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Manslaughter by Fake Artesunate in Asia—Will Africa Be Next?

2006; Public Library of Science; Volume: 3; Issue: 6 Linguagem: Inglês

10.1371/journal.pmed.0030197

1549-1676

Paul N. Newton, Rose McGready, Facundo M. Fernández, Michael D. Green, Manuela Sunjio, C Bruneton, Souly Phanouvong, Pascal Millet, C. W. M. Whitty, Ambrose Talisuna, Stéphane Proux, Eva Christophel, Grace Malenga, Pratap Singhasivanon, Kalifa Bojang, Harparkash Kaur, Kevin Palmer, Nicholas Day, Brian Greenwood, François Nosten, Nicholas J. White,

Crime, Illicit Activities, and Governance

Genuine hologram has the legend 'GUILIN PHARMA' here.Visible with the naked eye, as a thin strip below the waves.Letters are ~ 0.1mm high The photograph, left, is of the genuine hologram attached to the blister packs and packets of the genuine 'Guilin Pharma' artesunate.Below are pictures of 11 types of fake artesunate stickers & holograms with their distinguishing features.As hologram colour depends on the light, please do not use the colours printed here to judge whether artesunate is genuine or fake Guilin Pharmaceutical Co., Ltd.developed their hologram as a security device in response to the first type ('Type 1') of counterfeit artesunate circulated which had no hologram attached.As a result, any 'Guilin Pharma' artesunate now circulating without a blister pack hologram is almost certainly counterfeit or expired.Subsequently, at least 11 different types of counterfeit 'Guilin Pharma artesunate' have been found in Southeast Asia [Burma (Myanmar), Cambodia, China, Lao PDR, Thailand (only on the western border) and Vietnam] with counterfeit stickers or holograms, and there are probably more types circulating.Genuine and counterfeit holograms are ~ 13 mm in diameter.The genuine and 'Type 10' holograms have 'X-52' visible across the mountains when viewed under UV light.Other features of the counterfeit artesunate that differ from the genuine product include -poor printing of bar codes on packets,poor printing of codes on blister packs, codes on blister packs printed with the font made of numerous small dots, poor stamping of code 'AS' and score line on tablets, raised edges of tablets, very hard tablets, blisterpack abbreviations in capital letters ('MFG' and 'EXP') and unusually late expiry date in relation to date of manufacture (>3years).Counterfeits tend to be cheaper than the genuine product.This update has been issued following the discovery that counterfeit artesunate 'Types 4' and '9' contain small quantities of artesunate (~ 10mg) which will not be efficacious but may give misleading positive result on the Fast Red TR dye test and may facilitate the selection of artesunate-resistant malaria parasites.Although, regrettably, the counterfeiters have targeted the 'Guilin Pharma' product, it is possible that other fake artesunate products exist in Asia.Therefore, drug regulatory authorities should be vigilant and regularly monitor the quality of artesunate available on the market.If you are uncertain as the authenticity of any artesunate sample based on the characteristics of the packaging, please check by chemical analysis of the tablet Genuine hologram under UV light with 'X-52' at mountain base