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Recent developments of Raman spectroscopy for the qualitative analysis of falsified and substandard medicines

Quality medicines are essential to any healthcare system and are the final goal of any pharmaceutical manufacturer. Unfortunately, as stated recently by the World Health Organization (WHO), one in 10 medical products circulating in low and middle-income countries is either substandard or falsified (SF products).1 Although the exact prevalence of SF products is unknown in high-income countries, it remains a major risk,2 especially because the internet market is difficult to control.3

Raman SF medicines

BROADLY speaking, marketed medicines are expected to be compliant with local market specifications. These specifications ensure the correct active ingredient (identity testing) is present in the right amount (assay testing); the active pharmaceutical ingredient (API) is bioavailable (dissolution testing); and the amount of impurities is low enough (impurity testing). Although it is sometimes possible to visually identify SF products, only the pharmaceutical product testing following the complete pharmacopoeia monographs ensures the final quality and safety for the patient. However, this testing is lengthy and requires high-level equipment and staff. These limitations reduce the quantity of possibly tested samples and are impossible to implement for field testing during inspections. There is therefore an increasing need for fast, reliable and, if possible, portable solutions to detect SF products.

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