bottles of medications with warning stickers and information

Sun Pharmaceutical Industries is India’s largest drug manufacturer. It supplies many generic medications to the U.S. market. But the giant is once again in trouble with US regulators.

FDA Warning to Sun Pharmaceutical:

The Food and Drug Administration has issued another warning letter to the company because one of its major manufacturing plants has fallen short on quality control. The problems the FDA noted in its most recent communication are very similar to those named in a letter sent earlier this year.

Sun Pharmaceutical purchased another large Indian generic drug maker, Ranbaxy, which also ran afoul of FDA on quality control problems. Ranbaxy agreed to pay $500 million in fines in May 2013 after pleading guilty to making false statements and violating drug safety laws.

More Trouble in India:

Another Indian generic drug manufacturer, Dr. Reddy’s Laboratories, has also been the target of FDA scrutiny. The company received a warning letter last month because of quality control problems, especially data integrity.

Indian drug makers provide at least 40 percent of the generic drugs Americans take each year. This is not the first time we have written about trouble with poor quality control in certain Indian manufacturing plants. You can read more here and here.

The FDA and Foreign-Made Drugs:

The message we hear repeatedly from the FDA about generic drugs is that the agency has everything under control and there is nothing to worry about. Nevertheless, we keep reading about violations in India and other countries. Unfortunately, the FDA rarely reveals which medications have been affected.

There is no “country of origin” label on your prescription bottle so you have no way of knowing whether your medicine was made in China, Thailand, Brazil or West Virginia. And you have no way of knowing if the pills you are taking for high blood pressure, depression, cholesterol control or acid reflux were made in a top-notch pharmaceutical company with excellent quality control or a facility where cleanliness is not such a high priority and workers fudge data.

We all want affordable medicine but we also want an absolute guarantee that our pills are made under proper conditions and will perform exactly as the brand name medicine. The latest trouble in India does not instill confidence that such is the case.

Stories from Readers:

Leo, a pharmacist with years of experience:

“I am a registered pharmacist and have worked in the generic and brand pharmaceutical industry for 31 years. I guess the rules for drug integrity have changed. I am presently working in a chain pharmacy and have seen drugs on the shelves coming from all over the world; why, because they are cheap and that’s what we want in this country. I have drugs from: Island of Malta, Slovenia, Croatia, India, China, Taiwan and Poland just to name a few.

“It is a joke to believe that the FDA has been to these countries to truly perform inspections of the manufacturing plants.

“Pharmaceutical companies moved production to India, China and other countries because of economic reasons due to the fact that there is no EPA or OSHA, and minimal, if any, oversight from any government regulatory group.

“If supermarkets are required to label fish, poultry, and meat as to country of origin, then prescription labels should also be required. This may help make the public aware of what is actually going on. The FDA is under-staffed, overloaded and short on cash to do an effective job.”

This comes from a patient in New Mexico:

“I used Coreg for 15 years for blood pressure control and my heart condition and loved it. I was put on carvedilol because Medicaid would not pay for Coreg. The generic instantly proved it didn’t work. I’ve complained for a year. 

“My insurance company has refused to agree with my doctgor to give me back brand name Coreg. Today. I’ve been told to try at least one more generic for Coreg. There’s not another generic just another distributor. The generics come from India.

“Tomorrow starts a new generic. Hopefully the bad results show quickly and I can demand that I get my Coreg back. These insurance companies are slick.”

Eileen in Missouri:

“Wellbutrin XL 300 mg – was switched to the generic bupropion – horrible reactions. Insurance would no longer pay for the brand name.

“Fortunately I found a reputable, licensed Canadian pharmacy – need a prescription just like in the U.S. – and now I am getting 90 brand name tablets for way less than $200 which for me is a 3 month supply. It would be way over $1,000 if I had to pay out of pocket at a U. S. pharmacy. This pharmacy has been reliable and it is the same Brand name as I would get in the U. S.”

How sad it is that Americans have to buy brand name products from Canada to save money because they cannot rely on generic drugs imported from India and other countries.

Share your own experience and thoughts below in the comment section and please vote on this article at the top of the page.

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  1. joy
    Reply

    To the last commentor, how do you get around the “substitution permissible” signature the doctors always sign with, or worse yet, always electronically send? They choose generic for you (and which brand) and you can not demand otherwise. And often the ins. demands generic, even if the doctor doesn’t want it.

  2. Brian
    Philadelphia, PA
    Reply

    I continue to read about all of the warning letters that are sent repeatedly to the same pharmaceutical companies, most located in India. I would like to pose a question to Mr. Gradeon: just how many cGMP or other violation(s), must it take for the FDA to at least attempt to either shut these companies down or forbid them to manufacture these inferior medications? I’m aware that the FDA has cited several violations for the same company, yet they refuse to cooperate. How much will it take for the agency to actually enact a punishment?

