Contaminated prescription drugs from China in U.S. medicine cabinets

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contaminated-drugs(NaturalHealth365) China is a major supplier of the active ingredients found in many of the prescription drugs that Americans use on a daily basis. However, it has come to light that some of these drug components aren’t being properly tested for safety, contamination or dosage effects. Big pharma saves quite a bit of money by outsourcing to China, but the pharmaceutical industry doesn’t seem particularly motivated to hold Chinese companies to a high standard.

The U.S. Food and Drug Administration (FDA) has recently been forced to send a warning letter to the Shanghai company Tai Heng due to their systemic manipulation of key data and information. This fraudulent behavior has raised questions about the safety and quality of all Chinese products related to the pharmaceutical industry.

Chinese companies caught falsifying safety and quality records for prescription drugs

During a 2015 inspection of the Tai Heng plant, FDA inspectors uncovered processes that involved samples being routinely retested after failing to get acceptable results until such results were obtained. The drug quality failures were also never investigated to determine cause. After retesting, analysts would then manipulate the results shown in their computer systems. Operators also created “mock” sheets to current batch records look acceptable, according to the FDA warning letter.

The Tai Heng company promised to have a third party perform an audit of its systems. However, the FDA letter called for a total investigation into the data manipulation and its effects on finished prescription drugs these components may have ended up in. The Tai Heng company was also asked to determine why the drug quality failure readings occurred and address the issues instead of covering them up.

Blood thinner Heparin made with tainted Chinese components caused hundreds of deaths

Batches of the blood thinner Heparin made with tainted, unauthorized Chinese ingredients could currently be on the U.S. market. The FDA is being criticized for not moving quickly enough to prevent hundreds of deaths linked to tainted batches of the prescription drug. A congressional probe is now taking place nearly a decade after many of these deaths occurred.

It is suspected that Chinese manufacturers are using sheep and cow intestines as a Heparin raw material, when only pig intestinal membranes are safe for use. In the past, the Chinese were also suspected of including a deadly chemical in the manufacturing process. A recent letter sent to the FDA by the House Energy and Commerce Committee confirms the FDA had known about these risky practices since around 2007.

Alarming gaps still remain in Chinese drug manufacturing and safety standards

Testing guidelines for pharmaceutical companies were not enacted until 2012. However, many exemptions and loopholes still remain that allow Chinese companies in the prescription drug supply chain of big pharma to operate outside scrutiny.

The pharmaceutical industry receives affordable drug components from these companies and seems to have a policy of “no questions asked”, as long as they are receiving what appear to be viable materials. These components then end up in big pharma production lines and in the prescription drugs so many Americans rely on.

The FDA and pharmaceutical industry need to step up and ensure that all materials used in manufacturing prescription drugs are safe and effective. At this time, the quality control systems used by Chinese companies are suspect.

The rest of the FDA warning letter to the Tai Heng company can be found here.

Meanwhile, Americans have even more reason to seek out natural cures instead of relying on prescription drugs from big pharma.

References:

http://www.bloomberg.com/news/articles/2015-10-28/fda-shows-up-a-man-runs-and-questions-emerge-on-china-s-drugs

http://www.bloomberg.com/news/articles/2016-03-30/tainted-drugs-may-still-be-in-u-s-almost-a-decade-after-deaths

http://www.fiercepharma.com/manufacturing/shanghai-api-maker-slapped-around-fda-warning-letter

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm501282.htm

http://blogs.fda.gov/fdavoice/index.php/2015/06/chinas-pharmaceutical-future-both-complex-and-growing

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  • :Linda G

    Also, American pharmaceutical companies are looking to expand their operations to China. This is a financial move not one intended to provide better health. This is purely marketing and sales. This is startling move on the part of drug companies. Remember the drug companies expansion comes first.

  • Illene

    What everyone has to remember it is not that easy to regulate Chinese manufacturing methods. Just about every American knows that. So, how are the Drug companies overlooking this fact?

  • Mike Finegold

    I don’t want to buy anything made in China. I am sure I do, because this fact is hidden from consumers. Of all things I don’t want is a prescriptive drug coming from China.

    • overit

      are you aware that around 2 yrs ago(last time I took notice) america had only ONE manufacturer making paracetamol?
      you call it acetominophen i gather…
      all the rest are china indian imported.

  • overit

    the UNfunny thing re the first Heparin batch that killed?
    the so called “inspection” of the premises was made BY a FDA rep
    who seemingly managed to tour and inspect AND pass the QA GMP and process of the plant in China
    later that manufacturer said they had NEVER made Heparin.
    so?
    how did an expensive approval BY the FDA manage to be done in the WRONG plant?
    someone paid for it- a LOT! approvals arent cheap
    the place that did make it was down the rd a fair way apparently.
    we are expected to believe that for the large sums involved in approvals… and the colossal ramifications that can and did follow… the FDA didnt have? or hire a educated in pharma -translator, if required- to vouchsafe and translate the serious matters in process?
    and adding to this is the amount of BRAND NAMES that companies products were relabelled BY/Under.
    its correct that the vast majority of the excipients(base ingredients) all come from either India or China..no matter who onprocesses and mixes and sticks their label on it later.
    and frankly it isnt ALL China or India to be held accountable
    the importers seem to NOT be running every batch tests ON the products before theyre mixed and pilled n packed
    reports of recalls due to an “off odour”
    were due to contaminated ingredients NOT being assessed prior BY the final manufacturing plants..some of which were in America or other EU UK etc makers.
    the pharmas buy and sell hire n fire entire plants globally at the drop of a fraction of a cent profit n loss..many plants are in Sth American countries for cheap labour..
    and these…are the same people telling us that small companies and compounding pharmacy products are dodgy unsafe and probably dont contain correct /pure ingredients?
    bloody Farcical really!!!
    when they source from same/similar sources…just that they add 100’s of times profit margin.

  • disqus_k3oycamN0W

    Vaccines are now manufactured in China too, and FDA is nor allowed to set foot in their factories. Not that hoax vaccines produced anywhere are worth using.