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Keywords = substandard and falsified medicines

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7 pages, 158 KiB  
Commentary
Strengthening National Regulatory Authorities in Africa: A Critical Step Towards Enhancing Local Manufacturing of Vaccines and Health Products
by Alemayehu Duga, Nebiyu Dereje, Mosoka Papa Fallah, Tedi Angasa, Abebe Genetu Bayih, Edinam Agbenu, Ngashi Ngongo, Raji Tajudeen and Jean Kaseya
Vaccines 2025, 13(6), 646; https://doi.org/10.3390/vaccines13060646 - 16 Jun 2025
Viewed by 791
Abstract
The World Health Organization (WHO) Global Benchmarking Tool (GBT) classifies regulatory systems into four maturity levels, with Maturity Level 3 (ML3) signifying a stable and effective regulatory environment. As of January 2025, eight African nations—Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania, and [...] Read more.
The World Health Organization (WHO) Global Benchmarking Tool (GBT) classifies regulatory systems into four maturity levels, with Maturity Level 3 (ML3) signifying a stable and effective regulatory environment. As of January 2025, eight African nations—Egypt, Ghana, Nigeria, Rwanda, Senegal, South Africa, Tanzania, and Zimbabwe—have attained ML3 status, marking a significant milestone in the continent’s regulatory landscape. Achieving ML3 confers critical benefits, including reducing substandard and falsified medicines, which enhances public health safety and fosters trust in healthcare systems. This progress encourages local manufacturing, diminishing reliance on imported medicines and promoting economic development. Furthermore, ML3 NRAs are better equipped to address public health emergencies, enabling swift approvals for vaccines and therapeutics while upholding safety standards. Nonetheless, challenges persist, including fragmented regulatory systems, the prevalence of counterfeit medicines, and limited resources. Overcoming these hurdles necessitates enhanced organizational capacity, investments in training, and the promotion of collaboration among NRAs. There is an urgent call for greater political commitment and resource allocation to strengthen regulatory systems across Africa. Achieving and maintaining ML3 status is essential for enhancing medicine regulation, supporting local manufacturing, and improving public health outcomes across the continent. While progress has been made, sustained efforts are crucial to tackling existing challenges and harnessing the full potential of advanced regulatory frameworks. Full article
18 pages, 842 KiB  
Article
The Occurrence of Illicit Smart Drugs or Nootropics in Europe and Australia and Their Associated Dangers: Results from a Market Surveillance Study by 12 Official Medicines Control Laboratories
by Celine Vanhee, Eric Deconinck, Mark George, Andrew Hansen, Andreas Hackl, Uwe Wollein, Oliver El-Atma, Nico Beerbaum, Federica Aureli, Anna Borioni, Magdalena Poplawska, Agata Blazewicz, Karin Roschel, Claude Marson, Magnolia Mendoza Barrios, Birgit Hakkarainen, Andreas Blomgren, Ingrid Bakker-‘t Hart and Marta Miquel
J. Xenobiot. 2025, 15(3), 88; https://doi.org/10.3390/jox15030088 - 6 Jun 2025
Cited by 1 | Viewed by 4191
Abstract
In recent years, an increasing number of case reports have mentioned the presence of illicit nootropics, smart drugs or mind doping products on the market. To better understand the extent of the problem, a market surveillance study was organised by the General European [...] Read more.
