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

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 (Unpublished EMBA Signature Project Report).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 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 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

Address: UPEI School of Business 550 University Avenue Charlottetown, PE C1A 4P3

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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 Financial and Capital markets ...... 28 International Trade and Relations of India ...... 29 Biotechnology Sector Performance in India ...... 30 I F “ P ...... 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

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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 K B H C...... 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

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Tables ...... 89 Figures ...... 98 References ...... 107

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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.

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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 P F O EPI Environmental Performance Index EPS Employee Pension Scheme ETO World Trade Organization EYEI Energy-GDP-Emissions Index

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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

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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

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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

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Executive Summary

Globally, aquaculture continues to be the fastest-growing animal-derived food producing sector. It has an average annual growth rate of 8.2% between 2004 and 2009 and is expected to outpace the capture fisheries and the demand increase for fish by the human population growth. The sector is comprised of 336 species: Carp dominates the aquaculture segment in the Asia/Pacific regions while Salmonids dominates in Europe, North and South America. China is the world leader in fish production while the developing countries together contributed greater than 90% of food fish to the world. From 2004 to 2009, an increase of 38% and 53% were reported for freshwater and marine fish production respectively. Therapeutic agents and drugs are being used in disease management of farmed fish and vaccines have gained prominence as an eco-friendly alternative. The target country in this research is India where inland aquaculture production has increased substantially between 2000 and 2010 from 1.55 million tons to 3.72 million tons and is forecasted to reach between 8-10 million tons by 2020. It is also expected that a 45% and 50% increase in horizontal (expansion by land area for aquaculture) and vertical (productivity per farm site) expansion is possible to meet the demand of 8-10 million tons by 2020. Two states, namely Andhra Pradesh (AP) and West Bengal (WB), are the leaders in inland aquaculture although their average yields were still only 60-80%. Some of the reasons for the lack of success in curbing economic losses and increasing fish productivity per hectare were attributed to disease outbreaks and the lack of commercial vaccine providers in India. In order to realize the potential of increasing the profits and productivity, scholars have suggested the use of vaccines to increase the sustainability of the Indian aquaculture segment.

Aims and Objectives The aims of this research paper are a strategic analysis of the aquaculture industry and an evaluation of the attractiveness of aqua biologics with specific focus on vaccines for warm water fish species in the Indian market. Since vaccines have already proven their potential in the context of carp research in India and in western markets, the author assumes enormous commercial opportunity for fish vaccines in India. CPESTEL analysis was used to conduct exploratory research in understanding the macro business-environment factors in India that may help the new entrant to choose appropriate strategies to start a business. Evidence was gathered from academic and anecdotal sources and the report was synthesized under various headings of CPESTEL.

Competitor Analysis Competitor analysis revealed that the most likely competition for the new entrant may arise from the substitute manufacturers who are currently providing therapeutic agents for aquaculture use. As a result, aggressive competition tactics such as price reduction for substitutes may occur. The local or multinational firms that have animal health divisions are also likely to enter into this business.

Political Landscape India is the The political landscape in India is supportive for a knowledge-based economy reflected by the economic policy changes in 1991 and the introduction of the National Biotechnology Development Strategy in 2008. As a result, tariffs on imports were slashed from 90% to 30% in 1997 and many restrictions and licensing requirements (e.g. notification of producers to the government on any change in their production and employment) were abolished. The leftist ideology of economic nationalism such as the Swadeshi (nationalist) agenda, and India to be built by Indians could be leveraged by a new entrant either by tying a relationship as joint venture with a local company or operating as a wholly owned subsidiary thereof. Transaction costs for a business are expected to be high until the Jan Lokpal (anti-corruption) Bill is approved by the Indian parliament. Enforcement of property rights is bipolar among states, for example, AP state demonstrated more relaxed implementation of property rights, while the WB state was strict in enforcing the same. Political instability in AP due to Telangana Separatist Movement for an independent statehood, in spite of its attractive property rights, will be of concern for a new entrant when

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deciding the location for business to be established. To realize the benefits, a new entrant will require patience as the reforms and policy changes to ensure policy continuity and institutional stability in India take time even as the governments change.

Indian Economy The Indian economy is factor-driven such as, dependency on unskilled labor, natural resources, while selling basic commodities and competing on low prices. But the economic reforms of 1991 have accelerated the economic growth in India making it one of fastest growing economies in the region. These reforms have attracted foreign investments and stimulated information and communications technology as well as biotechnology industries. The GDP growth rate reached 8.0% for 2011/2012 and is expected to remain at this level through to 2025. Improvements to (the poor) infrastructure, with investments totalling USD 500 billion, coupled with the anti-corruption bill (if passed) should attract more foreign investments into the country. I ‘BI monetary policy by increasing the interest rates which is expected to reduce the inflation rate to 4% by 2016. The fiscal deficit in 2010 was 6.4% but India became a creditor to IMF in 2002. The debt-to-GDP ratio stood at 69.2% in 2011 indicating a high risk for investments and high borrowing costs. India is recognized for its mature financial and capital markets including strong regulatory frameworks to control these markets. The household savings rate is fairly high, standing at 25% of its GDP and discretionary spending in total consumption expenditure per household grew at a rate of 16% in 2010. To increase the momentum of exports, the government has developed a policy framework, signed international trade agreements, created incentives for sectors such as biotechnology and fisheries that are engaged in foreign trade. Incentives from the central and state governments may include, but are not limited to, relaxed price controls on drugs, subsidies, tax credits on R&D spending, cuts on tariffs etc. United Nations Conference on Trade and Development and Ernst & Young ranked India as the second and fifth most preferred global Foreign Direct Investment (FDI) destination respectively over the next three years while the biotechnology sector was ranked the third FDI destination in Asia-Pacific region.

Environment Aspects The environmental policy framework is still symbolic and enforcement is fragmented due to a crossover of responsibilities between various agencies and the lack of adequate resources. Air and water T B ‘ I methods rather than sustainability reflected by the lack of formal training in aquaculture methods. Minimum National Discharge Standards for effluents are set by Central Pollution Control Board (CPCB), which are technically feasible to abate pollution, but are found economically unrealistic. CPCB has categorized bio/pharmaceutical companies in the . The aquaculture segment was also on the radar for the abuse of drugs and discharge of effluents containing particulates and heavy metals into water bodies. Although maximum residue limits have been defined to mitigate the risks of transferring the MDR to human consumers, enforcement remains inadequate. The implementation of policies are improving but at a very slow pace.

Socio-cultural Aspects India is a secular country and the societal structure is archaic, built on the caste system. Frequent cataclysms due to the implementation of the affirmation policy for the oppressed groups have negative impacts on the economic freedom, capitalism and growth of the country. Gender bias and social stratification were also observed as issues. Social security programs are weak and the universal healthcare system is virtually nonexistent. The estimated literacy rate in 2011 stood at 74.04% with a wide gap between male and female literacy rates. It is projected that 20% of Indians speak English. Child labor is still a common practice in the industry especially in the fisheries and aquaculture segments. India is second to China in population size with an estimated 1.34 billion people in 2011 and the population rising at a rate of 1.344% per year. It was predicted that fish consumption in developing countries will reach a total of 98.6 million tons by 2020, which constitutes an increase of 57% compared to figures from 1997. F and is a cheaper alternative compared to meat from poultry, pork and beef for the poor in rural and urban areas. In India, the per capita annual consumption of fish was projected to reach 15 kg by 2030 up from 6.08 kg in 2010 due to rising disposable income and the current income elasticity of demand of 1.66 for fish and

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fish products (Income Elasticity of Demand is a measure of the rate of response of quantity demand due to increase (or decrease) in a consumers income). Cultural literacy is invaluable if the new entrant is a non-Indian. The Indian national culture may be characterized as a collectivist mind-set, hierarchy-oriented, ready to accept inequality of power distribution, male dominated, long-term oriented and willing to deal with ambiguity. Brassach suggested a package of Adaptation (authoritativeness, emotionality and empathy) and Leadership (results-oriented) would yield results in India when applied together. At the organization level managers are found to demonstrate individualism, both masculine (being very assertive and competitive) and feminine values (being modest and caring), flexibility to work in all kinds of efficiency- and result-oriented environments, just like Western managers (if his/her cultural-needs of modesty ). Generational differences were observed with the younger generation being more adaptive to the western working style.

Technological Aspects The technology management strategy in India is one in which the latest technologies benefit the . Such a strategy identifies the needs for change: the need to create innovation in technology and business models, and to forge public-private partnerships. The science and technology policy was proposed in 2003 and the 11th five year plan (2007-2011) prioritized R&D to achieve its policy objectives. The institutional infrastructure is well established with networks of microbial and animal cell culture repositories, bioinformatics centers, bioparks, incubators, and national research institutes etc. Institutions, initiatives and approaches such as SBIRI, NIF, Welcome Trust Fellowships, Re-entry Fellowship etc have been created to encourage innovation. Academia and small-to-medium sized enterprise interactions are enabled by schemes such as Ignition grants and The Biotechnology Industry Partnership Program. Sector specific bioparks and clusters such as a Marine Park and Veterinary Park are being built in Karnataka state to support the fishery sector. Various business models such as platform, product, vertical and hybrid approaches are evolving in the I ‘D the 11th five year plan to 2% of its Gross Domestic Product (GDP) (USD 17.93 billion) in the current 12th five year plan. As part of the plan, in the 2012-2013 budget, the Indian Government has allocated USD 493.72, 401.28, 295.99 million for S&T, scientific and industrial research and biotechnology respectively. Several state governments have also created incentives such as tax holidays for R&D spending and subsidies on capital investments to name a few. When innovation capacity is measured by the number of patents and peer reviewed papers in scientific journals, India has improved significantly. India received 10% more patents in 2011 compared to 2000 from the US-PTO and moved from the 12th position in 2007 to the 11th position in 2011 in terms of volume of peer reviewed publications in international journals. New technologies and innovative business models are emerging in the private sector. For example, Karuturi Global, KPIT Cummins Infosystems and the Serum Institute of India, and Attero Recycling have all earned global recognition.

Legal Landscape In India, the parliament makes the laws for the country. The legal and regulatory systems in India are comprehensive but ineffective due to insufficient resources. To ease the process of opening a business in India, several tax reforms were introduced. For example, Value Added Tax (VAT) system was rolled out in 2005, Goods and Services Tax (GST) (pending approval in the Indian parliament), fringe benefit tax (for example: cash allowances for employee transportation to work, entertainment, travel, employee welfare and accommodation) was abolished in 2009 and the online tax payment process was implemented in 2008 to attract FDI into the country. In summary, domestic corporations are now subject to tax at a basic rate of 35% plus a 2.5% surcharge. Foreign corporations pay a basic tax rate of 40%, 2.5% surcharge, and education tax at a rate of 2% on the tax payable. The corporate sector is also subject to a wealth tax at a rate of 1%, if net wealth exceeds USD 33,000. Tax is also payable on capital gains on the sale of assets. The western doctrine of hire and fire does not exist in India and permanent employment of an associate can only be terminated on the grounds of misconduct, or for habitual absence due to ill health, alcoholism, and the like with the provision of appropriate evidence, or upon reaching retirement age. Setting up a business in India requires about 24 approvals from various central, state and local levels of governments. Intellectual Property Rights (IPR) enforcement in India is weak. Today, in India, it takes about

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four years to grant a patent and costs about USD 2,000. The regulatory system for biologics and biotechnology-derived products is considered fragmented as it involves various committees under Central Drugs Standard Control organization (CDSCO). The vaccines fall into a CDSCO guidelines. The entire review process to obtain marketing authorization would take between 6 months to more than two years as a does not exist. Companies in this sector are using guidelines issued by World Health organization (WHO), International Conference on Harmonization (ICH) and the Department of Biotechnology (DBT), India, for product development and registration and the facility licenses, audits and inspections come under the purview of respective State Drug Regulatory Authorities (DRAs).

Implications of the Research Project The implications of this research lie in the value to the investors, new entrants and small and medium enterprises in understanding the CPESTEL factors of India and its biotechnology and aquaculture industries which may enable some entrepreneurs or company managements to choose an appropriate strategy to start a business for fish vaccines in India.

Conclusion Judging by the cover page of the book on I . Yet a review of CPESTEL reveals that the business proposition is also interesting with its major incremental if not radical developments. Naturally changes take time in a country with diverse cultural and ethnic groups which are divided by geopolitical and social ideologies, but progress in the right direction is still occurring albeit at a slower pace. Based on the evidence from this research it is concluded that the attractiveness of a business opportunity for fish vaccines in India is increasing at a rapid pace. CPESTEL analysis revealed that the overall business atmosphere is encouraging and conducive for establishing a potential new company with the exception of some of the bureaucratic processes being tedious. Therefore, a new entrant is expected to succeed in the Indian business landscape if the company can leverage some of the programs and benefits offered by various levels of governments.

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Aquaculture Industry Analysis and Market Attractiveness of Fish Vaccines in India

Introduction

The Food and Agriculture Organization (FAO) of the United Nations (FAO) defines aquaculture as the farming of aquatic organisms, which implies some form of intervention (such as regular stocking, feeding, protection from predators), in the rearing process to enhance production, plus individual or corporate ownership of the stock being reared (FAO, p. 1). Others have defined it as the cultivation of aquatic animals such as finfish, shellfish, and aquatic plants for recreational or commercial purposes, while marine aquaculture is called mariculture (Thieman & Palladino, 2008). Aquaculture is an ancient tradition in Asia and it was estimated that culturing of Chinese carps began at least 2,500 years ago (Shariff, 1998), while aquaculture in India dates back to 321-300 B.C and is confirmed by references to fish culture in Kautilya's Arthashastra and King Someswara's Manasoltara (1127 A.D.). The traditional practice of fish culture in small ponds in eastern India is known to have existed for hundreds of years (FAO-Statistics, 2010). Oceans have been the source of aquatic animals for food for millennia. However, the significant growth of the global human population has also led to an increased demand for food fish and other marine animals, thus resulting in overharvesting of fish in the wild and even the collapse of some fisheries (Thieman & Palladino, 2008). Therefore, the analysis of the aquaculture industry and subsequently the strategic attractiveness of the aqua biologics with specific focus on fish vaccines for warm water fish species are the aims of this research paper.

The Global Aquaculture Segment

Aquaculture continues to be the fastest animal-derived food producing sector in the world and is expected to outpace the capture fisheries and meet the increased demand for fish resulting from the human population growth. It is estimated that an additional 40 million tons of food from aquatic sources will be required by 2030 to maintain the current per capita consumption. Of the 59.4 million tons of production in 2004, 70% was contributed by China and 22% by the rest of Asia and in the Pacific region and the remaining 8% was produced by the rest of the world. Data from FAO reports suggest that the fish production (fresh water and marine) from the aquaculture segment has grown at an average annual growth rate of 8.2% between 2000 and 2009. A total of 336 species were cultured in 2004 of which cyprinids (carps) dominated the commercial production species in Asia and Pacific region while Salmonids dominated in Europe, North and South America (FAO, 2012). For freshwater fish species, 22.2 million tons were produced in aquaculture in 2004 which increased by 38% according to reports in 2009. Similarly a 53% increase in marine fish production to 1.95 million tons was recorded during the same time period. Carp, barbell and other cyprinids were the dominant species cultured in fresh water while salmon, trout and smelt dominated in the marine fish category (Ayyappan & Gopalakirshnan, 2008; FAO Year Book, 2009). A surge in export from developing Asian countries in recent times was driven in part by agreements such as the Generalized System of Preferences and International Trade Liberalization which has lowered tariff and non-tariff barriers. Future fish exports will depend mainly on supply constraints and compliance with food safety standards in the form of sanitary and phytosanitary (SPS) measures as well as other standards defined under the Technical Barriers to the Trade Agreement. SPS implementation for fisheries products has largely shifted from product inspection to hazard analysis and critical control point (HACCP) certification of harvest, postharvest, and processing standards which are expected to further add to this export surge (Issues Brief, 2008).

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One of the major limitations in increasing the global aquaculture production is the loss caused by disease (Abraham, Sil, & Vineetha, 2010; Ayyappan & Gopalakirshnan, 2008; R. P. Subasinghe, 2005). For example, Carp mortality in Indonesia due to diseases was approximated at USD 5.5 million, Koi carp mortality in Japan due to Koi herpes virus (KHV) infections at USD 1.4 million and abalone mortalities in Taiwan at USD 11.4 million (R. P. Subasinghe, 2005). In spite of the losses described above, the aquaculture sector, particularly the finfish segment, has demonstrated a faster growth rate compared to the capture-fishery sector and remains the major contributor to the global animal-derived food supply, with the most significant portion (>90%) being produced in the developing world. This specific sector comprises over 230 different species and significant culture system diversity (R. P. Subasinghe, 2005). The FAO projected the global average per capita demand for all seafood to rise from 18.4 kg in 2010 to 19.1 kg by 2015 (Ayyappan & Gopalakirshnan, 2008) which exerts significant pressure on the sector to meet the rising demand. To maintain the health of the aquaculture stock, therapeutic agents such as antimicrobials (including antibiotics), antiparasitics, fungicides, biologics, hormones, chemicals, and drugs were reported to be used in aquaculture enterprises globally. Concerns were expressed on the resistance development to antimicrobials and the subsequent transfer of these resistances to pathogens of human and veterinary interest. For example, in the Philippines, drug sensitivity tests on the isolated bacterial strains of Vibrio species from fish revealed a high resistance level to erythromycin, kanamycin, penicillin, streptomycin, chloramphenicol and prefuran and low sensitivity to oxytetracycline. Several other countries in the Asia-Pacific region, like Japan, Indonesia and Thailand also reported the development of resistant strains of bacteria through indiscriminate use of antibiotics. One of the human implications of such antimicrobial compound abuse was illustrated by Chloramphenicol which even at very low residual doses in food fish can cause irreversible aplastic anaemia in humans when ingested. Such threats pose a considerable risk to workers and the habitats of nearby aquafarms (Shariff, 1998). Therefore many governments across the world have introduced national regulations and legislations concerning the use of therapeutics in general, and within the aquaculture sector in particular including stipulations on the fish imported from other markets (Nomura, 2006). Commercial aqua culturists in western countries have realized the potential of using vaccines instead of antimicrobial agents as an alternative disease management tool and have demonstrated success in increasing their productivities of fish per pen/cage (R. Subasinghe, 2009). A sharp decline in antibiotic use was reported since the advent of the first furunculosis vaccine against the bacteria Aeromonas salmonicida in salmon in Norway (Nomura, 2006). The use of vaccines as an alternative to antibiotics was later adopted by other countries including but not limited to Canada, Chile, Thailand, Iceland, Faroe Islands, France, Turkey, UK, USA, etc to name a few. Yet more efforts should be placed on research to develop better health management in finfish aquaculture. The vacination approach holds promise for the rest of the world where vaccines are not currently being used providing immense potential for the research, development and commercialization of vaccines in aquaculture.

The Indian Aquaculture Segment

In this sub-section an overview of the current aquaculture segment in India is presented. India is the according to 2004 reports by the Fisheries and Aquaculture Department (FAD) of FAO of the United Nations (Brugère & Ridler, 2004) and ranks second in the world after China in overall aquaculture (Raghu, 2011). The inland aquaculture fish production in India has increased significantly between 2000 (1.55 million tons) i and 2010 (3.72 million tons) i (FAO-Statistics, 2010) and is forecasted to reach between 8 and 10 i million tons by 2020 (Paroda & Praduman, 2000) based on an estimated average growth rate of 0.4-0.6 million tons per year. As per the estimates of Central Statistical Organization (CSO) in this country, the value of the fisheries output during 2009-2010 was INR 67,913 crore (approximately USDii 12.21 billion) which is 4.9% of the

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total output of agriculture and related sectors and is recognized as I exports. Provisional estimates suggest that between 2010 and 2011, the total fishery sector produced 8.03 million tons of fish of which 63% (5.07 million tons) was contributed by the inland sector alone (aquaculture and capture fisheries). The total volume of fish and fish products exported from India was 0.75 million tons valued at INR 12,100 crore (approximately USD 2.18 billion) (Raghu, 2011). Producing about 4.7% of the world's fish volume, India exports up to 2.5% of its fish production making this segment one of the major foreign income earners (Ayyappan & Gopalakirshnan, 2008). With a current annual growth rate of 7% per year in this I 11th five year plan (2007-2011) projected the domestic demand for fish and fish products to rise to 9.74 million tons by the end of planning year (2011). It is expected that this demand will be met to a significant extent from inland aquaculture and culture-based captured fisheries in reservoirs (5.34 million tons) as well from marine capture fisheries (3.10 million tons) (Ayyappan, 2006; Raghu, 2011). Coupled with this expectation, the constraint of a closed capture fishing season of a minimum of 45 days during April and May each year implemented by Indian government in 2008 (this arguably the most important fisheries regulation measure implemented by the Government of India (GOI) in the new millennium) (Bavinck et al., 2008) emphasizes the reliance on aquaculture technologies. To achieve the ambitious production target in a sustainable manner, recognizing the economic, social, nutritional, environmental and aesthetic importance of inland fisheries and aquaculture and its products, the GOI has aspired to introduce draft guidelines: these include, to certify hatcheries and seed farms; to create quality benchmarks for a seed certification process and to improve the structure of the implementing agencies run by all State Governments (Raghu, 2011). The goal of the GOI is to augment the exports of fisheries and fisheries products by upgrading domestic processing and postharvest technologies to international standards. India has been pursuing the goals of enhancing production and productivity, generating employment and higher income, improving socioeconomic conditions for commercial fishers and aquaculturists, augmenting exports, increasing fish consumption, adopting integrated management, and conserving aquatic resources and genetic diversity through its comprehensive five year plan. This plan includes budgeting for training, extension, credit and other financial services, building skilled human resources, and market infrastructures (Issues Brief, 2008). To achieve the goals the Indian government has established the National Fisheries Development Board (NFDB) as one of its implementation bodies and aims to reap the untapped value of the fisheries sector with the application of modern tools of R&D, including biotechnology. Besides this, the Ministry of Food Processing Industries is also actively involved in schemes to encourage improvements in the processing of fish. Strategies focusing on the Development of Inland Fisheries and Aquaculture, which are implemented through State Governments and Union Territories administrations, play a significant role in the inland fishery sector, with the help of Fish Farmers Development Agencies (FFDAs). To date, a network of 429 FFDAs has been established in the country. During 2006-2007, about 721,000 hectare of water area was brought under scientific fish farming approaches through FFDAs. Similar programs have been developed for Marine Fisheries, Infrastructure and Post Harvest Operations (GOI- Entrepreneurship). The Indian major carps, namely, Catla (Catla catla), Rohu (Labeo rohita) and Mrigal (Cirrhinus mrigala) contribute as much as 87 % to the total Indian aquaculture production (Abraham et al., 2010). Exotic carps like Silver carp (Hypophthalmichthys molitrix), Grass carp (Ctenopharyngodon idellus) and Common carp (Cyprinus carpio) now form a second important group. In addition to the above species, the commercial aquaculture in India also produces 10 minor carp species. Catfish, such as 'Magur' (Clarias batrachus) and 'Singhi' (Heteropneustes fossilis) are also gaining importance in commercial aquaculture (Ayyappan & Gopalakirshnan, 2008; FAO, 2010). The two states, Andhra Pradesh (AP) and West Bengal (WB) contributed a major share in the production of carps by inland aquaculture albeit their yields were reduced by 20-40% due to diseases and other management issues (Abraham et al., 2010). Based on the significant growth stated above, Katiha et al, (2005) predicted an immense opportunity for further growth by expanding the land area for aquaculture (horizontal expansion) and an increase in productivity (vertical expansion) based on the evidence that the average farm fish yield is only one-third of that

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achieved in farm trials. The observed higher fish yield in the farm trials was mainly due to a much higher feed input. Currently, extensive aquaculture is the norm but the researchers found that aquaculturists with semi- intensive operations benefited the most from vertical expansion. The benefit:cost ratios for the above systems of aquaculture varied between 1.22 to 1.86 (Ayyappan, 2006) for extensive and semi-intensive operations respectively. Dedicated efforts are needed to meet the demand for quality fish seed and feed in order to achieve the desired 45% increase in horizontal expansion and greater than 50% increase in vertical expansion. Some of the reasons for the lack of success in vertical expansion and significant economic losses were attributed to disease outbreaks (bacterial or viral infections); both at the seed level and during the grow-out periods, as well as too little genetic diversity and disease resistance in farmed fish (D. Das & Gupta, 2007; M. K. Das & Das, 1995). Currently, farmers are depending on drugs (ciprofloxacin, oflokem TL, enrofloxacin, herbagastrin and parovit-12), chemicals such as, formalin (Best practices:Aquaculture, 2011; Bharathkumar & Abraham, 2011), potassium permanganate and malachite green, and antibiotics (oxytetracycline, althrocin, ampicillin, sparfloxacin, enrofloxacin, and acriflavine) for either therapeutic/prophylactic purposes or for growth promotion (Bharathkumar & Abraham, 2011; R. Subasinghe, 2009). Other authors have also reported the use of penicillin, clotrimazole, bacitracin, nitrofurazone, cloxacillin, amphotericin and erythromycin antibiotics (P. K. Sahoo & Mukherjee, 1997). Some of these antibiotics are also routinely employed for treatment of human infections. The overuse and abuse of these drugs and antibiotics however have raised concerns about increasing multidrug resistance development (MDR) in bacterial pathogens of fish or other aquatic bacteria (Arthur, Lavilla-Pitogo, & Subasinghe, 1996; Bharathkumar & Abraham, 2011; Burridge, Weis, Cabello, Pizarro, & Bostick, 2010; Manjusha, Sarita, Elyas, & Chandrasekaran, 2005; Rodgers & Furones, 2009). Bharathkumar and Abraham, T.J, (2011) reported MDR in Edwardsiella tarda (100%), Pseudomonas spp. (75%), Aeromonas hydrophila (69%) and A. caviae (55%). Points of concern from their study were the alarming incidence of MDR in 30% and 90% of carp and catfish hatcheries, respectively, in the state of WB alone. Similar findings were reported earlier by Sahoo and Mukhergee (1997) and Shome and Shome (1999b). The occurrence of MDR led to increased use and higher doses of the same antibiotics to control the disease in question (Rodgers & Furones, 2009). Employment of the above disease management agents not only poses an environmental hazard but also leaves residues in the final edible product (Boyd, 2003; Boyd et al., 2007; Burridge et al., 2010; Parthasarathy & Ravi, 2011). Moreover, the beneficial microbial flora in the fish gut may also be killed by the exposure to chemical drugs (Parthasarathy & Ravi, 2011) leading to opportunistic secondary fungal and viral infections. Subsequently the fish product may either be subjected to downgrading due to poor quality or may be rejected due to high residues thus preventing it from entering the food chain in export markets (Burridge et al., 2010). Another major impact of uncontrolled antibiotic use is the contamination of the environment with antimicrobial residues and the possibility of plasmid-mediated MDR transferred from aquaculture farms to bacterial human and/or animal pathogens posing a major public health concern (Shariff, 1998). Hence the regulations in the western markets prohibit the use of antibiotics and drugs that are toxic to the environment and unsafe for human health (Rodgers & Furones, 2009). Similarly, the Indian food safety guidelines stipulate the maximum residue limits for specific chemicals and listed the banned chemicals (merged) to minimize potential threats to human health and safety. The maximum residue limits of specific drugs, pesticides and heavy metals in fish and fishery products are shown in Table 1. Some infections caused by the bacterium, Mycobacterium species, have no preventative chemotherapeutic agents and hence the aquaculture experts suggest culling of the infected fish stock in order to prevent spreading of the disease (Peteri, 2006). Since aquaculture production needs to further intensify to meet the required future demand, current and new diseases may restrain the sector from expanding (Ayyappan & Gopalakirshnan, 2008). Therefore it is imperative to adopt vaccination strategies as a safer alternative to the use of chemotherapeutic agents to combat fish diseases and increase productivity (Rodgers & Furones, 2009; R. Subasinghe, 2009).

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Aims and Objectives

Considering the disease status and the losses attributed to bacterial and viral infections in the Indian carp aquaculture, technical experts have suggested vaccines as an alternative to chemotherapeutics for disease management. They also recommended the implementation of suitable diagnostic methods to combat the prevalent and emerging diseases in the wake of increased intensification of farming practices (Ayyappan & Gopalakirshnan, 2008). Since vaccines have already proven their potential in the context of carp research in India and in western markets, the author chose to undertake an industry analysis and determine the market attractiveness of fish vaccines in India. The objectives of the present research are to explore the Indian fisheries sector and aquaculture segment at macro level. The macro business-environment factors in the country, such as, competition, political, environmental regulations, socio-cultural, technological, economic, and legal factors (CPESTEL) that influence the business decisions are analyzed. Since fish vaccines fall under veterinary biologics category and are highly regulated, the regulatory and legal environment in India is also invest tigated. The present manuscript summarizes the findings and illustrates the macro business-environment factors that may help new entrants and potential entrepreneurs or small and medium enterprise owners (SME) who may want to set up a fish vaccines business in the Indian aquaculture market and may also help them to develop suitable strategies to be successful in this environment.

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Literature Review

Macro-Environment Factors

Strategic management scholars theorized that the environment exogenous to the firm has a strong influence on firm's strategic direction making and has to be constantly dealt with by the managers to maintain s (Aapo Länsiluoto & Tomas Eklund, 2008; Chung-An, 2008; Hamel & Prahalad, 1994). These dynamic changes in the surrounding environment may lead to uncertainty, impose constraints on decision making and create opportunities or threats (Sanders & Ritzman, 2004). Only those firms that are vigilant about the changing environment will succeed in taking corrective measures to remain competitive (Bourgeois III, 1985; Lumpkin & Dess, 1995; Porter, 1986) and become efficient than their rivals (Fombrun & Shanley, 1990; Gimeno & Woo, 1996). Additionally, the firm must design its strategy that confirms to the norms of its industry environment or may reshape its industry structure by introducing a radical strategy (Hill & Jones, 2006). The macro-environmental factors such as competition, political, economic, socio-cultural, technological, environmental and legal factors (Armstrong & Kotler, 2011; Fifield & Gilligan, 1997) activities in the short-term but also impact the long-term sustainability (Wheelen & Hunger, 2002). Goodnow and Hansz (Goodnow & Hansz, 1972) defined environmental determinants for successfully choosing an entry country. They defined the success factors as political stability, high market opportunity, economic development and performance, and cultural unity, and low legal barriers, physiographic barriers and geocultural distance. An understanding of these macro-environment factors is therefore essential for an entrant before establishing a firm in the entry country of choice. Methodology

The exploratory research presented in this paper was undertaken by gathering information about the aquaculture market in India and the rest of the world through a literature review of academic and anecdotal evidence. This exploratory research cannot be completely exhaustive in determining a competitive position but provides an overview of the industry and the macro-environment factors that influence this segment in the Indian market. It may thus be used to support and verify the market entry decisions for new entrants, entrepreneurs or SME owners as well as investors. Evidence was gathered from articles in peer reviewed journals and from databases such as EBSCO, Business Source Premier, PubMed, Google Scholar, and Google. Anecdotal evidence was collected from newspapers, periodicals, blogs, articles on the web, commentaries from experts, consultancy reports, government websites, government reports and I five year plans etc.

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Analysis

Competition in Fish Vaccines Segment in India

The most likely competitors in the market for a vaccine approach to prevent disease in aquaculture enterprises are the substitute manufacturers such as manufacturers of disinfectants, antimicrobials (including antibiotics), antiparasitics, fungicides, chemicals, and drugs. The list of the companies that manufacture and/or supply the substitute products for the Indian aquaculture segment is provided in Table 2. Aggressive competition from the above substitute providers may be an issue for a new entrant to face as those competitors may consider dropping the prices of their product offerings to keep them attractive to the aquaculturists. At present there are no direct competitors in the fish-vaccines segment other than universities and national research institutes that provide experimental vaccines. International companies such as Novartis, Merck, Pharmaq, and Centrovet who are manufacturing salmon vaccines, may be attracted by the market growth rate once a vaccine-based entrant is established and may become potential future competitors. These companies could easily infuse capital into their R&D programs and develop additional vaccines for warm-water fish or eventually may buyout or partner with a new entrant. O M I N P L “ an R&D facility that was setup to develop fish vaccines for the Asia-Pacific region (Merck, 2009). The constraints such as the diversity of fish species to be served, lack of knowledge of the fish biology of various species, and diverse sizes of the farms (Walker, Lester, & Bondad-Reantaso, 2005) are limiting the existing international fish vaccine companies to invest in an Asian fish vaccines R&D program. The profitability margin for fish vaccines in the Indian market is not yet established and the price tolerance of the customer is unknown. It is assumed that there could be as much as 50 to 70% gross margin in fish vaccines depending on the complexity involved in the development and manufacture of the product. Fixed costs are usually high in the biotechnology sector into which fish vaccines fall, which could potentially preclude new entrants from approaching this market until it is clear that the customer and the market is willing and ready to make a shift from conventional chemical treatments to vaccines. Manufacturing the products elsewhere and marketing them in India is not a viable option as the cost of goods sold will be much higher (if for example the vaccine is produced in established international companies outside India) and which will make the vaccines less attractive to aqua culturists in India. To mitigate the risk of poor adoption due to high cost of the product, a new entrant would have to set up the manufacturing facility in India and leverage the low labor and material costs of the region. Transport of fish pathogens from India to elsewhere for R&D, commercial production and testing is another challenge that the international companies face due to biosecurity issues and regulatory complexities. Local veterinary vaccine manufacturers constitute potential competitors, if they deem that this market is attractive, as they may also be capable of developing vaccines for the fisheries sector. The list of companies could include but is not limited to Venkateswara Hatcheries Ltd, Indian Immunologicals Ltd, and Serum Institute of India. One of the key reasons for these local companies to shy away from fish vaccines so far is the high volume needed and the low value proposition of fish vaccines. A further threat could result from technical staff of the new entrant deciding to leave the organization after gaining enough experience/knowledge and to establish a startup company with imitation products if the intellectual property is not protected sufficiently.

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The Political Landscape in India

The political structure and systems are key factors that drive the policy and shape the incentives for entrepreneurs to select a country and influence the strategy to choose for entry (Keren, 2009). Therefore the political landscape in India will be explored in this section to understand the political systems and its policies as well as their influences on the business environment.

