Clinical Trials in India

Industry Report

Publication Date	November 2005
Publisher	Cygnus
Product Type	Report
Pages	264
ISBN Number	not applicable
Product Code	CYG00014

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Summary

This report provides an in-depth understanding of clinical trials in India. While front-end sections such as Executive Summary and Highlights provide the essence of the report in a few pages, the remaining part of the report provides an exhaustive analysis of clinical trails in India. The middle of the report focuses on market scenario and major players. It also comprises an in-depth analysis of the growth prospects of the industry.

The report also covers issues such as technology, growth factors and critical success factors. The regulatory framework, under which the trials are conducted, is discussed briefly. The report also comprises a separate section on the issues and challenges confronting CRO's. The end section of the report contains an outlook for clinical trails in India besides utilities such as glossary. In the outlook section, the report builds upon the information and analysis of the previous chapters to forecast future trends. Life Sciences companies and the companies, which provide services to life sciences companies, will find this report useful.

This report provides a deep understanding of clinical trials in India. Clinical research Organizations (CROs) in India, which are already engaged in clinical trials, will find this report useful in putting their performance in perspective and fine-tuning their strategies as well. For companies planning to enter the clinical trails segment, this report will provide an overview of the current situation and issues that may crop up in the latter part of the trials. Bioservices, which is the fast-growing segment in the industry, is also covered in the report. This report will be useful to companies engaged in biotech services. It will also help Doctors (Investigators), the sponsors of trials and drug companies. Students, who plan to get into clinical trials, will certainly benefit from this report. The drug companies may use this report as a ready reckoner and a source of latest information.

