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.

  • @some_guy
    link
    69 months ago

    Seems like in 2019 there was a lot of energy / press about companies moving from China to India. The past year seems to suggest that India is unprepared to handle the load. I’ve seen articles like this one about manufacturing and I think another issue, but it’s early and I just woke up. Point being, we’re gonna rely on China for a bit longer than planned.

    Anyone know how it’s going elsewhere? The only other country I know of as a China-exit is Vietnam.