Political Structure and System

I I paper. I countries. It is a secular state with multi-ethnic and multi- religious citizens and a federal republic comprised of 28 states and seven union territories. India has three branches of governance: the legislature, the executive and the judiciary (Datamonitor, 2011). The judiciary is independent and the legal system is based on English Common Law (ICON Group, 2007). The federal legislature is bicameral parliament with the indirectly-elected Upper House, the Rajya Sabha (government assembly also called Council of States), the directly-elected Lower House, the Lok Sabha (House of the People), and two representatives of Anglo-Indians appointed by the President (ICON Group, 2007). The Rajya Sabha is a House elected by the members of the State Assemblies and two Union Territories in which States and Union Territories were given the number of seats in the Rajya Sabha based on the proportion of the population of each state or union territory. Elected membership is limited to 238. In addition to the elected members, the President nominates 12 members to the House based on their expertise in art, literature, science and social services. The Rajya Sabha is a permanent House and is not subject to dissolution. However, one-third of its Members retire after every second year but a member elected for a full term may serve for a total period of six years. The Vice-President of India is the ex-officio Chairman of the Rajya Sabha and presides over its sittings. Under the Constitution, the power is transferred to the President to issue Proclamations in the event of a national emergency, in the event of failure of constitutional machinery in a State, or in the case of a financial emergency. Apart from the Chairman and the Deputy Chairman, the Leader of the House is another functionary who plays a key role in the efficient and smooth conduct of the business in the House. The President appoints the leader of the majority party or a person who he believes commands a majority in the Lok Sabha (Rajya Sabha, 2012). The President is the constitutional head of the country but the real executive power is conferred in the council of ministers (Cabinet Ministers, Minister of States [independent charge or otherwise] and Deputy Ministers) headed by the Prime Minister (Datamonitor, 2011). The Lok Sabha is comprised of people elected representatives through General Elections, held on the basis of universal adult suffrage. The maximum strength of the House as per the Constitution is 552, made up of up to 530 elected members to represent the States, up to 20 members to represent the Union Territories , and two members of the Anglo-Indian Community to be nominated by the President. The total elective membership is disseminated among the States based on the ratio of number of seats allocated to each state and the population of the state, which may vary depending on the strength of the population over time. In legislative matters, both Houses have almost equal powers in passing laws. The President approves the bill and it becomes a law only after the consensus is agreed between both houses on the Bill with the exception of Money Billsiii, where the Lok Sabha has overriding powers. A Money Bill can be introduced only in the Lok Sabha while the Rajya Sabha can only recommend I L “ mendations of the Rajya Sabha (Lok Sabha, 2012). The present national government is the United Progressive Alliance (UPA), a coalition led by the Indian National Congress Party. The Indian Parliament structure is shown in Figure 1. The state legislations may be unicameral or bicameral, with a Chief Minister as head of the state and elected by the members of the legislative assembly. The Chief Minister reports to the respective state governor who is appointed

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by the President (Political Structure, 2011) The State Legislature structure is shown in Figure 2. Both national and state legislatures are elected for five-year terms (ICON Group, 2007).

The State of Politics in India

The parliament and the state assemblies in India are increasing in pluralism of political parties and substantial ideological divisions. These divisions among parties are causing significant obstacles in policy implementation. Added to this, the principle of nepotism has become a norm in politics and is now more deeply embedded since the independence (French, 2011). The leftist ideology of the opposition espoused policies of economic nationalism, has attempted to return to the Swadeshi (nationalist) agenda, and called for India to be built by Indians which is inhibiting Indian economy modernization by reducing subsidies, further privatization and labor law reforms. Other factors that are troubling this modernization are the lack of a business-friendly national policy (ICON Group, 2007) and the political weakness of the government, due to unstable coalitions, resulting in the difficulty to tailor policies to recognized needs. The efforts of weakening the countr Permit-License-Quota Raj (rent-seeking society) (Weede, 2010) which were aimed to reduce the bureaucratic processes in starting businesses have also been slowed (Keren, 2009).

Governance in India

In spite of the negative factors of pluralism, nepotism, linguistic and religious diversity, India's political system is more stable and institutionalized than other developing countries due to assertive new grass-roots movements that are revolutionizing the way governance works at the regional level (French, 2011). The reform in India is largely driven by the domestic factors and the forces of governance compel major parties to act pragmatically and avoid abrupt changes in policy and seek policies that are fair, I economic needs (ICON Group, 2007). This ensures policy continuity and institutional stability even as governments change (Narasimhan, 2012). Politicians in India (at central, state and local levels) generally do not wish to antagonize foreign investors and traders, which is evidenced by the commercial presence of international businesses such as Pfizer Inc., Novartis, Sanofi Pasteur Ltd etc in the country, reflecting the improvement in attractiveness of the Indian business environment (ICON Group, 2007). Keren (2009) quoted D "[the Indian] economy grows at night when the government (merged)(Keren, 2009)(Keren, 2009)(Keren, 2009)which reflects the negative impact of government intervention. In the setting of a polyarchial type of decision making where governments, local, state and central, have the authority and a say on the issue at hand, or where their approval is required, the investor may fear that one of the involved bodies will have a negative impact on the potentially productive capital and turn an approach or project into a white elephant. The 2010 survey of governance indicators conducted by the World Bank Institute and the World Bank Development Economics Research Group, revealed a decline in five of the six dimensions of governance in India, namely, political stability, government effectiveness, regulatory quality, rule of law, and control of corruption while voice and accountability dimensions improved. However, the government has agreed to take the Jan Lokpal Bill (anti-corruption bill) for approval in 2011 which will allow registering and investigating respective complaints against politicians and public servants. National security and relationships with neighboring countries is a fall back as well (Datamonitor, 2011). Therefore the transaction costs for businesses are high until this Jan Lokpal Bill is passed into law and improvements in the above five governance indicators are achieved. This very different in hierarchy-type political system such as China, where transaction costs are low since decisions on policy are made at the highest level of administration. Despite this weakness, Keren highlighted that the Indian

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entrepreneurship approach is more daring than the Chinese in conceptualizing and implementing novel strategies to develop new products (Keren, 2009).

Important Policies in India

In India, policy change started in the year 1991 and accelerated in the new century. As a result tariffs on imports were slashed from an average of 90% in 1991 to 30% in 1997 (The Economist, 2009) and many restrictions and licensing requirements (e.g. notification of producers to the government on any change in their production and employment) were abolished. Nevertheless, property rights are still either too weak or too strong depending if a state favors the entry of new firms or not. A case of property rights being too strong was illustrated in West Bengal in the event of Tata's plans to build a manufacturing plant to produce the Nano, the world's cheapest car. The local agricultural interests did not allow the West Bengal government to provide the company with the required land (Keren, 2009). The contrary case of property rights being handled in a much more open approach was exemplified by the state government of Andhra Pradesh where the government provided the required land to Novartis to build its Bioinformatics centre in its capital city, Hyderabad (Mathew, 2008). Other scholars have also raised concerns on Indian public policy and suggested that it has more room for improvement when compared to China. Furthermore I incomplete reforms were attributed to the diverse political ideologies of different states, their interests and the negative influences of radical groups (Maoists or Naxalites) threatening the political stability and economic freedom (Weede, 2010). Since 1991, successive governments have sought to pursue an economic policy that favors liberalization and garners investment. This policy reform has opened up the Indian market to international companies and reduced government control on foreign trade, investment and relations. The GOI recognized the potential of biotechnology and its influence on knowledge-based economy. As part of its recent policy initiatives, India has established a National Biotechnology Development Strategy in 2008. The government is also promoting sector-specific policies and is establishing the institutional infrastructure in the form of bioparks and special economic zones (SEZs) (Mroczkowski, 2011). Various fiscal incentives such as income tax and excise duty exemptions, write-off of revenue and capital expenditures on R&D etc are also part of this initiative to companies that promote R&D (Datamonitor, 2011). These fiscal incentives have been reflected in its latest five year plan (2007-2012) where the government targets to spend 2% of its GDP in R&D support by 2012. In addition, reforms have been introduced to the infrastructure sector, capital market, the financial sector and taxation. The local state governments responded in similar vein by establishing several biotechnology parks in an anticipation of incubating startup companies, developing novel research programs and collaborations. It is important to note that fish vaccines fall under the label of the biotechnology industry as they involve the use of microorganisms in the manufacture of the respective products. The educational institutions have introduced biotechnology courses and research programs to facilitate the supply of qualified skilled-labor force needed to support these industries. National Research Institutes such as the Central Institute of Fisheries Technology, the Centre for Cellular and Molecular Biology, the Indian Institute of Chemical Technology, the Indian Institute of Science, and the Indian Agricultural Research Institute to name a few, are forging links with private firms to develop intellectual property and to move concepts into markets. Recognizing the impact of such research activities on the economy, local and central governments are encouraging industry-academia collaborations by providing funding for outstanding research projects (Mroczkowski, 2011). Further details on the economic landscape will be described in the subsequent sections. Pereira (2006) reported that India is the only Asian country after Singapore with significant biotechnology foreign direct investment (BFDI). Foreign direct investment I reached

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the target of USD 10 billion by the end of the last decade. This demonstrates the serious commitment of the Indian government towards the development of a knowledge-based economy.

Regional Disparities

Regional political instabilities such as in the state of Andhra Pradesh are one of the major concerns for investors. The Telangana Separatist Movement pushing for an independent statehood for Telangana is causing turmoil and is having a negative impact on all the industry sectors in Andhra Pradesh (Political Scene, 2011). Issues such as frequent Bandhs (city shutdowns) to revolt against government initiatives, policies etc are of concern to the industry as they result in interruptions in the operations and the supply chain for the business.

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Economic Landscape

The economic environment of a country is an important aspect of strategic analysis aiming to determine the growth potential and future prospects of the industry in which a new entrant envisions to invest. It enables the decision makers to determine how well the economic policy is established and whether it aligns with the business interests of the interested investors.

Economic and Tax Reforms

The Indian economy is characterized as a actor-driven based on the institutions, infrastructure, macro-environment, and health and primary education. The Global Competitive Index (GCI) was built on the economic theory of stages of development, which assumes that, in the first stage, the economy is factor-driven and countries compete based on their factor competencies such as primarily unskilled labor and dependency on natural resources. In this stage companies compete on the basis of pricing and sales of basic products or commodities, with their low productivity reflected in low wages. Sustaining competitiveness at this stage of development depends primarily on well-functioning public and private institutions, a well-developed infrastructure, a stable macroeconomic environment, and a healthy workforce that has received at least a basic education. Once the country becomes more competitive, productivity and wages will improve, thus advancing economic development. When India is compared with other emerging economies in the region such as China, Singapore, and South Korea, China is in an efficiency-driven mode, while Singapore and South Korea are in an innovation-driven category (Schwab, 2011). Economic reforms initiated in India in 1991 have led to robust economic growth in India, and led the country to become one of the fastest growing Asian economies (Datamonitor, 2011). The reforms are attracting new foreign investment and other capital inflows, and stimulating new information and communication technology (ICT) industries. The 2011-2012 GDP growth rate is just above 8.0% and is expected to continue at an average annual rate of 8.3% in the medium term through to 2015, and in the long term at an average rate of 8.0% through 2025 followed by 6.9% through 2040 (Narasimhan, 2012). The 2010 GDP growth rate of 10.4% (GDP: USD 1.538 trillion, GDP per capita: USD 1,265) which was mainly driven by strong domestic consumption (Australian Govt, 2011). However, the recent lower growth rate was attributed to corruption, poor infrastructure (crowded ports, poor road and rail networks) (Hamm & Lakshman, 2007), customs delays, lack of cold storage and proper warehousing facilities. Hamm and Lakshman (2007) lamented on the poor infrastructure in India and pointed out J N B (professor at Columbia University) view, that the GDP growth would run two percentage points higher if the country had decent roads, railways, and electric power supplies. The lack of proper infrastructure such as roads is costing as much as USD 6.0 billion a year, according to Gajendra Haldea, an adviser to I Central Planning Commission. If the infrastructure was also up to the mark, India could have contributed more than one percent to the global trade as remarked by I C N‘ Narayana Murthy. Kamal Nath, Minister of India's Commerce & Industry in 2006, acknowledged the fact that without a better infrastructure, India . The lack of proper infrastructure was addressed in the country's 11th five year plan (2007-2011), with government budget investments in infrastructure totalling USD 500 billion for the period of 20092013 to accelerate the economic growth of the country. This prudent fiscal commitment is expected to provide significant support to the industrial and capital expenditure growth, along with overall services sector increase. Coupled with the above national fiscal input, the World Bank is also expected to allot funds to a special infrastructure fund (Datamonitor, 2011). Inflation remains another major challenge for the Indian economy. Between 2010 and 2011, the average inflation rate has been around 11.3%. As a result, the Reserve Bank of India (RBI) has aggressively tightened the monetary policy by increasing interest rates, which is forecasted to help the inflation rate to gradually decline to 4% by 2016. Nonetheless, high interest rates, along with a drop in investments may hamper India's growth

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prospects. To counter the negative effects of inflation, and to boost the foreign investments, the Indian government has enacted new tax reforms, such as the implementation of value-added tax (VAT), which has greatly aided indirect tax collection. A number of changes in taxation policy have been enacted to encourage foreign direct investment (FDI) in the country. Additionally, the revised credit rating of India M 2010 by Standard & Poor (S&P) has helped. However, S&P still retained its long-term sovereign rating at BBB and short-term rating at A-3, due to high debt burden and fiscal deficit. Some economists and credit analysts have argued that India deserves a better rating, based on its inherent strength and growth pace of the economy. The improved credit rating is expected to lower the cost of overseas debt for Indian companies (Datamonitor, 2011). As per the latest figures released by the Department of Industrial Policy and Promotion, GOI, the cumulative inflow of FDI equity from April 2000 to April 2011 stood at USD 197.93 billion. In the World Investment Prospects Survey 20102012, the United Nations Conference on Trade and Development (UNCTAD) ranked India second, in terms of global investment destinations. Ernst & Young ranked India in its Ninth Annual European Attractiveness Survey, June 2011, as the fifth most preferred global FDI destination over the next three years, based on the fact that India is a low cost business process outsourcing hub, and has a forecasted annual economic growth rate of more than 8%. It therefore provides an optimistic climate for the overall future investment which may further increase the FDI inflows (Datamonitor, 2011). The fiscal deficit of India was estimated to be around 6.4% during 200910, the highest in 16 years. However, India became a creditor to the International Monetary Fund in 2002, and started to repay its external debt. According to the figures released by the RBI, total foreign exchange reserves of India stood at USD 297.3 billion in 2010. The country's foreign currency assets tumbled from USD 274.3 billion in the fiscal year (FY) 2009 2010 to USD 254.68 billion in the FY 20102011, while gold reserves increased from USD 17.9 billion in the FY 20092010 to USD 22.97 billion in the FY 20102011 (Datamonitor, 2011). I debt stock grew to USD 334.9 billion in 2011, recording an increase of 12.6% from 2010 (USD 297.5 billion). High commercial borrowings and short-term debt which account for 84.7% have been attributed as reasons for this increase. Appreciation of the US Dollar as well as other major international currencies such as the Japanese Yen and the Euro were also accounted for the above reasons. As a result, the external debt-to-GDP ratio of 2011 also increased 3.1 percentage points from the previous fiscal year, from 16.9 (2010) to 20.0. Overall, this ratio has been declining rapidly since 1992, an indication that the external borrowings are reducing significantly and GDP improving (GOI- DEA, 2011; GOI-DEA, 2012). Reserves exceeded external debt, while the short-term debt-to-reserves ratio remains modest. As a result, the foreign currency assets and the gold reserves are well above the conventional criterion which is a good indication of the financial position of the country (Datamonitor, 2011). By the end of December 2011, a quick estimate suggested that India's foreign currency assets provide coverage of 88.6% to the external debt stock. All the key debt indicators, for example, debt-to-GNP ratio, debt service ratio, short-term-to-total external debt, and the cover of external debt provided by foreign exchange reserves were in a comfortable zone (GOI-DEA, 2011; GOI-DEA, 2012). Investors employ debt-to-GDP I -to-GDP ratio in India stood at 69.2%. From 1991 until 2010, India's average government debt-to-GDP ratio was 72.60 %, C debt-to-GDP ratio of 17.7% I 69.2% in 2011, which indicates a high risk for investments as well as borrowing costs in India. This may deter investors and may lead to concerns about India in their diversification exercises of investment portfolios. Nonetheless, the economists have shown that this ratio can be as high as 70% without negatively impacting the growth of the economy or its performance (Miller, Holmes, & Feulner, 2012). Despite the global economic meltdown in 2008- 2009, I USD 28,682 million in 2012) and import (USD 39,782 million in 2012) profiles are on the increasing trend, although not to the level of Chinese volumes and value, but the rate of increase is steady and

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significant. There is an apparent potential to further improve the export of goods from India to increase the balance of trade, which in turn will positively contribute to its GDP. The Indian industrial production rate averaged at 7.49% over the period of 1994 to 2010. The overall trend followed the global economic meltdown in 2008 which negatively impacted the production in India. But the Indian industrial aggregate production rate reached a record high of 17.7% in December 2009 for the manufacturing, mining, and utilities segments, and these segments have excelled in the sector during the period of 2008-2009. This rate of increase in the industrial sectors could not be sustained, and since 2009, it has been declining. A similar trend was recorded for China as well (Economic Profile-China; Economic Profile-India). To maintain momentum for imports and exports, the Indian government has developed an adequate policy framework, provided assistance and incentives to people, companies and organizations engaged in foreign trade (Importers and Exporters).

I Financial and Capital markets

Established and startup companies can leverage long-term financing from Capital Markets. The Indian government controls the issueing of shares and debentures under the Capital Issues (Control) Act, 1947. The Securities and Exchange Board of India (SEBI) was established under the Securities and Exchange Board of India Act of 1992, and is the regulatory authority that oversees 23 stock exchanges and other capital markets in the country (Datamonitor, 2011). A large number of financial institutions at national and state level have been established in India D B provide long-term financial assistance to industrial enterprises. Many national financial institutions were set up to support industry financing like: the Industrial Finance Corporation of India (IFCI); the Industrial Credit and Investment Corporation of India (ICICI); the Industrial Development Bank of India (IDBI), etc. At the State level, State Financial Corporation(s) (SFCs) and State Industrial Development Corporations (SIDCs) finance the companies. Besides the development banks, there are several other institutions called 'Investment Companies' or 'Investment Trusts,' which subscribe to the shares and debentures offered to the public by companies. These include the Life Insurance Corporation of India (LIC); the General Insurance Corporation of India (GIC); the Unit Trust of India (UTI), etc. If approved by the GOI, the Indian companies may also secure capital from foreign enterprises through the issue of shares to foreign collaborators or by importing technical knowledge, patents, drawings and designs of a plant or supply of specialized machinery (GOI-Start-up). For short-term financing of business requirements, Commercial Banks have been established that provide financial support in the form of loans, cash credit, overdraft, and discounting of bills (like bills of exchange, and promissory notes). These bills are discounted by banks at a price lower than their face value (GOI-Start-up). Venture Capital is gaining popularity in India, as an important source of financing for small- and medium-sized firms, which have very few avenues for raising funds. The SEBI regulates the venture financing segment under the Venture Capital Funds Regulations, 1996, and the Foreign Venture Capital Investors Regulations, 2000. ICICI Venture Funds Ltd, IFCI Venture Capital Funds Ltd (IVCF), SIDBI Venture Capital Ltd (SVCL) at the central government level, and Canbank Venture Capital Fund and Gujarat Venture Finance Ltd (GVFL) are the examples of state government level venture finance providers (GOI-Venture Capital). The household saving rate, which stands at 25% of I GDP, is fairly high compared with other developing economies at similar income levels. Narasimhan (2012) remarked that the Indian government needs to make India a favoured destination for foreign investment, to fill the resource gap from external resources. According to recent data published by the World Bank (2009: 378_379), India ranked fourth in gross national incomes (GNI) in terms of purchasing power parity after the United States, China, and Japan (Weede, 2010). The household disposable income grew at an average rate of 13% during 20002010, and is forecasted to maintain this pace alongside with the rising GDP rate. The rising trend of household disposable income provides more discretionary spending potential in total consumption expenditure per household, which grew at a rate of 16% in

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2010. With a median age of 25 in 2010 India has one of the youngest consumer segments in the world, which presents major opportunities for consumer goods companies. Other reasons that were identified for growing consumer spending include: urbanization, easy availability of credit in the form of personal loans and credit cards, greater consumer awareness, changes in consumer attitudes about consumption, increased literacy, and the availability of disposable income among younger consumers (Datamonitor, 2011). Rural India constitutes approximately 70% The buying power in the rural markets of India has also increased (although at a lower rate than urban India) due to better transportation of goods and leading to greater availability in the rural areas (ICON Group, 2007) which may translate into rural economic development in the future rise.

International Trade and Relations of India

Industrial liberalization and moderate relaxation in external trade barriers gave rise to more competitive firms in India, especially in sectors such as pharmaceuticals, software, and services. Thus Indian multinational companies (IMNCs) emerged (Raghavan, 2008). For example, the Anglo-Dutch steel manufacturer Corus Group, I T “ U“D I T C General Chemical Industrial Products Inc. in the United States for just over USD 1 billion in 2008, and Infosys signed an agreement to acquire McCamish Systems for USD 38 million (Burman, 2010). Hindalco, Suzlon, Bharat Forge, and Sundaram Fasteners are other examples of such IMNCs (Raghavan, 2008). The year 2007 was a record for out-bound mergers and acquisitions (M&A) from India with an increase of 300% over 2006. A total of 223 deals, worth USD 33 billion, were transacted (Raghavan, 2008). Although 2009 trended downward again in M&A, 2010 proved to be an excellent year for Indian M&As. According to Thomson Reuters, the deal volume was up more than threefold, from USD 21.3 billion in 2009 to USD 67.2 billion in 2010, which matched the historical numbers of 2007 at USD 69.4 billion (Lawyrs, 2011). It is interesting to recognize that The State Bank of India led a consortium and helped in financing Bhutan's largest cement plant, with an annual capacity of 1.34 million tons. It was also a first instance, where the RBI allowed rupee financing of INR 410 crore (~USD 88.55 million) to an overseas project (Burman, 2010). Such transformation of India to outward orientation from a largely autarkic state (a policy of national self-sufficiency and non-reliance on imports or economic aid) is anticipated to increase net exports thus contributing further to GDP growth (Narasimhan, 2012). A W Ca could control about 23%, and India over 10% of the gross world production. Inbound MNC acquisitions and investments also occurred. One such example is the formation of the National Infrastructural Development Finance Corporation nine international financial institutions have equity contribution in this undertaking. Recognizing the lack of infrastructure in India, some MNCs exploited it as a business opportunity. But some scholars emphasized that the License Raj and cultural hurdles are still to be overcome. In this light, L e was cited as helpful in understanding the industrial bias that MNCs face in India. Coopetition is described as the nature of the relationship between MNCs and host governments it is a combination of cooperation and competition occurring simultaneously, according to the economical and political environment. However, where economic and social goals are not complementary with MNC interests, for instance, in the food industry, where protectionist ideals are often employed by the Indian Government as warranted, it creates a serious interference in the form of bureaucratic and political barriers (Sebastian, Parameswaran, & Yahya, 2006). Recognizing the potential of export business, the Indian government has attempted to partner in trade with several of its neighbors and with developed economies around the world. India is known for international trade from ancient times (P. M. Kumar, 2005), and in the modern era the country has been forthcoming in establishing trade agreements. Among these are free trade agreements (FTA) with all of its neighboring countries in South Asia; the Asia Pacific Trade Agreement (APTA) with its Asia-Pacific counterparts; the Comprehensive Economic Partnership Agreement (CEPA) with Japan, New Zealand, and Australia; the South Asian Association for Regional Cooperation (SAARC) with south Asian countries. The South Asia Free Trade Area (SAFTA) agreements

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with the European Union and Chile are expected to complete by the end of 2012, while Canada is seeking to conclude the CEPA in 2013. Initial negotiations are underway for an India, Brazil, and South Africa trilateral agreement (IBSA), and a free trade agreement with the USA (FTAs; GOI-DoC). In an effort to enhance the export markets to bring foreign revenues into the country with the aim to increase its foreign reserves, the GOI realized the need to shed its past protectionist ideologies and open the doors for market expansion. India has a fast growing huge urban English-speaking middle class, which makes it a preferred investment destination for information technology and outsourcing services. Leveraging on its English-speaking demography and the approximately 65% of the population which is in the age group between 15 and 65 (median age is 25 years), India has focused on its services sector, which accounts for more than half of its output (USD 1,488 billion in 2011) despite employing less than one-third of its English speaking workforce. A large working age population is expected to provide sustained momentum to the economic growth in the country (Datamonitor, 2011).

Biotechnology Sector Performance in India

The biotechnology sector in India has been gaining the confidence of investors since 2006, as it is growing at a pace similar to the Chinese market (BiospectrumAsia, 2010), with overall revenues reported in 20102011 exceeding USD 4 billion, a 21.5% increase from the previous year (Datamonitor, 2011). At this pace, it was forecasted that the biotechnology sector would grow to USD 8 billion by 2015 at a cumulative annual growth rate (CAGR) of 20% (BiospectrumAsia, 2010). Some analysts at the Association of Biotech Enabled Enterprises have been even more optimistic with the target reaching a value of USD 15 billion by 2015. Additionally, this sector has proven to be among the most attractive investment destinations from foreign firms, ranking as third largest in the Asia Pacific region. Compared to the biotechnology sector, the Indian pharmaceutical industry was worth around USD 12 billion in 2010, growing at a CAGR of 1011%, and is expected to reach a value of USD 55 billion by 2020. Generics and export pharmaceutical products dominated the space and the sector supplies its products to almost 200 countries worldwide, leading to a global standing as fourth largest producer of drugs by volume. Improved healthcare infrastructure, higher disposable incomes, and improved intellectual property rights were suggested as the key growth drivers in this sector. In addition, the over-the-counter (OTC) pharmaceuticals segment is also progressing at almost the same CAGR as pharmaceuticals sector (Datamonitor, 2011). In the 11th five year plan (2007-2011), the government proposed to set up 10 biotechnology parks with incubators (Bhan, 2006) which would further boost the biotechnology sector with institutional infrastructure. Several state governments, particularly in southern India, are pursuing their own state biotechnology policies, to entice companies to set up facilities in their states (A. Kumar, 2007). Major foreign firms are trying to cut costs on their R&D programs and looking for enterprises in cheaper regions to fill their R&D pipelines. One example is the collaboration between DuPont and the Indian Institute of Chemical Technology (IICT). DuPont has recognized the cost of R&D in India being approximately one fifth of that in the US or European organizations (A. Kumar, 2007). Natesh and Bhan (2009), I N Biotechnology Development Strategy and suggested revisions to, and commended the Indian Government commitment. They feel that I I I creation and application. Whether and how far it succeeds will depend on a number of factors, including its Judging by recent developments, there is reason to believe that India will rise to the occasion (p. 169). Currently, there are 800 companies operating in various sectors of biotechnology, but only 25 companies have been successful working in the modern biotechnology segment. I I produces 60% of the global health vaccines. The country had revenue of USD 665 million in this space which was expected to reach USD 800 million soon, (Myint, 2011, p. 1) said Prof. Steven H. Myint, chairman of the Chennai-based company Green Signal Bio Pharma Private Ltd. Vaccine companies are one of the key players in the Indian

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biotechnology sector with 70% of the products O share stood at 40% (Myint, 2011). Therefore, it is apparent that the biotechnology industry has a major role to play in increasing I gross GDP. Government funding to the life sciences sector steadily increased by as much as 16 fold from the 8th five year plan (1992-1997) to the 11th five year plan (2007-2011). The Department of Biotechnology (DBT) has decided to dedicate rd of its budget to public-private partnership programs (Sector Briefing-UK, 2010). As a result, a firmer foundation of life sciences and biotechnology has been created from which strong innovation and enterprise creation can be expected. Fiscal incentives comprise relaxed price controls for drugs, subsidies on capital, and tax credits and breaks for R&D spending. Several state governments in India have responded by adding financial (e.g. tax concessions) and policy incentives (biotech parks, incubators of their own) to encourage investment in biotechnology. The DBT and other organizations have proactively taken up a number of initiatives to create human resources, institutional infrastructure (e.g. microbial culture collections, cell and tissue lines, gene banks, laboratory animals, facilities for oligonucleotide synthesis, etc), and a strong research foundation in the country.

I Fisheries Sector Performance

The institutional framework for the fisheries sector has also been recognized as one of the key requirements for the growing aquaculture segment of fisheries sector and its contribution to gross GDP in India. The I gross GDP 1.04% in 2004-2005 (Ayyappan & Gopalakirshnan, 2008; B. G. Kumar & Datta, 2008). Similarly, the share of fisheries in the agriculture GDP has increased robustly from 2.17% in 1980-1981 to 5.93% in 2004-2005 because of expansion of the culture fisheries segment. The fisheries sector in India has in fact been providing thrust to the agricultural growth for the past five and half decades. This growth trend has encouraged the Indian government to direct some of its investments into this sector (B. G. Kumar & Datta, 2008). In its 11th five year plan (2007-2011), the Planning Commission of India (PCI) has allocated INR 8,174 crore (~USD 1.84 billion) for the Department of Animal Husbandry and Dairying, of which an amount of INR 2,776 crore (~USD 0.62 billion) was allocated for Fisheries, INR 4,243 crore (~USD 0.95 billion) for Animal Husbandry (towards encouragement of public-private partnerships, technology transfer, institutional restructuring, etc) (GOI-Entrepreneurship). A sum of INR 157.14 crore (~USD 35.33 million) was budgeted for fisheries research by the ICAR (B. G. Kumar & Datta, 2008). The Working Group on Fisheries under the PCI has also recognized the importance of surveillance, monitoring, and reporting of fish diseases, and initiated the establishment of test centers and facilities in several Indian states (Ayyappan, 2006). The private sector, however, as opposed to the government sector, dominates the investment in the fisheries sector (Issues Brief, 2008). The Ministry of Agriculture of the GOI has set up a separate Division of Fisheries under the Department of Animal Husbandry and Dairying to serve as a nodal agency. This agency is accountable for planning, monitoring, and funding of the development schemes related to fisheries and aquaculture in all of the Indian states. Most of the states established a separate Ministry of Fisheries to oversee the developments, or gave the responsibility to the Ministry of Animal Husbandry in the absence of a separate Ministry of Fisheries. All states have well-organized fisheries departments involved in the overall development of the sector. The ICAR under the Department of Agricultural Research and Education has a Division of Fisheries, which undertakes the R&D in aquaculture and fisheries through a number of Research Institutes. There are about 400 Krishi Vigyan Kendras (Farm Science Centers) in the country, operated through the State Agricultural Universities, ICAR and NGOs, most of which also undertake aquaculture development. The Marine Products Export Development Authority (MPEDA) acts as a coordinating agency with different Central and State Government establishments engaged in marine products and related activities. Functioning under the Ministry of Commerce, besides its role in the export of aquatic products, MPEDA contributes towards the promotion of coastal aquaculture, by increasing exports, specifying standards, overseeing fish processing activities, assisting in

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marketing, and providing training (Aqua Overview). The GOI has also rapidly reduced tariffs on fisheries products to facilitate further exports (Issues Brief, 2008). Many other organizations and agencies are also supporting fisheries R&D, and may include but are not limited to the Departments of Science and Technology, the BDT, the University Grant Commissions, NGOs, and the private industry (Aqua Overview).

Overall Economic Performance in India

The World Economic Forum conducted a research survey on 142 countries and published a report during 2011-2012, based on the framework of The Global Competitive Index. It is worthwhile comparing the results of the factor-driven Indian economy with that of other economies, for example, the Chinese efficiency- and the South Korean innovation-driven economies. According to this GCI, India was one among 37 factor-driven economies surveyed (Schwab, 2011). The results of comparing the economies are shown in Figure 3. From this comparison, it is evident that India is lagging behind in innovation, infrastructure, macro-economic environment, higher education and training, health and primary education etc. In the process of improving its economic development, India has now established institutions that are on par with efficiency-driven (China) and innovation-driven (South Korean) economies. Moving forward, the government has to increase efforts and investments to utilize the institutional knowhow and to build public-private-partnerships to exploit the institutional infrastructure, and its technologies to accelerate the economic growth.

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Environmental Landscape

The environmental regulations in the region help a startup company dealing with fish vaccines to understand the functioning of the environmental framework and what policies have to be drafted in order to comply with the local, the state and the central regulations. Additionally, these regulations will also enable management to gauge public perception o business activities so that it can be prepared for any potential implications. It is likely that an investment is required for effluent treatment systems and the pollution abatement equipment and since vaccine production involves bio-hazardous substances, generation of effluents that demand oxygen, and live animals for testing, a deep understanding of the compliance requirements is essential to the entrant. Pollution is one of the major concerns in India and hence an overview of this landscape is important to take corporate social responsibility of designing and implementing systems and equipment that generate less pollutants and effluents.

Environmental Framework, Policies and Schemes of India

The Indian Constitution in its 42nd Amendment of the Environment (Protection) Act 1986 has imposed an obligation on the part of the state (Article 21iv, Article 47 v, Article 48A vi) and the citizens (Article 51A(g)).vii It attempts to protect and improve the environment, and to safeguard the forests and the wildlife of the country (GOI-EPA-29, 1986). Thus, various Acts were created to envision a sustainable environment. Some of the Acts that : the Indian Forest Acts, the Factories Act of 1948, the Rivers Boards Act of 1956, the Water (Prevention and Control of Pollution) Act of 1974, the Air (Prevention and Control of Pollution) Act of 1981, the Public Liability Insurance Act of 1991, the Coastal Zone Related Acts, and the Hazardous Substances Acts (Datamonitor, 2011). The Bhopal Gas leak disaster of December 1984 has intensified the implementation of environmental regulations, and as a result the Ministry of Environment and Forests (MoEF) was established and given greater powers. The Environment (Protection) Act, 1986 (EPA) was passed to act as an umbrella legislation, and the powers vested with the central government to take all the measures to control pollution and protect the environment. The EPA identifies the MoEF as the apex policy-making body in the field of environment protection and also as a nodal agency in the country, for the United Nations Environmental Program. The MoEF acts through the Central Pollution Control Board (CPCB) and the State Pollution Control Boards (SPCBs). The CPCB is a statutory organization and the nodal agency for pollution control, and prevention and abatement (GOI-EPA-29, 1986), which sets standards and limits for various pollutants. The EPA in 1986, and the amendments to the Air and Water Acts in 1987 and 1988, furthered the territory of the “PCB functions and powers. The roles and responsibilities of the central ministries, state ministries, and the local level bodies, in the creation of environment policy and setting the standards, as well as enforcement is shown in Figure 4. Accordingly, the regulatory jurisdictions and their roles have been depicted in the flow chart. The National Environmental Policy of the GOI, 2006 (GOI-NEP, 2006) (a revised version of its 1992 policy), was intended to be a guideline for action in regulatory reforms, creating programs, and projects for environmental conservation as well as enactment of legislation through the central, state and local governments. The policy was designed to ensure that people relying on the natural resources for livelihood, secure them through conservation means. To realize this goal, it seeks to manage the environment and the natural resources of the country by building partnerships with various stakeholders, such as: public agencies, local communities, academic, and scientific institutions (both local and international), as well as the international development partners. Using the cradle-to-grave strategy, the Ecomark Scheme was developed, by which the consumer can make a right environmental choice. The Ecomark label is granted only to those consumer goods that meet the minimum specified environmental criteria and the quality requirements defined by the Indian Standards. Under this scheme,

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the firm has to document the environmental conservation methods employed, starting with the raw material extraction to manufacturing and finally to the disposal. Other programs include but are not limited to the National Afforestation Program to develop forest resources with public participation and the National Action Program to combat desertification, which aims to improve drought management preparedness and mitigation, raise awareness, and support R&D, etc. The Grant-in-Aid Program was designed to develop initiatives in wasteland development and plantation, etc. by enrolling NGOs in influencing and motivating people at grassroots level (Datamonitor, 2011).

