What Is Schedule M Norms?
The Union Health Ministry has directed strict enforcement of the revised Schedule M norms under the Drugs and Cosmetics Act, 1940.
- The move follows reports of child deaths linked to a cough syrup adulterated with diethylene glycol (DEG), highlighting serious lapses in manufacturing quality.
- 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.
Features of Revised Schedule M:
- Mandatory adoption of a structured quality and risk management framework across all manufacturing stages.
- Identification and mitigation of product risks through scientific and evidence-based evaluation.
- ALCOA+ Principles: All records must be Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.
- Compulsory reporting and tracking of adverse drug events to ensure post-market surveillance.
- Lifecycle-based validation (Design, Installation, Operation, Performance Qualification).
- Complete raw material traceability with supplier audits and digital monitoring systems.
- Requirement for computerised storage systems, controlled environments, and regular self-inspections.
Diethylene Glycol (DEG):
- 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.
