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