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India's Risk-Based Inspection Plan: Well Begun?

Executive Summary

India's Central Drugs Standard Control Organization (CDSCO) is taking definitive steps to strengthen the regulatory regime and enforcement, including across areas such as data integrity, in the backdrop of industry's patchy manufacturing compliance story. The regulator has developed risk-based inspection criteria for manufacturing sites, backed by a comprehensive draft checklist and evaluation tool but the real test may lie in resolute implementation.

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