FOPE & PharmaState Academy host Session 12 of the PULSE series

On December 29, 2024, the Federation of Pharma Entrepreneurs (FOPE) and PharmaState Academy hosted Session 12 of the PULSE (Pharma Upgradation & Learning Series for Excellence) initiative, focusing on Complaints and Product Recall. The session provided clarity on the guidelines and cleared the queries of the pharma professionals.

Session highlights:

Chief Guest: The event began with a keynote address by Anil Matai, Director General, OPPI India. He opened the session by addressing the importance of product safety and quality, highlighting the global recognition of India’s pharmaceutical industry. He touched on the need for heightened awareness and the reputation risks the industry faces in cases of laxity in handling complaints and product recalls. He stressed that for India to continue strengthening its position in global markets, the pharmaceutical industry must ensure that complaints are addressed promptly and efficiently, which, in turn, could prevent public trust from eroding. 

The session was led by  A V Jayakumar, President- Quality, Ajanta Pharma 

Presentation highlights

Jayakumar provided valuable insights from his extensive experience in quality management and regulatory compliance. He recounted his own experience working with investigative teams and the importance of being proactive when handling complaints. He explained that instead of reacting after complaints have been received, companies should work towards preventing complaints and recalls through preventive actions and risk analysis. This proactive mindset, he explained, could significantly reduce the need for investigations and, ultimately, product recalls. 

Jayakumar also spoke about the detailed procedures and SOPs needed for investigating market complaints and how these systems should be integrated into a company’s overall quality management system. He further highlighted the importance of thorough documentation, communication with regulators, and the need for a comprehensive understanding of the revised Schedule M guidelines. He pointed out that India’s Schedule M had previously lacked alignment with these standards, but the updated guidelines now ensure that companies follow more stringent practices regarding complaint handling, product recalls, and overall quality management.

Panel discussion

The session’s panel discussion, moderated by Harish K Jain, President FOPE, Director Embiotic Laboratories, featured the following industry experts:

• Dr Sanjit Singh Lamba, Managing Partner, Trillyum Consulting and a pharmaceutical veteran with over 35 years of experience.
• A V Jayakumar, President- Quality, Ajanta Pharma

Q&A session with the panellists: 

The panel discussed practical aspects of complaint handling, emphasising the need for clear procedures to distinguish between critical and non-critical complaints. Jayakumar gave examples of common issues, such as packaging damage or consistency problems in ointments, stressing the importance of not dismissing seemingly minor complaints, as they could escalate into more significant quality issues. Dr Lamba delved into the logistics of product recalls, emphasising the importance of ensuring all affected products are retrieved and proper communication channels are in place with stakeholders like wholesalers, distributors, and healthcare facilities. The panel also noted the importance of mock recalls to test readiness for real-life scenarios.

As the session progressed, Jain highlighted the necessity of establishing preventive measures to avoid the recurrence of similar issues. The panel clarified that this approach should be part of a continuous improvement process that includes root cause analysis and the development of effective corrective and preventive actions (CAPA). They also discussed the increasing global emphasis on traceability and the tracking of recall effectiveness, which would require pharmaceutical companies to have detailed documentation of all affected products and batches.

The session concluded with a discussion on the severe consequences of failing to comply with recall regulations, which can range from legal actions and significant reputational damage to 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 demand for practical compliance knowledge grows, the PULSE initiative continues to serve as an essential resource for industry professionals.