Aquaculture Industry Analysis and Market Attractiveness of Fish Vaccines in India By Mahendra Kumar Pallapothu University of Prince Edward Island EMBA Signature Project Report Submitted to The University of Prince Edward Island, Charlottetown, Prince Edward Island In Partial Fulfillment of the Requirements for the Executive Masters in Business Administration June 30, 2012 Charlottetown, Prince Edward Island © Mahendra Kumar Pallapothu Advisor: Juergen Krause, Ph.D. Director, UPEI Centre for Health & Biotech Management Research Associate Professor, Biotech Management School of Business Preferred Citation Format: Pallapothu, M. K. (2012). Aquaculture industry analysis and market attractiveness of fish vaccines in India. (Unpublished EMBA Signature Project Report). University of Prince Edward Island, Canada. Retrieved from http://www.islandscholar.ca/download_ds/ir:4141/PDF PERMISSION TO USE SIGNATURE PROJECT REPORT Title of Signature Project: Aquaculture Industry Analysis and Market Attractiveness of Fish Vaccines in India Name of Author: Mahendra Kumar Pallapothu Department: School of Business Degree: Master of Business Administration Year: 2012 Name of Supervisor(s): Juergen Krause, Ph.D. In presenting this signature project report in partial fulfilment of the requirements for a Master of Business Administration degree from the University of Prince Edward Island, the author has agreed that the Robertson Library, University of Prince Edward Island, may make this signature project freely available for inspection and gives permission to add an electronic version of the signature project to the Digital Repository at the University of Prince Edward Island. Moreover the author further agrees that permission for extensive copying of this signature project report for scholarly (cid:393)(cid:437)(cid:396)(cid:393)(cid:381)(cid:400)(cid:286)(cid:400) (cid:373)(cid:258)(cid:455) (cid:271)(cid:286) (cid:336)(cid:396)(cid:258)(cid:374)(cid:410)(cid:286)(cid:282) (cid:271)(cid:455) (cid:410)(cid:346)(cid:286) (cid:393)(cid:396)(cid:381)(cid:296)(cid:286)(cid:400)(cid:400)(cid:381)(cid:396) (cid:381)(cid:396) (cid:393)(cid:396)(cid:381)(cid:296)(cid:286)(cid:400)(cid:400)(cid:381)(cid:396)(cid:400) (cid:449)(cid:346)(cid:381) (cid:400)(cid:437)(cid:393)(cid:286)(cid:396)(cid:448)(cid:349)(cid:400)(cid:286)(cid:282) (cid:410)(cid:346)(cid:286) (cid:258)(cid:437)(cid:410)(cid:346)(cid:381)(cid:396)(cid:859)(cid:400) (cid:393)(cid:396)(cid:381)ject work, or, in their absence, by the Dean of the School of Business. It is understood that any copying or publication or use of this signature project report or parts thereof for financial gain shall not be (cid:258)(cid:367)(cid:367)(cid:381)(cid:449)(cid:286)(cid:282) (cid:449)(cid:349)(cid:410)(cid:346)(cid:381)(cid:437)(cid:410) (cid:410)(cid:346)(cid:286) (cid:258)(cid:437)(cid:410)(cid:346)(cid:381)(cid:396)(cid:859)(cid:400) (cid:449)(cid:396)(cid:349)(cid:410)(cid:410)(cid:286)(cid:374) (cid:393)(cid:286)(cid:396)(cid:373)(cid:349)(cid:400)(cid:400)(cid:349)(cid:381)n. It is also understood that due recognition shall be given to the author and to the University of Prince Edward Island in any scholarly use which may be (cid:373)(cid:258)(cid:282)(cid:286) (cid:381)(cid:296) (cid:258)(cid:374)(cid:455) (cid:373)(cid:258)(cid:410)(cid:286)(cid:396)(cid:349)(cid:258)(cid:367) (cid:349)(cid:374) (cid:410)(cid:346)(cid:286) (cid:258)(cid:437)(cid:410)(cid:346)(cid:381)(cid:396)(cid:859)(cid:400) (cid:396)(cid:286)(cid:393)(cid:381)(cid:396)(cid:410)(cid:856) Address: UPEI School of Business 550 University Avenue Charlottetown, PE C1A 4P3 Mahendra Kumar Pallapothu Page 2 of 120 Table of Contents Acknowledgements ......................................................................................................................... 6 List of Abbreviations ....................................................................................................................... 7 Executive Summary ....................................................................................................................... 11 Introduction .................................................................................................................................. 15 The Global Aquaculture Segment ............................................................................................. 15 The Indian Aquaculture Segment ............................................................................................. 16 Aims and Objectives ...................................................................................................................... 19 Literature Review .......................................................................................................................... 20 Macro-Environment Factors ..................................................................................................... 20 Methodology ................................................................................................................................. 20 Analysis ......................................................................................................................................... 