A lot has changed since I held a workshop in Mumbai in January 2015, which many of you attended. During that visit, I also had breakfast with some of the key leaders in Indian Pharma at the Bombay Chamber of Commerce. At the time, regulatory compliance seemed to all of us like something far off in the future.
Your journey from last year to now—from wanting to grasp the new US DSCSA requirements to being prepared to comply with them—has been consumed with getting your packaging lines ready for to satisfy DGFT requirements. Working with your local line vendors, many of you are now serializing for DGFT on secondary and tertiary packages by modifying your lines and generating aggregation data. The good news for those of you who are serializing is that, as long as the secondary packaging is your sellable unit in the US, no change is required for you from the US DSCSA perspective.
But while US DSCSA has not required aggregation data, many large US wholesalers have. Citing ease of doing business, these wholesalers have made it clear that they prefer receiving aggregation data and that too much ahead of 2023. They have also expressed the need for this communication to occur in EPCIS format—an area where we can definitely help you achieve global compliance for global exports.
With November 2017 soon approaching, we believe that it is critical for Indian Pharma exporting to the US to start working backwards now to ensure that everything is in proper order. Once the lines are ready for serialization and labels are printed as required, it will be time for you to focus on acquiring a repository solution for global compliance. Frequentz’s single platform can help you achieve compliance anywhere around the world.
Since 2008, we have invested in developing and architecting a standards-based EPCIS repository that can also deliver reports based on country mandates. We have designed the repository with Scalability in mind so that it can accept large data sets with millions of serial numbers and events. With so much data, it is essential that the systems you use are mature, stable, and backed up with robust technology.
Frequentz’s fourth-generation, standard-based EPCIS platform has both the product maturity and the stable design to put you in control of your data. Architected by IBM engineers, our platform has the scalability to support your large data volumes and, with the private cloud, the flexibility to support your custom configuration and release installation.
With our IRIS solution in a private cloud, hosted from the US or India or your data center, we give your quality folks complete control over site audits and infrastructure qualification, and give your IT folks control over DR and other IT procedures.
In summary, we provide a “Made in India” solution that offers:
• Local support in your own time zone
• Local implementation teams
• Local development
• Your choice of your own local data center with your own dedicated hardware
• Local hosting, if desired, to allow you to choose your own secure protocols
Frequentz offers these options to give you maximum control over your data and ensure global compliance. Contact Frequentz today to determine which solution works best for you.
About Ranjit Pradhan
Ranjit Pradhan serves as Chief Product Officer & Global Business Development at Frequentz. Mr. Pradhan holds an M.S. in Electrical Engineering from the New Jersey Institute of Technology. Prior to joining Frequentz, Mr. Pradhan was an executive at Abbott Labs, where he held the Senior Director, Diagnostics Informatics position reporting into the EVP, Abbott Diagnostics. Mr. Pradhan has held senior positions for Fortune 100 corporations including GE Healthcare and Philips Healthcare, as well as Vice President of Healthcare IT Systems for Sysmex Corporation. He is Six Sigma BB certified, with previous general management responsibilities in product management, business development, marketing, R&D, services, and support.