Dissertations - Pharmaceutical Business & Technology
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Item Assessment of the Impact of Digital Health Technologies on Patient Recruitment and Engagement in Clinical Trials in India(2024-05) Prakash Kandangur, SyamCovid 19 pandemic has led to adoption of Digital health technologies in the Indian clinical trial sector which has led to breakthrough in the entire industry particularly in patient recruitment and engagement. The study delves into the impact of digital technologies on recruitment rates and ongoing patient engagement. The study uses a mixed method approach with both qualitative interviews and qualitative survey. Survey was conducted among 94 clinical trial coordinators (n=94). Interview was conducted for 6 professionals in the clinical trial sector. The study uses a combination of pragmatism and interpretivism philosophy for research methodology. 80 % of the respondents reports that the integration of the digital health technology has significantly improved the patient recruitment rates. It was also noted that m Health applications, EDC are the most leveraged tools in the Indian clinical trial industry. It was also found out that the majority of clinical trial professionals are using digital tools for day-to-day clinical trial activities. It was also evident from the data that even though DHT can overcome geographical and socio-economic barriers the complete potential of this technology platform has not yet been explored. The initial cost in investment hinders the sponsors from further investment in DHT. Moreover, the responsibilities of the technology vendors have not reached the mark, creating tensions in product running. However, looking forward to the future, the technology platform appears to be promising. CRO has increased their focus on the advancement of the tech platforms using AI and machine learning. Thus, the evolution of digital health in this sector us expected to bring moItem Regulatory Landscape and comparative analysis of Manufacturing Execution System (MES) Software and Computer System Validation (CSV) Process in Pharmaceutical manufacturing facilities in India(2024-05) Madackal Kuriakose, TonyPharmaceutical manufacturing facilities constantly works on providing the people lifesaving drugs. Documentation is a vital process in the lifecycle of a drug. Batch records reflects the quality of specific lots of drugs manufactured. All industries are currently undergoing Digital Transformation and pharmaceutical manufacturing facilities are no exception. The main purpose of these research is to comparatively analyse Manufacturing Execution System (MES) Software and Computer System Validation (CSV) Process in Pharmaceutical manufacturing facilities with different regulatory landscape in India and to evaluate whether the proposed technological platforms are effective in reducing the data integrity issues. The health regulatory system of India, The Central Drugs Standard Control Organization (CDSCO) provides only limited information regarding the Manufacturing Execution System (MES) Software and Computer System Validation (CSV) Process. In conclusion, majority of the pharmaceutical manufacturing facilities operating in India follows strict regulatory systems like U.S. Food and Drug Administration (US FDA), Medical and Healthcare Products Regulatory Agency (MHRA), The European Medicines Agency (EMA), The National Health Surveillance Agency (ANVISA), Therapeutic Goods Administration (TGA), and Health Canada. At the same time, India has several small-scale pharmaceutical manufacturing facilities for supplying drug products to domestic markets and third countries like Africa, Nigeria, Zimbabwe, Uganda, Philippines, Sudan, Tanzania, Kenya, Ghana, Namibia, and Sri Lanka which are not highly regulated as the former regulatory systems. Strict and accepted regulatory systems have advanced technologies and are continuously promoting digitalization. In addition, the study also helps other researchers to understand about the regulatory landscape of India and supportive measures the Government should initiate for the implementation of Manufacturing Execution System (MES) Software and Computer System Validation (CSV) Process.Item Identifying and assessing compliance risks in the manufacturing of sterile injectables within the Indian pharmaceutical industry(2024-05) Reddy Goli, RanjeethThe Indian Pharmaceutical industry is a global supplier of sterile injectable products, but in recent years, it has faced tougher regulations and demands for quality and compliance improvement. The research demonstrates that India is a major supplier of these life-saving drugs and hence authorities must seek strict compliance. The whole scheme relies on data collected from survey (surveys), and there was no in-depth analysis on the business factors that influence compliance. The purpose of the research is to raise the bar for sterile drug products quality and safety standards that are proactively identifying and rectifying compliance issues within the Indian pharmaceutical manufacturing systems. This study is aimed at exploring the views and involvement of the Indian pharmaceutical sector in ensuring conformity with sterile injectable drug production regulations. Our findings demonstrate a mix of opinions on the current regulatory model, and some of the participants voice their belief, whilst others express doubts about the level of compliance. Most of the responses are positive in maintaining sterile conditions during manufacturing, which are