Science & TechnologyImportant2025-11-07

CDSCO Mandates Immediate Schedule M Inspections

Q: 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.

C. Both 1 and 2 — Both statements are correct. The revised Schedule M aligns Indian pharmaceutical manufacturing with global WHO-GMP standards and strictly enforces data integrity through ALCOA+ principles.

In News

What Happened

On November 7, 2025, the Central Drugs Standard Control Organisation (CDSCO) directed State Licensing Authorities to immediately initiate inspections of pharmaceutical manufacturing firms. The inspections enforce compliance with the revised Schedule M norms, which mandate Good Manufacturing Practices (GMP) equivalent to WHO standards. The directive included strict regulatory action against MSMEs failing to meet their revised compliance deadlines.

Why It Matters

The mandate is critical for safeguarding patient health by eliminating substandard drugs from the domestic market. It also protects India's reputation and export economy as the 'Pharmacy of the World' by ensuring global trust in Indian pharmaceuticals.

Background

History & Context

Schedule M of the Drugs and Cosmetics Rules, 1945, originally laid down basic manufacturing norms for the pharmaceutical industry. In December 2023, the Union Health Ministry notified a comprehensively revised Schedule M to bridge the gap between Indian regulations and global WHO-GMP and PIC/S standards. While large manufacturers were required to comply by mid-2024, MSMEs were granted extensions into late 2025, culminating in this stringent inspection drive.

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

This connects to Class 12 Chemistry, Chapter 16: 'Chemistry in Everyday Life', which discusses the therapeutic action of different classes of drugs. The therapeutic efficacy and safety of these chemical agents depend entirely on rigorous Good Manufacturing Practices (GMP) during large-scale production, which CDSCO regulates via Schedule M.

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.

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