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Indian Pharmaceutical Industry
Publication Date: 01-JUL-08
Pages: 207
Study: TMRINP03
Format/Price: PDF document / $1,999.00

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The purpose of this TriMark Publications study is to describe the specific segment of the pharmaceutical market sector called 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; and 5) establish the essentials of the Indian pharmaceutical market including definitions, processes and trends.

Table of Contents:

1. Overview 8
1.1 Statement of Report 8
1.2 Scope of the Report 9
1.3 Methodology 10
1.4 Executive Summary 11
2. Introduction 15
2.1 India's Pharmaceutical Market to Triple Over the Next Decade 15
2.2 Indian Pharma's Global Foray 16
2.3 New Investments in 2007 20
2.4 Contract Research Deals in 2007 20
2.5 India's Major Pharma Export Destinations 22
3. The Indian Market 29
3.1 Projected Market Size 29
3.2 Present Core Competence 33
3.3 Analysis of Market 37
3.4 Indian Biotechnology Industry-A Snapshot for Investors 37
3.5 Genome Valley 38
4. Characteristics of the Indian Pharmaceutical Industry 40
4.1 Profitability 40
4.2 Location 41
4.3 Segmentation of the Indian Pharmaceutical Industry 41
4.3.1 Bulk Drug Industry 41
4.3.1.1 Production and Exports of Drugs and Pharmaceuticals 46
4.3.1.2 Projections for Bulk Drugs and Formulations-1997-1998 to 2001-2002 49
4.3.2 Formulations 50
4.4 Major Therapeutic Segments 50
5. Key Players in the Indian Pharmaceutical Industry 56
5.1 Contract Manufacturing and Clinical Trials in India 57
5.1.1 Multinational Corporations (MNC's) Playing a Critical Role 63
5.1.1.1 Glaxo 63
5.1.1.2 Glaxo SmithKline India 64
5.1.1.3 Pfizer India 65
5.1.1.4 Aventis Pharma 67
5.1.2 Aventis' New Introductions 67
5.1.2.1 Performance Drivers 68
5.1.2.2 Aventis Pharma 69
5.1.3 Novartis India 69
5.1.3.1 Novartis' Performance in Pharmaceuticals, 2007 70
5.1.3.2 Novartis' Performance in Vaccines and Diagnostics, 2007 71
5.2 Key Indian Players 71
5.2.1 Ranbaxy 71
5.2.1.1 Analyses 74
5.2.1.2 Ranbaxy's R&D Pipeline 75
5.2.1.3 Ranbaxy 75
5.2.2 Dr. Reddy's Labs (DRL) 75
5.2.3 Cipla 77
5.2.4 Sun Pharma 78
5.2.4.1 Sun Pharma's Highlights of Performance 78
5.2.5 Abbott India Ltd. (Knol) 80
5.2.6 Wockhardt Ltd. 81
5.2.7 Nicholas Piramal India Ltd. 85
5.2.8 Lupin Ltd. 86
5.3 Alembic Ltd. 88
5.3.1 Alembic and its Business Profile 88
5.4 Ajanta Pharmaceutical Ltd. 90
5.5 Strides Arcolab 90
5.6 Jubiliant Organosys Ltd. 92
5.7 Biocon Ltd. 92
5.8 Dabur Pharma Ltd. 93
6. Strategic Groups 94
7. Critical Success Factors (CSF) of the Industry 96
7.1 Research and Development 96
7.2 Production 97
7.3 Marketing, Sales and Distribution 97
7.4 Operational Efficiency 97
7.5 Alliances 97
7.6 Pre-2005 CSFs-Formulations 98
7.6.1 New Product Launches 98
7.6.2 Therapeutic Coverage 98
7.6.3 Sales and Distribution Network 98
7.6.4 Strong Brands 98
7.6.5 Exports 99
7.6.6 Critical Mass 99
7.7 Pre 2005 CSFs-Bulk Drugs 99
7.7.1 Low Cost Structure 99
7.7.2 Internationally Approved Manufacturing Facilities 99
7.7.3 Speedy Launches 99
7.8 Post 2005 CSFs-The Most Critical 100
7.8.1 Basic R&D 100
7.8.2 Applied Research and Development 101
7.8.3 Process Research or Reverse Engineering 102
7.8.4 Analogue or Discovery Research 102
7.9 Biotechnology Research 102
7.9.1 Biotech, Bio-Generics and Vaccines 102
