Examination of the business behavior of Boehringer Ingelheim, Bayer and Baxter in India
Examination of the business behaviour of Boehringer Ingelheim, Bayer and Baxter in Uganda
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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In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential component of public health programs. Its intention was... to facilitate the development of pharmacovigilance systems in the Region of the Americas and improve, strengthen, and promote the adoption of good practices to improve safety for patients and the general population, based on the needs of the Region.
Document also available in Spanish and Portuguese!
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Version 1.1. The WHO protocol has been adapted to resource-limited settings and builds on existing methodologies from the European Centre for Disease Prevention and Control (ECDC), the Global PPS project from University of Antwerp, the US Centers for Disease Control and Prevention (CDC), and the Med...icines Utilisation Research in Africa (MURIA).
Point Prevalence Surveys collects information on prescribing practices of antibiotics and other information relevant to treatment and management of infectious diseases in hospitalized patients, and complements surveillance of antimicrobial consumption.
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The aim of the Annual Inspection Report is to present findings of public sector health establishments inspected by the OHSC to monitor compliance with the National Core Standards (NCS) during the 2016/2017 financial year in South Africa.
The NCS define fundamentals for quality of care based on six ...dimensions of quality: Acceptability,Safety, Reliability, Equity, Accessibility, and Efficiency.
The NCS structured assessment tools were used to collect data during inspections across the seven domains namely: Patient Rights; Patient Safety, Clinical Governance and Clinical Care; Clinical Support Services; Public Health; Leadership and Governance; Operational Management and Facilities and Infrastructure. A total of 851 routine inspections were conducted with 201 of these facilities re-inspected. Inspection data was captured on District Health Information System (DHIS) data entry forms and exported for analysis to Statistical Analysis Software (SAS) version 9.4.
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Handbook of HUMANITARIAN HEALTH CARE LOGISTICS Designing the Supply Network and Managing the Flows of Information and Health Care Goods in Humanitarian Assistance during Complex Political Emergencies
Medicinal plants occupied an important position in the socio-cultural, spiritual and medicinal arena of rural people of India. T
The present report is based on contribution made by members of the task force and many other experts on medicinal plants. We hope the report on implementation will promot...e sustainable and equitable development of medicinal plants sector provide "Health for All", boost exports, and will improve livelihood of the people and green the country for the present and the
generation to come.
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For the Fiscal Year 2014-2015, the Health Sector continued to implement interventions and strategies meant to improve the availability, accessibility and utilization of quality healthcare services across public and private health facilities; and to ensure the reduction of the burden of communicable ...and non-communicable diseases in Rwanda. This annual report highlights key achievements registered by the health sector during the Fiscal Year 2014-2015. Achievements are highlighted under three big components: Health Programs, Health Systems Support and Budget Execution.
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The report aims to help policy-makers and programme managers identify the areas that need attention and to work towards effective implementation and enforcement of policies and legislations. The need for alcohol policy-specific infrastructures to support the alcohol policy process, including designa...ted responsible agency, policy and strategy, and law and regulation, is also required at the country level.
The report is presented in three sections. Section 1 gives an insight to the alcohol consumption situation in the WHO South-East Asia Region and cites the alcohol-related problems that the Region is facing. Section 2 illustrates the policy situation in the 10 areas of national action identified in the Global Strategy to Reduce the Harmful Use of Alcohol and gives specific recommendations pertaining to these areas. Section 3 provides overall recommendations.
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CHAPTER 206 | An Act to establish a national drug policy and a national drug authority to ensure the availability, at all times, of essential, efficacious and cost-effective drugs to the entire population of Uganda, as a means of providing satisfactory health care and safeguarding the appropriate us...e of drugs.
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How to address the global crisis in antibiotic research and development.
The report includes a comprehensive summary and critical evaluation of recent initiatives to overcome the barriers to achieve sustainable access to antibiotics. As antibiotic resistance will continue to develop as long as we ...depend on these medicines to treat bacterial infections, a continuous supply of new effective antibiotics is needed. The report identifies five key challenges that must be solved in order to achieve sustainable access for all, and charts out options for governmental action in response to each of them.
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Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,... which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la...test practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
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In the last decade, Timor-Leste has made remarkable progress in strengthening its health system and improving the health status of its population. This has resulted in an increased life expectancy, and the achievement of Millennium Development Goals such as a reduction in infant and under-five morta...lity, an improvement in maternal and child health outcomes, and an increase in immunization coverage. Further, the country has successfully eliminated infectious diseases such as polio, measles, and maternal and neonatal tetanus. There is full political commitment to reducing the incidence of tuberculosis (TB) by 80% and the number of deaths due to TB by 90% by 2030. The country has made great progress in the context of the pandemic, having established numerous quarantine facilities/isolation centres; trained health-care workers; streamlined the procurement and supply of medicines, consumables, personal protective equipment and other equipment; and strengthened the capacity in critical care across secondary and tertiary health care, to better respond to future pandemics and other disaster situations.
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The WHO Pharmaceuticals Newsletter provides you with the latest information on the safety of medicinal products and regulatory actions taken by authorities around the world.
In addition, this edition includes summary and recommendations from the virtual meeting of the members of the WHO Programme f...or International Drug Monitoring (PIDM) and other partners, which was held on 20 October 2022.
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Rabies is a fatal viral zoonosis and serious public health problem.1 All mammals are believed to be susceptible to the disease, and for the purposes of this document, use of the term animal refers to mammals. The disease is an acute, progressive encephalitis caused by viruses in the genus Lyssavirus....
2 Rabies virus is the most important lyssavirus globally. In the
United States, multiple rabies virus variants are maintained in wild mammalian reservoir populations such as raccoons, skunks, foxes, and bats. Although the United States has been declared free from transmission of canine rabies virus variants, there is always a risk of reintroduction of these variants.The rabies virus is usually transmitted from animal to animal through bites. The incubation period is
highly variable. In domestic animals, it is generally 3 to 12 weeks, but can range from several days to months, exceeding 6 months.8 Rabies is communicable during the period of salivary shedding of rabies virus. Experimental and historic evidence documents that dogs, cats, and ferrets shed the virus for a few days prior to the onset of clinical signs and during illness. Clinical signs of rabies are variable and include inappetance, dysphagia, cranial nerve deficits, abnormal behavior, ataxia, paralysis, altered vocalization, and seizures. Progression to death is rapid. There are currently no known effective rabies antiviral drugs.
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