Sector Specific Policies

In 2009, India has announced an ambitious biofuel policy for the energy sector to substitute 20% of petroleum fuels in transportation by bioethanol and biodiesel by 2017. This policy hopes to curb the carbon emissions, to reduce the dependency on fossil fuel imports and promote energy security, as well as rural development and reclamation of degraded lands. Globally, the range between five and twenty percent substitution was set by various countries to be in effect between 2010 and 2030. In the past (2007), India consumed about 156 million tons of crude oil, A I imports could rise to six million barrels per day by 2030, which would make it the third largest importer of oil (Ravindranath, Lakshmi, Manuvie, & Balachandra, 2011). The aquaculture sector is fortunate to attract attention on environmental policy matters as well. There is an increasing interest and practice concerning the use of voluntary instruments or soft law for the management of aquaculture, particularly for export-oriented commodities such as shrimp. These measures include Codes of Conduct, Codes of Practice, Good Aquaculture Practices, Better Management Practices, and other standards and certification schemes. Many countries suggested that the investments in environmental monitoring should be better connected to management measures (Phillips et al., 2009). Strict self-regulation and cluster approach for maintaining an environmentally friendly aquaculture was suggested by others (Pathak, Ghosh, & Palanisamy, 2000). The effluents from pond aquaculture resemble non-point sources of pollution and application of traditional effluent treatment methods to meet the effluent standards may not be achievable or sufficient (Boyd, 2003). With increased industrialization and urbanization, India is experiencing stress on water resources thus gradually shrinking the share of aquaculture in access to the country's freshwater resources. Increasing water productivity through recycling waste-water was suggested as an option for aquaculture enterprises, based on the case of Kolkata city, where sewage-fed aquaculture was practiced for decades without prior chemical or biological treatment. Effluents (e.g. low value water from dairy, brewery, rice mills, food and beverage plants, and silk reeling industries) have been effectively incorporated into the aquaculture system for fish production and have increased water productivity (Jayasankar, Mishra, Sahu, Giri, & Saha, 2011). To mitigate the negative environmental impact through the use of antibiotics and drugs, alternatives such as the use of probiotics (helpful microbes) and vaccines (Vignesh, Karthikeyan, Periyasamy, & Devanathan, 2011) were proposed. The success in the future will depend on the progress of biotechnology: to combat diseases using vaccines instead of chemotherapeutic agents; to promote the use of disease-resistant brood stock; to employ cost effective nutritious feed and feeding mechanisms; the use of live feed production for the larvae of fin fish; and to manage pond health and effluent treatments (Rath, Das, Jayaram, & Saha, 2011). Increased attention is also being paid to the aspects of safety, health and environment (SH&E) in aquaculture and other work places. A National Policy (GOI-NP-SH&E) on this matter has been created to address the key issues pertaining to SH&E in light of the estimated 18 million cases that are pending on occupational diseases such as, hearing loss, chronic obstructive lung disease, asthma, injuries, cancer, etc in India (Mandal, 2009).

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International Treaties on Environmental Change Ratified by India

On the international stage, India signed and ratified various treaties in an effort to share the responsibility of curtailing the factors impacting global climate change. Some examples include: the Vienna Convention for the Protection of the Ozone Layer (1991); the Montreal Protocol on Substances that Deplete the Ozone Layer (1992); the UN Framework Convention on Climate Change (UNFCCC) (1992); the Framework Convention on Climate Change (1993); the Convention on Biological Diversity (1994); the UN Law of the Sea (1995); the UN Convention to Combat Desertification in those Countries Experiencing Serious Drought and/or Desertification (1996); the Kyoto Protocol (2002); the Cartagena Protocol on Biosafety (2003); and the Stockholm Convention on Persistent Organic Pollutants (2006) (Datamonitor, 2011). Additionally, in 2010, as a first step to mitigate the emissions from industry, India and the U.S. signed an agreement on the Partnership to Advance Clean Energy (PACE) to establish a bilateral energy cooperation program to promote clean and energy-efficient businesses (India-Pollution).

Environmental Impacts

The environmental degradation in India (industrial pollution, soil erosion, deforestation, rapid industrialization, urbanization, and land degradation) is a problem natural resources with the growth of the economy. Being factor-driven, the Indian economy still relies on coal for energy generation. With the pertinent threat of climate change, India was called upon to make a strategic shift away from coal and use oil, gas, or renewable or nuclear energy instead, which would increase the cost burden on the country (Jain & Jain, 2011). Some scholars argued that renewable energy is comparatively cheaper than nuclear energy and cautioned the risks involved with nuclear plants due to the recent Fukushima disaster (Chokshi, 2011). Chokshi (2011) showed that the energy demand forecast of a 5.9% increase by 2030 (to be met by nuclear energy I P C ‘ can be easily met by upgrading the existing electricity distribution infrastructure and correcting transmission losses.

In 2007, India's per capita CO2 emissions were approximately 3,000 pounds compared to China (10,500 pounds) and the U.S. (42,500 pounds) in that year (India-Pollution). In a research paper, Goldar, Bhanot and Shimpo (2011) looked specifically at the emission level I foreign trade sector (for example, cotton textiles) and found that India is a net importer of emissions from trade inflows as the total (direct and indirect) emission coefficient was many times higher than its direct emission coefficient. Both China and India have initially declined to sign onto the emission caps fearing to sacrifice their economic growths as they do not have the resources to make a switch to clean technologies and have pointed out that the problem was created by industrialization of the West in the first instance (Dutta & Radner, 2012; India-Pollution). In response, the Western economies have discussed various punishment options that range from the possibility of trade-related sanctions to escalating targets on emission cuts if the first set targets are not met. Using a mathematical modeling approach, Dutta and Radner (2012) showed that such a sanction is ineffective and proposed curtailing the W B contingent foreign aid would be a feasible option to make China and India comply with the emission targets. A key provision of the Kyoto Protocol is that the signatories take on legally binding caps on their carbon emissions if they A B (which includes all high-income and transition economies), while the non-Annex B countries (mostly developing countries) do not have any caps (Atkinson, Hamilton, Ruta, & Van, 2011). Although India and China are non-Annex B countries, due to their higher emissions, they were asked to voluntarily participate in curtailing their emissions. By doing so, Du, et al. (2011) feared that environmental impacts will be shifted from service-oriented economies to other economies if the targets for emission caps are enforced on the location of emission rather than the location of final consumption. Taxing carbon at the border of an importing country was proposed and Atkinson et al. (2011) cautioned that such taxes could erode the open, fair, and rule-based trading system in turn aggravating the losses in efficiency and welfare, particularly in developing countries. Du et al. (2011)

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argued that such tax policies will trigger shifting carbon-intensive production to China or India, undermining efforts to cut GHG emissions and contain climate change. Carbon leakage (an increase in CO2 emissions in exporting country as a result of reduction in emissions in importing country with a strict climate policy) could also occur due to such initiatives. In 2010, India announced its target of a 2025% cut in its emission intensity by 2020, compared to its 2005 levels, after China announced the target of a 4045% cut. Vazhayil and Balasubramanian (2010) analyzed the intensity targets of India and China using elasticity parameters and showed that stringency factors evaluated for India (40%) are relatively more stable than those for China (90%). They have demonstrated the extent of coupling and decoupling of economic growth that is required to meet the emission targets using the energyGDPemissions index (EYE index). The bilateral India-US PACE agreement in 2010 was one such move to advance clean energy, which forms the core of the green partnership with a joint fiscal commitment of USD 175 million in the renewable energy sector. In a similar vein, the World Bank agreed on January 13, 2011 to further strengthen its partnership with India and to advance India's green-growth agenda. The Bank will now support the CPCB, the SPCBs and the biodiversity conservation initiatives to strengthen various projects (India-Pollution). Goldar, Bhanot and Shimpo (2011) showed that approximately 30 million tons of emissions could have been avoided if export-portfolio prioritization was considered based on the order of increasing emissivity: horticultural exports (agriculture exports); services exports; drugs and medicines; textiles (excluding cotton textiles); petroleum products and products of steel sector. To encourage the carbon cap movement, the World Development Report-2010 suggested transferring funds and technical assistance from wealthy countries to developing countries (Vazhayil & Balasubramanian, 2010). According to the World Human Development Index [which is an average of three indices: the life expectancy index (LEI), the education index (EI) and the GDP index (GDPI)], India stood at the 134th position and some scholars have argued that no country in history has improved its level of human development without corresponding increase in the per capita use of the energy (Vazhayil & Balasubramanian, 2010, p. 7443). An energy roadmap with an efficiency focus has been proposed I I E P P Commission, India, 2006) and it has rolled out the National Action Plans on Climate Change. China has been on the forefront of such integrated energy policy W I Vazhayil and Balasubramanian (2010) initiated a study to determine the developmental impact of climate change by correlating I 2007 HDI (0.6) with the per capita commercial-energy consumption of 365 kgoe and HDI with the per capita electricity consumption. They calculated that about 2,500 kgoe energy or 4,000 kwh electricity is required to attain a HDI value of 0.9. They also estimated a progressive GDP drop of 0.53%, 1.36% and 4.06% by 2030 for cumulative carbon caps of 10%, 20% and 30% respectively, leading to the rise of the poorer population fraction by 2.1%, 5.9% and 17.5% respectively. The empirical analysis shows that the stringency of achievement of the emission-cap target depends on the nature of intensity targets and the historical relationship between the GDP growth rate and the emissions growth rate, which is captured by the GDP elasticity of emissions. The elasticity parameters and stringency factors were found to be 0.611 and 40% respectively for India and 0.447 and 90% respectively for China (ideal elasticity being 1.0). The sensitivity analysis (with various economic growth scenarios) showed that the higher elasticity parameter of India gave a higher probability of achieving the emission intensity target. The structural nature of emissions and the past growth curve has also placed India on a greater stability path in reducing its emissions, independent of the fluctuations in the GDP growth rate. Chatterjee (2009) recognized HDI as the sustainability indicator but was critical of India 128th rank, out of 177 countries, by HDI ranking. This rank is far below few medium- and low-income countries such as Guinea. However, when GDP by Purchasing Power Parity (GDP-PPP) is considered (which is one of its main indicators of growth), India ranked fourth, next to Japan, out of 193 countries, placing India very high on the HDI. He argued that t I indices (HDI and GDP-PPP) shows that the rise in the purchasing power must come at some cost resulting in the lack of human well-being as observed in logical poverty, which is ignored in normal economic performance

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indicators like GDP or GNP. Chatterjee also argued that sustainable development is not all about the environment and suggested that the concept should be broken down into its local- and impact-level components and must compare apples-to-apples with the developmental drivers, which he determined are feasible at the local and impact level i.e., villages and village communities. He also suggested that the Integrated Energy Policy should be implemented to make the natural resources sustainable and the development flexible. Hiremath et al. (2010) remarked that an ecologically sound development of a region is possible only when the energy needs are integrated with the environmental concerns at the local and global level. They reasoned that the centralized energy planning (CEP) (which ignores energy needs of rural areas and the poor, as well as the environmental degradation due to fossil fuel consumption and forest degradation) would lead to a dysfunctional emission reduction. Instead, Hiremath et al. suggested that a bottom-up, decentralized energy planning strategy (from village to district) using various cost-effective development scenarios such as alternate energy sources could be evaluated. The scholars argued that the best scenario could then be selected based on low costs to the economy and the environment. By doing so, it was shown that the energy needs could be met up to 2020 using biogas and electricity from local biomass resources. This process would also enable the local regions to meet multiple goals such as self-reliance, creation of local employment, and reclamation of the waste land apart from the reduction of the CO2 emissions. Air quality remains another concern in India with the diesel fuel used in automotives containing up to 200 times the amount of sulfur than European diesel (Wakefield, 2009). As stated previously, to achieve a 20% substitution target in replacing the petroleum fuels for transportation, scholars have conducted a feasibility study and determined that land in the range of 3.82 million and up to 93.26 million hectares would be required for such an effort depending on the type of biofuel crops selected. Furthermore, the Biofuel Policy emphasized the production of those crops only on waste or marginal lands, which the scholars say could be possible in India (Ravindranath et al., 2011). To revive the deforested land and to rejuvenate the greenery, forest ecosystems and resources, the Joint Forest Management (JFM) Program was initiated during the early 1970s at a pilot scale. The program is currently implemented by 106,482 JFM Committees and covers 22 million hectares of forests spreading across 28 constituent states of India and the union territories. The idea of community participation was solidified in the form of the Government Order of June 01, 1990, which placed emphasis on sharing the responsibilities, control, and decision-making authority over forest-lands as well as the forest products between the Forestry Department and local user groups. This resulted in success as well as failure. Failure was attributed to the lack of a conflict resolution mechanism, a fragile institutional arrangement, inadequate participation of people, an inefficient accountability mechanism, and poor collaboration between the state forestry departments and the communities (Bhattacharya, Pradhan, & Yadav, 2010). Goffman (2008) observed that the globalization of any economy is bringing in its wake notions of materialism and consumerism that do not match with the Indian traditions of austerity, simplicity and spirituality. He questioned whether the future is for all, including the masses . . ., or will it be a future for a few: the well- educated, westernized, globally-connected, consumerist elites and middle class of India? (Goffman, 2008, p. 4). Population growth is one of the key driving factors putting pressure on natural resources, generating more waste, and leading to environmental degradation. To realize growth together with environmental improvement, Goffman argued that technical progress, in sync with the policies, which induce it, is by far one of the most important factors. This truism was emphasized in developed countries where the local air and water pollution levels are orders of magnitude lower than in the developing countries, even though their economic outputs per capita are an order of magnitude higher. He pointed out that in a globalized world, the analysis should include the consumer appetites of the developed countries, considering that many consumer goods are manufactured in less developed countries (Goffman, 2008).

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A growing population in India is placing increasing stress on its water resources as well, a situation likely to be aggravated further by climate change. A WW I I water in urban areas is expected to double and industrial demand to triple by 2025, rela (Goffman, 2008, p. 8). The Agricultural Policy cannot be separated from water use as I for agriculture. India rivers are getting polluted with human waste, garbage, industrial output, and human remains. Global warming is adding to this threat and scientists forecast that the Himalayan glaciers that are the sources of water for the river Ganges could disappear by 2030 (Goffman, 2008) and fluctuations and shifts in the timing of the overall amounts of rainfall could become common (Goffman, 2008; Jain & Jain, 2011). Unfortunately, the governance between central departments responsible for water-related issues is fragmented: the ministries of water resources, rural development, agriculture, and urban development work ineffectively together. However, at the local and grass-roots level, farmers and engineers, such as B. J. Kumara Swamy, are trying to implement techniques like rainwater harvesting, creating ponds to contain run offs, and conservation measures, to improve the situation (Goffman, 2008). Fiscal allocation for the National Ganga River Basin Authority has been doubled in 2010-11 to INR 500 crore (~USD 108 million) with a mission to clean the Ganga River by 2020 as per the National Clean Energy Fund (India-Pollution). In another instance, in 2007, the non-profit Earth Trust established Eco-Clubs at two disadvantaged schools in the region of the Nilgiris hill district (also described as the lungs of South India) to protect the rich biodiversity and dense shoal (stunted evergreen) forests. With the aim of developing green consciousness and social responsibility, the Eco-Clubs promoted waste recycling, composting, organic gardening, and the efficient use of school land, in two disadvantaged schools. The Eco-Clubs program was quickly expanded to 16 other schools. This encouraged many parents to create their own organic Kitchen gardens at home. For example, at the Thenali School, this led to the creation of at least 22 organic home gardens (Orr & Kumar, 2010). As much as 30% of India's gross agricultural output was estimated to be lost each year due to soil degradation, poor land management and counterproductive irrigation. It was also estimated that almost 5.3 million hectares of forest have been destroyed since the independence in 1947 (Wakefield, 2009). Biotechnology is , and environmental sustainability (Goel, Garg, & Garg, 2008) just as the Green Revolution had its origins in science and technology, particularly in the science of genetics. Therefore, the application of novel biotechnological tools could lead to gene revolution and thus enhance crop productivity (Dudhare & Deshmukh, 2008) with the same or less input of what has previously been used. The total energy input per a given land area can thus be minimized and the output maximized. Although the expectations resting on biotechnology are very high, skepticism was expressed in the case of genetically modified seed technology (Bt seeds), as they did not result in any exemplary improvements in agricultural practices and agrarian relations shaped by the Green Revolution. In turn, B proclaimed to be due to the cotton- experience and culturally consolidated ability to perform with the technology. Taking B V M the state of Andhra Pradesh, Shah (2008) “ that the enabling conditions for social and environmental learning involve a combination of a range of social, historical, and technological factors, which are culturally linked to reproducing a successful agricultural performance. The absence of such technological culture can result in the lack of such performance, even when the artefact (Bt cotton) in question is same (Shah, 2008, p. 444). T I (Shah, 2008). I 7,516 km of coastline has also come under attack from environmental sabotage, and overfishing remains a huge problem due to the lack of legislative enforcement (Wakefield, 2009). Residual insecticides from runoffs, industrial effluents, in addition to domestic sewage that is intentionally discharged into many of the rivers, are posing a major threat for fisheries (Rath et al., 2011). Aquaculture practices are not green either. Widespread use of antibiotics (Emerson, 1999; Patterson, 2011; Vignesh et al., 2011), disinfectants (Patterson, 2011), chemicals such as copper sulphate, ammonia (Rath et al., 2011), excessive application of fertilizers (Patterson, 2011),

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supplementary feed, and herbicides used for controlling aquatic weeds such as 2,4-D, Dalapon, Paraquat, Diuron, etc (Pathak et al., 2000), are posing significant environmental concerns and risks to consumers' health (Jayasankar et al., 2011). The global trade in aquatic animals and their products also poses a threat of trans-boundary spread of pathogens. Biosecurity, which is a system of cumulative steps for the prevention, control and eradication of infectious diseases to protect farm stock, requires to be stringently implemented from the hatchery through the rearing stages to the consumers (Jayasankar et al., 2011). Patterson (2011) explained that the issue of the environment remains the same even with global aquaculture. The fundamental problem, he states, is that aquaculture is profit driven and methods employed are not environmentally sustainable. L G ‘ I B ‘ s rapid production methods rather than sustainability. Deliberate use and abuse of antibiotics/antimicrobials demonstrated to be the threats to an ecosystem, as many of them remain recalcitrant. They were also shown to accumulate in edible tissue of aquatic animals which may cause allergies, toxic effects, changes in the intestinal composition of microbial fauna, and lead to the acquisition of drug-resistance etc. These treatments negatively affect the phylogenetic structure, create resistance expansion and create disturbances in ecological functions. Hektoen et al. (1995) showed that antibiotics buried in sediments as shallow as 1-7 cm have half lives of more than 300 days. This emphasizes the accumulation capability of these compounds in the aquatic environment to dangerous levels that may affect benthic (living organisms associated with the bottom of a body of water) communities and enter the food chain. At present, antibiotics contribute considerably to the growing problem of active medical substances circulating in the environment. It is for the above reasons that most of the importing countries have completely banned the use of certain antibiotics in aquaculture, which is seen as a solution to prevent malnutrition and poverty, particularly within the developing world where over 93% of global production is currently produced. It is expected to deliver an affordable and much needed source of high quality animal protein, lipids and other essential nutrients. In the wake of the Blue R to three decades, there was massive growth in fish and shrimp aquaculture segments contributing to India's export value and also negatively impacting the environment in the region (Vignesh et al., 2011). However, release of large volumes of water containing nutrients, organic matter, and waste at the time of fish harvest was reported to have resulted in eutrophication of receiving waters and algal blooms (Pathak et al., 2000). Seepage of toxic compounds, residual pesticides and the heavy metals used in feed supplements were shown to contaminate ground water, to lead to organic contamination of creeks, including bacterial [some fish pathogens such as Streptococcus sp. can infect humans (Emerson, 1999) pathogens of human interest such as Salmonella and Shigella (Surendraraj, Farvin, Yathavamoorthi, & Thampuran, 2009) were reported] and fungal contamination, and blue-green algae growth and increased algal toxins (Emerson, 1999). As a result, the above pollutants are also changing soil characteristics (Pathak et al., 2000). Many other deleterious effects to the environment are reported: for example, the fish of Kolleru Lake are contaminated with metals and not suitable for human consumption due to the discharge of industrial effluents into the lake (Kavitha, 2010). Global warming is likely to create favorable climatic conditions for the growth of fish pathogens and is likely to cause a rise in disease occurrences and outbreaks (Jayasankar et al., 2011) demanding use of more chemotherapeutic agents to fight the current and emerging diseases. Gandhian philosophy is the need of the day. Mahatma Gandhi, Father of India, an ardent champion of sustainable development, strictly opposed the colonial modernity, which went beyond the carrying capacity of the H E . Today, the mankind should remodel their life styles if they are concerned about the mother earth, and the future generations and lead the life of plain living and high thinking as advocated by Gandhiji (Jain & Jain, 2011, p. 138) which also resounds with E. F. Schumacher, an ecological economist, who with regards to mining says (Saleem, 2009, p. 8).

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Policy Implementation and Performance

Curmally (2002) pointed out that the SPCBs have restricted their approach to pollution control to the C C T maximum limits of emissions, and power to withdraw the resources to the company and the imposition of a penalty) implying function restricted to a watchdog role over the industries. Also, an analysis of the Air and Water Acts, reveals that these legislations are just symbolic in nature. The author rationalized that the lack of proper environmental governance and regulation in India was due to the following deficiencies in the system: lack of resources; inadequate technical skills and funding; high interference of politicians; variations in enforcement; and the lack of incentives for the industry to comply with regulations. While the National Discharge Standards set by the CPCB, are technically feasible to abate pollution, they are generally economically unrealistic leading the SPCB into an inflexible position. The SPCB must either close the facility that is not complying with the standards (Closure of a facility has been used as a last resort by SPCB due to loss of jobs and economic livelihood for the community) (Datamonitor, 2011) or not enforce the standards at all. Also, in order to enforce the CAC, the SPCB needs detailed information about the prevailing environmental status in the region as a base line against which they can measure the pollution level (Curmally, 2002). The lack of a holistic understanding of pollution on an impact-area basis was PIL separately presented to the Supreme and High Courts. For example, if a lake is polluted due to both industrial and domestic effluent as solid waste, the handling of the complaint becomes confusing due to overlapping responsibilities of the SPCBs and the local authority. The Criminal Procedure Code is followed as per the Indian Environmental Act, but only two convictions have been made in the entire country up to 2007. Added to these, only one time direction for clean up or remediation has been imposed without any programmatic follow up (Chatterjee, 2009). The lack of progress surrounding these issues has been reflected in a recent report by the analysts at Datamonitor (Datamonitor, 2011). As per the Environmental Performance Index (EPI) in a study (which is comprised of 21 indicators that derive information from 76 underlying datasets covering all aspects of the environment) conducted in 2010, India stood at 123rd position out of 163 countries in terms of environment quality and standards. In spite of the political will and strong environmental policy framework that is in place, the desired outcomes are yet to be realized at ground level as the translation of the policy into action was inadequate due to the reason outlined above. An I annual increase over the past 10 years in the manufacturing sector, which includes electronics and information technology, textiles, pharmaceuticals, and basic chemicals. Some of these industries, as for example pharmaceuticals and basic chemicals, have been designated by the CPCB as red category industries, based on the effluents, air emissions and hazardous wastes that these industries generated. Analysts at Datamonitor (2011) suggested that India will benefit significantly if it adopts the United Nations Framework Convention on Climate Change, which allows industries in developing countries to receive funds to upgrade their plants and production facilities to make them greener. Under the Clean Development Mechanism, the production of more than five million tons of CO2 could be prevented in India by 2012. This translates into curtailing 10% of the country's GHG per year. It was estimated that up to USD 4.0 billion could be earned by Indian companies by trading their carbon credits from more than 1,000 projects (the highest number in the world) that were cleared by the Indian government (Datamonitor, 2011). Extrapolating these data revealed that the companies in India could earn up to USD 10.0 billion by 2020 (India-Pollution) if they start selling their carbon credits in the United Nations Clean D M -biggest GHG trading market), which would also attract foreign investments into the country. Additionally, the prudent decision of the Indian government to invest USD 500 billion in infrastructure improvements, to be rolled out in installments between 2009 and 2013, is expected to add to the abatement of air borne pollutants in the country (Datamonitor, 2011).

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Environmental Impact Assessment (EIA) documents focus on the future or potential effects of the development while the Environmental Auditing (EA) focuses on the actual effects of current development activities. Both indicate how effective the pollution control law is. EIA is a mandatory compliance document containing systematic analyses of planned activities with the central goal of achieving sustainable development of economy using optimum solutions (Kaur & Gupta, 2011). However, Panigrahi and Amirapu (2012) pointed out various deficiencies including but not limited to: screening and scoping; poor quality EIA reports; inadequate public participation; and weak monitoring. They argued that EIA has just been used as a tool for project justification instead of a planning tool for sustainable development. Elsewhere, experience indicates that political factors rather than technical factors have been the driving forces behind the introduction and the practice of EIA. In order to make the EIA a useful tool, changes in attitudes and behaviors of political leaders and public officials are warranted. Another reason for failure could be that the environmental policy has been less directional and more a listing of global best-intentions regardless of their compatibility with conditions at the impact level. The amended National Environmental Policy of the GOI, 2006 (NEP 2006) still lacks a direction and emphasis in its intent of institutionalizing social monitoring, gathering impact-level information, as well as up-dating, preserving, and managing the natural resource-use at the receptor levels (Chatterjee, 2009). Environmental auditing is another area where India is facing obstacles due to the lack of appropriate legislation and it still has a long way to go to meet international standards (Kaur & Gupta, 2011). As a step in the right direction, in March 2010, the organization of an international conference on EA regarding water pollution by the Comptroller and Auditor General of India indicated the seriousness of government effort towards societal responsibility. This effort also needs to be carried forward by private enterprises. Therefore, now the onus of creating environmental sustainability along with economic development has shifted largely from government to the corporate sector. Summoning the principle of the Polluter Pays, many laws have been formulated to alleviate air, water and noise pollution created by industrial units to socially acceptable and sustainable limits. It is expected that the corporate world will share the responsibility by adopting proactive pollution control measures and promoting environmental protection as part of its corporate social responsibility. This necessitates the corporate world to have an understanding of the state of the environment, including perception of threats and as well as future problems and opportunities and in turn the EA could be leveraged by corporations to meet these goals. In developed countries, the EA proved to be an effective tool and further impetus in this direction is being given by the publication of Agenda 21 and by the Fifth Environmental Action Program (1992) of the European Commission as well as the British Standards Institution (BS 7750). In the future, this will become a marketing strategy for those countries as customers in India will prefer buying goods produced by an environmentally committed organization. In realizing this benefit, the Indian government has introduced the Ecomark scheme as described in the section of Environmental Framework, Policies and Schemes of India (Datamonitor, 2011). Bandopadhyay (2010) derived the technical efficiency scores of cement producing firms in the presence and absence of environmental regulation, and determined whether there exists an incentive for a firm to comply with the standards set for pollution abatement. The study found that the firms that complied “PCB using pollution abatement technologies had benefitted from the pollution abatement systems by recovering the material leaked into the atmosphere which in turn enabled the firm to achieve higher production efficiency. Therefore, the corporations have an incentive to participate in this movement (Kaur & Gupta, 2011) to improve their production efficiencies. Due to some of the deficiencies in implementation mentioned above, India ranked in 2011 as the seventh most environmentally hazardous country on absolute environment impact when compared to 179 countries by researchers at Harvard University, Adelaide University and the University of Singapore. The United States were rated second and China was ranked third worst (India-Pollution).

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Socio-cultural Factors

Socio-cultural factors are crucial for a new entrant and respective investors. They need to understand the cultural norms and dynamics in the region for the purposes of communication, training programs and interventions, the design of benefits packages, the inclusion of provident fund matching, and choosing appropriate leadership style to manage the business successfully. Hence this section explores and describes the socio-cultural landscape in India and provides an overview of the culture and the social beliefs. It also aims to enable a potential new entrant to determine what policies need to be put in place to develop and retain human capital within the organization; the choice of the location for the business to have easy access to resources; the resources required for marketing its products and the precautions (if any) to be taken concerning religious beliefs. A portrayal of the national culture and its influence on an organizational culture using five-cultural dimensions as developed by Geert Hofstede will also be provided.

The Social Structure in India

Religion which creates social harmony is an integral part of a culture system and defines the social customs and principles. Religion makes people share common beliefs and thus a common value system (Shivani, Mukherjee, & Sharan, 2006). India has multicultural ethnic groups, and is a secular nation, with the freedom to practice any religion. Hinduism constitutes the largest religion, and is practiced by 80.5% of the total population, followed by Islam (13.4%), Christianity (2.3%), Sikhism (1.9%), and other (1.9%) (Datamonitor, 2011). The societal structure was built on a caste system based on the role each caste plays in the society. Based on that social hierarchy, the society was grouped under four castes: Brahmins, Kshatriyas, Vaisyas, and Sudras according to the law book of Brahmins, Manusmriti (Balley, 2011). Each caste has further divisions, which are mainly controlled by the type of work a person undertakes (Indian Mirror) which is especially true for the Sudras and others including the backward caste (BC), the scheduled caste (SC) (groups having low social and ritual standing) and schedule tribes (ST) (groups distinguished by their tribal culture and physical isolation) (Chin & Prakash, 2011). Due to this social divide and the fact that Sudras are being oppressed, the GOI has come up with Sudras in an effort to uplift them in society using special preferences, like public sector jobs, parliamentary seats and college seats (Indian Mirror). Dr. B. R. Ambedkar, an eminent scholar who authored the Constitution of India introduced the ‘ matter of charity. It is a (Balley, 2011, p. 1). The divide is a result of people being grouped H L Manusmriti. In India (compared to China and the West), religion and the caste system had some harmful effects on the establishment of economic freedom, capitalism and growth (Weede, 2010). Basu (2006) argued that this division of India along castes, religions, and tribal lines stemmed from British Empire Loyalists such as Dr. Ambedkar, who continued the legacy B furthering division and thereby I future. This division has not only raised issues and made the situation worse, but was also extended to include Muslims and Christians into the scheduled categories. The reservation system failed to deliver its promise as evidenced in the educational sector, where only 3% combined of SCs and STs receive degrees in engineering or medicine, although they add up to nearly one-fourth of the population in India. It was argued that India could learn lessons from history, for example from “ U free mass education system that eliminated social and economic backwardness. Instead of the caste criteria for the affirmation policy, which was dysfunctional, Basu suggested a policy framework aimed at removing the inequality of opportunity (poverty and physical disability), just like in Japan, Korea, Taiwan, and Vietnam where backwardness was eliminated within ten years of its implementation. He further remarked, that implementing reservations based on the caste like in India constitutes the most unethical system one can imagine. Basu argued that there are underprivileged and deprived individuals even in the upper castes, who

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cannot access the benefits on one end, and multimillionaires in the reserved category, who are enjoying the quota system, on the other. Gender bias and social stratification are other issues in India. To overcome at least one of these issues Deininger et al (2011), suggested policy revisions to the women reservation system. They exemplified the cost/benefit scenario of female inclusion in leadership roles, and the resulting long-term benefits such as: willingness to contribute to various forms of public goods (e.g. maternal health and peri-natal care for girl children, drinking water, and food for work programs); enhancement of political participation in the presence of female leadership; improvement in access to health services etc, that would outweigh the short-term cost such as the lack of experience and limited autonomy in decision making. The researchers found that the willingness to contribute to various forms of activities for the public good is significantly higher in panchayats (village governments) with female Pradhans or Sarpanchs (President), compared to panchayats presided by a male Sarpanch.

Social Welfare Policy and Programs in India

In 1951, India became the first country to launch a family planning program in an attempt to control its population escalation. Contraception, reduction in maternal and infant mortality, and birth rates, became the central thrust in the subsequent five year plans of the nation. The importance of reducing the number of children desired by families took front seat in the past five year plans, while the emphasis shifted to health care in the 10th five year plan (2002-2007). Subsequently, the Planning Commission of India established a working group on population stabilization during its 11th five year plan (20072011) to review the progress on targets set in the National Population Policy of 2000, and to predict the timelines for population stabilization. In terms of human development India placed 119th out of 169 countries, as per 2010 HDI, due to poor performance in social indicators, as for instance 47% of the Indian children are underweight and 45% suffer from stunted growth. The respective numbers for China were 10% and 14%. The states of Bihar, Rajasthan, Uttar Pradesh, Madhya Pradesh, Jharkhand, and Chhattisgarh remain underdeveloped, with no visible progress in improving social indicators. Due to the lack of government attention to some of these states, more than 30% of Indian districts are under the influence of left-wing radicals (Naxalites), and Bihar, Jharkhand, and Chhattisgarh became naxal strongholds (Datamonitor, 2011).