7.9.2 Cost Advantage of Indian Biotech Industry 102
7.9.3 Challenges Facing the Indian Bio-Generics 102
7.9.4 Vaccine Manufacturing 103
7.9.5 Vaccine R&D 103
7.10 Bringing out a Generic Drug 103
7.11 New Drug Delivery System (NDDS) Research 103
7.12 Indian Council of Medical Research-Innovative New Products 103
7.13 Non-ICMR Vaccines 103
8. Policies and Regulations 104
8.1 Indian Patents Act (IPA) 1970 104
8.2 DPCO (Drug Price Control Order) 1970 104
8.3 GATT and WTO 104
8.4 Implications of the WTO 105
8.4.1 On Prices of Drugs 105
8.4.2 On R&D 105
8.5 Intellectual Property Rights (IPR) 105
9. Changing Scenario of Product Patent Regime 106
9.1 Critic's View 106
9.2 Price Escalation 106
9.3 MNC Dominance 108
9.4 R&D Expenditure 108
9.5 Technology 109
9.6 Conclusion 109
10. Laws Pertaining to Manufacture and Sale of Drugs in India 110
10.1 The Drugs and Cosmetics Act, 1940 110
10.2 The Pharmacy Act, 1948 110
10.2.1 State Pharmacy Councils 111
10.2.2 Registration of Pharmacists 111
10.3 The Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 111
10.4 The Narcotic Drugs and Psychotropic Substances Act, 1985 111
10.4.1 State Pharmacy Councils 112
10.4.2 Registration of Pharmacists 112
11. Marketing and Distribution in the Pharmaceutical Industry 113
11.1 In-Clinic Media 113
11.2 Outdoor Media 113
11.3 Electronic Media 113
12. The Changing External Environment 122
13. Porters Five Forces Model 123
13.1 Threat of New Entrants 123
13.2 Intensity of Competition 123
13.3 Threat of Substitutes 124
13.4 Bargaining Power of Buyers 124
13.5 Bargaining Power of Suppliers 124
14. Future Outlook for the Indian Pharmaceutical Industry 125
14.1 Government Policy-Update 125
14.1.1 Budget Proposals, 2005-2006 125
15. Emerging Trends 126
16. India-The Clinical Trial Destination 127
16.1 Clinical Trials-The India Opportunity 127
16.2 Clinical Research Organizations (CRO) 127
16.3 Indian Companies in Collaborative Manufacturing Partnerships with Pharmaceutical Multinationals 130
16.4 Product Patents will Transform Traditional Medicine 130
17. Risks-Weaknesses and Threats-Faced by Indian Industry 131
17.1 Global Pharmaceutical Market-India's Strengths 131
17.2 Production 131
17.3 Quality 132
17.4 Research and Development 132
17.5 Opportunities for the Future 132
17.6 Conclusion 133
18. Intellectual Property and Access to Medicines 134
18.1 Data Exclusivity 134
18.2 Interpretation of Product Patent Applicability 134
18.3 Mailbox Applications 134
18.4 Fears over Price Escalation 134
18.5 Quality 135
18.6 Availability 135
19. Evolving Indian Drug Research and Development 137
19.1 Composition of R&D Expenditure 137
19.2 A Shift in Focus is the Need of the Hour 137
19.3 Cost Advantages of Indian Firms 138
19.4 Achievements of in-House R&D Units Funded by the Indian Department of Scientific and Industrial Research during 2003 to 2004 140
20. Case of a Leading Indian Firm-Ranbaxy Laboratories 141
20.1 History 141
20.2 R&D is the Integrating Factor 141
20.3 Ranbaxy's Successful Report Card 142
20.4 Why has Ranbaxy been this Successful? 142
20.5 Creating Value through Functional Strategies 142
20.6 Marketing 143
20.7 Relationship Marketing 143
20.8 Co-Marketing 143
20.9 Sales Strength 143
20.10 Brand Recognition 144
20.11 Ranbaxy's Product Strategy 144
20.12 Ranbaxy R&D Strategy 144
20.13 Research Strategy 144
20.14 Ranbaxy's Human Resources Strategy 144