21 Competition in Fish Vaccines Segment in India ............................................................................ 21 The Political Landscape in India .................................................................................................... 22 Political Structure and System .................................................................................................. 22 The State of Politics in India ...................................................................................................... 23 Governance in India .................................................................................................................. 23 Important Policies in India ........................................................................................................ 24 Regional Disparities................................................................................................................... 25 Economic Landscape ..................................................................................................................... 26 Economic and Tax Reforms ....................................................................................................... 26 I(cid:374)(cid:282)(cid:349)(cid:258)(cid:859)(cid:400) Financial and Capital markets ....................................................................................... 28 International Trade and Relations of India ............................................................................... 29 Biotechnology Sector Performance in India ............................................................................. 30 I(cid:374)(cid:282)(cid:349)(cid:258)(cid:859)(cid:400) F(cid:349)(cid:400)(cid:346)(cid:286)(cid:396)(cid:349)(cid:286)(cid:400) “(cid:286)(cid:272)(cid:410)(cid:381)(cid:396) P(cid:286)(cid:396)(cid:296)(cid:381)(cid:396)(cid:373)(cid:258)(cid:374)(cid:272)(cid:286) ....................................................................................... 31 Overall Economic Performance in India ................................................................................... 32 Environmental Landscape ............................................................................................................. 33 Environmental Framework, Policies and Schemes of India ...................................................... 33 Sector Specific Policies .............................................................................................................. 34 International Treaties on Environmental Change Ratified by India ......................................... 35 Environmental Impacts ............................................................................................................. 35 Policy Implementation and Performance ................................................................................. 40 Socio-cultural Factors ................................................................................................................... 42 Mahendra Kumar Pallapothu Page 3 of 120 The Social Structure in India ..................................................................................................... 42 Social Welfare Policy and Programs in India ............................................................................ 43 Social Security Programs in India .............................................................................................. 43 Skills, Literacy Rates, Education, and Training the of Indian Population .................................. 45 The Healthcare and Nutrition Programs in India ...................................................................... 46 Census and Demographics of India ........................................................................................... 47 Socio-Economic Status in India ................................................................................................. 48 The National and Organizational Culture of India .................................................................... 49 Technological Factors in India ....................................................................................................... 53 I(cid:374)(cid:282)(cid:349)(cid:258)(cid:859)(cid:400) K(cid:374)(cid:381)(cid:449)(cid:367)(cid:286)(cid:282)(cid:336)(cid:286) B(cid:258)(cid:400)(cid:286) (cid:258)(cid:374)(cid:282) H(cid:437)(cid:373)(cid:258)(cid:374) C(cid:258)(cid:393)(cid:349)(cid:410)(cid:258)(cid:367)............................................................................. 53 The Policy Framework and Programs ....................................................................................... 54 The Institutional Infrastructure in India .................................................................................... 57 Business Models and Technologies in the Indian Agriculture, Food and Health Sectors ........ 58 R&D Expenditure in India .......................................................................................................... 