The device, known as CD-3, is a battery-operated tool that
uses different wavelengths of light to compare an authentic malaria drug with a
potentially fake product, the FDA said.
Malaria is a potentially deadly mosquito-borne disease that
often causes fever, chills and flu-like symptoms. In 2010, about 219 million
cases of malaria occurred worldwide and 660 000 people died, most in
sub-Saharan Africa, according to the World Health Organisation.
Some drugs cause
double the damage
"Fake or substandard anti-malarial drugs cause double
damage," FDA Commissioner Margaret Hamburg said in a statement.
"Without adequate, prompt treatment, the malaria parasite can kill a
person in a matter of days, and inadequate treatment can also lead to the
development of drug resistance, potentially rendering all treatment
The device will be first tested in Ghana, and information
from that test will inform additional testing programs in Africa and parts of
Southeast Asia, where the rates of malaria infection are high and where
counterfeit anti-malarial medicines are prevalent.
36% of anti-malarial
drugs analysed were fake
A global study last year found that 36% of anti-malarial
drugs analysed in Southeast Asia were fake, while a third of samples in
sub-Saharan Africa failed chemical testing because they contained either too
much or not enough active ingredient.
The FDA plans to roll out the device as part of a
public-private partnership with a variety of organisations, including the
National Institutes of Health, the Centers for Disease Control and Prevention,
and the President's Malaria Initiative, led by the US Agency for International
Development. CD-3 was developed by scientists at the FDA's Forensic Center in