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 Monehy 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.

 

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  1. AZR
    Reply

    I have the exact same problems with my generic pills. Ambien, Meloxicin, Tizandine, Pantoprazole to name the most inconsistent ones. I thought it was just me being weird. I have wondered often if the problems were caused from the generic pills. Besides the irritation of my pills changing shapes and colors, I have often thought they were just not working. I will investigate the name of the company to see if there is a pattern. Thank you for sharing this information. I am so glad my husband found your Web site.

  2. mnd
    Reply

    Yes- the generics from one pharmacy can absolutely differ!
    The pharmacies I have dealt with have one or two different generics for a particular drug that are dictated by the parent company and stocked by that chain’s warehouse. Another pharmacy may or may not have the same generic. That is the problem I ran into when my neighborhood chain pharmacy was bought by another chain. The warehouse that supplied them also changed, and I received a prescription for venlafaxine (Effexor) that plunged me back into depression. The new generic was manufactured by an Indian company that has had some of its generics banned by the FDA due to underdosing.
    I inquired as to what generic I had received previously (and that had worked fine), and found it at another pharmacy, to which I transferred my prescription. had to fight the insurance company for three months, however, since I had a 90-day supply of the inferior drug on hand that I could not use. You need to find out the manufacturer of generics that work for you (usually the name of the company or an abbreviation will be on the bottle)and make sure you receive it next time. Good luck!

  3. TJ
    Reply

    I wasn’t aware of this mess until I got a bad script of my ADHD medicine from Actavis. I suffered muscle pain so severe, I was bed ridden and couldn’t hold my son. I had headaches and nausea depression, and fell asleep on the medicine. It was awful and I was just furious.
    I highly doubt the prescription had any active ingredients. I felt better as soon as I stopped taking the drug which is how I realized it was the meds and not something I caught. Got the script changed but the new medicine is bad too. I won’t be taking this again unless I can count on quality. I’m so happy that I’m not sick like I was….terrible experience.

  4. MW
    Reply

    Here’s the solution. If a drug is found to be non bio-equivalent by the FDA, then for the remainder of the company’s existence, they must submit a sample of each drug batch (weekly) to independent testing to a facility of the FDA’s choosing, at the company’s expense, to prove that the drug is bio-equivalent. If a second batch of that drug or another drug the company makes is found to be non bio-equivalent, then all drugs that the company and its subsidiaries/parent company manufactures that are sold in the United States must undergo this weekly testing at their expense.
    If the company is bought, or sold or transferred out of bankruptcy, that requirement flows to the purchasing/new company.
    That will fix the problem.
    But of course, the government isn’t really interested in cracking down on cheap generics, is it?

  5. md
    Reply

    Some years ago,I was prescribed Effexor XL 75 mg. daily for anxiety and mild depression, and took the brand name drug with good results. Two years ago, I again was prescribed Effexor and had good results, even though this prescription was for the generic drug. In March, I refilled my prescription and within two or three weeks, felt very depressed, anxious, and teary. I checked with the drugstore that had filled my prescription (as well as all my past prescriptions). I found out that their supplier had changed since the drugstore chain was bought by another well-known drugstore chain. Many of their generics were now made by different manufacturers. This had caused them to switch me from the generic Effexor made by Aurobindo to one made by Zydus.
    I also found out that some drugs made by Zydus have been banned in the U.S. due to possible underdosing. I got a new prescription, fought with the insurance company for refilling my prescription too early, and switched pharmacies to one that could give me Aurobindo’s generic. Now I am back on an even keel. My husband and I have since switched all our generic prescriptions from the original pharmacy, after finding more instances of their new supplier having generics from companies, some in India, with complaints about their quality.

  6. mb
    Reply

    A reputable Pharmacy will have the following on each and every prescription label-name of drug (manufacturer) color of drug if caps or tab-will tell what it is generic for if generic-also auxiliary labels
    to advise how to be taken-with-without food-plenty of water etc-and if a mfg is changed upon refill (due to various reasons) the new color and the new mfg.
    Also take the time to read the literature given with each med and don’t be afraid to question the pharmacist-even if you have to wait a few minutes-most reputable pharmacies have private consultation areas-if you don’t like the manufacturer ask for another brand that your ins will pay for.

  7. mb
    Reply

    try natural sleep inducers such as valerian-melatonin-get the Tv out of your bedroom (too much excitement at bedtime) try some hops-chamomile-all these have no adverse effects and develop a routine for getting to bed-be repetitious!

  8. Don
    Reply

    It may be impractical, but I would like to see a legal requirement that all generic-advocating lobbyists, legislators, insurance executives, etc. be legally required to take only foreign-manufactured generic drugs (that are sole in the U.S.). Country of manufacture and manufacture’s name to be randomly selected, not their choice.

  9. CN
    Reply

    I have used the birth control Yasmin for nearly a decade, with no noticeable side effects at any point. The price increased slowly over time, until about 2010 when it skyrocketed, at which point my insurer had the pharmacy dispense the generic equivalent. However, within just a few months I began to notice weight gain, as well as mild depression. I demanded a switch back, explaining my plight to the pharmacist each time the generic was suggested, and within just a couple of months felt back to my old self.

  10. c t
    Reply

    I started a new generic for Lipitor 5,5 months. Four months ago I came down with diarrhea. I switched brands … manufactures, and we’ll see what happens. Anybody else having this problem?

  11. J.
    Reply

    I used to take 25 mg of Cozaar (losartan) for hypertension. Even though my bp was really high, this low dose worked. For insurance reasons I switched to generic. At 50 mg, not only did it not work, but seemed to make my bp higher. For 3 years, Dr. did not believe I was taking med. I had a small brain bleed last year attributed to bp spikes. Finally went to a different doctor and went back on brand (although a different ARB), lowest dose. Working very well. Stay away from losartan made by Lupin and/or Zygenetics. Both made in India. I reported to FDA Medwatch.

  12. ab
    Reply

    20+ years in the industry convinced me the FDA is powerless, having been sold lock, stock and barrel to the pharmaceutical industry. Our legislators are also well represented in the industry, as are many of their family members. The pharmaceutical industry is interested in one thing only, market share and the resulting obscene profits that generates. PATIENT BEWARE is an understatement.
    I have absolutely no faith in the “integrity” of the FDA, with the exception of my respect for Dr. David Graham.
    Things are only going to get worse.

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