scholarly journals Regulation of Medicines in Bhutan: Current Status, Challenges and Opportunities

2018 ◽  
Vol 6 (2) ◽  
pp. 54-58
Author(s):  
Pelden Chejor ◽  
Jigme Tenzin ◽  
Jigme Dorji
Keyword(s):  
Healthcare Delivery ◽  
Regulatory System ◽  
Current Status ◽  
Blood Products ◽  
Medicinal Products ◽  
National Agency ◽  
Traditional Medicines ◽  
Drug Regulatory Authority ◽  
Challenges And Opportunities ◽  
The Government

Medicines Regulatory Agencies (MRAs) are responsible for evaluation of quality, safety and efficacy of medicinal products before it is approved for consumption. The regulatory procedures, however, differs from one country to another. Medical products including vaccines, blood and blood products, diagnostics and medical devices are essential for healthcare delivery across the world. The Drug Regulatory Authority (DRA) is an independent national agency for regulation of medicinal products in Bhutan and reports to Bhutan Medicines Board (BMB), the highest policy making body for regulation of medicinal products in the country. Medicines Act of the Kingdom of Bhutan is the legal tool for regulation of medicines in Bhutan. Medicinal products are regulated through premarketing and post-marketing control systems. All medicinal products available in the Bhutanese market are registered. DRA regulates all the medicinal products including vaccines, blood products and traditional medicines used for human and veterinary. DRA is fully financed by the Government of Bhutan. Bhutan’s medicines regulatory system has evolved over the last one decade. However, as the regulatory mandate continues to increase, DRA is faced with several challenges in terms of human resource, infrastructure and testing laboratory among others. There are also opportunities for the DRA to improve its regulatory capacities to ensure availability of quality and safe medicines for the public. Understanding the current practice of medicines regulation in Bhutan can help identify gaps and existing opportunities for improving the regulatory capacity. This article documents the existing practices, challenges and opportunities for regulation of medicinal products in Bhutan.

scholarly journals Telemedicine in Covid-19: Challenges and Opportunities

2021 ◽  
pp. 32-35
Author(s):  
Imrana Masood ◽  
Ummul Baneen ◽  
. Nivedita
Keyword(s):  
Health Services ◽  
Healthcare Delivery ◽  
Delivery Of Healthcare ◽  
Revolutionary Change ◽  
Community Healthcare ◽  
Health Services Delivery ◽  
Services Delivery ◽  
The World ◽  
Challenges And Opportunities ◽  
The Government

The pandemic of COVID -19 is a healthcare emergency of International concern. It originated in Wuhan, China in December 2019 and was declared as pandemic by WHO on 12 March 2020. Since then it is raging relentlessly across the world with staggering more than 60 lakh cases in India currently. This has put a tremendous strain on already frail and overburdened Indian healthcare system and aggravated concern in the accessibility to healthcare by common mass due to prevailing lockdown conditions. This has sparkled to re-think and renew the policy on healthcare and focus on relevance, reach and utilize the potential of telemedicine services for the delivery of healthcare to community. This term telemedicine has been in use since 1970s but became fully operational globally in early 2000. Now about 20 years later we find a revolutionary change in the focus of health services delivery towards community healthcare and wellbeing In this article we aim to analyze the difficulties and hurdles faced by non COVID patients and challenges in front of the government to dispense basic healthcare to those in need. We need to tap all our resources particularly ICT for healthcare delivery and use this adversity of COVID 19 pandemic as an opportunity to build on our capacity and expertise in the area of Telemedicine for the betterment of community healthcare.

Regulatory Guillotine in the Field of Industrial Safety

2020 ◽  
pp. 22-28
Author(s):  
E.V. Klovach ◽  
◽  
A.S. Pecherkin ◽  
V.K. Shalaev ◽  
V.I. Sidorov ◽  
...  
Keyword(s):  
Russian Federation ◽  
Preventive Measures ◽  
Regulatory System ◽  
Industrial Safety ◽  
State Control ◽  
Regulatory Impact ◽  
The Russian Federation ◽  
The Law ◽  
The Government ◽  
Executive Body

