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Medicines Made in India May Not be Safe According to FDA

Medicines Made in India May Not be Safe According to FDA

Medicines Made in India May Not be Safe According to FDA

Medicines Made in India May Not be Safe According to FDA
Image by Benevere Pharmacy

India is coming under scrutiny by U.S. regulators due to potential safety lapses, falsified drug tests, and the selling of fake medications.  India is the second largest exporter of over the counter and prescription drugs, supplying approximately 40 percent of over the counter and prescription drugs in the U.S.

Dr. Margaret Hamburg arrived in India this week due to growing unease with “recent lapses in quality at a handful of pharmaceutical firms.”

The FDA recently de-certified one of the most recent approved factories operated by one of India’s largest drug producer.  They are also banning the sales of many drugs that do not meet U.S. standards.  This mostly applies to some generic copies of brand name drugs.

During Dr. Hamburg’s visit, Indian business leaders brought up the long approval period for new drugs about which Dr. Hamburg stated, “I told them that every company supplying the U.S. market has the responsibility of ensuring that their products are safe, effective and of high-quality. In my talks with regulators and companies here in India I have placed a great deal of emphasis on why quality matters. As I explained, quality is linked to product safety and without a direct focus on quality, the potential for patient harm increases significantly.”

FDA investigators are scrutinizing Indian drug plants utilizing some of the estimated $300 million in annual fees collected as a part of the law requiring the supervision of plants that are located overseas.

The FDA inspected 160 plants last year, roughly three times as many as in 2009.

“If I have to follow U.S. standards in inspecting facilities supplying to the Indian market, we will have to shut almost all of those,” stated ,” G. N. Singh, India’s top drug regulator.

Medicines Made in India May Not be Safe According to FDA.


About Katana Sohma

  • KS Subramanian

    Except the cheap intellectual labor force nothing made in India is, it seems, is good

  • Rual Abrero

    What is being done to inform the public? Which drugs? Are recalls in effect? How would anyone know if they are a using these bad drug?

  • 1FredsGirl1

    Why are we still importing any drugs from India if this is the attitude of their regulators.

    • mayreau

      Where do you think your $4 prescription at WalMart comes from? Do you really think someone can give you a quality product, dispense it, stock it, wait for reimbursement, etc. for $4???? Its all about what is cheapest.

  • Govi

    The FDA is a political body. It has approved unsafe drugs in USA and has stopped effective drugs because they were invented abroad. The FDA has not given one instance of a drug made in India having harmed anyone except due to error in usage. However, drugs made in USA ( especially for dispensing pharmacies with FDA approval) have killed and maimed people. .In 2005,the head of the FDA was a veterinarian! How trustworthy is the organization?

    • Samsroid

      You see things clearly. I wish there were more people like you out there…. not blinded by the media/lobbyist.

    • Annette Greco

      I don’t think this is trustworthy at all. It’s entirely political and part of a really negative series of moves that the U.S. has taken against India diplomatically and in other ways in recent months. On January 31, the U.S. downgraded India’s aviation safety ranking, making it more difficult for India to fly in the U.S. Then there’s the strip-searching and jailing of the Indian diplomat, Deyvani Khobragade, for allegedly slave-trading her maid by underpaying her. Now there’s this inexplicable new concern about Indian pharmaceuticals.
      The U.S. has really singled India out for some harsh and negative treatment lately. I’m concerned that India may start realigning with the East if we keep up this one-sided negative pattern of behavior.
      We’ve alienated many of our closest allies in recent months since Hillary Clinton left as Secretary of State, with Angele Merkel verbally berating Obama in public as one striking example. Lately, the strikingly shallow and incompetent crop of ambassadors and foreign diplomats that Obama has appointed recently has made the headlines, with one prospective appointee already creating a diplomatic crisis by insulting Norwegian politicians.
      Rather than reversing the decline of U.S. foreign standing abroad, this Administration seems bent on accelerating it. Is pattern of alienating allies intentional?

      • LiberalGilt

        It all comes down to this: Obama doesnt want to see anyone make money

  • mikalg .

    $300 millions seems like a low number for 40% of US OTC market. My understanding is that the FDA is under staffed, and under funded. Large amounts of products imported into the US that are regulated by the FDA go unchecked as a result. 160 plants were inspected (in India, or worldwide?) $300 million Nation wide, or paid by Indian firms? Seems to me the FDA and the writer of this story are lax in reporting important information to the public. Personally, I would think that all firms should pay for inspections by US FDA staff at their facility, and products received into the US on a regular basis. This would be for all products sold in the US regulated by the FDA. Under staffed and/or under funded does not have to be the case. I would expect a postal service model whereby all costs are recovered, no tax dollars are used, and everything is inspected. Failure to do so, means this situation continues. Do we really need products produced by anyone/anywhere that does not meet these standards? Would that not also equalize the playing field for US companies competing against potential inferior products worldwide? I will pay more for a product I know is safe, and works as intended. What is the other choice?

  • mayreau

    I’m a US pharmacist. I’ve know about this problem for about 10 years. I first noticed it in my practice and reported it to the FDA and my employer, to no avail. I did my best to obtain drugs that I felt confident about but this became increasingly problematic because so many drugs both brand and generic were sourced in India, China and eastern Europe. All were suspect.
    People everywhere should have confidence that the food they eat and the drugs they take, are pure, safe and meet quality standards. This is not the case of imported drugs and the importation should cease immediately. No one has any true idea about the untold consequences of taking adultrated, subpotent or fake drugs. This is a nation emergency and should be treated as such.

  • MaconSouthernGent

    The FDA needs to keep watch on domestic factories too. They say the generic drugs are as good as name brand and that may have been true at one time, but I will refuse RX drugs from a couple of companies because they aren’t as effective as other generic brands of the same med.

  • Samsroid

    BS! You just don’t want India to cut into the pharmaceutical piece of the pie in the US. Everyone knows that the Health Industry in the US is designed to keep/make people sick…. Big Business!

  • larry

    to begin with Ranbaxy sold antibiotics in the US that are unsafe. I was one of those people who got sick from them. If you have lived in India you know how low their standards are and how corrupt every aspect of indian society is. Any dealings you have with business people there are always tinged with corruption and bribery. Do you really want drugs from there to come here? Any time you make generalizations you come up short however if you know how badly US drugmakers screw up then you know how much worse they are in 3rd world countries. Indians are very sensitive about this but most of them want to come here and work.. something they wont allow american citizens to do. India will never be a first world country unless it can deal with the dual evils of caste and corruption. Its a shame too because its a really wonderful country with a long and illustrious history which was at its best during the Mughal period when muslims and hindus worked together to create a great and civilized empire.

    • mayreau

      Ranbaxy amoxicillin was the first one that I became aware of in my practice. Total junk!

      • Govi

        I have taken Ranbaxy Amoxicillin and it worked fine.

  • Johnny Ayoub

    I agree with Rual, when are they going to tell us which drugs are bad.. The country of origin should be printed on the labels.

    • mayreau

      Absolutely !!

  • LiberalGilt

    India makes great little blue pills for a buck a pop.