Fake Anti-Malarial Drugs May Have Met Their Match In FDA's Latest Handheld Device

More than a third of anti-malarial drugs available in Sub-Saharan Africa and Southeast Asia are counterfeit or substandard, according to the FDA. For this reason, the agency announced Wednesday its plans to implement a tool called the Counterfeit Detector Device, or CD-3, to better enable agencies and organizations to differentiate between real and fake medication.

Work on the device started in 2005 when Nicola Ranieri, a scientist in the FDA’s Forensic Chemistry Center, began examining the use of ultraviolet light sources used in crime scenes.

Knowing that counterfeit drug detection required sophisticated labs overseen by highly trained scientists, Ranieri envisioned channeling existing technology into a handheld, easy-to-use device that could cheaply and instantly expose fake drugs for what they were.

Together, he worked with Mark Witkowski, a vibrational spectroscopist, to develop and refine the device that went through two initial phases – CD-1 and CD-2 – before the duo came up with the latest version, which incorporates additional wavelengths, including infrared.

"CD-3 illustrates the spirit of innovation and commitment to public health that our scientists have," Melinda K. Plaiser, the FDA's acting Associate Commissioner for Regulatory Affairs, said in a press release. "They saw a need and invented a technology to address it.”

In all, the FDA reports that more than 200 million people contract malaria every year, resulting in more than 660,000 deaths globally, the majority of which are children.

Furthermore, FDA Commissioner Margaret A. Hamburg warned that fake and unregulated anti-malarial drugs “not only deprive people of life-saving treatment, but can also lead to parasites resistant to authentic medication.”

The detector will be deployed and tested in Ghana starting this year and into the next. A second testing program is also planned though a location has not been selected.

Drug samples to undergo investigation will be derived from hospitals, clinics and both public and private pharmacies.

Those drugs believed to be suspect will be retested at a quality control laboratory and given to Ghanaian authorities in the case of enforcement action.