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RESUMEN Objetivo. Identificar y analizar los incidentes de productos médicos subestándares, falsificados, no registrados y robados al inicio de la pandemia de COVID-19. Métodos. Búsqueda detallada en los sitios web de las autoridades reguladoras de las Américas. Identificación de los incidentes de medicamentos y dispositivos médicos (incluidos los de diagnóstico in vitro) subestándares falsificados, no registrados y robados. Se determinaron los tipos de productos, las etapas de la cadena de suministro en las que se detectaron y las medidas tomadas por las autoridades. Resultados. Se identificaron 1 273 incidentes en 15 países (1 087 productos subestándares, 44 falsificados, 123 no registrados y 19 robados). La mayor cantidad de incidentes corresponden a dispositivos médicos, desinfectantes y antisépticos. El punto en la cadena de suministro con mayor frecuencia de informes fue la adquisición a través de internet. Las medidas tomadas por las autoridades reguladoras corresponden en su mayoría a: alerta, prohibición de uso, prohibición de publicidad y fabricación, retiro del mercado y seguimiento de eventos adversos. Conclusiones. Se evidenció un número destacable de incidentes de productos médicos subestándares, falsificados, no registrados y robados al inicio de la pandemia por COVID-19. La escasez de insumos, la flexibilización en los requisitos regulatorios y el aumento de la demanda son factores que pueden favorecer el incremento del número de incidentes. Las autoridades reguladoras nacionales de referencia presentaron mayores frecuencias de detección de incidentes y de aplicación de medidas sanitarias. Se observó que se debe abordar el canal de venta por internet con alguna estrategia reguladora para garantizar la distribución segura de productos médicos.
ABSTRACT Objective. Identify and analyze incidents of substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic. Methods. Detailed search of the websites of regulatory authorities in the Americas. Identification of incidents of substandard, falsified, unregistered, and stolen medicines and medical devices (including in vitro diagnostics). The types of products were determined, as were the stages in the supply chain where they were detected, and the actions taken by authorities. Results. A total of 1 273 incidents were identified in 15 countries (1 087 substandard, 44 falsified, 123 unregistered, and 19 stolen products). The largest number of incidents involved medical devices, disinfectants, and antiseptics. The most frequently reported point in the supply chain was online purchasing. The principal measures taken by the regulatory authorities were: alerts, prohibition of use, prohibition of advertising and manufacture, recall, and monitoring of adverse events. Conclusions. A substantial number of incidents involving substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic were identified. Shortages of supplies, easing of regulatory requirements, and increased demand are factors that may have led to an increase in the number of incidents. The national regulatory authorities of reference reported more frequent detection of incidents and more frequent application of health measures. A regulatory strategy is needed in order to address online sales and ensure the safe distribution of medical products.
RESUMO Objetivo. Identificar e analisar incidentes de produtos médicos abaixo do padrão, falsificados, não registrados e roubados no início da pandemia de COVID-19. Métodos. Foi realizada uma busca detalhada nos sites das autoridades reguladoras das Américas. Foram identificados incidentes envolvendo medicamentos e dispositivos médicos (incluindo para diagnóstico in vitro) abaixo do padrão, falsificados, não registrados e roubados. Foram determinados os tipos de produtos, os estágios da cadeia de abastecimento em que foram detectados e as medidas tomadas pelas autoridades. Resultados. Foram identificados 1 273 incidentes em 15 países (1 087 produtos abaixo do padrão, 44 falsificados, 123 não registrados e 19 roubados). O maior número de incidentes estava relacionado a dispositivos médicos, desinfetantes e antissépticos. O ponto na cadeia de abastecimento com a maior frequência de relatos foi a de aquisição pela internet. As medidas tomadas pelas autoridades reguladoras foram principalmente alertas, proibições de uso, proibições de publicidade e fabricação, recolhimento de produtos do mercado e monitoramento de eventos adversos. Conclusões. Houve um número significativo de incidentes envolvendo produtos médicos abaixo do padrão falsificados, não registrados e roubados no início da pandemia de COVID-19. A escassez de insumos, a flexibilização das exigências regulatórias e o aumento da demanda são fatores que podem levar a um maior número de incidentes. As autoridades reguladoras nacionais de referência informaram um aumento na frequência de detecção de incidentes e implementação de medidas sanitárias. O canal de vendas pela internet precisa ser abordado com alguma estratégia regulatória para garantir a distribuição segura de produtos médicos.