In Russia, the reform of the regulatory guillotine is being implemented in the field of control and supervisory activity. It should result in a new regulatory system formed according to the principles specified in the key federal laws: «On state control (supervision) and municipal control in the Russian Federation» (Law on Control) and «On mandatory requirements in the Russian Federation» (Law on Mandatory Requirements) adopted in August 2020. In the field of industrial safety, this process was launched by the Decree of the Government of the Russian Federation № 1192, which will come into force on January 1, 2021. The main provisions are discussed in the article, which are related to the Law on Control and the Law on Mandatory Requirements. The Law on Control establishes the priority of preventive measures aimed at reducing the risk of causing harm in relation to the control activities, the grounds for carrying out control (supervisory) activities, the types of these activities in the forms of interaction with the controlled person and without such, the procedure for presentation of the results of control (supervisory) activity. The Law on Mandatory Requirements establishes that the provisions of regulatory legal acts should enter into force either from March 1 or September 1, but not earlier than 90 days after their official publication, and their validity period should not exceed 6 years. The drafts of regulatory legal acts developed by the federal executive bodies are subject to regulatory impact assessment. With a view to ensuring systematization of mandatory require ments, their register is kept. The federal executive body prepares a report on the achievement of the goals of mandatory requirements introduction. By January 1, 2021, 10 resolutions of the Government of the Russian Federation, 48 federal norms and rules in the field of industrial safety and 9 other regulatory legal acts of Rostechnadzor should be adopted. The drafts of all the documents are already prepared, some of the acts are completing the process of discussion and approval.

Current Status of Knowledge and Awareness of Diabetes Mellitus in Saudi Arabia

2020 ◽  
Vol 16 ◽  
Author(s):  
Asirvatham Alwin Robert ◽  
Ahmad Dakeel Al Awad ◽  
Mohamed Abdulaziz Al Dawish
Keyword(s):  
Diabetes Mellitus ◽  
Saudi Arabia ◽  
Disease Risk ◽  
Current Knowledge ◽  
Adult Population ◽  
Management Training ◽  
Control Measures ◽  
Current Status ◽  
Treatment Modalities ◽  
The Government

Abstract: Diabetes mellitus (DM) is a chronic disease, and the complications may be life-threatening; however, with proper treatment and control measures, it can be very well-managed. Self-management training and education of diabetes are critical in diabetes care and management. It is essential that patients with diabetes must have a comprehensive understanding of the nature of the disease, risk factors, complications, and possible treatment modalities to attenuate the complications. Over the last few years, DM in Saudi Arabia has been rapidly growing at an alarming rate. It has affected around one-fifth of the adult population, and by 2030, the numbers are predicted to rise further and exceed more than double the present number. An estimated tenfold increase has been reported over the past three decades in Saudi Arabia. However, there has not been much research focusing on understanding the knowledge and awareness of DM in Saudi Arabia as compared to developed nations. This review aims to present an overview of the current knowledge and awareness level of DM among the population of Saudi Arabia through an extensive review of the currently available literature. The review findings could be of immense assistance to the government, healthcare systems, educational institutions, and researchers to develop evidence-based programs, policies, and guidelines towards increasing the knowledge and awareness about diabetes and its management, so that early detection and management can be ensured to control the escalating burden of diabetes, in Saudi Arabia.

Upcoming Drifts In Bio-Similars

2020 ◽  
Vol 15 ◽  
Author(s):  
Geeta Aggarwal ◽  
Manju Nagpal ◽  
Ameya Sharma ◽  
Vivek Puri ◽  
Gitika Arora Dhingra
Keyword(s):  
Metabolic Diseases ◽  
Market Competition ◽  
Current Status ◽  
Medicinal Products ◽  
The Past ◽  
Biologic Activity ◽  
Emerging Trends ◽  
Regulatory Guidelines ◽  
Food Drug Administration ◽  
Insight Into

