Generic Drug Maker Ranbaxy Found Falsifying Data To FDA

The FDA has suspended all new drug applications from one of Ranbaxy’s plants in India—the Paonta Sahib plant—after “determining the facility was falsifying scientific data.” You may recall that last September the FDA banned the import of 30 popular generic meds made by Ranbaxy due in part to quality control issues from this very same plant. What do they think they are, a peanut butter factory?

So what type of data was falsified? Info regarding the shelf life of products, and data concerning production practices.

To be clear, it’s applications for new drugs that have been suspended. Nothing is being pulled off the market and there are no reports of anything bad happening to anyone.

“FDA Halts New Applications From Indian Drug Maker’s Plant” [U.S. News & World Report]

Comments

Edit Your Comment

  1. ptkdude says:

    Who knew Ranbaxy was a subsidiary of Peanut Corp of America and the Sheinhart Wig Company?

  2. FuryOfFirestorm says:

    Drug companies lying or falsifying claims to get product approval? Yeah, right! Next you’ll be telling me Enzyte won’t give me a bigger penis or that Xenadrine doesn’t let me lose weight without diet and exercise!

    • Murph1908 says:

      @FuryOfFirestorm:
      First of all, Enzyte and Xenadrine are ‘herbal suppliments’ that not governed by the FDA. Associating drug companies with those companies are like comparing doctors to voodoo priests.

      Second, yeah, those greedy drug companies are the debil! It would be better if we didn’t have pharmaceuticals at all!

    • Joewithay says:

      @FuryOfFirestorm: Your comment was not evaluated by the FDA

  3. lars2112 says:

    This is why I am against the importing of drugs, I know the FDA has its own issues but it is still better than what other countries like India and China have.

    • magic8ball says:

      @lars2112: OK, but what about countries like, say, Canada?

    • oneandone says:

      @lars2112: I don’t understand your reason for objecting to drug imports. The FDA discovered the falsification before the drugs were approved, and they were never imported. The system worked.

      Or is the fact that a foreign company attempted to get past regulations enough to make you frightened of all of them? Even though the company was caught and it seems like the safeguards in place were working?

  4. bohemian says:

    Manufacturers use foreign plants or foreign components is a-ok. Consumers buying foreign drugs is totally bad.

    I was rather disturbed to find out how many drugs are made in places like India and China and how many US manufacturers buy components overseas with only voluntary testing of the ingredients.

    I see US purchased drugs only slightly safer than ones purchased from other countries through a reliable source. Drugs from the EU and Canada are probably safer than ours in the US.

  5. RedwoodFlyer says:

    Hate to say it…but I TOLD YOU SO! Whenever there’s a post here about saving money by buying generic drugs because they’re 100% identical, someone defends that by claiming that there brother’s neighbor’s dog sitter’s boyfriend works for Pfizer and the only difference is the label the name brand guys decide to put on the bottle.

    If they work for you, then yes, by all means save money by buying generic… However, the different fillers and quality control used by generic companies can have a profound impact on how much medication is absorbed, and how quickly. There’s a reason that Generic Adderall costs $4/30, and the name brand costs about $97 – and it’s not just because Shire is pocketing the extra $93.

    • Anonymous says:

      @ComcastRedwoodFlyer:

      FAIL. Generic drugs are required to be bioequivalent to the brand (innovator) drug. This means that the generic drug delivers the same amount of its active ingredient in the same amount of time as the brand.

      http://www.fda.gov/opacom/factsheets/justthefacts/18generic.html

      And you save money with generics because there is no need to recoup costs of research & development or marketing.

      Sheesh. Take off your tin foil hat once in awhile.

    • parad0x360 says:

      @ComcastRedwoodFlyer: Actually they are pocketing the extra $93. You think its that expensive to make a pill? Yes you are paying for R&D but more often than not the company makes back their money in under a year.

      The reason they want to ban foreign drugs is because they dont have to follow US patent law and can in effect make the same drugs for cheaper. Sure some of the places may not be as “honest” as the very “honest” US drug companies but…every drug company has been caught lying about something in the last 15 years.

    • jaxbeachkid says:

      @ComcastRedwoodFlyer: actually redwood that is an incorrect statement. The FDA does evaluate the drug, and confirms that it is bio equavilant to the drug.

      What the issue with Ranbaxy is according to the FDA, is testing procedures, not wether or not the drug is safe or not. The FDA has said all along they cannot find products with the drugs, but since it appears that testing data was falsified that is why they have created the alert.