Report: Indian Pharmaceutical Industry TOC

1. Overview
- 1.1 Statement of Report
- 1.2 Scope of the Report
- 1.3 Methodology
- 1.4 Executive Summary
2. Introduction
- 2.1 India' s Pharmaceutical Market to Triple Over the Next Decade
- 2.2 Indian Pharma' s Global Foray
- 2.3 New Investments in 2007
- 2.4 Contract Research Deals in 2007
- 2.5 India' s Major Pharma Export Destinations
3. The Indian Market
- 3.1 Projected Market Size
- 3.2 Present Core Competence
- 3.3 Analysis of Market
- 3.4 Indian Biotechnology Industry-A Snapshot for Investors
- 3.5 Genome Valley
4. Characteristics of the Indian Pharmaceutical Industry
- 4.1 Profitability
- 4.2 Location
- 4.3 Segmentation of the Indian Pharmaceutical Industry
  - 4.3.1 Bulk Drug Industry
    - 4.3.1.1 Production and Exports of Drugs and Pharmaceuticals
    - 4.3.1.2 Projections for Bulk Drugs and Formulations-1997-1998 to 2001-2002
  - 4.3.2 Formulations
- 4.4 Major Therapeutic Segments
5. Key Players in the Indian Pharmaceutical Industry
- 5.1 Contract Manufacturing and Clinical Trials in India
  - 5.1.1 Multinational Corporations (MNC' s) Playing a Critical Role
    - 5.1.1.1 Glaxo
    - 5.1.1.2 Glaxo SmithKline India
    - 5.1.1.3 Pfizer India
    - 5.1.1.4 Aventis Pharma
  - 5.1.2 Aventis' New Introductions
    - 5.1.2.1 Performance Drivers
    - 5.1.2.2 Aventis Pharma
  - 5.1.3 Novartis India
    - 5.1.3.1 Novartis' Performance in Pharmaceuticals, 2007
    - 5.1.3.2 Novartis' Performance in Vaccines and Diagnostics, 2007
- 5.2 Key Indian Players
  - 5.2.1 Ranbaxy
    - 5.2.1.1 Analyses
    - 5.2.1.2 Ranbaxy' s R&D Pipeline
    - 5.2.1.3 Ranbaxy
  - 5.2.2 Dr. Reddy' s Labs (DRL)
  - 5.2.3 Cipla
  - 5.2.4 Sun Pharma
    - 5.2.4.1 Sun Pharma' s Highlights of Performance
  - 5.2.5 Abbott India Ltd. (Knol)
  - 5.2.6 Wockhardt Ltd.
  - 5.2.7 Nicholas Piramal India Ltd.
  - 5.2.8 Lupin Ltd.
- 5.3 Alembic Ltd.
  - 5.3.1 Alembic and its Business Profile
- 5.4 Ajanta Pharmaceutical Ltd.
- 5.5 Strides Arcolab
- 5.6 Jubiliant Organosys Ltd.
- 5.7 Biocon Ltd.
- 5.8 Dabur Pharma Ltd.
6. Strategic Groups
7. Critical Success Factors (CSF) of the Industry
- 7.1 Research and Development
- 7.2 Production
- 7.3 Marketing, Sales and Distribution
- 7.4 Operational Efficiency
- 7.5 Alliances
- 7.6 Pre-2005 CSFs-Formulations
  - 7.6.1 New Product Launches
  - 7.6.2 Therapeutic Coverage
  - 7.6.3 Sales and Distribution Network
  - 7.6.4 Strong Brands
  - 7.6.5 Exports
  - 7.6.6 Critical Mass
- 7.7 Pre 2005 CSFs-Bulk Drugs
  - 7.7.1 Low Cost Structure
  - 7.7.2 Internationally Approved Manufacturing Facilities
  - 7.7.3 Speedy Launches
- 7.8 Post 2005 CSFs-The Most Critical
  - 7.8.1 Basic R&D
  - 7.8.2 Applied Research and Development
  - 7.8.3 Process Research or Reverse Engineering
  - 7.8.4 Analogue or Discovery Research
- 7.9 Biotechnology Research
  - 7.9.1 Biotech, Bio-Generics and Vaccines
  - 7.9.2 Cost Advantage of Indian Biotech Industry
  - 7.9.3 Challenges Facing the Indian Bio-Generics
  - 7.9.4 Vaccine Manufacturing
  - 7.9.5 Vaccine R&D
- 7.10 Bringing out a Generic Drug
- 7.11 New Drug Delivery System (NDDS) Research
- 7.12 Indian Council of Medical Research-Innovative New Products
- 7.13 Non-ICMR Vaccines
8. Policies and Regulations
- 8.1 Indian Patents Act (IPA) 1970
- 8.2 DPCO (Drug Price Control Order) 1970
- 8.3 GATT and WTO
- 8.4 Implications of the WTO
  - 8.4.1 On Prices of Drugs
