Poor Quality Drugs Research Articles

Ways to Resolve Global Problem of Collection, Conveyance and Disposal of Hazardous Medical Wastes in Ukraine

This scientific paper studies the procedure and specific aspects of collection, conveyance and disposal of hazardous medical wastes in Ukraine. Drawing on analysis of the state of matters in the sphere of collection, conveyance and disposal of hazardous medical wastes in Ukraine, we proposed effective ways to resolve this problem. With a view to improve the procedure for collection, conveyance and disposal of hazardous medical wastes in Ukraine, we proposed, firstly, to strengthen public control over the state procurement with the help of “DoZor public”, an online platform, where everyone can provide a feedback to a state customer or supplier, society or law enforcement authorities regarding the conducted procurement procedure, discuss and evaluate the terms of a particular purchase, and analyze purchases of a particular customer. Secondly, insufficient control by the state also provokes emergence of such situations. In this context, it is expedient to lift the moratorium on inspections of business entities by the controlling bodies. It has been established that the main sources of generation of pharmaceutical and medical wastes in Ukraine are: medical waste from hospitals, health centers, health resorts, outpatient clinics, etc.; materials from laboratories and pharmaceutical manufacturing enterprises; tissues and body parts from surgical theaters; expired drug products; medical devices; leftover medicines in the form of liquid medicines, pills, solutions, etc. in a household setting; waste from pharmacies, pharmacy branches and pharmacy kiosks; packaging materials from drug products, etc. The author has investigated the main methods employed for destruction of poor-quality drugs in the form of solid products, powders (pills, capsules, granules, powders for injection), semisolid drugs (creams, gels, ointments) by means of encapsulation, inertization or high-temperature incineration.

P5712Research Network in Africa (RNA): quality assessment of antihypertensive generic drugs in 10 African countries

Abstract Introduction Hypertension results in more deaths than any other risk factor and has been on the rise in Sub-Saharan Africa over the past few decades. Generic drugs have helped improve accessibility and affordability of antihypertensive therapy in developing countries. However, assessment of quality standards of these products is important. Purpose We performed a quality assessment of five commonly used antihypertensive generic drugs in ten Sub-Saharan African countries and studied the impact of price on quality. Methods Drug samples were prospectively collected using standardized methods between 2012 and 2014. We developed a validated reversed-phase liquid chromatography with tandem mass spectrometry method to accurately quantify the active ingredient in a certified public laboratory. Quality was defined based on the percentage ratio of measured to expected dosage of active ingredient. Results A total of 1185 samples were assessed, of which 70.0% were generic (n=830). Among the generic drugs, the percentage of poor quality drugs was 24.3% (n=202/830). The percentage ratio of measured to expected dosage of active ingredient ranged from 49.2% to 111.3%; the majority (81.7%) of the poor quality samples had insufficient quantity of the active ingredient. Moreover, poor quality was not associated with purchase price of the drug. Conclusion In this study from ten Sub-Saharan African countries, nearly one-quarter of the available generic antihypertensive drugs were found to be of poor quality. Concerted measures to improve the quality of antihypertensive drugs could lead to major improvements in hypertension control with attendant reduction of its deleterious consequences in low and middle income countries. Figure 1. Percentage of poor quality in generic antihypertensive drugs according to the country of purchase. Acknowledgement/Funding Grant AAP-2014-042, ANSM (Agence Nationale Sécurité du Médicament

Falsified and Substandard Drugs: Stopping the Pandemic.

Falsified and substandard medicines are associated with tens of thousands of deaths, mainly in young children in poor countries. Poor-quality drugs exact an annual economic toll of up to US$200 billion and contribute to the increasing peril of antimicrobial resistance. The WHO has emerged recently as the global leader in the battle against poor-quality drugs, and pharmaceutical companies have increased their roles in assuring the integrity of drug supply chains. Despite advances in drug quality surveillance and detection technology, more efforts are urgently required in research, policy, and field monitoring to halt the pandemic of bad drugs. In addition to strengthening international and national pharmaceutical governance, in part by national implementation of the Model Law on Medicines and Crime, a quantifiable Sustainable Development Goal target and an international convention to insure drug quality and safety are urgent priorities.

