Search results for: pharmaceutical bureaucracy
Commenced in January 2007
Frequency: Monthly
Edition: International
Paper Count: 679

Search results for: pharmaceutical bureaucracy

649 Determinants of Profitability in Indian Pharmaceutical Firms in the New Intellectual Property Rights Regime

Authors: Shilpi Tyagi, D. K. Nauriyal

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This study investigates the firm level determinants of profitability of Indian drug and pharmaceutical industry. The study uses inflation adjusted panel data for a period 2000-2013 and applies OLS regression model with Driscoll-Kraay standard errors. It has been found that export intensity, A&M intensity, firm’s market power and stronger patent regime dummy have exercised positive influence on profitability. The negative and statistically significant influence of R&D intensity and raw material import intensity points to the need for firms to adopt suitable investment strategies. The study suggests that firms are required to pay far more attention to optimize their operating expenditures, advertisement and marketing expenditures and improve their export orientation, as part of the long term strategy.

Keywords: Indian pharmaceutical industry, profits, TRIPS, performance

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648 Regime under Trade Related Intellectual Property Rights Agreement 1994 and Its Impacts on Health in Pakistan: A Case Study of Pharmaceutical Patents

Authors: Muhammad Danyal Khan

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The standards of patentability are drawing a great impact upon medicine industry of Pakistan which is indirectly troubling the right to health of ordinary citizen. Globalization of intellectual property laws is directly impacting access to medicine for population in Pakistan. Pakistan has enacted Patent Ordinance 2000 to develop the standards of Patent laws in consonance with international commitments. Moreover, Pakistan is signatory to UN Millennium Development Goals (2000-2015), and three of them directly put stress upon the health standards. This article will provide a critical brief about implications of TRIPS Agreement on standards of health in Pakistan and will also propose a futuristic approach for the pharmaceutical industry. This paper will define the paradox of globalization and national preparedness on pharmaceutical patents utilizing industry statistics and case laws from Pakistan. Moreover, this work will contribute towards debate on access to medicine at legislative and interpretative levels that will further help development of equilibrium between pharmaceutical patents and right to health.

Keywords: TRIPS (Trade Related Intellectual Property Rights), patents, compulsory licensing, patent, lifesaving drugs, WTO, infringement

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647 Operational Excellence Performance in Pharmaceutical Quality Control Labs: An Empirical Investigation of the Effectiveness and Efficiency Relation

Authors: Stephan Koehler, Thomas Friedli

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Performance measurement has evolved over time from a unidimensional short-term efficiency focused approach into a balanced multidimensional approach. Today, integrated performance measurement frameworks are often used to avoid local optimization and to encourage continuous improvement of an organization. In literature, the multidimensional characteristic of performance measurement is often described by competitive priorities. At the same time, on the highest abstraction level an effectiveness and efficiency dimension of performance measurement can be distinguished. This paper aims at a better understanding of the composition of effectiveness and efficiency and their relation in pharmaceutical quality control labs. The research comprises a lab-specific operationalization of effectiveness and efficiency and examines how the two dimensions are interlinked. The basis for the analysis represents a database of the University of St. Gallen including a divers set of 40 different pharmaceutical quality control labs. The research provides empirical evidence that labs with a high effectiveness also accompany a high efficiency. Lab effectiveness explains 29.5 % of the variance in lab efficiency. In addition, labs with an above median operational excellence performance have a statistically significantly higher lab effectiveness and lab efficiency compared to the below median performing labs.

Keywords: empirical study, operational excellence, performance measurement, pharmaceutical quality control lab

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646 The Effect of Foreign Owned Firms and Licensed Manufacturing Agreements on Innovation: Case of Pharmaceutical Firms in Developing Countries

Authors: Ilham Benali, Nasser Hajji, Nawfal Acha

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Given the fact that the pharmaceutical industry is a commonly studied sector in the context of innovation, the majority of innovation research is devoted to the developed markets known by high research and development (R&D) assets and intensive innovation. In contrast, in developing countries where R&D assets are very low, there is relatively little research to mention in the area of pharmaceutical sector innovation, characterized mainly by two principal elements which are the presence of foreign-owned firms and licensed manufacturing agreements between local firms and multinationals. With the scarcity of research in this field, this paper attempts to study the effect of these two elements on the firms’ innovation tendencies. Other traditional factors that influence innovation, which are the age and the size of the firm, the R&D activities and the market structure, revealed in the literature review, will be included in the study in order to try to make this work more exhaustive. The study starts by examining innovation tendency in pharmaceutical firms located in developing countries before analyzing the effect of foreign-owned firms and licensed manufacturing agreements between local firms and multinationals on technological, organizational and marketing innovation. Based on the related work and on the theoretical framework developed, there is a probability that foreign-owned firms and licensed manufacturing agreements between local firms and multinationals have a negative influence on technological innovation. The opposite effect is possible in the case of organizational and marketing innovation.

Keywords: developing countries, foreign owned firms, innovation, licensed manufacturing agreements, pharmaceutical industry

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645 Corporate Life Cycle and Corporate Social Responsibility Performance: Empirical Evidence from Pharmaceutical Industry in China

