Regulatory Focus™ > News Articles > New Portable Anti-Counterfeiting Technology Promises 'Paradigm Shift'

New Portable Anti-Counterfeiting Technology Promises 'Paradigm Shift'

Posted 02 August 2012 | By

The US Pharmacopoeia (USP) has developed a new technology that holds the promise of detecting substandard and counterfeit medicines with greater accuracy, sensitivity and reliability than other field-based portable tools.

In a statement, USP said the development of the technology, called "PharmaCheck," was done in response to a challenge from the Bill & Melinda Gates Foundation and the needs of patients in the developing world.

"Substandard and counterfeit medicines for diseases including malaria, tuberculosis and HIV/AIDS pose a dire public health threat to patients in developing countries, in particular children and pregnant women," USP said. "Such medicines can exacerbate the course of these diseases, even leading to death, as well as contribute to the growth of drug-resistant disease parasites-threatening the viability of treatments for patients worldwide."

While portable technologies exist to assess the quality of medicines, they can be under-powered, insensitive and unreliable in comparison to their full-sized in-lab counterparts. USP said the new technology, which has reached the "proof of concept" stage of development, has overcome these challenges and is expected to deliver a stand-alone result that does not require later confirmatory testing in a lab.

A 'Paradigm Shift'

Officials quoted in USP's statement called the development "groundbreaking" and a "paradigm shift" in being able to assure the quality and integrity of medicines in areas where the pharmaceutical supply chain may be weak.

In a separate release, USP said the need for such technologies was paramount given the, "High percentage of antimalarial samples in the private and informal sectors [of developing countries] found to be of poor quality." In Guyana, for example, 58% of antimalarial drug samples were found to be of poor quality, while all samples obtained in Suriname failed visual and physical inspection requests outright because they lacked proper labeling. USP officials said this was problematic because patients would be unable to determine the correct dosing, indications for use or any contraindications. 

Across a region composed of Bolivia, Brazil, Colombia, Ecuador, Guyana, Suriname and Venezuela, 11.6% of antimalarials failed quality inspections, including 3% that also failed analytical tests.

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