Schedule M Standard for Pharma Sector

Why in news?

The Union Health Ministry has asked states/UTs to ensure strict compliance with Revised Schedule M – updated Good Manufacturing Practices (GMP) by all drug manufacturers.

• Schedule M – Refers to the Good Manufacturing Practices (GMP) standards for pharmaceutical and biopharmaceutical products in India
• Under the – Drugs and Cosmetics Act, 1940
• Purpose –
  • Quality Assurance – To ensure that pharmaceutical products are of high quality and fit for their intended use, meeting licence requirements.
  • Patient Safety – To prevent patients from being exposed to risks due to inadequate drug safety, quality, or potency.
  • Global Alignment – To bring India's GMP standards in line with international guidelines, such as those of the World Health Organization (WHO).
• The revised one was introduced in 2023-2024, brings India’s GMP norms closer to international standards.
• It mandates enhanced quality systems, with a compliance deadline of December 31, 2025.
• Key changes in the Revised Schedule M –
  • Establishes a comprehensive Pharmaceutical quality system (PQS) for managing quality across all aspects of drug manufacturing.
  •  Mandates the use of Quality Risk Management (QRM) principles to identify and mitigate potential quality issues.
  • Product quality review (PQR)
  • Qualification and validation
  • Implementation of a computerized storage system
  • Specific guidelines for new product category containing hazardous substances, such as sex hormones, anabolic steroids, cytotoxic compounds, biological products, and radiopharmaceuticals.

Quick Fact

References

1. The Hindu | Compliance with revised Schedule M norms
2. India Code | Drugs and Cosmetics Act, 1940