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Indian Pharmaceutical Industry

The purpose of this study is to describe the Indian pharmaceutical industry. This sector includes all of the generally-accepted pharmaceutical manufacturing activities that are currently used today, including the bulk drug industry, formulations and major therapeutic segments. It examines these clinical supplies as utilized in hospitals, clinics and doctor\'s offices.

The principal objectives of this analysis are to:

1) Identify viable technology drivers through a comprehensive look at various platform technologies for the Indian pharmaceutical industry

2) Obtain a complete understanding of the Indian pharmaceutical industry practices from its basic principles to its applications

3) Discover feasible market opportunities via an identification of high-growth applications in different areas of the Indian pharmaceutical industry, with a focus on the biggest and expanding markets for the Indian pharmaceutical industry

4) Focus on global industry development through an in-depth analysis of the major world markets for pharmaceutical manufacturing, including forecasts for growth

5) Establish the essentials of the Indian pharmaceutical market including definitions, processes and trends.

Table of Contents

• 1.Overview8
  • 1.1Statement of Report8
  • 1.2Scope of the Report9
  • 1.3Methodology10
  • 1.4Executive Summary11
  
  
• 2.Introduction15
  • 2.1India\'s Pharmaceutical Market to Triple Over the Next Decade15
  • 2.2Indian Pharma\'s Global Foray16
  • 2.3New Investments in 200720
  • 2.4Contract Research Deals in 200720
  • 2.5India\'s Major Pharma Export Destinations22
  
  
• 3.The Indian Market29
  • 3.1Projected Market Size29
  • 3.2Present Core Competence33
  • 3.3Analysis of Market37
  • 3.4Indian Biotechnology Industry-A Snapshot for Investors37
  • 3.5Genome Valley38
  
  
• 4.Characteristics of the Indian Pharmaceutical Industry40
  • 4.1Profitability40
  • 4.2Location41
  • 4.3Segmentation of the Indian Pharmaceutical Industry41
    • 4.3.1Bulk Drug Industry41
      • 4.3.1.1Production and Exports of Drugs and Pharmaceuticals46
      • 4.3.1.2Projections for Bulk Drugs and Formulations-1997-1998 to 2001-200249
    • 4.3.2Formulations50
  • 4.4Major Therapeutic Segments50
  
  
• 5.Key Players in the Indian Pharmaceutical Industry56
  • 5.1Contract Manufacturing and Clinical Trials in India57
    • 5.1.1Multinational Corporations (MNC\'s) Playing a Critical Role63
      • 5.1.1.1Glaxo63
      • 5.1.1.2Glaxo SmithKline India64
      • 5.1.1.3Pfizer India65
      • 5.1.1.4Aventis Pharma67
    • 5.1.2Aventis\' New Introductions67
      • 5.1.2.1Performance Drivers68
      • 5.1.2.2Aventis Pharma69
    • 5.1.3Novartis India69
      • 5.1.3.1Novartis\' Performance in Pharmaceuticals, 200770
      • 5.1.3.2Novartis\' Performance in Vaccines and Diagnostics, 200771
  • 5.2Key Indian Players71
    • 5.2.1Ranbaxy71
      • 5.2.1.1Analyses74
      • 5.2.1.2Ranbaxy\'s R&D Pipeline75
      • 5.2.1.3Ranbaxy75
    • 5.2.2Dr. Reddy\'s Labs (DRL)75
    • 5.2.3Cipla77
    • 5.2.4Sun Pharma78
      • 5.2.4.1Sun Pharma\'s Highlights of Performance78
    • 5.2.5Abbott India Ltd. (Knol)80
    • 5.2.6Wockhardt Ltd.81
    • 5.2.7Nicholas Piramal India Ltd.85
    • 5.2.8Lupin Ltd.86
  • 5.3Alembic Ltd.88
    • 5.3.1Alembic and its Business Profile88
  • 5.4Ajanta Pharmaceutical Ltd.90
  • 5.5Strides Arcolab90
  • 5.6Jubiliant Organosys Ltd.92
  • 5.7Biocon Ltd.92
  • 5.8Dabur Pharma Ltd.93
  