20.15 Information Technology 145
20.16 Revenue Model for a Pharmaceutical Company 145
21. Strategic Options for Pharmaceutical Firms 146
21.1 Invest in Research and Development Capabilities 147
21.2 Grow a Wide Product Portfolio 147
21.2.1 Growth through Mergers and Acquisitions 147
21.2.2 Growth through Brand Acquisition 147
21.2.3 Growth through Licensing Agreements 147
21.3 Remain a Generics Player 147
22. How to Build Sustainable Competitive Advantage 149
22.1 Product Portfolio Management 149
22.2 Integrated Healthcare Company 149
22.3 Distribution 149
22.4 Disease Management/Service Provider 149
22.5 Clinical Test Centers 149
22.6 Healthcare Funding Systems 149
22.7 Re-Engineering 150
22.8 Outsourcing Services 150
Appendix 152
1. Requirements and Guidelines for Permission to Import and/or Manufacture of New Drugs for Sale or to Undertake Clinical Trials 152
1.1 Application for Permission 152
2. Clinical Trial 154
2.1 Approval for Clinical Trial 154
2.2 Responsibilities of Sponsor 154
2.3 Responsibilities of the Investigator(s) 155
2.4 Informed Consent 155
2.5 Responsibilities of the Ethics Committee 155
2.6 Human Pharmacology (Phase I) 155
2.7 Therapeutic Exploratory Trials (Phase II) 156
2.8 Therapeutic Confirmatory Trials (Phase III) 156
2.9 Post-Marketing Trials (Phase IV) 157
3. Studies in Special Populations 158
3.1 Geriatrics 158
3.2 Pediatrics 158
3.3 Pregnant or Nursing Women 159
3.4 Post-Marketing Surveillance 159
3.5 Special Studies: Bioavailability/Bioequivalence Studies 160
4. Data to be Submitted Along with the Application to Conduct Clinical Trials/Import/Manufacture of New Drugs for Marketing in India 161
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 164
6. Structure, Contents and Format for Clinical Study Reports 165
7. Animal Toxicology (Non-Clinical Toxicity Studies) 167
7.1 General Principles 167
7.1.1 Systemic Toxicity Studies 167
7.1.1.1 Single-Dose Toxicity Studies 167
7.1.1.2 Repeated-Dose Systemic Toxicity Studies 167
7.1.2 Male Fertility Study 169
7.1.3 Female Reproduction and Developmental Toxicity Studies 169
7.1.3.1 Female Fertility Study (Segment I) 169
7.1.3.2 Teratogenicity Study (Segment II) 169
7.1.3.3 Prenatal Study (Segment III) 170
7.1.4 Local Toxicity 170
7.1.5 Allergenicity/Hypersensitivity 172
7.1.6 Genotoxicity 172
7.1.7 Carcinogenicity 173
8. Non-Clinical Toxicity Testing and Safety Evaluation Data of an Ind Needed for the Conduct of Different Phases of Clinical Trials 177
8.1 For Phase I Clinical Trials 177
8.2 For Phase II Clinical Trials 177
8.3 In vivo Genotoxicity Tests 177
8.4 For Phase III Clinical Trials 177
8.5 For Phase IV Clinical Trials 178
9. Animal Pharmacology 179
9.1 General Principles 179
9.1.1 Specific Pharmacological Actions 179
9.1.2 General Pharmacological Actions 179
9.1.2.1 Essential Safety Pharmacology 179
9.1.3 Follow-up and Supplemental Safety Pharmacology Studies 179
9.1.3.1 Follow-up Studies for Essential Safety Pharmacology 180
9.1.3.2 Supplemental Safety Pharmacology Studies 180
9.1.4 Conditions under which Safety Pharmacology Studies are not Necessary 180
9.1.5 Timing of Safety Pharmacology Studies in Relation to Clinical Development 180
9.1.5.1 Prior to First Administration in Humans 180
9.1.5.2 During Clinical Development 180
9.1.5.3 Before Applying for Marketing Approval 181
9.1.6 Application of Good Laboratory Practices (GLP) 181