Social Security Programs in India

In order to tackle the problem of unemployment in rural areas, the GOI launched the Mahatma Gandhi National Rural Employment Guarantee (MNREG) Scheme in 2005. Initially, 200 districts were enrolled which was extended to 130 more in 2007, and finally in 2008, to the entire country. In 2010, a record amount of USD 8 billion was allocated to this program. Subsequently, the wage rates were indexed to I inflation in the union budget for 20112012. The scheme envisages guaranteeing a minimum of 100 days of employment each year to every household whose adult member(s) is (are) willing to perform unskilled manual work (Datamonitor, 2011; Jha, Gaiha, & Pandey, 2012). Sharma (2010), expressed concern about one pitfall of this scheme: it could lead to phenomenon called de-skilling, where a skilled artisan could turn into a stone breaker if the unskilled job pays more (Sharma, 2010). Some analysts suggested that MNREG initiative, if implemented properly, is expected to minimize unemployment in the rural areas of India (Datamonitor, 2011). A survey, conducted in 2009-2010 by the National Sample Survey Office, found that the rural unemployment rate declined from 8.2% to 6.8% in 2004-2005, while the urban unemployment rate also declined by 2.5 percentage points to 5.8% during the same time frame (The Economic Times, 2012). On the contrary, the economic reforms post 1990, have further widened the gap between job vacancies and the number of unemployed individuals. Basu (2006) stated that in a market economy increasingly depending on external forces, this gap cannot be minimized even by the reservation system for the

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chosen groups (BCs, SCs and STs). He suggested that only a planned economy, which adjusts its production to the needs of the community, can distribute the work and guarantee a livelihood to every man, woman, and child. In spite of the MNREG program, over 25% Indians still live on an extremely low income of less than USDviii 1 (INR 45) a day and it was reasoned that 70% of the allocated funds do not reach the intended beneficiary due to poor governance and administration. On the contrary, innovation was co-evolving with the design of this policy as the overall scheme has been designed using the M Innovation Framework, where it became a law that the intended beneficiary is able to sue the government for not getting his or her entitlement. Other features include an inbuilt system of self-criticism and transparency (for example, advertising its own deficiencies). At the ground level, the programmatic scheme is allowing the villagers to develop creative solutions to their local problems, such as for instance K G F e idea of building check dams on a nullah (canal) which recharged all wells in the area. To date, the program has provided employment to 5.06 crore (50.6 million) households, and has taken up nearly 43 lakhix (4.3 million) projects, of which 42% were completed. The average minimum wage has also improved by 30% to INR 84 (USD 1.87) a day in the last three years. With the encouraging accomplishments, t attracted 156% more in funds reflecting an increase from INR 16,000 crore (~USD 3.66 billion) in 2005, to INR 41,000 crore (~USD 8.86 billion) in 2010 (Sharma, 2010). The Employees' Provident Fund (EPF) and the Employee Pension Scheme (EPS) were introduced by the Ministry of Social Justice and Empowerment, to provide pension coverage to the government employees. The EPF was further extended to surviving family members of the EPF members, under the Family Pension Scheme in 1971. In 2004, the government reformed the Pension System from the defined-benefit system to a defined-contribution system. While this program is mandatory for the government employees, contribution up to 10% of their salary, it is voluntary for self-employed individuals, private companies, and the unorganized sector. At the state level, initiatives such as the National Program for Rehabilitation of Persons with Disabilities, and other programs that cover the neglected and marginalized segment of the population, including abandoned, destitute, neglected, and delinquent juveniles are being implemented. Private corporations are also contributing to the formulation and the implementation of these policies and programs (Datamonitor, 2011). To cover the private sector workers in organizations with more than 20 employees across 177 industry categories, the Employees' Provident Fund Organization (EPFO) was set up in 1952, which is regulated under three sets of legislations namely, the Income Tax Act of 1961, the EPF Act of 1952, and the Indian Trusts Act of 1882 (Datamonitor, 2011). Article 43x and Article 39xi of the Indian Constitution under the title of living wages and equal pay for equal work were actually never implemented as a living wage act, but were transformed to a minimum wage act (Channa, 2010). The Central Government raised the minimum wage to INR 115/day (~USD 2.56) on April 01, 2011, from INR 100/day (~USD 2.07) in 2009, based on the increasing Consumer Price Index. The concept of the National Floor Level Minimum Wage was mooted on the basis of recommendations of the National Commission on Rural Labor (GOI-NFLMW, 2012). The Minimum Wages Bill is also implemented differentially in different regional states of India. Channa (2010) argued that in the wake of the rising cost of living in India, a minimum wage of INR 115/day can in no way cover complete meals as well as minimum requirements concerning housing, clothing, health care, and medicine. The Fair Wear Foundation computed the required wage for India to cover living expenses (corrected to inflation) as INR 7,698 per month, which translates to INR 296/day (~USD 5.32) (FWF, 2012). A gap of 157% still exists between the wage requires to cover basic living expenses and the minimum wage. This suggests that GOI, to provide a fair living wage to its citizens, still has the responsibility to catch up with rising inflation and cost of living. . In states like Haryana, the minimum wages were redefined as INR 186.42, 196.42, 206.42, and 211.42 (~USD 3.35, 3.53, 3.71 and 3.80) per day in unskilled, semi-skilled, skilled, and highly skilled job categories respectively (The Times of India, 2012). At least in Haryana for example, the minimum wages stipulated at the state level, are higher than the minimum specified by the GOI.

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A point to note is, that in coastal fishing 99% of the workforce is engaged in fishing and post harvest processing activities in the unorganized sector and does not receive any social security benefits (A. Kumar, Katiha, & Joshi, 2003). Kumar, Katiha, and Joshi (2003), argue that the process of industrial liberalization and the structural adjustments have increased the suffering of the poor coastal communities. According to their observation the survival of these communities is dependent on income generated from common pool resources of the coastal regions, which are declining and degrading. The developmental projects or areas such as ports, tourism, and aquaculture are aggravating this problem further. In order to supplement their family income, the coastal poor are changing occupation to seasonal laborers in agriculture or as part-time farmers. Child labor is a prevailing concern globally including India. Worldwide over 132 million children ages 5 to 14 years work in crop and livestock production, forestry, and fisheries. According to a report released by the US Department of Labor, Bangladesh along with India, Myanmar, Brazil, China, and the Philippines constitute the 'top six countries' linked to individual products that use children as forced laborers. In another study, conducted by the National Labor Institute of the GOI, child labor represents around 40% of the workforce in the fisheries sector. In 2001 I Census report estimated that about 12.7 million children between 5 and 14 were economically engaged in child labor. The fish processing units and the micro fish trading (e.g. collection of shrimp seeds and selling to middlemen, door to door selling of fishes etc) in various coastal states of India were found to employ child labor (The Centre for Education and Communication, National Labor Institute). Prohibition acts, such as for instance the Child Labor (Prohibition and Regulation) Act, were enacted in 1986, but the implementation progress and results are disappointing (Halim, 2010; NCPCR, 2006). Significant cooperation is required from public and private sectors to implement the above child labor act and mitigate the deprivation of child rights.

Skills, Literacy Rates, Education, and Training the of Indian Population

India has 12 years of mandatory education prior to high school. The GOI, through the Department of School Education and Literacy, is committed to providing a universal elementary education (primary and upper primary level) for all children ages 6 to 14. According to the National University of Educational Planning and Administration (District Information System for Education, 20052006), India has 1.12 million schools, which are either controlled by State School Boards or the Central School Board, or by the Council for the Indian School Certificate Examinations, or the National Institute of Open Schooling, depending on the affiliation of the school. International schools, with curricula similar to western school system are gaining popularity, but are significantly more expensive than the school systems mentioned above. The syllabi prescribed by any one of the above- mentioned councils or boards are followed in the international schools. (Datamonitor, 2011). Higher education in India on the other hand is indirectly controlled by the Department of Higher Education reporting to the Ministry of Human Resource Development, and funded by the state governments. In addition to the state controlled universities, there are 18 central universities which are governed and financed by the central government. Some of the world renowned institutes for learning include: the Indian Institutes of Technology, the Indian Institute of Science, the Indian Institute of Management, the All India Institute of Medical Sciences, the Indian Statistical Institute, the Tata Institute of Fundamental Sciences, and the Indian School of Business (Datamonitor, 2011). Strategic frameworks from international universities such as Stanford U India Initiative, B C U M I, are evolving to engage Indian students in projects such as joint academic research, co-op placements, student exchanges in the areas of clean energy, life sciences, new media and film sectors (SFU), as well as business/trade relations programs (SFU). I A (reservation) Policy, which was intended to improve the educational status of underserved communities, allocates reserved spots for students from these communities even in elite universities. In a study Basu (2006) reported that "none of India's elite universities and engineering institutes had filled its quota for members of scheduled castes" (p. 1).

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As of mid 2011 the estimated literacy rate totals 74.04%, an increase of 9.2 percentage points from 2001 results, which is still far less compared to China, which has achieved a 90% literacy rate. The literacy rate has increased by 6.9 percentage points for males and 11.8 for females since 2001, and in 2011 stands at 82.14% and 65.46% respectively. The gap between male and female literacy rates shrank from 21.59 to 16.68 percentage points from 2001 to 2011. The Planning Commission of India, envisions reducing this gender literacy-gap by another 10 percentage points by the end of 2012, with the ultimate goal of achieving 100% literacy in the country. To date, Kerala is the only Indian state to reach the 100% literacy goal. Literacy is considered as one of the key factors in human development, and analysts in 20102011recommended a 14% increase in investment towards social services, including education, to yield the desired literacy rates, raise the rates in the female population, and to improve I HDI rank of 119 in 2010 (Datamonitor, 2011). Vocational (occupational or professional) training plays a vital role in the growth of an economy. The lack of formal technical training or intrinsic knowledge on fish farming and management were reported to be common problems in several Asian countries, such as, Bangladesh, Vietnam, and Thailand as well as India. Abraham, Sil, and Vineetha (2010), conducted a survey of seven districts in AP state and 13 districts in WB, and compared the qualifications and formal training acquired by the fish farmers. These two states were the leaders in fish production. The findings suggested that 68% of the farmers surveyed in WB had undergone short-term training in aquaculture, and 15% of the farmers surveyed had graduate degrees. In the state of AP, only 2.7% of the fish farmers were graduates, and 41% of the individuals interviewed had training in aquaculture. The majority (48%) of the farmers in AP learned about aquaculture through day-to-day experience and gathered information from the government outreach workers, educational institutions, peers, friends, and neighbors. The feed and drug sales personnel were the information source on disease management for 60% of the AP farmers interviewed, while the role of non- NGO this exercise was found negligible. On the other hand, about 50% of WB farmers learned aquaculture similar to their counterparts in AP. The results also revealed a lack of coordination in implementing the scientific advancements in aquaculture between the government outreach officers and the farmers.

The Healthcare and Nutrition Programs in India

The Health and Family Welfare Department in India, in line with the National Health Policy, introduced major health programs such as national programs for the eradication of malaria, blindness, leprosy, tuberculosis, and AIDS, the control of sexually transmitted diseases, and cancer. The major drawback in the health care system is that there is no universal health insurance that covers the entire population (Datamonitor, 2011). The plan for basic health coverage for the poor and marginal workers (workers who had not worked for the major part of the reference period i.e. less than 6 months) is known as the Rashtriya Swasthya Bima Yojana, which has now been extended to the beneficiaries of Mahatma Gandhi National Rural Employment Guarantee Act, like beedi (Indian local cigarette) workers, workers in hazardous mining industries, like slate and slate pencil, dolomite, mica, and asbestos and associated industries. In the 2011 national budget, the Finance Ministry announced a USD 5.3 billion or 20% increase over the previous year for health care spending in 2011-2012. In absolute terms, the total healthcare expenditure (public and private) increased from USD 53.6 billion in 2009 to USD 66.4 billion in 2010. Critics argue that this level of spending is inadequate, considering the scale of the healthcare scarcity in the country and the substandard service quality. Under the constitutional structure of India, public health care is the responsibility of the individual states. If significant improvements in public health services in the country are to be achieved, substantial resources need to be directed towards the health care sector from the central government budget. The National Health Policy of 2002 was formulated taking into consideration these veracities (Datamonitor, 2011).

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The urban areas in India are covered by private hospitals, such as Apollo, Escorts, Tata Cancer Institute, Care, and Max India. Additionally, there are a large number of regional/city-specific hospital chains. India has one of the biggest private hospital networks in the world. The private-hospital sector is gaining popularity in medical tourism from developed nations, due to its expertise, quality of treatment, and cost benefits (Datamonitor, 2011). Unfortunately, these hospital networks are inaccessible and unaffordable to the poor rural population of India. Life expectancy in India has increased from 60 years in 1990 to about 67 years in 2011, while the infant mortality rate has declined from 8% in 1990 to 4.6% in 2011. (Datamonitor, 2011; Index Mundi, 2012b). Although remarkable improvement was recorded longitudinally, horizontally when compared to the neighboring country C C higher and the infant mortality rate at 1.606% is significantly lower than India (Index Mundi, 2012a). The Indian government has enacted significant initiatives in the rural areas, such as creating a large-scale rural health infrastructure, supported by over 0.5 million trained doctors (working under plural systems of medicine), a vast force of frontline workers, and community volunteers (Datamonitor, 2011). The Article 47 of the Constitution of India mandates as its primary duties raising the level of nutrition, the standard of living of its people, and the improvement of public health (Channa, 2010). As Jha, Bhattacharyya, and Gaiha (2011) pointed out, more than 75% of the population has a daily per capita calorie-consumption below 2,100 in the urban areas and below 2,400 in the rural areas. These numbers were referred to as the minimum calorie intake requirements for a typical Indian and the optimal cutoff points for daily intake of various nutrients are defined between 2,400 and 2,800 calories for urban and rural Indians respectively. When it comes to the nutritional deprivation, most attention was paid only to the macronutrient-calorie consumption, ignoring the need for macronutrient-protein consumption and the intake of various micronutrients, which raised concerns. Evidence points to the fact that this nutritional deficiency is leading to a vicious cycle of a poverty-nutrition-trap, where malnutrition is leading to decreased productivity, which in turn leads to low wages, and consequently again to inadequate nutrition. In a similar vein, Channa (2010), reflected Swami A wage program, in which a need-based minimum-wage should be determined, allowing meeting the minimum food requirement based on a net intake of 2,700 calories per consumption unit, as one of the decisive factors. Therefore, a properly designed and implemented workfare scheme (social welfare program such as MNREG, in which capable adults are required to perform work, often in public-service jobs, as a condition of receiving aid) was recommended (Jha et al., 2011). To address the macronutrient-protein deficiency, protein from fish-meat sources could be a very cheap and efficient alternative.

Census and Demographics of India

India, with 1.2 billion people, is the nation with the second highest population in the world (after China estimated to be 1.34 billion in 2011), of which approximately 70.2% live in rural areas, the remainder in urban areas. Its population is increasing at a rate of 1.344% per year (2011 estimate) which is raising concerns. In comparison, C population growth rate seems under control and is now estimated at 0.493%. I population is young, with a median age of 25 years, which indicates that India has a significant working age population, and those above the age of 65 constitute just 5.3% of the population. India has formulated a population policy that makes provisions for educating and controlling its escalating population. The median age in India in 2000 was 22.4, compared to the median age of 30 in China, 38 in Europe, and 41 in Japan. It is estimated that more than one- I 15 years of age, which gives India a competitive edge over other nations in coming years. In 2010, the age group between 15 and 64 constituted 64.6% and 30.1% were between 0 and 14 years. The female:male ratio improved seven points in a decade from 933:1000 in 2001 to 940:1000 in 2011. But for the gender ratio in children of age 0 to 6 years, a drop of 13 points was estimated in 2011 compared to the 2001 census, which remains a concern due to preference of male over female children. This

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preference of one gender over the other was primarily attributed to the mindset of the male-dominated society of India, which believes that females are a financial burden (dowries) for the families (Datamonitor, 2011; Index Mundi, 2012b).

Socio-Economic Status in India

Urban India, although it has less than one- I makes up two-thirds of the GDP s (Datamonitor, 2011). In the recent times, a strong migration of people from rural to urban areas was observed. It was estimated, that the net migration rate was slightly reduced to -0.05 migrant(s) per 1000 people in 2011 (Index Mundi, 2012b). People are moving in search for employment and better access to amenities and this migration exerts excessive pressure on urban planning and infrastructure, resulting in densely populated cities, such as Mumbai and Bangalore (Datamonitor, 2011). I 400 million of poor individuals, of which 75% inhabit rural areas. The GOI defined poverty line as a person living with INR 10 (~USD 0.215) or less per day (Channa, 2010). Some authors agree that poverty has continued to decline since the industrial reform in 1990, although at a slower pace. Between 1981 and 2005, it declined from 60% of the population living below USD 1.25 per day to 42% (Chin & Prakash, 2011; Siggel, 2010). According to 20042005 estimates, 46% of STs, 37% of SCs, and 23% of non-SC/STs were living below the official Indian poverty line (Chin & Prakash, 2011). The household disposable income in India grew at an average rate of 13% per year during 20002010, which translates into a disposable income of USD 5,386 per household in 2010. As a result of this increase, the rate of consumption-expenditure per household grew to 16% in 2010. A wide disparity in economic development is visible among the states of India, which leads to the social unrest. Bihar, Jharkhand, Madhya Pradesh, Orissa, Chhattisgarh, Rajasthan, and Uttar Pradesh were thus classified as lagging states due to poor economic development (Datamonitor, 2011). The rise of Asia might also be illustrated in a different way. According to 2009- World Bank data, India ranked fourth, next to Japan in terms of GNIs and PPP. Weede (2010) suggested that this rate of economic development in India and China will not only make the global poverty rates fall but also change the global balance of power. Since the focus of this research is centered on the fisheries sector in India, it is worthwhile to understand the socio-economic profile of fish farmers. Kumar, Katiha, and Joshi (2003), noted that commercialization of the fisheries sector in India is following the trend of economic growth, which has shown a positive influence on the poor in terms of direct and indirect income gains, employment, and the acquisition of skills that contribute to income-earning capacity. Abraham, Sil, and Vineetha (2010), conducted a study to compare the socio-economic profiles of the fish farmers in the states of AP and WB. They have surveyed a total of 153 aquaculture farms. As aquaculture is an age-old practice in AP, 31% of the farmers acquired the aquaculture property from their ancestors and are very experienced. About 84% of the AP farmers own their own ponds. They have chosen fish culture as a profession and converted their agricultural land into fish ponds. A similar scenario was observed in WB. Seventy five percent of the aquaculture farms owned by the WB farmers, who practiced aquaculture either in their own ponds (33%), or in leased ponds on a co-operative basis (67%). Fish farming is the major source of income generation to the farmers both in AP and WB states. As stated in the health and nutrition section, protein plays a key role in nutrition in India. Fish protein is considered as protein for the poor, and as a cheap alternative to other sources. It was predicted, that the fish consumption in developing countries will increase by 57%, from 62.7 million tons in 1997 to 98.6 million tons by 2020 (Imelda et al., 2010). According to 66th round of the National Sample Survey (2009-2010) Report # 541, the national level data showed that only 28.2% of the households in rural and 20.9% in urban areas consumed fish during a seven day period. This percentage, when taken into consideration with the per capita consumption in a 30

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day period of 269g and 238g in rural and urban areas respectively, translates into 766,833 tons in rural and 213,453 tons in urban consumption on annual basis. The rural and urban data taken together total a per capita annual consumption of 6.08 Kg (NSS 66, 2012). Based on the current trend of a rising per capita income as well as household disposable income, the rate of increase in per capita annual consumption was assumed by the Central Institute of Freshwater Aquaculture, India, to reach 15 Kg by 2030. It is difficult to exactly determine the rate of increase in per capita fish consumption, as the data in the previous years were reported as an aggregate of eggs, fish and meat. Since the poor households respond more positively to the higher income, a significant shift in the demand for fish is expected in the near future. Based on the income elasticity of the demand for 1.66 for fish and fish products (Income Elasticity of Demand is a measure of the rate of response of quantity demand due to increase [or decrease] , it was postulated that with an increase in the income, people would spend more on fish than other types of meat (Jayasankar et al., 2011). However, the fish consumption in India was found asymmetrical with the highest fish consumers in eastern (65%) and southern (47%) regions, and lowest in western (20%) and northern (4%) India (Rath et al., 2011). The projected additional demand by 2020 for fish in India is approximately 3.21 million tons (raw fish), of which about 90% is expected to be provided from freshwater fishing and aquaculture. It is projected that by 2030 a three-fold increase in the aquaculture production is needed to meet the rising demand (Jayasankar et al., 2011). The size of the urban food market in India is estimated to be INR 350,000 crore (~USD 78 billion). Due to the changing demographic profile of the country (30% of I population is under the age of 14 years; a rise in the number of working women and changing lifestyles; a growing number of consumers having an outlook on value-for-money; and an increased disposable income level) the spending is expected to accelerate the growth of the organized retail sector. The consumption pattern of the population and the preference for a variety of fish and fish-products are also expected to significantly increase the consumption levels in India, thus influencing the growth of inland fisheries, as it is already happening in other parts of the world (Rath et al., 2011). The change in the lifestyle (social and cultural), such as the shift in social attitudes toward consumption of wine and its growing popularity were also reported to be of impact. A few years ago for instance, some states like Karnataka delinked wine from hard liquor and beer, wine tavern licenses. According to Anand Dikshit, Executive Director of corporate finance and investment banking at PricewaterhouseCoopers in India, the wine consumption in the country has consistently at 15% to 18% in recent years and at present is close to 17 million liters with a value of INR 1,400 crore (~USD 0.25 billion) annually (India Knowledge Wharton, 2012).

The National and Organizational Culture of India

National and organizational cultures are interlinked and are essential pillars to consider for the new entrant and the investors. Knowing the cultural requirements will allow them to select the right approaches to adopt and implement suitable human resource practices, leadership styles, and communication tools to efficiently manage the operations, and deal successfully with customers. After all, it is fair to believe that the cross-cultural literacy minimizes loss of time and costs of operation in unfamiliar markets (Arora, 2005). Culture is the way things are handled in an organization and is built on the the . It allows for collaboration amongst and a feeling of belonging for employees, thereby enabling a company to operate smoothly. Culture can take many shapes from approaches to decision-making all the way to certain dress codes (Burman, 2010). India recognized this constraint of cultural perception of MNCs I I a multi-cultural society and most of the MNCs do not understand the diversity and the multi-plural nature of the society, (Arora, 2005, p. 6). H tool and the process to apply it, provide a step forward Hofstede (2009) stated that there is no special national culture for executives, nor for people who aspire to once take their place, like the MBA students who provided the perceptions in our study. National cultures have centuries-old roots and their

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differences are unlikely to disappear (Hofstede, 2009, p. 486). Hence in this section, the Hoefstede model of five dimensions of culture will be used to explore and understand the culture in the Indian business environment. India has two major ethnic groups, the one in the North is called Aryans (72% of population), and the one in the South is called Dravidians (25% of population). The remaining minorities include Mongol decent and others. It is home to four major religions: Hinduism, Islam, Christianity, and Sikhism, and is considered to be a pluralistic society (Arora, 2005). The family is the most influential of all the means of socialization, followed by caste, religion, and school. The collectivist mind-set has links to family, as individual members have to adjust to the collective norms of the family. E same link as family, and its importance in the daily life also created s, providing emotional security. The values and behavior patterns of Indians are not family-specific, but caste-specific or sub-caste- T has originated from the caste-based thinking, making it the second most important factor of socialization. Although the caste-based thinking is declining in urban India, it still has a major influence on a typical Indian (Arora, 2005). Religion is the third most important influence in the socialization process in India. As Hinduism is the major religion, the cultural legacy of Hinduism is deeply embedded throughout the country. According to Hinduism, it is believed that the human soul is eternal and that after death, it undergoes reincarnation (rebirth), and as per the law of karma one has to experience the fruits of her/his actions (either good or bad) in a course of many lives to follow. Liberation (Moksha) from the eternal sequence of birth and death comes from a supreme experiential wisdom, at which point the soul is not required to be reborn. These three guiding principles of Hinduism (reincarnation, law of karma, and moksha) thus influence the behavior of individuals by making them fatalistic, less materialistic, and less deterministic (Arora, 2005). To an extent this may explain why there is no -and- I because Indians believe that firing someone may lead to a bad karma haunting them by having to face similar consequences in the future. A distinction between the core (values, beliefs, and assumptions) and surface (style, fads, food, symbols, etc) cultural aspects in India was also presented. While the core part of Indian culture is characterized as fixed, the surface part is very adaptable. Depending on the place (desh), time (kal), and person (patra or context of the situation, or the role the individual plays in a situation), a typical Indian may choose to exhibit a core-based behavior or surface-part of the culture. Since the area of work life requires adaptation to change, Indians demonstrate more of their surface culture at work, but do not necessarily initiate changes in the core part of their culture. The existence of a core and surface culture was also used to explain variability in the behavior of the Indian management (Arora, 2005). As seen in other parts of the globe, a social institution called middle class is emerging as the driving force for the development of the state and its society. In India, the middle class is viewed as a cultural sub-group (the most polymorphous middle class in the world), which is contributing to the modernization of Indian society since economic reforms were introduced in 1990. Originating from assisting the British in administrative activities during their rule in India, a class comparable to the British was created with educated members like doctors, teachers, lawyers, government employees, etc. Rather than stratified along caste and gender, as seen in the traditional hierarchy of the Indian society, the middle class was measured on the basis of occupation, education, and income level, making it is competitive rather than hierarchical. As this middle class is still in the process of transformation, it could potentially become a major link for international companies to understand and bridge the cultural differences between them (Arora, 2005). Power Distancexii is the most indicative dimension of Indian managerial and corporate culture (Burman, 2010). The hierarchical structure built on the socio-religious, caste-based Indian society speaks to this value (Sebastian et al., 2006). The organizational structure is a classic Pyramid with the power vested at the peak (Raghavan, 2008). On this dimension, India scored high (77) compared to Japan (54) and South Korea (60). This

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implies that both China and India are more egalitarian cultures and accept the inequality of power distribution (Mani, 2007). Maintaining the power distance is the core goal of the Chinese, Indian, and Brazilian executives in the business world, and the subordinates expect and accept such inequalities, which may cause friction when countries with smaller power distances are acquiring companies in countries with larger power distances (Hofstede, 2009). On the contrary, Migliore (2011) contended the view of Hofstede and, based on her findings, suggested that rapid changes in ICTs have influenced the decrease in power distance for the US and Indian H in 1980. Considering the traditional view of this dimension, Arora (2005) B E I culture-specific leadership style. Such a leadership style combines Adaptation (authoritativeness, emotionality and empathy) and Leadership (result-orientation). Both components have some potential alone, but basically form an inseparable unit, which only in its entirety generates the best possible results. This entirety can also be called a deliberate, demanding, differentiated Paternalism (dddP) (merged). Empirical results confirmed the hypothesis and indicated, that an Indian employee is flexible to work in all kinds of efficiency- and result-oriented environments, if his cultural-needs such as the desire of belonging to a big family are fulfilled. On the dimension of Uncertainty Avoidancexiii, both India (40) and China (30) are comfortable dealing with the unknown, although, the score of 30 for China indicates that the Chinese are slightly better dealing with the unknown than Indians. On the contrary, when looking at this dimension for Japan (92), South Korea (85), and the rest of the world (average 64), a more structured approach (Arora, 2005; Mani, 2007) using risk analysis and risk mitigation strategies to evaluate the unknown is favored. At the organizational level, Migliore (2011) found that US managers (33) (country level score 46) are more comfortable with ambiguity than the Indian managers (64). Individualism xiv scores indicate a balance in decision making between individual interests and those of a group. India (48) and Japan (46) are on par, while China (20) and South Korea (18) are even further inclined towards collectivistic behavior. In contrast to these Asian countries, Western countries namely the UK, the US, and Germany are on the extreme other end of the spectrum i.e., individualistic (Mani, 2007). Although, India has been characterized as collectivistic, the higher numbers compared to other Asian countries suggest that both collectivist and individualist characteristics co-exist in India. It i I with similar per capita GNP countries, such as Argentina (46) and Turkey (37), it is strikingly higher, which usually is an attribute of a rich and affluent nation (Arora, 2005). India (56), China (66), and South Korea (39) exhibit less Masculinity xv and more feminine characteristics, while Japan (95) displays higher level of competitiveness, aggression, and material success. The Western countries exhibit masculine values to a slightly greater extent than India (Mani, 2007). It was argued that the score of 56 for India, implies the co-existence of both masculine and feminine values in Indian society and organizations. Regional differences were also observed with southern India on average being more feminine than the northern part (Arora, 2005). T the work place in India were attributed to the Hindu belief of Law of Karma (Arora, 2005). Hence, the score of 61 (on long-term orientation) signifies, Indians willing to accept delayed fulfillment of material, social, and emotional needs (Mani, 2007), and the importance of perseverance and being thrifty (Arora, 2005). A Longer-term Orientation xvi was reported for all the Asian countries, with China (118), having the highest score in this cultural attribute. On the contrary, the Western countries namely the UK, the US, and Germany are short-term oriented (Mani, 2007). Migliore (2011) reported a 31 point drop in this dimension for India (a drop from 61 to 30) and a 12 point rise for the US (a rise of 29 to 41) H . These changes were ascribed to the influences of changes in the global economy, although Migliore recognized the need for further research on this topic. In spite of the change observed in this dimension between the two countries, at the level of national culture (namely, India and the US), the management behavior reflected contrary scores (US = 39 and India = 28) to that of their respective national cultures. Overseas acquisitions by IMNCs illustrate this long-term orientation phenomenon, where the top management teams at Corus, Jaguar, and Land

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Rover have been retained after takeover, with the Tata headquarters (acquirer) getting involved in setting a long- term direction and large investment decisions. Sundaram Fasteners is another such example that has exhibited long-term orientation (Raghavan, 2008). In India, China, and Germany, where performance of shares in markets play a much smaller role in the business governance than in the US and the rest of the Anglo world, the management maintains a more strategic long-term view. This approach of emphasizing a more long-term strategy (or deemphasizing the share value in the market place as the guiding principle of the business performance) by Indian, Chinese, and German companies, was assumed to be more focused on the interests of the society in general, rather than the growth of the individual organization (Hofstede, 2009). Entrepreneurship is promoted by many countries, as it is directly linked to the development of an economy, which in turn helps to develop a society. Fuller, Spears, and Parker (2010), by comparing the locus of control for both countries, reported that the Indian culture is more entrepreneurial than the Chinese culture. Sebastian, Parameswaran and Yahya (2006), cited similar findings of Deshpande and Farlay (1999), who used a universal high performance model, and concluded that India has more entrepreneurial culture than Japan. Mueller and Thomas (2001), observed that an internal locus of control is most often found in cultures that are individualistic and exhibit low uncertainty avoidance, such as India, rather than in collectivistic and high uncertainty avoidance cultures such as China (Fuller et al., 2010). Sebastian, Parameswaran, and Yahya (2006), concurred that Western work culture exists in Indian organizations, based on the evidence of co-existence of vertical collectivism from indigenous cultural conditioning, and individualism due to Western management. This co-existence of collectivism and individualism was much more pronounced in the younger generation, who is more adaptive to the western working style than older workers. Other scholars have also identified gender differences in the entrepreneurship. They have reported that female entrepreneurs in India have experienced a lesser degree of success than the male counterparts in businesses due to the lack of family support (Shivani et al., 2006). In summary, the acceptance of organizational hierarchy (power inequality), the willingness to deal with the unknown (low uncertainty avoidance), participation and identification in group activities (collectivism), and perseverance at work (long-term orientation for the business results, etc) paint the picture of the four major values in Indian organizational culture. The urban middle class constitutes an exception and its organizational behavior may sometimes project values contrary to the general mind set in India. It was stated that this behavior stemmed from the surface culture of the middle class, reflecting a desire to adapt concerning the work culture but not necessarily a refutation of the core culture. One has to be cautious in generalizing this view as the above organizational behaviors are influenced by the size, ownership, and branch characteristics of the business in question. For example, the software and large Indian companies work based on a western egalitarian model, small scale enterprises work on a family model, while the medium sized firms use a hybrid of the above two. Nonetheless, professionalization in India seems to reduce the lacuna between its own management culture and that of other countries, and thus, holds a promise of convergence (Arora, 2005).

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Technological Factors in India

Technology is defined as the branch of knowledge that deals with the creation and use of technical means and their interrelation with life, society, and the environment, drawing upon such subjects as the industrial (Dictionary.com.). Technology is the vector by which the scientific concept can be translated into commercial value. Therefore it (technology) is an input to a solution (Malhotra, 2011) an (Schwab, 2011). India has a long convention and a prominent tradition of science and technology from historic times to modern days. Several scientific and technological innovations originated around 2500 BC during the Indus Valley Civilization. Archeological excavations at Kalibangan and Lothal revealed the scientific planning of towns and buildings using burnt bricks, interlinked drainage systems, wheel turned ceramics, solid wheel carts and the use of copper and bronze in various products. The medical and surgical procedures were inscribed in Charak Samhita (internal medicine) and “ “m (surgery) during the sixth century. Other examples include fundamental concepts in mathematics, geometry and astronomy that have roots from India (Mishra & Kumar, 2011). An unknown concept to the Western world is the fundamental right of an Indian citizen in developing a scientific temper as defined in the Fundamental Duties Article 51-A(h) of the Constitution of India (Malhotra, 2012). In modern day India, science plays a major role in the fields of basic research, atomic science and space exploration. The country is one among the few who has capabilities in space technologies. Examples that highlight some accomplishments are the Nobel Prize-earning research in physics of C.V. Raman in the 1920s and the founding of the Tata Institute in 1945 demonstrating how the Indian skill and commitment to world-class science emerged long before the economic reforms of the 1980s and 1990s (Nichols, 2008). The three main pillars of a good science system include human capital, institutional framework, and governance, which enable the develop I science and technology (Malhotra, 2011). Hence, this section describes the technological landscape of India in terms of science, technology and aquaculture using the above framework. A subsection elaborating the state of the biotechnology field, which is essential in both aquaculture and vaccine development will be presented.

I Knowledge Base and Human Capital

English is the major language of communication in the world and Indians are adept in this language. It is estimated that nearly 20% of Indians can speak English. It is also the most popular language of instruction at the university level, which gives India a competitive advantage over the other countries in knowledge-based services- and outsourcing-industries (Datamonitor, 2011). The 2008 data from the All India Council for Technical Education found that a total of about 12.4 million were enrolled in higher education of which 36% were enrolled in technical and professional degree programs across 430 universities and 22,000 colleges. The GOI India recognized talent development in technical fields as an important step and hence it has planned to create two new Indian Institutes of Technology, seven new National Institutes of Technology, 12 new Central Universities and five new Indian Institutes of Science Education and Research (IISERs) as announced by the Ministry of Human Resource Development. The DBT is in the process of formulating a new program of ignition grants to encourage young innovators (Natesh & Bhan, 2009) and has launched postgraduate biotechnology programs in eight new universities in addition to the current 62 universities. In addition, more than a dozen fisheries colleges affiliated with state agricultural or veterinary universities offer specialized courses at Bachelor, Master and Doctoral levels in Fisheries Science and Aquaculture (Ayyappan & Gopalakrishnan, 2006). Currently drugs or antibiotics for the aquaculture segment are prescribed by veterinary doctors only. The College of Fisheries, Mangalore, is the first institute that has designed courses in aquatic medicine including pharmacology and toxicology as part of the

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Bachelor of Fisheries Science curriculum so that the graduates can also prescribe treatments and medications for the aquaculture industry (The Fish Site, 2012).

