By Ed Silverman // November 14th, 2012 // 8:14 am
A European trade group that represents chemical manufacturers believes that European Union efforts to safely oversee active pharmaceutical ingredient production in other regions is sorely lacking and now wants inspections of all API manufacturing facilities around the world to become mandatory.
The European Fine Chemicals Group argues that recent legislative efforts, including those aimed at reducing the supply of counterfeit medicines, have failed. Inspections may cost about $3.3 million over a three-year period, but this “would be a small price to pay to guarantee the quality of APIs meets the EU standard, irrespective of its global source,” the group says.
The recommendation comes amid heightened concern over the global supply chain for pharmaceuticals as more drugmakers rely on low-cost suppliers, especially those located in countries such as China, where the heparin scandal originated and led to 81 deaths in 2007 and 2008 (back story).
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