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Union Health Ministry enhances Pharma Quality Control with Revised Schedule M rules
Industry News- Jan 09,24
Schedule M outlines the Good Manufacturing Practices (GMP) for pharmaceutical products, and the revised version aims to ensure adherence to GMP standards, emphasising the requirements for premises, plant, and equipment related to pharmaceutical production.
In an effort to bolster stringent quality control measures for pharmaceutical and biopharmaceutical products, the Union Health Ministry announced updated regulations on January 6 under Schedule M of the Drugs and Cosmetics Rules, 1945.
Schedule M outlines the Good Manufacturing Practices (GMP) for pharmaceutical products, and the revised version aims to ensure adherence to GMP standards, emphasising the requirements for premises, plant, and equipment related to pharmaceutical production.
GMP serves as mandatory standards that enhance product quality through control over materials, methods, machinery, processes, personnel, and facility/environment. Initially incorporated into Schedule M of the Drugs and Cosmetics Rules in 1988, the latest amendment in June 2005 introduced the replacement of 'Good Manufacturing Practices' with 'Good Manufacturing Practices and Requirements of Premises, Plant, and Equipment for Pharmaceutical Products.'
In an attempt to align with global benchmarks, particularly those set by the World Health Organisation (WHO), the recent modification introduces changes to keep pace with the evolving manufacturing and quality landscape. A senior Health Ministry official emphasised the need to bring GMP recommendations in line with global standards, ensuring the production of pharmaceuticals meeting international quality standards.
Key amendments in the revised Schedule M include the introduction of a pharmaceutical quality system (PQS), quality risk management (QRM), product quality review (PQR), qualification and validation of equipment, and the implementation of a computerised storage system for all drug products.
According to the December 28, 2023 notification, manufacturers are now required to take responsibility for the quality of pharmaceutical products, ensuring their fitness for intended use, compliance with license requirements, and absence of risks to patients due to inadequate safety, quality, or efficacy.
Companies must market finished products only after obtaining "satisfactory results" from ingredient tests and retain sufficient samples of intermediate and final products for repeated testing or verification of a batch.
Sudarshan Jain, Secretary General of the Indian Pharmaceutical Alliance (IPA), praised the government's move, considering it a positive step that will elevate and update the quality standards of medicines. The revised regulations are expected to contribute significantly to India's journey toward becoming a global benchmark in quality.
The implementation of the revised Schedule M is contingent on company turnovers. Small and medium manufacturers, with an annual turnover of less than Rs 250 crore, are given a 12-month timeframe, while large manufacturers with turnovers exceeding Rs 250 crore have six months to comply with the updated rules.
The revised Schedule M comprises 13 parts, providing GMP guidelines for specific requirements in pharmaceutical drug manufacturing. Additionally, the updated rules introduce five new categories of drugs, including pharmaceutical products containing hazardous substances such as sex hormones, steroids (anabolic and androgenic), cytotoxic substances, biological products, and radiopharmaceuticals.
Source: The Hindu
Union Health Ministry
Pharma Quality Control
Revised Schedule M Rules
Drug and Cosmetics Rules
Sudarshan Jain
WHO Standards
Schedule M Amendments
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