The Policy Framework and Programs

Metcalfe (1995) defined a National Innovation System as one that contains a distinct set of institutions that collaborate and contribute to the development and diffusion of new technologies as well as one that provides the framework within which the governments draft and implement policies to influence the innovation process (Bagchi-Sen & Smith, 2008). The MoST is the apex body in India that develops the innovation system for the nation with the help of all research branches, such as DBT and DSIR. The Indian Science and Technology Policy of 2003 articulated eleven strategies for achieving the objectives in R&D (Fan, 2011). The 11th five year plan (2007-2011) prioritized R&D by increasing opportunities in science and expanding R&D in universities (Datamonitor, 2011). In an effort to set up policies and the required framework, the government approved the National Biotechnology Development Strategy in September 2007, which seeks to integrate multiple disciplines and skills across sectors to enhance synergies and increase productivity. India has demonstrated its commitment to a knowledge-based economy and is engaged in a phase of (Natesh & Bhan, 2009) of its science enterprise, to create knowledge and develop applications. To enable this, India has undertaken several initiatives as for example: the adoption of liberal policies to promote R&D activities in the country; the implementation of a concession rate of only 5% duty on all research institutions registered with the Directorate of Science and Education; the reduction of the duty on certain equipment and machinery used in the pharmaceutical and biotechnology sectors; and the promotion of various fiscal incentives to companies that engage in R&D (Datamonitor, 2011). Natesh and Bhan (2009) commented on the scale of undertakings and inferred that there is reason to believe that the country will reach its targets based on the progress of this initiative. To accelerate the development of biotechnology, an independent DBT was established within the MoST in 1986 to create the human capital and infrastructure network in life sciences R&D. Techno-nationalism, inclusive growth, techno-globalism, and global leadership were described by Dr. R. A. M I I (Nichols, 2008). Inclusive development for India means having a technology management strategy that exploits the latest technologies that benefit the mass rather than a selected few. Such a strategy would identify the needs for change: the need to create innovation in technology and in the business model and to forge public-private partnerships (Raman, 2010). The National Innovation Foundation (NIF) in India has taken various initiatives to promote innovation at the grass-roots level by providing extrinsic forms of incentives such as monetary support, rewards, and patenting. However, some scholars have doubted whether patents provide adequate protection to small innovators as they often fail to generate enough economic value from their patents (Bhaduri & Kumar, 2011). For example, Bhaduri and Kumar (2011) found that farming communities in Indian villages often do not hesitate to share their innovations with others. The researchers expressed concern that such a strong extrinsic incentive-based policy may negatively impact the forms of pro-social acts. They also found it relevant in drug discovery research where a crowding out theory suggests that extrinsic forms of incentives (Intellectual Property Rights) may crowd out intrinsic motivation to innovate because is to accumulate wealth and assets. Hence, low commercial prospects. Adopting the know-how developed elsewhere by repatriating the expatriate intellectuals is one way to accelerate the technology progress. To realize this benefit and to reverse the brain-drain caused due to the draw of job markets in Europe and the US, the DBT has developed the Welcome Trust Fellowship in an effort to create good working conditions at home and attract the expatriates back to India. Similarly, the Ramalingaswami Re-entry Fellowship Scheme was created and has successfully repatriated 25 applicants between 2007 and 2008

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(Natesh & Bhan, 2009). Bagchi-Sen and Smith (2008) have concluded that the initiative to reverse the brain-drain has played an important role in fostering indigenous biotechnology companies and is now being exploited by large pharmaceutical companies in attracting scientists from overseas to promote their new drug development programs. The Small Business Innovation Research Initiative (SBIRI) of the DBT encompasses the Biotechnology Industry Partnership Program (BIPP) with allocation of INR 350 crore (~USD 79 million) during the 11th five year plan (2007-2011). This initiative envisions promoting high-risk, cutting edge industry research and futuristic technology with the aim of making the Indian industry globally competitive and focuses on IP creation and ownership in biotechnology. Under the DBT-Stanford Biodesign Program, industry and research has been brought together through: collaborations between the Translational Science and Technology Institute, India, and the Health Sciences and Technology of the Massachusetts Institute of Technology at Harvard, as well as the establishment of the Stem Cell Institute. Similarly, the Biotechnology Industry Research Assistance Council (BIRAC) was establishment to help bridge the gap between science and the marketplace, and steering T publicly-funded R&D Bill of 2007 (Protection, Utilization and Regulation of Intellectual Property), which is currently tabled in the Indian Parliament will address the challenges of the transfer and management of IP. A recent positive landmark decision of the DSIR was to allow the scientists from the National Research Institutes and academia to start companies while retaining their jobs in the institutions. This model has been proven successful in the western world and in India and is expected to go a long way in transforming innovation into value creating enterprises (Natesh & Bhan, 2009). Other related programs include: the Program Aimed at Technological Self-Reliance; the Sponsored Research and Developments Scheme; and the Program for Acceleration of Commercial Energy Research. These were designed to facilitate and promote technology-testing, up-scaling, and commercialization. After the 1990 economic reform, fiscal policies have been created to support innovation activities and the development of indigenous technologies. To provide risk-sharing funds and managerial expertise for technology development and commercialization, the Technology Policy Statement (1983), the Research and Development Cess Act (1986), and the Technology Development Board Act (1995) were enacted for the provision of venture capital funds (Fan, 2011). E . Except for the Jawahar Navodaya Vidyalayas (Schools), all other schools are city-centric and heavily focused on those who are proficient in English, which accounts for only 5% of the student population. Almost all the academic programs test only scholastic abilities and none test for creativity. To enhance the creativity in the pupils in rural areas, the Moving Academy of Medicine and Biomedicine in Pune designed outreach programs for cultivating science talent. These programs include: discovering little scientists, a mobile science fair, learning through experimentation, and resource mobilization to the regional hub for science and technology (Deo & Pawar, 2011). New programs such as INSPIRE were devised by the DST to increase the awareness of science, and to enrich and encourage the students to develop an appetite for science at an early age (Malhotra, 2011). To provide industry training for the students who completed the first year of a Master of Science or a Master of Technology, a Finishing School Program was introduced in 1992. The introduction of a bench fee of INR 50,000 (~USD 1,099) per student in 2004 accelerated the rate of student uptake by the participating companies. During the four years between 200405 and 200708, 185 companies have offered six-month training to 665 postgraduates of which approximately 27% have been absorbed by industry. Approximately 700 midcareer scientists DBT B A and obtained 612 month training in some of the most reputed laboratories across the world (IBEF, 2011a; Natesh & Bhan, 2009). To encourage and improve innovation, the DST devised introduced a program, which gives research institutes and universities an incentive grant based on the number of publications and the h-index. Initially the government gave INR 200 crore (~USD 45 million) for three years to 14 universities. After three years all the 14 universities were surveyed for the publication quality and output. It was found that publication output not only

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increased but also the h-index improved significantly, which implies an improvement in the innovation quality. A total of 43 universities now receive incentive grants under this scheme. Another such program is the Consolidation of University Research for Innovation and Excellence (CURIE), which aims at enhancing the laboratory and research infrastructure for women-only universities (Malhotra, 2011). Nationally-oriented linear models (such as science, which leads to technology, which leads to new products or services) are becoming obsolete as the new world of science and industry depends more on networking and cross-functional alliances across disciplines and borders (Nichols, 2008). Realizing the importance of such interactions, the DST in India is building public-private (institute-industry) partnerships to solve local issues. It is acting as a catalyst in connecting various scientific functions horizontally in an effort to make the technologies deliver socio-economic value. For example, the Central Salt and Marine Chemicals Research Institute (CSMCRI) developed a technology for potash fertilizers using sea water. The DST and the Ministry of Fertilizers together promoted a researchindustry partnership and established a test bed for potash-based fertilizers on the factory premises. Also, the DST is interfacing between the nonlinear processes of scientists working on growth and the linear processes of the bureaucrats and civil servants and enabling them to make proper decisions (Malhotra, 2011). BIRAC is another such program that is trying to bring together the public and private sectors that have different goals. Referring to the biopharmaceutical sector in India, Bagchi-Sen and Smith (2008) suggested that the resolution of the public (science for societal benefit) and the private (science for profit) sector goals to promote innovation and commercialization is the key to success in leveraging opportunities at home and overseas which they say in turn would help with the successful transfer of technology from public laboratories to private companies. Mohan (2011) highlighted the importance of publicly funded R&D institutes in India which generate and disseminate knowledge, typically drawing on national, international, industrial, and scientific knowledge that helps the industries to develop a strategic approach towards technology. In turn, research institutes are getting exposed to applied research, which may also lead to the development of new commercially viable technologies. For the industry, this would mean accessing government funding, sharing R&D costs and lowering internal risk of potential capital loss. This interaction would also enable them to access and advance product development by allocating their internal resources to their core competencies. In light of this advantage, the Indian government has reformed its industrial research institutes (IRIs) to improve their performance by efficiently using government resources in delivering projects of high commercial impact. For instance, since 1990, national laboratories and institutes of the CSIR and the DST were instructed to earn at least 3050% of their R&D expenditures either by retaining equity holdings in private enterprises (that leveraged their technology through the commercialization of indigenously developed technologies) or the generation and capitalization of patents or both (Fan, 2011). Therefore, it is a win-win outcome for both public and private institutions. In the life sciences sector, various steps were taken to support the commercialization process. They include: strengthening translational research; building capacity to address the entire innovation value chain; working towards a new regulatory system (Biotech Regulatory Authority); improving ethical standards in human research; creating reliable product validation capacity; and creating a new institutional mechanism for idea - Dr. M. K. Bhan, Secretary of the DBT proclaims that they have made a transformational change in the way academiaindustry (SME) interactions are enabled through support programs such as SBIRI, BIPP, and Ignition Grants, and also by: nurturing the young talent pool to meet innovation requirements; and establishing BIRAC and the Clinical Development Service Agency (CDSA). Dr. Bhan says that the government is also focusing on other needs such as a strong regulatory system, quality people, leadership and global best practices (Malhotra, 2011). Focus areas such as the aquaculture segment have also attracted new programs such as the National Mission for Protein Supplements (NMPS) with an outlay of INR 100 crore (~USD 22.3 million) for undertaking cage and pen culture in reservoirs and for intensive aquaculture in ponds and tanks in 12 states. The objectives of the scheme were to enhance the fish production and productivity of reservoirs, ponds, and tanks (Raghu, 2011).

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China has also implemented similar policies to strengthen its NIS. Recognizing the disconnect between science and technology (S&T) activities in public research institutes and industrial sectors, China reformed its NIS in 1997 making amendments to bridge these two sectors (Fan, 2011). In 1986, the High-tech Research and Development Plan or Program 863 was introduced to promote high-quality basic research in eight areas (biotechnology, aero-space, information, laser, automation, energy resources, new materials and oceanology) that were crucial progress. In June 1997 the National Program for Priority Basic Research and Development (Program 973) was introduced to strengthen indigenous innovation and to target innovation related to sustainable development in the areas of agriculture, energy, information, resources and environment, population and health, and materials. The Torch Program (1988) is another such initiative to encourage innovation in commercially viable technologies. It emphasized in its 1995 Decision on Accelerating S&T Development that S&T research should closely link to the market (Fan, 2011).

The Institutional Infrastructure in India

The institutional infrastructure is vital for the progress of research and innovation in any country. Realizing the importance of this infrastructure, the DBT and other organizations have proactively taken up a number of initiatives to build institutional infrastructure in India. They have set up 35 facilities as for example: microbial culture collections, cell and tissue lines, gene banks, laboratory animal facilities, facilities for oligonucleotide synthesis, etc (IBEF, 2011a). Also, a strong research base in the country was established in the areas of agriculture and forestry, human health, animal productivity, environmental safety, and industrial production. A strong bioinformatics program known as Biotechnology Information System (BTISnet-BioGrid India) was introduced in 198687, with more than 150 bioinformatics centers spread across the country. Over 150 subject-specific databases and software packages are now available on the BTISnet for open access. This acts as a database and distribution network, and has become a successful vector for the transfer and exchange of scientific information, knowledge and technology packages in the country. At the IIT, Delhi, a national in silico drug development facility was also set up (Natesh & Bhan, 2009). Cluster development is a key strategy to promote innovation, expedite the technology or product development, and to build successful enterprises. The inter-disciplinary nature of science and biotechnology prescribes that facilities which promote scientific and engineering research, entrepreneurship, and infrastructure should be located under one roof to maximize synergy and efficiency. Clusters and knowledge cities also provide a social environment for creative people (Natesh & Bhan, 2009). The Biotech Park and incubator facility at the Shapoorji Pallonji Biotech Park, Genome Valley, Hyderabad, has mainly been designed for the development and scale-up of bio-processes and technologies. The pilot plant facilities, compliant with cGMP, are available for the manufacture of commercial-grade material for clinical testing. A Pre-Biotechnology Process Generator (PBPG), a component of the BioTechnology Incubation Centre (BTIC) was set up at IICT, Hyderabad, to act as an intermediate size front-end facility to develop the lab- and bench-scale process technologies for biotech processes. A BTIC in Kerala is being established at the Kalamassery, Ernakulum Dist., Kochi, to promote small entrepreneurs and units for knowledge development on traditional medicine, herbs, and plant varieties, spices etc. Initiatives are underway in Himachal Pradesh to set up a Biotech Park. The Biotech Park initiative at Bangalore, Karnataka, is being pursued for the promotion of Public-Private partnerships. The Biotech Park at Karnataka will be structured into three components, namely: an Institutional & R&D Block, BTIC, a Common Instrumentation Facility, and the biotechnology industry cluster, comprised of independent private industry units. (Biotech Parks, 2011). The biotechnology park in Lucknow city in the state of Utter Pradesh is now operational and is emerging as a good model. A Bio-Business Block was set up at this biotech park which offers: a plant tissue culture unit, a

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biofertilizer plant, an extraction block, a diagnostic manufacturing facility, distillation and vermin-composting units, as well as other features (Biotech Parks, 2011). The Karnataka State Chief Minister, Mr. B.S. Yeddyurappa, said that four sector-specific biotech parks would be set up across the state to spread the biotech revolution beyond Bangalore. The first sector-specific park was proposed in Mysore in collaboration with the Central Food Technological Research Institute (CFTRI) for nutraceutical and pharmaceutical products, furthermore an Agritech Park at Dharwad with the University of Agricultural Sciences (UAS), a Marine Park at Mangalore with the state fisheries department and a Veterinary Park at Bidar with the Veterinary University in northern Karnataka (SiliconIndia News, 2011). In addition to the Karnataka state, several other state governments (e.g. Andhra Pradesh, Maharashtra, Himachal Pradesh, Uttar Pradesh, Kerala, and Gujarat) are also ramping up policy incentives (biotech parks, incubators of their own) to spur investment in biotechnology (Natesh & Bhan, 2009). In total, there are 26 operational biotech parks across India (IBEF, 2011a) and in the 11th five year plan (2007-2011), the central and the state governments have announced to build 10 new biotech parks with incubators. In comparison, China built more than 153 bioindustry parks (Mroczkowski, 2011). According to the Global Competitiveness Report: 20112012 (Schwab, 2011) technological readiness (the ninth pillar) was measured using information and communication technologies (ICT) as an indicator. This pillar measures the agility with which an economy adopts existing technologies to improve the productivity of its industries. Specific attention is paid to ability to increase the efficiency and competitiveness by fully leveraging the ICT in day-to-day activities and production processes. The ICT has evolved into an industry-wide enabling infrastructure. Based on this indicator, India ranked 93rd in comparison to China (77), South Korea (18), Singapore (10) and the United States (20). Business sophistication (eleventh pillar) in the GCI compares the quality of and strategies against the quality of a , which are both interlinked. When companies and suppliers from a particular sector are interconnected in geographically proximate groups, called clusters, efficiency is improved, greater opportunities for innovation (in processes and products) are created, and the barriers to entry for new firms are reduced. Following are the ranking in ascending order: the United States (10), Singapore (15), South Korea (25), China (37), and India (43) (Schwab, 2011). Finally, the twelfth pillar pertaining to technology landscape is innovation. In the short- to medium-term substantial progress can be achieved in a factor-driven economy by improving institutions or human capital, building infrastructure, reducing the macroeconomic instability, etc. In the long-term, the above factors may not support the expected returns as the transition into efficiency-driven and subsequently to innovation-driven economy requires new technologies and innovative products to reap the benefits. During this transition, the frontiers of knowledge and the possibility of integrating and adopting the exogenous technologies tend to become obsolete, innovation could yield a competitive advantage only by increasing the development of novel products and processes. For the interim, the countries that are in the early phases of a knowledge-based economy such as India may benefit from the existing technologies or make incremental improvements in other areas. Therefore, succession into advanced economies require an environment that is conducive to innovative activities, supported by both the public and the private sectors, supported by sufficient investment in the R&D, and protection of the intellectual property. Again, in this dimension, India stood last (38) in comparison to the United States (5), Singapore (8), South Korea (14), and China (29) (Schwab, 2011).

Business Models and Technologies in the Indian Agriculture, Food and Health Sectors

In India, b boom similar to the information technology (IT) boom in the past. This is often described as IT I T BT B T B e country). Bagchi-Sen and Smith (2008) highlight the conflicting

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objectives of the public- and private-sectors involved in biotechnology. Science-for-profit is the corporate goal which represents Laxmi (goddess of wealth) and science-for-the-society is the goal of the scientists in institutes and universities which represent Saraswati (goddess of knowledge). Biotechnology has been portrayed as a classic example of a , IT. Disruptive technologies are often found to be lagging in adoption due to lack of understanding and awareness of the risks and benefits. The global biotechnology industry is now at the beginning of a technology curve whose upside potential was assumed limitless. Therefore, governments across the globe are espousing biotechnology as the next driver of innovation and economic growth (Natesh & Bhan, 2009). MK dimensions of environmental selection pressures market transactions and economic impacts; institutions and interactions; and scientific and engineering knowledge are used as a theoretical framework to examine the development of the Indian biotechnology sector. Dedicated biotechnology corporations founded in the 1990s, for example, Shantha Biotechnics (SB), Bharat Biotech (BB), etc have succeeded in the marketplace. Biocon India (BI) was established in 1978 as the first biotech company (Bagchi- Sen & Smith, 2008). The biotechnology sector is currently made up of four major segments: biopharmaceuticals (vaccines, human therapeutics, diagnostic products, and animal healthcare); industrial biotechnology; agricultural biotechnology, and custom services (contract research, contract manufacturing, and clinical trials). The biopharmaceutical segment accounts for the major share (51%) (Konde, 2009). Konde (2009) states that a typical business model consists of three components value proposition, value-chain structure, and revenue generation. He notes that the forecast of future developments in the biotechnology sector is rather difficult to ascertain due to enormous diversity and number of innovations. Broadly spoken, this sector was categorized into Platform, Product, Vertical, and Hybrid business models. The platform-based companies develop a set of tools or integrated technologies for use in different applications. One advantage of this business model is that revenue is generated relatively quickly in the form of rights, licenses or royalties. It is also one of the methods of attracting financing for start-up companies in this segment. But the established companies have started transitioning into the other categories. In the integrated or vertical business model, the drug development ends at either the end of clinical studies or by licensing, where the value creation extends as far as possible in the value chain. In India, this business model is well established and approximately half of the firms who adopted this model have attained global recognition. In the product-business model, the value creation ends at commercialization phase, which is considered as a high risk model with inherent high attrition rate of the projects and long development timelines requiring significant investment and resources. Biocon, Dr. ‘ L, Bharat Biotech, Bharat Serums, Gennova Biopharma, and Indian Immunologicals Ltd., are a few companies that have successfully adopted this model. This model also offers advantages in terms of partnerships and strategic alliances for cost- and risk-sharing. Due to constraints in internal financial resources, the global biopharmaceutical industry has shifted to cheaper countries that have hybrid business models. In this category, a dual-hybrid business model (product and platform) was adopted by a range of companies (for example: Advinus, Bhat Bio-tech, Panacea Biotec, Reliance Life Sciences, Shanta Biotechnics, and Wockhardt) that are capable of generating a pipeline of products together with offering contract research, clinical trial execution, and manufacturing services as a package. Shanta Biotechnics now supplies 40% of the global requirement of Hepatitis-B vaccine to UNICEF in many countries. Panacea Biotec (PB), supplies oral polio vaccine to the GOI supporting its Expanded Program of Immunization (EPI), and to UNICEF. BI developed a proprietary process for recombinant-insulin (Insugen) production that has forced the international competitors to cut their prices by 40%, even before the product entered the Indian market. The Serum Institute of India (SII) is not only the largest supplier of vaccines to the EPI, (Natesh & Bhan, 2009). It is I the W -biological products by volume, next to GlaxoSmithKline, Sanofi-Pasteur, Merck, and Novartis. The main customers of SII are UNICEF, the WHO, and the Pan-American Health Organization. T Progress is not only about

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how we grow. I (Stassen & Halldén, 2011, p. 38). Mr. Poonawalla (Chairman of SII) remarks on t I follows: if companies were judged not on their market cap but on the number of people whose lives they positively affect, Serum Institute of India would be among the biggest, most valuable businesses in the world. As things stand today, it is (Stassen & Halldén, 2011, p. 39). Clinical trial services I biotechnology portfolio and accounted for approximately 2% of the global trials in 2007. In all of the above cases, a for in-house technological capabilities by developing products and processes or by providing contract services (Bagchi-Sen & Smith, 2008). I biotechnology sector, companies have started switching from generic-drug development to the development of new drug candidates (Bagchi-Sen & Smith, 2008; Konde, 2009). BI is one such example, as it has already started drug discovery research for new biological entities. For instance, BIOMAb-EGF‘ Nimotuzumab), a humanized anti-epidermal growth factor receptor monoclonal antibody (mAb) for head and neck cancer, is the first-of-its-kind to be developed in India (N. Sahoo & Manchikanti, 2011). As described previously, various business models exist in the Indian biotechnology sector and to reap the benefits from these different types of models, Konde (2009) suggested that the companies should synergize the benefits of different business models and leverage the co- optition path. Agribiotech has a long history in India compared to biopharmaceuticals. This is highlighted by the fact that at least 35 different vegetable and commercially important GM or biotech crops are being cultivated in India. Globally, agricultural land that was brought under biotech crop cultivation has increased 73.5 fold from 1.7 million hectare (m ha) in 1996 to 125 m ha in 2008. During the same time period, the number of countries growing biotech crops has also increased from 6 to 25, of which 15 are developing countries (Natesh & Bhan, 2009). Biotechnology and genetic engineering have a vital role to play in the enhancement of aquaculture production in coming years. Traditional selective breeding is being employed aside from molecular-genetic tools to reduce time, space, and investment and to attain sustainability. With the advent of high throughput genomics platforms, trait associated genes are being identified (Jayasankar et al., 2011). The technologies of breeding and seed production, for fish and prawn species of high commercial value, have placed aquaculture on a fast track development. R&D efforts are underway in the areas of: genomics and transgenics, breed improvement, bioremediation, as well as feed and health management (Ayyappan & Gopalakirshnan, 2008). Transgenics in fisheries have a long and popular history in India with the introduction of a growth hormone (GH) gene into commercial grown rainbow trout (1984). The same gene is now introduced into Catla catla and Labeo rohita at the Centre for Cellular and Molecular Biology (CCMB), Hyderabad, to accelerate the growth rate and reduce the production-cycle time. The Central Institute of Fisheries Education (CIFE), Mumbai, and the CCMB, Hyderabad, are trying to isolate and characterize salt-resistance genes from the marine environment. Similar research is ongoing at the M. S. Swaminathan Research Foundation, Chennai, the Central Marine Fisheries Research Institute (CMFRI), Kochi, the National Bureau of Fish Genetic Resources (NBFGR), and the Central Institute of Fisheries Technology (CIFT), Kochi, on salt tolerance genes from mangrove plants like Avicenia sp., sea grasses, and marine microbes (Ayyappan & Gopalakrishnan, 2006). Even though many genetically modified fish have been produced experimentally, the techniques have not been commercialized yet in any country (Ayyappan & Gopalakrishnan, 2006) but cloning by nuclear transplantation and gynogenesis in carp was practiced over a period of thirty years (R. P. Subasinghe, Curry, McGladdery, & Bartley, 2003). Advanced technologies like remote sensing are also being employed in the development of the aquaculture segment. The remote sensing techniques are based on satellite images and are increasingly utilized as data sources in conjunction with GIS for mapping of various land resources, for monitoring of changes over time, (Jayanthi, 2011) and for the environmental impact analysis of lakes (Kavitha, 2010). In order to expand horizontally, a geographical information system (GIS platform) using remote sensing is being employed to identify potential new aquaculture zones in the country (Ayyappan & Gopalakirshnan, 2008). To meet the domestic and international demand, experts are hoping that these cutting edge technologies could help

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to increase the number of diversified finfish and shellfish species with commercial value in aquaculture production to an estimated 15-20 as opposed to the current 7-8 major species (Ayyappan & Gopalakirshnan, 2008). The Network of Aquaculture Centers in Asia-Pacific (NACA), a lead centre in carp farming, has demonstrated its strength in global aquaculture. Today, it has the ability to provide technology for utilizing almost every type of water body for effective fish production (Jayasankar et al., 2011). The story of the Central Institute of Brackish Water Aquaculture (CIBA) holds a good promise for the hatchery seed production of sea bass, a technology that has been developed for the first time in India (Rath et al., 2011). Disease management practices, biosecurity issues, emerging new diseases, disaster management, hygienic fish handling, refrigerated shipping chains, and quality assurance in exports, have come into the limelight as needs to be addressed. Packaging technologies are also co-evolving to support this segment for export markets (Ayyappan & Gopalakirshnan, 2008). Research in immunology and fish microbiology has also taken centre stage in new developments to combat diseases and includes: effective quarantine protocols, diagnostics, immunoprophylaxis, probiotics, bioremediation, and chemotherapeutic agents. Identification of gene(s) in host-pathogen interactions, application of nanotechnology in disease prevention, vaccine development, and water remediation are the priority areas (Jayasankar et al., 2011). Parthasarathy and Ravi (2011) developed a probiotics therapy and investigated the use of probiotic bacteria like L. plantarum and Bacillus megaterium on the growth and immune responses against the devastating Aeromonas hydrophila infection that causes dropsy in the Indian major carp, Catla catla. To address the same disease, Shome and Shome (1999a; 2005) evaluated formalin killed, toxoid, and live attenuated vaccines, against A. hydrophila and found that the attenuated vaccine was superior to that of toxoid, and killed vaccines (heat or chemical inactivated vaccines) in Cirrhinus mrigala, Catla catla, and catfish. Globally, organic food production is gaining momentum based on health consciousness and food safety, and to maintain the biodiversity and ecological balance of the planet. This entails that aquatic food production has to follow stringent principles of organic aquaculture such as: avoidance of hormones; culture of native species; no use of inorganic fertilizers, synthetic pesticides and herbicides; being eco-friendly; use of only natural medicines; processing of aquaculture products following organic principles; and monitoring environmental parameters to detect negative impacts (Rath et al., 2011). Integrated techniques such as vermi-pisciculture as an alternative option for recycling of solid municipal waste in rural India are being developed (Ghosh, 2004). In Himachal Pradesh state, ten tons of table-size trout is being produced. Common carp seed is produced in state fish farms for ponds and rice-cum-fish culture, and for stocking lakes and reservoirs in all the Indian Himalayan states (Sehgal, 1999). Mariculture in Indian sea waters is yet to be popularized (Imelda et al., 2010). Although, the commercial scale marine-cage culture was pioneered by Norway in the seventies, the origin of the use of cages for holding and transporting fish for short periods can be traced back almost two centuries in the Asian region. The first successful marine-cage farming in Asia was reported in Japan for the culture of Japanese amberjack or yellowtail (Seriola quinqueradiata) and red seabream (Pagrus major). The Central Marine Fisheries Research Institute (CMFRI) in India has been conducting pilot studies on inshore marine-cage culture since 2007, at the Visakhapatnam coast in the Bay of Bengal, with financial support from the MoA. The study successfully harvested 550 kg seabass in a culture period of about four month from 1400 fingerlings (Imelda et al., 2010). Intensive and semi-intensive type mono- or polyculture-techniques are being practiced in the commercial freshwater aquaculture in Andhra Pradesh and the West Bengal states. Some farmers have also adopted modified-extensive and extensive farming. The Indian major carps, especially catla (Catla catla) and rohu (Labeo rohita) are the most common species. Monoculture of Macrobrachium rosenbergii (12%) was also practiced, due to its high price in the international market as well as catfish (4%). Few farmers practiced integrated farming with horticulture. Besides C. catla and L. rohita, also Cirrhinus mrigala, Cyprinus carpio, Ctenopharyngodon idella, Pangassius spp. and Clarias spp., Oreochromis mossambicus, Channa striatus, and Penaeus monodon were cultured for sale in local markets. In West Bengal, about 9% of the farmers were involved in sewage-fed

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aquaculture. The raw sewage was treated with lime before letting it into the aquaculture pond at a dilution rate of 5-7% every 10-15 days (Abraham et al., 2010). Concepts like biofloc technology, cropping cycle, intercropping with compatible species, oxygen enrichment, diet enrichment, feed automation, farm automation, etc have been introduced in the aquaculture systems for vertical expansion (Jayasankar et al., 2011). Products of importance in medicine, surgery, industry, and food processing such as chitin and chitosan, surgical sutures from freshwater carp guts, collagen-chitin film as artificial skin, fish oil with Omega-3 fatty acids, and other compounds from marine animals were identified as potential targets from this segment (Ayyappan & Gopalakirshnan, 2008).

R&D Expenditure in India

I the R&D program as a percentage of its GDP was around 0.90% in 2010. In comparison, China invested 1.9% of its GDP in R&D (Datamonitor, 2011; Mroczkowski, 2011). India and South Korea currently stand as second-tier challengers with an equal total amount of investment in dollars (Mroczkowski, 2011). According to the available data from 2010, India was one among the 10 world leading R&D investors, although it ranked only eighth on the list with USD 33.3 billion while China was third (USD 141.4 billion), and South Korea was fifth (USD 42.9 billion) (IBEF, 2011b). B I economic growth rate makes it attractive in the long run in comparison to countries in BRIC other than China and South Korea (Mroczkowski, 2011). Nonetheless, it is important to note that to realize significant progress in innovation and R&D in the region, the Indian Government has to reach the 2% minimum mark of GDP allocation to this endeavor. Mr. Ashwani Kumar, the Minister of State, Science and Technology, announced that the GOI agreed to nearly triple the budget for R&D, from INR 33,000 crore (~USD 7.74 billion) in the 11th five year plan (2007-2011) to around INR 90,000 crore (~USD 16.18 billion) in the 12th five year plan (2012-2016) which means the commitment to this initiative has also reached 2% of the GDP as opposed to the current spending of 0.98% (IBEF, 2012). In the Indian Union Budget of 2012-2013, the MoST has allocated the following budget amounts: INR 2,477 crore (~USD 445 million) to the DST; INR 2,013 crore (USD 362 million) to the DSIR; and INR 1,485 crore (~USD 267 million) to the DBT. When compared to the revised estimates of 2011-12 (INR 2,252, 1,830 and 1,350 crore respectively) and the actual expenditures of 2010- 11, (INR 1,933, 1,596 and 1,120 crore respectively), it can be inferred that each department received an increase of about 10% in the current budget planning. (GOI-DBT-Budget-Notes, 2012; GOI-DSIR-Budget-Notes, 2012; GOI-DST- Budget-Notes, 2012; IBEF, 2012). Similarly, the MoA, under which the DAHDF falls, would receive INR 1,910 crore (~USD 343 million), a 74% increase from the actual expenditures in 2010-2011. Comparatively, only a 3% increase was realized for the entire Fisheries Program (GOI-DAHDF-Budget-Notes, 2012). Therefore GOI in its S&T program demonstrate a remarkable commitment. Historically, the government spending on the S&T sector increased eight fold from the 8th five year plan to the 11th five year plan, and the support to the life sciences sector steadily increased by 16-fold in the same period (Natesh & Bhan, 2009). For the next five years, the focus of the MoST is in the areas of: nano-sciences, genomics, neurosciences, biotechnology, clean technology, and water conservation (IBEF, 2012). In addition to the above investments in R&D, fiscal incentives include relaxed price controls for drugs, subsidies on capital limits, and tax holidays for R&D spending. Several State Governments (e.g. Andhra Pradesh, Karnataka, Maharashtra, Himachal Pradesh, Uttar Pradesh, Kerala, and Gujarat) have devised additional fiscal (e.g. tax concessions) and policy incentives (biotech parks and incubators of their own) on top of the central commitment to stimulate investment in biotechnology (Natesh & Bhan, 2009). Experts at Datamonitor (2011) say that a good knowledge base, low costs, and strong support from the GOI make India an attractive R&D destination. The country annually produces more than 60,000 computer professionals and 440,000 engineering graduates, which adds to the current level of knowledge-workers of over

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three million scientific and technical workers. Policies were designed to favor the nation's growing R&D needs even though it was a late starter, especially in the biotech sector.

Cost Advantages in India

Research expertise is available at a much lower cost in India in comparison to developed countries. The average annual salary of a researcher in India is about USD the US (Datamonitor, 2011). One study also concluded, that in addition to the obvious cost saving the efficiency is also improving in the sector (Santos-Paulino & Wan, 2011). Government initiatives such as: fostering linkages of the science sector with the business sector, providing incentives for innovation activities, and balancing the import of technology and indigenous R&D efforts, are further enticing the industry-institution collaboration in novel research. Therefore, it can be assumed that the resulting potential in export capability of India could drive the future economic growth similar to China and Brazil. These countries are increasingly engaged in sophisticated, technology-intensive production, and international trade, reflected by their trade specialization, shift from labour- intensive to capital-intensive commodities, and rapid productivity gains across all manufacturing activities. It was reported in the literature that countries with a higher share of technology-intensive sectors benefit more from technological learning and innovation. Finally, the shift in the adoption of new patterns of specialization challenges the traditional hypothesis that knowledge creation is exclusively the domain of advanced economies (Santos- Paulino & Wan, 2011). A number of additional advantages have been ascribed for the rise in conducting clinical trials in India, which is gaining momentum in the economy. These include the low cost of trials, a large patient pool, good doctors, easy recruitment, strong government support, and an evolving IPR environment and are forecasted to increase the global percentage share of clinical trials in India from the current 2% to greater than 5% in the near future (Natesh & Bhan, 2009).

