Indian Pharmaceutical Industry

Content

• 1. Overview
  • 1.1 Statement of Report
  • 1.2 Scope of the Report
  • 1.3 Methodology
  • 1.4 Executive Summary
• 2. Introduction
  • 2.1 Indias Major Pharma Export Destinations
• 3. The Indian Market
  • 3.1 Projected Market Size
  • 3.2 Present Core Competence
  • 3.3 Key Market Intelligence
  • 3.4 Analysis of Market
  • 3.5 Indian Biotechnology IndustryA Snapshot for Investors
• 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 Formulations1997-98 to 2001-02
    • 4.3.2 Formulations
  • 4.4 Major Therapeutic Segments
• 5. Key Players in the Indian Pharmaceutical Industry
  • 5.1 Multinational Corporations (MNCs) Playing a Critical Role
    • 5.1.1 Glaxo
      • 5.1.1.1 Performance Summary
      • 5.1.1.2 Performance Drivers in 2004
    • 5.1.2 Pfizer India
      • 5.1.2.1 Performance Summary
      • 5.1.2.2 Performance Drivers in 2005
      • 5.1.2.3 Analyst Expectations
    • 5.1.3 Aventis Pharma
      • 5.1.3.1 Performance Summary
      • 5.1.3.2 Performance Drivers in 2QCY04
      • 5.1.3.3 Analyst Forecast
    • 5.1.4 Novartis India
      • 5.1.4.1 Performance Summary
      • 5.1.4.2 Performance Drivers in 3QFY05
      • 5.1.4.3 Analyst Expectations
  • 5.2 Key Indian Players
    • 5.2.1 Ranbaxy
      • 5.2.1.1 Analyses
      • 5.2.1.2 Performance Drivers in 2004
    • 5.2.2 Dr. Reddys Labs (DRL)
      • 5.2.2.1 Performance Summary
      • 5.2.2.2 Performance Drivers
    • 5.2.3 Cipla
      • 5.2.3.1 Performance Summary
      • 5.2.3.2 Performance Drivers in 3QFY05
    • 5.2.4 Sun Pharma
      • 5.2.4.1 Performance Summary
      • 5.2.4.2 Performance Drivers in 2QFY05
      • 5.2.4.3 Analyst Expectations
    • 5.2.5 Abbott India Limited (Knol)
    • 5.2.6 Wockhardt
      • 5.2.6.1 Performance Summary
      • 5.2.6.2 Peformance Drivers in 2004
    • 5.2.7 Nicholas Piramal India
    • 5.2.8 Lupin
• 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 CSFsFormulations
    • 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 CSFsBulk Drugs
    • 7.7.1 Low Cost Structure
    • 7.7.2 Internationally Approved Manufacturing Facilities
    • 7.7.3 Speedy Launches
  • 7.8 Post 2005 CSFsThe 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 ResearchInnovative New Products
  • 7.13 Non-ICMR Vaccines
• 8. A Farsighted Strategy in Competition and Cooperation
  • 8.1 NCE/Proprietary Drugs
  • 8.2 Marketing Alliances with International Players
  • 8.3 R&D in India
  • 8.4 Investment and R&D
  • 8.5 Profitability
• 9. Indian Pharma Exports
• 10. Policies and Regulations
  • 10.1 Indian Patents Act (IPA) 1970
  • 10.2 DPCO (Drug Price Control Order)1970
  • 10.3 GATT and WTO
  • 10.4 Implications of the WTO
    • 10.4.1 On Prices of Drugs
    • 10.4.2 On R&D
  • 10.5 Intellectual Property Rights (IPR)
• 11. Changing Scenario of Product Patent Regime
  • 11.1 Critics View
  • 11.2 Price Escalation
  • 11.3 MNC Dominance
  • 11.4 R&D Expenditure
  • 11.5 Technology
  • 11.6 Conclusion
• 12. Laws Pertaining to Manufacture and Sale of Drugs in India
  • 12.1 The Drugs and Cosmetics Act, 1940
  • 12.2 The Pharmacy Act, 1948
    • 12.2.1 State Pharmacy Councils
    • 12.2.2 Registration of Pharmacists
  • 12.3 The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954
  • 12.4 The Narcotic Drugs and Psychotropic Substances Act, 1985
    • 12.4.1 State Pharmacy Councils
    • 12.4.2 Registration of Pharmacists
• 13. Marketing and Distribution in the Pharmaceutical Industry
  • 13.1 In-clinic Media
  • 13.2 Outdoor Media
  • 13.3 Electronic Media
• 14. The Changing External Environment
• 15. Porters Five Forces Model
  • 15.1 Threat of New Entrants
  • 15.2 Intensity of Competition
  • 15.3 Threat of Substitutes
  • 15.4 Bargaining Power of Buyers
  • 15.5 Bargaining Power of Suppliers
• 16. Future Outlook for the Indian Pharmaceutical Industry
  • 16.1 Government PolicyUpdate
    • 16.1.1 Budget Proposals 2005-06
