Indian pharmaceutical industry

Indian Pharmaceutical Industry The purpose of this 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 For more information, please visit :http://www.aarkstore.com/reports/Indian- Pharmaceutical-Industry-1321.html Contact :Sanaa Aarkstore Enterprise Tel : +912227453309 Mobile No: +919272852585 Email : contact@aarkstore.com

Indian pharmaceutical industry

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