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Assessment of the Pharmaceutical Manufacturing Industry in Kenya to Forecast Local Production Sufficiency

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Assessment of the Pharmaceutical Manufacturing Industry in Kenya to Forecast Local Production Sufficiency ASSESSMENT OF THE PHARMACEUTICAL MANUFACTURING INDUSTRY IN KENYA TO FORECAST LOCAL PRODUCTION SUFFICIENCY SARAH KADESA VUGIGI (M.PHARM) P97/25201/2013 A THESIS SUBMITTED IN FULFILLMENT OF THE REQUIREMENTS FOR THE AWARD OF THE DEGREE OF DOCTOR OF PHILOSOPHY (PHARMACEUTICS) IN THE SCHOOL OF PHARMACY OF KENYATTA UNIVERSITY OCTOBER 2017 ii DECLARATION This thesis is my original work and has not been presented for a degree in any other University or for any other award. Signature...………………………………………….Date ……………………………. Sarah Kadesa Vugigi - P97/25201/2013 Department of Pharmaceutics and Industrial Pharmacy SUPERVISORS We confirm that the work reported in this thesis was carried out by the candidate under our supervision. Signature……………………………………………Date …………………………. Prof. Ikoni Ogaji Department of Pharmaceutics and Industrial Pharmacy, Kenyatta University Signature.…………………………………………...Date…………………………...... Prof. Grace N. Thoithi Department of Pharmaceutical Chemistry, University of Nairobi Signature.…………………………………………...Date…………………………...... Dr. Everlyne Wanzala Department of Pharmacognosy and Pharmaceutical Chemistry, Kenyatta University Signature……………………………………………Date …………………………… Dr. Daniel Oyoo Department of Gas & Petroleum Engineering, Kenyatta University iii DEDICATION This thesis is dedicated to my parents for their impact on the core of my being. iv ACKNOWLEDGEMENTS First and foremost, I am thankful to God Almighty for without His help this study would not have been possible. Appreciation is extended to my supervisors, colleagues, various institutions, family and friends for their contribution towards this study. I am indebted to my supervisors, Prof. Ikoni Ogaji and Prof. Grace Thoithi for their dedication and continuous guidance. I am thankful to Prof. Ogaji, for his scholarly advice, insightful comments and systematic involvement in all aspects of this thesis. I sincerely appreciate Prof. Thoithi, for her invaluable suggestions, constructive criticism and consistent encouragement. I wish to acknowledge Dr. Everlyne Wanzala and Dr. Daniel Oyoo for their assistance and worthy input during correction of thesis after the Oral Defense. I owe much gratitude to Prof. Nicholas Gikonyo for his thoroughness in ensuring that the thesis corrections were effected. I am grateful to Kenyatta University, Department of Pharmacy and Complementary/Alternative Medicine, School of Medicine, for admission into a Ph.D. program. Special appreciation goes to the past and incumbent chairpersons of the department, Dr. Phillip Mwagiru and Dr. Gladys Mwangi for facilitation of the process to ensure successful completion of this study. I also wish to thank Ms. Rose Munene for providing regular updates on graduate school requirements. Manufacturers for availing essential data for this study. I wish to acknowledge the national Pharmacy and Poisons Board and Federation of Kenya Pharmaceutical Manufacturers for availing essential data for this study. My sincere gratitude is extended to Mr. Ashok Patel, the Managing Director, Elys Chemical Industries Ltd., for providing a flexible time window that I needed in order to pursue graduate studies. Lastly, I would like to thank my family and friends for consistent encouragement and spiritual support while on this journey. I am extremely grateful to my late parents for their inspiration towards a mind-set of scaling any wall and to my brother James Sangale, whose selfless generosity has contributed immensely to this realization. v TABLE OF CONTENTS DECLARATION .............................................................................................................. ii DEDICATION ................................................................................................................. iii ACKNOWLEDGEMENTS ............................................................................................. iv TABLE OF CONTENTS .................................................................................................. v LIST OF TABLES ............................................................................................................ x DEFINITIONS OF TERMS ........................................................................................... xii ABBREVIATIONS AND ACRONYMS ....................................................................... xv ABSTRACT ................................................................................................................. xviii CHAPTER ONE : INTRODUCTION .......................................................................... 1 1.1 Background information to the study .......................................................................... 1 1.2 Statement of the problem ............................................................................................ 5 1.3 Justification ................................................................................................................. 6 1.4 Research questions ...................................................................................................... 7 1.5 Research hypothesis .................................................................................................... 7 1.6 Objectives .................................................................................................................... 7 1.6.1 General objective ..................................................................................................... 7 1.6.2 Specific objectives ................................................................................................... 7 1.7 Delimitation ................................................................................................................. 8 CHAPTER TWO : LITERATURE REVIEW ............................................................. 9 2.1 Pharmaceutical production .......................................................................................... 9 2.2 Pharmaceutical production requirements .................................................................. 10 2.2.1 Pharmaceutical quality standards ........................................................................... 10 2.2.2 Quality assurance ................................................................................................... 11 2.2.3 Pharmaceutical production premises and utilities .................................................. 14 2.2.4 Market authorization of pharmaceutical product ................................................... 15 2.2.4.1 Marketing authorization dossier .......................................................................... 15 2.2.4.2 Common technical document content ................................................................. 16 2.2.4.3 Research and development .................................................................................. 16 2.2.4.4 Bioequivalence requirement ............................................................................ 17 2.3 Production capacity utilization .................................................................................. 17 2.4 Local pharmaceutical production in developing countries ....................................... 19 vi 2.5 Essential medicines ................................................................................................... 20 2.5.1 Production of essential medicines .......................................................................... 20 2.5.2 Challenges of essential medicines production ....................................................... 21 2.6 Pharmaceutical production in Kenya ........................................................................ 22 2.6.1 Pharmaceutical manufacturing industry ................................................................. 22 2.6.2 Regulation of the pharmaceutical manufacturing industry .................................... 24 2.6.3 Kenya pharmaceutical manufacturers’ affiliation .................................................. 25 2.6.4 Essential medicines demand and market share ...................................................... 26 2.6.5 Competitiveness of pharmaceutical products ......................................................... 28 2.6.6 Production capacity utilization ............................................................................... 30 2.7 The cGMP standards and quality of pharmaceutical products in Kenya .................. 31 2.7.1 The cGMP standards .............................................................................................. 31 2.7.2 Standard for market authorization of pharmaceutical product ............................... 32 2.8 Case studies on successful and progressive pharmaceutical production .................. 36 2.8.1 Developed countries ............................................................................................... 36 2.8.2 Developing countries ............................................................................................. 37 2.8.3 Lessons from the case studies ................................................................................ 43 2.9 Production capacity forecasting ................................................................................ 43 2.9.1 Forecasting methods ............................................................................................... 44 2.9.2 Time Series forecasting .......................................................................................... 44 CHAPTER THREE : MATERIALS AND METHODS ............................................ 47 3.1 Research
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