• 17. Emerging Trends
• 18. IndiaThe Clinical Trial Destination
  • 18.1 Clinical Trials The India Opportunity
  • 18.2 Clinical Research Organizations (CRO)
  • 18.3 Indian Companies in Collaborative Manufacturing Partnerships with Pharmaceutical Multinationals
  • 18.4 Product Patents will Transform Traditional Medicine
• 19. RisksWeaknesses and ThreatsFaced by Indian Industry
  • 19.1 Global Pharmaceutical MarketIndias Strengths
  • 19.2 Production
  • 19.3 Quality
  • 19.4 Research and Development
  • 19.5 Opportunities for the Future
  • 19.6 Conclusion
• 20. Intellectual Property and Access to Medicines
  • 20.1 Data Exclusivity
  • 20.2 Interpretation of Product Patent Applicability
  • 20.3 Mailbox Applications
  • 20.4 Fears over Price Escalation
  • 20.5 Quality
  • 20.6 Availability
• 21. Evolving Indian Drug Research and Development
  • 21.1 Composition of R&D Expenditure
  • 21.2 A Shift in Focus is the Need of the Hour
  • 21.3 Cost Advantages of Indian Firms
  • 21.4 Achievements of in-House R&D Units Funded by the Indian Department of Scientific and Industrial Research during 2003 to 2004
• 22. Case of a Leading Indian FirmRanbaxy Laboratories
  • 22.1 History
  • 22.2 R&D is the Integrating Factor
  • 22.3 Ranbaxys Successful Report Card
  • 22.4 Why has Ranbaxy been this Successful?
  • 22.5 The Evolution of RanbaxyTime Line Analysis
    • 22.5.1 1970 to Early 1980s
    • 22.5.2 Early 1980s to 1994
    • 22.5.3 1994 to 1997
    • 22.5.4 1997 Onwards
  • 22.6 Leveraging Mergers and Alliances
  • 22.7 Research and Development
  • 22.8 Alliances for Entry into U.S. and European Markets
  • 22.9 Growth of Market Share and Product Portfolio
  • 22.10 Creating Value through Functional Strategies
  • 22.11 Marketing
  • 22.12 Relationship Marketing
  • 22.13 Co-Marketing
  • 22.14 Sales Strength
  • 22.15 Brand Recognition
  • 22.16 Ranbaxys Product Strategy
  • 22.17 Ranbaxy R&D Strategy
  • 22.18 Research Strategy
  • 22.19 Ranbaxys Human Resources Strategy
  • 22.20 Information Technology
  • 22.21 Revenue Model for a Pharmaceutical Company
• 23. Strategic Options for Pharmaceutical Firms
  • 23.1 Invest in Research and Development Capabilities
  • 23.2 Grow a Wide Product Portfolio
    • 23.2.1 Growth through Mergers and Acquisitions
    • 23.2.2 Growth through Brand Acquisition
    • 23.2.3 Growth through Licensing Agreements
  • 23.3 Remain a Generics Player
• 24. How to Build Sustainable Competitive Advantage
  • 24.1 Product Portfolio Management
  • 24.2 Integrated Healthcare Company
  • 24.3 Distribution
  • 24.4 Disease Management/Service Provider
  • 24.5 Clinical Test Centers
  • 24.6 Healthcare Funding Systems
  • 24.7 Re-Engineering
  • 24.8 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 Perinatal 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 Subjects 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 1: Projected Analysis of Indian Pharmaceutical and Biotechnology Industry
  • Figure 2: Production Trends of Pharmaceuticals in India
  • Figure 3: Pfizer Indias Performance
  • Figure 4: Sales Trends of Aventis Pharma
  • Figure 5: Strategic Group Mapping
  • Figure 6: Porters Five Forces Model Applied
  • Figure 7: Ranbaxys Focus during 1970 to Early 1980s
  • Figure 8: Ranbaxys Focus during Early 1980s to 1994
  • Figure 9: Ranbaxys Focus during 1994 to 1997
  • Figure 10: Ranbaxys Focus from 1997 Onwards
  • Figure 11: Value Chain of Ranbaxy
  • Figure 12: Strategic Options Available for Pharmaceutical Firms
• INDEX OF TABLES
  • Table 1: Indias Major Pharma Exports to Various Destinations for 2000 to 2001
  • Table 2: Indian Global Generics Market Size from 2003 to 2010
  • Table 3: Present Core Competence of Indian Pharmaceutical Industry
  • Table 4: Data on Production of Selected Bulk Drugs of Selected Companies in the Organized Sector During 1999-2000, 2000-01, 2001-02, 2002-03 and 2003-04
