India pharma quality lapses force U.S. to look to China for vital drugs (asia.nikkei.com)

submitted 2 years ago by Stamau123@lemmy.world to c/news@lemmy.world

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In the final weeks of 2022, a small team of inspectors from the U.S. Food and Drug Administration were far from home, investigating a pharmaceutical factory in western India.

Indian drugmaker Intas was making cancer drugs for the United States at the plant where, in a trash bin, inspectors found documents doused in acetic acid. More papers with manufacturing and drug testing data were shredded and tucked away in plastic bags under a stairwell, indicating that Intas executives had manipulated data and tried to cover it up.

Six months later, the FDA called the drugs adulterated and halted imports from the plant, contributing to a severe shortage of life-saving cancer drugs in the United States.

U.S. physicians say the cancer drug shortage could lead to thousands of deaths. The crisis has compelled Washington to turn to China despite broader efforts at reducing its reliance on the nation. China’s Qilu Pharmaceutical has been called in to make up for the shortfall.

India’s lax regulatory oversight, analog practices where things should be digitized, and data integrity issues have far-reaching consequences that include hundreds of children dying from contaminated cough syrups across the world, and the potential to reshape geopolitical dynamics in the global drug trade.

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[-] Corkyskog@sh.itjust.works 6 points 2 years ago

Good point. Americans are conditioned to think all Chinese stuff is cheap crap, when in reality it's because we moved manufacturing over there so we could make cheap crap. It's not that they can't make quality, we're just not paying for quality.

this post was submitted on 23 Mar 2024

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