Background: Biopharmaceuticals such as Biologic medicinal products have been in clinical use over the past three decades and have benefited towards the therapy of degenerative and critical metabolic diseases. It is forecasted that market of biologics will be going to increase at a rate of 20% per year, and by 2025, more than ˃ 50% of new drug approvals may be biological products. The increasing utilization of the biologics necessitates for cost control, especially for innovators products that have enjoyed a lengthy period of exclusive use. As the first wave of biopharmaceuticals is expired or set to expire, it has led to various opportunities for the expansion of bio-similars i.e. copied versions of original biologics with same biologic activity. Development of biosimilars is expected to promote market competition, meet worldwide demand, sustain the healthcare systems and maintain the incentives for innovation. Methods: Appraisal of published articles from peer reviewed journals, PubMed literature, latest news and guidelines from European Medicine Agency, US Food Drug Administration (FDA) and India are used to identify data for review. Results: Main insight into the quality requirements concerning biologics, current status of regulation of biosimilars and upcoming challenges lying ahead for the upgrading of marketing authorization of bio-similars has been incorporated. Compiled literature on therapeutic status, regulatory guidelines and the emerging trends and opportunities of biosimilars has been thoroughly stated. Conclusion: Updates on biosimilars will support to investigate the possible impact of bio-similars on healthcare market.

RURAL TOURISM IN INDIA CHALLENGES AND OPPORTUNITIES

2018 ◽  
Vol 6 (26) ◽  
Author(s):  
Pankaj Sharma ◽  
Ravi Parkash
Keyword(s):  
Private Sector ◽  
Rural Areas ◽  
Economic Condition ◽  
Rural Tourism ◽  
Rural Location ◽  
Different Types ◽  
Challenges And Opportunities ◽  
Political Background ◽  
The Government

The paper analyze the role of rural tourism for the development of rural areas, The study analyzed how the different types of tourist product diversifications influence the development possibilities of studied rural areas in India. The government should sponsor private Sector to promote tourism in rural areas. For upgrading the rural tourism government requires to understand the rural location, demography, socio-culture, financial and political background of that area. How we can involve the rural citizens to improve their socio-economic condition. The objective of this paper is to present an update on rural tourism expansion and development in India. Rural tourism is rising in terms of number of visitors and the government of India should focus on it as an engine of growth

scholarly journals The Implementation of Childhood Obesity Related Policy Interventions in Malaysia—A Non Communicable Diseases Scorecard Project

2021 ◽  
Vol 18 (11) ◽  
pp. 5950
Author(s):  
Wilfred Kok Hoe Mok ◽  
Noran Naqiah Hairi ◽  
Caryn Mei Hsien Chan ◽  
Feisul Idzwan Mustapha ◽  
Thamil Arasu Saminathan ◽  
...  
Keyword(s):  
Risk Factors ◽  
Childhood Obesity ◽  
Communicable Diseases ◽  
Overweight And Obesity ◽  
Current Status ◽  
Non Communicable Diseases ◽  
Modified Delphi ◽  
Policy Interventions ◽  
Non Governmental Organizations ◽  
The Government

(1) Background: The prevalence of overweight and obesity among children has increased tremendously in the ASEAN region, including Malaysia. In Malaysia, the National Strategic Plan for Non-Communicable Diseases (2015–2025) provides the overall framework for its response to the non-communicable diseases (NCD) epidemic. Preventing childhood obesity is one of the key strategies for early intervention to prevent NCDs. The objective of this research is to examine the current status of policy interventions in addressing childhood obesity in Malaysia. (2) Methods: A panel of 22 stakeholders and experts from Malaysia, representing the government, industry, academia and non-governmental organizations, were sampled using a modified Delphi technique. Data were collected using a modified NCD scorecard under four domains (governance, risk factors, surveillance and research and health systems response). A heat map was used to measure the success of the four realms of the NCD scorecard. For each domain of the NCD scorecard, the final score was grouped in quintiles. (3) Results: A total of 22 participants responded, comprising of eight (36.4%) males and 14 (63.4%) females. All the domains measured in implementing policies related to childhood obesity were of low progress. Nine governance indicators were reported as 22.5% (low progress), four in the risk factors domain, and two in the surveillance. This shows that timely and accurate monitoring, participatory review and evaluation, and effective remedies are necessary for a country’s surveillance system. (4) Conclusion: Although Malaysia has published several key strategic documents relating to childhood obesity and implemented numerous policy interventions, we have identified several gaps that must be addressed to leverage the whole-of-government and whole-of-society approach in addressing childhood obesity in the country.

