Challenges and opportunities for the innovation of novel drugs

Table of Contents

1. Introduction

1.1. Background

1.2. Objective, research gaps and research question

1.3. Definitions and concepts

1.4. Delimitation

1.5. Outline of the thesis

2. Methodology

2.1. Analytical framework

2.2. Methodological approach

2.2.1. Research philosophy

2.2.2. Research perspective

2.2.3. Research strategy

2.3. Data collection

2.3.1. Surveys

2.3.2. Secondary data

2.3.3. Design of the field phase

2.3.4. Reliability

2.3.5. Validity

2.4. Summary

3. Theoretical framework

3.1. The sectoral innovation system

3.2. The innovation value chain and open innovation

3.3. Learning and idea generation through R&D collaborations

3.4. Summary

4. Research context

4.1. Self-reliance policy: Amendment of the patent law and introduction of the New Drug Policy (1947-1991)

4.2. The phase of liberalization, de-control and product patent (1991- today)

4.3. Summary

5. Key components of the SIS of the API sector in India

5.1. Descriptive Analysis

5.2. The Government of India

5.2.1. Overall policy framework

5.2.2. The patent regime

5.2.3. Product and quality regulations

5.3. The academia

5.4. The industry

5.4.1. Balance of Trade

5.4.2. Production of APIs

5.4.3. R&D intensity

5.4.4. R&D stages and skills to develop NCEs

5.5. Summary

6. R&D collaboration strategies

6.1. Sources of innovation information

6.2. Prime motives for R&D collaborative projects

6.3. Collaborative R&D projects aimed at early stage drug development

6.3.1. Invention stage of early stage R&D collaboration projects

6.3.2. Most important objectives of early stage R&D collaboration projects

6.3.3. The contribution to success of early stage R&D collaboration projects

6.3.4. Problems related to early stage R&D collaboration projects

6.4. R&D collaboration cases

6.4.1. In-licensing

6.4.2. Out-licensing

6.4.3. Contract research and manufacturing services

6.4.4. Collaborative research projects

6.4.5. Public private R&D partnerships

6.5. Summary

7. Conclusion and research implications

7.1. Key findings and conclusion

7.2. Conclusions for theory

7.3. Limitations and avenues for further research

Research Objectives and Themes

The primary research objective is to analyze whether and to what extent external sourcing activities and R&D collaborations between Indian pharmaceutical firms and their partners in the sectoral innovation system constitute a viable option for upgrading into the development of new, enhanced drugs.

• Analysis of the Indian pharmaceutical industry's sectoral innovation system.
• Investigation of internal vs. external knowledge sourcing strategies.
• Evaluation of R&D collaboration modes and their impact on firm capabilities.
• Identification of barriers (bureaucratic, legal, and trust-related) in collaborative R&D.
• Assessment of the role of academia and public-private partnerships in drug innovation.

Excerpt from the Book

Summary of Chapters

1. Introduction: Introduces the research context regarding the Indian pharmaceutical industry and defines the core research questions concerning R&D collaborations.

2. Methodology: Outlines the qualitative and mixed-methods research design, including data collection via surveys with firms and industry experts.

3. Theoretical framework: Explains the Sectoral Innovation System (SIS) approach combined with the innovation value chain and open innovation theory.

4. Research context: Reviews the historical evolution of Indian pharmaceutical policies from 1947 to the present, focusing on patent law and liberalization.

5. Key components of the SIS of the API sector in India: Provides a detailed analysis of the roles of government, academia, and industry in the Indian API sector.

6. R&D collaboration strategies: Examines different collaborative R&D modes and their effectiveness in fostering innovation in early-stage drug development.

7. Conclusion and research implications: Summarizes key findings and provides theoretical conclusions as well as avenues for further research.

Keywords

Sectoral Innovation System, SIS, Indian pharmaceutical industry, R&D collaboration, Open innovation, API, Drug discovery, Patents, Knowledge sharing, Technology transfer, Public-private partnerships, Product innovation, Process innovation, Pharma emerging markets.

Frequently Asked Questions

What is the core focus of this thesis?

The thesis examines the dynamics of the Indian pharmaceutical industry's sectoral innovation system and investigates whether R&D collaborations with external partners help firms transition toward the development of novel, enhanced drugs.

What are the central themes discussed in the research?

The research explores the impact of public policy, the patent regime, the role of academic institutions, and the effectiveness of various R&D collaboration modes, such as in-licensing, out-licensing, and public-private partnerships.

What is the primary research question?

The research asks how interdependencies between Indian pharmaceutical firms and their external partners influence R&D activities, and to what extent these collaborations help overcome structural constraints in the innovation system.

Which scientific methodology is applied?

The study employs a mixed-methods research approach, incorporating secondary data analysis and primary data gathered through semi-structured e-mail surveys conducted with industry professionals and experts.

What does the main body of the work cover?

The main body investigates the institutional environment (policy/patents), the characteristics of industry components (firms/academia), and empirical case studies of collaborative R&D projects to evaluate their contribution to technological and scientific competence building.

Which keywords best characterize the work?

The work is defined by terms such as Sectoral Innovation System (SIS), R&D collaboration, Open Innovation, Active Pharmaceutical Ingredients (API), and patent regime impact.

How does the patent landscape influence Indian R&D?

The thesis finds that the shift to product patents in 2005, while essential for international compliance, created strict standards that have reduced the number of patent approvals for minor process improvements, challenging firms to move toward genuine innovation.

What is the role of trust in R&D collaborations?

Trust is identified as a critical but rare factor. The study reveals that a lack of trust between Indian firms and their international partners, often rooted in concerns over confidentiality and intellectual property loss, significantly hinders the effectiveness of collaborative projects.