62 Cost Advantages in India ........................................................................................................... 63 The Indian Innovation Capacity (Publications, Patents and Accomplishments) ...................... 63 The Legal Environment in India .................................................................................................... 66 The Legal Structure and Framework in India ............................................................................ 66 The Industrial Acts, Legislation, Taxation, and Regulations of Business Concern in India ....... 66 Establishing a Business in India ................................................................................................. 68 Intellectual Property Rights in India ......................................................................................... 69 The Indian Biotechnology and Fisheries Regulations ............................................................... 69 The Effectiveness of the Indian Legal System ........................................................................... 72 Limitations of the Research .......................................................................................................... 75 Discussion...................................................................................................................................... 76 Competitor Analysis .................................................................................................................. 77 The Political Landscape ............................................................................................................. 77 The Indian Economy .................................................................................................................. 77 Environmental Aspects ............................................................................................................. 78 Socio-cultural Aspects ............................................................................................................... 80 Technological Aspects ............................................................................................................... 82 The Legal Landscape ................................................................................................................. 83 Conclusion ..................................................................................................................................... 86 Mahendra Kumar Pallapothu Page 4 of 120 Tables ............................................................................................................................................ 89 Figures ........................................................................................................................................... 98 References .................................................................................................................................. 107 Mahendra Kumar Pallapothu Page 5 of 120 Acknowledgements I dedicate this work to my wife, Pushpa and my daughters, Sushmitha and Sonya who have supported me all along in completing this journey of accomplishing the Executive Masters of Business Administration (EMBA) degree. Without their support I could have not been able to attain this goal. I take the opportunity to thank few important people whom I worked with during the course of completing my EMBA Degree at the University of Prince Edward Island (UPEI). First, my supervisor and mentor Dr. Juergen Krause for all his support, guidance and scholarship. His expertise in the field of biotechnology, sound advice and encouragement motivated me to complete this Signature Project report, for which, I am very grateful to him. I would like to thank the faculty of the EMBA program. I appreciate the opportunity to have experienced a rich learning environment and self-development which they provide. I would also extend my acknowledgement to the EMBA program co-coordinator, Ms. Grace McCourt and EMBA administrative assistant, Ms. Angie MacDonald for their excellent and timely support on various administrative aspects. I am indebted to many of my fellow classmates and cohorts for their insightful and enriched discussions in the classroom sessions. I would also extend my gratitude to my group mates: Jamie Whynacht, Jodi Murphy, Liz Sajdak, and Marla Haines; Bus720 team: ToyIn Ojo, Omar Hashem, and Jeremy Moore; Bus701: Beth Pearce, John Davidson, and Gregg McCardle; Bus702 team: Edward Cross and Kent Nicholson for their dedication, hard work and contributions in the group assignments. You made the EMBA experience memorable, challenging and gratifying, and for that, I consider you all the greatest of friends. Mahendra Kumar Pallapothu Page 6 of 120 List of Abbreviations AP Andhra Pradesh APHIS Animal and Plant Health Inspection Service BB Bharat Biotech Ltd BC Backward Caste BFDI Biotechnology Foreign Direct Investment BI Biocon India Ltd BIPP The Biotechnology Industry Partnership Program BIRAC Biotechnology Industry Research Association Council BTIC Biotechnology Incubation Center cGMP current Good Manufacturing Practices CAA Coastal Aquaculture Authority