Biotechnology in India: Public – Private Partnerships Viren Konde Date Received (In Revised Form): 10Th September, 2007

Biotechnology in India: Public – private partnerships Viren Konde Date Received (in revised form): 10th September, 2007

Viren Konde is an Assistant Professor at the MITCON Institute of Management Pune, India. After his PhD in Biotechnology, he was a postdoctoral researcher at the University of Houston, Texas, USA, and L.C.B.-C.N.R.S., Marseille, France. He has worked in the areas of molecular neurobiology and bacteriology. Presently, he teaches subjects like the business of biotechnology and bioinformatics at the postgraduate level.

Abstract As the purpose of this study was a survey of public sector– private industry collaborations of the biotechnology sector in India, an organisational and functional overview of this sector was needed. Therefore, rather than studying a hypothetical biotech sector in India, the focus of this work was to study the public– private partnerships (PPP) that are occurring in India in the area of modern biotechnology. The Indian Government has been playing an important role in the development of the Biotech sector from the very beginning and there are large numbers of R& D institutions (Scientiﬁ c, Medical, Industrial and Agricultural) that have been set up by the Government during the past 2– 3 decades. The Indian Biotechnology industry is advancing towards new heights in alignment with the growth and progression observed globally. The past performance of the industry indicates that it has surpassed the growth rate of many other industries. This paper also highlights the favourable national policies undertaken to strengthen the Indian biotechnology industry. It is in this context that the paper shows that these collaborations are an expression of more general trends towards a changing role of the country in economic production. Journal of Commercial Biotechnology (2008) 14, 43– 55. doi:10.1057/palgrave.jcb.3050079; published online 27 November 2007

Keywords: India , biotechnology , public – private partnership , national policies

INTRODUCTION will drive countries like India forward in the This paper is concerned with the role of coming decades. The biotechnology public– private sector partnerships in the development in India is crucial in this era development of Indian biotechnology. Its because of its generic status implications for basic message is that since the role of such economic production in sectors as widely partnerships is becoming increasingly common dispersed as agriculture, health, industry and in the developing countries at an early stage environment. In fact, the growth in of economic development, there is especially biotechnology research and development a need for technology development since that (R & D) has been rapid in the recent years but most of it has taken place in the private sector. 1 Correspondence: Dr Viren Konde, MITCON Institute of Management, Opp. Shivchattrapati Krida Sankul, Near Octroi Naka, Bypass Highway, The Indian biotechnology sector crossed Balewadi, Pune 411 045, India the US $ 2bn mark during 2006– 2007. Tel: +91 20 66289600 Although this accounts for only a little more Fax: +91 20 66289801 E-mail: [email protected] than 1 per cent share of the global biotech Website: http://www.mima.edu.in market, the encouraging sign is that the sector

is riding on a healthy growth rate of over 35 to reach its optimal level in a country like per cent annually over the last fi ve years. The India. The fi rst rule that needs to be fi xed prognosis is good and consensus among for the private as well as the public research industry leaders and policy makers is that, to have a reasonable incentive to invest with proper fi scal and policy initiatives, the in research leading to economic application sector could easily scale the US $ 25bn fi gure is the rule of intellectual property by 2015. There are today about 300 biotech protection. companies in India, with the top ten Strategies for technology and competency accounting for 50 per cent of the revenue development or acquisition are the central generated, and R& D investment of the top factor determining the success of these fi ve exceeding US $ 300m. Geographically, ventures. Indian policy of research support the biotech companies have developed in and human resource development through three major bio-clusters across the country. the funding of several public research and The largest in terms of revenue generated is teaching institutions is of course a critical the western India, followed by the south and factor determining the technology the northern area. Exports contributed to availability. The interactions between 42.17 per cent of the total business, with bio- those public institutions and the Indian pharma products currently contributing to companies were the object of this specifi c 73.15 per cent of the exports. The key analysis. It appears that institutions and opportunity segments are: bio-pharmaceutical companies are learning to work together (vaccines, therapeutics, diagnostics), bio-agri and the effects of this collaboration can (transgenics, biofertilisers, biopesticides), bio- help the companies at various stages of industry, bio-informatics and bio-services their development. It also appears that (R & D, clinical trials and manufacturing on companies often adopt alternative solutions contract). The bio-agri segment registered the to collaboration with Indian institutes highest growth rate during the year at 154 such as collaborations with foreign companies per cent , followed by bio-services (54.6 or institutions. The personal networks per cent), bio-industry (34.55 per cent), built by the managers of these Indian fi rms – bio-pharma (30 per cent) and bio-informatics many of them have had an international (25 per cent).2 academic or corporate carrier – are the main According to the traditional view, there determinants of those international is a natural division of labour between the connections.3 public sector, which is responsible for the The public– private environment can production of public goods, and the private greatly infl uence the growth of the sector, which does the same for private biotechnology sector in India to understand goods. The former commodities that cannot the mechanisms of interaction between the be given a market price are therefore best public research institutions and the companies funded out of collective tax revenues, whereas with biotech activities. The public– private the latter are the commodities that can be involvement plays a critical role in the allocated using prices. The resultant need for development of the biotechnology increased taxation to pay for these public sector. The areas include human resource commodities has proved both politically development, public research and unpopular and unmanageable, where the infrastructure development. The main revenues cannot be raised. The result has government agencies are responsible for often been a decline in the level and quality fi nancing and supporting research in of such ‘ public’ goods and services. The biotechnology. The share of each budget research and development in biotechnology actually dedicated to biotechnology research needs certain rules to be clearly fi xed in order funding is not available.