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Abstract Counterfeiting of medicines, also known as "falsification" or "adulteration", is the process in which the identity, origin, or history of genuine medicines are intentionally modified. Currently, counterfeit medicines are a global crisis that affects and is mostly caused by developing countries in Asia, Africa and Latin America. These countries lack strict law enforcement against this practice and have low-income populations with medicinal needs. Lately, the crisis has escalated, impacting developed countries as well, e.g., the US and the EU, mainly via the Internet. Despite this extension, some current laws aim to control and minimize the crisis' magnitude. Falsification of medicines maintains an illegitimate supply chain that is connected to the legitimate one, both of which are extremely complex, making such falsification difficult to control. Furthermore, political and economic causes are related to the crisis' hasty growth, causing serious consequences for individuals and public health, as well as for the economy of different countries. Recently, organizations, technologies and initiatives have been created to overcome the situation. Nevertheless, the development of more effective measures that could aggregate all the existing strategies into a large functioning network could help prevent the acquisition of counterfeit medicines and create awareness among the general population.
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Brésil , Médicaments contrefaits/effets indésirables , Escroquerie/législation et jurisprudence , Commerce Électronique , Législation sur les produits chimiques ou pharmaceutiques/normesRésumé
RESUMEN El objetivo de este informe especial es presentar los avances en Latinoamérica sobre la regulación de la venta de productos médicos a través de internet y ofrecer orientación a las Autoridades Reguladoras Nacionales (ARN) en la planificación y ejecución de estrategias para la regulación y fiscalización del comercio electrónico de productos médicos. Se presentan los avances regulatorios y de programas, e iniciativas efectuadas por cuatro países de América Latina para el control de la venta de productos médicos a través de Internet, incluyendo revisiones complementarias de la literatura y de programas para el control del comercio electrónico de agencias de referencia. A partir de esta revisión, se proponen las siguientes líneas estratégicas: fortalecimiento del marco regulatorio y normativo; fortalecimiento de la capacidad fiscalizadora; colaboración con autoridades y otros actores clave nacionales e internacionales; y comunicación y sensibilización con la comunidad y los profesionales de salud. Cada una de estas estrategias deben ir acompañadas con acciones específicas, que pueden servir como orientaciones para las ARN de las Américas, y de países con contextos similares para el fortalecimiento de sus marcos regulatorios y la protección de los pacientes y consumidores.
ABSTRACT The objective of this special report is to present the advances in Latin America on regulation of the online sale of medical products and to offer guidance to national regulatory authorities (NRAs) on planning and implementing strategies to regulate and oversee the e-commerce of medical products. The regulatory advances and the programs and initiatives implemented in four Latin American countries to control the online sale of medical products are presented, including complementary reviews of the literature and reviews of e-commerce control programs of agencies of reference. Based on this review, the following strategies are proposed: strengthening the regulatory and policy framework; strengthening the capacity for oversight; collaboration with national and international authorities and other key players; and communication and awareness-raising with the community and health care professionals. Each of these strategies should be accompanied by specific actions that can serve as guidelines for NRAs in the Americas and in countries with similar contexts, to strengthen their regulatory frameworks and patient and consumer protections.
RESUMO O objetivo deste relatório especial é apresentar os avanços na regulamentação da comercialização de produtos médicos pela internet na América Latina e oferecer orientações às Autoridades Reguladoras Nacionais (ARN) sobre planejamento e execução de estratégias de regulamentação e fiscalização do comércio eletrônico de produtos médicos. São apresentados avanços regulatórios e programáticos, bem como iniciativas realizadas por quatro países latino-americanos para controlar a venda de produtos médicos pela internet, incluindo revisões complementares da literatura e programas de controle do comércio eletrônico por agências reguladoras de referência. Com base nesta revisão, propõem-se as seguintes linhas estratégicas: fortalecimento do marco regulatório e normativo; fortalecimento da capacidade de fiscalização; colaboração com autoridades e outros atores-chave nacionais e internacionais; e comunicação e sensibilização da comunidade em geral e dos profissionais de saúde. Cada uma dessas estratégias deve ser acompanhada de ações específicas, que podem servir de diretrizes para as ARN das Américas - e de países com contextos semelhantes - para fortalecer seus marcos regulatórios e a proteção de pacientes e consumidores.
