Confronting Illusions of Quality in Indian Generics Manufacturing

A sharp increase in data integrity findings has raised questions about the quality of pharmaceutical manufacturing in India. What’s happening and why, who’s responsible, and how can drug makers and the regulatory agencies that watch over them put a stop to it?

The issue of poor data integrity in India, which surfaced nine years ago at several Ranbaxy facilities, now appears increasingly pervasive and intractable.

As FDA and European authorities get better at identifying and responding to this problem, they remain so far unable to strike at the root cause.

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