SCIENTIFIC SUPPORT MSc in Biotechnology or Bio-informatics in several institutions. The State Governments Government agencies are responsible for the establishment of State The Central Government is responsible for Universities and colleges, and provide plan major policy relating to higher education in grants for their development and non-plan India. Figure 1 shows the administrative grants for their maintenance. 4 – 6 organisational set-up of the government agencies involved in the funding of public research. The National Biotechnology Board Research institutes (NBTB) under the Ministry of Science and The research institutions supervised by DBT Technology, as an apex coordinating body to include: The National Institute of identify priorities, oversee and plan for Immunology (NII), New Delhi; National required manpower, integrated industrial Centre for Cell Science (NCCS), Pune; development and large-scale use of National Brain Research Centre (NBRC); biotechnology products and processes. Several National Centre for Plant Genome Research government agencies like Department of (NCPGR), New Delhi; and Centre for DNA Science and Technology (DST), Department Fingerprinting and Diagnostics (CDFD), of Scientiﬁ c and Industrial Research (DSIR), Hyderabad. Council for Scientiﬁ c and Industrial Research The CSIR laboratories involved in major (CSIR), Indian Council for Agricultural biotechnology-related research include: Centre Research (ICAR), Indian Council for Medical for Biochemical Technology (CBT), Delhi; Research (ICMR), Department of Atomic Centre for Cellular and Molecular Biology Energy (DAE) and University Grant (CCMB), Hyderabad; Indian Institute of Commission (UGC) are dedicated to Chemical Technology (IICT), Hyderabad; biotechnology development in India. The Central Drug Research Institute (CDRI), UGC is responsible for the coordination, Lucknow; Institute of Microbial Technology determination and maintenance of standards (IMT), Chandigarh; Indian Institute of and for the release of grants. The Department Chemical Biology (IICB), Calcutta and of Biotechnology (DBT) is promoting the Central Food Technological Research development of specialised degrees, such as Institute (CFTRI), Mysore. 4 – 6

Central Government

Ministry of Human Ministry of Ministry of Ministry of Science Resource and Health Agriculture and Technology Development

DAE DBT DSIR DST

UGC ICMR ICAR CSIR

Figure 1 : Administrative organisation of the government agencies involved in the funding of public research