Authors: Jing (Claire) LI

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The topic of corporate social responsibility (CSR) is significant for pharmaceutical companies in China at this current stage. This is because, as a rapid growth industry in China in recent years, the pharmaceutical industry in China has been undergone continuous and terrible incidents relating to CSR. However, there is limited research and practice of CSR in Chinese pharmaceutical companies. Also, there is an urgent call for more research in an international context to understand the implications of corporate life cycle on CSR performance. To respond to the research need and research call, this study examines the relationship between corporate life cycle and CSR performance of Chinese listed companies in pharmaceutical industry. This research studies Chinese listed companies in pharmaceutical industry for the period of 2010-2017, where the data is available in database. Following the literature, this study divides CSR performance with regards to CSR dimensions, including shareholders, creditors, employees, customers, suppliers, the government, and the society. This study uses CSR scores of HEXUN database and financial measures of these CSR dimensions to measure the CSR performance. This study performed regression analysis to examine the relationship between corporate life cycle stages and CSR performance with regards to CSR dimensions for pharmaceutical listed companies in China. Using cash flow pattern as proxy of corporate life cycle to classify corporate life cycle stages, this study found that most (least) pharmaceutical companies in China are in maturity (decline) stage. This study found that CSR performance for most dimensions are highest (lowest) in maturity (decline) stage as well. Among these CSR dimensions, performing responsibilities for shareholder is the most important among all CSR responsibilities for pharmaceutical companies. This study is the first to provide important empirical evidence from Chinese pharmaceutical industry on the association between life cycle and CSR performance, supporting that corporate life cycle is a key factor in CSR performance. The study expands corporate life cycle and CSR literatures and has both empirical and theoretical contributions to the literature. From perspective of empirical contributions, the findings contribute to the argument that whether there is a relationship between CSR performance and various corporate life cycle stages in the literature. This study also provides empirical evidence that companies in different corporate life cycles have difference in CSR performance. From perspective of theoretical contributions, this study relates CSR and stakeholders to corporate life cycle stages and complements the corporate life cycle and CSR literature. This study has important implications for managers and policy makers. First, the results will be helpful for managers to have an understanding in the essence of CSR, and their company’s current and future CSR focus over corporate life cycle. This study provides a reference for their actions and may help them make more wise resources allocation decisions of CSR investment. Second, policy makers (in the government, stock exchanges, and securities commission) may consider corporate life cycle as an important factor in formulating future regulations for companies. Future research can explore the "process-based" differences in CSR performance and more industries.

Keywords: China, corporate life cycle, corporate social responsibility, pharmaceutical industry

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644 Prediction of Incompatibility Between Excipients and API in Gliclazide Tablets Using Infrared Spectroscopy and Principle Component Analysis

Authors: Farzad Khajavi

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Recognition of the interaction between active pharmaceutical ingredients (API) and excipients is a pivotal factor in the development of all pharmaceutical dosage forms. By predicting the interaction between API and excipients, we will be able to prevent the advent of impurities or at least lessen their amount. In this study, we used principle component analysis (PCA) to predict the interaction between Gliclazide as a secondary amine with Lactose in pharmaceutical solid dosage forms. The infrared spectra of binary mixtures of Gliclazide with Lactose at different mole ratios were recorded, and the obtained matrix was analyzed with PCA. By plotting score columns of the analyzed matrix, the incompatibility between Gliclazide and Lactose was observed. This incompatibility was seen experimentally. We observed the appearance of the impurity originated from the Maillard reaction between Gliclazide and Lactose at the chromatogram of the manufactured tablets in room temperature and under accelerated stability conditions. This impurity increases at the stability months. By changing Lactose to Mannitol and using Calcium Dibasic Phosphate in the tablet formulation, the amount of the impurity decreased and was in the acceptance range defined by British pharmacopeia for Gliclazide Tablets. This method is a fast and simple way to predict the existence of incompatibility between excipients and active pharmaceutical ingredients.

Keywords: PCA, gliclazide, impurity, infrared spectroscopy, interaction

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643 Civil Service Reforms in Kazakhstan and Its Influence on Modernization

Authors: Aliya Idrissova

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Civil service (public administration) is an important social institution of society properties. Civil service institution had a significant impact on modernization processes in Kazakhstan through ensuring the functioning of all the subsystems of social life. This article is an attempt to analyses the reforms of public service institution in Kazakhstan and to assess its influence on modernization processes.

Keywords: civil service, Kazakhstan, modernization, a national model of civil service, civil service reforms, bureaucracy

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642 Multiobjective Optimization of a Pharmaceutical Formulation Using Regression Method

Authors: J. Satya Eswari, Ch. Venkateswarlu

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The formulation of a commercial pharmaceutical product involves several composition factors and response characteristics. When the formulation requires to satisfy multiple response characteristics which are conflicting, an optimal solution requires the need for an efficient multiobjective optimization technique. In this work, a regression is combined with a non-dominated sorting differential evolution (NSDE) involving Naïve & Slow and ε constraint techniques to derive different multiobjective optimization strategies, which are then evaluated by means of a trapidil pharmaceutical formulation. The analysis of the results show the effectiveness of the strategy that combines the regression model and NSDE with the integration of both Naïve & Slow and ε constraint techniques for Pareto optimization of trapidil formulation. With this strategy, the optimal formulation at pH=6.8 is obtained with the decision variables of micro crystalline cellulose, hydroxypropyl methylcellulose and compression pressure. The corresponding response characteristics of rate constant and release order are also noted down. The comparison of these results with the experimental data and with those of other multiple regression model based multiobjective evolutionary optimization strategies signify the better performance for optimal trapidil formulation.

