Counterfeit medicine: a major public health concern and effective remedies for combatting the crisis

The pharmaceutical sector has taken a significant lead in last few decades with development of more effective and safe drugs. As these newer drugs are costly, they are always at the risk of being imitated or counterfeited. These substandard copies of the innovator product often result in treatment failure and pose a major challenge to public health. This treatment failure has more pronounced impact on successful outcomes in treatment of human immunodeficiency virus infection and acquired immune deficiency syndrome (HIV/AIDS), tuberculosis (TB) and cancer patients resulting in substantial loss of disability adjusted life years (DALY). As per world health organization (WHO) estimates that almost 10% drugs are falsified. In order to reduce the threat presented by fake pharmaceuticals, which has reached terrible proportions in recent years, modern technology and extensive processes are required. The use of analytical techniques is essential for detecting counterfeit drugs to ensure safety, verify quality, protect public health, comply with regulations, and maintain trust in the pharmaceutical industry. Apart from the conventional analytical methods like Nuclear Magnetic Resonance (NMR), Mass Spectrometry (MS), Fourier-transform infrared spectroscopy (FTIR), X-ray diffraction (XRD), Liquid chromatography mass spectroscopy (LC–MS), Gas chromatography (GC) etc., regulatory bodies and pharmaceutical industries are adopting newer technological advancements such as block chain, quantum dots, AI model etc. This review will try to include the details about counterfeit drug, their impact on patient access to medications, problems faced by the pharmaceutical industry, several analytical techniques employed by the pharma sector to curb the growing number of counterfeit pharmaceuticals and also the recent policy shift adopted by various drug regulatory agency around the world.

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Publication Details

Journal
Discover Pharmaceutical Sciences
Published
2025-03-07
DOI
https://doi.org/10.1007/s44395-025-00004-6
Citations
4
Primary Topic
Pharmaceutical Quality and Counterfeiting
Type
article
Field-Weighted Citation Impact
7.51
Controls
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Counterfeit medicine: a major public health concern and effective remedies for combatting the crisis

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Discover Pharmaceutical Sciences
Pharmaceutical Quality and Counterfeiting
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article

Counterfeit medicine: a major public health concern and effective remedies for combatting the crisis

Atin Kalra, Tushar Yadav, Pradip Nirbhavane, Ankit Raj, Swapnil Patil, Satish Sardana
article en
4 citations

Abstract

The pharmaceutical sector has taken a significant lead in last few decades with development of more effective and safe drugs. As these newer drugs are costly, they are always at the risk of being imitated or counterfeited. These substandard copies of the innovator product often result in treatment failure and pose a major challenge to public health. This treatment failure has more pronounced impact on successful outcomes in treatment of human immunodeficiency virus infection and acquired immune deficiency syndrome (HIV/AIDS), tuberculosis (TB) and cancer patients resulting in substantial loss of disability adjusted life years (DALY). As per world health organization (WHO) estimates that almost 10% drugs are falsified. In order to reduce the threat presented by fake pharmaceuticals, which has reached terrible proportions in recent years, modern technology and extensive processes are required. The use of analytical techniques is essential for detecting counterfeit drugs to ensure safety, verify quality, protect public health, comply with regulations, and maintain trust in the pharmaceutical industry. Apart from the conventional analytical methods like Nuclear Magnetic Resonance (NMR), Mass Spectrometry (MS), Fourier-transform infrared spectroscopy (FTIR), X-ray diffraction (XRD), Liquid chromatography mass spectroscopy (LC–MS), Gas chromatography (GC) etc., regulatory bodies and pharmaceutical industries are adopting newer technological advancements such as block chain, quantum dots, AI model etc. This review will try to include the details about counterfeit drug, their impact on patient access to medications, problems faced by the pharmaceutical industry, several analytical techniques employed by the pharma sector to curb the growing number of counterfeit pharmaceuticals and also the recent policy shift adopted by various drug regulatory agency around the world.

Discover Pharmaceutical SciencesVol. 1(1)
Indian Drugs and Pharmaceuticals Limited (IN)
Openalex Percentile: Top 3%
Pharmaceutical Quality and Counterfeiting
7.51
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