  
• 6.Strategic Groups94


• 7.Critical Success Factors (CSF) of the Industry96
  • 7.1Research and Development96
  • 7.2Production97
  • 7.3Marketing, Sales and Distribution97
  • 7.4Operational Efficiency97
  • 7.5Alliances97
  • 7.6Pre-2005 CSFs-Formulations98
    • 7.6.1New Product Launches98
    • 7.6.2Therapeutic Coverage98
    • 7.6.3Sales and Distribution Network98
    • 7.6.4Strong Brands98
    • 7.6.5Exports99
    • 7.6.6Critical Mass99
  • 7.7Pre 2005 CSFs-Bulk Drugs99
    • 7.7.1Low Cost Structure99
    • 7.7.2Internationally Approved Manufacturing Facilities99
    • 7.7.3Speedy Launches99
  • 7.8Post 2005 CSFs-The Most Critical100
    • 7.8.1Basic R&D100
    • 7.8.2Applied Research and Development101
    • 7.8.3Process Research or Reverse Engineering102
    • 7.8.4Analogue or Discovery Research102
  • 7.9Biotechnology Research102
    • 7.9.1Biotech, Bio-Generics and Vaccines102
    • 7.9.2Cost Advantage of Indian Biotech Industry102
    • 7.9.3Challenges Facing the Indian Bio-Generics102
    • 7.9.4Vaccine Manufacturing103
    • 7.9.5Vaccine R&D103
  • 7.10Bringing out a Generic Drug103
  • 7.11New Drug Delivery System (NDDS) Research103
  • 7.12Indian Council of Medical Research-Innovative New Products103
  • 7.13Non-ICMR Vaccines103
  
  
• 8.Policies and Regulations104
  • 8.1Indian Patents Act (IPA) 1970104
  • 8.2DPCO (Drug Price Control Order) 1970104
  • 8.3GATT and WTO104
  • 8.4Implications of the WTO105
    • 8.4.1On Prices of Drugs105
    • 8.4.2On R&D105
  • 8.5Intellectual Property Rights (IPR)105
  
  
• 9.Changing Scenario of Product Patent Regime106
  • 9.1Critic\'s View106
  • 9.2Price Escalation106
  • 9.3MNC Dominance108
  • 9.4R&D Expenditure108
  • 9.5Technology109
  • 9.6Conclusion109
  
  
• 10.Laws Pertaining to Manufacture and Sale of Drugs in India110
  • 10.1The Drugs and Cosmetics Act, 1940110
  • 10.2The Pharmacy Act, 1948110
    • 10.2.1State Pharmacy Councils111
    • 10.2.2Registration of Pharmacists111
  • 10.3The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954111
  • 10.4The Narcotic Drugs and Psychotropic Substances Act, 1985111
    • 10.4.1State Pharmacy Councils112
    • 10.4.2Registration of Pharmacists112
    
    
• 11.Marketing and Distribution in the Pharmaceutical Industry113
  • 11.1In-Clinic Media113
  • 11.2Outdoor Media113
  • 11.3Electronic Media113
  
  
• 12.The Changing External Environment122


• 13.Porters Five Forces Model123
  • 13.1Threat of New Entrants123
  • 13.2Intensity of Competition123
  • 13.3Threat of Substitutes124
  • 13.4Bargaining Power of Buyers124
  • 13.5Bargaining Power of Suppliers124
  
  
• 14.Future Outlook for the Indian Pharmaceutical Industry125
  • 14.1Government Policy-Update125
    • 14.1.1Budget Proposals, 2005-2006125
    
    
• 15.Emerging Trends126


• 16.India-The Clinical Trial Destination127
  • 16.1Clinical Trials-The India Opportunity127
  • 16.2Clinical Research Organizations (CRO)127
  • 16.3Indian Companies in Collaborative Manufacturing Partnerships with Pharmaceutical Multinationals130
  • 16.4Product Patents will Transform Traditional Medicine130
  
  
• 17.Risks-Weaknesses and Threats-Faced by Indian Industry131
  • 17.1Global Pharmaceutical Market-India\'s Strengths131
  • 17.2Production131
  • 17.3Quality132
  • 17.4Research and Development132
  • 17.5Opportunities for the Future132
  • 17.6Conclusion133
  
  
• 18.Intellectual Property and Access to Medicines134
  • 18.1Data Exclusivity134
  • 18.2Interpretation of Product Patent Applicability134
  • 18.3Mailbox Applications134
  • 18.4Fears over Price Escalation134
  • 18.5Quality135
  • 18.6Availability135
  