  - 8.4.2 On R&D
- 8.5 Intellectual Property Rights (IPR)
9. Changing Scenario of Product Patent Regime
- 9.1 Critic' s View
- 9.2 Price Escalation
- 9.3 MNC Dominance
- 9.4 R&D Expenditure
- 9.5 Technology
- 9.6 Conclusion
10. Laws Pertaining to Manufacture and Sale of Drugs in India
- 10.1 The Drugs and Cosmetics Act, 1940
- 10.2 The Pharmacy Act, 1948
  - 10.2.1 State Pharmacy Councils
  - 10.2.2 Registration of Pharmacists
- 10.3 The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
- 10.4 The Narcotic Drugs and Psychotropic Substances Act, 1985
  - 10.4.1 State Pharmacy Councils
  - 10.4.2 Registration of Pharmacists
11. Marketing and Distribution in the Pharmaceutical Industry
- 11.1 In-Clinic Media
- 11.2 Outdoor Media
- 11.3 Electronic Media
12. The Changing External Environment
13. Porters Five Forces Model
- 13.1 Threat of New Entrants
- 13.2 Intensity of Competition
- 13.3 Threat of Substitutes
- 13.4 Bargaining Power of Buyers
- 13.5 Bargaining Power of Suppliers
14. Future Outlook for the Indian Pharmaceutical Industry
- 14.1 Government Policy-Update
  - 14.1.1 Budget Proposals, 2005-2006
15. Emerging Trends
16. India-The Clinical Trial Destination
- 16.1 Clinical Trials-The India Opportunity
- 16.2 Clinical Research Organizations (CRO)
- 16.3 Indian Companies in Collaborative Manufacturing Partnerships with Pharmaceutical Multinationals
- 16.4 Product Patents will Transform Traditional Medicine
17. Risks-Weaknesses and Threats-Faced by Indian Industry
- 17.1 Global Pharmaceutical Market-India' s Strengths
- 17.2 Production
- 17.3 Quality
- 17.4 Research and Development
- 17.5 Opportunities for the Future
- 17.6 Conclusion
18. Intellectual Property and Access to Medicines
- 18.1 Data Exclusivity
- 18.2 Interpretation of Product Patent Applicability
- 18.3 Mailbox Applications
- 18.4 Fears over Price Escalation
- 18.5 Quality
- 18.6 Availability
19. Evolving Indian Drug Research and Development
- 19.1 Composition of R&D Expenditure
- 19.2 A Shift in Focus is the Need of the Hour
- 19.3 Cost Advantages of Indian Firms
- 19.4 Achievements of in-House R&D Units Funded by the Indian Department of Scientific and Industrial Research during 2003 to 2004
20. Case of a Leading Indian Firm-Ranbaxy Laboratories
- 20.1 History
- 20.2 R&D is the Integrating Factor
- 20.3 Ranbaxy' s Successful Report Card
- 20.4 Why has Ranbaxy been this Successful?
- 20.5 Creating Value through Functional Strategies
- 20.6 Marketing
- 20.7 Relationship Marketing
- 20.8 Co-Marketing
- 20.9 Sales Strength
- 20.10 Brand Recognition
- 20.11 Ranbaxy' s Product Strategy
- 20.12 Ranbaxy R&D Strategy
- 20.13 Research Strategy
- 20.14 Ranbaxy' s Human Resources Strategy
- 20.15 Information Technology
- 20.16 Revenue Model for a Pharmaceutical Company
21. Strategic Options for Pharmaceutical Firms
- 21.1 Invest in Research and Development Capabilities
- 21.2 Grow a Wide Product Portfolio
  - 21.2.1 Growth through Mergers and Acquisitions
  - 21.2.2 Growth through Brand Acquisition
  - 21.2.3 Growth through Licensing Agreements
- 21.3 Remain a Generics Player
22. How to Build Sustainable Competitive Advantage
- 22.1 Product Portfolio Management
- 22.2 Integrated Healthcare Company
- 22.3 Distribution
- 22.4 Disease Management/Service Provider
- 22.5 Clinical Test Centers
- 22.6 Healthcare Funding Systems
- 22.7 Re-Engineering
- 22.8 Outsourcing Services

