SITUATION ANALYSIS AND RECOMMENDATIONS
These guidelines are applicable to all biomedical, social and behavioural science research for health conducted in India involving human participants, their biological material and data.
The purpose of such research should be: i. directed towards enhancing knowledge about the human condition while ...maintaining sensitivity to the Indian cultural, social and natural environment; ii. conducted under conditions such that no person or persons become mere means for the betterment of others and that human beings who are participating in any biomedical and/or health research or scientific experimentation are dealt with in a manner conducive to and consistent with their dignity and well-being, under conditions of professional fair treatment and transparency; and iii. subjected to a regime of evaluation at all stages of the research, such as design, conduct and reporting of the results thereof.
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El Estado Mundial de la Infancia 2017 trata sobre un tema extraordinario que influye cada vez más en casi todos los aspectos de la vida de millones de niños en todo el mundo y, de hecho, de todos nosotros: la tecnología digital. A medida que aumenta la influencia de la tecnología digital, y espe...cialmente de internet, el debate sobre sus repercusiones se intensifica: ¿es una bendición para la humanidad, ya que ofrece oportunidades ilimitadas para la comunicación y el comercio, el aprendizaje y la libertad de expresión? ¿O es una amenaza para nuestra forma de vida, ya que socava el tejido social, incluso el orden político, y amenaza nuestro bienestar?
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The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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Pre-Publication draft version. Lat reviewed on 7th July 2017
Mission report: June 11-20, 2017
Policy and Legal Opportunities for HIV Testing Services and Civil Society Engagement
El objetivo fue determinar cuáles son las percepciones de distintos actores del sistema de salud
colombiano sobre los problemas del sistema que están detrás de la crisis. Se realizó un estudio
cualitativo a partir de entrevistas semiestructuradas y en profundidad con cuarenta agentes del
sect...or salud, en Bogotá, Cali, Ibagué, Espinal y Calima-Darién. Los resultados mostraron que la
corrupción, el incumplimiento de normas y los conflictos entre los intereses de diversos actores
del sistema debilitan la legitimidad de este último, atomizan la cooperación y cohesión de los
actores y fortalecen el interés particular.
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Research Article
PLOS Medicine | DOI:10.1371/journal.pmed.1002253 April 4, 2017
In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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