Partnerships and Expertise Guide Promius Pharma’s Serialization Efforts

Promius Pharma, a Dr. Reddy’s Laboratories subsidiary, sees its trading partners pushing to meet aggregation requirements earlier than current regulatory requirements.

Promius Pharma is a wholly owned subsidiary of Dr. Reddy’s Laboratories, an integrated pharmaceutical company and one of India’s largest global pharmaceutical companies. Promius Pharma designs personal and practical healthcare solutions for people, resulting in treatments that address dermatology and neurology conditions. Promius products are packaged in a variety of configurations, depending on user requirements.

In this Q&A, Healthcare Packaging discussed the company’s serialization strategies with Amit Kulkarni, Associate Director Package Engineering and Development, and Javier Gonzalez, Director of Combination Products and Packaging Development.

Healthcare Packaging: To many pharmaceutical manufacturers, serialization involves a considerable investment in capital and time to achieve DSCSA compliance. How does your company justify this economically?

Kulkarni: Serialization is mandated under Title II of the DQSA (Drug Quality and Security Act 2013) and we take compliance of all regulations seriously. When it comes to compliance, we invest accordingly with the most practical solution. Promius Pharma is committed to patient safety and supply chain security and we strongly believe that our smart investments comply with the serialization requirements.

Healthcare Packaging: Does your company address serialization and aggregation simultaneously? Do you have personnel assigned specifically to these tasks?

Gonzalez: Although aggregation is required by 2023, many downstream trading partners have requested an earlier phase-in date. While our primary focus is on meeting the 2017 requirements as indicated in the regulations, we continue to explore opportunities with our manufacturing sites and trading partners to support the request for early aggregation. Like most pharma companies, we have a full cross-functional team supporting the project.

Healthcare Packaging: Describe how your company began working with Adept Packaging, and for what specific needs and requirements? Why Adept as opposed to other vendors? Describe the serialization benefits Adept provides your company.

Kulkarni: Before working with Adept Packaging, Promius evaluated many serialization consultancies. We have an aggressive goal to achieve compliance, therefore we decided to work with a trusted partner that had proven expertise and experience in implementing serialization and Adept Packaging fit our needs. Adept is uniquely positioned in the packaging industry with significant experience not only in serialization, but also in multiple packaging engineering areas.

Gonzalez: Adept has proven success in working with the top global pharmaceutical companies, and has a consultative and thorough approach to serialization. Adept Packaging provides Promius Pharma with technical expertise for serialization, aggregation, labeling and packaging. We also rely heavily on Adept for project management for serialization implementation at Promius manufacturing sites and contractors.Adept Packaging feels like an extension of our packaging engineering team. It’s been a good partnership.

“Serialization, and in fact traceability and IOT, are transformational initiatives and require strong partnerships to deliver sustaining results,” adds Prateek Lal, CEO, Adept Packaging. “Javier and Amit have a keen appreciation for partnering with world-class organizations to leverage expertise and disciplined execution for Promius. They set a high bar for excellence and we are very proud to have earned their trust to deliver their aggressive plans.”

Healthcare Packaging: How does your company work with vendors to become “serialization-ready?”

Kulkarni: Promius works with multiple manufacturing and packaging partners. Our partners work in close coordination with the team to align on project planning, activities and requirements, and they are responsible of the software and hardware selection. Promius partners manage the equipment selection, installation and testing while ensuring that our corporate requirements are met.

Healthcare Packaging: Did/do these machinery changes have any impact on the packaging components and materials you use? If so, how?

Gonzalez: Promius, in collaboration with Adept Packaging, provided clear serialization requirements to our manufacturing partners as input to their serialization architecture and design. We reviewed extensively those requirements to minimize the changes to our packaging components. Besides the routine artwork revisions, we don’t have any significant changes.”