Appendix

1. Requirements and Guidelines for Permission to Import and/or Manufacture of New Drugs for Sale or to Undertake Clinical Trials
- 1.1 Application for Permission
2. Clinical Trial
- 2.1 Approval for Clinical Trial
- 2.2 Responsibilities of Sponsor
- 2.3 Responsibilities of the Investigator(s)
- 2.4 Informed Consent
- 2.5 Responsibilities of the Ethics Committee
- 2.6 Human Pharmacology (Phase I)
- 2.7 Therapeutic Exploratory Trials (Phase II)
- 2.8 Therapeutic Confirmatory Trials (Phase III)
- 2.9 Post-Marketing Trials (Phase IV)
3. Studies in Special Populations
- 3.1 Geriatrics
- 3.2 Pediatrics
- 3.3 Pregnant or Nursing Women
- 3.4 Post-Marketing Surveillance
- 3.5 Special Studies: Bioavailability/Bioequivalence Studies
4. Data to be Submitted Along with the Application to Conduct Clinical Trials/Import/Manufacture of New Drugs for Marketing in India
5. Data Required to be Submitted by an Applicant for Grant of Permission to Import and/or Manufacture a New Drug Already Approved in India
6. Structure, Contents and Format for Clinical Study Reports
7. Animal Toxicology (Non-Clinical Toxicity Studies)
- 7.1 General Principles
  - 7.1.1 Systemic Toxicity Studies
    - 7.1.1.1 Single-Dose Toxicity Studies
    - 7.1.1.2 Repeated-Dose Systemic Toxicity Studies
  - 7.1.2 Male Fertility Study
  - 7.1.3 Female Reproduction and Developmental Toxicity Studies
    - 7.1.3.1 Female Fertility Study (Segment I)
    - 7.1.3.2 Teratogenicity Study (Segment II)
    - 7.1.3.3 Prenatal Study (Segment III)
  - 7.1.4 Local Toxicity
  - 7.1.5 Allergenicity/Hypersensitivity
  - 7.1.6 Genotoxicity
  - 7.1.7 Carcinogenicity
8. Non-Clinical Toxicity Testing and Safety Evaluation Data of an Ind Needed for the Conduct of Different Phases of Clinical Trials
- 8.1 For Phase I Clinical Trials
- 8.2 For Phase II Clinical Trials
- 8.3 In vivo Genotoxicity Tests
- 8.4 For Phase III Clinical Trials
- 8.5 For Phase IV Clinical Trials
9. Animal Pharmacology
- 9.1 General Principles
  - 9.1.1 Specific Pharmacological Actions
  - 9.1.2 General Pharmacological Actions
    - 9.1.2.1 Essential Safety Pharmacology
  - 9.1.3 Follow-up and Supplemental Safety Pharmacology Studies
    - 9.1.3.1 Follow-up Studies for Essential Safety Pharmacology
    - 9.1.3.2 Supplemental Safety Pharmacology Studies
  - 9.1.4 Conditions under which Safety Pharmacology Studies are not Necessary
  - 9.1.5 Timing of Safety Pharmacology Studies in Relation to Clinical Development
    - 9.1.5.1 Prior to First Administration in Humans
    - 9.1.5.2 During Clinical Development
    - 9.1.5.3 Before Applying for Marketing Approval
  - 9.1.6 Application of Good Laboratory Practices (GLP)
10. Informed Consent
- 10.1 Checklist for Study Subject' s Informed Consent Documents
  - 10.1.1 Essential Elements
  - 10.1.2 Additional Elements, which may be Required
- 10.2 Format of Informed Consent Form for Subjects Participating in a Clinical Trial
11. Fixed Dose Combinations (FDCs)
12. Undertaking by the Investigator
13. Ethics Committee
- 13.1 Number of Persons
- 13.2 Format for Approval of Ethics Committee
14. Stability Testing of New Drugs
15. Stability Testing of New Drug Substances and Formulations
16. Contents of the Proposed Protocol for Conducting Clinical Trials
- 16.1 Title Page
- 16.2 Table of Contents
17. Data Elements for Reporting Serious Adverse Events Occurring in a Clinical Trial

