The U.S. Food and Drug Administration has just announced the development of a new hand-held device, called CD-3, capable of detecting substandard or counterfeit anti-malarial medicines.

Malaria is a life threatening mosquito-borne infectious disease that kills more than 660,000 people around the world each year. According to the World Health Organization, there were close to 219 million cases of malaria in 2010.

There is currently no effective vaccine for the disease and it is particularly difficult to treat due to drug resistance, limited availability of medications and an increase in substandard or counterfeit medications.

Substandard anti-malarial medicines lack active ingredients which do not help treat the condition. In fact, they can actually lead to resistant strains of the parasite which makes treating the disease with authentic medicines even more troublesome.

The FDA developed the device in partnership with with Skoll Global Threats Fund, the U.S. Pharmacopeia (USP), the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the multi-agency President's Malaria Initiative (PMI).

The CD-3 is a handheld battery-operated tool that uses a variety of wavelengths of light to provide a visual comparison of an unverified product with an authentic one.

They hope to use the handheld CD-3 device to identify counterfeit or substandard anti-malarial medicines, including falsified products across areas where malaria infection rates are high, such as Africa and Southeast Asia.

A previous study conducted last year revealed that around a third of sub-Saharan African ani-malarial drugs were considered substandard.

The agency even announced that it is intending to improve and manufacture the tool on a larger scale, having signed a letter of intent with Corning Incorporated.

FDA Commissioner Margaret A. Hamburg, M.D., said:

 
"Fake or substandard anti-malarial drugs cause double damage: 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 ineffective.

The development of the CD-3 and the formation of this important partnership are critical steps toward the FDA's goal of improving the global product safety net in order to protect consumers in the U.S. and worldwide."

They will begin testing the effectiveness of the tool in Ghana in 2013 and 2014. Results and information obtained from the tests in Ghana will be used to help develop a second testing program.

The Institute of Medicine believes that such a device is key to controlling the trade of counterfeit or substandard medicines.

Commissioner Hamburg, said:

 
"The proliferation of counterfeit or substandard medicines around the world is a major public health problem and the developing world is disproportionately affected.

The FDA is pleased that CD-3 has the potential to be used as a frontline tool in protecting the global supply chain and make a positive impact on public health efforts to combat malaria in developing regions of the world that are particularly hard hit by the disease."

The World Health Organization has announced that substandard and fake medicines harm and kill patients and that urgent action is needed to tackle this scandal.



Written by Joseph Nordqvist