assured owing to cGMP adherence, with cleanrooms strictly monitored. The analysis brings a positive response to quality control measures, particularly training and education of the staff. Businesses that focus on their employee training are typically associated with higher confidence in production processes, quality control and effectiveness in operations. In fact, it can be asserted that high-quality control rigour, trust in the maintenance of sterile conditions, and the right infrastructure design are tightly correlated with each other as well. Although a well-established majority of respondents are confident in data security and robust infrastructure design; some do have a little anxiety which hints at the possible existence of weaknesses or obsolescence of the structures. The outcome of the study emphasizes the need for reliable quality systems, performing training regularly, installing systems of data integrity control and upgrading facilities for the manufacture of aseptic drug products in India.Item Examining pharmaceutical waste management in Nigeria: Improving environmental sustainability(2024-05) Rejoice Anwuri, AmesiNigeria's pharmaceutical waste management (PWM) faces significant challenges due to inadequate infrastructure, evolving regulations, and socio-cultural barriers. This mixedmethods case study investigates current PWM practices, awareness levels, and potential solutions. Survey results (n=84) reveal a paradox: 87.8% of respondents know about pharmaceutical waste hazards, and only 18.1% are "very familiar" with proper disposal techniques, indicating a critical gap between awareness and action. This is corroborated by qualitative interviews with healthcare professionals citing inadequate training and resources. The study identifies limited infrastructure, weak regulatory enforcement, and socio-cultural factors as key barriers. While 83.1% of respondents perceive a link between healthcare sector growth and increasing pharmaceutical waste, there is also a strong consensus (95.2%) that raising awareness can positively impact PWM policies. Interviewees emphasize the need for comprehensive guidelines, stricter enforcement, targeted training, and infrastructure investment. The study's findings have significant implications for policymakers, highlighting the need for comprehensive regulatory reforms, infrastructural investment, and educational initiatives to address the multifaceted challenges of pharmaceutical waste management in Nigeria. Further research should explore the perspectives of diverse stakeholders, incorporate longitudinal and comparative studies, and investigate the economic aspects of PWM. By implementing a multifaceted and collaborative approach, Nigeria can move towards a more sustainable and effective system for managing pharmaceutical waste and protecting public health and the environment.Item The emerging trend of “green” cosmetic formulations and how they contribute to sustainability practices in the pharmaceutical industry considering their impact on consumer perceptions and preferences(2024-05) Benny, ReshmaIn today’s fast-paced world, where the echoes of environmental consciousness and sustainability reverberates louder than ever, the pharmaceutical industry particularly the cosmetic one is witnessing a profound transformation. At the forefront of this evolution lies the emergence of “green” cosmetics – a revolutionary concept that not only embodies sustainability but also reshapes consumer perceptions and preferences in the pharmaceutical landscape. In the reality where beauty meets sustainability, this concept has captured both the industry insiders and eco-conscious consumers. Green cosmetics, often referred to as biocosmetics/ eco-cosmetics/ eco- friendly cosmetics/ or sustainable cosmetics, represent a departure from conventional beauty products by embracing natural, organic formulations, derived from renewable plant and bacteria sources. These ecofriendly alternatives not only prioritize the well-being of consumers. Beyond their botanical origins, these cosmetics promote transparency in production and packaging, striving for biodegradability and low-waste management practices. The image of green cosmetics extends far beyond mere aesthetics, tapping into a growing global consciousness surrounding sustainability. With increasing awareness of environmental degradation and the adverse effects of conventional effects on the consumer health and skin, interest in green cosmetics continues to surge. Studies have shown that individuals are increasingly drawn to products that encourage ethical sourcing, cruelty-free, vegan practices, and, minimal environmental footprint. This evolving mindset underscores the need for the cosmetic industry to embrace sustainable practices and offer products that resonate with sustainable consumers. The theory of planned behaviour has often been used by researchers to analyse the behaviour of customers in the current market. Developed by Icek Ajzen, the virtue of this theory is to analyse human behaviour regarding certain actions. According to this theory, certain factors like perceived behaviour, control, behaviour intentions, subjective norms and attitude towards the behaviour affect human actions. Against this backdrop, it is crucial to understand the significance of green cosmetics in advancing sustainability efforts within the pharmaceutical sector. Thus, this study aims to look into consumer perceptions, preferences, and purchasing behavior considering the efforts made by industries to practice sustainability.