In one of my previous blogs Global Compliance for Indian Pharma: Here it Comes, Fast and Furious, I talked about the strides India is making to get its pharma industry moving towards serialization. Meanwhile in Brazil and China, the momentum has stalled with both countries having suspended some or all of their serialization initiatives.
Let’s talk about Brazil first. With RDC 54/2014 driving the requirement for 3-lot pilots in 2015 to serialization in 2016 (as defined by ANVISA), we find ourselves in a position where 2015 pilot requirements were suspended , while the requirements for traceability that were defined for December 2016 are currently still in effect. There is much discussion that once the new law passes, the current requirements for 2016 will fizzle out. Until that happens, word to the wise is to be ready for any eventuality in terms of readiness!
In addition, another requirement suspended was the reporting requirement put on wholesalers and pharmacies to send data back to registration holders or manufacturers. In its place, there is now a discussion of centralized database in the new law. Once approved, it will supersede what’s in effect at this point.
If you look at the pharma industry in Brazil related to traceability compliance, the majority of organizations had conformed to the 2015 pilot RDC-54 requirements. But given all the uncertainty in the air, these same organizations have understandably put the projects on hold. They also do not seem particularly eager to begin new pilots. There are a few who are adding new lines for serialization in anticipation of December 2016 deadline. All we can do now is wait and see. Will there be adjustments to RDC 54 by the end of the year? Or are we looking at a complete overhaul? Only time will tell!
Now let’s shift to that other major market, China, and examine the CFDA updates related to serialization. As you all know, we entered the year with the requirement to use government-issued serial numbers for encoding as well as for aggregation. This carried along with it the challenges of non-standard (Non GS1-Compliant) systems creating custom requirements for global pharma trade. Needless to say, it does not help to be different when efficient product flow depends on interoperability and trading-partner handshakes.
Whether due to this lack of interoperability, domestic awareness of issues related to Alibaba, or just a strong desire to do better than how it started, China has suspended its non-standard drug monitoring program for now. Along with its suspension, CFDA has published a draft document and is seeking public comments to revise its requirements. The feedback period is expected to end by Monday, May 23, 2016.
It’s not rocket science to comprehend that we all win big time if China does decide to go the GS1 route! Let’s hope we get some clear signals soon from both countries and get back on track with our efforts to comply with the requirements.
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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.