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Present Situation Of Drug Pedigree

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Drug PedigreeAbout 1% of all the medicines sold in the world are likely to be counterfeit. In percentage terms 1% may seem to be small, but given that the global medicine trade is in the several billions, this small percentage is a very large number in absolute terms.The problem of counterfeiting is especially rampant in Asia & Africa but it also exists, surprisingly in a region like North America. Here, the problem may not be of only counterfeiting, but also of diversion.

The problem of counterfeiting is especially rampant in Asia & Africa but it also exists, surprisingly in a region like North America. Here, the problem may not be of only counterfeiting, but also of diversion. For example, hospital pharmacies may divert cheaper subsidized drugs meant for Medicaid beneficiaries to other fully paid patients, charge them the normal price & pocket the difference. To counter this problem the US FDA has mandated that all intermediaries in the pharma supply chain should ensure that the drugs that they handle can demonstrate their source or “pedigree”. However at present there is no national or international system in place to have such a pedigree check.
The US FDA had made a deadline of December 2006 for all pharma supply chain intermediaries to put in place a pedigree tracking system. This was actually enacted as an act , known as the PDMA (Prescription Drugs Management Act), a long time back, but the deadline to comply kept getting extended again and again. With so many cases of counterfeit, diverted and / or banned drugs in the supply chain the FDA finally gave a final ultimatum to the pharma industry to “comply or else..” by December 2006. However, as always, this too got extended.... And the story goes on. 
Now there is talk of co-operation between EPCGIobaI, the organization that allots Electronic Product Codes (similar to barcodes, but in RFID format) and the Pharma industry & trade associations to have a universal system that would make it easy to track the movement of drugs by using EPC tracking codes and the EPCGIobaI database. This same database is already in use for keeping track of consumer items and there was no earthly reason why this could not be used for tracking drugs.

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