10. Informed Consent 182
10.1 Checklist for Study Subject's Informed Consent Documents 182
10.1.1 Essential Elements 182
10.1.2 Additional Elements, which may be Required 182
10.2 Format of Informed Consent Form for Subjects Participating in a Clinical Trial 183
11. Fixed Dose Combinations (FDCs) 184
12. Undertaking by the Investigator 185
13. Ethics Committee 187
13.1 Number of Persons 187
13.2 Format for Approval of Ethics Committee 187
14. Stability Testing of New Drugs 189
15. Stability Testing of New Drug Substances and Formulations 190
16. Contents of the Proposed Protocol for Conducting Clinical Trials 191
16.1 Title Page 191
16.2 Table of Contents 191
17. Data Elements for Reporting Serious Adverse Events Occurring in a Clinical Trial 194
INDEX OF FIGURES
Figure 2.1: Region-wise Indian Exports of Pharmaceutical Products, 2004-2006 23
Figure 3.1: New Drug Approvals, 2002-2006 36
Figure 4.1: Global Pharmaceuticals Market Segmentation by Value, 2006 51
Figure 4.2: Global Pharmaceuticals Market Value Forecast, 2006-2011 52
Figure 5.1: Overall Indexed Clinical Trial Costs 63
Figure 6.1: Strategic Group Mapping 94
Figure 13.1: Porter's Five Forces Model Applied 123
Figure 20.1: Value Chain of Ranbaxy 142
Figure 21.1: Strategic Options Available for Pharmaceutical Firms 146
INDEX OF TABLES
Table 1.1: Annual Drug Expenditure Per Capita in Selected Countries 12
Table 1.2: Comparative Prices of Some Products in U.S. and India 12
Table 1.3: Number of Patent Applications in Top Ten Countries 14
Table 2.1: India Projected to be the Tenth Largest Market, 2005 and 2015 16
Table 2.2: Incremental Growth, 2005-2015 16
Table 2.3: Overseas Investments by Indian Companies 17
Table 2.4: Acquisitions in CRAMS Market and Joint Ventures, 2006-2007 18
Table 2.5: New Investments, 2007 20
Table 2.6: Contract Research Deals, 2007 20
Table 2.7: Key Contract Research Organizations in India 21
Table 2.8: India's Major Pharma Exports to Various Destinations, 2005-2006 22
Table 2.9: India's Pharmaceutical Industry 23
Table 2.10: Major Therapeutic Segments 23
Table 2.11: List of Patent Expiry Drugs 25
Table 2.12: List of Drugs, Which are Going Off Patent 25
Table 2.13: India's Top Ten Pharmaceutical Company Sales 26
Table 2.14: Principal Products of India's Leading Drug Manufacturers 26
Table 3.1: Budget Proposals Benefiting Pharmaceutical Industry 29
Table 3.2: Budget Proposals and the Immediate Beneficiaries of Indian Pharma Companies 30
Table 3.3: Indian Pharmaceutical Market, 2000-2006 31
Table 3.4: India's Pharmaceutical Imports, 1999-2005 31
Table 3.5: India's Pharmaceutical Imports by Product Group, 1999-2005 31
Table 3.6: India's Pharmaceutical Imports from Top-Seven Countries, 2002-2006 32
Table 3.7: India Projected to be the Tenth Largest Market by 2015 32
Table 3.8: India's Pharmaceutical Market will be the Third Largest During 2005-2015 33
Table 3.9: Present Core Competence of Indian Pharmaceutical Industry 34
Table 3.10: Competitive and Cooperative Strategies Adopted by Indian Pharma Firms, 2006 35
Table 3.11: Foreign Resource Mobilization by Indian Companies, 1994-2006 36
Table 3.12: Indigenous Modern Vaccine Development in India 37
Table 3.13: List of Selected Indian Biotechnology Companies 38
Table 3.14: India's Top 20 Biotechnology Companies' Sales, 2003-2005 39
Table 4.1: Guiding Stars of Indian Pharmaceutical Industry, 2006 40