The Indian Innovation Capacity (Publications, Patents and Accomplishments)

Scholars have expressed conflicting views with respect to the influence of innovation capacity on the economic development for latecomers, C I B , some have argued that the growth in China and India is due to low-cost production factors such as cheap labor and land, in addition to foreign investments, and technologies The scholars who supported the theory acknowledged that the productivity growth resulting from learning, entrepreneurship, and innovation has been the critical source of growth in these countries. To analyze the innovation capacity, Fan (2011) analyzed the contributions of capital, labor, and technology to the GDP growth rate. The share of the technology component was measured by the total factor productivity (TFP) (portion of output not explained by the amount of inputs used in production) growth rate. In China, from 1986 to 2000, technology became the major driver of GDP growth, contributing to half of the GDP growth rate (with the exception of the years 1991 to 1995), while from 2001 to 2004 the contribution from technology declined, as its share in GDP growth rate was only 3.8% per annum. This contribution from technology was dissimilar to the role of capital that caused the rise of GDP growth rate of 3.5% per annum. Unlike in China, labor plays I has consistently contributed to the rise of its GDP growth rate from 1.2% to 1.5% (Fan, 2011). Innovation capacity was also measured by the number of granted patents. A quick review of the 2011 granted patent status in the US Patent Office revealed that India had 1,259 granted patents while China had 3,786 granted patents. These numbers in 2011, when compared to 2000, demonstrate a significant achievement for both countries, as they showed a 10 and 24 fold increase respectively. In comparison, South Korea obtained 13,239

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patents in 2011, which constitutes a fourfold increase since 2000 (U.S. PTO, 2011). Among the domestic patents in India during 2006 and 2009, the state of Maharashtra, which also has a maximum GDP share of 16.23%, dominated by patent volume with 31.61%. When the leverage ratio (a ratio of percentage share of patents and percentage share of GDP) is calculated, it results in only 1.95 indicating that the state of Maharashtra could not excel in leveraging its strong GDP in innovation development. Delhi took the first place based on the leverage ratio and Karnataka the second (Kshitij & Joshi, 2012; Sinha, 2012). Sahoo and Manchikanti (2011) probed the biopharmaceutical patent portfolio and found that the claimed inventions mostly related to production processes for modified proteins (analogs, fusion proteins, or glycosylated proteins), to the development of new stable formulations, to the development of modified culture media for enhanced protein production, or to protein purification methods. It was outlined that innovation capacity can only be improved by a fiscal boost from the governments into R&D, resources, and human capital. In one of the interviews, Mr. Welch, the then Chief Operating Officer of General Electric, stated: India is a developing country, but it is a developed country as far as its intellectual infrastructure is concerned. We get the highest intellectual capital per dollar here (Fan, 2011, p. 58). The scientific contribution of a nation to research can also be measured by the number and quality of peer-reviewed journal publications as they promote the knowledge-building process and policy creation (Buchandiran, 2011). During 2001 to 2011, the S&T publication productivity showed that, India ranked 11th by volume (293,049 papers) while China and South Korea took the 2nd (836,255) and 12th (282,328) positions (Science Watch, 2011) as shown in Table 3. The move of India in 2011 to 11th position indicates that research productivity has improved since G D (2008) study, where they reported that India ranked 12th among the top 20 countries in the world in S&T (as seen from the world publications output data for 1997-2007) I share of global publications between 1997 and 2007 was 2.11%, while the top countries (United Kingdom, Japan, China, Germany, and France) contributions ranged between 4.5% and 7.5%. With respect to growth rate, the developed countries averaged between 0% and 5%, but had remarkable growth rates in the range of 5% to 20%. The only area where India was lagging behind was health sciences. Regional disparities in publication output were also observed in India, as the outputs from the states of Tamil Nadu, Maharashtra, Delhi, Karnataka, West Bengal, Uttar Pradesh, Andhra Pradesh, and Kerala, together accounted for 89% share of the publication output. Others have measured the innovation capacity by developing an index with five pillars: institutional environment; human capital, training and social inclusion; regulatory and legal frameworks; R&D; and adoption and the use of ICT. Using these parameters Lopez-Carlos and Mata (2010) found India again scoring poorly in comparison to other benchmarked countries. Even though India received a low ranking on the innovation index (Table 4), it is noteworthy to recognize individual companies that are striving to innovate, despite the lack of resources. Through their novel technologies and innovative business models, a few companies are not only showing consistently high business growth rates, but are bringing disruptive innovation to traditional industries. As of August 2011, the Innovator Community includes more than 310 members from 70 countries and various regions that have a positive impact on the economies and societies in which they operate. Twenty four such global Community members have been recognized as Trailblazers, Shapers and Innovators. Indian corporations included in the list are: Karuturi Global, KPIT Cummins Infosystems, and Serum Institute of India. Karuturi Global is responsible for the planting, cultivation, storage, export, and distribution of roughly 555 million rose-stems annually. The company is a genuine change agent for global growth, prosperity, and cultural and economic transformation in a sustainable manner. The company uses indigenous greenhouses, rainwater harvesting, environmentally-friendly fertilizers, and hydroponic cultivation in its operations. KPIT Cummins Infosystems, in collaboration with Bharat Forge, India, announced Revolo, an industry-shaping, plug-in parallel- hybrid solution for automobiles at one-fifth the price of currently available hybrid-automotive options. The company claims an improvement in fuel efficiency by over 35% and reduction of green house gasses by over 30%. KPIT Cummins has filed over 35 patents on its technologies. Finally, SII was also recognized for its philanthropic

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business model that succeeded in maintaining a healthy bottom-line, while providing affordable vaccines for millions of underprivileged children across the globe (Stassen & Halldén, 2011). The World Economic Forum, in its 2012 Technology Pioneers Report, listed a few pioneering companies of Indian origin. No other company from the region (Singapore, China or South Korea) was named, which indicates the evolution of innovative and creative technologies as well as and business models at the company level in India. Financial Inclusion Network & Operations developed an electronic payment platform that provides micro-financing opportunities to more than 30 million customers at 15,000 transaction points, in 300 districts, and across 24 states in India and has thereby also contributed to the development of I ulation. Attero Recycling pioneered a fully-integrated zero land-fill system and an environmentally-friendly, electronic waste-processing technology I -waste in 20 major Indian cities. F E P revolutionary cooking stoves are inexpensive, highly efficient, burn biomass pellets (oorja) that are made from the compressed residue of agricultural waste, and work on a radically new biomass-gasification technology developed and patented by the

Indian Institute of Science. It is estimated that the pellets could reduce CO2 emissions by up to 70%. The firm sold stoves to over 485,000 households and claims that it has already saved about 32,000 tons of wood or kerosene (Technology Pioneers, 2012). In the mobile industry, Vihaan Networks Ltd (VNL), an Indian telecom company, developed a solar-powered base-station to power cell towers that can be built for one-tenth of the cost of a regular cell tower that relies on a diesel-powered generator. VNL was one of the 26 global firms chosen by the World Economic Forum as a Technology Pioneer in 2010. Raman (2010) commented that VNL is one of the most innovative start-ups in the world and will have a critical spillover effect on the future of business and society globally.

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The Legal Environment in India

The legal environment allows a company to operate effectively and protect its intellectual property to recoup the costs incurred in R&D. An understanding of the judicial system and the legal Acts will enable companies and their management to comply with laws and regulations, while utilizing the freedom to operate within the defined legal boundaries. It is also crucial to consider specific jurisdictions and the state legislation when drafting policies for the business, especially policies around pricing, labor and taxation. In this section the judicial system of India and its states will be explored and the regulatory systems for environment, taxation and biotechnology- derived products will be analyzed.

The Legal Structure and Framework in India

The legal and regulatory framework in India is thorough and based on the 1950 constitution and English Common Law (Political Structure, 2011), which enabled companies to grow their businesses in the country. It has a three-tier judiciary system with the highest court being the Supreme Court (headed by the chief justice of India), followed by 21 High Courts, one in each state, and a large number of Civil Courts at the district level. The Lok Adalats or Panchayat Courts are self governing courts presided by the Pradhan or the Sarpanch (leader) in villages and they resolve local disputes through conciliatory (peace-making) methods. The power to create country laws is housed within the parliament, while the state authorities legislate for the individual states. T “ C jurisdiction extends to all disputes on the federal and state level (between the federal level and one or more states,or between two or more states). The chief justice of the Supreme Court of India and 25 other judges are all appointed by the president, while the chief justice of a high court is appointed by the president in consultation with the chief justice of India and the governor of the state. The chief justice of the Supreme Court and High court judges retain their tenure until the ages of 65 and 62 respectively (Datamonitor, 2011). The exclusive right of the Parliament to legislate encompasses areas of national defense, foreign affairs, currency, income tax, excise duty, railways, shipping, posts, and telegraphs. The state legislatures creates laws in sectors such as public order, police, public health, communications, agriculture, lotteries, taxes on entertainment and wealth, sales tax, and state customs. Both parliament and the state legislatures have the power to govern and enforce on items such as electricity, newspapers, criminal law, marriage and divorce, stamp duties, trade unions, and price controls (Datamonitor, 2011). The general overview of legislation processes in India and China is provided in the Figures 5 and 6 respectively.

The Industrial Acts, Legislation, Taxation, and Regulations of Business Concern in India

The Companies Act of 1956 and the Indian Contract Act of 1872 are the two basic laws that control business and corporate bodies. Labor laws define wages, employee welfare, and working hours as well as working conditions. A separate Child Labor Act was declared in 1986, which protects deprived children. International trade in India is regulated by the Foreign Trade Act, 1992. Taxation is based on the income generated by both, individuals and companies. Value-added tax (VAT) was introduced on April 1, 2005 as part of the country's tax reform which aided in indirect tax collection and included a number of changes in taxation policies covering the entire value chain with a national VAT, thereby easing the process of opening a business in India and attracting foreign direct investment (FDI) into the country;. Since all the states are enrolled into the VAT platform, the manufacturers can mitigate the issues dealing with different rates of taxation on products moving across states, which is expected to reduce inventory and warehousing costs, enabling companies to respond to demand situations faster while benefiting the state's treasury (Datamonitor, 2011). Many countries have introduced VAT system in a similar vein. In India without VAT, the companies cannot get a tax refund for their products from abroad. Fringe benefit tax (for

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example: cash allowances for employee transportation to work, entertainment, travel, employee welfare and accommodation) was abolished in 2009 (Swiss Life, 2012) and the online tax payment process was introduced in 2008 (GOI-Income Tax, 2008) in an effort to reduce the cumbersome administrative processes in its corporate tax system (Datamonitor, 2011; Rediff Business Desk, 2005). The finance ministry proposed the execution of a Direct Tax Code from April 2012, which aims to widen tax slabs and quash several of the tax exemptions that are currently in place over which some have expressed concern; considering the adverse affects on individuals' after tax returns. The tax code has extended the tax base considerably, lowering the tax burden in general, and is expected to not only enhance tax compliance (discourage tax evasion) due to a lower income tax rate, but also to increase government revenues from tax. Under this new Tax Code, the minimum alternate tax payable by corporate enterprises will be calculated at 2% of the value of the gross assets of a firm although this is considered to negatively impact companies incurring losses. Plans are underway to seek approval from the standing committee of Indian Parliament to launch a Goods and Services Tax (GST) in 2012. Through GST, levies like excise, service tax, state tax, entry tax, and purchase tax will be collected at each step in the value chain. The government approved setting up a special purpose vehicle (SPV) to provide an IT infrastructure and network for the GST implementation with common permanent account number (PAN)-based registration, returns filing and payments processing for all states on a shared platform (PTI, 2012). To encourage international trade, taxes paid on services used for the export of goods will be refunded. In summary, domestic corporations are subject to a basic tax rate of 35% plus a 2.5% surcharge. Foreign corporations pay a basic tax rate of 40%, 2.5% surcharge, and education cess (tax) at a rate of 2% on the tax payable. The corporate sector is also subject to a wealth tax at a rate of 1%, if the net wealth exceeds USD 33,000. Tax is also payable on capital gains on the sale of assets (Datamonitor, 2011). Reforms in legal and regulatory systems were undertaken in 1992 in the area of corporate governance, which resulted in laws, regulations and codes of corporate governance. For instance: (a) Securities and Exchange Board of India (SEBI) was established in 1992 to regulate and enforce equity trading on all Indian stock exchanges; (b) The Listing Agreement was enforced by the SEBI, the Department of Company Affairs, and the Registrar of Companies; (c) The National Stock Exchange of India was incorporated in 1992 to provide an electronic trading platform and mitigate conflicts at the broker-owned Bombay Stock Exchange; and (d) The Corporate Governance Code for India, [built by the Aditya Birla Group (ABG) in 2000 with a Clause 49] was approved by SEBI. Some of the recommendations from the ABG were mandatory while others were voluntary (Datamonitor, 2011). Corporate governance is a concept, rather than an individual instrument. The Ministry of Corporate Affairs (MCA) under the Ministry of Finance, and the SEBI together formulated the regulatory framework for listed companies specifically for Corporate Audits and Governance in 2000. Subsequently in 2002, to examine various corporate governance issues, the Naresh Chandra Committee was appointed. The fundamental objectives of corporate governance are to enhance shareholders' value and to protect the interests of other stakeholders by improving the corporate performance and accountability and to generate trust and confidence amongst those having competing or conflicting interests. Financial and non-financial disclosures, independent auditing, and board oversight of management were some of the recommendations by this committee. It is also making efforts to bring transparency to the structure of corporate governance through the enactment of the Companies Act and its amendments. The Ministry of Corporate Affairs is also responsible for administering the Competition Act of 2002 and controlling the Institute of Chartered Accountants of India (ICAI), the Institute of Company Secretaries of India (ICSI), and the Institute of Cost and Works Accountants of India (ICWAI) (GOI-Corp.Govern). Labor law is another important area to be understood by businesses in India. The Ministry of Labor and Employment is responsible for protecting and safeguarding the interests of workers. The labor legislation makes clear distinction between workers in the organized or formal sector (92% of the work force) and those in the unorganized or informal sector (8% of the work force). The doctrine of hire and fire does not exist in India and permanent employment of an associate can only be terminated on the grounds of misconduct, or for habitual

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absence due to ill health, alcoholism, and the like, with the provision of appropriate evidence, or on reaching retirement age (Datamonitor, 2011). The Industrial Disputes Act of 1947 governs the retrenchment, closure, and layoffs, and the firm requires prior government permission to lay off workers or close businesses employing more than 100 people but downsizing through voluntary retirement schemes is permitted. Section 25 G of the Act lays down the procedure of retrenchment (Country conditions.2012; Ray, 2011). The stipulated working hours are eight hours per day. There are around 10 major central unions of workers and every other union is affiliated to one of these central ones (Datamonitor, 2011). Some of the important laws that regulate business conduct in the country are the Companies Act, the Patents Act, the Copyrights Act, the Trademarks Act, the Special Economic Zones Act, the Right to Information Act, the Information Technology Act, the Environment Protection Act, and the Foreign Exchange Management Act. The regulatory bodies that enact the preceding laws according to their jurisdictions are the Registrar of Companies, the Director General of Foreign Trade, and the Telecom Regulatory Authority of India. The financial markets in the country are regulated by the RBI, the SEBI, the Forward Markets Commission, and the Insurance Regulatory and Development Authority with overlapping functions. Other countries like Norway, Japan and South Korea, these are covered by a single regulator. It was recommended that consolidating different regulatory bodies into one will benefit the economies of scale, information sharing, and elucidate accountability (Datamonitor, 2011). The main objective of the Competition Commission of India was to regulate the combinations (mergers) formulated in an anti-competition manner in India. In 2011, the RBI attempted to regulate banking related mergers and acquisitions (M&A) in India and is awaiting clearance of the Banking Laws (Amendment) Bill of 2011 by the Parliamentary Standing Committee on Finance. To streamline the banking transactions, an integrated banking law has been proposed and the cap on mobile banking financial transactions (transfer of funds between accounts in different banks using mobile phone) has been removed by the RBI. These reforms would help with merger and acquisition transactions in India in the coming years (Dalal, 2012).

Establishing a Business in India

According to the World Bank Survey, it takes 13 procedures, 33 days, and costs 74.59% of GNI per capita to start a business in India. In the survey, India ranked 111th while Australia ranked first, followed by Canada, New Zealand, and the US for starting a business. Ray (2011) and experts at Datamonitor (2011) listed various government approvals at the central, state, and local levels in India which totals to 24 steps as presented in Table 5. The World Economic Forum surveyed 142 countries globally and ranked the countries under various legal indicators in its Global Competitive Index 2011-2012. From the GCI 2011-2012 report, the rankings for China, Singapore, and South Korea were compared with India and tabulated below (Table 6 and 7) (Schwab, 2011). From an earlier study, Ray (2011) reported the results of W B Doing Business Survey 2010, where India ranked 133 among 183 countries surveyed. The survey gave India a poor ranking of 169th place in starting a business, 183rd for enforcing contracts and a rank of 175th for getting construction permits. Concessions such as tax holidays are available in special economic zones, which were set up to boost exports and make the Indian industry globally competitive. Infrastructure sector projects also qualify for tax holidays. Many Indian states also offer incentives in the form of various tax concessions, capital and interest subsidies, and reduced power tariffs for companies to attract foreign investments. There are four options for a foreign enterprise to set up operations in India namely: (1) wholly owned subsidiary company with the regulations that apply to any other Indian company; (2) as an Indian company through a joint venture with a local partner; (3) as a foreign company operating through a liaison office which entails market research and allied activities without any income generation; and finally (4) as a foreign company with a project office to execute specific projects (Datamonitor, 2011).

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Intellectual Property Rights in India

India inherited its original patent law from the British, who banned the country from producing local versions of patented drugs such as medications for malaria or antibiotics. In 1972, Indira Gandhi, the then Prime Minister, learned that Indians were paying higher prices for medicines than many Western countries. At the height of the Green Revolution during that time, she adopted a law that made it illegal to patent food or medications in India (Nolen, 2012). In 1995, India joined the World Trade Organization (WTO) (Embassy of India) and signed the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) (Datamonitor, 2011). Later in 2005, TRIPS was approved with a clause, 3(d), stating that a design or a drug must show a marked difference in novelty and or efficacy from previous versions to be patentable. India's patent law is more stringent in comparison to the US patent law, which often grants trivial patents on routine pharmaceutical improvements to a drug (Bhola, 2012; Nolen, 2012; Shetty, 2012). Today the Indian Patent Office (IPO) has been modernized and is digitizing its patent information. New patent examiners are being recruited and trained to handle the surge in patent application filings at the IPO. Recently, India was designated as an International Search Authority (ISA) and as an International Preliminary Examination Authority (IPEA), making India the only English-speaking Asian country to be granted this privilege (Evalueserve, 2010). India is also a signatory of the 1883 Paris Convention for the Protection of Intellectual Property and the 1928 Berne Convention on copyright (Datamonitor, 2011). Since the introduction of WTO-TRIPS in 1995, India has amended the Legislation and Acts in accordance with its obligations under the TRIPS Agreement. These amendments are well established at all levels: statutory, administrative, and the judicial levels. The IPRs are protected under various statues and are as follows: Patents, Copyrights, Trademarks, Geographical Indications, Industrial Designs, Layout Designs of Integrated Circuits, and Protection of Undisclosed Information. India has developed a Patent Dispute Resolution System with four dispute resolution platforms, namely: the Indian Patent Office (IPO), the IP Appellate Board (IPAB), District courts, High courts, and the Supreme Court. It has also mapped the sequential steps and timelines involved as well as the procedures under the headings, Detect and Protect, Pre-Grant and Post-Grant Opposition, Suit for revocation of patents, and Suit for infringement. Further details can be found in the Patent Dispute Resolution System in India (Evalueserve, 2010). However, India remains on the 'priority watch list' for 2011, compiled by the Office of the US Trade Representative (USTR). In addition, India has yet to approve the treaties of the World Intellectual Property Organization (WIPO), an UN agency dealing with IPRs, which focuses on promoting IPRs all over the world. But India argued with WIPO, that it had gone too far in boosting patents and copyrights, at the expense of consumers and the public in general (BMIL, 2012). In spite of introducing the TRIPS-IPR in 1995, India did not formally grant patents on drugs until 2005, helping its manufacturing sector to (Bajaj & Pollack, 2012; Noonan, 2012). Today, it takes about four years and costs about USD 2,000 to get a patent granted (Bhola, 2012). The organizational structure of the Office of the Controller General of Patents and comparative trends of IPR granted in India are presented in Figure 7 and Table 8 respectively.

The Indian Biotechnology and Fisheries Regulations

The biotechnology-derived products in India are regulated by many departments and the framework for registering the products falls under three ministries, namely: the Ministry of Health and Family Welfare, the Ministry of Environment and Forestry (MoEF), and the Ministry of Chemicals and Petrochemicals (Naralkar, Karande, & Vasani, 2010; N. Sahoo & Manchikanti, 2011). It is under the purview of the Ministry of Agriculture to approve agricultural biotechnology-products, while the MoEF regulates and approves licenses for biotechnology- derived pharmaceuticals (Kak, 2009). The Central Drugs Standard Control organization (CDSCO) and the Genetic Engineering Approval Council (GEAC) are the apex bodies that oversee the process of registration. For biologicals,

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along with approval from the Drug Controller General (India) (DCG (I)), additional approvals are required by other offices and agencies, including: the Genetic Engineering Approval Council (GEAC); the Recombinant DNA Advisory Committee (RDAC); the Review Committee on Genetic Manipulation (RCGM); the Institutional Biosafety Committees (IBSC); the State Biosafety Coordination Committees (SBCC); and the District Level Committees (DLC) (Kak, 2009; Naralkar et al., 2010; N. Sahoo & Manchikanti, 2011). The roles and functions of various Ministries and the State Governments for regulating the biotechnology-derived products for human consumption and therapeutic applications are shown in Table 9 and Figure 8 (S. K. Singh, 2008). The CDSCO has issued guidelines for clinical trials (Document No CT/71108, version 1.1) and the marketing authorization (Document No MA/71108, version 1.1) applications for biological products. The chemistry and pharmaceutical information of a given molecule has been described in the Common Technical Document (CTD) format (Naralkar et al., 2010; N. Sahoo & Manchikanti, 2011) and the requirements for nonclinical and clinical trials are defined in Schedule Y of the Drug and Cosmetics Rules, 1945. Post-approval changes in biological products are covered in the guideline Document No. PAC/1108, version 1.1. (Naralkar et al., 2010). At the centre, the CDSCO controls the DCG (I) which registers all imported drugs, new drugs, biologicals, and drugs in selected categories. At the state level, 35 DRAs act as Food and Drug Administrators (Kak, 2009), one in each state and territory. These have responsibilities in accrediting manufacturing plants, conducting the quality monitoring, and site inspections (Naralkar et al., 2010). The Indian drug regulatory framework is presented in Figure 9 and the clinical trial approval timelines are presented in Table 10. The flow chart for the clinical trial approval path is given in Figure 10. In 2005, the National Pharmacovigilance System was put in place to cover the post-marketing surveillance by the regulatory authorities. The process of enforcement and its efficiency are yet to be seen. The regulatory aspects related to the manufacture, sale, import, export, and clinical research of drugs and cosmetics in India are covered under the following Acts and Rules: The Drugs and Cosmetics Act 1940 (D&C Act); the Pharmacy Act, 1948; the Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954; the Narcotic Drugs and Psychotropic Substances Act, 1985; the Medicinal and Toilet Preparations (Excise Duties) Act, 1956, and the Drugs (Price Control) Order, 1995 (under the Essential Commodities Act) (Naralkar et al., 2010). The official standards and specifications setting body is the Indian Pharmacopoeia Commission (IPC). The IPC works in collaboration with the National Institute of Biologicals (NIB) to regulate biologicals (including recombinant-DNA and biotechnology-derived products). Periodically, the IPC publishes Official Pharmacopeia Monographs for biologics approved by DCG(I). To meet international standards and to harmonize the regulations, the IPC has signed a Memorandum of Understanding (MoU) with international standard setting bodies such as the United States Pharmacopoeia (USP), the European Pharmacopeia (Ph. Eur.), the British Pharmacopeia (BP), and others. It also provides reference standards for the industry through these collaborations (Kak, 2009). Specific guidelines for biotechnology-derived (including r-DNA-derived) biologics are also in place (DBT-Guidelines). Dhawan (2010) pointed out that the current Indian regulatory system is fragmented and spread across three different ministries and departments: the Ministry of Agriculture (MoA), the MoEF, and the DBT in the MoST. Also, these regulatory bodies lack autonomy and credibility as well as clear roles and responsibilities. Finally, the current regulatory strategy is not harmonized with the Cartagena Protocol on Biosafety of the Convention on Biological Diversity, of which India is a signatory (Dhawan, 2010; M. P. Singh, 2010). Considering these differences, Dhawan proposed some recommendations to help ensure strong and transparent regulation. They include: clear understanding of the regulatory process (product or process-based); institutional autonomy; independent and qualified regulators; and harmonization with international standards for reliable and transparent information (Dhawan, 2010). Some regulatory scholars also concurred with the idea that India could adopt the regulatory framework from elsewhere in the world, as the current system is ineffective and time consuming (Scoones, 2012). In July 2011, the MoST presented the Biotechnology Regulatory Authority of India (BRAI) Bill to the Indian Parliament. The proposed BRAI Bill is expected to centralize the authority as it is solely responsible for regulating, releasing and controlling GMOs across all states and also a promoter of GMOs, thus creating a conflict of interest.

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It was argued that the BRAI should be independent of the MoST or more specifically within the DBT, which is the promoter of GMOs in India, in order to avoid: being democratically unaccountable; failing to recognize the multiple stakeholders of state governments; being excessively dependent on narrow technocratic expertise; overriding other important legislation (including the Right to Information Act); ignoring public concerns; and making objection and protest impossible. The argument was, that the Bill is unconstitutional and should be rejected (merged)(Pradhan, 2012; Scoones, 2012)(Pradhan, 2012; Scoones, 2012)(Pradhan, 2012; Scoones, 2012) as this bill has no provision for public participation, which is a violation of article 23.2 of the Cartagena Protocol on Biosafety (M. P. Singh, 2010). However, Dr. S. R. Rao, Advisor for the DBT, told a Times of India correspondent that the decisions on health and agriculture will continue to be the subject matter of the concerned state which is not going to change (Pradhan, 2012). Sahoo and Manchikanti (2011) compared the GMP guidelines issued by the EMA, the US FDA, and the Indian authorities and found that there were considerable differences across the countries. They reported that in India, committees such as the SBCC, the RDAC, the RCGM, and the GEAC review the submitted dossier and release N O C NOC. Subsequently, the Licensee has to obtain approval for the clinical trials, the new drug manufacturing, and the import license from the DCG (I) of the CDSCO. The entire review process up to marketing authorization can take six months to more than two years. In their survey of companies, they found that 42% of the respondents considered delays in regulatory approval as the major constraint for the development of the biopharmaceutical industry. Delays in inspections, scheduling audits, and unavailability of audit reports within a stipulated time were regarded as hurdles to the commercialization of biopharmaceuticals. The authors suggested harmonizing the guidelines across countries and introducing I to improve efficiency. At least for now in India, there is no formal procedure to interact with the regulatory reviewer(s). Currently “ M the Drugs and Cosmetics Act of 1940 states GMPs that have to be followed by the industry. The 'Guidance for Industry' published by the CDSCO defines the quality data required for a new biopharmaceutical marketing-authorization application. The interviewees in the above research identified a high need for concrete review timelines, similar to the FDA and the EMA, and found deficiencies in the above guidelines on specifications with regard to cell-bank establishment, virus safety evaluation, purification, and stability studies, etc. Under the present guidelines, all vaccines in India are considered to be new drugs but no specific guidelines on biotechnologically-derived investigational drugs have been drafted. The drug approval procedures for recombinant drugs in the European Union, the USA, and India are compared in Table 11 and the flow chart is shown in Figure 11. However, despite these hurdles, 14 Indian companies were compliant with the cGMP standards of the WHO, 10 companies hold cGMP licenses from the US FDA, and nine from the EMA of which only four companies exported their products to the EU and US. The survey also revealed that 17 biopharmaceutical companies (89%) followed the International Conference on Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use guidelines and these companies considered it important to achieve quality standards. The drugs, vaccines, and biotechnology-derived drug-products for veterinary use must undergo a thorough review from various committees as outlined previously. The registration process is time consuming and cumbersome, as it may take at least two years to obtain a marketing authorization (P. K. Das, 2012). Some critical steps involved in the registration and the respective forecasted timelines are presented in Table 12. Web links to guidelines and regulations developed by international agencies (VICH, USDA and WHO) are also provided, which may be of help to the new entrant in choosing some methodologies in testing and understanding the specifications for in-process and final-product testing. For the aquaculture sector, the National Policy for the Containment of Antimicrobial Resistance has, for the first time, put a cap on how much antibiotics can be used in sea food products, including shrimps and prawns or fish and fishery products. The policy includes common antibiotics like tetracycline, oxytetracycline, trimethroprim and oxolinic acid and has defined tolerance limits and covers over 20 antibiotics or

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pharmacologically active substances that are prohibited in sea food and poultry products. The measure was initiated to prohibit fish and meat containing prohibited drugs or levels exceeding residue limits, to enter the food chain in order to prevent the emergence of antibiotic resistance of pathogens in human consumers (Rath et al., 2011). The Ministry of Commerce and Industry published (in Part II section 3, sub-section (ii) of the Gazette of India, on 17th May 2002) the MRLs for antibiotics, pesticides, and heavy metals in fish and fishery products and also forwarded the list to the Export Inspection Council for enactment (GOI-MoC, 2002). Phillips et al. (2009) argued that, to industries, there is no specific environmental legislation designed specifically for (p. 202). Aquaculture is not specifically named within existing EIA legislation and it is separately regulated by the Coastal Aquaculture Authority (CAA), under the DAHDF of the MoA. The current framework overseeing the aquaculture segment includes the District Level Committees (DLC) for regulating the coastal aquaculture which are headed by the Collector (Head of Civil Administration) of the District, and the Assistant Director of Fisheries of the respective district as a Member Secretary. The following lists the members from the State Administration: the Deputy Director of Agriculture; the Director of Science, Technology and Environment; the Senior Town Planner; the Executive Engineer of Irrigation Department; the Senior Extension Officer of the Brackishwater Fisheries Development Agency (BFDA); and a representative from SPCB. The Secretary and the Director of Fisheries control the State-Level Committee (SLC) (Phillips et al., 2009). The guidelines from GOI stipulate that any farm of 40 hectares or more should obtain consent from the SPCB under Sec. 25/26 of the Water (Prevention & Control of Pollution) Act of 1974, while f N O C from the same board. However, the lack of enactment of these guidelines is of major concern (Pathak et al., 2000). Nonetheless, if it is planned to introduce a transgenic fish strain or an exotic fish species into the aquaculture production, the firm has to seek approvals from both the DBT and the IBSC in addition to the approvals from the MoEF.

The Effectiveness of the Indian Legal System

India has a ratio of 15 judges per 1 million people, a ratio considered poor, when compared to other countries such as Canada (around 75/1 million) and the US (104 /1 million). However, in 2002, the Supreme Court in India determined that this ratio should be raised to 50 judges per 1 million people in a phased manner. This was reflected in the 10th five year plan (2002-2007) where the judiciary was allocated a meager budget of 0.078% of total expenditure, a minute increase of 0.071% compared to previous five year plans, but the successive governments have ignored this issue. Due to the lack of proper resources, delays are common. As a result, an average case can take several years to resolve. It was estimated that in 2010, 27.2 million, 4.06 million and 54,000 cases were pending in the District Courts, the High Courts, and the Supreme Court respectively, with over 70% of I The legal experts have estimated, that with the current ratio of judges-to- population and current efficiency of the judicial system, it would take around 320 years to clear the backlog of 31.3 million cases. Therefore, law enforcement is almost non-existent and laws remain ineffective. To address some of these issues and to improve conditions, the Information Technology Act was introduced in 2000 to help the situation in India by digitalizing the data, but the legislation ignored the protection of the data. Due to the above reasons, also in corporate governance and governance of the audit professions no effective implementation was reported, although India has one of the best corporate governance laws. The Harshad Mehta scam, the Ketan Parikh scam, the UTI scam, and the recent scam of Satyam Computers highlight the poor implementation of the law (Datamonitor, 2011). According to B M I L, BMI Legal Framework Rating for India, China, Singapore and South Korea are presented in Table 13. India ranked poorly at least in the contract enforcement and corruption, while other indicators such as the investor protection and the rule of law

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( ) are comparable to countries like Singapore and South Korea. China fared well only in the contract enforcement indicator (BMIL, 2012). On the environmental sustainability front, India launched a Green Court on October 19, 2010 to implement the Polluter Pay and stepped up its policing efforts to enforce the country's environmental laws. This is indeed a rare move, as India is only one of three countries in the world, after Australia and New Zealand, to set up such a tribunal. The P P on May 26, 2011, when the Haryana SPCB ordered the closure of 639 polluting companies identified in 2010-2011 and directed other highly polluting companies to set up online monitoring stations to ensure compliance with the air emissions standards. The Haryana State Government has launched trials against 151 polluting units in the Special Environment Courts in Faridabad and the Kurukshetra districts, and made them install 9,239 units of pollution control devices (India- Pollution). Historically, such environmental laws were enforced on the owners of intensive prawn culture, who were ordered to bear the costs of restoring the ecological systems of the coastal areas destroyed by the intensive prawn aquaculture and to also pay six years wages as compensation to the affected workers (GOI-Supreme Court, 1996). In Andhra Pradesh, the High Court has directed the state government to adhere to the standards laid down by the MoEF under Order No. 120 (intended to protect the lake from encroachments) pertaining to the lakes and effluents in the region. It ruled categorically that no aquaculture be permitted in Kolleru Lake other than traditional activities like fishing (Kavitha, 2010). In another instance, the Supreme Court of India on February 20, 2010, ‘ -sensitive Aravalli Hills. On August 24, 2010, the MoEF has rejected permission for the Anil Agarwal promoted Vedanta mining project in Orissa. (India- Pollution). India is one of the dumping grounds for hazardous waste from various countries. Twenty containers with goods of plastic, medical, and toxic battery waste were detained in 2010 by the officials of the Special Intelligence and Investigation Branch of the Customs Department in Tamil Nadu state. In October 2011, 170 countries attended the UN Environmental Conference in Cartagena, Colombia, and the countries agreed to a global ban on the export of hazardous waste from developed countries to developing countries (India-Pollution). Chatterjee (2009) expressed concern on the confusing and overlapping roles of the CPCB and the SPCBs. He stated, that if a water body such as a lake is polluted due to both industrial and domestic effluents, in addition to solid waste, the handling of the complaint can get complicated and confused because of the overlapping roles. Another concern was that the Criminal Procedure Code does not have a programmatic follow up with the company at fault after the enforcement of the court ordinance. He argued that the Directive Principles of the State Policy of the Indian Constitution in Articles 48 A and 51 A (g) does not state clearly whether the development will be curtailed by the state action in favor of complying with the environmental laws. Also, the penalty for companies consuming and polluting water is set very low in the statute of the Water (Prevention and Control of Pollution) Cess Act of 1977, which does not hamper the profitable firms to pay the charges. The Swadeshi (nationalist) agenda, and the ideology of India to be built by Indians restricted India to approve the IPR until 2005. Lack of adequate resources was stated as one of the reasons in one of the annual reports of the Office of the Controller General of Patents (GOI-MC&I, 2010) and as a result more than 75 patent infringement cases are pending in the Delhi High Court, and several cases are pending in various other High Courts (Datamonitor, 2011). In addition, it U“T‘ priority watch list for poor enforcement of IPR in India (BMIL, 2012). Bhola (2012) estimated that about 153 pre-granting oppositions are on file as of 2009 and about 29 patent litigation cases were filed in 2011. The trend of pre-granting oppositions and the number of patent cases are shown in Figure 12 and Table 14. Lack of patent enforcement has also resulted in soaring piracy rates across entertainment, business software, and the online book industries (Datamonitor, 2011). On March 09, 2012, the Indian Supreme Court issued a license to Natco Pharma Ltd. on B patented drug sorafenib tosylate, used as a treatment for liver and kidney cancers, based on the argument that Bayer was not selling the drug at an affordable price for Indian patients. This court order

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defensive stand concerning its generics industry (Estavillo, 2012; Nolen, 2012; Shetty, 2012). According to the decision, Natco must pay a quarterly royalty of 6% on its net sales to Bayer, which is in line with the 4% royalty recommended by the United Nations Development Program. The royalty can be adjusted 2% upwards or downwards depending on the particular therapeutic value of the product(s) or if the drug was developed using public funds (Estavillo, 2012). According to the decision N I (Bajaj & Pollack, 2012; Noonan, 2012). Shamnad Basheer, Professor at the West Bengal National University of Juridical Sciences, who has written extensively about the case, commended the decision and said that I and I (Bajaj & Pollack, 2012, p. 1). Others suggested that this ruling puts companies on a warning that patents are not granted merely to enable them to (Shetty, 2012, p. 1). India is not the first to use this tool. In 2007, Brazil issued a compulsory license on the AIDS drug Efavirenz after failing to negotiate lower drug prices with Merck. Pharmaceutical giant Novartis I P L, specifically the Clause 3(d), a patent by subtle improvements a practice most pharmaceutical companies commonly use to extend the life of their patents. Novartis Imatinib mesylate (Gleevec), costs roughly, USD 30 for one 100-milligram pill and an equivalent generic version from an Indian company costs as little as one- tenth N . A favorable verdict for Novartis would significantly impact other generic drugs in India, such as essential and life-saving AIDS and Tuberculosis drugs, says Leena Menghaney, an activist at the non- governmental organization (NGO) Médecins Sans Frontières (Doctors without Borders), India. Such a verdict would furthermore mean that India's status as the pharmacy of the poor the developing world is actually under attack, as it exports generic medicines to developing countries to treat over 6.6 million people living with HIV/AIDS. In 2006, the Chennai Patent B N G el enough to be C H C N with the TRIPS agreement. But then, in 2009, I I P A B ruling of the Chennai Patent Board and recognized the Gleevec modification as novel and inventive, but the patent extension was not granted because the efficacy of the new version was not significantly enough improved from the previous version to qualify under Clause 3(d) (Nolen, 2012; Shetty, 2012). Nolen (2012) argued that Gleevec was developed in the United States, mostly in publicly-funded laboratories, and patented there and elsewhere in the early 1990s by Novartis. Yusuf Hamied, the owner of Cipla Pharmacuticals stated: E and I (p. 1). Some lobby groups for other sectors in Indian industry counter argued that if the country has to see economic growth then India must be seen as a country that respects IPR. IPR litigations are not restricted to the pharmaceutical sector, but are also seen in the automotive sector, where litigations were filed to defend the design patents. One such case between TVS Motors and Bajaj Auto is worth mentioning. Following securing a - DT“I J 2005 Bajaj Auto sued TVS Motors for patent infringement for using the same technology in the TVS Flame motorcycle. Subsequently, TVS Motors filed a revocation suit in the IP Appellate Board, however, an initial judgment of the Chennai High Court on February 16, 2008, ruled in favor of Bajaj Auto and prohibited TVS Motors from manufacturing, marketing, selling, B Due to this decision, TVS Motors incurred a loss of INR 1 billion (~USD 25.16 million) in sales as well as loss of goodwill and share value (Evalueserve, 2010). From the above analysis it can be inferred that the IPR activism is gaining momentum, but only in national interests.