Keywords: pharmaceutical formulation, multiple regression model, response surface method, radial basis function network, differential evolution, multiobjective optimization

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641 An Enhanced Approach in Validating Analytical Methods Using Tolerance-Based Design of Experiments (DoE)

Authors: Gule Teri

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The effective validation of analytical methods forms a crucial component of pharmaceutical manufacturing. However, traditional validation techniques can occasionally fail to fully account for inherent variations within datasets, which may result in inconsistent outcomes. This deficiency in validation accuracy is particularly noticeable when quantifying low concentrations of active pharmaceutical ingredients (APIs), excipients, or impurities, introducing a risk to the reliability of the results and, subsequently, the safety and effectiveness of the pharmaceutical products. In response to this challenge, we introduce an enhanced, tolerance-based Design of Experiments (DoE) approach for the validation of analytical methods. This approach distinctly measures variability with reference to tolerance or design margins, enhancing the precision and trustworthiness of the results. This method provides a systematic, statistically grounded validation technique that improves the truthfulness of results. It offers an essential tool for industry professionals aiming to guarantee the accuracy of their measurements, particularly for low-concentration components. By incorporating this innovative method, pharmaceutical manufacturers can substantially advance their validation processes, subsequently improving the overall quality and safety of their products. This paper delves deeper into the development, application, and advantages of this tolerance-based DoE approach and demonstrates its effectiveness using High-Performance Liquid Chromatography (HPLC) data for verification. This paper also discusses the potential implications and future applications of this method in enhancing pharmaceutical manufacturing practices and outcomes.

Keywords: tolerance-based design, design of experiments, analytical method validation, quality control, biopharmaceutical manufacturing

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640 Local Religion 'Parmalim': Between Civilization and Faith

Authors: Sabrina Yulianti

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This study aims to explain the identity struggles of local religious communities in Indonesia. Local religion in Indonesia is not recognized by the government and is not incorporated into the official religion in Indonesia. This makes the local religions in Indonesia experienced the challenges and obstacles in fulfilling their rights as citizens of Indonesia. Challenges and barriers they experience such as: difficulty in making of the birth certificate and marriage. It is as experienced by one of the local religions namely Parmalim which located in North Sumatra. Not only difficulty in taking care of the bureaucracy as a citizen, but the local religion is seen as a minority and sometimes regarded as follower of deviate religion.

Keywords: local religion, faith, struggles, civilization, discrimination

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639 Implementation of Big Data Concepts Led by the Business Pressures

Authors: Snezana Savoska, Blagoj Ristevski, Violeta Manevska, Zlatko Savoski, Ilija Jolevski

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Big data is widely accepted by the pharmaceutical companies as a result of business demands create through legal pressure. Pharmaceutical companies have many legal demands as well as standards’ demands and have to adapt their procedures to the legislation. To manage with these demands, they have to standardize the usage of the current information technology and use the latest software tools. This paper highlights some important aspects of experience with big data projects implementation in a pharmaceutical Macedonian company. These projects made improvements of their business processes by the help of new software tools selected to comply with legal and business demands. They use IT as a strategic tool to obtain competitive advantage on the market and to reengineer the processes towards new Internet economy and quality demands. The company is required to manage vast amounts of structured as well as unstructured data. For these reasons, they implement projects for emerging and appropriate software tools which have to deal with big data concepts accepted in the company.

Keywords: big data, unstructured data, SAP ERP, documentum

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638 An Empirical Analysis of HRM in Different Pharmaceutical Departments of Different Pharmaceutical Industries in Pakistan

Authors: Faisal Ali, Mansoor Shuakat, Cui Lirong, Rabia Riasat

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HR is a department that enhances the power of employee performance in regard with their services, and to make the organization strategic objectives. The main concern of HR department is to organize people, focus on policies and their system. The empirical study shows the relationship between HRM (Human Resource Management practices) and their Job Satisfaction. The Hypothesis is testing on a sample of overall 320 employees of 5 different Pharmaceutical departments of different organizations in Pakistan. The important thing as Relationship of Job satisfaction with HR Practices, Impact on Job Satisfaction with HR Practices, Participation of Staff of Different Departments, HR Practices effects the Job satisfaction, Recruitment or Hiring and Selection effects the Job satisfaction, Training and Development, Performance and Appraisals, Compensation affects the Job satisfaction , and Industrial Relationships affects the Job satisfaction. After finishing all data analysis, the conclusion is that lots of Job related activities raise the confidence of Job satisfaction of employees with their salary and other benefits. Implications of HR practices discussed, Limitations, and future research study also offered write the main conclusion for your paper.

Keywords: HRM, HR practices, job satisfaction, TQM

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637 Exploring Drivers and Barriers to Environmental Supply Chain Management in the Pharmaceutical Industry of Ghana

Authors: Gifty Kumadey, Albert Tchey Agbenyegah

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(i) Overview and research goal(s): This study aims to address research gaps in the Ghanaian pharmaceutical industry by examining the impact of environmental supply chain management (ESCM) practices on environmental and operational performance. Previous studies have provided inconclusive evidence on the relationship between ESCM practices and environmental and operational performance. The research aims to provide a clearer understanding of the impact of ESCM practices on environmental and operational performance in the context of the Ghanaian pharmaceutical industry. Limited research has been conducted on ESCM practices in developing countries, particularly in Africa. The study aims to bridge this gap by examining the drivers and barriers specific to the pharmaceutical industry in Ghana. The research aims to analyze the impact of ESCM practices on the achievement of Sustainable Development Goals (SDGs) in the Ghanaian pharmaceutical industry, focusing on SDGs 3, 12, 13, and 17. It also explores the potential for partnerships and collaborations to advance ESCM practices in the pharmaceutical industry. The research hypotheses suggest that pressure from stakeholder positively influences the adoption of ESCM practices in the Ghanaian pharmaceutical industry. By addressing these goals, the study aims to contribute to sustainable development initiatives and offer practical recommendations to enhance ESCM A practices in the industry. (ii) Research methods and data: This study uses a quantitative research design to examine the drivers and barriers to environmental supply chain management in the pharmaceutical industry in Accra.The sample size is approximately 150 employees, with senior and middle-level managers from pharmaceutical industry of Ghana. A purposive sampling technique is used to select participants with relevant knowledge and experience in environmental supply chain management. Data will be collected using a structured questionnaire using Likert scale responses. Descriptive statistics will be used to analyze the data and provide insights into current practices and their impact on environmental and operational performance. (iii) Preliminary results and conclusions: Main contributions: Identifying drivers/barriers to ESCM in Ghana's pharmaceutical industry, evaluating current ESCM practices, examining impact on performance, providing practical insights, contributing to knowledge on ESCM in Ghanaian context. The research contributes to SDGs 3, 9, and 12 by promoting sustainable practices and responsible consumption in the industry. The study found that government rules and regulations are the most critical drivers for ESCM adoption, with senior managers playing a significant role. However, employee and competitor pressures have a lesser impact. The industry has made progress in implementing certain ESCM practices, but there is room for improvement in areas like green distribution and reverse logistics. The study emphasizes the importance of government support, management engagement, and comprehensive implementation of ESCM practices in the industry. Future research should focus on overcoming barriers and challenges to effective ESCM implementation.

