The Indian pharmaceutical industry is undergoing a significant transformation with the introduction of the revised Schedule M under the Drugs and Cosmetics Rules, 1945. This revision aims to elevate Good Manufacturing Practices (GMP) to align with international standards, ensuring the production of high-quality and safe pharmaceutical products.
Scope of the Revised Schedule M: All pharmaceutical manufacturers, excluding those producing medical devices, homeopathic, Unani, and Ayurveda products, are mandated to obtain the Revised Schedule M certification from the Drug Authority. This certification is crucial for companies aiming to operate within the domestic market and is a prerequisite for obtaining the Certificate of Pharmaceutical Product (COPP) for export purposes.
Compliance Deadlines and Extensions: Recognizing the diverse capacities of pharmaceutical companies, the Ministry of Health & Family Welfare has outlined specific compliance timelines:
- Large Manufacturers: Companies with an annual turnover exceeding ₹250 crore were required to comply with the Revised Schedule M standards by June 28, 2024.
- Small and Medium Enterprises (SMEs): Manufacturers with a turnover of ₹250 crore or less were initially given until December 28, 2024, to achieve compliance. However, considering requests for additional time to upgrade infrastructure, train personnel, and secure financial resources, the government has conditionally extended this deadline to December 31, 2025. To avail of this extension, SMEs must submit an upgradation plan in Form ‘A’ to the Central License Approving Authority within three months from February 11, 2025, which sets the submission deadline on May 11, 2025.
Financial Incentives: To support SMEs in this transition, the government offers a 20% subsidy on expenses incurred towards compliance with the Revised Schedule M standards. This initiative aims to alleviate the financial burden associated with infrastructural and procedural upgrades.
Key Compliance Areas: The revised guidelines emphasize several critical areas to ensure comprehensive quality management:
The Pharmaceutical Quality System (PQS) requires manufacturers to establish a robust framework overseeing all aspects of production and quality control, ensuring products consistently meet predefined quality standards. Integral to this is Quality Risk Management (QRM),which involves implementing systematic processes to assess, control, and communicate risks related to product quality, thereby safeguarding patient health. Validation and Qualification processes are mandated to confirm that facilities, systems, and equipment are properly designed, installed, and operate as intended, ensuring reliability and compliance. Upgrading Plant and Infrastructure is essential, with specific standards set for premises, including advanced air handling systems and contamination control measures to maintain a controlled manufacturing environment. The use of modern, validated Equipment is emphasized to maintain consistent production quality and efficiency. Meticulous Documentation practices are required to ensure traceability and adherence to GMP standards, facilitating transparency and accountability. Ensuring that Technical Staff are adequately trained and qualified is crucial for effective operation and compliance with the revised guidelines. Finally, the implementation of validated Computerized Systems for process control and data management is necessary to enhance accuracy, efficiency, and data integrity in manufacturing operations.
How Medwisdom Can Assist: Navigating the complexities of Revised Schedule M compliance can be challenging. Medwisdom offers a suite of services tailored to assist pharmaceutical companies in this journey:
- Regulatory Compliance Guidance: Providing expert advice to achieve full adherence to Revised Schedule M and WHO-GMP standards.
- Facility Upgradation Support: Conducting comprehensive gap analyses and recommending cost-effective infrastructural and equipment enhancements.
- Staff Training Programs: Offering specialized training sessions to equip your team with the necessary skills and knowledge to operate under updated GMP protocols.
- Mock Audits: Performing thorough pre-assessment audits to identify potential areas of non-compliance and suggesting actionable improvements.
- Documentation Assistance: Helping in the preparation of Standard Operating Procedures (SOPs) and guiding the completion of Form ‘A’ for extension applications.
Our services are accessible through teleconsultation and on-site visits across India. By sharing your facility layout, existing documentation, and equipment details, our experts can provide a customized gap analysis. We are committed to ensuring your Form ‘A’ submission is completed promptly, facilitating a seamless extension process.
For more information, please visit our website: https://medwisdom.in/
To discuss how we can further assist you, contact us at: Email: info@medwisdom.in Phone: +91 9264127040
Partner with Medwisdom to ensure your compliance with the Revised Schedule M standards, positioning your company to sustain success in both domestic and international markets.