking were also made by companies in more promising locals such as Canada, Western Europe and Israel. I merely had to ask my pharmacist to make the substitutions. Also, the FDA lists a large number of “authorized generics”at their web site that are made by the same companies that made and sold the patented drugs.

    • Penelope
      Reply

      Jeffrey, Could you give us a hint where to start to find out how you could find out where drugs were manufactured? This sounds like a promising way to go.

      • Jeffrey
        Massachusetts
        Reply

        Thanks for asking. It was simple. I looked on the prescription bottle and found the name of the manufacturer. I then used an internet search engine to learn about that particular manufacturer. Their web sites indicate where they manufacture and where their home offices are. My pharmacist was more than happy to search his list of generic manufacturers of my specific drugs. Then back to the search engine to confirm which were made in either the U.S., Canada, Western Europe or Israel. I was able then to easily change to one of the more desirable makers. Voila!

  19. alxzba
    nc
    Reply

    would like to receive comments by readers.

  20. Anne
    Wisconsin
    Reply

    Talk about a conundrum. Insurance practically forces you to go with generics!

    • GW
      So Cal
      Reply

      If at all possible, request your pharmacy to provide generics only from US or Canada. I have discontinued all purchases of third world drugs.

    • JAS
      Reply

      If a health care insurance company demands that you take a generic that does not work well for you, then call the insurance company, explain the situation and request that you get an exemption from being forced to take the generic instead of the brand version. It never hurts to try; you probably will need to get the doctor who prescribed the generic to verify that you need the brand instead of the generic version.

  21. Essi
    Reply

    Given some of the outrageous decisions handed out by the FDA over the past several years, it’s my opinion that this agency is not acting for the safety and benefit of the American public–their decisions essentially ALWAYS benefit certain industrial/corporate concerns. I have no confidence in the FDA assessment of “safety” when it has allowed unsafe imports from China and other places and obviously has certain favorites when it comes to pronouncing some companies’ products “safe.”

    • Laina
      Naples FL USA
      Reply

      Agree! I had years of the exact two Rxs and I am the coal mine canary for both. All at once for two months was in misery. Then realized the big chain store had switched brands. On both.
      Once recovered with the regular generic I REPORTED both to the FDA. Went to a lot of trouble to do it, and they denied ANYTHING WAS WRONG.
      Waste of time.

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