Schedule M Norms

News: 18 States use the Online National Drugs Licensing System (ONDLS), but none has fully met the Corrective and Preventive Action (CAPA) requirements under the revised Schedule M norms.

About Schedule M Norms

• Schedule M prescribes Good Manufacturing Practices (GMPs) to ensure medicines are safe, effective, and of consistent quality.
• Legality: It is a key part of the Drugs and Cosmetics Act, 1940 (and Rules, 1945).
• Origin: It was first established in 2001.
• Recent revision (2023–2024): The revised Schedule M updates India’s Good Manufacturing Practices (GMP) for pharmaceutical products and mandates stronger, system-based quality controls.
• Compliance deadline: Manufacturers must achieve full compliance with these revisions by December 31, 2025.
• Scope: Applies to all pharmaceutical manufacturing units in India for both domestic and export markets.
• Key features of revised Schedule
  • It mandates stronger quality systems, including a Pharmaceutical Quality System (PQS), Quality Risk Management (QRM), and Product Quality Review (PQR) to ensure consistent product quality.
  • It requires qualification and validation of equipment so that manufacturing processes remain reliable and controlled.
  • It asks manufacturers to set up computerised storage systems for all drug products to improve control, traceability, and record-keeping.
  • It introduces regulatory tools such as the Online National Drugs Licensing System (ONDLS) for licensing and Corrective and Preventive Action (CAPA) for continual improvement and issue prevention.
  • It aligns India’s Good Manufacturing Practices with international GMP guidelines, bringing them closer to WHO-GMP and PIC/S (Pharmaceutical Inspection Co-operation Scheme) guidelines