The Pharmaceutical supply chain has never been in such turmoil and under such attack from governments and regulators globally. The evidence is stark and mounting. Supply chain shortages in the US have moved even the President to demand urgent remediation; high level congressional committees have also asked searching questions of FDA and other involved stakeholders, in an attempt to discover what has been going on with high profile supply chain failures. Counterfeiting has become almost endemic, with detection and enforcement efforts stretched to the limit. Finally, and possibly most worrying of all, are the cases where materials have been adulterated or substituted with toxic alternatives (for economic gain) and have progressed undetected through one or more stages in the supply chain causing eventual patient death.
In response, regulators are demanding tightened controls on the global supply, manufacture, movement and storage of goods intended for human consumption. The FDA has produced an important report titled “Pathway to Global Product Safety and Quality” and the European Medicines Agency (EMA) is consulting on radical tightening of Good distribution Practice (GDP) Guidelines, as follow-on to the Falsified Medicines Directive. Vitally important though this is to reduce the risk of possible further death or injury to patients, these issues are symptoms of an underlying pathology borne of a modus operandi that is no longer ‘fit for purpose’. The supply chain patient is sick and in need of treatment.
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