Links and Files

• Quality and Compliance in the Pharmaceutical Industry: Navigating a Transformed Landscape

Authors

• Partha Anbil, Prashant Deshpande, and Partha Khot, Coforge Limited

Abstract

• Generic drugs produced in non-advanced economies exhibit substantially higher serious recall rates, reflecting reverse-engineering limitations and market incentives that underfund quality differentiation.
• Recent cGMP breakdowns and rising FDA warning letters underscore heightened enforcement, with recall-associated sites heavily concentrated in the US and India.

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Journal

Pharmaceutical Commerce

Type of publication

Magazine

Classification Areas

• Regulatory