TABLE OF CONTENTS

Page
Contents No.
Preface I
Acknowledgement IV
Table of Contents VI
List of Tables IX
List of Figures X
List of Abbreviations/Acronyms XI
Chapter -I: Introductory Background, Research Design
1
and Framework of the Study
1.1. Introduction 2
1.2. Statement of Problem 6
1.3. Review of Literature 7
1.4. Research Gap, Need and Importance of the Study 35
1.5. Scope of the Study 37
1.6. Objectives of the Study 38
1.7. Hypotheses of the Study 38
1.8. Methodology of the Study 40
1.8.1. Collection of Data 40
1.8.2. Analytical Tools 41
1.9. Expected Contribution of the Study 47
1.10. Limitations of the Study 48
1.11. References 49
Chapter - II: Indian Pharmaceutical Industry: An Overview 56
2.1. Introduction 57
2.2. The Global Pharmaceutical Industry 57
2.3. Evolution and Growth of Indian Pharmaceutical Industry 61
2.3.1. The Initial Stage (till the early 1970s) 61
2.3.2. The Self-Reliance Stage (the late 1970s and 1980s) 64
2.3.3. The Liberalization Stage (the 1985 onwards) 67
2.4. Current status of Indian Pharmaceutical Industry 70
2.5. SWOT Analysis of Indian Pharmaceutical Industry 11
2.5.1. Strength 11
2.5.2. Weaknesses 78
2.5.3. Opportunities 82
2.5.4. Threats 84
2.6. The Pharmaceutical Production Cycle 85
2.6.1. Discovery 85

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 2.6.2. Clinical Trial 88 1
2.6.3. Production and Manufacturing 89
2.6.4. Marketing and Distribution 90
2.7. Mc. Kinsey Projection For Indian Pharmaceutical Market 91
2.8. Brief Profiles of Top Five Indian Pharmaceutical
Companies 93
2.8.1. Ranbaxy Laboratories 94
2.8.2. Cipla Ltd. 97
2.8.3. Dr Reddy's Laboratories 100
2.8.4. Aurbindo Pharmaceuticals Ltd. 102
2.8.5. Nicholas Piramal India Limited. (NPIL) 104
2.9.References 107
CHAPTER- III: TRIPs and Indian Patent Act, 1970 110
3.1. Introduction 111
3.2. Concept and Types of Intellectual Property Rights 111
3.2.1. Copyright and Related Rights 112
3.2.2. Trademarks 113
3.2.3. Geographical Indications 113
3.2.4. Industrial Designs 114
3.2.5. Patents 114
3.2.6. Layout-Designs of Integrated Circuits 115
3.2.7. Undisclosed Information or Trade Secret 116
3.3. Benefits and Threats of Patents 116
3.4. History and Background of TRIPS Agreement 119
3.5. Features of TRIPs Agreement 121
3.5.1. Structure of TRIPs Agreement 123
3.5.2. Main Provisions of TRIPs Related to Pharma 125
3.6. Flexibilities Under TRIPs 132
3.6.1. Exemptions from Grant of Patent 132
3.6.2. Exceptions to Exclusive Rights 132
3.6.3. Parallel Import 133
3.6.4. Use Without Authorization of Right Holder 134
3.6.5. Public, Non-Commercial Use of Patents 134
3.6.6. Limiting to Data Protection 135
3.7. Doha Declaration on Health 135
3.8. History and Background of Indian Patent Act, 1970 137
3.9. Indian Patent Act, 1970 Main Features 139
3.10. Comparison Between TRIPs and Indian Patent Act, 1970 142
3.11. Amendment in Indian Patent Act, 1970 towards TRIPs

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 Compliance 144
3.11.1. Indian Patent Amendment Act, 1999 146
3.11.2. Indian Patent Amendment Act, 2002 147
3.11.3. Indian Patent Amendment Act, 2005 149
3.12. References 150
Chapter-IV: Impact Assessment of TRIPs on Indian
154
Pharmaceutical Industry
4.1. Introduction 155
4.2. Impact of TRIPs on Pharmaceutical Production 156
4.2.1. Pattern and Trend in Production of Indian
Pharmaceutical Industry: Analysis and
Interpretations 156
4.2.2. Testing of Hypothesis 168
4.3. Impact of TRIPs on Pharmaceutical Export 173
4.3.1. Pattern and Trend in Export of Indian
Pharmaceutical Industry: Analysis
Interpretations 174
4.3.2. Testing of Hypothesis 185
4.4. Impact of TRIPs on Pharmaceutical Import 190
4.4.1. Pattern and Trend in Import of Indian
Pharmaceutical Industry: Analysis and
Interpretations 190
4.4.2. Testing of Hypothesis 203
4.5. Impact of TRIPs on R&D Expenditure 208
4.5.1. Pattern and Trend in R&D Expenditure of Indian
Pharmaceutical Industry: Analysis and
Interpretations 209
4.5.2. Testing of Hypothesis 220
4.6. References 225
Chapter-V: Findings, Conclusions, Suggestions and
226
Recommendations
5.1. Introduction 227
5.2. Findings 227
5.3. Suggestions and Recommendations 234
5.4. Direction for Future Research 241
5.5. Conclusions 242
Bibliography 245
Appendices 260

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