  
• 19.Evolving Indian Drug Research and Development137
  • 19.1Composition of R&D Expenditure137
  • 19.2A Shift in Focus is the Need of the Hour137
  • 19.3Cost Advantages of Indian Firms138
  • 19.4Achievements of in-House R&D Units Funded by the Indian Department of Scientific and Industrial Research during 2003 to 2004140
  
  
• 20.Case of a Leading Indian Firm-Ranbaxy Laboratories141
  • 20.1History141
  • 20.2R&D is the Integrating Factor141
  • 20.3Ranbaxy\'s Successful Report Card142
  • 20.4Why has Ranbaxy been this Successful?142
  • 20.5Creating Value through Functional Strategies142
  • 20.6Marketing143
  • 20.7Relationship Marketing143
  • 20.8Co-Marketing143
  • 20.9Sales Strength143
  • 20.10Brand Recognition144
  • 20.11Ranbaxy\'s Product Strategy144
  • 20.12Ranbaxy R&D Strategy144
  • 20.13Research Strategy144
  • 20.14Ranbaxy\'s Human Resources Strategy144
  • 20.15Information Technology145
  • 20.16Revenue Model for a Pharmaceutical Company145
  
  
• 21.Strategic Options for Pharmaceutical Firms146
  • 21.1Invest in Research and Development Capabilities147
  • 21.2Grow a Wide Product Portfolio147
    • 21.2.1Growth through Mergers and Acquisitions147
    • 21.2.2Growth through Brand Acquisition147
    • 21.2.3Growth through Licensing Agreements147
  • 21.3Remain a Generics Player147
  
  
• 22.How to Build Sustainable Competitive Advantage149
  • 22.1Product Portfolio Management149
  • 22.2Integrated Healthcare Company149
  • 22.3Distribution149
  • 22.4Disease Management/Service Provider149
  • 22.5Clinical Test Centers149
  • 22.6Healthcare Funding Systems149
  • 22.7Re-Engineering150
  • 22.8Outsourcing Services150
  
  

 

Appendix152

 

• 1.Requirements and Guidelines for Permission to Import and/or Manufacture of New Drugs for Sale or to Undertake Clinical Trials152
  • 1.1Application for Permission152
  
  
• 2.Clinical Trial154
  • 2.1Approval for Clinical Trial154
  • 2.2Responsibilities of Sponsor154
  • 2.3Responsibilities of the Investigator(s)155
  • 2.4Informed Consent155
  • 2.5Responsibilities of the Ethics Committee155
  • 2.6Human Pharmacology (Phase I)155
  • 2.7Therapeutic Exploratory Trials (Phase II)156
  • 2.8Therapeutic Confirmatory Trials (Phase III)156
  • 2.9Post-Marketing Trials (Phase IV)157
  
  
• 3.Studies in Special Populations158
  • 3.1Geriatrics158
  • 3.2Pediatrics158
  • 3.3Pregnant or Nursing Women159
  • 3.4Post-Marketing Surveillance159
  • 3.5Special Studies: Bioavailability/Bioequivalence Studies160
  
  
• 4.Data to be Submitted Along with the Application to Conduct Clinical Trials/Import/Manufacture of New Drugs for Marketing in India161


• 5.Data Required to be Submitted by an Applicant for Grant of Permission to Import and/or Manufacture a New Drug Already Approved in India164


• 6.Structure, Contents and Format for Clinical Study Reports165


• 7.Animal Toxicology (Non-Clinical Toxicity Studies)167
  • 7.1General Principles167
    • 7.1.1Systemic Toxicity Studies167
      • 7.1.1.1 Single-Dose Toxicity Studies167
      • 7.1.1.2Repeated-Dose Systemic Toxicity Studies167
    • 7.1.2Male Fertility Study169
    • 7.1.3Female Reproduction and Developmental Toxicity Studies169
      • 7.1.3.1Female Fertility Study (Segment I)169
      • 7.1.3.2Teratogenicity Study (Segment II)169
      • 7.1.3.3Prenatal Study (Segment III)170
    • 7.1.4Local Toxicity170
    • 7.1.5Allergenicity/Hypersensitivity172
    • 7.1.6Genotoxicity172
    • 7.1.7Carcinogenicity173
    
    
• 8.Non-Clinical Toxicity Testing and Safety Evaluation Data of an Ind Needed for the Conduct of Different Phases of Clinical Trials177
  • 8.1For Phase I Clinical Trials177
  • 8.2For Phase II Clinical Trials177
  • 8.3In vivo Genotoxicity Tests177
  • 8.4For Phase III Clinical Trials177
  • 8.5For Phase IV Clinical Trials178
  