The Tata Institute of Fundamental guidelines, Pharma Policy, Seed Policy, Research (TFIR) and National Centre for Special Economic Zone (SEZ) Act and Biological Science (NCBS) in Bangalore are Foreign Trade Policy, are essentially roadmaps funded by DAE, which carries out basic for the respective sectors and aim at research in biological sciences. The ICMR unshackling of controls, creating an has established centres for developing atmosphere of trust and transparency, molecular medicine at Sanjay Gandhi Post simplifying procedures, along with offering Graduate Institute of Medical Sciences attractive incentives where possible. Put (SGPGIMS) New Delhi; All India Institute of together, they create a vibrant atmosphere for Medical Sciences (AIIMS), Lucknow; Post the holistic growth of the life sciences/ Graduate Institute of Medical Education and biotechnology sector.7,8 Research (PGIMER), Chandigarh; and Recently, a draft policy on National Jawaharlal Nehru University (JNU), New Biotechnology Development Strategy has Delhi. The ICAR has established a National been made public to invite wide comments. Research Centre on Plant Biotechnology A quick reading indicates that it is clearly an (NRCPB) at the Indian Agricultural Research industry-friendly policy with most of the Institute (IARI), New Delhi. major demands of the industry fi nding Some other institutes based in India are not prominent mention in it. It aims to make the directly under the supervision of any Indian processes easier, quicker and friendly for the Public Agency. For example, the International common man. The policy will provide Centre for Genetic Engineering and adequate support to basic, translational and Biotechnology (ICGEB) is in fact an clinical research. Up to 30 per cent of the international organisation whose statutes were biotechnology research budget will be spent signed by 26 countries under the form of an through public– private partnerships (PPP). A international treaty in 1994. The Institution is major aim of the Strategy is the development structured in two components located in of human resources. The government plans to Trieste, Italy, and in New Delhi, India. The set up centres of excellence in the fi elds of ICGEB is an autonomous, international, marine biotechnology, animal biotechnology, intergovernmental organisation supported by herbal medicine, molecular medicine and bio- the United Nations Industrial Development informatics. There will be no restriction on Organization (UNIDO). Some Indian the quantum foreign direct investment (FDI) institutes such as the Bose Institute in biotech companies and there may not be a (Independent research institute of outstanding need for FIBP (Foreign Investment scientifi c level located in Kolkata) also work Promotion Board) approval for equity without any direct support from any Indian investment in biotech companies. The Indian public agency. The revenues from these Foreign Trade Policy is essentially a roadmap centres come from external project for the development of India’ s foreign trade. funding. 4 – 6 Identifying and nurturing different special focus areas to facilitate development of India as a global hub for manufacturing, trading and NATIONAL POLICIES services is one of the key strategies Government support has given a signifi cant highlighted in the Policy to increase the boost to the fl edgling Indian biotech sector. country’ s foreign trade. With an idea to boost In recent times, the Indian government has exports, rope in investments, development of formulated a few new policies and made infrastructure and generate employment, the amendments to the existing ones, which government introduced the concept of SEZs support the biotech segment. Many of these in the year 2000. The SEZ Act came into policies, like the Stem Cell Research force in India on 10th February, 2006.7,8

The Indian rules and regulations as well as environment as well as human and animal procedures for handling of the genetically health. Keeping up with the recent trends/ modifi ed organisms (GMOs) and rDNA public perceptions on GM foods, appropriate products have been formulated under the measures and mechanisms are being evolved Environment Protection Act (EPA) 1986.8 to label the same. GM detection and The rules enforced since 1993 cover analytical food safety laboratories have been manufacture, use/ import / export and storage established to facilitate the generation of of hazardous micro-organisms, genetically scientifi c data. Similarly, containment facilities engineered organisms or cells. These at the biosafety levels three and four are also guidelines have been revised to match with available for both research and in vivo the newer aspects of technology. In order to evaluations. The main objectives of the provide a special thrust to genetically National Seed Policy are the creation of an engineered drugs, the Mashelkar committee appropriate climate for the seed industry to report 9 on recombinant pharma products utilise available and prospective opportunities, streamlines the regulatory process for the safeguarding the interests of the Indian farmers approval of all recombinant DNA products. and the conservation of the agro-biodiversity. The recommendations of the report came In the context of application of modern into effect from 1st April, 2006. According to technologies to agriculture, it aims at the Task Force Report, Living Modifi ed providing a conducive atmosphere for Organisms (LMOs) are defi ned as only those application of frontier sciences in varietal organisms modifi ed by rDNA techniques development and enhanced investments in through human interventions where the end R & D. The Pharmaceutical Policy has laid product is a living modifi ed organism. The emphasis on indigenous research and second group of public action is gathered development in the pharma sector. To under the name of regulation, that is, the provide encouragement, the policy has led to defi nition of the legal environment, for the establishment of the Pharmaceutical example concerning the protection of the Research and Development Support Fund intellectual property, but also the appointment (PRDSF) under DST. The DST has also of public agency in charge of the different constituted a Drug Development Promotion control procedures, as well as the defi nition of Board (DDPB) on the lines of the the different fi scal, trade and investment Technology Development Board to administer norms. the utilisation of the PRDSF.10 Regulatory policies in general are With the third amendment to the Patents compliance friendly. However, the major Act 1970 in 2005, India entered the product- criticism in this respect is that at present there patent regime and became TRIPS-compliant. are too many agencies involved in giving The salient feature of the amended Act is that regulatory clearances. To address the concern it provides for product patents unless of both the public and the private sector, otherwise excluded. Interpreted in the context efforts are under way to establish a single- of life sciences/ biotechnology, plants, animals window regulatory mechanism or to put in and seeds, including essential biological place a structure that could promote speedy processes used for propagating plants and commercialisation of recombinant products animals, are not patentable. Microorganisms, and processes. Overall, the system is relatively however, are patentable. Synthetic genes (as open and transparent yet precarious in its distinct from naturally occurring gene approach. In a nutshell, there is enough segments) and genetic interventions would expertise in technology and risk assessment of now be the subject matter of patentability. genetically modifi ed (GM) plants and Genetic interventions will include single therapeutics in terms of safety to the nucleotide polymorphism (SNP), vectors,