Corruption and Medicine Quality in Latin America: A Pilot Study

Abstract Fake and substandard medicines are a significant problem in developing nations, and a growing problem in developed ones too. There have been assessments of basic medicine quality from many countries and regions across the world but almost none in Central and South America. Over the past decade, as part of our research, we have collected over ten thousand samples of medicines from 22 cities in emerging markets, but the only one from the Latin region was Sao Paolo in Brazil. We have now rectified this gap, at least for one critical medicine, the broad spectrum antibiotic ciprofloxacin. Using original, self-collected data from ten countries in Latin America, we test whether the 687 Ciprofloxacin treatments pass the Global Pharma Health Fund e.V. Minilab® protocol to identify substandard or counterfeit medicines. In terms of quality, 93 percent of drugs were good quality. Within the drugs that failed the quality test, the majority were substandard rather than fake. About 26 % of the poor quality drugs were fake, with zero active pharmaceutical ingredient (API), while the rest were substandard, with less than 80 % API. In line with results from our earlier studies, we find that products that were locally registered, as well as those with SRA or WHO pre-qualification, were more likely to pass the test. A new finding in this paper is that corruption is a key predictor of poor quality drugs. Less corrupt countries had higher levels of passing drugs.

Substandard drugs among five common antihypertensive generic medications: an analysis from 10 African countries.

Hypertension results in more deaths than any other risk factor and has been on the rise in sub-Saharan Africa over the past few decades. Generic drugs have helped improve accessibility and affordability of antihypertensive therapy in developing countries. However, assessment of quality standards of these products is important. We performed a quality assessment of five commonly used antihypertensive generic drugs in 10 sub-Saharan African countries and studied the impact of price on quality. Drug samples were prospectively collected using standardized methods between 2012 and 2014. We developed a validated reversed-phase liquid chromatography with tandem mass spectrometry method to accurately quantify the active ingredient in a certified public laboratory. Quality was defined based on the percentage ratio of measured to expected dosage of active ingredient. A total of 1185 samples were assessed, of which 70.0% were generic (n = 830). Among the generic drugs, the percentage of poor-quality drugs was 24.3% (n = 202/830). The percentage ratio of measured to expected dosage of active ingredient ranged from 49.2 to 111.3%; the majority (81.7%) of the poor-quality samples had insufficient quantity of the active ingredient. Moreover, poor quality was not associated with purchase price of the drug. In this study from 10 sub-Saharan African countries, nearly one-quarter of the available generic antihypertensive drugs were found to be of poor quality. Concerted measures to improve the quality of antihypertensive drugs could lead to major improvements in hypertension control with attendant reduction of its deleterious consequences in low-income and middle-income countries.

Aberrant use and poor quality of trypanocides: a risk for drug resistance in south western Ethiopia

BackgroundTrypanocidal drugs have been used to control African animal trypanosomosis for several decades. In Ethiopia, these drugs are available from both authorized (legal) and unauthorized (illegal) sources but documentation on utilization practices and quality of circulating products is scanty. This study looked at the practices of trypanocidal drug utilization by farmers and the integrity of active ingredient in trypanocides sold in Gurage zone, south western Ethiopia. The surveys were based on a structured questionnaire and drug quality determination of commonly used brands originating from European and Asian companies and sold at both authorized and unauthorized markets. One hundred farmers were interviewed and 50 drug samples were collected in 2013 (Diminazene aceturate = 33 and Isometamidium chloride = 17; 25 from authorized and 25 from unauthorized sources). Samples were tested at the OIE-certified Veterinary Drug Control Laboratory (LACOMEV) in Dakar, Senegal, by using galenic standards and high performance liquid chromatography.ResultsTrypanosomosis was found to be a major threat according to all interviewed livestock keepers in the study area. Diminazene aceturate and isometamidium chloride were preferred by 79% and 21% of the respondents respectively, and 85% of them indicated that an animal receives more than six treatments per year. About 60% of these treatments were reported to be administered by untrained farmers. Trypanocidal drug sources included both unauthorized outlets (56%) and authorized government and private sources (44%). A wide availability and usage of substandard quality drugs was revealed. Twenty eight percent of trypanocidal drugs tested failed to comply with quality requirements. There was no significant difference in the frequency of non-compliance between diminazene-based and isometamidium chloride products (P = 0.87) irrespective of the marketing channel (official and unofficial). However, higher rates of non-compliant trypanocides were detected for drugs originating from Asia than from Europe (P = 0.029).ConclusionThe findings revealed the presence of risk factors for the development of drug resistance, i.e. wide distribution of poor quality drugs as well as substandard administration practices. Therefore, it is strongly recommended to enforce regulatory measures for quality control of veterinary drugs, to expand and strengthen veterinary services and to undertake trypanocidal drug efficacy studies of wider coverage.

