When serialization of drugs was first being considered for pharmaceuticals back in the mid-2000s, I recall that it seemed to rattle the traditional brand protection vendors who offered package-level authentication technologies. They were more than a little worried that drug companies would end up using serial numbers in place of their more traditional offerings, like holograms, specialty inks, micro-printing and other technologies. Back then, some drug companies were looking at using Radio Frequency IDentification (RFID) tags to carry the serial numbers on their drug packaging, and perhaps these vendors feared that they would be left out.
Last month India’s Central Government published a proposal for comment that, if enacted, would cause all drugs entering the Indian domestic supply to contain unique serial numbers encoded within 2D barcodes, and including aggregation and data reporting–all 180 days after publication of the final rule.
If you download the PDF, don’t be disappointed when you find that the first couple of pages are in Hindi. The full text is also included in English, starting on page 3.
This is the sixth anniversary of the beginning of RxTrace and over that time I have published 325 essays. Pageviews and subscribers to RxTrace have continued to rise the entire time. I thank you all for that because I enjoy writing (and thinking), and without you as readers, I would not be able to do it.
I was poking around on the FDA website yesterday to find out if any new DSCSA documents had been released recently. I just returned from a near three-week trip to Western Europe and wanted to see if perhaps I missed something. No. Nothing released recently. You can find a list of DSCSA documents released by the FDA on their website and the most recent one was published on December 31, 2014.
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.