Yong Y.L*, Lau Y.H., Lim T.B., Yang Chiew Yung., Lim Chin Chin
6th European Academy of Forensic Science Conference,
20-24 Aug 2012, The Hague, Netherlands (Poster Presentation)
The World Health Organisation defines counterfeit medical products as medicines which are manufactured below established standards of safety, quality and efficacy, and are deliberately and fraudulently mislabeled to hide their identity and source. They may include products with the correct ingredients or with the wrong ingredients, incorrect quantities of the active pharmaceutical ingredients (API), as well as fake packaging. Counterfeit medical products are a global major health risk for all communities. There has been a growing threat of counterfeits in recent years due to counterfeiters employing increasingly innovative and sophisticated manufacturing techniques, which makes detection more challenging.
An integrated forensic methodology was developed for counterfeit medical products and their packaging material. It involved the examination of the packaging as well as the chemical profiles of the dosage form. Optical microscopy methods were employed to examine the printing quality, security features and tool marks found on the packaging materials (cartons, bottles, blister packaging, etc.). Besides obtaining the API dosage information of the drug by conventional liquid chromatography techniques, an array of other analytical techniques was employed to further characterise the chemical composition of the drug dosage form. Chemical profiles of the drugs were acquired using Fourier Transform Infrared Spectroscopy (FTIR), Raman Spectroscopy, Scanning Electron Microscopy with Energy Dispersive X-Ray Analysis (SEM/EDX) and Isotope Ratio Mass Spectrometry (IR-MS). As the molecular spectroscopic methods like Raman and FTIR provide fingerprint data on the suspected medical products, information from these analyses enables association of different counterfeit samples and provided linkages to their source of origin. The IR-MS is also used to provide isotopic information on the classification and provided further confirmation of counterfeit medical products. These various techniques complement one another and their results provide a comprehensive and reliable means to easily differentiate counterfeit and authentic drugs, as well as link seizures of counterfeits, thus providing critical information to investigations and prosecutions.