In recent years, an increasing number of case reports have mentioned the presence of illicit nootropics, smart drugs or mind doping products on the market. To better understand the extent of the problem, a market surveillance study was organised by the General European Official Medicines Control Laboratory Network and associated member Australia to detect substandard, falsified or illegal medicines or dietary supplements containing unauthorised nootropic molecules of natural or synthetic origin. From January 2020 to September 2024, 159 different samples were documented, which yielded a comprehensive dataset of 166 molecular identification entries. Within this dataset, 34 distinct molecules were identified. Most samples were sold or presented as dietary supplements (49%) or medicines (32%). The vast majority (69%) were collected from the illegal market. Prescription drugs and non-authorised drugs only available on prescription in Russia were found in pharmacological quantities; some of the latter (noopept, phenylpiracetam and phenibut) were intercepted as large bulk quantities of raw material. Unauthorised novel foods, prescription or higher amounts of melatonin, and clinically uncharacterised research molecules were also reported. This study highlights the need for more active monitoring and screening of such products, as consumption of some of the reported samples could have detrimental health effects. Furthermore, as a large number of the samples were presented as dietary supplements, consumers may not be aware of the possible dangers and side-effects of these products. Full article
(This article belongs to the Section Nutraceutics)
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13 pages, 2074 KiB  
Article
A Cost-Effective Liquid Chromatography Method with Ultraviolet Detection for Identity Screening and Assay of Injectable Antibiotics
by Haile Kassahun Desta, Gebremariam Ketema, Ann Van Schepdael and Erwin Adams
Molecules 2025, 30(10), 2151; https://doi.org/10.3390/molecules30102151 - 13 May 2025
Viewed by 454
Abstract
The presence of substandard and falsified (SF) medicines poses a significant challenge in resource-limited countries. Low-quality antibiotics are commonly reported in low-income countries. The present study aimed to develop and validate a liquid chromatography method with ultraviolet detection (LC-UV) for the identity screening [...] Read more.
The presence of substandard and falsified (SF) medicines poses a significant challenge in resource-limited countries. Low-quality antibiotics are commonly reported in low-income countries. The present study aimed to develop and validate a liquid chromatography method with ultraviolet detection (LC-UV) for the identity screening and assay of 13 different injectable antibiotics, i.e., cefepime, amoxicillin, cefazolin, ampicillin, chloramphenicol, ceftazidime, ceftriaxone, cefotaxime, vancomycin, flucloxacillin, cloxacillin, benzylpenicillin, and meropenem in pharmaceutical formulations. Separation was performed using an XBridge C18 column and gradient elution. Mixtures of acetonitrile and 20 mM phosphate buffer (pH 8.0) were used as the mobile phases. The screening method was validated in terms of specificity and robustness, while linearity, precision, accuracy, and sensitivity were checked for the quantification method. The determination coefficients (R2) following linear regression were all greater than 0.999. The method showed good precision, with relative standard deviation values below 1%. The percentage recovery values were close to 100%. The method was applied to analyze 17 injectable antibiotics collected from the Ethiopian market. All commercial samples analyzed contained the correct API and met USP content specifications. Full article
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14 pages, 2084 KiB  
Article
Quantification of Metronidazole in Tablets: Combining Thin-Layer Chromatography in the GPHF-Minilab™ with Image Processing Using Open-Source ImageJ Software
by Christopher L. Harmon, Sean Butts, Mary Elizabeth Sowers, Ed Bethea and David Jenkins
Analytica 2024, 5(4), 538-551; https://doi.org/10.3390/analytica5040036 - 16 Oct 2024
Cited by 1 | Viewed by 2335
Abstract
The GPHF-Minilab™ is a portable toolkit for performing qualitative methods such as thin-layer chromatography (TLC) on common pharmaceuticals. It is particularly useful in resource-limited locations where it is more challenging to monitor for substandard and falsified (SF) medicines. However, the GPHF-Minilab™ TLC methods [...] Read more.
