The production of counterfeit or substandard anti-infective drugs is a widespread and under-recognised problem that contributes to morbidity, mortality, and drug resistance, and leads to spurious reporting of resistance and toxicity and loss of confidence in health-care systems. Counterfeit drugs particularly affect the most disadvantaged people in poor countries. Although advances in forensic chemical analysis and simple field tests will enhance drug quality monitoring, improved access to inexpensive genuine medicines, support of drug regulatory authorities, more open reporting, vigorous law enforcement, and more international cooperation with determined political leadership will be essential to counter this threat.

https://www.thelancet.com/pdfs/journals/laninf/PIIS1473-3099(06)70581-3.pdf

Counterfeit anti-infective drugs

Plasmodium falciparum malaria remains a major public health problem. A vital component of malaria control rests on the availability of good quality artemisinin-derivative based combination therapy (ACT) at the correct dose. However, there are increasing reports of poor quality anti-malarials in Africa. Seven collections of artemisinin derivative monotherapies, ACT and halofantrine anti-malarials of suspicious quality were collected in 2002/10 in eleven African countries and in Asia en route to Africa. Packaging, chemical composition (high performance liquid chromatography, direct ionization mass spectrometry, X-ray diffractometry, stable isotope analysis) and botanical investigations were performed. Counterfeit artesunate containing chloroquine, counterfeit dihydroartemisinin (DHA) containing paracetamol (acetaminophen), counterfeit DHA-piperaquine containing sildenafil, counterfeit artemether-lumefantrine containing pyrimethamine, counterfeit halofantrine containing artemisinin, and substandard/counterfeit or degraded artesunate and artesunate+amodiaquine in eight countries are described. Pollen analysis was consistent with manufacture of counterfeits in eastern Asia. These data do not allow estimation of the frequency of poor quality anti-malarials in Africa. Criminals are producing diverse harmful anti-malarial counterfeits with important public health consequences. The presence of artesunate monotherapy, substandard and/or degraded and counterfeit medicines containing sub-therapeutic amounts of unexpected anti-malarials will engender drug resistance. With the threatening spread of artemisinin resistance to Africa, much greater investment is required to ensure the quality of ACTs and removal of artemisinin monotherapies. The International Health Regulations may need to be invoked to counter these serious public health problems.

/pdf/poor-quality-vital-anti-malarials-in-africa-an-urgent-3p1jdbb5yv.pdf

Poor quality vital anti-malarials in Africa - an urgent neglected public health priority.

Development of NIRS method for quality control of drug combination artesunate–azithromycin for the treatment of severe malaria

Pharmaceutical counterfeiting is becoming a serious problem all over the world. This paper presents several of the most important methods used to elucidate this problem including near- and mid-infrared spectroscopy, Raman spectroscopy, isotopic characterization, chromatographic and mass spectrometric approaches. Key Words : counterfeit drugs; spectroscopic methods ; pharmaceutical drugs; herbal   medicines.

https://dergipark.org.tr/en/download/article-file/83588

Spectroscopic Analytical Methods for Detection of Counterfeit Pharmaceutical Preparations – A Mini- Review

Carrying out chemical analysis of antimalarials to detect low-quality medications before they reach a patient is a costly venture. Here, we show that a library of chemical color tests embedded on a paper card can presumptively identify formulations corresponding to very low quality antimalarial drugs. The presence or absence of chloroquine (CQ), doxycycline (DOX), quinine, sulfadoxine, pyrimethamine, and primaquine antimalarial medications, in addition to fillers used in low-quality pharmaceuticals, are indicated by patterns of colors that are generated on the test cards. Test card sensitivity for detection of these pure components ranges from 90% to 100% with no false positives in the absence of pharmaceutical. The color intensities from reactions characteristic of CQ or DOX allowed visual detection of formulations of these medications cut with 60% or 100% filler, although samples cut with 30% filler could not be reliably detected colorimetrically. However, the addition of unexpected fillers, even in 30% quantities, or substitute pharmaceuticals, could sometimes be detected by other color reactions on the test cards. Tests are simple and inexpensive enough to be carried out in clinics, pharmacies, and ports of entry and could provide a screening method to presumptively indicate very low quality medicines throughout the supply chain.

/pdf/paper-test-cards-for-presumptive-testing-of-very-low-quality-5fhl0yi9xu.pdf

Paper Test Cards for Presumptive Testing of Very Low Quality Antimalarial Medications

Corrigendum to "Use of refractometry and colorimetry as field methods to rapidly assess antimalarial drug quality" [J. Pharm. Biomed. Anal.

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Corrigendum to "Use of refractometry and colorimetry as field methods to rapidly assess antimalarial drug quality" [J. Pharm. Biomed. Anal.