A lifeline to treatment: the role of Indian generic manufacturers in supplying antiretroviral medicines to developing countries

<p>Abstract</p> <p>Background</p> <p>Indian manufacturers of generic antiretroviral (ARV) medicines facilitated the rapid scale up of HIV/AIDS treatment in developing countries though provision of low-priced, quality-assured medicines. The legal framework in India that facilitated such production, however, is changing with implementation of the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights, and intellectual property measures being discussed in regional and bilateral free trade agreement negotiations. Reliable quantitative estimates of the Indian role in generic global ARV supply are needed to understand potential impacts of such measures on HIV/AIDS treatment in developing countries.</p> <p>Methods</p> <p>We utilized transactional data containing 17,646 donor-funded purchases of ARV tablets made by 115 low- and middle-income countries from 2003 to 2008 to measure market share, purchase trends and prices of Indian-produced generic ARVs compared with those of non-Indian generic and brand ARVs.</p> <p>Results</p> <p>Indian generic manufacturers dominate the ARV market, accounting for more than 80% of annual purchase volumes. Among paediatric ARV and adult nucleoside and non-nucleoside reverse transcriptase inhibitor markets, Indian-produced generics accounted for 91% and 89% of 2008 global purchase volumes, respectively. From 2003 to 2008, the number of Indian generic manufactures supplying ARVs increased from four to 10 while the number of Indian-manufactured generic products increased from 14 to 53. Ninety-six of 100 countries purchased Indian generic ARVs in 2008, including high HIV-burden sub-Saharan African countries. Indian-produced generic ARVs used in first-line regimens were consistently and considerably less expensive than non-Indian generic and innovator ARVs. Key ARVs newly recommended by the World Health Organization are three to four times more expensive than older regimens.</p> <p>Conclusions</p> <p>Indian generic producers supply the majority of ARVs in developing countries. Future scale up using newly recommended ARVs will likely be hampered until Indian generic producers can provide the dramatic price reductions and improved formulations observed in the past. Rather than agreeing to inappropriate intellectual property obligations through free trade agreements, India and its trade partners - plus international organizations, donors, civil society and pharmaceutical manufacturers - should ensure that there is sufficient policy space for Indian pharmaceutical manufacturers to continue their central role in supplying developing countries with low-priced, quality-assured generic medicines.</p

Metalliferous coals of coals of Azey deposit in Irkutsk coal basin

Актуальность работы обусловлена необходимостью поиска новых источников ценных элементов, определяющих развитие современной инновационной экономики. В качестве их перспективного источника рассматриваются угли и золы углей. Изучение геохимических особенностей углей и форм нахождения химических элементов в углях и золах углей необходимо для оценки металлоносности угольных месторождений, разработки критериев выявления металлоносных углей и методик по извлечению ценных элементов. Перспективным источником ценных элементов является Азейское месторождение, в котором содержание ряда ценных элементов достигает возможных промышленно значимых рудных концентраций. Цель исследований: выявить геохимические особенности и формы нахождения элементов-примесей в углях, золах углей и неугольных прослоях угольных пластов Азейского месторождения. Объектами исследования являются угли и углевмещающие породы Азейского месторождения Иркутского бассейна. Методы: инструментальный нейтронно-активационный анализ, масс-спектрометрический метод с индуктивно-связанной плазмой, рентгенофазовый анализ, сканирующая электронная микроскопия с рентгеноспектральным анализом, озоление проб с определением зольности и влажности, экстрагирование битумов и гуминовых кислот. Результаты. Выявлено обогащение углей Азейского месторождения рядом редких элементов-примесей (REE, Sc, Zr, Hf, Ta, Th), важную роль в котором играет пирокластический материал как источник редкоземельных элементов, тория, тантала, циркония и гафния. Установлено, что угли из зоны окисления характеризуются аномально высокими концентрациями редких элементов примесей (REE, Sc, Cr, Co, Au), припочвенные зоны угольных пластов обогащены тяжелыми редкоземельными элементами, Sc, Co, Sb, Ta, Hf, Ba. Выявлено наличие самородной и интерметаллической минерализации в углях. Установлено, что в малосернистых углях (~0,5 %) с низким содержанием сульфидной серы преобладают самородные формы элементов-халькофилов. Всего обнаружено свыше 80 минеральных форм элементов-примесей, в том числе монацит, бастнезит, циркон, бадделеит, самородные и интерметаллические соединения и т. д.The relevance of the research is caused by the need to find new sources of valuable elements that determine the development of modern innovative economy. Coals and ashes of coals are considered as their perspective source. The study of geochemical characteristics of coal and modes of occurrence of chemical elements in coals and ashes of the coals is required for estimation of metal content in coal deposits and development of the criteria for detecting metalliferous coals and techniques for extraction of valuable elements. A promising source of valuable elements is Azeyskoe deposit, where the content of a number of valuable elements reaches possible industrially important ore concentrations. The main aim of the research is to study the geochemical characteristics and modes of occurrence of impurity elements in coals, coal ashes and noncoal intercalations in coal seams of Azeyskoe deposit. Objects of the research are coal and coal bearing rocks of Azeyskoe deposit of Irkutsk basin. Methods: instrumental neutron activation analysis, mass spectrometry method with inductively coupled plasma, x/ray phase analysis, scanning electron microscopy with x/ray spectral analysis, ashing with determination of ash content and humidity, extraction of bitumen and humic acids. Results. The authors have determined the enrichment of Azeiskoe deposit coals with a number of rare impurity elements (REE, Sc, Zr, Hf, Ta, Th). Pyroclastic material as a source of rare earth elements, thorium, tantalum, zirconium and hafnium, is very important in this enrichment. It was determined that the coals in oxidation zone are characterized by anomalously high concentrations of rare impurity elements (REE, Sc, Cr, Co, Au), bottom formation zones of coal seams are enriched with heavy rare earth elements, Sc, Co, Sb, Ta, Hf, Ba. Presence of native and intermetallic mineralization in coals is revealed. It is established that in low/sulfur coals (~0,5 %) with a low content of sulfide sulfur native forms of elements-chalcophiles prevail. In total, more than 80 mineral forms of impurity elements, including monazite, bastnezite, zircon, baddeleyite, native and intermetallic compounds, etc., were found out

Molecular imaging of breast cancer in a transgene mouse model [Molekulare Bildgebung des Mammakarzinoms in einem transgenen Mausmodell]

Background: Purpose of the study was to detect early breast cancer and its precursors by in vivo optical molecular imaging in an animal model. Material and methods: Females of the transgene mouse strain WAP-TNP8 develop non-invasive and consequently invasive tumours of the mammary glands due to specific expression of the viral SV40 large tumour antigen induced by lactation. The molecular target for imaging was extradomain-b fibronectin (EDB-FN), which is associated with tumour angiogenesis. The optical probe was designed as a compound of an anti-EDB-FN antibody fragment and a near-infrared fluorescent dye. 30h after intravenous injection of the contrast agent, optical imaging was performed using a pulsed Laser system for excitation and an intensified CCD-camera to record fluorescence images. After optical molecular imaging all animals were sacrified and the tumours were examined histologically. Results: Initiated transgene female animals developed palpable masses of the mammary gland within 6 months (median 4 months). Imaging was performed in 5 animals with a total of 9 tumours (diameter 2–7mm, median 4mm). Applying optical molecular imaging 8 of 9 tumours were detected. The urogenital tract was contrasted unspecifically. Histological examination proved invasive epithelial tumours of the mammary gland in all cases. Conclusion: Breast cancer can be detected in vivo by near-infrared fluorescence molecular imaging targeting neoangiogenesis in a transgene mouse-model