INDEX OF FIGURES

Figure 2.1: Region-wise Indian Exports of Pharmaceutical Products, 2004-2006
Figure 3.1: New Drug Approvals, 2002-2006
Figure 4.1: Global Pharmaceuticals Market Segmentation by Value, 2006
Figure 4.2: Global Pharmaceuticals Market Value Forecast, 2006-2011
Figure 5.1: Overall Indexed Clinical Trial Costs
Figure 6.1: Strategic Group Mapping
Figure 13.1: Porter' s Five Forces Model Applied
Figure 20.1: Value Chain of Ranbaxy
Figure 21.1: Strategic Options Available for Pharmaceutical Firms

INDEX OF TABLES

Table 1.1: Annual Drug Expenditure Per Capita in Selected Countries
Table 1.2: Comparative Prices of Some Products in U.S. and India
Table 1.3: Number of Patent Applications in Top Ten Countries
Table 2.1: India Projected to be the Tenth Largest Market, 2005 and 2015
Table 2.2: Incremental Growth, 2005-2015
Table 2.3: Overseas Investments by Indian Companies
Table 2.4: Acquisitions in CRAMS Market and Joint Ventures, 2006-2007
Table 2.5: New Investments, 2007
Table 2.6: Contract Research Deals, 2007
Table 2.7: Key Contract Research Organizations in India
Table 2.8: India' s Major Pharma Exports to Various Destinations, 2005-2006
Table 2.9: India' s Pharmaceutical Industry
Table 2.10: Major Therapeutic Segments
Table 2.11: List of Patent Expiry Drugs
Table 2.12: List of Drugs, Which are Going Off Patent
Table 2.13: India' s Top Ten Pharmaceutical Company Sales
Table 2.14: Principal Products of India' s Leading Drug Manufacturers
Table 3.1: Budget Proposals Benefiting Pharmaceutical Industry
Table 3.2: Budget Proposals and the Immediate Beneficiaries of Indian Pharma Companies
Table 3.3: Indian Pharmaceutical Market, 2000-2006
Table 3.4: India' s Pharmaceutical Imports, 1999-2005
Table 3.5: India' s Pharmaceutical Imports by Product Group, 1999-2005
Table 3.6: India' s Pharmaceutical Imports from Top-Seven Countries, 2002-2006
Table 3.7: India Projected to be the Tenth Largest Market by 2015
Table 3.8: India' s Pharmaceutical Market will be the Third Largest During 2005-2015
Table 3.9: Present Core Competence of Indian Pharmaceutical Industry
Table 3.10: Competitive and Cooperative Strategies Adopted by Indian Pharma Firms, 2006
Table 3.11: Foreign Resource Mobilization by Indian Companies, 1994-2006
Table 3.12: Indigenous Modern Vaccine Development in India
Table 3.13: List of Selected Indian Biotechnology Companies
Table 3.14: India' s Top 20 Biotechnology Companies' Sales, 2003-2005
Table 4.1: Guiding Stars of Indian Pharmaceutical Industry, 2006
Table 4.2: Data on Production of Bulk Drugs of Selected Companies in the Organized Sector
Table 4.3: Strategic Options for Indian Companies
Table 4.4: Strengths and Weaknesses of India' s Pharmaceutical Industry
Table 4.5: Value of Production of Bulk Drugs and Formulations, 2000-2005
Table 4.6: Value of Imports and Exports of Bulk Drugs and Formulations, 2000-2006
Table 4.7: India' s Pharmaceutical Exports, 1999-2006
Table 4.8: India' s Pharmaceutical Exports to Top-15 Countries, 2003-2005
Table 4.9: Indian Pharmaceutical Exports by Commodity, 2002-2006