Table 4.2: Data on Production of Bulk Drugs of Selected Companies in the Organized Sector 43
Table 4.3: Strategic Options for Indian Companies 46
Table 4.4: Strengths and Weaknesses of India's Pharmaceutical Industry 46
Table 4.5: Value of Production of Bulk Drugs and Formulations, 2000-2005 47
Table 4.6: Value of Imports and Exports of Bulk Drugs and Formulations, 2000-2006 47
Table 4.7: India's Pharmaceutical Exports, 1999-2006 47
Table 4.8: India's Pharmaceutical Exports to Top-15 Countries, 2003-2005 48
Table 4.9: Indian Pharmaceutical Exports by Commodity, 2002-2006 48
Table 4.10: Top 20 Suppliers for UNICEF 49
Table 4.11: Bulk Drug and Formulations 49
Table 4.12: Global Pharmaceuticals Market Segmentation, 2006 51
Table 4.13: Global Pharmaceuticals Market Value, 2002-2006 52
Table 4.14: Global Pharmaceuticals Market Value Forecast, 2006-2011 52
Table 4.15: Leading Therapeutic Segments 53
Table 4.16: Market Share of Major Therapeutic Segments 54
Table 4.17: Leading Brands in Each Category 54
Table 4.18: Market Growth Rates, 2003 and 2004 54
Table 4.19: Marketing Tie-ups 55
Table 5.1: Key Players and Their Characteristics 56
Table 5.2: Major Players in Terms of Market Capitalization, 2005 56
Table 5.3: India's Top Seven Drug Companies in 2008 57
Table 5.4: Likely Winners Among Contract Research Vendors in India 58
Table 5.5: Selected CRAMS Products and Deals in India 58
Table 5.6: "Advantage India" in Outsourcing 59
Table 5.7: Pre-Clinical and Clinical Development in India 59
Table 5.8: Clinical Trial Approval Time in India 60
Table 5.9: Number of R&D Vendors in Bangalore, Mumbai and Hyderabad 60
Table 5.10: CRO Landscape in India 60
Table 5.11: International Quality Standards in Indian CROs 61
Table 5.12: Multimillion Dollar R&D Deals with Multiple Vendors 61
Table 5.13: U.S. FDA-Approved Facilities in Countries Outside the U.S. 62
Table 5.14: Pfizer India-Capacity Data 65
Table 5.15: Pfizer India-Raw Materials Data 65
Table 5.16: Top 15 Products of Pfizer India, 2007 66
Table 5.17: The Composition of Aventis' R&D Portfolio 68
Table 5.18: Excerpt of Novartis Pharma's Clinical Pipeline, 2007 70
Table 5.19: Novartis India Capacity Data 71
Table 5.20: Novartis India Raw Material Data 71
Table 5.21: List of Subsidiaries and Joint Ventures of Ranbaxy Laboratories 72
Table 5.22: Ranbaxy's Key Financials, 2005-2007 73
Table 5.23: Ranbaxy Price History, 2005 73
Table 5.24: Ranbaxy Interim History 74
Table 5.25: Ranbaxy-Capacity Data 74
Table 5.26: Ranbaxy-Raw Materials Data 74
Table 5.27: Ranbaxy's Foreign Acquisitions 75
Table 5.28: Dr. Reddy's Labs Capacity Data 76
Table 5.29: Dr. Reddy's Labs Raw Materials Data 76
Table 5.30: Cipla-Capacity Data 77
Table 5.31: Cipla-Raw Materials Data 77
Table 5.32: List of Subsidiaries of Sun Pharma 78
Table 5.33: New Products from Sun Pharma 79
Table 5.34: Sun Pharma-API Products List 80
Table 5.35: Sun Pharma-Raw Materials Data 80
Table 5.36: Abbott India Ltd. (Knol)-Capacity Data 81
Table 5.37: Abbott India Ltd. (Knol)-Raw Materials Data 81
Table 5.38: The Acquisition History of Wockhardt 82
Table 5.39: Wockhardt's 15 Years of Transformation 82
Table 5.40: Wockhardt's Performance Snapshot-CAGR (Last 15 Years) 83
Table 5.41: Wockhardt's Comprehensive Manufacturing Capabilities 83
Table 5.42: Wockhardt's R&D Activity 83
Table 5.43: Wockhardt's Focus on Major Therapeutic Areas, 2006 83
