Article preview from "The Gold Sheet" January 6, 2009
Read about why a profound identity crisis has rocked the pharmaceutical industry after someone in China oversulfated cheap chondroitin sulfate and substituted it for real heparin sodium API starting materials.
Article preview from "The Gold Sheet" January 6, 2009
A profound identity crisis has rocked the pharmaceutical industry after someone in China oversulfated cheap chondroitin sulfate and substituted it for real heparin sodium API starting materials.
By law, manufacturers must test every lot of a drug product to confirm the active ingredient’s identity before putting it on the U.S. market.
But even though it was present in concentrations as high as 27 percent, the heparin adulterant easily fooled the required compendial tests.
Tragically, FDA found that in the first five months of this year, 146 U.S. patients treated with heparin sodium suffered hypotension or allergies – adverse events the adulterant could have caused – and later died. There were only three such deaths in 2007, as in the year before.
The heparin case raised the specter of a new type of threat facing the globalized pharmaceutical industry, coming as it did in the context of similar incidents involving adulteration of glycerin in over-the-counter medicines with diethylene glycol, and of pet food and infant formula with melamine and related industrial chemicals.
Although laws for ensuring drug quality bristle with measures added in response to a series of crises over the years, they never have addressed cases like these, where it appears suppliers secretly substituted indistinguishable cheaper ingredients for economic gain, regardless of the health consequences.
Victimized by this new form of identity theft, the industry and those who regulate it and set standards for it are struggling to prevent a recurrence.
Notably, they are reviewing standard identity tests in a new light. Most of these tests date from an era when such a fraud would have been unthinkable because operations were concentrated at the end product manufacturer’s site rather than scattered among suppliers around the world.
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