Content

Executive Summary
Highlights
1. Introduction
- 1.1 A Brief History
- 1.2 Effectiveness and Safety
- 1.3 Clinical Trials: Benefits galore
  - 1.3.1 Research and Innovation
  - 1.3.2 Investigational New Drug application (IND)
- 1.4 Global Scenario
- 1.5 Indian Scenario
  - 1.5.1 Rising tide of research and clinical trials
  - 1.5.2 India as a destination for CROs
  - 1.5.3 Potential of CRO industry
  - 1.5.5 Major Diseases
  - 1.5.6 Infrastructure facilities
  - 1.5.7 Competitors in the sector
  - 1.5.8 Laboratory Trials (Pre-clinical trials)
  - 1.5.9 Recent Trends
  - 1.5.10 Trends in Drug Development
  - 1.5.11 Regulatory Developments
  - 1.5.12 Ethical Review Boards
2. Market Scenario
- 2.1 Global Scenario
  - 2.1.1 Worldwide New Drug Launches
  - 2.1.2 Biotech/Biological Launches
  - 2.1.3 Laboratory-developed Tests
  - 2.1.4 Inspections
  - 2.1.5 Education and Training Requirements
  - 2.1.6 Quality Control
- 2.2 Market data and R&D productivity
- 2.3 Drug withdrawals/Clinical Trial failures
- 2.4 Research on Drug Price Controls
  - 2.4.1 Loss of Future Drug Therapy
  - 2.4.2 Slowdown in Drug Availability
- 2.5 Indian Scenario
  - 2.5.1 Indian Companies
  - 2.5.2 Multinational Companies
  - 2.5.3 Outsourcing Clinical trials
  - 2.5.4 Clinical Trial components
  - 2.5.5 Support services in clinical trials
  - 2.5.6 Market related factors
3. Major Players
- 3.1 Market Size
- 3.2 Tata Memorial Centre
- 3.3 The Players Listed in BSE / NSE
  - 3.3.1 Clinigene
  - 3.3.2 Dr Reddy's Laboratories Limited
  - 3.3.3 GlaxoSmithKline
  - 3.3.4 Lupin Limited
  - 3.3.5 Novartis
  - 3.3.6 Pfizer Limited
  - 3.3.7 Ranbaxy Laboratories Limited
  - 3.3.8 Torrent Pharmaceuticals Limited
  - 3.3.9 Vimta Labs Limited
  - 3.3.10 Zydus Cadila Unlisted in BSE / NSE
  - 3.3.11 Asian Clinical Trials Limited
  - 3.3.12 BioServe Clinical Research Pvt. Ltd.
  - 3.3.13 Clininvent Research Pvt. Ltd.,
  - 3.3.14 ClinTec International
  - 3.3.15 Eli Lilly and Company (India) Pvt. Ltd
  - 3.3.16 iGATE Clinical Research International
  - 3.3.17 Intas Pharmaceuticals
  - 3.3.18 Johnson & Johnson India
  - 3.3.19 Lambda Therapeutic Research Ltd
  - 3.3.20 Lotus Labs Pvt. Ltd.
  - 3.3.21 Matrix Laboratories Ltd.
  - 3.3.22 Merck Limited
  - 3.3.23 Novo Nordisk India Private Ltd.
  - 3.3.24 Pharmanet
  - 3.3.25 Quintiles Research (India) Private Limited
  - 3.3.26 Reliance Clinical Research Services
  - 3.3.27 Roche India Ltd.,
  - 3.3.28 Sanofi-Aventis (Aventis Pharma Limited)
  - 3.3.29 Siro Clinpharm Pvt Ltd.
  - 3.3.30 SRL Ranbaxy
  - 3.3.31 Sristek
  - 3.3.32 Synchron Research Pvt. Ltd.
- 3.4 Support services
  - 3.4.1 Companies entering into support services
  - 3.4.2 IT-pharma ventures
  - 3.4.3 Other IT/ITES companies' bio-initiatives
  - 3.4.4 Future of support services
4. Technology
- 4.1 Drug Development
- 4.2 Biochemistry of the Drugs
- 4.3 Drug Design
  - 4.3.1 The challenges in drug design
  - 4.3.2 Computers in drug design
  - 4.3.3 RACHEL Software Package
- 4.4 Animal Studies
- 4.5 Field Studies
- 4.6 Bioavailability (BA) / Bioequivalence (BE) studies
  - 4.6.1 Types of studies
  - 4.6.2 Facilities for Conducting Bioavailability and/Or Bioequivalence Studies
- 4.7 Recent Trends in Technology
5. Growth Drivers
- 5.1 Claims of Superiority
- 5.2 Availability of Patients
- 5.3 Infrastructure Facilities
  - 5.3.1 Availability of Animal Houses
  - 5.3.2 Hospitals
  - 5.3.3 Facilities for Clinical Trials
  - 5.3.4 Biotechnology Laboratories
- 5.4 Drug development and price control
- 5.4 Reduction in R&D expenses
- 5.5 Decrease in Time-to-Market Clinical Trials
- 5.6 Regulations and Support from Local Bodies
- 5.7 FDA Approval
  - 5.7.1 Clinical Trials and FDA
  - 5.7.2 Clinical Trial Process
6. Critical Success Factors
- 6.1 Infrastructure
- 6.2 Research Design
- 6.3 Speed and Quality of trials
- 6.4 Professionally Trained Manpower
- 6.5 Hospitals
- 6.6 Role of radiology
- 6.7 Product Pricing and Market Analysis
- 6.8 Drug Imports
- 6.9 Multiple tasks in approvals
- 6.10 Government Procedures/Sanctions
7. Regulatiory Issues
- 7.1 Government Regulations
  - 7.1.1 FDA
- 7.2 Patent Regime
  - 7.2.1 Importance of Intellectual Property Rights (IPR)
- 7.3 Customs Duty
- 7.4 GATT / TRIPS / WTO
- 7.5 Clinical Evaluation of Herbal Remedies and Medicinal Plants
  - 7.5.1 Categories of Herbal Products
  - 7.5.2 Guidelines
- 7.6 Unsafe Drugs
- 7.7 Industry's Growing Influence over Research
- 7.8 Academia & Industry - Eroding boundaries
- 7.9 Regulatory System in India
  - 7.9.1 Exemption of Customs Duty
  - 7.9.2 Tax benefit
  - 7.9.3 Role of IACUC
- 7.10 Regulation of Ethical Issues
  - 7.10.1 Ethics of Patenting DNA
  - 7.10.2 Mental Disorders and Genetics
  - 7.10.3 Animal-to-Human Transplants: Ethics of Xenotransplantation
  - 7.10.4 Human Tissue: Ethical and Legal Issues
  - 7.10.5 Clinical Trials without Ethical Review
8. Issues And Challenges
- 8.1 Training for Clinical Trials
  - 8.1.1 Training Opportunities
- 8.2 Clinical Trials - Design & Management
  - 8.2.1 Good Clinical Practices (GCP)
- 8.3 Quality of Clinical Trial Data
- 8.4 Finding people for trials is always difficult
- 8.5 Segmenting Physicians
- 8.6 Protecting Research and Research Participants
- 8.7 Ethical Problems
  - 8.7.1 The role of ethics in clinical trials
  - 8.7.2 Three major ethical problems
  - 8.7.3 Scientific and Ethical Standards
- 8.8 Illegal Clinical Trials
- 8.9 Studies in the Developing World
- 8.10 Data Protection
- 8.11 Assessing Risks and Benefits
- 8.12 Host Country's Capacity to Review and Conduct Clinical Trials
- 8.13 Additional FDA guidelines for conducting trials
  - 8.13.1 Clinical Trials Conducted Outside United States
  - 8.13.2 Clinical Trial Registration
  - 8.13.3 Computerized Clinical Research Systems
- 8.14 Clinical trials in India - Challenges
  - 8.14.1 Addressing the challenges
9. Future Outlook
Bibiliography
Glossary
Annexure 1
- Good Clinical Practices (GCP)
Annexure 2
- A Comparison of FDA vs. ICH Regulations
Annexure 3
- Good Manufacturing Practices
Annexure 4
- A New Chapter Opens