  
• 9.Animal Pharmacology179
  • 9.1General Principles179
    • 9.1.1Specific Pharmacological Actions179
    • 9.1.2General Pharmacological Actions179
      • 9.1.2.1Essential Safety Pharmacology179
    • 9.1.3Follow-up and Supplemental Safety Pharmacology Studies179
      • 9.1.3.1Follow-up Studies for Essential Safety Pharmacology180
      • 9.1.3.2Supplemental Safety Pharmacology Studies180
    • 9.1.4Conditions under which Safety Pharmacology Studies are not Necessary180
    • 9.1.5Timing of Safety Pharmacology Studies in Relation to Clinical Development180
      • 9.1.5.1Prior to First Administration in Humans180
      • 9.1.5.2During Clinical Development180
      • 9.1.5.3Before Applying for Marketing Approval181
    • 9.1.6Application of Good Laboratory Practices (GLP)181
    
    
• 10.Informed Consent182
  • 10.1Checklist for Study Subject\'s Informed Consent Documents182
    • 10.1.1Essential Elements182
    • 10.1.2Additional Elements, which may be Required182
  • 10.2Format of Informed Consent Form for Subjects Participating in a Clinical Trial183
  
  
• 11.Fixed Dose Combinations (FDCs)184


• 12.Undertaking by the Investigator185


• 13.Ethics Committee187
  • 13.1Number of Persons187
  • 13.2Format for Approval of Ethics Committee187
  
  
• 14.Stability Testing of New Drugs189


• 15.Stability Testing of New Drug Substances and Formulations190


• 16.Contents of the Proposed Protocol for Conducting Clinical Trials191
  • 16.1Title Page191
  • 16.2Table of Contents191
  
  
• 17.Data Elements for Reporting Serious Adverse Events Occurring in a Clinical Trial194

 

INDEX OF FIGURES

Figure 2.1: Region-wise Indian Exports of Pharmaceutical Products, 2004-200623

Figure 3.1: New Drug Approvals, 2002-200636

Figure 4.1: Global Pharmaceuticals Market Segmentation by Value, 200651

Figure 4.2: Global Pharmaceuticals Market Value Forecast, 2006-201152

Figure 5.1: Overall Indexed Clinical Trial Costs63

Figure 6.1: Strategic Group Mapping94

Figure 13.1: Porter\'s Five Forces Model Applied123

Figure 20.1: Value Chain of Ranbaxy142

Figure 21.1: Strategic Options Available for Pharmaceutical Firms146

INDEX OF TABLES

Table 1.1: Annual Drug Expenditure Per Capita in Selected Countries12

Table 1.2: Comparative Prices of Some Products in U.S. and India12

Table 1.3: Number of Patent Applications in Top Ten Countries14

Table 2.1: India Projected to be the Tenth Largest Market, 2005 and 201516

Table 2.2: Incremental Growth, 2005-201516

Table 2.3: Overseas Investments by Indian Companies17

Table 2.4: Acquisitions in CRAMS Market and Joint Ventures, 2006-200718

Table 2.5: New Investments, 200720

Table 2.6: Contract Research Deals, 200720

Table 2.7: Key Contract Research Organizations in India21

Table 2.8: India\'s Major Pharma Exports to Various Destinations, 2005-200622

Table 2.9: India\'s Pharmaceutical Industry23

Table 2.10: Major Therapeutic Segments23

Table 2.11: List of Patent Expiry Drugs25

Table 2.12: List of Drugs, Which are Going Off Patent25

Table 2.13: India\'s Top Ten Pharmaceutical Company Sales26

Table 2.14: Principal Products of India\'s Leading Drug Manufacturers26

Table 3.1: Budget Proposals Benefiting Pharmaceutical Industry29

Table 3.2: Budget Proposals and the Immediate Beneficiaries of Indian Pharma Companies30

Table 3.3: Indian Pharmaceutical Market, 2000-200631

Table 3.4: India\'s Pharmaceutical Imports, 1999-200531

Table 3.5: India\'s Pharmaceutical Imports by Product Group, 1999-200531

Table 3.6: India\'s Pharmaceutical Imports from Top-Seven Countries, 2002-200632

Table 3.7: India Projected to be the Tenth Largest Market by 201532

Table 3.8: India\'s Pharmaceutical Market will be the Third Largest During 2005-201533