  3. merna
    Qualicum Beach Canada
    Reply

    I am interested in Zopiclone I have been taking one 7.5 mg for years When it was changed to a generic it didn’t work anymore unless I take 2 but my GP says, No way!
    I have now been prescribed Trazadone 50 mgs which is supposed to help me get off the Zopiclone Egads…………………. Everyone that I know are addicted Any suggestions would be appreciated

  4. Lynn
    California
    Reply

    Hi, I noticed a comment made by Eileen in Missouri about a reputable pharmacy in Canada. Is it possible to find out the name of the pharmacy? I was going to try the Success program but not sure about it. I am on Medicare and have the prescription insurance also.
    This month I went to fill my Wellbutrin and the cost was $580.00.
    I would love to find a reputable pharmacy but don’t know how to find one. I filled the generic brand Par, but have only been on it a few days. I was one of the patients in the original complaint, had a horrible reaction to the generic Wellbutrin at that time .
    Hope someone will have a suggestion.
    Thanks for your time
    Lynn

  5. Jo
    Florida
    Reply

    I’ve been taking metformin for years. Seems to be working and no side effects. I started having horrible gastro problems and my blood sugar started creeping up. After a couple of weeks I started feeling like I had an electric current under my skin. I realized that all this started when I got my new rx for metformin. Called the mail order supplier and they said same manufacturer, aurobindo, but a different lot number. I had the rx transferred to my local pharmacy with a different manufacturer. My blood sugar has gone down to the fasting norm of 120 from 187 and weirdly my blood pressure went back to normal from a high of 193/111. My gastro problems for the most part have cleared up. I know that metformin should not have that strong of an effect, but this seemed to making me sick instead of just not correcting a problem.

  6. Bonnie
    NC
    Reply

    I believe that this is why I have had so many drug reactions & allergies because of cheap fillers in these generic drugs. There is no way that these drugs are being properly monitored as there is no way to do it efficiently and effectively.
    We must do something to be able to afford the brand name drug without serious high costs and our having to go to Canada to order online.

    • Terry Graedon
      Reply

      We would argue that if the generic drugs were truly high-quality and well-monitored, that would solve the problem. That is what the FDA thinks it is already doing.

  7. Arnaldo
    Puerto Rico
    Reply

    The big problem is that everybody in the US government know about this situation, but no body take action.

  8. Ruth
    Carrboro, NC
    Reply

    I have Parkinson’s Disease and was prescribed Sinemet ER which is supposed to extend the “on” time to 6 hrs. The first generic extended my “on” time from 2 hrs for the immediate release Sinemit to about 4 to 4.5 hrs. Then at the beginning of 2015 my pharmacy changed suppliers and my “on” time decreased. That prompted me to weigh the tablets I had received they came in at 300 mg for a tablet that was supposed to contain 250 mg of drug.

    I explained this to my neurologist and she prescribed the brand name Sinemet ER as a result I have 5-6 hrs of “on” time. The first thing I did when I got the brand named Sinemet ER was to weigh them. They weighed 500 mg !!!!! My insurance won’t cover the brand named drug so it costs me an extra $100/month. I complained to the supplier of the generic and filled out the FDA forms but no help so far.

  9. Carla
    NE Ohio
    Reply

    I take only one prescription medication and have been buying it in Canada. At first, it was made in the U.K. Now, the medication sent to me from Canada is made in India. We really cannot win in this age of the multi-national corporations running everything.

  10. Eileen M.
    Kirkwood, MO
    Reply

    As a follow-up to my previous comment about the Wellbutrin XL 300 mg (comment above), I recently did a price check and was horrified to find the price is no longer the $1,000 I previously stated which used to be correct. The new price in the St Louis, MO area is now approximately $4,000 for 90 tablets. Yes, that’s correct. You can feel to check it. I’m not sure when those prices went into effect since it was awhile since I last checked but I couldn’t believe it. At my pharmacy in Canada the price has actually DROPPED slightly from the price I last quoted you.

  11. Jeffrey
    MAssachusetts
    Reply

    There are several different ways to avoid generic drugs from less-than-best practice countries. There are often alternative versions available from the U.S., Western Europe, Canada and Israel. You have but to request one of those from your pharmacist. Also, the FDA’s web site lists what are termed “authorized generics”, made by the original manufacturer of the drug. Again, you can request one of these be substituted. Not every drug has an authorized version, but many commonly used ones do.

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