The GPHF-Minilab™ is a portable toolkit for performing qualitative methods such as thin-layer chromatography (TLC) on common pharmaceuticals. It is particularly useful in resource-limited locations where it is more challenging to monitor for substandard and falsified (SF) medicines. However, the GPHF-Minilab™ TLC methods are only semi-quantitative at best and thus have issues monitoring product quality effectively. We have improved on the GPHF-Minilab™ TLC method for metronidazole, a common antibiotic, by making it fully quantitative. Sample solutions were spotted on TLC plates alongside three metronidazole standards at different concentrations. After development, plates were imaged in a lightbox with two different smartphone cameras. Images were processed through the open-source program ImageJ and resulting pixel data from the standard spots were used to create a calibration curve, enabling quantitation of the sample. The USP Metronidazole Tablet high-performance liquid chromatography (HPLC) assay was used as the reference method. We validated this TLC method using 250 and 500 mg metronidazole tablets from different manufacturers and assessed linearity, range, accuracy, precision, intermediate precision, specificity, and robustness. These improvements should enhance the GPHF-Minilab™ TLC methods for metronidazole product screening. Additionally, the procedure is extensible to other analytes, although further validation would be required for each Minilab method. Full article
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18 pages, 4236 KiB  
Article
Development and Validation of a Near Infra-Red (NIR) Hand-held Spectrophotometric Method Using PCA Approaches and Chemometric Tools: Application for Qualitative and Quantitative Determination of Tadalafil Marketed in Kinshasa—D.R. Congo
by Jocelyn Mankulu Kakumba, Patient Ciza Hamuli, Merdie Mpemba Luyinama, Freddy Mugisho Kasago, Malachie Tembo Monyele, Dadit Ive Kitenge, Trésor Bayebila Menanzambi, Trésor Kimbeni Malongo, Didi Mana Kialengila and Jérémie Mbinze Kindenge
Spectrosc. J. 2024, 2(3), 105-122; https://doi.org/10.3390/spectroscj2030007 - 3 Jul 2024
Viewed by 1783
Abstract
A hand-held NIR spectrophotometric method was developed, validated, and applied for the determination of tadalafil in tablets. The aim of our work was to develop analytical methods based on vibrational techniques using low-cost portable equipment. Based on different chemometric modeling, we attempted to [...] Read more.
A hand-held NIR spectrophotometric method was developed, validated, and applied for the determination of tadalafil in tablets. The aim of our work was to develop analytical methods based on vibrational techniques using low-cost portable equipment. Based on different chemometric modeling, we attempted to validate the method, which gave encouraging results from the principal component analysis (PCA), DD-SIMCA, and PLS modeling. Following this, we optimized the method using an appropriate experiment plan. For validation, we used the total error approach with acceptance limits set at ±10% with a risk level of 5%. The method showed that it was possible to perform both qualitative and quantitative analysis of pharmaceutical products using low-cost portable NIR systems with chemometric tools. The developed approach enabled the completion of the first step in implementing an NIR method for quality control of tadalafil-based drugs in the DRC. Validation difficulties of the PLS method resulted from the lack of information about inter-day serial variations of spectral responses. It would be interesting to extend the study to a larger calibration interval in order to correct uncertainties that may result from the variability observed under different conditions and to verify robustness. These are the limitations of this work, but the results are nevertheless very encouraging. Full article
(This article belongs to the Special Issue Feature Papers in Spectroscopy Journal)
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15 pages, 1746 KiB  
Article
Development and Optimization of a New UPLC-UV/MS Method through DoE and MLR for Detecting Substandard Drug Products to Treat Tuberculosis
by Javier Suárez-González, Amor R. Cáceres-Pérez, Alexis Oliva, Ana Santoveña-Estévez and José B. Fariña
Molecules 2022, 27(20), 7141; https://doi.org/10.3390/molecules27207141 - 21 Oct 2022
Viewed by 3301
Abstract
Drug products used for treating tuberculosis are one of the most widely reported medicines to be classified as falsified or substandard in low- and middle-income countries, representing a major hazard to health. The aim of this study was, firstly, to develop an ultra-performance [...] Read more.