  • Table 5: Indian Production of Bulk Drugs and Formulations 1980 to 2000
  • Table 6: Indian Production of Bulk Drugs
  • Table 7: Indias Global Exports of Bulk Drugs and Formulations
  • Table 8: Bulk Drug Formulations
  • Table 9: ProductionFormulations
  • Table 10: Global PharmaGrowth Patterns
  • Table 11: Leading Therapeutic Segments
  • Table 12: Market Share of Major Therapeutic Segments
  • Table 13: Leading Brands in Each Category
  • Table 14: Market Growth Rates for 2003 and 2004
  • Table 15: Key Players and their Characteristics
  • Table 16: Glaxo SmithKline (Price History as on March 16, 2005)
  • Table 17: Glaxo SmithKline Interim Results
  • Table 18: Glaxo SmithKline FinancialsEquity Share Data
  • Table 19: Glaxo SmithKline Income Data
  • Table 20: Glaxo SmithKline Balance Sheet Data
  • Table 21: Glaxo SmithKline Share Holders
  • Table 22: Glaxo SmithKline Capacity Data
  • Table 23: Glaxo SmithKline Table Raw Materials
  • Table 24: Glaxo SmithKline Performance Summary
  • Table 25: Glaxo SmithKline Segmental Snapshot
  • Table 26: Glaxo SmithKline Cost Analysis
  • Table 27: Pfizer India Price History (as on March 16, 2005)
  • Table 28: Pfizer India Interim Results
  • Table 29: FinancialsPfizer India Equity Share Data
  • Table 30: Pfizer India Income Data
  • Table 31: Pfizer India Balance Sheet Data
  • Table 32: Pfizer India Share Holding
  • Table 33: Pfizer India Capacity Data
  • Table 34: Pfizer India Raw Materials Data
  • Table 35: Pfizer India Performance Summary
  • Table 36: Pfizer India Performance Drivers in 2005
  • Table 37: Pfizer India Cost Structure
  • Table 38: Aventis Pharma Price History (as on March 6, 2005)
  • Table 39: Aventis Pharma Interim Results
  • Table 40: Aventis Pharma FinancialsEquity Share Data
  • Table 41: Aventis Pharma Income Data
  • Table 42: Aventis Pharma Balance Sheet Data
  • Table 43: Aventis Pharma Share Holding
  • Table 44: Aventis Pharma Capacity Data
  • Table 45: Aventis Pharma Performance Summary
  • Table 46: Aventis Pharma Cost Analysis
  • Table 47: Novartis India Price History (as on March 16, 2005)
  • Table 48: Novartis India Interim Results
  • Table 49: Novartis India FinancialsEquity Share Data
  • Table 50: Novartis India Income Data
  • Table 51: Novartis India Balance Sheet Data
  • Table 52: Novartis India Share Holding
  • Table 53: Novartis India Capacity Data
  • Table 54: Novartis India Raw Material Data
  • Table 55: Novartis India Performance Summary
  • Table 56: Novartis India Performance Drivers in 3QFY05
  • Table 57: Novartis India Cost Analysis
  • Table 58: Ranbaxy Price History (Price History as on March 16, 2005)
  • Table 59: Ranbaxy Interim History
  • Table 60: Ranbaxy Financial PerformanceA Snapshot
  • Table 61: Ranbaxy FinancialsEquity Share Data
  • Table 62: Ranbaxy Income Data
  • Table 63: Ranbaxy Balance Sheet Data
  • Table 64: Ranbaxy Shareholding
  • Table 65: Ranbaxy Capacity Data
  • Table 66: Ranbaxy Raw Materials Data
  • Table 67: Dr. Reddys Labs Price History as on March 16, 2005
  • Table 68: Dr. Reddys Labs Interim Results
  • Table 69: Dr. Reddys Labs FinancialsEquity Share Data
  • Table 70: Dr. Reddys Labs Income Data
  • Table 71: Dr. Reddys Labs Balance Sheet Data
  • Table 72: Dr. Reddys Labs Share Holding
  • Table 73: Dr. Reddys Labs Capacity Data
  • Table 74: Dr. Reddys Labs Raw Materials Data
  • Table 75: Dr. Reddys Labs Performance Summary
  • Table 76: Dr. Reddys Labs Segmental Revenues*
  • Table 77: Dr. Reddys Labs Cost Break-up
  • Table 78: Cipla Price History (as on March 16, 2005)
  • Table 79: Cipla Interim Results
  • Table 80: Cipla Equity FinancialsShare Data
  • Table 81: Cipla Income Data
  • Table 82: Cipla Balance Sheet Data
  • Table 83: Cipla Capacity Data
  • Table 84: Cipla Raw Materials Data
  • Table 85: Cipla Performance Summary
  • Table 86: Cipla Business Snapshot
  • Table 87: Cipla Cost Analysis