Fighting fake medicines: First quality evaluation of cardiac drugs in Africa

BackgroundThe growing menace of poor quality and falsified drugs constitutes a major hazard, compromising healthcare and patient outcomes. Efforts to assess drug standards worldwide have almost exclusively focused on anti-microbial drugs; with no study to date on cardiovascular drugs.Our study aims to assess quality of seven routinely used cardiovascular medications (anticoagulants, antihypertensives and statins) in ten Sub-Saharan African countries. MethodsDrugs were prospectively collected using standardized methods between 2012 and 2014 from licensed (random pharmacies) and unlicensed (street-markets) places of sale in Africa. We developed a validated reversed-phase liquid chromatography with tandem mass spectrometry method to accurately quantify the active ingredient in a certified public laboratory. Three quality categories were defined based on the ratio of the measured to the expected dosage of the active ingredient: A (good quality): 95% to 105%, B (low quality): 85 to 94.99% or 105.01 to 115%, C (very low quality): <85% or >115%. ResultsAll expected medicines (n=3468 samples) were collected in Benin, Burkina-Faso, Congo-Brazzaville, the Democratic Republic of Congo, Guinea, Côte d'Ivoire, Mauritania, Niger, Togo and Senegal. Out of the 1530 samples randomly tested, poor quality (types B and C) was identified in 249 (16.3%) samples. The prevalence of poor quality was significantly increased in certain specific drugs (amlodipine 29% and captopril 26%), in generic versions (23%) and in drugs produced in Asia (35%). The proportion of poor quality reached 50% when drugs produced in Asia were sold in street-markets. ConclusionIn this first study assessing the quality of cardiovascular drugs in Africa, we found a significant proportion of poor quality drugs. This requires continued monitoring strategies.

Poor-Quality and Counterfeit Drugs: A Systematic Assessment of Prevalence and Risks Based on Data Published From 2007 to 2016

Counterfeit drugs can hurt patients and harm the pharmaceutical industry. In 2006, the International Medical Products Anti-Counterfeiting Taskforce expressed a need to generate more and better data to calculate a worldwide prevalence of counterfeiting. This review analyzes field test data that were published in the time frame January 2007 to December 2016, were accessible via Pubmed, and which addressed the prevalence of counterfeit drugs. Based on the 41 studies identified, it is still not possible to make a reliable statement about the prevalence of counterfeit drugs due to the heterogeneity of the results. To make further progress in this area, both the quantity and quality of documented field tests should be increased. Without a differentiated analysis considering therapeutic class, source, and country of counterfeit drugs, it will remain difficult to identify the root causes of market infiltration and useful points of attack to combat them. Studies with high sample power and randomized sampling, packaging inspection, and detailed chemical analysis will be necessary to correctly identify (especially professional) counterfeit samples. The classification system presented in this review should help to calculate not only the prevalence of counterfeit drugs but also the risks to the patient associated with different types of counterfeited medicines.

IDENTIFICATION OF SOME COMPOSITE MEDICINAL DRUGS CONTAINING PARACETAMOL, WITH IR-SPECTROMETRY METHOD

A serious threat to the health of the population is falsified medicines. In a number of cases, they are identified in the process of incoming quality control for compliance with the requirements of regulatory documents for indicators “Description”, “Packaging”, “Marking”. However, in order to identify sophisticated counterfeits, only a visual assessment of the drug is not enough. Purpose screening evaluation of potentially counterfeited or poor-quality drugs using the IR spectrometry along the total spectrum. Materials and methods. The objects of research were available in freely available commercially available tablets produced by domestic and foreign manufacturers “Paracetamol Extratab”, “Solpadein fast”, “Citrapac”, “Citramon P”, “Ascofen-P”, corresponding to the requirements of the current regulatory documents. The studies were carried out on a Fourier-Spectrophotometer infrared “FSM 1201”. Results and discussion. On the example of the tablets “Citramon P”, “Ascophen-P”, “Citrapac”, “Paracetamol Extratab”, “Solpadein Fast” the possibility of using the total IR spectra as a primary screening index of authenticity is shown. It was established that the total IR spectra of medicines of similar composition reflect the similarity of serial samples of the products of one manufacturer and the difference in serial samples of products of different manufacturers.

