Identification of Falsified Drugs and Counterfeit Drugs

The World Health Organization (WHO) defined falsified and counterfeit pharmaceutical products as those that are deliberately and fraudulently mislabelled with respect to identity and/or source. In general, falsified and counterfeit drugs fall into the following three categories: (i) products without active ingredients: about 30%; (ii) products containing the wrong amount of active ingredients: about 20%; and (iii) products containing wrong contents: about 20% ^[1].

To prevent counterfeiting, manufacturers protect themselves by using special packaging labels or product labels. However, despite increasing efforts to eliminate falsified and counterfeit drugs from the pharmaceutical market, this phenomenon has not yet disappeared. In order to prevent the aggravation of the phenomenon of falsified and counterfeit drugs, it is necessary to develop methods to distinguish genuine and counterfeit drugs.

The Dangers of Falsified Drugs and Counterfeit Drugs

Falsified and counterfeit drugs can have a serious negative impact on individuals, health care systems, and even society as a whole.

• Health Risks: Falsified and counterfeit drugs may not contain the correct amount or type of active ingredients, or may contain harmful substances. This can result in serious health risks such as poisoning, organ damage, or even death.
• Treatment Failure: Falsified and counterfeit drugs may not work as intended, resulting in treatment failure. This poses a direct threat to the health of the patient.
• Economic Losses: Falsified and counterfeit drugs can cause economic losses to individuals and health care systems. Individuals may waste money on ineffective or harmful drugs, and health care systems may incur additional costs for treating patients who are harmed by these drugs.
• Loss of Trust: Falsified and counterfeit drugs can erode public trust in the health care system and government institutions responsible for regulating and ensuring the safety and efficacy of drugs.

Our Services

Alfa Chemistry uses advanced laboratory methods to identify falsified and counterfeit drugs, and on this basis to determine their possible adverse effects on patients taking falsified or counterfeit drugs. Our services include, but are not limited to the following.

• Identification of active pharmaceutical ingredients (APIs) in drugs
• Determination of the levels of APIs present in drugs
• Impurity analysis and impurity identification
• Screen for organic volatiles / residual solvents

Our Technology Platforms

Currently, Alfa Chemistry uses techniques such as mass spectrometry (MS) and nuclear magnetic resonance (NMR) to explore their applicability in identifying falsified and counterfeit drugs.

MS has the characteristics of high throughput, minimum sample preparation and great selectivity. It allows the investigation of drugs with little or no sample preparation, which facilitates the identification of substandard drugs. A powerful tool for identifying falsified and counterfeit drugs is the combination of MS and chromatography. The latter can separate the chemical species to be tested, while the former can quantify them.

One of the advantages of NMR is that it allows the analysis of samples in their original state without the need for sample preparation. This means that drugs can be analyzed without altering them, which is essential for identifying substandard drugs. NMR can provide information about the chemical composition and quantity of the sample substance. For example, researchers have investigated 40 samples of anabolic steroids through 1H NMR (600 MHz) and have been able to identify and quantify different types of defects: absence of the API, lower API dosage or additional substances ^[2].

At Alfa Chemistry, we are committed to providing customers with high-quality services and strive to exceed their expectations. If you want to know more about the service, please contact us immediately. Alfa Chemistry is always your project partner.

References

1. Fahelelbom, K. M. S.; et al. Combatting substandard and falsified medicines: public awareness and identification of counterfeit medications. Frontiers in Public Health. 2021, 9: 754279.
2. Bakker, I. M. E.; et al. Current challenges in the detection and analysis of falsified medicines. Journal of Pharmaceutical and Biomedical Analysis. 2021, 197: 113948.

Our services are for research use only.