Contaminated Drugs, Shredded Papers: US FDA Uncovers Failures in India Pharma Factories

Bloomberg | May 31, 2023

US inspectors have in recent months uncovered wide-ranging lapses at factories run by some of India’s biggest pharmaceutical firms, as the world’s top supplier of cheap medicine faces increased scrutiny after a spate of deadly manufacturing incidents.

Dozens of drugmakers were issued notices and warning letters by the US Food and Drug Administration, which is increasing visits to Indian factories after the lifting of Covid-19 restrictions last year. Inspectors detailed unsanitary conditions in manufacturing plants and poorly trained staff; shredded paperwork and under-investigated customer complaints; and evidence of exporting contaminated drugs to the US.

The expansive lapses — detailed in FDA records obtained by Bloomberg News under the Freedom of Information Act — suggest that a nearly two-year hiatus in factory audits during the pandemic meant faults were missed in some Indian plants that export to the US. The South Asian nation is the largest supplier of generic drugs to the US and dozens of other countries. The $50 billion sector is under the spotlight after a number of recent scandals linked to smaller, privately-held Indian companies, including the deaths of dozens of children in Gambia and Uzbekistan from adulterated cough syrup, and supplying contaminated chemotherapy drugs to the US.

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2 Comments on Contaminated Drugs, Shredded Papers: US FDA Uncovers Failures in India Pharma Factories

  1. Great reason to source dietary supplements from countries that don’t have massive populations and massive problems with air and groundwater pollution, such as India and the PRC.

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