Centre notifies revised rules for quality control of pharma products

• The Union Health Ministry has announced updated rules under Schedule M of the Drugs and Cosmetics Rules, 1945
• It aimed at ensuring robust quality control for pharmaceutical and biopharmaceutical products.

Background

• Schedule M outlines Good Manufacturing Practices (GMP) for pharmaceutical products.
• GMP was first introduced in 1988, with the last amendment in June 2005.
• The revised Schedule M replaces 'Good Manufacturing Practices' with 'Good Manufacturing Practices and Requirements of Premises, Plant and Equipment for Pharmaceutical Products.'
• It Aim is to align with global standards, particularly those of the World Health Organization (WHO).
• Notified changes include:
  • The introduction of a pharmaceutical quality system (PQS)
  • Quality risk management (QRM)
  • Product quality review (PQR)
  • Qualification and validation of equipment
  • A computerised storage system for drug products.

Manufacturer Responsibilities

• Manufacturers are mandated to ensure the quality of pharmaceutical products, compliance with licensing requirements, and avoidance of risks to patients.
• Market release is allowed only after satisfactory test results of ingredients, with retention of sufficient product samples for verification.

Categories and New Guidelines

• Revised Schedule M includes 13 parts with guidelines for manufacturing pharmaceutical drugs.
• Introduces five new categories of drugs, including those with hazardous substances (sex hormones, steroids, cytotoxic substances, biological products, and radiopharmaceuticals)

PrelimsTakeaway

• Schedule M
• Drugs and Cosmetics Rules, 1945