Keywords: environmental supply chain, sustainable development goal, ghana pharmaceutical industry, government regulations

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636 Factors Affecting Profitability of Pharmaceutical Company During the COVID-19 Pandemic: An Indonesian Evidence

Authors: Septiany Trisnaningtyas

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Purpose: This research aims to examine the factors affecting the profitability of pharmaceutical company during the Covid-19 Pandemic in Indonesia. A sharp decline in the number of patients coming to the hospital for treatment during the pandemic has an impact on the growth of the pharmaceutical sector and brought major changes in financial position and business performance. Pharmaceutical companies that provide products related to the Covid-19 pandemic can survive and continue to grow. This study investigates the factors affecting the profitability of pharmaceutical company during the Covid-19 Pandemic in Indonesia associated with the number of Covid-19 cases. Design/methodology/approach: This study uses panel-data regression models to evaluate the influence of the number of Covid-19 confirmed cases on profitability of ninelisted pharmaceuticalcompanies in Indonesia. This research is based on four independent variables that were empirically examined for their relationship with profitability. These variables are liquidity (current ratio), growth rate (sales growth), firm size (total sales), and market power (the Lerner index). Covid-19 case is used as moderating variable. Data of nine pharmaceutical companies listed on the Indonesia Stock Exchange covering the period of 2018–2021 were extracted from companies’ quarterly annual reports. Findings: In the period during Covid-19, company growth (sales growth) and market power (lerner index) have a positive and significant relationship to ROA and ROE. Total of confirmed Covid-19 cases has a positive and significant relationship to ROA and is proven to have a moderating effect between company’s growth (sales growth) to ROA and ROE and market power (Lerner index) to ROA. Research limitations/implications: Due to data availability, this study only includes data from nine listed pharmaceutical companies in Indonesian Stock exchange and quarterly annual reportscovering the period of 2018-2021. Originality/value: This study focuses onpharmaceutical companies in Indonesia during Covid-19 pandemic. Previous study analyzes the data from pharmaceutical companies’ annual reports since 2014 and focus on universal health coverage (national health insurance) implementation from the Indonesian government. This study analyzes the data using fixed effect panel-data regression models to evaluate the influence of Covid-19 confirmed cases on profitability. Pooled ordinary least squares regression and fixed effects were used to analyze the data in previous study. This study also investigate the moderating effect of Covid-19 confirmed cases to profitability in relevant with the pandemic situation.

Keywords: profitability, indonesia, pharmaceutical, Covid-19

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635 Enabling Rather Than Managing: Organizational and Cultural Innovation Mechanisms in a Heterarchical Organization

Authors: Sarah M. Schoellhammer, Stephen Gibb

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Bureaucracy, in particular, its core element, a formal and stable hierarchy of authority, is proving less and less appropriate under the conditions of today’s knowledge economy. Centralization and formalization were consistently found to hinder innovation, undermining cross-functional collaboration, personal responsibility, and flexibility. With its focus on systematical planning, controlling and monitoring the development of new or improved solutions for customers, even innovation management as a discipline is to a significant extent based on a mechanistic understanding of organizations. The most important drivers of innovation, human creativity, and initiative, however, can be more hindered than supported by central elements of classic innovation management, such as predefined innovation strategies, rigid stage gate processes, and decisions made in management gate meetings. Heterarchy, as an alternative network form of organization, is essentially characterized by its dynamic influence structures, whereby the biggest influence is allocated by the collective to the persons perceived the most competent in a certain issue. Theoretical arguments that the non-hierarchical concept better supports innovation than bureaucracy have been supported by empirical research. These prior studies either focus on the structure and general functioning of non-hierarchical organizations or on their innovativeness, that means innovation as an outcome. Complementing classic innovation management approaches, this work aims to shed light on how innovations are initiated and realized in heterarchies in order to identify alternative solutions practiced under conditions of the post-bureaucratic organization. Through an initial individual case study, which is part of a multiple-case project, the innovation practices of an innovative and highly heterarchical medium-sized company in the German fire engineering industry are investigated. In a pragmatic mixed methods approach media resonance, company documents, and workspace architecture are analyzed, in addition to qualitative interviews with the CEO and employees of the case company, as well as a quantitative survey aiming to characterize the company along five scaled dimensions of a heterarchy spectrum. The analysis reveals some similarities and striking differences to approaches suggested by classic innovation management. The studied heterarchy has no predefined innovation strategy guiding new product and service development. Instead, strategic direction is provided by the CEO, described as visionary and creative. Procedures for innovation are hardly formalized, with new product ideas being evaluated on the basis of gut feeling and flexible, rather general criteria. Employees still being hesitant to take responsibility and make decisions, hierarchical influence is still prominent. Described as open-minded and collaborative, culture and leadership were found largely congruent with definitions of innovation culture. Overall, innovation efforts at the case company tend to be coordinated more through cultural than through formal organizational mechanisms. To better enable innovation in mainstream organizations, responsible practitioners are recommended not to limit changes to reducing the central elements of the bureaucratic organization, formalization, and centralization. The freedoms this entails need to be sustained through cultural coordination mechanisms, with personal initiative and responsibility by employees as well as common innovation-supportive norms and values. These allow to integrate diverse competencies, opinions, and activities and, thus, to guide innovation efforts.