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RESUMO Objetivo. Identificar as estratégias de atuação dos sistemas regulatórios na vigilância e controle de medicamentos abaixo do padrão, falsificados e não registrados em nível regional-global, especialmente quanto aos processos de recall. Métodos. Foi realizada uma revisão integrativa da literatura nas bases de dados MEDLINE via PubMed, Embase e SciELO. Foram selecionados estudos publicados no período de 2007 a 2019, em inglês, português e espanhol, que abordavam estratégias desenvolvidas pelos sistemas regulatórios dos países, com foco no recall de medicamentos abaixo do padrão, falsificados e não registrados. Resultados. Dos 483 estudos inicialmente identificados, foram incluídas 21 publicações de alcance global, regional ou nacional. As estratégias de prevenção, detecção e resposta, incluindo o recall, foram agrupadas em dois modelos (passivo-reativo e proativo) de atuação dos sistemas regulatórios na vigilância e controle de medicamentos. Esses modelos parecem combinar estratégias passivas e proativas, complementares ou concorrentes, variando conforme o nível de desenvolvimento dos países e a capacidade regulatória. Embora seja considerado a resposta mais eficaz de proteção da população, o recall não foi implementado de forma uniforme no âmbito dos sistemas regulatórios, segundo os estudos. Conclusões. A complexidade e a magnitude do problema dos medicamentos abaixo do padrão, falsificados e não registrados exigem esforços, investimentos e mudanças profundas na abordagem, nos processos e nas capacidades dos sistemas regulatórios, podendo as estratégias de vigilância e controle do mercado convergir para um modelo híbrido, multisetorial, multidisciplinar, global e sistêmico de proteção da saúde humana.
ABSTRACT Objective. To identify the strategies employed by regulatory systems for the market surveillance and control of substandard, falsified, and unregistered medicines at the regional-global levels, especially regarding drug recall procedures. Method. An integrative literature review was performed. Searches were performed in MEDLINE via PubMed, Embase, and SciELO to select articles published from 2007 to 2019 in English, Portuguese, and Spanish, covering national regulatory system initiatives, with a focus on the recall of substandard, falsified, and unregistered medicines. Results. Of 483 articles initially identified, 21 global, regional, or national scope studies were selected. Prevention, detection, and response strategies, including drug recall, were grouped according to two broad market surveillance and control models (passive-reactive and proactive) used by regulatory systems. These models seem to combine passive and proactive, complementary or concurring actions that varied according to country development level and regulatory capacity. Although considered the most effective response for protection of populations, medicine recall was not implemented in a uniform manner in different regulatory systems as indicated by the studies. Conclusions. Addressing the complexity and magnitude of the problem of substandard, falsified, and unregistered medicines will demand effort, investment, and profound changes in the approaches, processes, and capacity of regulatory systems, with market surveillance and control strategies possibly converging toward a hybrid, multisectoral, multidisciplinary, global, and systemic model of human health protection.
RESUMEN Objetivo. Identificar las estrategias de actuación de los sistemas regulatorios en la vigilancia y control de los medicamentos subestándar, falsificados y no registrados a nivel regional-mundial, especialmente en lo que se refiere a los procesos de retirada de medicamentos del mercado (recall). Métodos. Se realizó una revisión bibliográfica integral en las bases de datos de MEDLINE a través de PubMed, Embase y SciELO. Se seleccionaron los estudios publicados entre 2007 y 2019, en inglés, portugués y español, en los que se abordaban las estrategias elaboradas por los sistemas regulatorios de los países, con énfasis en la retirada de los medicamentos subestándar, falsificados y no registrados. Resultados. De los 483 estudios identificados inicialmente, se incluyeron 21 publicaciones de ámbito nacional, regional o mundial. Las estrategias de prevención, detección y respuesta, incluida la retirada de medicamentos, se agruparon en dos modelos de actuación (pasivo-reactivo y proactivo) de los sistemas de regulación en la vigilancia y el control de los medicamentos. Estos modelos parecen combinar estrategias pasivas y proactivas, complementarias o concurrentes, que varían según el nivel de desarrollo de los países y su capacidad de regulación. Aunque la retirada de productos se considera la respuesta más eficaz para proteger a la población, según los estudios esta no se ha aplicado de manera uniforme en los sistemas de regulación. Conclusiones. La complejidad y la magnitud del problema de los medicamentos subestándar, falsificados y no registrados exigen esfuerzos, inversiones y cambios profundos en el enfoque, los procesos y las capacidades de los sistemas de regulación; y las estrategias de vigilancia y control del mercado pueden converger hacia un modelo híbrido, multisectorial, multidisciplinar, mundial y sistémico de protección de la salud humana.
