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Posts Tagged ‘india’

Indian Pharmaceutical Exporters Must Add 2D Codes to All Packs

serialization for indian drug exportsInteresting times for drug exporters in India. The government published a requirement on 10 January that stipulates a GS1 datamatrix track and trace system for all exported drugs: Exporter of Pharmaceutical products will build track and trace capability for their exported medicines using barcode technology as per GS 1 global standards. At least, thankfully, India didn’t go with a proprietary or quirky system that doesn’t fit with anything else globally.  If you’re going to push the big red traceability button, GS1 is the way to go. But rather than ease themselves in stepwise, the requirement is for traceability at three packaging levels: Primary Level packaging: Incorporation of 2D (GS 1 Data matrix) barcodes on medicines at strip/vial/bottle level encoding unique product identification code (GTIN), Batch Number, Expiry Date and Serial Number of the Primary pack. Secondary Level packaging Incorporation of barcodes (1D or 2 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Serial Number of the Secondary pack. Tertiary Level packaging Incorporation of barcodes (1 D) encoding unique product identification code (GTIN), Batch Number, Expiry Date and Serial Number of the Tertiary pack (shipper/carton) No mention is made of whether there is to be any recording of parent-child relationships between these codes to allow so-called “inference”.  Without this, boxes have to unpacked and repacked every time the data is checked during transit, but inference is a major thorny problem that has caused delays in similar systems in Turkey and elsewhere. Neither is there any mention of security.  I can easily duplicate a 2D barcode and so can a counterfeiter, so in itself it is not a security feature.  Other authentication technology is also needed if Indian exports are to be made secure. Manufacturers were given some time to phase this in.  Since California, the largest state within the worlds most lucrative and sophisticated pharmaceutical market, needs until 2015 to figure this out, you would imagine that five years or so would be reasonable for India’s hundreds of drug manufacturers to get their systems designed, ordered, installed, tested and operational. You would be wrong. In order to enable exporters of pharmaceutical products for incorporation of this technology, adequate time is being given and that is why [the requirement] will be made applicable on 1st July 2011. The exporters have five MONTHS.  Now, I know that Parkinson’s Law says that “work expands to fit the time available”, but I’m not aware of evidence that it works in reverse. The Indian pharmaceutical industry and government have routinely played down the counterfeit problem domestically and have always denied that significant quantities of fake drugs are exported from India.  They have sought to portray the issue as a slur emanating from western multinationals trying to protect their high-priced medicines from generic competition.  That may or may not be so, and I don’t intend to wade into the murky waters of international intellectual property law here.  The new initiative is an admirable step forward in principle, but without a more realistic timescale and some degree of outside help, the system will be late, expensive, incomplete and perhaps ultimately worthless. That’s not what the legitimate pharmaceutical producers, who form the majority of drug exporters, need.
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Pharmaceutical Anti-Counterfeiting

Combating the Real Danger from Fake Drugs has become a must-have primer on anti-counterfeiting and is widely used by drug companies, regulators and others. The book covers the legal, strategic and political issues as well as the technical counter-measures such as process control, digital serialisation and physical security.

Pharmaceutical Anti-Counterfeiting book