Keywords: bureaucracy, heterarchy, innovation management, values

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634 The Potential Impact of Big Data Analytics on Pharmaceutical Supply Chain Management

Authors: Maryam Ziaee, Himanshu Shee, Amrik Sohal

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Big Data Analytics (BDA) in supply chain management has recently drawn the attention of academics and practitioners. Big data refers to a massive amount of data from different sources, in different formats, generated at high speed through transactions in business environments and supply chain networks. Traditional statistical tools and techniques find it difficult to analyse this massive data. BDA can assist organisations to capture, store, and analyse data specifically in the field of supply chain. Currently, there is a paucity of research on BDA in the pharmaceutical supply chain context. In this research, the Australian pharmaceutical supply chain was selected as the case study. This industry is highly significant since the right medicine must reach the right patients, at the right time, in right quantity, in good condition, and at the right price to save lives. However, drug shortages remain a substantial problem for hospitals across Australia with implications on patient care, staff resourcing, and expenditure. Furthermore, a massive volume and variety of data is generated at fast speed from multiple sources in pharmaceutical supply chain, which needs to be captured and analysed to benefit operational decisions at every stage of supply chain processes. As the pharmaceutical industry lags behind other industries in using BDA, it raises the question of whether the use of BDA can improve transparency among pharmaceutical supply chain by enabling the partners to make informed-decisions across their operational activities. This presentation explores the impacts of BDA on supply chain management. An exploratory qualitative approach was adopted to analyse data collected through interviews. This study also explores the BDA potential in the whole pharmaceutical supply chain rather than focusing on a single entity. Twenty semi-structured interviews were undertaken with top managers in fifteen organisations (five pharmaceutical manufacturers, five wholesalers/distributors, and five public hospital pharmacies) to investigate their views on the use of BDA. The findings revealed that BDA can enable pharmaceutical entities to have improved visibility over the whole supply chain and also the market; it enables entities, especially manufacturers, to monitor consumption and the demand rate in real-time and make accurate demand forecasts which reduce drug shortages. Timely and precise decision-making can allow the entities to source and manage their stocks more effectively. This can likely address the drug demand at hospitals and respond to unanticipated issues such as drug shortages. Earlier studies explore BDA in the context of clinical healthcare; however, this presentation investigates the benefits of BDA in the Australian pharmaceutical supply chain. Furthermore, this research enhances managers’ insight into the potentials of BDA at every stage of supply chain processes and helps to improve decision-making in their supply chain operations. The findings will turn the rhetoric of data-driven decision into a reality where the managers may opt for analytics for improved decision-making in the supply chain processes.

Keywords: big data analytics, data-driven decision, pharmaceutical industry, supply chain management

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633 Understanding Stock-Out of Pharmaceuticals in Timor-Leste: A Case Study in Identifying Factors Impacting on Pharmaceutical Quantification in Timor-Leste

Authors: Lourenco Camnahas, Eileen Willis, Greg Fisher, Jessie Gunson, Pascale Dettwiller, Charlene Thornton

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Stock-out of pharmaceuticals is a common issue at all level of health services in Timor-Leste, a small post-conflict country. This lead to the research questions: what are the current methods used to quantify pharmaceutical supplies; what factors contribute to the on-going pharmaceutical stock-out? The study examined factors that influence the pharmaceutical supply chain system. Methodology: Privett and Goncalvez dependency model has been adopted for the design of the qualitative interviews. The model examines pharmaceutical supply chain management at three management levels: management of individual pharmaceutical items, health facilities, and health systems. The interviews were conducted in order to collect information on inventory management, logistics management information system (LMIS) and the provision of pharmaceuticals. Andersen' behavioural model for healthcare utilization also informed the interview schedule, specifically factors linked to environment (healthcare system and external environment) and the population (enabling factors). Forty health professionals (bureaucrats, clinicians) and six senior officers from a United Nations Agency, a global multilateral agency and a local non-governmental organization were interviewed on their perceptions of factors (healthcare system/supply chain and wider environment) impacting on stock out. Additionally, policy documents for the entire healthcare system, along with population data were collected. Findings: An analysis using Pozzebon’s critical interpretation identified a range of difficulties within the system from poor coordination to failure to adhere to policy guidelines along with major difficulties with inventory management, quantification, forecasting, and budgetary constraints. Weak logistics management information system, lack of capacity in inventory management, monitoring and supervision are additional organizational factors that also contributed to the issue. There were various methods of quantification of pharmaceuticals applied in the government sector, and non-governmental organizations. Lack of reliable data is one of the major problems in the pharmaceutical provision. Global Fund has the best quantification methods fed by consumption data and malaria cases. There are other issues that worsen stock-out: political intervention, work ethic and basic infrastructure such as unreliable internet connectivity. Major issues impacting on pharmaceutical quantification have been identified. However, current data collection identified limitations within the Andersen model; specifically, a failure to take account of predictors in the healthcare system and the environment (culture/politics/social. The next step is to (a) compare models used by three non-governmental agencies with the government model; (b) to run the Andersen explanatory model for pharmaceutical expenditure for 2 to 5 drug items used by these three development partners in order to see how it correlates with the present model in terms of quantification and forecasting the needs; (c) to repeat objectives (a) and (b) using the government model; (d) to draw a conclusion about the strength.

