Global Traceability and Serialisation in Pharma Report
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Fake pharmaceuticals have the potential to be harmful for consumption. This possibility was seen back in 2013 when the FDA alerted the industry of the existence of a counterfeit cancer medicine that was distributed in the US. The regulator advised against its use due to concerns that the pharmaceutical may have been unsafe or ineffective.
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The World Health Organization (WHO) defines a counterfeit medicine as follows:
“A counterfeit medicine is one which is deliberately and fraudulently mislabeled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging.”
Experts note that public awareness of counterfeit medicines gathered speed since a discussion on the matter arose at a 1985 WHO Conference.
Pfizer notes that recent years have seen a significant rise in the level of counterfeit medicines reaching consumers across Europe through illicit sources such as the internetas patients scout the web to find cheaper offers with an element of convenience.
For counterfeit drugs to reach hospitals, a long supply chain only needs a single weakness for a breach to take effect.
Serialisation acts as a security measure, enabling accountability and traceability of every pharmaceutical in the supply chain, assuring a level of product safety.
However adhering to serialisation’s new requirements is not an easy task for all, and presents added costs. Nitin Dahad notes that, theoretically, for firms familiar to cold chain
monitoring, the cost of serialisation may not be too significant to collect additional data, however for others, a drastic change in infrastructure may be required.
In this 2015 Serialisation Report, Pharma IQ presents the findings of its latest industry
survey while drawing trends on previous years to explore the shifts in industry consensus.
Plus, Pharma IQ presents its printable Serialisation Deadline Worldmap in this 2015 Serialisation Report, Pharma IQ presents the findings of its latest industry survey while drawing trends on previous years to explore the shifts in industry consensus. Plus, Pharma IQ presents its printable Serialisation Deadline Worldmap.
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