E-drug: Regulatory controls for intermediary traders of pharmaceuticals
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Dear friends,
In 2008 quite a broad agreement came out of an E-drug debate that, when buying either active pharmaceutical ingredients or final pharmaceutical products at brokers or international traders, it is often hard or even impossible to verify if their quality has properly been assured, since the international traders or brokers seem to not to be subject to appropriate regulatory controls (see http://www.essentialdrugs.org/edrug/archive/200811/msg00013.php).
An article published yesterday on the Spanish daily newspaper El Pais brings this subject back to our attention, broadening it to non-active pharmaceutical ingredients. Actually, El Pais reports that a Spanish tribunal has requested to archive the case related to a lethal poisoning due to the DEG contained in an anti-cough syrup. The case had been reported in E-drug in 2006 (http://www.essentialdrugs.org/edrug/archive/200610/msg00052.php) and further analyzed in the WHO Bulletin in 2008 (http://www.who.int/bulletin/volumes/86/10/07-049965.pdf). The syrup was manufactured in Panama using glycerin of Chinese origin, which had been imported in Panama through a Spanish intermediate wholesaler, and which ultimately caused the DEG lethal poisoning.
According to the reporter of El Pais (http://www.elpais.com/articulo/sociedad/Espana/archiva/caso/jarabe/mato/cientos/panamenos/elpepusoc/20110607elpepisoc_7/Tes), the judge ruled that the wholesaler is just a commercial trader and that it is not obliged to carry out any quality analyses on the products in transit. On the other hand, the families of the victims and the government of Panama claim that the wholesaler was aware of the fact that the product received from China was not appropriate for human use, and that this represents at least a very serious negligence.
I would say that this case bring our attention back to the problem, already discussed in 2008, of how to control the "no-man-land" between the exporting and the importing country and how to protect the health of the final user.
Regards,
Raffaella Ravinetto
ITM Antwerp (Belgium)
rravinetto@itg.be
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