Table 3.9: Present Core Competence of Indian Pharmaceutical Industry34

Table 3.10: Competitive and Cooperative Strategies Adopted by Indian Pharma Firms, 200635

Table 3.11: Foreign Resource Mobilization by Indian Companies, 1994-200636

Table 3.12: Indigenous Modern Vaccine Development in India37

Table 3.13: List of Selected Indian Biotechnology Companies38

Table 3.14: India\'s Top 20 Biotechnology Companies\' Sales, 2003-200539

Table 4.1: Guiding Stars of Indian Pharmaceutical Industry, 200640

Table 4.2: Data on Production of Bulk Drugs of Selected Companies in the Organized Sector43

Table 4.3: Strategic Options for Indian Companies46

Table 4.4: Strengths and Weaknesses of India\'s Pharmaceutical Industry46

Table 4.5: Value of Production of Bulk Drugs and Formulations, 2000-200547

Table 4.6: Value of Imports and Exports of Bulk Drugs and Formulations, 2000-200647

Table 4.7: India\'s Pharmaceutical Exports, 1999-200647

Table 4.8: India\'s Pharmaceutical Exports to Top-15 Countries, 2003-200548

Table 4.9: Indian Pharmaceutical Exports by Commodity, 2002-200648

Table 4.10: Top 20 Suppliers for UNICEF49

Table 4.11: Bulk Drug and Formulations49

Table 4.12: Global Pharmaceuticals Market Segmentation, 200651

Table 4.13: Global Pharmaceuticals Market Value, 2002-200652

Table 4.14: Global Pharmaceuticals Market Value Forecast, 2006-201152

Table 4.15: Leading Therapeutic Segments53

Table 4.16: Market Share of Major Therapeutic Segments54

Table 4.17: Leading Brands in Each Category54

Table 4.18: Market Growth Rates, 2003 and 200454

Table 4.19: Marketing Tie-ups55

Table 5.1: Key Players and Their Characteristics56

Table 5.2: Major Players in Terms of Market Capitalization, 200556

Table 5.3: India\'s Top Seven Drug Companies in 200857

Table 5.4: Likely Winners Among Contract Research Vendors in India58

Table 5.5: Selected CRAMS Products and Deals in India58

Table 5.6: "Advantage India" in Outsourcing59

Table 5.7: Pre-Clinical and Clinical Development in India59

Table 5.8: Clinical Trial Approval Time in India60

Table 5.9: Number of R&D Vendors in Bangalore, Mumbai and Hyderabad60

Table 5.10: CRO Landscape in India60

Table 5.11: International Quality Standards in Indian CROs61

Table 5.12: Multimillion Dollar R&D Deals with Multiple Vendors61

Table 5.13: U.S. FDA-Approved Facilities in Countries Outside the U.S.62

Table 5.14: Pfizer India-Capacity Data65

Table 5.15: Pfizer India-Raw Materials Data65

Table 5.16: Top 15 Products of Pfizer India, 200766

Table 5.17: The Composition of Aventis\' R&D Portfolio68

Table 5.18: Excerpt of Novartis Pharma\'s Clinical Pipeline, 200770

Table 5.19: Novartis India Capacity Data71

Table 5.20: Novartis India Raw Material Data71

Table 5.21: List of Subsidiaries and Joint Ventures of Ranbaxy Laboratories72

Table 5.22: Ranbaxy\'s Key Financials, 2005-200773

Table 5.23: Ranbaxy Price History, 200573

Table 5.24: Ranbaxy Interim History74

Table 5.25: Ranbaxy-Capacity Data74

Table 5.26: Ranbaxy-Raw Materials Data74

Table 5.27: Ranbaxy\'s Foreign Acquisitions75

Table 5.28: Dr. Reddy\'s Labs Capacity Data76

Table 5.29: Dr. Reddy\'s Labs Raw Materials Data76

Table 5.30: Cipla-Capacity Data77

Table 5.31: Cipla-Raw Materials Data77

Table 5.32: List of Subsidiaries of Sun Pharma78

Table 5.33: New Products from Sun Pharma79

Table 5.34: Sun Pharma-API Products List80

Table 5.35: Sun Pharma-Raw Materials Data80

Table 5.36: Abbott India Ltd. (Knol)-Capacity Data81

Table 5.37: Abbott India Ltd. (Knol)-Raw Materials Data81

Table 5.38: The Acquisition History of Wockhardt82

Table 5.39: Wockhardt\'s 15 Years of Transformation82

