Category:

Risk Management

New FDA warning letters show Indian drug makers’ quality concerns persist

The latest regulatory crackdown shows US regulator’s stance is hardening toward lapses in quality control even as it seeks cheaper drugs to contain health care costs. Indian pharmaceutical factories collectively produce about 40 per cent of the American generic drug supply and have been faulted in the past by the FDA for everything from lax documentation to open toilet drains and malfunctioning equipment.

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