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2015 ; 92
(6 Suppl
): 113-118
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Responding to the pandemic of falsified medicines
#MMPMID25897060
Nayyar GML
; Attaran A
; Clark JP
; Culzoni MJ
; Fernandez FM
; Herrington JE
; Kendall M
; Newton PN
; Breman JG
Am J Trop Med Hyg
2015[Jun]; 92
(6 Suppl
): 113-118
PMID25897060
show ga
Over the past decade, the number of countries reporting falsified (fake,
spurious/falsely labeled/counterfeit) medicines and the types and quantities of
fraudulent drugs being distributed have increased greatly. The obstacles in
combatting falsified pharmaceuticals include 1) lack of consensus on definitions,
2) paucity of reliable and scalable technology to detect fakes before they reach
patients, 3) poor global and national leadership and accountability systems for
combating this scourge, and 4) deficient manufacturing and regulatory challenges,
especially in China and India where fake products often originate. The major
needs to improve the quality of the world's medicines fall into three main areas:
1) research to develop and compare accurate and affordable tools to identify
high-quality drugs at all levels of distribution; 2) an international convention
and national legislation to facilitate production and utilization of high-quality
drugs and protect all countries from the criminal and the negligent who make,
distribute, and sell life-threatening products; and 3) a highly qualified,
well-supported international science and public health organization that will
establish standards, drug-quality surveillance, and training programs like the
U.S. Food and Drug Administration. Such leadership would give authoritative
guidance for countries in cooperation with national medical regulatory agencies,
pharmaceutical companies, and international agencies, all of which have an urgent
interest and investment in ensuring that patients throughout the world have
access to good quality medicines. The organization would also advocate strongly
for including targets for achieving good quality medicines in the United Nations
Millennium Development Goals and Sustainable Development Goals.