July 31, 2008 The counterfeiting of medicines has been known of since around 1990 and is a growing problem—in both developing and developed countries. Counterfeit medicines are estimated as more than 10% of the global medicines market and in some developing countries it is thought to be as high as 50%. One prediction is that global counterfeit drug sales will reach $75 billion by 2010.
Counterfeiting can apply to both branded and generic products, with counterfeit products including drugs with the correct ingredients or with the wrong ingredients; without active ingredients, with insufficient active ingredient or with fake packaging. The increased occurrence of counterfeit medicines has several serious consequences. These may include illness or death of patients, higher medical insurance and lost revenues to pharmaceutical manufacturers and governments. Children are particularly at risk. Diminished public confidence in both health care providers and the medicines supply chain could indirectly lead to increased illness (as a result of non-adherence) which would strain health care services. Damage to a brand’s credibility could tarnish a manufacturer’s reputation, not to forget the substantial loss of revenues.
The recent discovery of counterfeit medicines in the UK supply chain prompted Professor Moffat, Dr O’Neil and their colleagues at the Centre for Pharmaceutical Analysis, The School of Pharmacy, University of London, to develop a rapid, precise and portable analytical technique for in-field use. Working with samples provided by the Korean Food and Drugs Agency and a portable transmittance near infrared (NIR) spectrometer developed by NIR Technology Systems they have the answer to identifying counterfeits where they choose. This ability to replace laboratory analysis with the use of a portable instrument at the point of sampling is an attractive option for regulatory authorities. Furthermore, the NIR technique is rapid, precise, non-destructive and costs very little to operate.
Their findings have been published in the latest edition of the Journal of Near Infrared Spectroscopy. “Near infrared spectroscopy is a scientific tool which has helped us understand the differences between genuine and counterfeit drugs, even those which look exactly the same to the naked eye,” Professor Moffat said.
As well as being able to identify counterfeit from genuine tablets, the chemical information provided by NIR spectroscopy helps identify the likely origin of the tablet. Thus law enforcement agencies obtain valuable information about the laboratories manufacturing counterfeit medicines.
The present paper was presented at the 13th International Conference on Near Infrared Spectroscopy in Umeå, Sweden. Professor Moffat, together with his students and collaborators, are also developing the technique of NIR spectroscopy for the quality assurance of medicines and to ensure that manufacturing methods are efficient and effective. “Our studies also have relevance to the formulation development of new medicines to make sure that patients get the right drug at the right amount at the right time”, said Professor Moffat.
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