Comparative Chromatographic and Spectrophotometric Methods for Quantitative Estimation of Paracetamol in Analgesic Tablet Dosage Forms

Poor quality drugs pose a challenge to many countries especially the developing countries. This present study is a scientific approach to further combat medicines counterfeiting as well as the validation of claimed drug specification on labels. This was achieved by comparing two analytical methods viz; spectrophotometric (UV-Vis) and Chromatographic (HPLC) techniques for quantification of Paracetamol (4-acetamidophenol) in selected analgesics marketed in Lafia, Nigeria. The statistical validation parameters such as linearity and methodic error (accuracy, precision) tests were verified and reported in terms of deviation and significance. The tagged 500 mg/tab Paracetamol concentrations for procured Para-P, X, Y and Z were estimated to range between 505.62-570.70 mg/tab and 459.42-512.58 mg/tab using UV-Visible and HPLC respectively. It was reported that experimental paracetamol concentration compares well with the claimed label specification and are within limits prescribed by existing legislation. From results in this study, deviations in API’s concentration values between the two techniques are reasonable but of no statistical significance.

Outbreak of facio-troncular dystonia in central Africa due to diazepam replaced by haloperidol in oral medications

During week 52, 2014, in the north-east of the Democratic Republic of Congo, an African area included in the “Meningitis belt of Africa” and in which malaria is endemic, patients with suspected but atypical meningitis were reported. In January 2015, Médecins sans Frontières (MSF) Geneva, was approached by the Ministry of Health to support the outbreak. At the scene, data were collected on individual chart file records. Thereafter, at MoH and MSF case-management sites, information for each patient were recorded in a standardized Excel line-list. Patients’ demographic characteristics, clinical features, and discharge were recorded. At per request of the attending physician, cerebrospinal fluid was analysed for evidence of meningitis and blood for malaria. Toxicological analysis included liquid chromatography–Mass spectrometry and high performance liquid chromatography–UV spectrometry on urine specimens. Initial examination suggested that an illness other than bacterial meningitis was the cause of patients’complaints. Thereafter non-tonico-clonic seizures were considered. The MSF referent toxicologist was consulted. The definitive diagnosis made on pictures and videos. From January to August 2015, 1021 hospitalisations were recorded in 925 patients. Looking for the source of haloperidol showed that tablets sold as ‘diazepam’ and consumed by symptomatic patients contained haloperidol as the sole active pharmaceutical ingredient, suggesting that this large outbreak was due to haloperidol toxicity from falsified diazepam. However, the cause of the error is presently under investigation. This outbreak emphasizes the need to consider toxicity resulting from error in medicines when facing collective atypical signs and symptoms. To address such outbreaks, an international multidisciplinary collaboration, including clinical toxicologists, working in collaboration with medicine regulatory authorities is mandatory to address the major challenge of poor-quality drugs in developing countries. The mechanism and the cause of error in dosing are presently under investigation.

Pilot testing of dipsticks as point-of-care assays for rapid diagnosis of poor-quality artemisinin drugs in endemic settings.

BackgroundGood-quality artemisinin drugs are essential for malaria treatment, but increasing prevalence of poor-quality artemisinin drugs in many endemic countries hinders effective management of malaria cases.MethodsTo develop a point-of-care assay for rapid identification of counterfeit and substandard artemisinin drugs for resource-limited areas, we used specific monoclonal antibodies against artesunate and artemether, and developed prototypes of lateral flow dipstick assays. In this pilot test, we evaluated the feasibility of these dipsticks under different endemic settings and their performance in the hands of untrained personnel.ResultsThe results showed that the dipstick tests can be successfully performed by different investigators with the included instruction sheet. None of the artemether and artesunate drugs collected from public pharmacies in different endemic countries failed the test.ConclusionIt is possible that the simple dipstick assays, with future optimization of test conditions and sensitivity, can be used as a qualitative and semi-quantitative assay for rapid screening of counterfeit artemisinin drugs in endemic settings.