Table 4.10: Top 20 Suppliers for UNICEF
Table 4.11: Bulk Drug and Formulations
Table 4.12: Global Pharmaceuticals Market Segmentation, 2006
Table 4.13: Global Pharmaceuticals Market Value, 2002-2006
Table 4.14: Global Pharmaceuticals Market Value Forecast, 2006-2011
Table 4.15: Leading Therapeutic Segments
Table 4.16: Market Share of Major Therapeutic Segments
Table 4.17: Leading Brands in Each Category
Table 4.18: Market Growth Rates, 2003 and 2004
Table 4.19: Marketing Tie-ups
Table 5.1: Key Players and Their Characteristics
Table 5.2: Major Players in Terms of Market Capitalization, 2005
Table 5.3: India' s Top Seven Drug Companies in 2008
Table 5.4: Likely Winners Among Contract Research Vendors in India
Table 5.5: Selected CRAMS Products and Deals in India
Table 5.6: "Advantage India" in Outsourcing
Table 5.7: Pre-Clinical and Clinical Development in India
Table 5.8: Clinical Trial Approval Time in India
Table 5.9: Number of R&D Vendors in Bangalore, Mumbai and Hyderabad
Table 5.10: CRO Landscape in India
Table 5.11: International Quality Standards in Indian CROs
Table 5.12: Multimillion Dollar R&D Deals with Multiple Vendors
Table 5.13: U.S. FDA-Approved Facilities in Countries Outside the U.S.
Table 5.14: Pfizer India-Capacity Data
Table 5.15: Pfizer India-Raw Materials Data
Table 5.16: Top 15 Products of Pfizer India, 2007
Table 5.17: The Composition of Aventis' R&D Portfolio
Table 5.18: Excerpt of Novartis Pharma' s Clinical Pipeline, 2007
Table 5.19: Novartis India Capacity Data
Table 5.20: Novartis India Raw Material Data
Table 5.21: List of Subsidiaries and Joint Ventures of Ranbaxy Laboratories
Table 5.22: Ranbaxy' s Key Financials, 2005-2007
Table 5.23: Ranbaxy Price History, 2005
Table 5.24: Ranbaxy Interim History
Table 5.25: Ranbaxy-Capacity Data
Table 5.26: Ranbaxy-Raw Materials Data
Table 5.27: Ranbaxy' s Foreign Acquisitions
Table 5.28: Dr. Reddy' s Labs Capacity Data
Table 5.29: Dr. Reddy' s Labs Raw Materials Data
Table 5.30: Cipla-Capacity Data
Table 5.31: Cipla-Raw Materials Data
Table 5.32: List of Subsidiaries of Sun Pharma
Table 5.33: New Products from Sun Pharma
Table 5.34: Sun Pharma-API Products List
Table 5.35: Sun Pharma-Raw Materials Data
Table 5.36: Abbott India Ltd. (Knol)-Capacity Data
Table 5.37: Abbott India Ltd. (Knol)-Raw Materials Data
Table 5.38: The Acquisition History of Wockhardt
Table 5.39: Wockhardt' s 15 Years of Transformation
Table 5.40: Wockhardt' s Performance Snapshot-CAGR (Last 15 Years)
Table 5.41: Wockhardt' s Comprehensive Manufacturing Capabilities
Table 5.42: Wockhardt' s R&D Activity
Table 5.43: Wockhardt' s Focus on Major Therapeutic Areas, 2006
Table 5.44: Wockhardt' s Strengths and Weaknesses
Table 5.45: Wockhardt' s Business Highlights
Table 5.46: Wockhardt' s R&D Activity
Table 5.47: Wockhardt' s Ramp-up in U.S.
Table 5.48: Wockhardt-Capacity Data
Table 5.49: Wockhardt-Raw Material Data
Table 5.50: List of Subsidiaries of Wockhardt Ltd.
Table 5.51: Nicholas Piramal' s Foreign and Domestic Acquisitions
Table 5.52: Nicholas Piramal' s CRAMS Pipeline, 2008
