Health
Contaminated Drugs, Shredded Papers: US FDA Uncovers Failures in India Pharma Factories
- Cipla, Lupin and Sun Pharma among firms issued FDA notices
- Companies say they are addressing concerns from audits
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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.