recombinant products such as vaccines, Further, in the light of the agreement on enzymes, hormones, etc. Trade Related Intellectual Property Rights However, much still needs to be done if (TRIPS) of the World Trade Organization India is to assume its rightful role in the (WTO), entrepreneurs have started thinking global bioeconomy. The draft National more and more about indigenous Biotechnology Development Strategy technologies, their development, perfection (prepared by DBT after nearly two years of and absorption by the industry. Through consultations with all stakeholders) has concerted support to R& D by government, identifi ed a number of issues that require many research leads are now available. The urgent attention in the quest to create a contribution of the private sector in the R& D favourable and enabling environment for efforts has also improved considerably. The enterprise creation and private sector commercialisation of new technologies needs development. Some of the issues that need to to be accelerated to meet the future be urgently translated into policies and actions challenges in order to realise the full potential are: (a) creating a pool of technologically of biotechnology. 12 skilled human resource in adequate numbers; The DBT has initiated a new programme (b) capacity building in areas such as IPR for establishing biotech parks and incubators management, technology transfer and clinical to facilitate up-scaling, pilot-level production trials, etc; (c) creating institutions with a new and fi nally commercialisation of indigenous ethos for seamless conversion of knowledge biotech products. These parks offer privileged into products and processes; (d) greater conditions to the companies implanted support to industry, especially small and within their location. Those advantages can medium sector enterprises; and (e) putting in take the form of good infrastructures for place a world-class regulatory system and water and electrical supply, air treatment, ensuring adequate training for regulatory etc as well as special regulatory schemes. personnel. Recently, the Global Institute of From the point of view of the public power, Intellectual Property (GIIP), co-headquartered the concentration of companies of a same in New Delhi and San Jose, USA, announced type in a limited area allows to maximise the launch of a Post Graduate Diploma the local externalities and to experiment Program in Patents and Intellectual Property more easily specifi c regulatory schemes. (IP) services. The GIIP programme is claimed Therefore, more than a certain kind of to be the fi rst of its kind in the world to train public action, the settlement of a professionals for the rapidly growing global biotechnology park is a way to enhance the patent and IP services business , in effi ciency of focused policies by gathering the collaboration with the Indian Institute of companies of the targeted sector in a Technology (IIT) Delhi.11 restricted geographical area. Several projects of biotech parks have been launched by public authorities. At the central level, the creation of biotechnology parks has been identifi ed as BIOTECH PARKS AND the thrust area of pro-industry intervention INCUBATORS for the DBT, whose action had been The idea of biotechnology parks is directly previously mainly directed towards education derived from the successful experience of the and research.13 information technology parks in this country. At the State level, the States of Andhra With the opening up of the country’ s Pradesh, Karnataka, Maharashtra and Tamil economy and liberalisation, Indian industry Nadu, which have issued biotechnology has taken many steps to reorient itself, and to policy papers, have included the creation of move towards knowledge-based economy. biotechnology parks in their agenda.