Table 5.53: Highlights of Lupin Pharmaceutical
Table 5.54: Lupin' s Globally Accredited Facilities
Table 5.55: Lupin' s U.S./E.U. Product Development
Table 5.56: Top-Ten Brands of Alembic in the Domestic Market
Table 5.57: Industry Ranking of Alembic Products
Table 5.58: The Ten-Crore Plus Brands of Alembic
Table 5.59: High Growth Brands of Alembic
Table 5.60: Key Markets of Alembic, 2008
Table 5.61: Alembic' s New Product Launches, 2005-2006
Table 5.62: New APIs Under Development in Alembic
Table 5.63: Ajanta Pharma' s Performance Highlights
Table 5.64: Strides Arcolab' s Expenditure on R&D, 2005 and 2006
Table 5.65: Strides Arcolab' s Subsidiaries and Joint Ventures
Table 6.1: India' s Pharmaceutical Firms by Size, Sales, Function, Exports and R&D Capabilities
Table 7.1: Government Run Research Organizations and Industry Collaborations
Table 7.2: Number of Brand Acquisitions
Table 7.3: India' s Pharmaceutical R&D Expenditures, 2000-2006
Table 7.4: R&D Spending by Selected Indian Pharmaceutical Firms
Table 9.1: Indian Patent Regime in Place
Table 9.2: India' s Pharmaceutical R&D Expenditures, 2000-2006
Table 10.1: Drugs Control Administration by the Central Drug Standard Control Organization under the Aegis of Directorate General of Health Services of the Ministry of Health and Family Welfare of the Government of India
Table 11.1: List of Drugs Approved During 1999 to 2004
Table 11.2: New Drugs Approved from August 2004 to February 2005
Table 11.3: List of Drugs Prohibited for Manufacture and Sale through Gazette Notifications under Section 26A of Drugs and Cosmetics Act 1940 by the Ministry of Health and Family Welfare
Table 11.4: Other Drugs Prohibited for Manufacture, Sale and Distribution
Table 16.1: Projected Growth of Indian Clinical Research Industry, 2010
Table 19.1: Chemical and Allied Industries
Table 20.1: Ranbaxy' s IT Initiatives
Table 21.1: Typical Price Drops after a Drug Goes Off Patent
Table 22.1: Some of the Select Contract Manufacturing Deals in India
Table A7.1: Animal Toxicity Requirements for Clinical Trials and Marketing of a New Drug
Table A7.2: Local Toxicity Studies
Table A7.3: Special Toxicity Studies
Table A7.4: Number of Animals Required for Repeated-Dose Toxicity Studies
Table A7.5: Laboratory Parameters to be Included in Toxicity Studies
Table A7.6: Urinalysis Parameters
Table A7.7: Blood Biochemical Parameters
Table A7.8: Gross and Microscopic Pathology
Table A10.1: Informed Consent Form to Participate in a Clinical Trial
Table A15.1: Study Conditions for Drug Substances and Formulations Intended to be Stored under General Conditions
Table A15.2: Study Conditions for Drug Substances and Formulations Intended to be Stored in a Refrigerator
Table A15.3: Study Conditions for Drug Substances and Formulations Intended for Storage
Table A17.1: Contact Information-Major Indian Pharma Industries
Table A17.2: Contact Information-Pharmaceutical Research
Table A17.3: Contact Information-Biotechnology, Bioinformatics, Clinical Trials

Indian Pharmaceutical Industry

Table of Contents

INDEX OF FIGURES

INDEX OF TABLES