Risk Management in New Formulated Drug Product Development: An Evidence from Pakistan

Abstract

This study is investigates the current practices of risk management in new formulated drug products development in Pakistan. Risk management is a very new process in Pakistani pharmaceutical industry but its importance cannot be denied. Pakistan’s Pharmaceutical industry has shown considerable growth and progress particularly since the last decade. Irrespective of the fact, Pakistan is the world’s 6th largest populated country; limited research is carried out in pharmaceutical industry in Pakistan. The study objectives were to distinguish salient features of pharmaceutical industry and current practices of risk management, give a detailed account of various approaches, processes, techniques and tools which could assist in risk management and describe the best known practices of risk management in pharmaceutical projects of drug development. Literature was studied and then to conclude the prerequisites of the process of management of risks for drug development projects 15 semi-structured interviews were conducted along with the discussion sessions. Qualitative techniques are used for this research study as this area of risk management is not mature. As the approach for risk management in new formulated drug products will increase, further studies could be qualitative or quantitative. The proposed framework of risk management is quite complicated and it would be difficult for a pharmaceutical industry to implement it at once. Hence, it should be refined depending upon the size of the organization, its hierarchy, and nature of the product as well. After the development of the framework a research study was conducted. This study concluded that it is a start for the future studies in this regard as its importance was highlighted by this study. Moreover, it provides a new era of risk management in pharmaceutical industry which was previously neglected.