Schedule M

What it is?

• Schedule M is a section of the Drugs and Cosmetics Act, 1940, prescribing Good Manufacturing Practices (GMP) for pharmaceutical products in India.
• It defines the minimum requirements for facilities, equipment, quality systems, documentation, and personnel to ensure safe, effective, and consistent drug production.

Origin and Evolution:

• Origin: Introduced under the Drugs and Cosmetics Rules, 1945, to regulate drug manufacturing quality across India.
• Earlier Framework: Focused mainly on facility hygiene and record-keeping, with limited emphasis on process validation or data integrity.
• Recent Revision (2023–24): The revised Schedule M brings Indian GMP norms in alignment with WHO-GMP and PIC/S standards, strengthening India’s position as a global pharmaceutical hub.
• Implementation Deadline: All units must achieve compliance by December 31, 2025.

Key Features of Revised Schedule M:

1. Pharmaceutical Quality System (PQS): Mandatory adoption of a structured quality and risk management framework across all manufacturing stages.
2. Quality Risk Management (QRM): Identification and mitigation of product risks through scientific and evidence-based evaluation.
3. Data Integrity – ALCOA+ Principles: All records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.
4. Pharmacovigilance System: Compulsory reporting and tracking of adverse drug events to ensure post-market surveillance.
5. Equipment & Process Validation: Lifecycle-based validation (Design, Installation, Operation, Performance Qualification).
6. Supply Chain & Vendor Traceability: Complete raw material traceability with supplier audits and digital monitoring systems.
7. Infrastructure Modernisation: Requirement for computerised storage systems, controlled environments, and regular self-inspections.

About Diethylene Glycol (DEG):

• Definition
• • Diethylene Glycol (DEG) is a colorless, odorless, syrupy organic chemical compound (formula: C₄H₁₀O₃).
  • It is a synthetic industrial solvent, belonging to the glycol family, and is not approved for pharmaceutical or food use.
  • Chemically, DEG is a by-product of ethylene oxide hydrolysis, often used where water-miscible, low-volatility liquids are required.
• Applications:

• • Antifreeze and Coolants: Used as a de-icing and coolant agent in automobile and aircraft industries.
  • Paints and Plastics: Acts as a solvent in paints, plasticizers, resins, and polyurethane foams.
  • Brake Fluids and Lubricants: Used to maintain fluid stability in hydraulic and brake systems.
• Pharmaceutical contamination occurs when industrial-grade DEG is mistakenly or fraudulently substituted for pharmaceutical-grade glycerine or propylene glycol during drug formulation — often due to poor quality control or cost-cutting.