scholarly journals Evidence for Range Expansion and Origins of an Invasive Hornet Vespa bicolor (Hymenoptera, Vespidae) in Taiwan, with Notes on Its Natural Status

Insects ◽  
2021 ◽  
Vol 12 (4) ◽  
pp. 320
Author(s):  
Sheng-Shan Lu ◽  
Junichi Takahashi ◽  
Wen-Chi Yeh ◽  
Ming-Lun Lu ◽  
Jing-Yi Huang ◽  
...  
Keyword(s):  
Range Expansion ◽  
Ecological Niche Modeling ◽  
Phylogenetic Analyses ◽  
Current Status ◽  
Mountain Areas ◽  
Colony Losses ◽  
Short Branch ◽  
Branch Lengths ◽  
The Government ◽  
Central Taiwan

The invasive alien species (IAS) Vespa bicolor is the first reported hornet that has established in Taiwan and is concerning as they prey on honeybee Apis mellifera, which leads to colony losses and public concerns. Thus, the aim of this study was to assess the current status of V. bicolor abundance, dispersal, and impact and to trace the origins of Taiwan’s V. bicolor population. Our studies took place in five areas in northern to central Taiwan. We used mtDNA in the phylogenetic analyses. Field survey and ecological niche modeling (ENM) were used to understand the origins and current range of the invasive species. Two main subgroups of V. bicolor in the phylogenetic tree were found, and a clade with short branch lengths in Southeastern China and Taiwan formed a subgroup, which shows that the Taiwan population may have invaded from a single event. Evidence shows that V. bicolor is not a severe pest to honeybees in the study area; however, using ENM, we predict the rapid dispersion of this species to the cooler and hilly mountain areas of Taiwan. The management of V. bicolor should also involve considering it a local pest to reduce loss by beekeepers and public fear in Taiwan. Our findings highlight how the government, beekeepers, and researchers alike should be aware of the implications of V. bicolor’s rapid range expansion in Taiwan, or in other countries.

Restoration of smart grids: Current status, challenges, and opportunities

2021 ◽  
Vol 143 ◽  
pp. 110909
Author(s):  
Dongming Fan ◽  
Yi Ren ◽  
Qiang Feng ◽  
Yiliu Liu ◽  
Zili Wang ◽  
...  
Keyword(s):  
Smart Grids ◽  
Current Status ◽  
Challenges And Opportunities

Challenges and opportunities for social entrepreneurs in civil engineering in Brazil

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Ernesto Ferreira Vasconcellos ◽  
Bernardo Henrique Leso ◽  
Marcelo Nogueira Cortimiglia
Keyword(s):  
Civil Engineering ◽  
Social Innovation ◽  
Social Enterprises ◽  
Exploratory Research ◽  
Social Entrepreneurs ◽  
Content Type ◽  
Challenges And Opportunities ◽  
Research Findings ◽  
Development Goals ◽  
The Government

Purpose This paper aims to identify challenges and opportunities for social enterprises (SE) in civil engineering in Brazil. Design/methodology/approach Starting from the transformative social innovation theory and inspired by grounded theory principles, this paper conducts three-stage exploratory research. First, this paper mapped the Brazilian SE civil engineering ecosystem. Next, this paper classified the SE initiatives along with an organizing framework. Finally, this paper conducted 11 interviews with key ecosystem actors and analyzed data through iterative, parallel and interrelated content analysis procedures. Findings The 37 SE found were classified along “Sustainability,” “Housing,” “Transportation” and “Sanitation” pillars, which are aligned with the United Nations’ social development goals. This paper found 50 challenges and opportunities, which were aggregated along seven dimensions. Three elements are particularly relevant as opportunities: opportunities for SE with ecosystem supporters, specialized investors and partnership with major companies; while government and early investment are the most relevant challenges. Research limitations/implications Research findings and conclusions cannot be extended to other sectors and countries. Usual limitations associated with exploratory qualitative research must also be highlighted. Practical implications The government should offer financial and technical support for civil engineering in working in partnership with ecosystem supporters. Academy could use SE content and ecosystem for its students and should offer diverse resources for network creation. Originality/value Focusing on civil engineering SE in Brazil, this study sheds light on a high-impact sector that has not been studied yet.

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