Drug shortages for cancer patients could worsen due to quality control issues


The following is from Becker’s Hospital Review.

FDA investigators discovered more quality issues at an Intas Pharmaceuticals factory in Ahmedabad, India, which halted some production after a November inspection found a truck full of shredded documents, Bloomberg reported June 15. 

In May, the FDA inspected the facility and investigators said they could not ensure the “safety, efficacy, purity and overall quality of drug products manufactured” at the site, according to a 30-page report obtained by Bloomberg

Some drug supply experts have pointed to the site’s shutdown in November as a cause of the shortages of cisplatin and carboplatin, two cancer drugs that have seen low supply for months.

Intas produced about 20 percent of the nation’s supply of carboplatin, according to The Wall Street Journal

The latest report could spur worsened drug shortages, Bloomberg reported, because the May visit found employees altering recorded data that did not meet U.S. standards for particles, such as black specks, fiber and glass, found in injectable drugs. The FDA also recorded evidence of Intas employees disregarding three years’ worth of more than 1,000 “spore-forming organisms.”

On June 1, the FDA instituted an import ban on all but 25 of Intas’ drugs made at its three India-based facilities, according to agency documents.

The products excluded from the import ban include multiple cancer drugs in shortage, including cisplatin, carboplatin, fluorouracil and docetaxel. 

The drugmaker also has not verified its quality test procedures for more than 100 of its drugs. Intas did not respond to Bloomberg‘s requests for comment.  

Link to article here.

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7 thoughts on “Drug shortages for cancer patients could worsen due to quality control issues”

  1. it is high time we stop treatments and start healing! there are therapies available for years that can heal cancers, not just treat them. Budwig, Moerman, and probably several others, had a high success rate (I think Budwig something like 75%) but forbidden in the US unless you also do the cut, burn and poison treatment, because that is where the money is

    1. INGRID C DURDEN,

      Re : “. . . there are [[ other ]] therapies available . . . “

      This isn’t medical advice, but
      my experience with a tumor :
      1 ) two pieces of Ezekiel Flax-
      seed bread toasted ( found
      in freezer section of store );
      2 ) generously slathered with
      REAL AMISH butter—then,
      3 ) use 1 tablespoon ( or more )
      of unsugared habanero sauce
      on each piece (( keep water
      handy ! ! ! )).

      Got the idea online—from a guy
      who cured his prostate cancer
      doing that ( still there ).

      I used the above recipe twice/
      day—for three weeks. Tumor
      got smaller and smaller each
      week.

      Why does Cayenne Pepper
      fight cancer cells ?

      A L K A L I N I T Y !, as it’s
      about 12 pH to 14 pH.

      Cancer thrives in an acidic body,
      and LOVES sugar :

      Stop eating table sugar,
      without any exception—
      NO cake / NO ice cream /
      NO candy.

      Hot Peppers Fight Cancer Cells :
      https://www.naturalnews.com/2017-01-11-the-spicy-active-ingredient-in-chilies-found-to-kill-off-cancer-cells.html

      -Rick

  2. This article ? You would be surprised in life when somebody makes phone calls or gets a hold of a supplier to create shortages to create supply and demand Inflations ? Other Chem. Mol. examples; I watched a program a year and a half ago on PBS and Chemist on program say they have had New computer software and labs now that can create synthetic chemicals and compounds to almost anything now ?

  3. My earlier post more insight when producing synthetic replacement compounds make sure you treat with ultra- violet light to ensure non- Contamination ? Just don’t use my chemical formulas I spent a Year and a Half on for New Cancer drugs. I reported and Documented with the Federal Trade Commission after I found out Beaves and Butt Head the giggling hackers in background of my computer was trying to steal along with New Antibiotic Formulas ..Those Criminal giggling Jerks ?

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