Keywords: inventory management, pharmaceutical forecasting and quantification, pharmaceutical stock-out, pharmaceutical supply chain management

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632 Post Covid-19 Landscape of Global Pharmaceutical Industry

Authors: Abu Zafor Sadek

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Pharmaceuticals were one of the least impacted business sectors during the corona pandemic as they are the center point of Covid-19 fight. Emergency use authorization, unproven indication of some commonly used drugs, self-medication, research and production capacity of an individual country, capacity of producing vaccine by many countries, Active Pharmaceutical Ingredients (APIs) related uncertainty, information gap among manufacturer, practitioners and user, export restriction, duration of lock-down, lack of harmony in transportation, disruption in the regulatory approval process, sudden increased demand of hospital items and protective equipment, panic buying, difficulties in in-person product promotion, e-prescription, geo-politics and associated issues added a new dimension to this industry. Although the industry maintains a reasonable growth throughout Covid-19 days; however, it has been characterized by both long- and short-term effects. Short-term effects have already been visible to so many countries, especially those who are import-dependent and have limited research capacity. On the other hand, it will take a few more time to see the long-term effects. Nevertheless, supply chain disruption, changes in strategic planning, new communication model, squeezing of job opportunity, rapid digitalization are the major short-term effects, whereas long-term effects include a shift towards self-sufficiency, growth pattern changes of certain products, special attention towards clinical studies, automation in operations, the increased arena of ethical issues etc. Therefore, this qualitative and exploratory study identifies the post-covid-19 landscape of the global pharmaceutical industry.

Keywords: covid-19, pharmaceutical, businees, landscape

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631 Understanding How Democratic Governance Influence Resource Allocation and Utilisation in Economies in Transition: The Case of Cameroon

Authors: Terence Maisah Seka

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This paper examines democratic governance within the private and public sectors in economies in transition (Cameroon) by exploring how they influence development in terms of resource allocation to priorities that are locally conceptualized. The benefit of this is an improvement in indigenous and the quality of life for the local population. Using an ethnographic approach, this paper suggests that institutional corruption and state bureaucracy has limited the impact of democratic governance in influencing development. This has seen funds for developments being embezzled; local projects are not being done to satisfaction among others. The paper contributes by proposing measures to eliminate corruption to improve democratic governance, which will improve resource allocation and utilization.

Keywords: democratic governance, resource allocation, utilisation, Cameroon

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630 Does Indian Intellectual Property Policy Affect the U. S. Pharmaceutical Industry? A Comparative Study of Pfizer and Ranbaxy Laboratories in Regards to Trade Related Aspects of Intellectual Property Rights

Authors: Alina Hamid Bari

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Intellectual Property (IP) policies of a country have a huge impact on the pharmaceutical industry as this industry is all about patents. Developed countries have used IP protection to boost their economy; developing countries are concerned about access to medicine for poor people. U.S. company, Pfizer had a monopoly for 14 years for Lipitor and it all came to end when Pfizer decided to operate in India. This research will focus at the effects of Indian IP policies on USA by comparing Pfizer & Ranbaxy with regards to Trade Related Aspects of Intellectual Property Rights. For this research inductive approach has been used. Main source of material is Annual reports, theory based on academic books and articles along with rulings of court, policy statements and decisions, websites and newspaper articles. SWOT analysis is done for both Pfizer & Ranbaxy. The main comparison was done by doing ratio analysis and analyses of annual reports for the year 2011-2012 for Pfizer and Ranbaxy to see the impact on their profitability. This research concludes that Indian intellectual laws do affect the profitability of the U.S. pharmaceutical industry which can in turn have an impact on the US economy. These days India is only granting patents on products which it feels are deserving of it. So the U.S. companies operating in India have to defend their invention to get a patent. Thus, to operate in India and maintain monopoly in market, US firms have to come up with different strategies.

Keywords: atorvastatin, India, intellectual property, lipitor, Pfizer, pharmaceutical industry, Ranbaxy, TRIPs, U.S.

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629 Kitchen Bureaucracy: The Preparation of Banquets for Medieval Japanese Royalty

Authors: Emily Warren

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Despite the growing body of research on Japanese food history, little has been written about the attitudes and perspectives premodern Japanese people held about their food, even on special celebratory days. In fact, the overall image that arises from the literature is one of ambivalence: that the medieval nobility of the Heian and Kamakura periods (795-1333) did not much care about what they ate and for that reason, food seems relatively scarce in certain historical records. This study challenges this perspective by analyzing the manuals written to guide palace management and feast preparation for royals, introducing two of the sources into English for the first time. This research is primarily based on three manuals that address different aspects of royal food culture and preparation. The Chujiruiki, or Record of the Palace Kitchens (1295), is a fragmentary manual written by a bureaucrat in charge of the main palace kitchen office. This document collection details the utensils, furnishing, and courses that officials organized for the royals’ two daily meals in the morning (asagarei gozen) and in the afternoon (hiru gozen) when they enjoyed seven courses, each one carefully cooked and plated. The orchestration of daily meals and frequent banquets would have been complicated affairs for those preparing the tableware and food, thus requiring texts like the Chûjiruiki, as well as another manual, the Nicchûgyôji (11th c.), or The Daily Functions. Because of the complex coordination between various kitchen-related bureaucratic offices, kitchen officials endeavored to standardize the menus and place settings depending on the time of year, religious abstinence days, and available ingredients flowing into the capital as taxes. For the most important annual banquets and rites celebrating deities and the royal family, kitchen officials would likely refer to the Engi Shiki (927), or Protocols of the Engi Era, for details on offerings, servant payments, and menus. This study proposes that many of the great feast events, and indeed even daily meals at the palace, were so standardized and carefully planned for repetition that there would have been little need for the contents of such feasts to be detailed in diaries or novels—places where historians have noted a lack of the mention of food descriptions. These descriptions were not included for lack of interest on the part of the nobility, but rather because knowledge of what would be served at banquets and feasts would be considered a matter-of-course in the same way that a modern American would likely not need to state the menu of a traditional Thanksgiving meal to an American audience. Where food was concerned, novelty more so than tradition prompted a response in personal records, like diaries.