  • Table 88: Sun Pharma Price History (as on March 16, 2005)
  • Table 89: Sun Pharma Interim Results
  • Table 90: Sun Pharma FinancialsEquity Share Data
  • Table 91: Sun Pharma Income Data
  • Table 92: Sun Pharma Balance Sheet Data
  • Table 93: Sun Pharma Share Holding
  • Table 94: Sun Pharma Capacity Data
  • Table 95: Sun Pharma Raw Materials Data
  • Table 96: Sun Pharma Performance Summary
  • Table 97: Sun Pharma Sales Break-up
  • Table 98: Abbott India Limited (Knol) (Price History as on March 16, 2005)
  • Table 99: Abbott India Limited (Knol) Interim Results
  • Table 100: Abbott India Limited (Knol) Financials Equity Share Data
  • Table 101: Abbott India Limited (Knol) Income Data
  • Table 102: Abbott India Limited (Knol) Balance Sheet Data
  • Table 103: Abbott India Limited (Knol) Share Holding
  • Table 104: Abbott India Limited (Knol) Capacity Data
  • Table 105: Abbott India Limited (Knol) Raw Materials Data
  • Table 106: Wockhardt Price History (as on March 16, 2005)
  • Table 107: Wockhardt Interim Results
  • Table 108: Wockhardt FinancialsEquity Share
  • Table 109: Wockhardt Income Data
  • Table 110: Wockhardt Balance Sheet Data
  • Table 111: Wockhardt Share Holding
  • Table 112: Wockhardt Capacity Data
  • Table 113: Wockhardt Raw Material Data
  • Table 114: Wockhardt Performance Summary
  • Table 115: Wockhardt Geographical Mix
  • Table 116: Wokhardt Business Mix
  • Table 117: Number of Brand Acquisitions
  • Table 118: R&D Investment of Indian Pharmaceutical Companies
  • Table 119: Investment in Indian Pharmaceutical Industry
  • Table 120: R&D* Expenditure by Indian Pharmaceutical Companies
  • Table 121: Profitability Ratios in Pharmaceutical Industry (CMIE Calculations)
  • Table 122: Indian Pharma Exports
  • Table 123: Top 15 Countries of Exports of Drugs and Pharmaceuticals from India during 2002 to 2003 with Comparative Figures for Previous Years
  • Table 124: CHEMEXCILs Region-wise Export Statistics of Drugs, Pharmaceuticals and Fine Chemicals for 2000-01, 2001-02 and 2002-03
  • Table 125: Indias Export of Drugs and Pharmaceutical Products through Major Ports
  • Table 126: Drugs under DPCO and the Share of the Industry
  • Table 127: Indian Patent Regime in Place
  • Table 128: 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 129: List of Drugs Approved During 1999 to 2004
  • Table 130: New Drugs Approved from August 2004 to February 2005
  • Table 131: 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 132: Other Drugs Prohibited for Manufacture, Sale and Distribution
  • Table 133: Projected Growth of Indian Clinical Research Industry
  • Table 134: Exports of Drugs, Pharmaceuticals and Fine Chemicals
  • Table 135: R&D Spend of Leading Indian Companies
  • Table 136: Industry-wide Change in R&D SpendReported R&D Expenditure by Indian Pharmaceutical Firms (1991 to 2000)
  • Table 137: Ongoing Projects of Drugs and Pharmaceutical Research Program
  • Table 138: Chemical and Allied Industries
  • Table 139: Ranbaxys IT Initiatives
  • Table 140: Typical Price Drops after a Drug Goes Off Patent
  • Table 141: Animal Toxicity Requirements for Clinical Trials and Marketing of a New Drug
  • Table 142: Local Toxicity Studies
  • Table 143: Special Toxicity Studies
  • Table 144: Number of Animals Required for Repeated-Dose Toxicity Studies
  • Table 145: Laboratory Parameters to be Included in Toxicity Studies
  • Table 146: Urinalysis Parameters
  • Table 147: Blood Biochemical Parameters
  • Table 148: Gross and Microscopic Pathology
  • Table 149: Informed Consent Form to Participate in a Clinical Trial
  • Table 150: Study Conditions for Drug Substances and Formulations Intended to be Stored under General Conditions
  • Table 151: Study Conditions for Drug Substances and Formulations Intended to be Stored in a Refrigerator
  • Table 152: Study Conditions for Drug Substances and Formulations Intended for Storage