Public sector undertaking / management of IPCL has submitted a international collaboration proposal for acquisition of controlling shares Bharat Immunologicals and Biologicals of IVCOL and revival of the company. The Corporation Limited (BIBCOL) was proposal has been considered and is being incorporated in March 1989 as a Public submitted to the competent authority for its Sector company at Bulandshahar, UP, to decision shortly. It is expected that within the manufacture Oral Polio Vaccine (OPV) and next few months, IVCOL will be restructured other immunobiologicals. It is a highly and revived.14 modern manufacturing facility that follows Good Manufacturing Practice (GMP) as INDUSTRY PROMOTION specifi ed by WHO and US Federal The main national biotechnology strategy is Standards. 14 to create such tools and technologies that The company has been formulating OPV address the problems of the largest section of from imported bulk since January 1996 and the society, provide products and services at about 700 million doses have been supplied to affordable prices and make India globally the National Immunization Programme. This competitive in the emerging bio-economy. includes OPV supplied through UNICEF. Developing a strong biotechnology industry The company is making profi t in its current and technology diffusion capacity is critical to operations for the last few years. As a result of fulfi l this vision. The advancement of biotech this, it has been possible to achieve a one- as a successful industry confronts many time settlement with the fi nancial institutions challenges related to research and and banks. The company’ s net worth has development, creation of investment capital, become positive and, therefore, it has been technology transfer and technology absorption, discharged from the purview of the Sick patentability and intellectual property, Industrial Companies (Special Provision) Act, affordability in pricing, regulatory issues and 1985 in August 2002. The process of public confi dence and tailor-made human obtaining cabinet approval for fi nancial resource related to all these aspects. Central to restructuring of the company to give effect to societal impact are two key factors: one-time settlement with Banks and Financial affordability and accessibility to the products Institutions is at an advanced stage. of biotechnology. Policies that foster a balance The Indian Vaccines Corporation Limited between sustaining innovation and facilitating (IVCOL) was incorporated as a joint venture technology diffusion need to be put in company in March 1989 to undertake place. 15 research and development and manufacture of The key mechanisms shall be ensuring viral vaccines. Owing to problems arising out participation of small and medium enterprises of change in product mix and technology (SME) while developing technology strategies transfer, the company is on hold since nationally, increased public contribution for February 1992. early stage, high-risk research for SMEs, The decision of the Cabinet to restructure increase the access of SME scientists to public IVCOL and to utilise the assets created has institute facilities and vice versa, new models been substantially implemented. The National of partnership with large industry to pursue Brain Research Centre has been established path-breaking technology initiatives and on the premises. The pattern of shareholding building greater fl exibility in public institutes in the Indian Petrochemicals Corporation to be able to work with industry. Specifi c Limited (IPCL), one of the promoters of initiatives are: IVCOL, has changed with the acquisition of controlling shares of IPCL by Reliance • Major expansion of the Small Business Industries Limited (RIL). The new Innovation Research Initiative (SBIRI):