Table 5.40: Wockhardt\'s Performance Snapshot-CAGR (Last 15 Years)83

Table 5.41: Wockhardt\'s Comprehensive Manufacturing Capabilities83

Table 5.42: Wockhardt\'s R&D Activity83

Table 5.43: Wockhardt\'s Focus on Major Therapeutic Areas, 200683

Table 5.44: Wockhardt\'s Strengths and Weaknesses83

Table 5.45: Wockhardt\'s Business Highlights84

Table 5.46: Wockhardt\'s R&D Activity84

Table 5.47: Wockhardt\'s Ramp-up in U.S.84

Table 5.48: Wockhardt-Capacity Data84

Table 5.49: Wockhardt-Raw Material Data85

Table 5.50: List of Subsidiaries of Wockhardt Ltd.85

Table 5.51: Nicholas Piramal\'s Foreign and Domestic Acquisitions86

Table 5.52: Nicholas Piramal\'s CRAMS Pipeline, 200886

Table 5.53: Highlights of Lupin Pharmaceutical87

Table 5.54: Lupin\'s Globally Accredited Facilities87

Table 5.55: Lupin\'s U.S./E.U. Product Development87

Table 5.56: Top-Ten Brands of Alembic in the Domestic Market88

Table 5.57: Industry Ranking of Alembic Products88

Table 5.58: The Ten-Crore Plus Brands of Alembic89

Table 5.59: High Growth Brands of Alembic89

Table 5.60: Key Markets of Alembic, 200889

Table 5.61: Alembic\'s New Product Launches, 2005-200689

Table 5.62: New APIs Under Development in Alembic90

Table 5.63: Ajanta Pharma\'s Performance Highlights90

Table 5.64: Strides Arcolab\'s Expenditure on R&D, 2005 and 200691

Table 5.65: Strides Arcolab\'s Subsidiaries and Joint Ventures92

Table 6.1: India\'s Pharmaceutical Firms by Size, Sales, Function, Exports and R&D Capabilities95

Table 7.1: Government Run Research Organizations and Industry Collaborations96

Table 7.2: Number of Brand Acquisitions99

Table 7.3: India\'s Pharmaceutical R&D Expenditures, 2000-2006100

Table 7.4: R&D Spending by Selected Indian Pharmaceutical Firms100

Table 9.1: Indian Patent Regime in Place106

Table 9.2: India\'s Pharmaceutical R&D Expenditures, 2000-2006109

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 India112

Table 11.1: List of Drugs Approved During 1999 to 2004114

Table 11.2: New Drugs Approved from August 2004 to February 2005118

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 Welfare120

Table 11.4: Other Drugs Prohibited for Manufacture, Sale and Distribution121

Table 16.1: Projected Growth of Indian Clinical Research Industry, 2010127

Table 19.1: Chemical and Allied Industries140

Table 20.1: Ranbaxy\'s IT Initiatives145

Table 21.1: Typical Price Drops after a Drug Goes Off Patent148

Table 22.1: Some of the Select Contract Manufacturing Deals in India151

Table A7.1: Animal Toxicity Requirements for Clinical Trials and Marketing of a New Drug174

Table A7.2: Local Toxicity Studies175

Table A7.3: Special Toxicity Studies175

Table A7.4: Number of Animals Required for Repeated-Dose Toxicity Studies175

Table A7.5: Laboratory Parameters to be Included in Toxicity Studies176

Table A7.6: Urinalysis Parameters176

Table A7.7: Blood Biochemical Parameters176

Table A7.8: Gross and Microscopic Pathology176

Table A10.1: Informed Consent Form to Participate in a Clinical Trial183

Table A15.1: Study Conditions for Drug Substances and Formulations Intended to be Stored under General Conditions190

Table A15.2: Study Conditions for Drug Substances and Formulations Intended to be Stored in a Refrigerator190

Table A15.3: Study Conditions for Drug Substances and Formulations Intended for Storage190

Table A17.1: Contact Information-Major Indian Pharma Industries195

Table A17.2: Contact Information-Pharmaceutical Research201

Table A17.3: Contact Information-Biotechnology, Bioinformatics, Clinical Trials202

 

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