6th European Academy of Forensic Science Conference (2012)
Theme 3: Strength of Forensic Evidence (Oral Presentation)
Title: Applying an Integrated Forensic Methodology in the Examination of Counterfeit
Medical Products and Their Packaging
Yong Yuk Lin BSc, Lau Yen Hui MSc, Lim Thiam Bon MSc, Yang Chiew Yung MSc, Lim
Chin Chin MSc, Forensic Chemistry and Physics Laboratory, Applied Sciences Group,
Health Sciences Authority, 11 Outram Road, Singapore 169078
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 (IRMS). 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.
Key words: Integrated Forensic Methodology, Counterfeit Medical Products, Packaging
Analysis
Number of words: 308