SBIRI scheme widely acclaimed in the visible after the announcement of the draft country by SMEs. A Special-Purpose human genome sequence in the year 2000. Vehicle (SPV) may be created for There are no authentic statistics on the managing this scheme professionally. investment in the private sectors. This is • Biotechnology Industry Research because the defi nition of biotechnology and Assistance Programme (BIRAP) may be its indicators vary for different estimations. An put in place for monitoring, supporting Indian directory prepared by Biotechnology and nurturing R& D in small and medium Consortium India Ltd. (BCIL) includes biotechnology companies. biotechnology activities of about 176 • Public-funded successful R& D Enabling companies in the private sector whose Public Institutions to work with Industry: products range from those in agriculture, institutes may be allowed and supported environment and healthcare. On the other to establish not-for-profi t companies to hand, estimates have also been made that facilitate collaborative work with industry. about 800 companies are operating in various In these facilities, industry scientists can sectors of biotechnology, based on the pursue innovative projects for defi ned defi nition that biotechnology includes basic periods on user charge basis providing industry such as food processing and highly access to centralised equipments and sophisticated recombinant products. scientifi c consultation. Employing the same defi nition, one estimate • Public Partnership with Large Industries: states that 10 per cent (80) of these companies Public partnership with large-scale are operating in modern biotechnology sectors companies may be encouraged and while according to another conservative supported in areas that are vital to the estimate there are only 20 companies engaged national development from a scientifi c, in sophisticated biotechnology business. economic or social perspective and Similarly, it is also estimated that the industry focused on technology and product employs 10– 20,000 people and generates development. The company would then roughly revenue of US$ 500m annually. The have preferential access to the intellectual Indian share of the biotechnology market was property generated in such jointly funded estimated at US$ 800m in 1999 and has risen projects. approximately to US$ 2.5bn this year. Notwithstanding these fi gures by various Biotechnology industry in India has been estimations, it can be concluded that India’ s growing at an average annual rate of 40 per burgeoning biotechnology sector is an oasis of cent and the biotechnology business segment rich picking for investors as the government has the potential of generating revenues to the leads the drive to develop the industry. tune of US $ 10bn and creating one million Building a biotechnology industry is a part of jobs by 2010 through bio-products and the knowledge economy strategy of the services. The Indian Biotech sector is government. A growing number of high- acquiring global visibility and is being seen as quality Indian biotechnology investment a major investment opportunity. These opportunities exist for both early- and late- resources need to be effectively marshalled, stage investors. Some of the major investors championed and synergised to create a including Connect Capital, ING Barings, productive enterprise. 15 Dresdner Kleinwort Benson, London and Warburg Pincus are evaluating Indian biotechnology investment opportunities. And Industry funding that is not all; a London Stock Exchange- Private sector investment has also been listed biotechnology company (with a market picking up since 1997 and became particularly capital of US $ 125m) is keen to ally with an

Table 1: Public– private partnerships of Indian biotechnology sector * Private company Public partners

Avestha Gengraine Technologies Pvt. Ltd., Bangalore NCBS University of Agricultural Sciences ICRISAT Imperial College, London, UK

Bangalore Genei Pvt. Ltd., Bangalore CCMB IBA – ICAR

Bharat Biotech, Hyderabad DBT – AIIMS ICGEB – AIIMS CBT

Biological E., Hyderabad IISc International Centre for Diarrhoeal Disease Research (ICDDR), Bangladesh. National Institute of Health (NIH), USA. Nederlands Vaccine Institute (NVI), Netherlands

Genotypic Technology, Bangalore CBT IISc Madhurai Kamraj University

Monsanto, Bangalore IISc TERI Kenyan Agricultural Research Institute

Nicholas Piramal India Ltd., Mumbai CBT Panacea Biotec, New Delhi NII Jawaharlal Nehru University, New Delhi Biotechnology Consortium of India National Institute of Health, USA

Rallis India, Mumbai ICGEB IISc University of Madurai World Health Organization (WHO)

Serum Institute of India Ltd., Pune World Health Organization, Switzerland Health Protection Agency, UK Program for Appropriate Technology in Health (PATH), USA

Shantha Biotechnics Ltd., Hyderabad CCMB IISc Bhabha Atomic Research Center NII IICB JNU ICGEB NCCS Anna University Osmania University BARC Tata Memorial Hospital International Vaccine Institute, Korea

Shapoorji Pallonji Biotech Park Pvt. Ltd., CCMB Hyderabad University of Hyderabad Research Triangle Park, USA Technologie Park Heidelberg, West Germany

Strand Genomics Ltd., Bangalore IISc CSIR Project Team CDFD

Wockhardt Ltd., Mumbai ICGEB

* Data collected from the companies’ websites and Google search.

