Bruker help Chinese fight counterfeit drugs

By Wai Lang Chu

- Last updated on GMT

Related tags: Drugs, Pfizer

Bruker Optics have reached an agreement with the Chinese State Food
and Drug Administration (SFDA), which sees Bruker technology
integrated into regional Food and Drug Administration offices
aiding the fight against illegal counterfeit drugs.

The deal aims to stamp down on the problem that has seen an increase in incidents across the country, which the state's authorities are keen to clamp down on.

Recent figures from the United States Food and Drug Administration (FDA) estimates that counterfeit drugs make up more than 10 per cent of the global medicines market, and other reports indicate that millions of Chinese are hospitalised due to counterfeit drug usage each year.

Under the terms of the agreement, 28 regional offices will be equipped with 300 FT-NIR spectrometers, which the SFDA claim is the largest of its kind in the world

Spectrometers are instruments that can detect proteins present even in ultra-small concentrations by measuring the relative masses of ionised atoms and molecules.

Mass spectrometers can provide a complete protein profile and essentially make identification of fakes from the real thing possible.

Additional terms will see Bruker Optics instruments integrated into a large fleet of mobile laboratory vehicles, which will be deployed across China for the rapid screening of pharmaceutical products.

Although full financial terms are not disclosed, Bruker Optics' chief financial officer Rolf Lang said that the project, which includes hardware, method development and support services, is valued at over $15 million (€12.4 milion), making it the largest single order in the company's history.

"Our technology and expertise in molecular spectroscopy can play a supporting role in China's effort to crack down on the counterfeit drugs problem. We are committed to a long-term relationship with the Chinese government and are pleased to be able to assist the SFDA with its needs,"​ said Qian Wang, vice president of Bruker Optics.

The SFDA project has been led by the National Institute for the Control of Pharmaceutical and Biological Products of China (NICPBP), an organisation set up to monitor rising levels of counterfeit products within the Chinese market.

The problem is not restricted to China, having been identified as a worldwide problem. The business of selling fake drugs is a burgeoning global industry, estimated to grow 13 per cent a year to reach $75 billion in 2010, a 92 per cent increase from 2005 - compared to just 7.5 per cent estimated annual growth for global pharmaceutical commerce, according to market research analysts Gartner and Frost & Sullivan.

The US Food and Drug Administration (FDA) has reported the existence of counterfeit versions of Pfizer's Lipitor (atorvastatin) and Viagra (sildenafil), and an unapproved product promoted as a generic version of Eli Lilly's Evista (raloxifene) to US consumers at pharmacies in Mexican border towns.

Related topics: Contract Manufacturing & Logistics, QA/QC

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