Table 5.44: Wockhardt's Strengths and Weaknesses 83
Table 5.45: Wockhardt's Business Highlights 84
Table 5.46: Wockhardt's R&D Activity 84
Table 5.47: Wockhardt's Ramp-up in U.S. 84
Table 5.48: Wockhardt-Capacity Data 84
Table 5.49: Wockhardt-Raw Material Data 85
Table 5.50: List of Subsidiaries of Wockhardt Ltd. 85
Table 5.51: Nicholas Piramal's Foreign and Domestic Acquisitions 86
Table 5.52: Nicholas Piramal's CRAMS Pipeline, 2008 86
Table 5.53: Highlights of Lupin Pharmaceutical 87
Table 5.54: Lupin's Globally Accredited Facilities 87
Table 5.55: Lupin's U.S./E.U. Product Development 87
Table 5.56: Top-Ten Brands of Alembic in the Domestic Market 88
Table 5.57: Industry Ranking of Alembic Products 88
Table 5.58: The Ten-Crore Plus Brands of Alembic 89
Table 5.59: High Growth Brands of Alembic 89
Table 5.60: Key Markets of Alembic, 2008 89
Table 5.61: Alembic's New Product Launches, 2005-2006 89
Table 5.62: New APIs Under Development in Alembic 90
Table 5.63: Ajanta Pharma's Performance Highlights 90
Table 5.64: Strides Arcolab's Expenditure on R&D, 2005 and 2006 91
Table 5.65: Strides Arcolab's Subsidiaries and Joint Ventures 92
Table 6.1: India's Pharmaceutical Firms by Size, Sales, Function, Exports and R&D Capabilities 95
Table 7.1: Government Run Research Organizations and Industry Collaborations 96
Table 7.2: Number of Brand Acquisitions 99
Table 7.3: India's Pharmaceutical R&D Expenditures, 2000-2006 100
Table 7.4: R&D Spending by Selected Indian Pharmaceutical Firms 100
Table 9.1: Indian Patent Regime in Place 106
Table 9.2: India's Pharmaceutical R&D Expenditures, 2000-2006 109
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 112
Table 11.1: List of Drugs Approved During 1999 to 2004 114
Table 11.2: New Drugs Approved from August 2004 to February 2005 118
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 120
Table 11.4: Other Drugs Prohibited for Manufacture, Sale and Distribution 121
Table 16.1: Projected Growth of Indian Clinical Research Industry, 2010 127
Table 19.1: Chemical and Allied Industries 140
Table 20.1: Ranbaxy's IT Initiatives 145
Table 21.1: Typical Price Drops after a Drug Goes Off Patent 148
Table 22.1: Some of the Select Contract Manufacturing Deals in India 151
Table A7.1: Animal Toxicity Requirements for Clinical Trials and Marketing of a New Drug 174
Table A7.2: Local Toxicity Studies 175
Table A7.3: Special Toxicity Studies 175
Table A7.4: Number of Animals Required for Repeated-Dose Toxicity Studies 175
Table A7.5: Laboratory Parameters to be Included in Toxicity Studies 176
Table A7.6: Urinalysis Parameters 176
Table A7.7: Blood Biochemical Parameters 176
Table A7.8: Gross and Microscopic Pathology 176
Table A10.1: Informed Consent Form to Participate in a Clinical Trial 183
Table A15.1: Study Conditions for Drug Substances and Formulations Intended to be Stored under General Conditions 190
Table A15.2: Study Conditions for Drug Substances and Formulations Intended to be Stored in a Refrigerator 190
Table A15.3: Study Conditions for Drug Substances and Formulations Intended for Storage 190
Table A17.1: Contact Information-Major Indian Pharma Industries 195
Table A17.2: Contact Information-Pharmaceutical Research 201
Table A17.3: Contact Information-Biotechnology, Bioinformatics, Clinical Trials 202

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