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RESUMEN Objetivo: Analizar la regulación de la venta de medicamentos por procedimientos telemáticos en España, así como los riesgos y ventajas que esta presenta. Metodología: Se analizó e interpretó la legislación en materia de regulación de venta de medicamentos de uso humano a través de Internet en el ordenamiento jurídico español. Resultados: Dicha regulación se encuentra en el Real Decreto 870/2013, de 8 de noviembre, por el que se regula la venta a distancia al público, a través de sitios web, de medicamentos de uso humano no sujetos a prescripción médica. Este Real Decreto limita la venta de medicamentos a través de Internet a aquellos que no requieran prescripción médica, ya que en Internet se pueden vender medicamentos ilegalmente, lo cual supone una amenaza para la salud pública. No obstante, también existen ventajas de dicha actividad como es la garantía de acceso a los medicamentos por parte de la población. En la presente contribución se analiza el caso de las nuevas condiciones de dispensación establecidas durante la pandemia provocada por el nuevo coronavirus SARS-CoV-2. Conclusiones: Para garantizar la seguridad de los pacientes se limita la venta de medicamentos vía online, no obstante, en situaciones especiales, como la crisis sanitaria generada por el nuevo coronavirus se amplió el marco normativo para garantizar el acceso de la población a los medicamentos.
SUMMARY Aim: To analyze the regulation of the sale of medicines by telematic procedures in Spain, as well as the risks and advantages that it presents. Methodology: The legislation on the regulation of the sale of medicines for human use through the Internet in the Spanish legal system was analysed and interpreted. Results: Said regulation is found in Royal Decree 870/2013, of November 8, which regulates the distance sale to the public, through websites, of medicines for human use not subject to medical prescription. This Royal Decree limits the sale of medicines through the Internet to those that do not require a medical prescription, since medicines can be sold illegally on the Internet, which poses a threat to public health. However, there are also advantages of this activity, such as the guarantee of access to medicines by the population. This contribution analyses the case of the new dispensing conditions established during the pandemic caused by the new SARS-CoV-2 coronavirus. Conclusions: To guarantee the safety of patients, the sale of medicines online is limited, however, in special situations, such as the health crisis generated by the new coronavirus, the regulatory framework was expanded to guarantee the population's access to medicines.
RESUMO Objetivo: Analisar a regulamentação da comercialização de medicamentos por procedimentos telemáticos em Espanha, bem como os riscos e vantagens que apresenta. Metodologia: A legislação foi analisada e interpretada sobre a regulamentação da comercialização de medicamentos de uso humano pela Internet no ordenamento jurídico espanhol. Resultados: O referido regulamento consta do Real Decreto 870/2013, de 8 de novembro, que regulamenta a venda à distância ao público, através de websites, de medicamentos para uso humano não sujeitos a receita médica. Este Decreto Real limita a venda de medicamentos pela Internet aos que não necessitem de receita médica, uma vez que os medicamentos podem ser comercializados ilegalmente na Internet, o que representa uma ameaça para a saúde pública. Porém, também há vantagens dessa atividade, como a garantia de acesso a medicamentos por parte da população. Esta contribuição analisa o caso das novas condições de dispensação estabelecidas durante a pandemia causada pelo novo coro-navírus SARS-CoV-2. Conclusões: Para garantir a segurança dos pacientes, a venda de medicamentos online é limitada, porém, em situações especiais, como a crise de saúde gerada pelo novo coronavírus, o marco regulatório foi ampliado para garantir o acesso da população aos medicamentos.
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Astragali Complanati Semen has a long-term history of use as a common Chinese traditional and herbal medicine. Through a herbal textual research on the appellation, origin, efficacy, genuine producing area and counterfeit of Astragali Complanati Semen, the evolution of its appellation underwent three stages of "white terrestris", "Shayuan terrestris", and "Astragali Complanati Semen"; The botanical origin and medicinal part is dried mature seed from Astragalus complanatus of Legume family recorded in the literatures of past dynasties; And the varieties of ancient and modern application are basically the same. Its kidney-nourishing and essence-enriching efficacy has been progressively cleared with clinical application since records began in Bencao Yanyi in the Song dynasty; The genuine producing areas of Astragali Complanati Semen were Shayuan in Shaanxi Province from the Song Dynasty, and gradually moved to Tongguan in Shaanxi Province and Shanxi Province in the Ming and Qing Dynasties. After the founding of new China, it was mainly distributed in Shaanxi Province and then spread to northern adjacent provinces, in which the Tongguan in Shaanxi Province was preferred. Its counterfeits included Mapiao semon, an unknown counterfeit with a hint of green and Astragalus sinicus seed based on herbal literatures published before 1949, and mainly included the seeds of A. sinicus, Crotalaria pallida, Asfraglus chinensis and Astragalus adsurgens after 1949. Based on a systematic herbal textual research, this article takes a radical reform of Astragali Complanati Semen, so as to provide reference for its further development and utilization.