Indian biotechnology fi rm, possibly via a services. As companies realise they can no merger. It has also been predicted recently by longer afford to rely solely on their own both Indian and US Business leaders that US R & D and need to acquire ideas from others, stock market listings by Indian technology there has been a trend in many sectors away companies could explode to 100 or more new from a mostly closed to a more open model issues within the next fi ve years. of innovation. Considering the smaller size of SMEs are the most dynamic segment of the the Indian biotech industry, the growth can Indian economy, and their growth generates be effectively managed by pooling resources ripple effects in urban and rural areas – (research facilities, technological competence, creating jobs, fuelling small-scale businesses manpower requirements, risk-taking ability, through the supply chain and expanding etc) and passing the knowledge between fi rms prosperity. But the equity marketplace in more quickly and effectively to catch up with India virtually ignored SMEs until recently, the industry in the west. The latest when prescient backing by the Small technologies in the information and Enterprise Assistance Fund (SEAF) and the communication fi eld could be used to achieve United States Agency for International the same. Also, the knowledge spillover can Development (USAID) in 2004 demonstrated be effectively used for the industry by their bullish potential. managing the clusters effectively. Alliances USAID and SEAF joined forces to mobilise have become very popular on account of the investments in small, fast-growing businesses desire by most companies to achieve higher at a time when SMEs had a ‘ high-risk’ returns in their R& D as well as operations. reputation. They were untapped by Indian Innovations have become the key to survival banks and fi nancial institutions. USAID’ s and growth in this highly growing support of $ 5m including substantial equity technological era. Owing to the limitations of participation in the Fund, combined with knowledge resources to generate greater SEAF’ s international experience building innovative capabilities, companies have taken businesses in emerging economies, sparked the the route of collaboration. Alliances provide interest of fi nanciers to eventually generate a access to complementary skills and capabilities $160m ‘ India Growth Fund’ – a pool that and also bring economies of scale and scope. well exceeded expectations.15 India already has strong assets for the Metahelix, an agricultural biotech company, development of a competitive and innovative is developing home-grown Indian seed industry with a countrywide network of varieties and new technologies for farmers. It research institutions. These institutions have a is close to launching the fi rst Indian Bt cotton recognised academic level to transfer their seed on the market, with a price tag that is knowledge to the industry, either by expected to be 40 per cent less than what is institutional collaboration, or by the direct available on the market today. It is looking to migration of scientists from the public to the export its products to underserved agricultural private sector. markets in Vietnam and Bangladesh. Table 1 shows the interactions between some of the public research institutions and private companies in the fi eld of modern ACADEMIA – INDUSTRY biotechnology. The companies listed here COLLABORATIONS have more than one academic partner, As companies face the pressure from increased indicating the fact that companies and competition, shortening product lifecycles and institutions are still learning how to work growing product complexities, many are together. fi nding that they need to change the way Several factors have contributed to the they develop new technologies, products and current upbeat feeling about India’ s biotech

52 © 2008 PALGRAVE MACMILLAN LTD 1462-8732 $30.00 JOURNAL OF COMMERCIAL BIOTECHNOLOGY. VOL 14. NO 1. 43–55 JANUARY 2008 Biotechnology in India: Public – private par tnerships sector. Among the strengths we can count are molecules; fi ctionalisation of alkane to our wealth of biodiversity: a sizeable English- advanced nano-materials and composites; speaking scientifi c workforce, a robust IT defunctionalisation of carbohydrates to base, a reasonably good infrastructure biodegradable plastics; novel offi ce computing network, a well-positioned pharma industry, platforms to low-cost horizontal axis wind a strong MNC presence and a large, diverse, turbines; and new targets and markers for therapy-naï ve population with a varying gene cancer to advanced drug-delivery systems. pool. The Government, both at the centre India’ s National Association of Software and in the states, has provided several fi scal and Service Companies (NASSCOM), the and other incentives to the sector in terms of not-for-profi t trade body of the IT software tax holidays, capital subsidies, creation of and services industry, has mooted an India biotech parks, special economic zones, Innovation Fund to provide angel stage incubators, etc. Private fi rms can approach funding to start-ups to drive innovation in DST ’ s Technology Development Board emerging technologies in the areas of IT and ( http://www.tdbindia.org/), which offers soft biotechnology. The fund will be set up loans with minimum interest, and DBT’ s through a PPP, where the government role Small Business Innovation Research Initiative will be limited. The investment decisions will ( http://dbtindia.nic.in/SBIRI/SIBRI_main- be taken up by professional fund managers. F.html), which funds early/ late-stage research, The fund will allow private investors to that was set up to boost PPP. India’ s IPR acquire stakes in the professionally managed regime has become fully TRIPS compliant PPP fund.15,16 to promote innovation.1 A single-window biotech regulatory authority is on the anvil to ensure a science-based effi cient process. Indian Benefi ts for the public biotech companies have not only been for partnerships with the resourceful in leveraging various fi nancing private sector opportunities from both domestic and The private sector has a number of international sources but also proactive in comparative advantages and the public sector establishing and maintaining collaborations and can benefi t from the following: partnerships in India and abroad. They have also aimed to become competitive by • The private sector has huge networks of patenting products and technologies on a companies ranging from small-intensive to global basis. large multinational companies. CSIR has designed a unique PPP called • It has large R& D funding available to ‘ New Millennium Indian Technology carry out high return short-term and Leadership Initiative’ (NMITLI).15 It is the long-term biotechnology projects. biggest PPP in post independence India • It has a good understanding of market involving 65 private sector companies and 160 knowledge and distribution systems. institutions and universities. It has a high • It has large talent pool of scientifi c emphasis on drugs and pharma R& D research resources and demand-driven partnerships. Some of the NMITLI projects effi cient R & D facilities. funded by CSIR initiative are shown in Table 2. To maximise these benefi ts, developing At present, there are 37 ongoing projects, countries like India should depart from the which cover diverse areas ranging from liquid tradition of viewing the private sector as crystals to decentralised power packs; being a profi t-propelled establishment. The mesoscale modelling to nano-material catalysts; PPP should be viewed as a mutual benefi cial microbiological conversions to biotech association.

