Right now we are waiting for major new announcements regarding serialization and tracing requirements in the United States (4 overdue FDA guidance documents), the European Union (final publication of the Delegate Act related to the Falsified Medicines Act), Brazil (major redesign of their regulation), and Russia (first official publication of their regulation). But last week, the India Directorate General of Foreign Trade (DGFT) published a new public notice containing details of the “Implementation of the Track and Trace System for Export of Pharmaceuticals and Drug Consignments”. These details are for drugs made in India but exported to other markets.
The new document can be found here and an excellent breakdown of it was posted by 24 Insight Group here. If you are impacted by drugs exported from India you should review both postings. The primary purpose of this new notice is to set the deadlines for collecting aggregation data (parent-child packaging relationships), which had been deferred back in May 2015 “…[un]til further notice”.
This new notice introduces a split in the deadlines based on “SSI” and “non-SSI”, terms which are not defined in the notice itself. According to the 24 Insight Group article, SSI stands for “small scale industry”.
Non-SSI manufacturers now get until April 1, 2016 to begin capturing aggregation data and reporting it to the DGFT through the new (and award-winning!) Drug Authentication and Validation Application (DAVA). This is despite the fact that machine readability of the data on primary and secondary drug packaging is not mandatory for non-SSI manufacturers until April 1, 2017. I wonder how that is going to work? Badly, I think. SSI manufacturers have until April 1, 2017 to begin capturing and uploading aggregation data.
You would think that the DGFT would make sure their new document was as clear as possible considering how confusing their public notices about this regulation were last spring (see “India’s Pharma Export Regulations Update And The NECC Story” and “India’s Pharma Export Serialization Deadlines: April Fools!”), but they still use contradictory terms and confusing indentation. For example:
“The bar code labeling at primary level is exempted till further notification; however, the above mentioned details are required to be printed in human readable form on optional basis till further notification.” (DGFT’s emphasis.)
OK, I think it’s clear that printing the human readable information on primary packaging is optional until further notification, so why use the word “required”?
The confusion from the indentation problem occurs, ironically, at the heading “Explanation”. On first look, that heading is under paragraph vii, but based on the actual content, it clearly applies to the entire regulatory text. From that point down the indentation only makes partial sense. Can you figure out what they mean? I think so, but shouldn’t regulations like this be written much more carefully so that the need for making assumptions is minimized? Indentation is an important tool in regulatory texts for facilitating understanding. As evidence of confusion, I note that the author of the 24 Insight Group interprets the deadlines a little differently than I do.
Will the dates stick this time? Hard to say, but given the long history of lines drawn in the sand by the DGFT for exported drug serialization I wouldn’t be surprised if we see a similar public notice sometime next summer with newly updated dates, well after the April 1 deadline passes, as is the pattern. Notice that this new notice also updates some deadlines that had been set for October 1 of last year. Were any exports cut off after that date for non-compliance? I don’t know, but I doubt it.