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OBJECTIVE：To provide reference for further clarifying the definition of counterfeit and inferior drugs and law enforcement for revelent departments ，and guaranteeing the safety of drug use and legitimate right for the public. METHODS ： Through comparative research ，literature research and interpretation of the new law ，comprehensive analysis and research was conducted for the relevant provisions of counterfeit and inferior drugs in the newly revised Drug Administration Law in respect of the definition ，penalty rules and identification basis of counterfeit and inferior drugs. The challenges and impacts of these changes on drug law enforcement were put forward from the perspective of drug law enforcement practice. RESULTS & CONCLUSIONS ： In terms of definition ，the newly revised Drug Administration Law redefined the counterfeit and inferior drugs ，which was reduced from 15 cases before the amendment to 11 kinds，but the content was more abundant. It cancelled the concept of punishing counterfeit and inferior drugs ；increased the prohibition of the use of counterfeit and inferior drugs ；punished violation behavior of drug administration order not according to counterfeit and inferior drugs ；removed two items that being punished as counterfeit drugs；adjusted the definition of contaminated drugs from counterfeit drugs to inferior drugs ；clarified the definition of excipients. In terms of penalty provisions ，the provisions of legal liability for counterfeit and inferior drugs in the newly revised Drug Administration Law comprehensively used a variety of punishment measures ，greatly increased the amount of fine ；differentiated the situation of production ，wholesale and retail of inferior drugs ，and set different punishment ranges ；appropriately reduced the punishment range of producing and selling TCM decoction pieces that did not meet the drug standards ；increased the punishment for the violation of drug management order ，and the scope of punishment was similar to that of counterfeit and inferior @qq.com drugs. The “double penalty system ”was implemented for serious illegal acts and punished to individuals. The punishment for drug users who used counterfeit and inferior drugs was clarified. The situation of heavier punishment for producing and selling counterfeit and inferior drugs was increased ，and the first responsibility system and punitive compensation were added to protect the legitimate rights and interests of consumers. In terms of identification basis ，the newly revised Drug Administration Law had deleted the provisions that specific situation of quality inspection conclusion may not be specified ，and only provided the principle provisions. The challenges and impacts of the newly revised Drug Administration Law on law enforcement included how to understand the “ingredients”in the definition of counterfeit drugs；how to distinguish between deteriorated drugs and contaminated drugs ；how to investigate and deal with unauthorized acts ； whether drug inspection reports were required in all cases of counterfeit and inferior drugs ；how to understand the situation that did not affect the safety and effectiveness ，and connecting administrative law enforcement with criminal justice for counterfeit and inferior drugs ，etc. It is suggested to further strengthen the law popularization ，and introduce the interpretation of the newly revised Drug Administration Law as soon as possible ，clarify the legislative intent ，and guide the grassroots law enforcement ；issue Amendment Ⅺ to the Criminal Law of the People ’s Republic of China as soon as possible ，increase the charges of illegal acts against the order of drug administration ，do a good job in connecting administrative law enforcement with criminal justice and crack down on the illegal and criminal acts in the field of drugs ，and further promote the administration according to law.
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@#Poor quality medicines have been described as a global pandemic that threatens the lives of millions of people. The problem is much more severe in poor-resource countries where pharmaceutical legislation and regulation are limited. Poor quality medicines are divided into three categories: substandard, degraded and falsified and the countermeasures vary according to each category. The use of poor quality medicine leads from minimal to severe complications (including death) for the individuals but also harms the community. Furthermore, they lead to a loss of confidence of the patients in essential medicines, in manufacturers and in health system and they increase the work burden for health workers, customs and police. To detect them, different techniques have been developed, each with advantages and limits. This article describes these aspects of poor quality medicines and also presents the factors that contribute to the existence and spread of poor quality medicines. A section of the article is devoted to the issue of poor quality medicine in Laos.
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Through market investigation, the adulteration of Zaocys dhumnades on markets was found out, and samples of authentic and adulterated Z. dhumnades on markets were collected. The origin and properties of the adulterated Z. dhumnades were studied in order to provide reference for the identification of Z. dhumnades. The counterfeit Z. dhumnades sold on markets were as follows: Ptyas korros, P. mucosus, Najanaja atra, Sinonatrix annularis, Dinodon septentrionalis, etc. It is found that there existed a obvious difference between the traits of the Z. dhumnades and counterfeits. Genuine Z. dhumnades with "sword ridge" "iron tail", strongly ribbed scales and other features, is the key point to identify the difference from adulterants.
