Main description:

To tackle the rising burden of disease, disability and premature deaths, the demand for newer and better treatment is more than ever. Drug registration is a critical step for the introduction of medicines in a country. There has been a great deal of international interaction and cooperation in the area of public health, particularly since the conception of the Millennium Development Goals. However, international cooperation vis-a-vis mechanisms to achieve shared goals of public health are still very limited. Regulation of drugs, more specifically drug registration, is one such neglected area. This report, the first-of-its-kind, based on extensive desk and field research in 4 Indian states-Maha-rashtra, Karnataka, Gujarat and Telangana-and 7 countries-USA, UK, Switzerland, Germany, South Africa, Singapore and Indonesia-incorporates views of more than 150 stakeholders to identify lessons as well as opportunities for the Government of India in its effort to address challenges of drug regulation in particular, and public health more generally, in the country.

Contents:

List of Tables, Figures and Appendix
List of Abbreviations
Foreword
Acknowledgements
Executive Summary
1. Introduction
1.1 Importance of the Subject-Rationale
1.2 Major Pathways of International Cooperation for Registration of Medicines
1.3 Need for India to Respond from a Public Health Perspective
2. Research Methodology
3. Analysis of Drug Registration Procedures and International Cooperation Initiatives
3.1 India
3.2 United States
3.3 Europe
3.4 ASEAN
3.5 South Africa
4. Cross-Country Implications for Stakeholders
4.1 Public Health
4.2 Regulator
4.3 Industry
5. A Game Theoretic Approach to Understanding International Cooperation
6. Policy Recommendations
6.1 International Cooperation
6.2 Drug Registration Procedures: Dossier Submission and Review
6.3 Addressing Additional Gaps
7. Conclusion
Appendix
Bibliography