Keywords: banquets, bureaucracy, Engi shiki, Japanese food

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628 Environmental Evaluation of Two Kind of Drug Production (Syrup and Pomade Form) Using Life Cycle Assessment Methodology

Authors: H. Aksas, S. Boughrara, K. Louhab

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The goal of this study was the use of life cycle assessment (LCA) methodology to assess the environmental impact of pharmaceutical product (four kinds of syrup form and tree kinds of pomade form), which are produced in one leader manufactory in Algeria town that is SAIDAL Company. The impacts generated have evaluated using SimpaPro7.1 with CML92 Method for syrup form and EPD 2007 for pomade form. All impacts evaluated have compared between them, with determination of the compound contributing to each impacts in each case. Data needed to conduct Life Cycle Inventory (LCI) came from this factory, by the collection of theoretical data near the responsible technicians and engineers of the company, the practical data are resulting from the assay of pharmaceutical liquid, obtained at the laboratories of the university. This data represent different raw material imported from European and Asian country necessarily to formulate the drug. Energy used is coming from Algerian resource for the input. Outputs are the result of effluent analysis of this factory with different form (liquid, solid and gas form). All this data (input and output) represent the ecobalance.

Keywords: pharmaceutical product, drug residues, LCA methodology, environmental impacts

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627 The Effect of Culture and Managerial Practices on Organizational Leadership Towards Performance

Authors: Anyia Nduka, Aslan Bin Amad Senin, Ayu Azrin Bte Abdul Aziz

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A management practice characterised by a value chain as its relatively flexible culture is replacing the old bureaucratic model of organisational practice that was built on dominance. Using a management practice fruition paradigm, the study delves into the implications of organisational culture and leadership. Developing a theory of leadership called the “cultural model” of organisational leadership by explaining how the shift from bureaucracy to management practises altered the roles and interactions of leaders. This model is well-grounded in leadership theory, considering the concept's adaptability to different leadership ideologies. In organisations where operational procedures and borders are not clearly defined, hierarchies are flattened, and work collaborations are sometimes based on contracts rather than employment. This cultural model of organizational leadership is intended to be a useful tool for predicting how effectively a leader will perform.

Keywords: leadership, organizational culture, management practices, efficiency

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626 Speciation, Preconcentration, and Determination of Iron(II) and (III) Using 1,10-Phenanthroline Immobilized on Alumina-Coated Magnetite Nanoparticles as a Solid Phase Extraction Sorbent in Pharmaceutical Products

Authors: Hossein Tavallali, Mohammad Ali Karimi, Gohar Deilamy-Rad

Abstract:

The proposed method for speciation, preconcentration and determination of Fe(II) and Fe(III) in pharmaceutical products was developed using of alumina-coated magnetite nanoparticles (Fe3O4/Al2O3 NPs) as solid phase extraction (SPE) sorbent in magnetic mixed hemimicell solid phase extraction (MMHSPE) technique followed by flame atomic absorption spectrometry analysis. The procedure is based on complexation of Fe(II) with 1, 10-phenanthroline (OP) as complexing reagent for Fe(II) that immobilized on the modified Fe3O4/Al2O3 NPs. The extraction and concentration process for pharmaceutical sample was carried out in a single step by mixing the extraction solvent, magnetic adsorbents under ultrasonic action. Then, the adsorbents were isolated from the complicated matrix easily with an external magnetic field. Fe(III) ions determined after facility reduced to Fe(II) by added a proper reduction agent to sample solutions. Compared with traditional methods, the MMHSPE method simplified the operation procedure and reduced the analysis time. Various influencing parameters on the speciation and preconcentration of trace iron, such as pH, sample volume, amount of sorbent, type and concentration of eluent, were studied. Under the optimized operating conditions, the preconcentration factor of the modified nano magnetite for Fe(II) 167 sample was obtained. The detection limits and linear range of this method for iron were 1.0 and 9.0 - 175 ng.mL−1, respectively. Also the relative standard deviation for five replicate determinations of 30.00 ng.mL-1 Fe2+ was 2.3%.

Keywords: Alumina-Coated magnetite nanoparticles, Magnetic Mixed Hemimicell Solid-Phase Extraction, Fe(ΙΙ) and Fe(ΙΙΙ), pharmaceutical sample

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625 Typical Characteristics and Compositions of Solvent System in Application of Maceration Technology to Isolate Antioxidative Activated Extract of Natural Products

Authors: Yohanes Buang, Suwari

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Increasing interest of society in use and creation of herbal medicines has encouraged scientists/researchers to establish an ideal method to produce the best quality and quantity of pharmaceutical extracts. To have highest the antioxidative extracts, the method used must be at optimum conditions. Hence, the best method is not only able to provide highest quantity and quality of the isolated pharmaceutical extracts but also it has to be easy to do, simple, fast, and cheap. The characterization of solvents in maceration technique, in present study, involved various variables influencing quantity and quality of the pharmaceutical extracts, such as solvent’s optimum acidity-alkalinity (pH), temperature, concentration, and contact time. The shifting polarity of the solvent by combinations of water with ethanol (70:30) and (50:50) were also performed to completely record the best solvent system in application of maceration technology. Among those three solvents threated within Myrmecodia pendens, as a model of natural product, the results showed that water solvent system with conditions of alkalinity pH, optimum temperature, concentration, and contact time, is the best system to perform the maceration in order to have the highest isolated antioxidative activated extracts. The optimum conditions of the water solvent are at the alkalinity pH 9 up, 30 mg/mL of concentration, 40 min of contact time, 100 °C of temperature, and no ethanol used to replace parts of the water solvent. The present study strongly recommended the best conditions of solvent system to isolate the pharmaceutical extracts of natural products in application of the maceration technology.

