Pharmaceutical companies requested more time to adopt the revised manufacturing practices mandated under Schedule M of the Drugs and Cosmetics Act, 1945.
- The Union Ministry of Health and Family Welfare updated Schedule M in January 2024 to align India’s GMP standards with global standards, particularly those recommended by the WHO.
About Schedule M:
- Schedule M is a key part of the Drugs and Cosmetics Act, 1940, which focuses on Good Manufacturing Practices (GMP) for pharmaceuticals in India.
- These practices are essential for ensuring the quality, safety, and efficacy of pharmaceutical products.
- GMP was first introduced in Schedule M in 1988 to build and maintain quality through controls on materials, methods, machines, and processes.
Key Components:
- Facility Requirements: Specifies construction and maintenance standards for manufacturing facilities to ensure a controlled production environment.
- Personnel Guidelines: Outlines necessary qualifications, training, and hygiene practices for personnel to maintain product integrity.
- Manufacturing and Control: Details protocols for manufacturing processes, safety testing, and quality assurance to ensure product consistency and safety.
- Storage and Transport: Establishes guidelines for the proper storage and transportation of materials to prevent contamination and degradation.
- Written Procedures and Records: Mandates comprehensive documentation for traceability, accountability, and regulatory compliance.
- Quality Control and Laboratories: Emphasizes the need for quality check laboratories and robust quality control systems to monitor and maintain product standards.
- Equipment and Housekeeping: Focuses on the cleaning of equipment, housekeeping, and prevention of cross-contamination to maintain a sterile manufacturing environment.
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Frequently Asked Question:
What is Schedule M of the Drugs and Cosmetics Act, 1940?
Schedule M provides guidelines for Good Manufacturing Practices (GMP) in India, ensuring the quality, safety, and efficacy of pharmaceutical products.
When was Good Manufacturing Practices (GMP) first introduced in Schedule M?
GMP was first introduced in Schedule M in 1988 to enhance and maintain pharmaceutical product quality.