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Limitations of the Research

The aims of this research paper are a strategic (CPESTEL) analysis of the aquaculture industry and an evaluation of the attractiveness of aqua biologics with specific focus on vaccines for warm water fish species in the Indian market. Secondary sources such as published manuscripts in scientific and management literature, government plans and reports, and anecdotal sources of evidence were surveyed to obtain the relevant data in each section of CPESTEL analyses. The research was limited to the objective of gaining an overall understanding of each factor that may impact the decision making for a new entrant. Following are some of the limitations. 1.1. Data from secondary sources were used in this research and hence primary market research would be recommended to better understand the specifics on epidemiological problems. 1.2. Exploratory research is required to develop the distribution networks for the supply from the potential vaccine products to the consumer. 1.3. Although the competition is describ P Five Forces analysis is recommended to understand the perceptions of the existing vaccine manufacturers and substitute providers in the sector. It may also enable a new entrant to determine the intentions of the incumbents and gauge their marketing strategies or potential retaliation behaviors. U P F F he marketing team of a new entrant may identify synergies of any potential complementary products that may be co-marketed with the vaccine products. 1.4. Networking options such as public-private partnerships with the national research institutes may help accelerate the R&D work and may help a new entrant to tap into the national funding programs. Understanding the networking options could be a potential future research topic.

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Discussion

The aims of this research paper are a strategic analysis of the Indian aquaculture industry and an evaluation of the attractiveness of fish vaccines in the Indian market. Globally, aquaculture continues to be the fastest growing animal-derived food producing segment. It had an average annual growth rate of 8.2% between 2004 and 2009 and is expected to outpace the capture fisheries and the increasing demand for fish by the growing human population. The fish farming sector comprises of 336 species: Carp dominate the aquaculture segment in the Asia/Pacific regions, while Salmonids dominate in Europe, North and South America (FAO, 2012). China is the world leader in fish production with about 42 million tons of production in 2004 and the developing countries together generate more than 90% of food fish. In 2004 13 million tons were produced by the rest of Asia and the Pacific region, and the remaining 4.8 million tons was produced by the rest of the world (Ayyappan & Gopalakirshnan, 2008; FAO Year Book, 2009). From 2004 to 2009, an increase of 38% in freshwater and 53% marine fish production was reported, but according to FAO estimates, an additional 40 million tons of food from aquatic sources will be required by 2030 to meet the rising demand, based on per capita consumption. Thus the finfish segment has demonstrated the fastest growth rate and remained the major contributor to the global animal-derived food supply (R. P. Subasinghe, 2005). Therapeutic agents, such as antimicrobials (including antibiotics), antiparasitics, fungicides, biologics, hormones, chemicals, and drugs are reportedly being used in aquaculture globally as disease and aquaculture management tools, and concerns were expressed on the resistance development to antimicrobials and subsequent transfer of resistance to the pathogens of human and veterinary interest (Shariff, 1998). The target country of this research is India, largest food-fish producer as per 2004 FAD of FAO data (Brugère & Ridler, 2004; Kutty, 1999). The inland-aquaculture production has increased substantially between 2000 (1.55 million tons) and 2010 (3.72 million tons) (FAO, 2010) and is forecasted to reach between 8-10 million tons by 2020 (Paroda & Praduman, 2000). According to the estimates of the CSO in the India, the value of fisheries output during 2009-2010 was 4.9% of the total output of agriculture and related sectors. It was also recognized as one of the key I , based on the 2010-11 total volume of 0.75 million tons, worth INR 12,100 crore (USD 2.18 billion), of fish and fish products exported (Raghu, 2011). The two states AP and WB are the leaders in inland aquaculture, although their yields were only 60-80% (Abraham et al., 2010). Some of the reasons for the lack of success in increasing their productivity (vertical expansion) and curbing economic losses were attributed to the disease outbreaks (bacterial or viral infections) (D. Das & Gupta, 2007; M. K. Das & Das, 1995) and the lack of commercial vaccine providers in India. As a result aquaculturists in Indian aquaculture are relying on drugs and antibiotics, which has raised concerns on the development of MDR in bacterial fish pathogens or other aquatic bacteria (Arthur et al., 1996; Burridge et al., 2010; Manjusha et al., 2005; Rodgers & Furones, 2009) posing threats to the environment (Boyd, 2003; Boyd et al., 2007; Burridge et al., 2010) and the human consumers by subsequent transfer of MDR to the bacterial pathogens of human and/or veterinary health concern (Burridge et al., 2010; Shariff, 1998). Hence, the regulations in the western markets (Rodgers & Furones, 2009) and the Indian food safety guidelines stipulate prohibition of or maximum residue limits for specific chemicals (Confederation of Indian Industry, 2004) to minimize potential threats to human health and safety. To enable the sustainability in aquaculture production, scholars have suggested adoption of vaccination strategy as a safer alternative (Rodgers & Furones, 2009; R. Subasinghe, 2009) to manage the current and emerging diseases that may restrain the sector growth (Ayyappan & Gopalakirshnan, 2008). Since vaccines have already proven their potential in the context of Carp research in India and in western markets for Salmonids, the author chose to undertake this study.

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Competitor Analysis

A competitor analysis in India revealed that the most likely competition that a new entrant may face is from the substitute manufacturers, who are currently providing drugs, antibiotics, and chemicals for the aquaculture use. Their aggressive marketing tactics may pose a threat to the new entrant pressurizing the entrant to compete on pricing, as the incumbents may increase their price discounts and commissions on their products to retain their market share. Multinational firms who are currently engaged in supplying salmon vaccines or local veterinary manufacturers may find this business segment attractive and either may start a similar business in India or may partner with a new entrant once established. They both have the financial, marketing, and intellectual muscle to compete head-on with a new entrant. A risk for a new entrant could also result from the fact that some of his employees may eventually use the acquired knowhow on the manufacturing and production processes to start a spinoff company. Hence, a thorough P F Forces analysis would be warranted, but is out of the scope of this research.

The Political Landscape

The political landscape is not obstructive in terms of opposing new technologies or the introduction of a new business that supports further economic development. The leftist ideology of the opposition espoused policies of economic nationalism such as the Swadeshi (nationalist) agenda, and India to be built by Indians (ICON Group, 2007) could be leveraged by a new entrant either by tying relationships in a joint venture with a local company, or by operating as a wholly owned subsidiary within the country. Further details in favor of this approach will be discussed in the following sections. Transaction costs (e.g. borrowing costs) for businesses are high in India, due to the lack of a framework to combat corruption in politics (Datamonitor, 2011). Now that the Jan Lokpal (anti-corruption) bill is awaiting approval by the Indian parliament, the issue of the transaction costs for the business can be expected to wane. In spite of the lack of such a law, Keren (2009) highlighted that Indian entrepreneurs have been more courageous than their Chinese counterparts, and have successfully conceptualized and implemented novel strategies to develop new products. The Indian politicians and the ruling government at the central and the state level have recognized the importance of an open and knowledge-based economy, and have initiated economic policy changes in 1991, and introduced the National Biotechnology Development Strategy in 2008. As a result, in 1997, tariffs on imports were slashed from 90% to 30% (The Economist, 2009) and many restrictions and licensing requirements (e.g. notification of producers to the government on any change in their production and employment) were abolished. Property rights remain a challenge in some states like WB, but not in the more attractive states of AP and Karnataka, etc, who are willing to provide land at cheaper prices, but the political instability in AP, due to the Telangana Separatist Movement for an independent statehood, has to be of concern for an entrant when determining the potential location for its new business. A new entrant requires patience as the reforms and policy changes in India take time to ensure policy continuity and institutional stability especially if governments change.

The Indian Economy

The Indian economy is factor-driven, due to its dependency on unskilled labor and natural resources, the selling of basic commodities, and the competition on low prices. But the economic reforms of 1991 have accelerated economic growth in India, making it one of fastest growing economies in the region (Datamonitor, 2011). The reforms have attracted new foreign investment and other capital inflows, and stimulated ICT as well as biotechnology industries. The annual GDP growth rate has reached 8.0% (2011-2012) and is expected to remain at the same level through to 2025 (Narasimhan, 2012). The poor infrastructure in India was claimed to be one of the

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pitfalls in the development of the economy. Improvements to infrastructure were addressed in the country's 11th five year plan (2007-2011), with investments totalling USD 500 billion during 20092013 (Datamonitor, 2011). This approach, coupled with the anti-corruption bill (if passed by the Indian Parliament), should attract more foreign investments into India. Inflation, which is another issue inhibiting economic growth, ‘BI aggressive tightening of the monetary policy (increasing the interest rates), which will reduce the inflation rate to 4% by 2016. The debt-to-GDP ratio, which shows a , stood at 69.2% in 2011 indicating high risk in investments and borrowing costs. But Miller, Holmes, and Feulner (2012) have shown that the debt-to-GDP ratio could reach up to 70% without negatively impacting the performance or growth of a economy. Unfortunately, in the interim, high interest rates mean high borrowing costs for a new entrant. To leverage short- or long-term financial support for a business entrant may have to tap into various networks of financial institutions or even venture capital funds. India is recognized for its mature financial and capital markets, and when a new entrant is ready for a initial public offering, frameworks are in place to go public through SEBI. Contingent on the approval of GOI, a new company may even secure capital from abroad, through the subscription of a foreign collaborator to their share capital or by way of supplying technical knowledge, patents, drawings, and designs of plants, or assets like equipment (GOI-Start-up). The household savings rate is also fairly high, standing at 25% of I GDP, which means that the rising household disposable income and discretionary spending could allow to find angel investors (who have disposable incomes and household savings) willing to take risks in multiplying their investments. The export potential for fish vaccines to neighbouring countries like Bangladesh, China, Sri Lanka, Thailand, etc is likely high, and the international trade agreements of India with these countries could allow a new company to not just serve the Indian market, but to expand into the above markets too. The biotechnology and fisheries sectors are enjoying the fiscal incentives from the central and the state governments in the form of relaxed price controls on drugs, subsidies on capital, tax credits, and breaks on R&D spending, but it requires that the firm registers with Directorate of Science and Education to obtain these benefits (Datamonitor, 2011). The GOI has also slashed tariffs on fisheries products to facilitate further exports. To maintain momentum for imports and exports, the government has developed an adequate policy framework, assistance, and incentives to individuals, companies, and organizations engaged in foreign trade. Thus a new entrant can expect further positive developments in its segment of interest.

Environmental Aspects

Using the cradle-to-grave strategy, an Ecomark scheme was developed in India by which the consumer can make a right environmental choice (Datamonitor, 2011). The Ecomark label is granted only to those consumer goods that meet the minimum specified environmental criteria and the quality requirements of the Indian standards. Under this scheme, the firm has to document the methods employed in the environmental conservation, right from raw material extraction, to manufacturing, and finally, to the disposal. The new entrant may choose the option to obtain Ecomark as a strategy to market the firm and its products as environmentally friendly. It would also serve its public relations efforts and demonstrate the corporate social responsibility. The management may also draft policies to manage their water resources carefully which are under significant stress in India. Air quality remains a major concern in India due to the poor quality of the fossil fuels used in automotives for transportation and power generators to substitute for the frequent power outages. An area where the new entrant could make a difference is by investing in solar or wind based energy generation, as both resources are abundant in India. This could add to the Ecomark strategy as well. T B ‘ in India is gearing up more towards rapid production methods rather than environmental sustainability (Patterson, 2011). As a result, the management and the field staff of a new entrant may have to walk a treacherous path in educating their customers and convincing them to switch to their vaccine

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products in place of antimicrobials and drugs, which will contribute to aquaculture sustainability,. Vocational training is considered a major role player in the growth of the aquaculture segment and the economy. Lack of technical training or own knowledge on fish farming and management, were reported to be some of the common problems in several of the Asian countries including India. Abraham, Sil and Vineetha (2010) conducted a survey in the states of AP and WB and compared the qualifications and formal training acquired by the fish farmers. The findings suggested that 68% of farmers in WB had undergone short-term training in aquaculture and 15% of the farmers surveyed had graduate degrees, while in the state of AP only about 2.7% were graduates, and 41% had training in aquaculture. Interestingly, 48% of the AP farmers learned aquaculture through day-to-day experience and gathered information from government extension workers, educational institutions, peers, friends and neighbors. Feed and drug sales personnel were the source of information on disease management for 60% of the AP farmers interviewed, while the role of NGOs was found negligible, whereas about 50% of WB farmers learned this aquaculture content from similar sources. The results also revealed the lack of or poor co-ordination between Government Extension Officers and the farmers in implementing the scientific advancements in aquaculture. As described, the aquaculturists in India are dependent on the sales personnel to choose an appropriate product, and there exists the potential, that a price war could be waged by these existing substitute-product sales forces to secure their market share. Building relationships with Krishi Vigyan Kendras (Farm Science Centers) in the country, operated through the State Agricultural Universities, the ICAR, and the NGOs, along with the MPEDA (which acts as a coordinating agency with different Central and State Government establishments and promotes coastal aquaculture, by increasing exports, specifying standards, processing, marketing, and training the export of aquatic products), (Aqua Overview) may enable a firm to reach its customers, and help to initiate a dialog on the use of vaccines and its benefits. This will also help a new company to convince the customer with help from these agencies, as the customer already has good relationships with these agencies. Additionally, the firm may offer services such as educating the aquaculturists on biosecurity issues and the negative implications of using antimicrobials on the fish (e.g., higher residue limits disqualifying them for export, risks of transferring the MDR to human consumers, and subsequent usage of high doses of antimicrobials to combat resistance), which in turn would increase their costs and their risk of losing export capability. The package may also include diagnostic services to the customer, with which a new entrant may get access to the etiological agents for the current/emerging diseases. The firm could also approach various divisions of fisheries and research institutes of the ICAR to tap into their repositories of culture banks. Infected fish tend to be anorexic and do not feed as often as healthy fish. Therfore, a vaccine supplier t can use this fact as a marketing strategy to inculcate knowledge that the vaccination method would allow fish to combat diseases and remain healthy leading to better feed conversion and thus reducing the organic load in the effluents. This will not only enable the farmers to increase their productivity/profits due to better growth rates through higher feed conversion but also protect the environment by generating BOD effluents containing less particulates, nutrients, and heavy metal contamination from supplements. It was noted that the Minimum National Discharge Standards that are set by the CPCB (which are technically feasible to abate pollution, but found economically unrealistic) lead the SPCBs to either closing a polluting facility (that is not complying with the standards) or not enforcing the standards at all (Datamonitor, 2011), due to lack of knowledge on the current levels of emission at the local level. Therefore, adopting EIA and EA methods are expected to help a vaccine manufacturing firm to assess the impact of its production processes on the environment. It is not only prudent that a firm invests upfront on pollution abatement technologies and equipment, but also designs processes that generate minimal effluents, although this would mean higher upfront costs. Bandopadhyay (2010) has proven, using statistical evidence, that cement producing firms have reaped the “PCB the corporate world has an incentive to participate in this environmental movement (Kaur & Gupta, 2011). Alternatively, the effluents rich in nutrients such as buffers and spent media may be sterilized properly and used as

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fertilizer in the agricultural fields. These pollution abatement processes when documented appropriately in the EIA and EA dossiers, may help a company in winning the Ecomark Label as well as good a reputation with the pollution control boards, who have categorized bio/pharmaceutical companies in the . Since it is out of the scope of this research, to assess the value of carbon credits that the firm can generate, by adopting novel technologies to minimize the environmental foot print, further research in this area may shed more light on converting these credits into cash.

Socio-cultural Aspects

India is a secular country, with the freedom to practice any religion. The societal structure is archaic, built on the caste system. The society was grouped in four castes: Brahmins, Kshatriyas, Vaisyas and Sudras (Balley, 2011) and each caste has further divisions, which are mainly controlled by the type of work a person undertakes (Indian Mirror), especially the groups that include the BCs, SCs, and STs (Chin & Prakash, 2011). Due to this social divide, and the reasons of Sudras being oppressed, the GOI has implemented oppressed groups in an effort to uplift them in the society by assigning special preferences, like public-sector jobs, parliamentary seats, and college seats. As a result, there are frequent cataclysms regarding such reservations (Indian Mirror) and also negative impacts on the economic freedom and growth as well as capitalism (Weede, 2010). Gender bias and social stratification is another issue in India. Deininger et al (2011) have proven through their research that women leaders have contributed to various forms of the public-good than male leaders. This implies that the need exists for a policy on how a caste and gender issues in the day to day operations. A hiring policy that defines the selection criteria, how to retain staff, as well as conflict resolution mechanisms is warranted. Another aspect to which attention needs to be paid is the pension system. Although this scheme is voluntary in the private sector, a system matching 10% of the salary to is a positive incentive that will help the management to attract and retain talent in the company. Simultaneously, enrollment of the firm in the EPFO is required if the firm employs more than 20 staff members on its payroll (Datamonitor, 2011). For the unskilled or semi-skilled labor force it is mandatory to follow the guidelines of the central government with a minimum wage of INR 115/day (US$2.56), which could superseded by the minimum wage stipulated by the state (which is usually higher than that of central govt.) where a firm is anticipating to set up its facilities. Alternatively, these services could be outsourced to contractors in order to minimize dealings with regulators. The fisheries sector and the aquaculture segment are notorious for engaging child labor in their T C“‘ obligations and to contribute to the abolishment of child labor, the management of the new entrant could play its part by sponsoring a few children in their schooling, which would further demonstrate their dedication to the social welfare of the fishery and the aquaculture communities. Kumar, Katika and Joshi (2003) noted that commercialization of the fisheries sector in India is following the trend of economic growth. This growing trend has had a positive influence on the poor in terms of direct- and indirect-income gains, employment, and the acquisition of skills that contribute to the income-earning capacity. It was predicted that the fish consumption in developing countries will increase by 57%, from 62.7 million tons in 1997 to 98.6 million tons by 2020 (Imelda et al., 2010). The per capita annual consumption of both, the rural and the urban fish-eating population in India totals 6.08 Kg (NSS 66, 2012). Based on the current trend of rising income per capita, as well as the disposable income in India, the rate of increase in per capita annual consumption of food-fish and fish products combined is projected to reach 15 Kg by 2030, according to the CIFA, India (Jayasankar et al., 2011). Since poor households respond more positively to the income increases, a significant shift in the demand for fish and fish products is expected in the near future due to the current income elasticity of 1.66 (Income Elasticity of Demand is a measure of the rate of response of quantity demand due to . The projected additional demand for fish in India by 2020 is about

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3.21 million tons (raw fish), of which about 90% is expected to be met from freshwater sources and aquaculture. It is projected, that by 2030 a three-fold increase in aquaculture production is required to meet the rising demand (Jayasankar et al., 2011). Rath et al. (2011) stated that the consumption pattern of the urban population and the preference to a variety of fish and fish products, are also expected to revolutionize the consumption levels in India and thus influence the growth of inland fisheries, as it is already happening in other parts of the world. According to Channa (2010), a net intake of 2,700 calories per consumption unit was prescribed as a minimum to avoid malnutrition for an Indian. To prevent the macronutrient-protein deficiency, fish protein is considered as protein for the poor and is a cheaper alternative for rural, urban and poor consumers (A. Kumar et al., 2003). Campaigns to educate the population on the benefits of fish protein in the nourishment may therefore not only increase the market for fish, but also indirectly help a company to increase its vaccines market. Cultural literacy is invaluable to the new entrant, especially if the top management is from a foreign country. Family is the most influential of all the areas of socialization, followed by caste, religion, and school. As a result a collectivist mind-set, emotionality at work, and dependency proneness all have links to family, as individual members have to adjust to the collective norms of a family to gain emotional security. The caste-based thinking has led to hierarchy-orientation, although this thinking is declining in the urban and middleclass population. Taken together, a hierarchical structure built on the socio-religious caste-based Indian society speaks to the power distance (Sebastian et al., 2006) which is a major factor in the managerial and the corporate cultures in India (Burman, 2010). Therefore, Indians have a more egalitarian culture and readily accept the inequality of power distribution (Mani, 2007). As Brassach suggested, a package of Adaptation (authoritativeness, emotionality and empathy) and Leadership (results-oriented) would yield results in India when applied together. In practice this package means being deliberate, demanding (adaptation and leadership), differentiated (individualized for each employee), and paternalistic (strong authoritative elements, fatherly empathy and true leadership) (dddP). The western countries exhibit masculine values to a slightly greater extent than India (Mani, 2007). It was suggested that the score of 56 for India, implies that both masculine and feminine values co-exist in Indian societies and organizations. Regional differences were also observed with southern India on average being more feminine oriented than the northern part. Therefore an Indian employee is flexible to work in all kinds of efficiency- and result-oriented environments, if his or her cultural-needs of modesty, caring, and belonging to a big family are fulfilled (Arora, 2005). If the management decides to assign an expatriate to lead the business, then the leader should understand the long-term orientation of the Indian team. This means that the top management has the responsibility to create a vision for the company and to make strategic decisions of long-term orientation, meaning that the interests of the society rather than just the growth of the organization should be the priority (Hofstede, 2009). It is interesting to note that India (48) scored higher than China (20) and South Korea (18) on the individualism dimension and is on par with Japan (46). Sebastian, Parameswaran and Yahya (2006) reasoned, that the western work culture of individualism exists in Indian organizations, based on the co-existence of vertical collectivism from indigenous cultural conditioning, and individualism due to the western management. This was much more pronounced in the younger generation, who are more adaptive to the western working style than the older workers. On the dimension of uncertainty avoidance, Indians are much more open to venturing into the unknown, although Migliore (2011) noted that at the managerial level US managers are more comfortable in dealing with ambiguity than their Indian counterparts. Nonetheless, it would be an advantage to a new entrant to engage Indians in long-term projects, which in turn would not only satisfy their long-term orientation, but also give them the opportunity to learn to deal with the unknown outcome of such projects. In summary, the leader of new business in India has the challenge of professionalizing the activities in the business by converging the national and organizational cultures, as well as western cultures through understanding the cultural needs of the society. Ideally, an experienced and competent citizen of Indian origin, who has

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experience overseas in western markets, may be suitable to bridge the cultural differences between western and Indian workforce. Alternative a culturally savvy western expatriate who has experience in India could also satisfy these requirements.

Technological Aspects

Inclusive development, four pillars I “ T means having a technology management strategy that exploits the latest technologies benefiting few. Such a strategy has to identify the needs for change; create innovation in technology and business models; and forge public-private partnerships (Raman, 2010). Such partnerships are to the benefit of a new entrant and will enable the firm to tap into various resources such as government funds, repositories, and technologies that are close to commercialization. If the new entrant determines to choose a citizen of Indian origin to lead and run the company, it can secure the DBT W T F T fellowship opportunity may ease some of the initial expenditures for the management (Natesh & Bhan, 2009). The DBT “BI‘I and BIPP envision and promote high-risk, cutting edge industry research, and futuristic technology areas, with the aim of making the Indian industry globally competitive with a focus on IP creation and ownership in the biotechnology sector. Similarly, the BIRAC was establishment to champion bridging the gap between science and the marketplace and steering new companies A recent positive landmark decision of the DSIR was to allow the scientists from the National Research Institutes and academia to start companies, while retaining their jobs in the institutions. This model has been proven successful in the western world and in India and it is expected to go a long way in transforming the innovation into value creating enterprises (Natesh & Bhan, 2009). All the above initiatives could work in favor of a new entrant regarding leveraging joint venture business relationships. Also, a new company could take advantage of the finishing school program introduced by the DST, where a bench fee of INR 50,000 could be obtained per student-trainee for enrolling into the co-op program. Similarly, the DBTs Biotechnology Associateship could be an avenue to hire postdoctoral associates to carryout research for the firm, for tenure of 6-12 months (IBEF, 2011a; Natesh & Bhan, 2009). The DST is also putting its efforts towards bringing public and private firms together, to address local issues and create socio-economic value. Therefore, registering the company with the DST, will allow the management to seek help from DST affiliated institutes in identifying the sites for field trials in collaboration with the fisheries research institutes and in designing clinical trials. The fastest approach to commercializing fish vaccines in India could be through obtaining equity in projects of veterinary importance from the national fisheries institutes, which are close to commercialization. Two of examples of such late stage technologies are probiotic bacteria reported by Parthasarathy and Ravi (2011) and the live attenuated A. hydrophila vaccines by Shome and Shome (1999a; 2005). According to the CSIR and the DST, securing equity in the late stage technologies, developed by one of the nation research institutes, would satisfy the earning needs of these institutes towards their R&D expenditures, while a new entrant could speed up the process of commercializing vaccine products. The CSIR or the DST could proclaim the success of commercialization of their product concepts, which would in turn attract more funding from the GOI. This could be a win-win outcome for both parties. The institutional infrastructure in India is well developed, and a new entrant can enjoy these facilities to gain access to databases for research activities on r-DNA vaccines. One such database is the BTISnet-BioGrid India (Natesh & Bhan, 2009). To avoid capital investments, the new entrant may leverage the infrastructure such as the BTIC P G, which was set up in IICT, Hyderabad, AP. This facility offers intermediate and front-end options to develop lab- and bench-scale process technologies for early-stage product development and commercialization, while the Shapoorji Pallonji Biotech Park, Genome Valley, Hyderabad, offers cGMP compliant facilities for the development and scale-up of bio-processes and technologies (Biotech Parks, 2011). Although not

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built yet, a new entrant may lease space in the future Marine Park in the Mangalore district from the state fisheries department of the state of Karnataka. (SiliconIndia News, 2011). The Minister of State, Science and Technology, announced that the GOI agreed to triple the budget for R&D from INR 33,000 crore (~USD 7.44 billion) in the 11th five year plan (2007-2011) to around INR 90,000 crore (~USD 16.18 billion) in the 12th five year plan, which means the commitment to R&D initiatives will reach 2% of the GDP compared to current 0.98% (IBEF, 2012). In the Union Budget of 2012-2013, the MoST has allocated INR 1,485 crore (~USD 267 million) to the DBT, an increase of about 10% over the actual expenditures in 2010-11 (GOI-DBT- Budget-Notes, 2012; IBEF, 2012). The fisheries segment has gained a reputation as one of the thrust areas to the growth of the agriculture sector for the past 55 years. As a result, the MoA allocated INR 1,910 crore (~USD 343 million) to the DAHDF, a 74% increase from the expenditures in 2010-2011. Compared to DBT and other departments of MoST, the entire fisheries program secured an increase of only 3% from the previous year budget (GOI-DAHDF-Budget-Notes, 2012). Infusion of capital into the ‘D approach for a new firm, as it can leverage funding from the national research institutes for collaborative projects, and it can also expect more basic research fundings in the areas of vaccine research. According to the GCI of 2011-2012, India stood last in comparison to the US, Singapore, South Korea, and China on the technology landscape. Nonetheless, Indian research institutes and companies have been creative in delivering new research (as measured by publications and patents) and in developing successful novel business strategies that have earned global reputation. For example, Attero Recycling, and Serum Institute of India (Technology Pioneers, 2012). Therefore, it is encouraging to learn that innovation capacity is improving and business models are evolving. P in aquaculturists minds (personal communication) due to the lack of knowledge of the existence of todays state-of-the-art systems. Such equipment is commercially available from Norway and is used to vaccinate salmon in Western countries. Therefore, investment in such vaccination equipment and training personnel on how to use it would be a start-up cost to be borne by a new entrant. Currently therapeutic agents are being prescribed only by veterinarians and The College of Fisheries, Mangalore, is the first institute in India that has designed courses on aquatic medicine including, pharmacology and toxicology, in Bachelor of Fisheries Science program, This will enable the graduates to prescribe medications for the aquaculture segment (The Fish Site, 2012). One avenue, which could lead to market penetration and or expansion, is to approach such fisheries colleges and conduct seminars and symposiums to transfer knowledge on the benefits of the use of vaccines as eco-friendly alternatives. At the same time, shedding light on the existence of vaccine-delivery equipment could enable the new graduates to transfer knowledge to the farmers and change their mindsets.

The Legal Landscape

Legal system in India was categorized as more symbolic rather than effective. In April of 2005, a VAT system was rolled out as part of the country's tax reform, which aided in indirect tax collection and a number of changes in taxation policy covering the entire value chain. It was noted that since all the states are enrolled into the VAT platform, the manufacturers can mitigate the issues in dealing with different rates of taxation on products moving across states, which favors an entrant in reducing the inventory and the warehousing costs, and will enable it to respond to customer demand faster. Another initiative such as GST (if approved) (PTI, 2012), is expected to attract FDI into the country and ease the process of opening a business in India (Datamonitor, 2011). In India without VAT, the companies cannot get a tax refund for their products from abroad in the event a firm intends to export vaccines to the neighboring countries (Datamonitor, 2011; Rediff Business Desk, 2005). To encourage international trade, taxes paid on services used for the export of goods will be refunded (Datamonitor, 2011). The fringe benefit tax (for example: cash allowances for employee transportation to work, entertainment, travel, employee welfare and accommodation) was abolished in 2009 (Swiss Life, 2012) and the online tax payment

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process was implemented in 2008 (GOI-Income Tax, 2008) in an effort to reduce the cumbersome administrative processes in the corporate tax system (Datamonitor, 2011; Rediff Business Desk, 2005). Under the new Direct Tax Code of April 2012, the minimum alternate tax payable by a corporation will be calculated at 2% of the value of gross assets of a firm, although it may negatively impact the firm during the first few years until revenues start flowing into the corporation from its sales. In summary, domestic corporations are subject to tax at a basic rate of 35% plus a 2.5% surcharge. Foreign corporations pay a basic tax rate of 40%, a 2.5% surcharge, and an education cess (tax) at a rate of 2% on the tax payable. The corporate sector is also subject to a wealth tax at a rate of 1%, if the net wealth of a company exceeds USD 33,000. Tax is also payable on capital gains on the sale of assets. Therefore it can be an advantage to register a company as a wholly owned subsidiary of or as a joint venture with a local partner to enjoy these tax benefits (Datamonitor, 2011). Labor law is an area of significant importance before starting a business in India. The western doctrine of hire and fire does not exist in India, and permanent employment of an associate can only be terminated on the grounds of misconduct, or for habitual absence due to ill health, alcoholism, and the like, with the provision of appropriate evidence, or on reaching retirement age (Datamonitor, 2011). The Industrial Disputes Act of 1947 governs retrenchment, closure, and layoffs, and a firm requires prior government permission to lay off workers or close businesses employing more than 100 people, but downsizing through voluntary retirement schemes is permitted. Section 25 G of the Act lays out the procedure of retrenchment (Country conditions.2012; Ray, 2011). The stipulated working hours are eight hours per day. To set up a business in India a new entrant should have patience and perseverance as it takes about 24 approvals from various levels of governments (Ray, 2011), which are considered as too much bureaucracy compared to Australia, Canada, New Zealand, and the US as well as W B Doing Business Survey 2010. To address this issue, Sebastian, Parameswaran and Yahya (2006) suggested that dedicating or delegating a person, who has connections in political circles, to the local partner could mitigate delays and interruptions. In spite of introducing the TRIPS in 1995, India did not formally grant patents on drugs until 2005 (Bajaj & Pollack, 2012; Noonan, 2012). Today, it takes about four years and costs about USD 2,000 to get a patent granted (Bhola, 2012). It would also take years to hear the verdict on litigation cases on patent disputes if any should emerge. To avoid the hassles of going through this litigation process, as the enforcement of the patent law is weak in India, it is prudent for a new entrant to keep the knowhow as trade secrets or as proprietary knowledge as opposed to applying for a patent. By so doing, (s)he can minimize the costs of maintaining the patents as well as transferring the costs to the customers in the form of higher product price. A new firm would be well advised totake measures such as signing non-compete, confidentiality, and non-disclosure agreements with its staff to mitigate the risks of piracy and creating competition. Sahoo and Manchikanti (2011) compared the regulatory landscape for biologics and biotechnology- derived products. They reported that in India, committees such as the SBCC, RDAC, RCGM, and GEAC, review the N O C NOC, after which the Licensee has to obtain approval for clinical trials, new drug manufacturing, and import licenses from the DCG (I) of the CDSCO. The entire review process up to and including marketing authorization can take six months up to more than two years. Delays in inspections, scheduling audits, and non-availability of audit reports within a stipulated time are to be expected, as there is neither a nor a formal procedure to interact with the regulatory reviewer(s). This means the dossier must be in compliance with the requirements specified in CTD to minimize multiple reviews “ M Drugs and Cosmetics Act of 1940 states the GMPs that have to be followed by the industry and the 'Guidance for Industry' published by CDSCO defines the quality data required for a new biopharmaceutical marketing authorization application. As a general guideline, the flow chart provided in Figure 13 is expected to be helpful for registering LMOs which may be of importance in fish vaccines as an LMO enables mass vaccination.