Keywords: extracts, herbal medicine, natural product, maceration technique

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624 RV Car Clinic as Cost-Effective Health Care

Authors: Dessy Arumsari, Ais Assana Athqiya, Mulyaminingrum

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Healthcare in remote areas is one of the major concerns in Indonesia. Building hospitals in a nation of 18.000 islands with a larger-than-life bureaucracy and problems with corruption, a critical shortage of qualified medical professionals and well-heeled patients resigned to traveling abroad for health care is a hard feat to accomplish. To assuring that all populations have access to appropriate and cost-effective care, a new solution to tackle this problem is with the presence of RV Car Clinic. This car has a concept such as a walking hospital that provides health facilities inside it. All of the health professionals who work in RV Car Clinic will do the rotation for a year in order to the equitable distribution of health workers. We need to advocate the policy makers to help realize RV Car Clinic in remote areas. Health services can be disseminated by the present of RV Car Clinic. Summarily, the local communities can get cost effectively because RV Car Clinic will come to their place and serve the health services.

Keywords: health policy, health professional, remote areas, RV Car Clinic

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623 Pharmaceutical Applications of Newton's Second Law and Disc Inertia

Authors: Nicholas Jensen

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As the effort to create new drugs to treat rare conditions cost-effectively intensifies, there is a need to ensure maximum efficiency in the manufacturing process. This includes the creation of ultracompact treatment forms, which can best be achieved via applications of fundamental laws of physics. This paper reports an experiment exploring the relationship between the forms of Newton's 2ⁿᵈ Law appropriate to linear motion and to transversal architraves. The moment of inertia of three discs was determined by experiments and compared with previous data derived from a theoretical relationship. The method used was to attach the discs to a moment arm. Comparing the results with those obtained from previous experiments, it is found to be consistent with the first law of thermodynamics. It was further found that Newton's 2ⁿᵈ law violates the second law of thermodynamics. The purpose of this experiment was to explore the relationship between the forms of Newton's 2nd Law appropriate to linear motion and to apply torque to a twisting force, which is determined by position vector r and force vector F. Substituting equation alpha in place of beta; angular acceleration is a linear acceleration divided by radius r of the moment arm. The nevrological analogy of Newton's 2nd Law states that these findings can contribute to a fuller understanding of thermodynamics in relation to viscosity. Implications for the pharmaceutical industry will be seen to be fruitful from these findings.

Keywords: Newtonian physics, inertia, viscosity, pharmaceutical applications

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622 Role of Judiciary in Developing Countries

Authors: Amir Shafiq, Asif Shahzad, Shabbar Mehmood, Muhammad Saeed, Hamid Mustafa

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Administration of justice in a society is evolutionary process. In pre-modern societies vital organs that we consider separate today i.e. legislation, implementation and adjudication were controlled by a King, the sovereign authority. Whereas now it is recognized that Development of a country revolves in seven arenas i.e. Civil Society, Political Society, Economic Society, Legislature, Judiciary, Executive & Bureaucracy. Each society whether developing or developed, has need of institutions and structures that can resolve difference of opinions of private or public nature between contending parties. Administration of justice has a key-role in the development of the society. Through this paper, it is to highlight that an independent judiciary having the support of public opinion therefore is inevitable to wriggle out from such problems in order to restore and protect the fundamental rights, constitution and democratic political system in third world countries like Pakistan.

Keywords: role of judiciary, developing countries, judicial activism, present scenario

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621 Comparing Performance Indicators among Mechanistic, Organic, and Bureaucratic Organizations

Authors: Benchamat Laksaniyanon, Padcharee Phasuk, Rungtawan Boonphanakan

Abstract:

With globalization, organizations had to adjust to an unstable environment in order to survive in a competitive arena. Typically within the field of management, different types of organizations include mechanistic, bureaucratic and organic ones. In fact, bureaucratic and mechanistic organizations have some characteristics in common. Bureaucracy is one type of Thailand organization which adapted from mechanistic concept to develop an organization that is suitable for the characteristic and culture of Thailand. The objective of this study is to compare the adjustment strategies of both organizations in order to find key performance indicators (KPI) suitable for improving organization in Thailand. The methodology employed is binary logistic regression. The results of this study will be valuable for developing future management strategies for both bureaucratic and mechanistic organizations.

Keywords: mechanistic, bureaucratic and organic organization, binary logistic regression, key performance indicators (KPI)

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620 Spectrophotometric Determination of 5-Aminosalicylic Acid in Pharmaceutical Samples

Authors: Chand Pasha

Abstract:

A Simple, accurate and precise spectrophotometric method for the quantitative analysis of determination of 5-aminosalicylic acid is described. This method is based on the reaction of 5-aminosalicylic acid with nitrite in acid medium to form diazonium ion, which is coupled with acetylacetone in basic medium to form azo dyes, which shows absorption maxima at 470 nm. The method obeys Beer’s law in the concentration range of 0.5-11.2 gml-1 of 5-aminosalicylic acid with acetylacetone. The molar absorptivity and Sandell’s sensitivity of 5-aminosalicylic acid -acetylacetone azo dye is 2.672 ×104 lmol-1cm-1, 5.731 × 10-3 gcm-2 respectively. The dye formed is stable for 10 hrs. The optimum reaction conditions and other analytical parameters are evaluated. Interference due to foreign organic compounds have been investigated. The method has been successfully applied to the determination of 5-aminosalicylic acid in pharmaceutical samples.

Keywords: spectrophotometry, diazotization, mesalazine, nitrite, acetylacetone

Procedia PDF Downloads 155