Sujets)
Animaux , Contamination de médicament , Matière médicale , Normes de référence , SerpentsRésumé
Background: Counterfeit drugs are a global problem and suffered almost all developing and developed countries worldwide. In India, it is a major problem which results life threatening issues as well as financial loss on health system. So, we conducted a cross sectional questionnaire-based study on knowledge and exposure to counterfeit drugs of doctors at SHKM Govt. Medical College, Nuh, Haryana, India.Methods: A structured questionnaire was distributed to 100 registered doctors. The questionnaire was based on knowledge, attitude and its consequence on the heath system by the practices of counterfeit medication.Results: There were Twenty questionnaires excluded from the study due to incomplete information. Only 57.77% (46/80) subjects having the knowledge of questionnaire correct meaning of counterfeit drug. However, almost 90% (72/80) subjects were aware about its dangerous effects. More than 50% of the subjects have suggested that modern technology is capable to control counterfeiting of the medicine.Conclusions: Counterfeit drugs create a people health hazard and waste to consumer income. The proper knowledge, awareness and modern technological approaches are the devices may helpful in diminution of counterfeit medication practices.
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Patients use medicines to gain speedy recovery from illness or to maintain wellbeing under the care of their physicians. For chronic illnesses, the pharmacotherapy may continue for the entire lifetime. Significant expenditure is incurred in sustaining this pharmacotherapy. Quite expectedly, the patients are concerned about the quality of medicines that they receive and consume. In recent times, the quality concerns have increased phenomenally due to media hype and overexposure all around. Ensuring quality of medicines in developing countries is not easy. Multi-pronged approaches are needed to ensure procurement of good quality medicines by institutional buyers. However, ensuring the procurement of good quality medicines is not enough. The quality of medicines has to be maintained till their consumption by patients and a rational, scientific method has to be adopted to ensure this goal. A structured approach in ensuring good quality medicines for optimum pharmacotherapy is being presented in this review.
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OBJECTIVE: To study the high-performance thin layer chromatographic (HPTLC) fingerprint of volatile oil constituents from Amomum villousm and its related species so as to set up the identification protocol of the medicinal plant and provide scientific information for its quality control. METHODS: TLC was used to analyze comparatively 10 batches of Amomum villosum Lour.samples, 10 batches of Amomum villousm crude drugs collected from different producing areas and stored for different time, 10 batches of the fruits of counterfeit species and 10 kinds of related species in the Zingiberaceae family. The samples were separated on silica gel G precoated plates with a mixture of cyclohexane-chloroform-ethyl acetate (13:2:2) as developing solvent system. The relative humidity was 67%. The spots were visualized with 5% vanillin sulfuric acid solution, then were analyzed by utilizing CHROMAP 1.5 solution software. RESULTS: The fingerprint of volatile oil of Amomum villosum, with 9 specific bands examined under natural light, was set up. The quality of Amomum villosum stored for different time or collected from different areas was distinctly variable. Obvious difference existed in the chemical composition of the volatile oils between Amomum villosum and its counterfeit and other related species. CONCLUSION: The HPTLC fingerprint analysis method can be used for rapid identification and quality control ofAmomum villosum.
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Drug counterfeiting and production of substandard drug is a global problem. Substandard or counterfeit drugs are threat for the effective treatment of diseases and highly worsen the quality of life of patients. This study was aimed to assess the pharmaceutical quality of ranitidine hydrochloride tablets manufactured in Bangladesh. Tablets were collected from different parts of Bangladesh and quality parameters were evaluated according to the United States Pharmacopoeia and the British Pharmacopoeial methods. The potency of tablets was measured spectrophotometrically. Weight variation and disintegration time were performed according to pharmaceutical monographs. Among 43 brands tested, 8 failed to comply with the USP specification (active ingredient: 90±10%) due to containing of less amount of ranitidine of which 6 brands were spurious and 2 were substandard in nature. Two brands did not comply with the specification for weight variation of tablets whereas all brands passed disintegration time test. The findings clearly demonstrate the production of substandard ranitidine tablets in Bangladesh. The drug control authority of Bangladesh should take effective steps to prevent the production of substandard drugs to secure public health.