CAC Command and Control CAGR Cumulative Annual Growth Rate CCMB Centre for Cellular and Molecular Biology CDSCO Central Drugs Standard Control organization CEP Central Energy Planning CFR Code of Federal Regulations CIBA Central Institute of Brackish Water Aquaculture CIFE Central Institute of Fisheries Education CIFT Central Institute of Fisheries Technology CMFRI Central Marine Fisheries Research Institute CO2 Carbon Dioxide CSIR Council of Scientific and Industrial Research CSO Central Statistics Organization of India CPCB Central Pollution Control Board CTD Common Technical Document DAHDF Department of Animal Husbandry, Dairying and Fisheries DBT Department of Biotechnology DCG(I) Drug Controller General (India) DLC District Level Committee DSIR Department of Scientific and Industrial Research DST Department of Science and Technology EBSCO Elton B. Stephens Company EA Environmental Auditing EI Education index EIA Environmental Impact Assessment EMA European Medicines Agency EPA Environment (Protection) Act EPF Employee Provident Fund EPFO E(cid:373)(cid:393)(cid:367)(cid:381)(cid:455)(cid:286)(cid:286)(cid:400)(cid:859) P(cid:396)(cid:381)(cid:448)(cid:349)(cid:282)(cid:286)(cid:374)(cid:410) F(cid:437)(cid:374)(cid:282) O(cid:396)(cid:336)(cid:258)(cid:374)(cid:349)(cid:460)(cid:258)(cid:410)(cid:349)(cid:381)(cid:374) EPI Environmental Performance Index EPS Employee Pension Scheme ETO World Trade Organization EYEI Energy-GDP-Emissions Index Mahendra Kumar Pallapothu Page 7 of 120 FAD Fisheries and Aquaculture Department FAO Food and Agriculture Organization FFDA Fish Farmers Development Agencies FY Fiscal Year GCI Global Competitive Index GDP Gross Domestic Product GDPI Gross Domestic Product Index GEAC Genetic Engineering Approval Council GH Growth Hormone GHG Green House Gasses GIS Geographical Information System GMO Genetically Modified Organism GNI Gross National Income GNP Gross National Product GOI Government of India GST Goods and Services Tax FDI Foreign Direct Investment FDA Food and Drug Administration NACA Network of Aquaculture Centers in Asia-Pacific NIF National Innovation Fund NOC No Objection Certificate HACCP Hazard analysis and critical control point HDI Human Development Index IBSC Institutional Biosafety Committee ICAR Indian Council of Agricultural Research ICH International Conference on Harmonization ICICI Industrial Credit and Investment Corporation of India IDV Individualism IICT Indian Institute of Chemical Technology IISC Indian Institute of Science IIT Indian Institute of Technology IMNC Indian Multi National Company IMF International Monitory Fund INR Indian Rupee IP Intellectual Property IPC Indian Pharmacopoeia Commission IPO Indian Patent Office IPR Intellectual Property Rights JFM Joint Forest Management Kgoe Kilograms of Oil Equivalent KHV Koi Herpes Virus LEI Life Expectancy Index LMO Live Modified Organism LTO Long Term Orientation mAB Monoclonal Antibody M&A Mergers and Acquisitions Mahendra Kumar Pallapothu Page 8 of 120 MAS Masculinity MDR Multi Drug Resistance MNC Multi National Company MNREG Mahatma Gandhi National Rural Employment Guarantee MoA Ministry of Agriculture MoEF Ministry of Environment and Forests MoST Ministry of Science and Technology MPEDA Marine Products Export Development Authority MRL Maximum Residue Limits NBFGR National Bureau of Fish Genetic Resources NEP National Environmental Policy NFDB National Fisheries Development Board NGO Non-Governmental Organization NIF National innovation Foundation PACE Partnership to Advance Clean Energy PB Panacea Biotech PBPG Pre-Biotechnology Process Generator PCI Planning Commission of India PDI Power Distance Index Ph. Eur. European Pharmacopeia PIL Public Interest Litigation PPP Purchase Power Parity R&D Research and Development RBI Reserve bank of India RCGM Review Committee on Genetic Manipulation RDAC Recombinant DNA Advisory Committee r-DNA Recombinant Deoxyribo Nucleic Acid SB Shanta Biotechnics Ltd SBCC State Biosafety Coordination Committee SBIRI Small Business Innovation Research Initiative S&P Standard and Poor S&T Science and Technology SC Scheduled Caste SEBI Securities and Exchange Board of India SEZ Special economic zones SH&E Safety Health and Environment SII Serum Institute of India Ltd SLC State Level Committees SPC Summary of Product Characteristics SPCB State Pollution Control Board SPS Sanitary and Phytosanitary ST Scheduled Tribe TRIPS Trade Related Aspects of Intellectual Property Rights UAI Uncertainty Avoidance Index UNCTAD United Nations Conference on Trade and Development UNFCCC UN Framework Convention on Climate Change Mahendra Kumar Pallapothu Page 9 of 120 UNICEF United Nations International Children's Emergency Fund UPA United Progressive Alliance USD United States Dollar USDA United States Department of Agriculture USPTO United States Patent and Trademark Office USTR United States Trade Representative VAT Value Added Tax VICH Veterinary division of ICH WB West Bengal WHO World Health Organization WIPO World Intellectual Property Organization Mahendra Kumar Pallapothu Page 10 of 120
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