Table 2: NMITLI projects funded by CSIR initiative 16 Project Public Private

Development of novel fungicides IICT, Hyderabad, IMT, Chandigarh and Rallies India Ltd., Bangalore MS University, Baroda

A catalytic process for the economical IICT, Hyderabad Indian Petrochemicals Corporation Ltd, production of acetic acid from ethane Baroda

Latent M. tuberculosis: New targets, Bose Institute, Kolkata, CDRI, Lucknow, Lupin Laboratories Ltd, Mumbai drug-delivery systems and bioenhancers CDFD, Hyderabad, IICT, Hyderabad, IISc, Astrazeneca India, Bangalore and therapeutics Bangalore, Tuberculosis Research Centre, Chennai

Biodegradable polymers from agricultural Central Pulp and Paper Research EIDParry Ltd., Chennai, Godawari Sugar wastes: cellulose esters based on Institute, Saharanpur Mills/Somaiya Organic Chemicals Group, bagasse-derived cellulose Mumbai, Reliance Industries, Mumbai Biotechnology of leather: Towards cleaner Central Leather Research Institute, SPIC Science Foundation, Chennai processing Chennai

Value-added polymeric materials from CFTRI, Mysore, IICT, Hyderabad, IIT, Godavari Sugars Pvt. Ltd. (Somaiya Group renewable resources: lactic acid and lactic Bombay of Industries), Mumbai Prathishta Biotech acid-based polymers Industries Pvt. Ltd, Hyderabad and Reliance Industries Ltd, Mumbai

Biotechnological approaches for Central Institute for Medicinal and Aromatic ITC Ltd., Kolkata, Ballarpur Industries improvement of plant species with special Plants, Lucknow, Forest Research Ltd., Gurgaon, and J.K. Paper Ltd., reference to pulp and paper Institute, Dehra Dun, Lucknow University, New Delhi Lucknow, Osmania University, Hyderabad

Synthesis of selective 3-adrenegic Central Drug Research Institute, Glenmark Pharmaceuticals & Research receptor design, synthesis and testing of Lucknow, and Indian Institute of Centre, Mumbai new chemical agonists as a novel therapy Chemical Biology, Kolkata for obesity

Factors preventing PPP sector is in some cases not supportive of Despite the efforts of Indian government in meaningful partnerships with the private promoting the public– private tie-up, there are sector. various factors that hinder the growth of PPP at the regional, national and global levels. CONCLUSION First, there is a lack of information and The main aim of this monograph has been to awareness on possibilities of this kind of show in some detail that PPP are an essential collaboration on the part of the public sector. component in the establishment of a Secondly, the public is often suspicious of the biotechnology capacity in developing private sector and perceives it as an entry only countries like India and especially where the interested in maximising profi ts. This needs and opportunities are demanding. The forecloses opportunities for collaboration in PPP are not a new phenomenon but have mutually benefi cial factors. Thirdly, there is actually played a fundamental role in the mismatch in technological and fi nancial advancement of biotechnology in developed resource capability between the public and countries and many parts of the developing private sectors. This makes fi nding the world. The paper has also shown a range of common ground for research on an equal interesting examples of institutional– industrial basis diffi cult. Further, the general collaborations that have been increasing in infrastructure (skilled human resources, India. Conversely, the state-of-the-art research equipment and facilities) in the public biotechnology knowledge and facilities are

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