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OBJECTIVE:To provide reference for the identification,processing,processing technology and research for ther-mal decomposition products. METHODS:Thermogravimetry- derivative thermogravimetry (TG-DTG) and differential thermal-de-rivative differential thermal (DTA-DDTA) analysis were conducted to scan thermal spectrum of tripterygium from 3 places and T. hypoglaucum,T. regelii,common counterfeits Actinidia arguta and Vitis quinquangularis,determine 7 medicinal materials,its dregs and extractum,and analyze differential spectrum of T. wilfordii and dregs. RESULTS:The TG-DTG and DTA-DDTA thermal spectrum were not only basically similar to each other but also to their dregs. There was a singlet main characteristics peak at about (299±3)℃ only in the DTG curves of extracts of tripterygium from 3 places and T. hypoglaucum extractum with similar intensity, while T. regelii,counterfeits A. arguta and V. quinquangularis showed multiple peaks,and (299 ± 3)℃ was not the main peak. CONCLUSIONS:The thermal spectrum can not distinguish tripterygium and its counterfeits;extractum DTG curves can do it;suit-able processing temperature of tripterygium was 200-380℃. The study can provide reference for the identification,processing,pro-cessing technology and research for thermal decomposition products.
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OBJECTIVE:To investigate the characteristics and trends of illegal circulation of counterfeit drugs in China,and to put forward monitoring countermeasures. METHODS:In empirical study,3 typical cases of counterfeit drugs manufacturing and selling in China were analyzed (including Jiangsu Wuxi Internet transnational counterfeit drugs manufacturing and selling case, Shanghai Avastin eye drug case,Sichuan Dazhou counterfeit drugs case),to compare the sources of counterfeit drug and illegal cir-culation pathway,thus find out the monitoring problems. RESULTS & CONCLUSIONS:Main reasons for illegal circulation of counterfeit drugs in China are as follows as drug circulation regulation absence of foreign-funded medical institutions,the existence of hidden drug circulation monitoring holes in urban medical institutions,under-developed and weak ability of distinguishing talse drug information internet counterfeit drugs sales regulatory means. It is suggested to establish drug management norms for for-eign-funded medical institutions,improve drug circulation monitoring in primary medical institutions,establish pharmaceutical logis-tics(transportation)licensing system and strengthen online fake drug sale information monitoring and information publication.
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Background: Drug counterfeiting poses a great danger to every society. The actual prevalence of counterfeit drugs is difficult to ascertain presently but just like other crimes, drug counterfeiting is an underground business that often comes to light mostly when death occurs. About 10% of drugs circulating worldwide are fake drugs with enormous associated health risk. Preventing the problem is a primary duty of every responsible nation in order to save lives. Objective: This paper aims at studying the factors associated with drug counterfeiting, its consequences and possible solutions. Methods: This article reviews relevant literatures published from 2004 to 2015 from medical journals, health survey reports, books, Google search and health-related websites such as World Health Organization. Results: Several researchers have identified corruption and conflict of interest, poor health seeking behavior of Nigerians, high prices of locally manufactured drugs due to high taxes and tariffs, inadequate legislation, unordered drug distribution system, inadequate cooperation from government agencies and discriminatory regulation by exporting countries as the major factors associated with drug counterfeiting in Nigeria. Conclusion/ Recommendations: Drug counterfeiting is one of the greatest atrocities of our time and it affects both developing and developed countries. There is an urgent need for the government as well as professional bodies to ensure massive public enlightenment and the effective enforcement of the existing drug laws in Nigeria.
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Counterfeit drugs have emerged as a major global problem. This issue has been brought to the centre of the Indian media due to the death of 15 women attending a sterilization camp in Chhattisgarh. India’s pharmaceutical industry exports drugs worth 15 billion dollars, which means a high prevalence of counterfeiting in India’s drug industry has global repercussions. However, accurate figures on the extent of counterfeit drugs in India are not available. The scientific literature as well as media reports often quotes figures of 10-35%, though studies done by the Indian Government dispute this. Counterfeit drug numbers have been known to be under represented by Governments due to fear of undermining their economy and health systems. On the other hand, rival companies in other countries may have an incentive to over hype India’s counterfeit problem to dent India’s growing status as the leading global supplier of generic medicines. Lack of clear definitions and differences between laws of countries further complicate reporting. A high prevalence of counterfeit drugs has a large impact on both health and economic indicators. Additionally, counterfeit drugs provide significant challenges to Pharmacovigilance programmes. Hence, here we discuss the significance of use of counterfeit drugs in India and challenges faced by Pharmacovigilance due to the extensive use of counterfeit drugs.