Re-framing ‘counterfeit from a public health perspective’: A case for fraudulent medicine

‘Black market’ counterfeiters operating outside of authorised industry are often framed as the perpetrators of dangerous and defective medicines within legal pharmaceutical markets. However, the assumption that all medicines which deliberately violate regulatory standards and quality specifications have black market origins is ill conceived, as poor medicine quality can occur regardless of who the manufacturer of the medicine may be. This paper proposes a reframing of all pharmaceutical products which intentionally, or negligently, fail to comply with regulatory standards and which are then fraudulently depicted as being of standard, from ‘counterfeit’ to ‘fraudulent medicines’. This proposal is reinforced with examples from Australian law, where Australian pharmaceutical companies, who deliberately violated regulatory standards and produced defective and dangerous medicines, have been prosecuted using legislation designed to capture poor-quality counterfeit drugs. The paper argues that these corporate crimes should not be framed as ‘counterfeiting’ but as ‘frauds’, thus containing acts of ‘counterfeiting’ to existing intellectual property law and providing due recognition for all acts which defraud and cause harm to the consumer.

Pharmacological Iatrogenesis: Substance/Medication-Induced Disorders That Masquerade as Mental Illness

Introduction: This paper addresses the epidemiological consequences of not teaching prescribers and patients what they need to know about human distress and adverse effects of medications. Materials and Methods: Published data available in the public arena revealed increased morbidity, demand for care and costs, increased youth and adult suicides and homicides within taxpayer-funded Mental Health Services in New South Wales and increased disability and requirement for support. The origins of the dominant mental health care paradigm of the antidepressant era were identified in multiple forms: fraudulent promotion, biased education by drug companies, captured regulators, institutional ideologies, ghost-written clinical practice guidelines, poor quality product information and drug approval procedures that ensured neither safety nor efficacy. Misreported clinical trial data for new antidepressants and atypical antipsychotics revealed undisclosed suicides, deaths and drop-outs in clinical trials demonstrating lack of safety and efficacy. Results: There have been increases in costs, demand, morbidity, suicide, homicide, deaths and disability under mental health care consistent with known adverse effects of medication. The background of some 600 cases of adverse drug reactions causing hospital admissions, suicides, violence confirmed that the epidemic comprised of adverse effects of medications. 95% were persons were misdiagnosed with mental illnesses after medication and 5 percent had mental illnesses before. Both groups had adverse drug reactions. Discussion: Information about safety and efficacy has been manipulated in favor of the pseudo-scientific ideology of the pharmaceutical industry. There was a pill for every ill and another for each side effect Regulators and governments remain in denial although this public health problem is in plain sight and in the public arena. Misinformation has resulted in prescribing practices that produced an epidemic of akathisia-related suicide and homicide as well as substance/medication-induced conditions mimicking the mental illnesses that the drugs were supposed to cure or prevent.

Assessing the quality of anti-malarial drugs from Gabonese pharmacies using the MiniLab®: a field study.

BackgroundRecent studies alluded to the alarming scale of poor anti-malarial drug quality in malaria-endemic countries, but also illustrated the major geographical gaps in data on anti-malarial drug quality from endemic countries. Data are particularly scarce from Central Africa, although it carries the highest burden of malaria. The aim of this medicine quality field survey was to determine the prevalence of poor-quality anti-malarial drugs in Gabon.MethodsA field survey of the quality of anti-malarial drugs in Gabonese pharmacies was conducted using the Global Pharma Health Fund Minilab® tests, following the Medicine Quality Assessment Reporting Guidelines. Anti-malarial drugs were purchased randomly from selected pharmacies in Gabon. Semi-quantitative thin-layer chromatography (TLC) and disintegration testing were carried out to measure the concentration of active pharmaceutical ingredients (APIs). The samples failing the TLC test were analysed by high-performance liquid chromatography. Following the collection of anti-malarial drugs, a street survey was conducted to understand where people purchase their anti-malarial drugs.ResultsA total of 432 samples were purchased from 41 pharmacies in 11 cities/towns in Gabon. The prevalence of poor-quality anti-malarial drugs was 0.5% (95% CI 0.08–1.84%). Two out of 432 samples failed the MiniLab® semi-quantitative TLC test, of which a suspected artemether-lumefantrine (AL) sample was classified as falsified and one sulfadoxine-pyrimethamine (SP) sample as substandard. High performance liquid chromatography with ultraviolet photo diode array detection analysis confirmed the absence of APIs in the AL sample, and showed that the SP sample did contain the stated APIs but the amount was half the stated dose. Of the people interviewed, 92% (187/203) purchased their anti-malarial drugs at a pharmacy.ConclusionUsing the GPHF Minilab®, the prevalence of poor-quality anti-malarial drugs is far lower than anticipated. The findings emphasize the need for randomized and robust sampling methods in order to collect representative data on anti-malarial drug quality.Trial registration: NTR4341 (Dutch Trial Registry)Electronic supplementary materialThe online version of this article (doi:10.1186/s12936-015-0795-z) contains supplementary material, which is available to authorized users.

