FOPE & PharmaState Academy’s PULSE Program Delivers Comprehensive and Precise Insights on Complaints and Product Recall under Revised Schedule M Guide

On December 29, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 12 of the PULSE Series (Pharma Upgradation & Learning Series for Excellence), focusing on the critical topic of Complaints and Product Recall. The session provided actionable insights and addressed key queries from pharma professionals, empowering them to navigate the complexities of the Revised Schedule M guidelines with confidence.

Session Highlights:

Chief Guest:

Mr. Anil Matai (Director General, OPPI India)

Mr. Anil Matai delivered an impactful keynote, emphasizing the importance of product safety and quality in maintaining global trust in India’s pharmaceutical industry. He highlighted the reputational risks of inadequate complaint handling and product recalls, stressing that prompt and efficient responses are crucial for safeguarding public trust. Mr. Anil Matai urged the industry to adopt proactive measures to address complaints, ensuring that India continues to strengthen its position in global markets.

Expert Educator:

Mr. A V Jayakumar (President - Quality, Ajanta Pharma Limited)

Presentation Highlights: Mr. Jayakumar shared valuable insights from his extensive experience in quality management and regulatory compliance. He emphasized the importance of adopting a proactive approach to complaint handling, focusing on preventive actions and risk analysis to minimize complaints and recalls. He outlined detailed procedures and SOPs for investigating market complaints and integrating them within a company’s overall quality management system.

Key takeaways included the significance of:

• Thorough documentation and communication with regulators.
• Proactive measures to prevent complaints.
• Comprehensive understanding of the Revised Schedule M guidelines, which now align with stringent global standards.

Panel Discussion:

The session’s panel discussion, moderated by Mr. Harish K Jain (President FOPE, Director Embiotic Laboratories), featured esteemed industry experts:

• Dr. Sanjit Singh Lamba, (Managing Partner at Trillyum Consulting), with over 35 years of pharmaceutical expertise.
• Mr. A V Jayakumar, President - Quality, Ajanta Pharma Limited.

Engaging Q&A Session: The panel delved into practical aspects of complaint handling and product recalls. Key points included:

• Clear Procedures: Distinguishing between critical and non-critical complaints.
• Real-Life Examples: Mr. Jayakumar shared cases such as packaging damage or consistency issues in ointments, stressing the importance of addressing even minor complaints.
• Effective Recalls: Dr. Lamba highlighted the logistics of ensuring all affected products are retrieved and maintaining clear communication with stakeholders like wholesalers, distributors, and healthcare facilities.
• Mock Recalls: The panel emphasized the importance of mock recalls to test readiness for real-life scenarios.

Preventive Measures and Continuous Improvement: The panel underscored the necessity of establishing preventive measures to avoid recurring issues. This includes:

• Root cause analysis.
• Developing effective Corrective and Preventive Actions (CAPA).
• Embracing traceability and tracking recall effectiveness through detailed documentation of all affected products and batches.

The session concluded with a discussion on the severe consequences of non-compliance with recall regulations, including legal actions, reputational damage, and loss of market trust.

Looking Ahead:

The next session in the PULSE series, focusing on Materials, Vendor Qualification, and Reference Standards, is scheduled for January 5, 2025. As the demand for practical compliance knowledge continues to grow, the PULSE initiative remains an indispensable resource for industry professionals.

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Stay tuned for more invaluable insights and practical strategies to elevate your pharma operations!