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Objective: The aqueous extracts of donkey-hide and its counterfeits (horse-hide and mule-hide) were identified using 1H-NMR metabolomics to provide the basis for the identification and quality control of donkey-hide gelatin. Methods: The water-soluble components of the hairless donkey-hide and its counterfeits were extracted and the 1H-NMR technique was applied to analyzing the components. Moreover, the NMR data were analyzed and the component belongings were recognized using relevant software for the multivariate statistical analysis. Results: Forty-two water-soluble components were identified in donkey-hide by 1H-NMR. There were more acetate, leucine, valine, isoleucine and less lactate, serine, pyroglutamate, and creatine in the horse-hide than in the donkey-hide; While there were more acetate, creatine, alanine, choline and less glycerol and acetate in mule-hide than in donkey-hide. And they were all in a significant difference (P 1H-NMR metabolomics was established for the first time, which provides the experimental references for the donkey-hide identification and quality control study.
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Objective To build an identification method for Norvascand its counterfeit drugs based on the differences of their pharmaceutical excipients with the original and generic Amlodipine besylatetablets as tools .Methods Raman spectra of pharmaceutical excipients which were usually used in tablets were collected .Similarity algorithm and characteristic Raman bands were used to search the excipients contained in the tablets .If the excipients was not the same as excipients contained in Nor-vasc ,the tablet was judged as counterfeit drugs .Otherwise ,principal component analysis was used to identify counterfeit and generic .Results and conclusion The method based on Raman spectra of pharmaceutical excipients could identify Norvasc and counterfeit drugs efficiently and accurately .
Résumé
We examined the difference in prevalence of substance use and sexual risk behaviors among at-risk youth participants in programs offered by community-based organizations in Juiz de Fora, Minas Gerais State, Brazil, by gender and organization type (governmental vs. non-governmental). 388 adolescents were recruited from 25 intervention-based organizations servicing at-risk youth between the ages of 12 and 17 in Juiz de Fora. Participants completed a 15-item survey assessing substance use and sexual risk behaviors, along with socio-demographic predictors of these behaviors. Males were more likely to report drug and alcohol use associated with homelessness and abandonment. Females were more likely to report sexual risk taking associated with neighborhood crime. Participants from non-governmental organizations were less likely to engage in all measured risk behaviors. The present analysis points to the need to understand how Brazil’s Child and Adolescent Act is being applied and the implications this has for intervention and the promotion of positive health outcomes for young people.
Examinou-se a diferença na prevalência do uso de drogas e comportamento sexual de risco entre os jovens de alto risco em programas oferecidos por organizações localizadas na comunidade de Juiz de Fora, Minas Gerais, Brasil .Foram recrutados 388 adolescentes de 25 organizações de intervenções preventivas que servem jovens de alto risco entre as idades de 12-17. Participantes completaram um questionário com 15 perguntas que avalia o uso de substâncias e o comportamento sexual de alto risco, juntamente com indicadores sociodemográficos. Os adolescentes do sexo masculino foram mais propensos a relacionar o uso de drogas e álcool com a falta de moradia e abandono. As adolescentes do sexo feminino foram mais propensas a reportar comportamentos sexuais de alto risco em associação com o crime comum. Participantes de ONGs foram menos propensos a se envolver nos comportamentos de alto risco pesquisados. A presente análise aponta para a necessidade de se entender as implicações que isso tem para a intervenção preventiva e a promoção de resultados positivos na saúde dos jovens.
Examinamos las diferencias en la prevalencia de uso de sustancias estupefacientes y el riesgo sexual entre los jóvenes participantes de los programas ofrecidos por las organizaciones de base comunitaria en Juiz de Fora, Minas Gerais, Brasil. Se incorporaron 388 adolescentes de 25 organizaciones de apoyo e intervención a la juventud, que atienden a chicos de entre de 12-17 años en Juiz de Fora. Los participantes completaron un estudio con 15-ítems para evaluar el consumo de sustancias estupefacientes y el riesgo sexual, junto a aspectos socio-demográficos predictores de estos comportamientos. Los varones tenían más probabilidades de uso de drogas y alcohol, asociado al desamparo y abandono. Las mujeres tenían más probabilidades de riesgos sexuales, relacionados con la delincuencia del barrio. Los participantes de las organizaciones no gubernamentales tenían menos probabilidades de comportamientos de riesgo. El presente análisis apunta la necesidad de entender cómo se está aplicando la ley del niño y del adolescente y las consecuencias que tiene para la intervención y la promoción de los resultados positivos para la salud.