The global pandemic of falsified medicines: laboratory and field innovations and policy perspectives.

This supplement to the American Journal of Tropical Medicine and Hygiene, entitled “The pandemic of falsified medicines: laboratory and field innovations and policy perspectives,” showcases 17 articles on detection technologies and methods, field surveillance data, multisectorial perspectives, and policy interventions and recommendations needed to create a coordinated and effective response to curb the pandemic of poor-quality medicines. The goal of this special issue is to alert scientists, public health authorities, and decision makers to the problem of poor-quality drugs and to take prompt actions to mitigate and resolve the growing peril. Poor-quality medicines are a real and urgent threat to decades of success in global public health, particularly for programs combating human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), tuberculosis, and malaria where mortality rates have seen dramatic declines worldwide.1–3 Safe, effective, high-quality, and affordable medical products are essential to positive and equitable health outcomes for all, as noted by the U.S. Food and Drug Administration (FDA) Commissioner, Margaret Hamburg, in her Foreword to this supplement.4 Although previously thought to be limited to low-income countries with weak pharmaceutical regulatory systems and problems with antimalarials (Figure 1 ), increasing reports of a large variety of poor-quality medicines and medicinal products, such as vitamin supplements, in high- and middle-income economies are illustrative of the pandemic nature of this problem.5–7 It is estimated that falsified medicines result in $75 billion in illegal annual revenues to criminals and have caused prolonged, severe illness and deaths worldwide; this figure needs more precision.8 The increasing number of countries reporting breaches of the supply chain, and products being falsified, along with the recent doubling of articles published on “fake drugs” every 5 years in PubMed indicate the problem is of pandemic proportions and growing. This may be an underestimate of the problem. Incidents regarding the distribution and use of poor-quality pharmaceuticals often go unreported due to poor surveillance systems and are kept from the public record by governments and pharmaceutical companies.9 Further clouding the problem is an ongoing debate and confusion over terms related to poor-quality medicines.10,11 In this summary, we use the term falsified as a synonym for counterfeit, devoid of considerations of intellectual property. We classify poor-quality drugs into three main types: falsified (intentional fraudulent manufacturing), substandard (unintentional errors caused in manufacturing), and degraded (medicines that become poor quality after manufacturing because of poor storage environments or handling). Figure 1. Increasing reports of poor-quality antimalarials, 1976–2012, Worldwide Antimalarial Resistance Network (WWARN), Antimalarial Quality Surveyor.5 In 2013, an estimated 122,350 deaths in children under 5 years of age in 39 sub-Saharan African countries were associated with the consumption of poor-quality antimalarials, representing 4% of all under-five deaths, as reported by Renschler and others.12 The impact of falsified and substandard medicines goes beyond the morbidity and mortality affecting vulnerable patients and extends to increased microbial resistance, when active drug is in low amounts in the product; existing drug-resistant microbes in patients can be spread by mosquitoes and other vectors when no active ingredient is present. In addition, socioeconomic losses and loss of public trust are associated with poor-quality medicines, all of which jeopardize years of global public health success and investments.13 Over the last decade, many new stakeholders have joined the cause to combat poor-quality medicines, yet little tangible progress has been made. Moreover, the problem continues to spread globally, creating an even greater challenge to cooperation among stakeholders, many with limited resources.8,10,13 The need is urgent for collaboration among those with expertise in policy, technology, surveillance, and logistics to secure global medicine supply chains.

