CDSCO Mandates Immediate Schedule M Inspections
In News
What Happened
Why It Matters
Background
History & Context
What Changed
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Quality Risk Management: BEFORE, risk management was not explicitly defined in the rules; NOW, a formal, mandatory Quality Risk Management (QRM) framework is required.
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Data Integrity: BEFORE, standard paper-based record keeping was sufficient; NOW, strict digital data integrity rules based on ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate) are enforced.
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Supply Chain Traceability: BEFORE, active pharmaceutical ingredient (API) tracking had limited regulatory oversight; NOW, full supply chain traceability and vendor qualification are compulsory.
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Product Review Systems: BEFORE, periodic checklist-based batch testing was standard; NOW, comprehensive Product Quality Reviews (PQR) and system-based GMP demonstrations are mandatory.
Prelims Angle
NCERT Connection
Practice Questions
Q1
Correct Statement(s)Which of the following statements is/are correct regarding the Revised Schedule M of the Drugs and Cosmetics Rules, 1945? 1. It aims to align India's Good Manufacturing Practices (GMP) with World Health Organization (WHO) and PIC/S standards. 2. It introduces mandatory data integrity protocols based on ALCOA+ principles.