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It is unclear what guidelines to follow for the registration of veterinary biologics. It is assumed that if the guidelines developed by the WHO (Chaloner-Larsson, Anderson, & Egan, 1997) and ICH are followed, the new product registration may meet or exceed the Indian regulatory requirements set forth by the DCG (I) and the DBT, as they have adopted the key elements of the guidelines from the above mentioned international organizations. As the vaccines fall int nder the present guidelines (N. Sahoo & Manchikanti, 2011), fish vaccines (inactivated and killed) may need to obtain drug approvals under the new biologics entity from DCG (I) and IBSC. The recombinant vaccines for fish fall under more elaborate screening and approval process similar to biologics and r-DNA vaccines for human use as shown in Figure 13 (GOI-DBT, 2006). Therefore, the author assumes that the product registration and processes for obtaining marketing authorizations for fish vaccines may be under the purview of DCG (I), GEAC, RDAC, RCGM, IBSC, and many more such committees, at the state and district levels. According to the survey of the biopharmaceutical companies in India by Sahoo and Manchikanti (2011) (r-DNA ICH T ‘ ‘ Pharmaceuticals for Human Use guidelines and considered them important to achieve quality standards. Similarly, Technical Requirements for Registration of Veterinary -Products (VICH) is the overseeing section of ICH that covers the veterinary biologics. Several guidelines are available online for various sections of the dossier and these guidelines are regarded as the highest standard set by harmonizing the guidelines from the EU, Japan and the USA (VICH). Therefore, the author assumes that the new entrant may choose the WHO and VICH guidelines to develop the Summary of Product Characteristics (SPC) and validation documents which may deem equivalent or superior to I A, the US D A Code of Federal Regulations, Title 9, (9 CFR) (define regulations for vaccines of veterinary application and associated memoranda; provide guidance for various activities in veterinary vaccine development and registration). Therefore 9 CFR could be an alternate path. Similarly the facility licenses, audits and inspections may have to be obtained from the State DRAs. It is clear that considerable amount of time and documentation is warranted in order to obtain marketing authorization. The regulatory and marketing departments of the new entrant may also need to realize the language diversity between the states of India and hence labeling and brochures for product promotions have to be drafted in at least two languages, for example, English and a regional language in order to comply with regulations. Hence, additional costs on translations and printing have to be expected.

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Tables

Table 1: The maximum residue limits of specific drugs, pesticides and heavy metals in fish or fishery products. (GOI- MoC, 2002) Pesticide Maximum Permissible residual level in ppm BHC 0.3 Aldrin 0.3 Dieldrin 0.3 Endrin 0.3 DDT 5.0 Heavy Metals Maximum Permissible residual level in ppm Mercury 1.0 Cadmium 3.0 Arsenic 75 Lead 1.5 Tin 250 Nickel 80 Chromium 12 Antibiotics Maximum Permissible residual level in ppm Tetracycline 0.1 Oxytetracycline 0.1 Trimethoprim 0.05 Oxolinic acid 0.3

Table 2: Manufacturers and Suppliers of common pesticides and antimicrobials used in aquaculture for the management of diseases and pests (Pathak et al., 2000). Pesticide/Chemical/Antibiotic Brand Name Manufacturer Dichlorvos Nuvan Hindustan Ciba-Geigy Ltd. Malathion Cythion Cyanamid India Ltd. Quinophos Ecalux Sandoz India Benzene hexachloride Gammexene Local companies Copper Sulphate Local companies Sodium Chloride Common salt Local companies Calcium Chloride Lime Local companies Oxytetracycline TM-50 Pfizer Ltd. Chlortetracycline Aurofac-20 Cyanamid India Ltd. Doxycycline AFS Forte Vesper Nitrofurazone+Furazolidone Bifuran Eskaylab Ltd. Furazolidone Groviron Glaxo Laboratories Sulphadiazine+Trimethoprim Bactrisol, Neochlor Forte Alved Pharma Pvt. Ltd. (Vetcare division of Tetragen Chemie Ltd.) Neomycin+Doxycycline Neodox Forte Alved Pharma Pvt. Ltd.

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Table 3: Comparison of S&T publication productivity between 2001 and 2011 (Science Watch, 2011). Rank by Papers Rank by Citations Rank by Cites Cites per volume of Citations per Papers Paper Papers India 11 293,049 16 1,727,973 3 5.90 China 2 836,255 7 5,191,358 - 6.21 USA 1 3,049,662 1 48,862,100 - 16.02 South Korea 12 282,328 14 2,024,609 - 7.17

Table 4: Comparison of innovation capacity indices for India, China, the USA, South Korea and Singapore in 2010- 2011 (Lopez-Claros & Mata, 2010). Rank Pillar 1 Pillar 2 Pillar 3 Pillar 4 Pillar 5 Institutional Human Regulatory R&D Adoption and use of Environment capital, and legal information and training and framework communication social technologies inclusion India 75 97 89 74 96 China 58 78 70 49 85 USA 27 15 5 9 12 South Korea 34 35 51 5 10 Singapore 10 31 2 10 13

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Table 5: Approval list from various levels of government in India to start a business (Ray, 2011). Clearances/approvals from central government 1. Obtaining director identification number (DIN) on-line 2. Obtaining digital signature certificate on-line 3. Reserving the company name with the Registrar of companies on line 4. Presenting the company documents duly stamped by Superintendant of Stamps or the authorized bank along with the registration fee to the Registrar of Companies to get the certificate of incorporation 5. Obtaining a Permanent Account Number (PAN) from National Securities Depository Services Limited (NSDL) or Unit Trust of India (UTI) Investor services Limited or their authorized agent. 6. Obtaining a Tax Account Number (TAN) for tax deduction at source (TDS) from Income Tax department 7. Obtaining Environmental Clearance under environment impact assessment( EIA) notifications of 2006 8. Clearance for diversion of forest land 9. Coastal Zone regulation (CRZ) under CRZ Notification 10. Wildlife clearance under Wildlife ( Protection) Act,1972 11. Stack height clearance under Aircraft Act, 1934 12. Clearances required from Ministry of Defense 13. Clearances under Electricity Act,2003 14. Clearance from chief controller of explosives (CCE) to use explosives under Explosives Act, 1884 and Explosive Rules, 1973 15. Clearance to use groundwater in exploited blocks 16. Security clearance 17. Obtaining importer-exporter code Clearances/approvals from state/local government 1. Approval of building plans by Municipal authorities and factory inspectorate 2. Licenses required from Chief Inspector of Factories under the Factories Act,1948 3. Permission to use water and power allocation 4. Consent to establish and operate and grant of emission and discharge from Pollution Control Board (PCB). 5. Registrations under labor laws such as Provident fund (PF) and Employees State Insurance (ESI). 6. Registration with VAT and professional tax authorities 7. Registration under Shops and Establishment Act.

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Table 6: The Global Competitive Index 2011- ‘ covered by the GCI 2011-2012 (Schwab, 2011). Ranks Property IP Judicial Burden of Efficiency of Efficiency Protection Strength of Rights Protection independence govt. legal of legal of minority investor regulations framework in framework share protection settling in disputes challenging interests regulations India 69 68 51 96 64 51 62 36 China 41 47 63 21 42 44 60 77 Singapore 3 2 20 1 1 8 6 2 South Korea 53 46 69 117 84 97 110 60

Table 7: The Global Competitive Index 2011- ‘ covered by the GCI 2011-2012 (Schwab, 2011). Ranks Effectiveness Extent No of No of days Burden of Hiring & Redundanc Regulation Legal rights of anti- and procedures to start a Customs Firing y costs, of index monopoly Effect of to start a business procedures practices weeks of securities policy taxation business salary exchanges India 31 39 119 96 89 66 93 26 20 China 48 29 131 112 56 44 118 53 60 Singapore 11 6 8 3 1 2 6 2 1 South Korea 41 91 78 58 50 115 118 77 39

Table 8: Comparative trends of IPR granted by Office of the Controller General of Patents, Designs and Trademarks of India (GOI-MC&I, 2010). Year 2005-06 2006-07 2007-08 2008-09 2009-10 Patents 4,320 7,539 15,316 16,061 6,168 Designs 4,175 4,250 4,928 4,772 6,025 Trade Marks 184,325 109,361 100,857 102,257 67,490

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Table 10: Regulatory approval timelines in India (Naralkar et al., 2010).

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Table 11: Comparison of drug approval procedures for recombinant drugs in the EU, US and India (N. Sahoo & Manchikanti, 2011).

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Table 12: The regulatory path and timelines for registration of veterinary biologics in India (P. K. Das, 2012). Registration of Inactivated & Killed Bacterial/Viral Vaccines in India Procedure Other Agency Guidelines of Importance 1. Test license to manufacture small batches of vaccines is required from FDA Bhawan, New 1. Aquatic Animal Health Code. Delhi using Form-30 before initiation of a test batch. The procedure and check lists may be Fourteenth Edition, 2011. obtained from: http://www.cdsco.nic.in/test_licences.htm World Organization for Animal 2. Form-29 will be issued by FDA Bhawan which is a test license, after fulfilling the Health. OIE. Paris, France. requirements described in Form-30. Manufacturing process of a test batch of vaccine may 2011, Vol. 14, XVII + 323 + II. begin after securing test license. ISBN 978-92-9044-833-4. p1- 3. Submission of samples from test batch to Biological Standardization, Indian Veterinary 306. Research Institute (IVRI), Bareilly, Utter Pradesh State, is required for evaluation http://www.oie.int/doc/ged/D of efficacy and potency of the test batch. A release certificate will be issued by IVRI after 10907.PDF testing on test batch samples is complete satisfactorily. 2. VICH guidelines for the 4. Application for NOC for conducting clinical trial in required species as applicable in Form-44 manufacture, in-process- and is required by enclosing Release Certificate from IVRI along with complete dossier to Drug final-product testing as well as Control General (India) (DCGI)), CDSCO, New Delhi. facility and equipment 5. After six weeks post-submission of product dossier, the Licensee will be invited to DCGI), validations may be found in: New Delhi for a technical presentation. http://www.vichsec.org/en/gui 6. As per Indian regulations pre-clinical studies such as toxicity studies are not required for delines2.htm veterinary biologics, however if product is prepared with exotic microorganisms obtained 3. USDA-APHIS Code of Federal from other countries, then the licensee must request DGCI / Department of Animal Regulations, Title 9, pertaining Husbandry Dairying and Fisheries, Ministry of Agriculture, New Delhi to import Exotic to various animal vaccines and organisms and must follow Indian Guidelines and international guidelines as per B.P. and testing requirements may be Ph.Eur. found at: 7. Once clinical field trials in target or alternate species is complete, submission of Form-44 for http://www.aphis.usda.gov/an new drug approval is required with complete dossier including clinical trials reports. In imal_health/vet_biologics/vb_ parallel, a license to manufacture large volume parenterals has to be obtained from each of vs_memos.shtml the following agencies: respective State Licensing Authority, Central License Approving Authority, Concerned Zonal/Sub-zonal Offices of CDSCO. The procedure is defined in the link: http://cdsco.nic.in/html/seravacci.html and the cGMP guidelines and containment standards are provided in: http://cdsco.nic.in/html/GMP/ScheduleM(GMP).pdf 8. A second visit to DCG(I), New Delhi, may be required for the technical presentation. 9. After the review and fulfilling of requirements for licensure, which may take another one year minimum, DCG(I) will issue Marketing Authorization. The licensing procedure and the associated forms are presented in the web link: http://cdsco.nic.in/html/copy%20of%201.%20d&cact121.pdf Registration of r-DNA Vaccines and Vaccines derived from Live Modified Organisms (LMOs) in India 1. In addition to the requirements as stated above, additional approvals and N O 1. Some of the guidelines for r- C are required from each of the IBSC, SBCC, RDAC, RCGM, and GEAC review DNA and LMO vaccines from committees before submitting the dossier to DCG(I) of CDSCO. The guidelines and international agencies may be regulations for r-DNA products are provided in the link below: found in the web links http://dbtindia.nic.in/guidelines_90.pdf . provided above. 2. It may take between 6-18 months for the review and approval of r-DNA or LMO vaccines in India (Naralkar et al., 2010; N. Sahoo & Manchikanti, 2011)

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Table 13: The BMI Legal Framework Rating (BMIL, 2012). Scores out of 100, with 100 representing the best score for each Indicator Investor Rule of Contract Corruption Protection law Enforcement India 64.2 65.4 11.3 45.3 China 58.5 26.8 86.4 29.3 Singapore 95.6 72.6 76.7 60.1 South Korea 11.1 77.0 40.3 68.4

Table 14: Number of patent litigation cases filed in India between 2006 and 2011 (Bhola, 2012). Year Number of Patent Litigation Cases Filed (Estimate) 2006 7 2007 10 2008 17 2009 21 2010 23 2011 29

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Figures

Figure 1: The Indian Parliament structure (Datamonitor, 2011).

Figure 2: The structure of State Legislature in India (Datamonitor, 2011).

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Figure 3: Comparison of Factor-, Efficiency- and Innovation-driven Economies of India, China and South Korea in various dimensions (Schwab, 2011).

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Figure 4: Outline of environmental regulatory structure in India (Chatterjee, 2009).

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Figure 5: Legislative process in India (Yadav, 2008).

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Figure 6: Legislative process in China (Yadav, 2008).

Figure 7: The organizational structure of the Office of the Controller General of Patents, Designs and Trademarks (GOI-MC&I, 2010).

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Figure 8: The roles of various Ministries and State Governments for Biotechnology derived products for human consumption and therapeutic applications (S. K. Singh, 2008).

Figure 9 I drug regulatory framework (Naralkar et al., 2010).

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Figure 10 I clinical trial process for pharmaceutical products and medical devices (Naralkar et al., 2010).

Figure 11: A comparison of drug approval timelines between the EMA, the USFDA and CDSCO of India. (CHMP: Committee for Medicinal Products for human Use) (N. Sahoo & Manchikanti, 2011).

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Figure 12: The trend of publication versus pre-grant oppositions in India between 2006 and 2009 (Bhola, 2012).

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Figure 13: The licensing procedure for Live Modified Organisms (LMO) and recombinant drugs in India (GOI-DBT, 2006; GOI-MoEF, 1989).

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Malhotra, R. (2012). Science communication and scientific temper Indian Academy of Sciences. Mandal, A. K. (2009). Strategies and policies deteriorate occupational health situation in India: A review based on social determinant framework. Indian Journal of Occupational and Environmental Medicine, 13(3), 113-120. Retrieved from http://search.ebscohost.com/login.aspx?direct=true&db=cmedm&AN=20442828&site=ehost- live Mani, R. (2007). Global mindset, Indian roots: The experience of a small Indian company--application of Hofstede scores. ICFAI Journal of Management Research, 6(11), 20-31. Retrieved from http://search.ebscohost.com/login.aspx?direct=true&db=buh&AN=27615444&site=ehost-live Manjusha, S., Sarita, G. B., Elyas, K. K., & Chandrasekaran, M. (2005). Multiple antibiotic resistances of vibrio isolates from coastal and brackish water areas. American Journal of Biochemistry and Biotechnology, 1(4), 201-206. Retrieved from http://search.ebscohost.com.rlproxy.upei.ca/login.aspx?direct=true&db=lah&AN=20063153075&site=ehost- live; http://www.scipub.us/c4p.php?j_id=ajbb Mathew, J. C. (2008, Nov 17, 2008). Novartis to shift 100 jobs. Business Standard Merck. (2009). Merck Intervet Norbio, Singapore Retrieved 06/21, 2012, from http://aqua.merck-animal- health.com/country/singapore/index.aspx Migliore, L. A. (2011). Relation between big five personality traits and Hofstede's cultural dimensions: Samples from the USA and India. Cross Cultural Management, 18(1), 38-54. Retrieved from http://search.ebscohost.com/login.aspx?direct=true&db=buh&AN=57546649&site=ehost-live Miller, T., Holmes, K. R., & Feulner, E. J. (2012). Highlights of the 2012 index of economic freedom. The Heritage Foundation and The Wall Street Journal. Mishra, S., & Kumar, N. (2011). Shaking the roots of western science in Amitav Ghosh's the Calcutta chromosome. Asiatic: IIUM Journal of English Language & Literature, 5(1), 78-85. Retrieved from http://search.ebscohost.com/login.aspx?direct=true&db=lkh&AN=62970528&site=eds-live Mohan, S. R. (2011). Understanding interactions between research institutes and industry: Indian perspective. Journal of Technology Management for Growing Economies, 2(2), 113-138. Mroczkowski, T. (2011). The new players in life sciences innovation: Best practices in R&D from around the world The FT Press Operations Management. Myint, S. (2011, May 16, 2011). I India Post. Retrieved from http://www.indiapost.com/indias-vaccine-manufacturing-set-to-soar-to-800m-prof-steven-myint/ Naralkar, S., Karande, K., & Vasani, P. (2010, The Indian pharmaceutical environment. Regulatory Rapporteur, 7, 9- 11. Narasimhan, J. (2012). Medium- and long-term: Outlook. India Country Monitor, 26-28. Natesh, S., & Bhan, M. K. (2009). Biotechnology sector in India: Strengths, limitations, remedies and outlook. Current Science, 97(2), 157-169. NCPCR. (2006). Abolition of child labour in India, strategies for the eleventh five year Plan (2007-2012). India: National Commission for the Protection of Child Rights. Retrieved from http://www.ncpcr.gov.in/Reports/Abolition_of_Child_Labour_in_India_Strategies_for_11th_5_Year_Plan_Su bmitted_to_Planning_Commission.pdf Nichols, R. W. (2008). Innovation, change, and order: Reflections on science and technology in India, China, and the United States. Technology in Society, 30, 437-450. doi: 10.1016/j.techsoc.2008.04.011 N “ M D I The Globe and Mail. Retrieved from http://www.theglobeandmail.com/news/world/drug-companies-watching-indias-drug- patent-case/article534381/?page=all Nomura, I. (2006). State of world aquaculture-2006. FAO fisheries technical paper 500., 1-147. Retrieved from http://www.fao.org/docrep/009/a0874e/a0874e00.htm Noonan, K. E. (2012, March 12, 2012). Indian supreme court to rule on Gleevec patent. Message posted to http://www.patentdocs.org/2012/03/indian-supreme-court-to-rule-on-gleevac-patent.html

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Ravindranath, N. H., Lakshmi, C. S., Manuvie, R., & Balachandra, P. (2011). Biofuel production and implications for land use, food production and environment in India. Energy Policy, 39(10), 5737-5745. doi: http://www.sciencedirect.com/science/journal/03014215 Ray, G. (2011). Doing business in India: Opportunities and challenges. Journal of Marketing Development & Competitiveness, 5(4), 77-95. Rediff Business Desk. (2005, March 22, 2005). What is fringe benefit tax? Message posted to http://www.rediff.com/money/2005/mar/22spec.htm Rodgers, C. J., & Furones, M. D. (2009). Antimicrobial agents in aquaculture: Practice, needs and issues. Options Méditerranéennes, 86, 41-59. Sahoo, N., & Manchikanti, P. (2011). Recombinant drug development, regulation, and commercialization: An Indian industry perspective. BioDrugs, 25(2), 105-113. Sahoo, P. K., & Mukherjee, S. C. (1997). In-vitro susceptibility of three bacterial pathogens of catfish to 23 antimicrobial agents. Indian Journal of Fisheries, 44(4), 393-397. Saleem, A. H. (2009). Mining dilemma. Alternatives Journal, 35(1), 8-11. Retrieved from http://search.ebscohost.com/login.aspx?direct=true&db=ehh&AN=39461821&site=ehost-live Sanders, N. R., & Ritzman, L. P. (2004). Integrating judgmental and quantitative forecasts: Methodologies for pooling marketing and operations information. International Journal of Operations and Production Management, 24(5), 514-529. Retrieved from http://search.ebscohost.com/login.aspx?direct=true&db=edsbl&AN=RN151146503&site=eds-live&scope=site Santos-Paulino, A., & Wan, G. (2011). Southern growth engines and technology giants: Introduction. Economic Change & Restructuring, 44(1), 1-5. doi: 10.1007/s10644-010-9096-2 Schwab, K. (2011). The global competitiveness report 20112012. World Economic Forum. Retrieved from http://www3.weforum.org/docs/WEF_GCR_Report_2011-12.pdf Science Watch. (2011). Top 20 countries in all fields, 2001-2011. Retrieved 06/10, 2012, from http://sciencewatch.com/dr/cou/2011/11decALL/ Scoones, I. (2012, ). Getting hotter: Regulating biotechnology in India. The crossing. (blog). Message posted to http://stepscentre-thecrossing.blogspot.ca/2012/02/getting-hotter-regulating-biotechnology.html Sebastian, R., Parameswaran, A., & Yahya, F. (2006). Doing business in India. New Zealand Journal of Asian Studies, 8(1), 17-40. Sector Briefing-UK. (2010). Biotechnology and pharmaceutical opportunities in India. UK Trade and Investment. Retrieved from http://www.clustercollaboration.eu/documents/10147/101938/Biotechnology+and+Pharmaceutical+Opport unities+in+India.pdf Sehgal, K. L. (1999). In Peter T. (Ed.), Fish and fisheries at higher altitudes: Asia Fisheries and Aquaculture Department. SFU. (a). Simon Fraser University: India initiative. Retrieved 06/15, 2012, from http://www.india.sfu.ca/ SFU. (b). Simon Fraser University: India mobility initiative. Retrieved 06/15, 2012, from http://www.india.sfu.ca/ Shah, E. (2008). What makes crop biotechnology find its roots? the technological culture of Bt cotton in Gujarat, India. European Journal of Development Research, 20(3), 432-447. doi: http://www.palgrave- journals.com/ejdr/archive/index.html Shariff, M. (1998). Impact of diseases on aquaculture in the Asia-Pacific region as exemplified by epizootic ulcerative syndrome (EUS). Journal of Applied Ichthyology, 14(3), 139-144. doi: 10.1111/j.1439- 0426.1998.tb00631.x Sharma, A. (2010). Reforming governance and society at one go. Business Today, 19(11), 66-68. Retrieved from http://search.ebscohost.com/login.aspx?direct=true&db=buh&AN=51129405&site=ehost-live Shetty, P. (2012, March 21, 2012). Novartis challenges I patent law: Drug Company up for rematch against clause prohibiting indefinite extension of patents. Nature News, Retrieved from http://www.nature.com/news/novartis-challenges-india-s-patent-law-1.10262

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Shivani, S., Mukherjee, S. K., & Sharan, R. (2006). Socio-cultural influences on Indian entrepreneurs: The need for appropriate structural interventions Journal of Asian Economics, 17, 5-13. doi: 10.1016/j.asieco.2006.01.002 Shome, R., & Shome, B. R. (1999a). Evaluation of killed Aeromonas hydrophila whole cell vaccine against acute infectious abdominal dropsy in Indian Major Carps. Indian Journal of Fisheries, 46(3), 313-317. Retrieved from http://epubs.icar.org.in/ejournal/index.php/IJF/article/view/8613/3556 Shome, R., & Shome, B. R. (1999b). Antibiotic resistance pattern of fish bacteria from freshwater and marine sources in Andamans. Indian Journal of Fisheries, 46(1), 49-56. Shome, R., & Shome, B. R. (2005). Evaluation of three types of Aeromonas hydrophila vaccines against acute infectious dropsy disease in Indian Major Carps. Indian Journal of Fisheries, 52(4), 405-412. Retrieved from http://epubs.icar.org.in/ejournal/index.php/IJF/article/view/7105/2782 Siggel, E. (2010). Poverty alleviation and economic reforms in India. Progress in Development Studies, 10(3), 247- 259. Retrieved from http://search.ebscohost.com/login.aspx?direct=true&db=buh&AN=51431947&site=ehost-live SiliconIndia News. (2011, May 05, 2011). By 2015 Indian biotech industry to reach $10 billion. Message posted to http://www.siliconindia.com/shownews/By_2015_Indian_Biotech_industry_to_reach_10_Billion-nid-83139- cid-3.html Singh, M. P. (2010, February 18, 2010). Activists voice concerns over biotech regulatory authority bill The Hindu. Retrieved from http://www.thehindu.com/news/national/article108821.ece Singh, S. K. (2008). India biotechnology annual 2008. GAIN report. Global Agriculture Information Network. (No. IN8077). USDA Foreign Agricultural Service. Retrieved from http://www.fas.usda.gov/gainfiles/200808/146295379.doc Sinha, K. (2012, January 28, 2012). Maharashtra leads in filing patents. The Times of India. Retrieved from http://articles.timesofindia.indiatimes.com/2012-01-28/india/30673639_1_filing-patents-leverage-research- hub Stassen, F., & Halldén, H. (2011). Trailblazers, shapers and innovators. models of success from community growth companies. World Economic Forum. Retrieved from http://www3.weforum.org/docs/WEF_GGC_ProfileBook_2011.pdf Subasinghe, R. (2009). Disease control in aquaculture and the responsible use of veterinary drugs and vaccines: The issues, prospects and challenges. Options Méditerranéennes, (86), 5-11. Retrieved from http://ressources.ciheam.org/om/pdf/a86/00801057.pdf Subasinghe, R. P. (2005). Epidemiological approach to aquatic animal health management: Opportunities and challenges for developing countries to increase aquatic production through aquaculture Preventive Veterinary Medicine, 67(2-3), 117-124. doi: 10.1016/j.prevetmed.2004.11.004 Subasinghe, R. P., Curry, D., McGladdery, S. E., & Bartley, D. (2003). Recent technological innovations in aquaculture. FAO Fisheries Circular, (886) Retrieved from http://search.ebscohost.com/login.aspx?direct=true&db=lah&AN=20033057250&site=eds-live Surendraraj, A., Farvin, K. H. S., Yathavamoorthi, R., & Thampuran, N. (2009). Enteric bacteria associated with farmed freshwater fish and its culture environment in Kerala, India. Research Journal of Microbiology, 4(9), 334-344. Retrieved from http://search.ebscohost.com/login.aspx?direct=true&db=lah&AN=20103025774&site=ehost-live; http://www.academicjournals.net Swiss Life. (2012). India: Fringe benefit tax abolished on July 6, 2009. Retrieved 05/06, 2012, from http://www.swisslife.com/international/corporateclients/news_events/news_archive/news/india__fringe_be nefit.html Technology Pioneers. (2012). Technology pioneers 2012. The World Economic Forum. Retrieved from http://www3.weforum.org/docs/WEF_TP_Brochure_2012.pdf The Economic Times. (2012, May 21, 2012). Unemployment on decline in urban, rural areas: Government. The Economic Times. Retrieved from http://articles.economictimes.indiatimes.com/2012-05- 21/news/31800990_1_rural-areas-unemployment-rate-urban-areas

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The Economist. (2009, May 07, 2009). Economics focus: Opening the floodgates. The Economist, Retrieved from http://www.economist.com/node/13610915 The Fish Site. (2012, June 06, 2012). Fisheries course to include aquatic medicine. The Fish Site News Desk, The Times of India. (2012, February 23, 2012). State govt. hikes daily labour wages. Retrieved from http://articles.timesofindia.indiatimes.com/2012-02-23/gurgaon/31090527_1_minimum-wages-act-highly- skilled-workers-labour-department Thieman, W. J., & Palladino, M. A. (2008). Introduction to biotechnology (2nd ed.) Benjamin Cummings. U.S. PTO. (2011). Patents by country, state and year-all patent types. ( No. Patent Technology Monitoring Team Report). USA: U.S. Patent and Trademark Office. Retrieved from http://www.uspto.gov/web/offices/ac/ido/oeip/taf/cst_all.pdf Vazhayil, J. P., & Balasubramanian, R. (2010). Copenhagen commitments and implications: A comparative analysis of India and China. Energy Policy, 38(11), 7442-7450. doi: http://www.sciencedirect.com/science/journal/03014215 VICH.International cooperation on harmonisation of technical requirements for registration of veterinary medicinal products. Retrieved from http://www.vichsec.org/en/guidelines2.htm Vignesh, R., Karthikeyan, B. S., Periyasamy, N., & Devanathan, K. (2011). Antibiotics in aquaculture: An overview. South Asian Journal of Experimental Biology, 1(3), 114-120. Retrieved from http://search.ebscohost.com/login.aspx?direct=true&db=lah&AN=20123039607&site=ehost-live; http://www.cabi.org/cabdirect/showpdf.aspx?PAN=20123039607; http://sajeb.org/article/view/7962 Wakefield, O. (2009, March 26, 2009). The environmental issues in India. Message posted to http://ezinearticles.com/?The-Environmental-Issues-in-India&id=2146109 Walker, P. J., Lester, R. G., & Bondad-Reantaso, M. G. (Eds.). (2005). Diseases in Asian aquaculture V-proceedings. Network of Aquaculture Centres in Asia-Pacific. Weede, E. (2010). The rise of India: Overcoming caste society and permit-license-quota raj, implementing some economic freedom. Asian Journal of Political Science, 18(2), 129-153. Wheelen, T. L., & Hunger, J. D. (2002). Strategic management and business policy Upper Saddle River, NJ [u.a.]. Retrieved from http://search.ebscohost.com/login.aspx?direct=true&db=edszbw&AN=EDSZBW342142062&site=eds- live&scope=site Xe Currency Charts. (2012). Universal currency converter. Retrieved 07/01, 2012, from http://www.xe.com/currencycharts/?from=USD&to=INR&view=5Y Yadav, V. (2008). Business lobbies and policymaking in developing countries: The contrasting cases of India and China. Journal of Public Affairs, 8(1), 67-82. doi: 10.1002/pa.285

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i The inland aquaculture fish production in tons was calculated at 80% from the total aquaculture production in that year which represents the carp aquaculture production. ii USD 1 = INR 55.625 (as of July 1, 2012) (Xe Currency Charts, 2012) All the INR conversions to USD were made based on the conversion rate of INR to USD at the beginning of the respective year. iii A Bill is deemed to be a 'Money Bill' if it contains only provisions dealing with all or any of the following matters: (a) the imposition, abolition, remission, alteration or regulation of any tax; (b) the regulation of the borrowing of money or giving of any guarantee by the GOI, or the amendment of the law with respect to any financial obligations undertaken or to be undertaken by the GOI; (c) the custody of the Consolidated Fund or the Contingency Fund of India, the payment of moneys into or the withdrawal of moneys from any such Fund; (d) the appropriation of moneys out of the Consolidated Fund of India; (e) the declaring of any expenditure to be expenditure charged on the Consolidated Fund of India or the increasing of the amount of any such expenditure; (f) the receipt of money on account of the Consolidated Fund of India or the public account of India or the custody or issue of such money or the audit of the accounts of the Union or of a State; or (g) any matter incidental to any of the matters specified in sub-clauses (a) to (f) [Art.110] . iv Article 21: A is guaranteed to all persons. N hall be deprived of his life or (GOI-EPA-29, 1986). v Article 47: The State's responsibility with regard to raising the level of nutrition and the standard of living and to improve public health has been laid down of the under Article 47 Constitution which reads as follows: "The State shall regard the raising of the level of nutrition and the standard of living of its people and the improvement of public health as among its primary duties and, in particular, the State shall endeavour to bring about prohibition of the consumption except for medicinal purposes of intoxicating drinks and of drugs which are injurious to health"(GOI-EPA-29, 1986). vi Article 48A: State shall endeavor to protect and improve environment and to safeguard the forests and wildlife of the country (GOI-EPA-29, 1986). vii Article 51 A(g): It shall be the duty of every citizen of India to protect and improve the natural environment including forests, lakes, rivers and wild life, and to have compassion for living creatures (GOI-EPA-29, 1986). viii USD 1 = INR 45 (beginning of 2010). Refer to currency charts (USD/INR) for 2010. (Xe Currency Charts, 2012) ix 1 lakh = 100,000 x Article 43 C I T “ to secure, by suitable legislation or economic organization or in any other way, to all workers, agricultural, industrial or otherwise, work, a living wage, conditions of work ensuring a decent standard of life and full enjoyment of leisure and social and cultural opportunities and, in particular, the State shall endeavor to promote cottage industries on an individual or co- I However, this article was never actually implemented in any way as a living wage act but was converted to its practical manifestation as a minimum wage act (Channa, 2010). xi Article 39 of the constitution that states (a) that the citizen, men, and women equally shall have the right to an adequate livelihood and (b) that there is equal pay for equal work for both men and women (Channa, 2010).

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xii Power Distance: Power Distance has been defined as the extent to which the less powerful members of organizations and institutions (like the family) accept and expect that power is distributed unequally. This represents inequality (more versus less), but defined from below, not from above. It suggests that a society's level of inequality is endorsed by the followers as much as by the leaders. Power and inequality, of course, are extremely fundamental facts of any society. All societies are unequal, but some are more unequal than others (Hofstede, 2011, p. 9). xiii Uncertainty Avoidance is not the same as risk avoidance; it deals with a society's tolerance for ambiguity. It indicates to what extent a culture programs its members to feel either uncomfortable or comfortable in unstructured situations. Unstructured situations are novel, unknown, surprising, and different from usual. Uncertainty avoiding cultures try to minimize the possibility of such situations by strict behavioral codes, laws and rules, disapproval of deviant opinions, and a belief in absolute Truth; 'there can only be one Truth and we have it'. (Hofstede, 2011, p. 10). xiv Individualism on the one side versus its opposite, Collectivism, as a societal, not an individual characteristic, is the degree to which people in a society are integrated into groups. On the individualist side we find cultures in which the ties between individuals are loose: everyone is expected to look after him/herself and his/her immediate family. On the collectivist side we find cultures in which people from birth onwards are integrated into strong, cohesive in-groups, often extended families (with uncles, aunts and grandparents) that continue protecting them in exchange for unquestioning loyalty, and oppose other in groups. Again, the issue addressed by this dimension is an extremely fundamental one, regarding all societies in the world (Hofstede, 2011, p. 11). xv Masculinity versus its opposite, Femininity, again as a societal, not as an individual characteristic, refers to the distribution of values between the genders which is another fundamental issue for any society, to which a range of solutions can be found. The IBM studies revealed that (a) women's values differ less among societies than men's values; (b) men's values from one country to another contain a dimension from very assertive and competitive and maximally different from women's values on the one side, to modest and caring and similar to women's values on the other. The assertive pole has been called 'masculine' and the modest, caring pole 'feminine'. The women in feminine countries have the same modest, caring values as the men; in the masculine countries they are somewhat assertive and competitive, but not as much as the men, so that these countries show a gap between men's values and women's values. In masculine cultures there is often a taboo around this dimension (Hofstede, 2011, p. 12). xvi Long-Term vs. Short-Term Orientation This dimension was first identified in a survey among students in 23 countries around the world, using a questionnaire designed by Chinese scholars (Chinese Culture Connection, 1987). As all countries with a history of Confucianism scored near one pole which could be associated with hard M H B dimension Confucian Work Dynamism. The dimension turned out to be strongly correlated with recent economic growth. As none of the four IBM dimensions was linked to economic I B H & Bond, 1988). Because it had been identified in a study comparing students from 23 countries, most of whom had never heard of Confucius, I re-named it Long- Term versus Short-Term Orientation; the long-term pole corresponds B C W Dynamism. Values found at this pole were perseverance, thrift, ordering relationships by status, and having a sense of shame; values at the opposite, short term pole were reciprocating social obligations, respect for tradition, protecting one's 'face', and personal steadiness and stability. The positively rated values of this dimension were already present in the teachings of Confucius from around 500 BC. There was much C teachings so Long-Term Orientation is not Confucianism per se, but it is still present in countries with a Confucian heritage (Hofstede, 2011, p. 13).

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