Rapid and specific drug quality testing assay for artemisinin and its derivatives using a luminescent reaction and novel microfluidic technology.

Globally, it is estimated that about 10–30% of pharmaceuticals are of poor quality. Poor-quality drugs lead to long-term drug resistance, create morbidity, and strain the financial structure of the health system. The current technologies for substandard drug detection either are too expensive for low-resource regions or only provide qualitative results. To address the current limitations with point-of-care technologies, we have developed an affordable and robust assay to quantify the amount of active pharmaceutical ingredients (APIs) to test product quality. Our novel assay consists of two parts: detection reagent (probe) and a microfluidic testing platform. As antimalarials are of high importance in the global fight against malaria and are often substandard, they are chosen as the model to validate our assay. As a proof-of-concept, we have tested the assay with artesunate pure and substandard samples (Arsuamoon tablets) from Africa and compared with the conventional 96-well plate with spectrophotometer to demonstrate the quantitative efficacy and performance of our system.

Current scenario of spurious and substandard medicines in India: a systematic review.

Globally, every country is the victim of substandard or spurious drugs, which result in life threatening issues, financial loss of consumer and manufacturer and loss in trust on health system. The aim of this enumerative review was to probe the extent on poor quality drugs with their consequences on public health and the preventive measures taken by the Indian pharmaceutical regulatory system. Government and non-government studies, literature and news were gathered from journals and authentic websites. All data from 2000 to 2013 were compiled and interpreted to reveal the real story of poor quality drugs in India. For minimizing spurious/falsely-labelled/falsified/counterfeit drugs or not of standard quality drugs, there is urgent requirement of more stringent regulation and legal action against the problem. However, India has taken some preventive steps in the country to fight against the poor quality drugs for protecting and promoting the public health.

Poor-Quality Drugs and Global Trade: A Pilot Study

AbstractExperts claim that some Indian drug manufacturers cut corners and make substandard drugs for markets with nonexistent, underdeveloped, or emerging regulatory oversight, notably Africa. This paper assesses the quality of 1,470 antibiotic and tuberculosis drug samples in solid oral form (tablet or capsule) that claim to be made in India and were sold in Africa, India, and five mid-income non-African countries. We find that 10.9 percent of those products fail a basic assessment of active pharmaceutical ingredients (API), and the majority of the failures are substandard (7 percent) as they contain some correct API but the amount of API is underdosed. The distribution of these substandard products is not random: they are more likely to be found as unregistered products in Africa than in India or non-African countries. Moreover, our finding is robust for manufacturer-drug fixed effects, and is unlikely to be explained by differences in storage conditions as the five Indian cities in our sample are on av...

Antiplasmodial Activity of Aqueous leaf Extract of Cymbopogon citratus against Plasmodium falciparum Infected Rats

In Nigeria, malaria is a major public health problem and there are high cost of the effective antimalarial drugs, poor quality drugs and increased emergence of Plasmodial resistance. Thus, there is a need for alternative source of medicine in malaria treatment and prevention. The antimalarial potential of aqueous leaf extracts of Cymbopogon citratus was investigated in this present study. Twenty five Swiss albino rats with average weight of 30.80g were distributed into five groups (A, B, C, D and E) with five mice per group. Group B was infected with 0.2 ml O+ human parasitized blood of Plasmodium falciparum and 0.1ml Chloroquine (Bini Laboratories Pvt Ltd). Group C, D, and E were infected with 0.2 ml O+ human parasitized blood of Plasmodium falciparum treated with 40 mg/kg, 80 mg/kg and 120 mg/kg of Cymbopogon citratus extracts respectively for three days. The mice infected with 0.2 ml O+ human parasitized blood of Plasmodium falciparum were observed for 72 hours for general symptoms of malaria. The mice tail was punctured, blood was examined under light microscope (x10) resolution) and several malaria parasites were found. Significant decrease of parasitemia levels was observed in 120 mg/kg body weight treated group compared to 0.1 ml Chloroquine the positive control. The result showed that Cymbopogon citratus possessed a good antimalarial property and can be use for prophylactic and chemotherapeutic purposes.