Drug products used for treating tuberculosis are one of the most widely reported medicines to be classified as falsified or substandard in low- and middle-income countries, representing a major hazard to health. The aim of this study was, firstly, to develop an ultra-performance liquid chromatography (UPLC) method which is able to analyze fixed combination tablets with up to four active pharmaceutical ingredients, including isoniazid, pyrazinamide, rifampicin, and ethambutol. Secondly, we aimed to optimize it through the design of experiments and multi-linear regression based on a central composite design and to validate it according to the guidelines of the International Conference on Harmonization. The application of this tools enabled the identification of the influential factors (flow rate, formic acid, and temperature) and their effects on the studied responses (retention factor and percentage for each drug) as part of the quality by design approach. The method proved to be to be linear in the range from 5.0 to 15 µg/mL for isoniazid, pyrazinamide, and rifampicin, being precise (<1%) and accurate (97–101%). In addition, the method validated for ethambutol proved to be linear from 1.4 to 4.2 µg/mL, as well as precise (0.54%) and accurate (97.3%). The method was stability indicated for all the active pharmaceutical ingredients studied and was able to detect two substandard formulations sampled on the African market. Full article
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16 pages, 2945 KiB  
Article
Discrimination of Falsified Erectile Dysfunction Medicines by Use of an Ultra-Compact Raman Scattering Spectrometer
by Tomoko Sanada, Naoko Yoshida, Kazuko Kimura and Hirohito Tsuboi
Pharmacy 2021, 9(1), 3; https://doi.org/10.3390/pharmacy9010003 - 24 Dec 2020
Cited by 11 | Viewed by 3423
Abstract
Substandard and falsified medicines are often reported worldwide. An accurate and rapid detection method for falsified medicines is needed to prevent human health hazards. Raman scattering spectroscopy has emerged as a non-destructive analysis method for the detection of falsified medicines. In this laboratory [...] Read more.
Substandard and falsified medicines are often reported worldwide. An accurate and rapid detection method for falsified medicines is needed to prevent human health hazards. Raman scattering spectroscopy has emerged as a non-destructive analysis method for the detection of falsified medicines. In this laboratory study, Raman spectroscopy was performed to evaluate the applicability of the ultra-compact Raman scattering spectrometer (C13560). Principal component analysis (PCA) was also performed on the Raman spectra. This study analyzed tadalafil (Cialis), vardenafil (Levitra), and sildenafil (Viagra) tablets. We tested the standard product and products purchased from the internet (genuine or falsified). For Cialis and Levitra, all falsified tablets were identified by the Raman spectra and PCA score plot. For Viagra, the Raman spectra of some falsified tablets were almost comparable to the standard tablet. The PCA score plots of falsified tablets were dispersed, and some plots of falsified tablets were close to the standard tablet. In conclusion, C13560 was useful for the discrimination of falsified Cialis and Levitra tablets, whereas some falsified Viagra tablets had Raman spectra similar to that of the standard tablet. The development of detection methods that can be introduced in various settings may help prevent the spread of falsified products. Full article
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11 pages, 1318 KiB  
Article
Substandard and Falsified Medicines in Myanmar
by Mirai Sakuda, Naoko Yoshida, Takashi Takaoka, Tomoko Sanada, Mohammad Sofiqur Rahman, Tsuyoshi Tanimoto, Theingi Zin, Kazuko Kimura and Hirohito Tsuboi
Pharmacy 2020, 8(1), 45; https://doi.org/10.3390/pharmacy8010045 - 19 Mar 2020
Cited by 9 | Viewed by 4462
Abstract
Background: substandard and falsified medicines (SFMs) are a threat to public health. The availability of SFMs in Myanmar was reported by the World Health Organization (WHO) in 1999, but there have been few systematic surveys on falsified medicines in Myanmar since then. The [...] Read more.
Background: substandard and falsified medicines (SFMs) are a threat to public health. The availability of SFMs in Myanmar was reported by the World Health Organization (WHO) in 1999, but there have been few systematic surveys on falsified medicines in Myanmar since then. The aim of this study is to examine the extent of SFMs for sale in Myanmar. Methods: target medicines were tablets of candesartan, metformin, and pioglitazone, and infusions of ciprofloxacin and levofloxacin. Samples were collected from hospitals, pharmacies, and wholesalers located in the Mandalay region in 2015. We carried out observation testing, authenticity investigation, and quality testing to search for SFMs, and analyzed the relationship between SFMs and the price and store type. Results: There were no falsified medicines found in the authenticity check, though there remained a problem due to low response rates from manufacturers and regulatory authorities. In the quality test, some tablets of metformin and pioglitazone made in India failed the dissolution test. Conclusions: although no serious problems were found, some substandard medicines were detected. Regular surveys to monitor SFMs are therefore recommended, together with further regulatory guidance to improve conditions in all medicine manufacturers, distributors, and pharmacies. Full article
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