The rise in fake medicines has led to greater regulatory scrutiny of supply chains. With new guidance on its way Ciarán Brady, PLS Pharma Logistics, looks at the potential impact on role of the Responsible Person.
In September 2011, Operation PANGEA IV closed down almost 13,500 websites that were selling fake medicines. Nearly 2.5m items of illegal or counterfeit medicines, worth US$6.3m (€4.7m), were seized worldwide by regulators and customs. According to Interpol, this was the largest operation of its kind, involving 81 countries in an international week of action targeting the sale of medicines on the Internet. The outcome of PANGEA IV demonstrates that from an enforcement perspective, governments and regulators are prepared more than ever to co-operate against the threat of fake and counterfeit medicines.
From a regulatory perspective also, changes are coming that will raise significantly expectations of the supply chain in the fight against fake medicines. In particular, the pending introduction of the Falsified Medicines Directive, and ongoing consultation on new ‘Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use’, both serve notice on the pharmaceutical industry that it is about to get much tougher to meet the standards required.
However, meet them it must, for while it may be impossible to stop every criminal producer from turning out fake drugs from an unknown factory and trading them over the Internet, the pharmaceutical industry must at least ensure that the legitimate supply chain is free of counterfeits and falsified medicines. At the same time, it has a responsibility to guarantee that its products are distributed in a carefully controlled manner so that drugs reach patients in a condition that is safe and fit for purpose.
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