Stem Cell Science in India

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SPECIALREPORT

10.2217/17460751.2.1.75 2007 Future Medicine Ltd ISSN 1746-0751 Regenerative Med.(2007) 2(1), 7589 75

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Stem cell science in India: emerging economiesand the politics of globalizationBrian Salter1,

Melinda Cooper1,Amanda Dickins1&Valentina Cardo1

Author for correspondence1Global Biopolitics ResearchGroup, Edith CavellBuilding, University of EastAnglia, Norwich, NR4 6NY,UKTel.: +44 160 359 7135;Fax: +44 160 359 7132;E-mail: [email protected]

Keywords: economics,globalization, India, politics

The globalization of stem cell science is increasingly being shaped by the emerging

economies of the Asia/Pacific region. Undaunted and unhampered by the more established

views of the commercialization of science, countries such as India are constructing models of

innovation, policies and patterns of investment that challenge such orthodoxies. This report

examines the position of India within the globalization of stem cell science, its adjustments

to the developing knowledge market in this field and its particular contribution to the likely

future of this promising bioeconomy.

On January 29, 2007, the first annual confer-ence of the newly launched Stem Cell Research

Forum of India took place in Bangalore, India, aclear indicator of Indian interest and intent inthis rapidly evolving field [101]. It followed theearlier announcement in January 2005 by theIndian Council of Medical Research (ICMR)and the Department of Biotechnology (DBT) ofplans for a national stem cell initiative thatwould prioritize research funding, focus on clini-cal applications and promote stem cell city clus-ters [102]. The National Task Force on Stem CellResearch was established in April 2005 to takethese plans forward [103].

As in some other countries, Indian govern-ment and industry is beginning to think throughthe steps required if India is to establish anadvantageous position in the fast developing glo-bal stem cell market. The unprecedented 25%increase in its 2005 R&D budget, coupled withthe rapidly expanding activities of the DBT,show the extent of Indias ambition with regardto its science as a whole. In the case of stem cellscience, what policies, interventions andresources are necessary to support the develop-ment in India of this promising area of regenera-tive medicine and how and when should they beintroduced? In the UK, the response to thesequestions is embodied in the report and recom-mendations of the UK Stem Cell Initiative (Pat-tison Report) of November 2005, which sets outa 10-year strategy for the development of stemcell research, therapy and technology dealingwith state investment, the organization of sci-ence, venture capital, publicprivate alliancesand regulatory issues, such as those connectedwith intellectual property rights (IPR) andhuman embryo research [1]. As yet, India has notproduced such a strategy.

Should it decide that strategic state interven-tion is required, its approach is likely to diverge

in several respects from that of the UK. Unlikethe UK, India is an emerging rather than adeveloped economy. Its science, tax regimes,regulation, supporting industries and financialmarkets are at a different stage of evolution andit brings its own unique characteristics and con-siderations to the fluid politics of stem cell glo-balization. Its response to the commercialopportunities offered by stem cell science, itsview of what constitutes an appropriate modelof innovation in this field and its interpretationof its political interests will therefore be distinc-

tive. Given this context, this article analyzes thecurrent position of India as a player in the glo-bal stem cell knowledge market, the signifi-cance of its status as an emerging economy andthe issues it will need to address if it is to com-pete effectively. India is already making policychoices that directly and indirectly impact onits ability to support this new form of healthbiotechnology, aware of the crucial role thestate can play in technological development [2].

Political choices, commercial models& global opportunitiesIn reflecting on the forms of intervention toadopt in this field, any state must recognizethat the journey to commercialization will becomplex and arduous [104]. Depending on themodel of commercialization adopted, the statecan choose to intervene in any or all of thestages of innovation, from the basic science,through translational research and clinicalexperimentation to the production of cell-based therapies. As Figure 1 indicates, there ismore than one route through the innovationprocess and choices will need to be made
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SPEC IA L REPOR T Salter, Cooper, Dickins & Cardo

76 Regenerative Med.(2007) 2(1) future science grouputure s ien e group

regarding which is the most viable. Thelengthy interval between the early-stageresearch and the promised therapeutic product(commonly estimated to be between 15 and20 years), means either a sustained and costlystate commitment to this one scientific fieldamong many (for any state a risky politicalchoice in the high pressure arena of science

policy) or a combination of state and marketinvolvement in clearly demarcated arenas ofcommercial activity where both the risk andthe product are identifiable.

For example, in the short to medium term, celllines from human embryonic stem cells (hESCs)could be used as disease models to explore thepathology of a disease, as drug screening assays todemonstrate efficacy and as the means for thetoxicity testing of candidate drugs. Such inter-vening usages in the overall commercial modelwould generate an early cash flow to nurture the

development of the field (in September, 2006,the Roslin Cells Center in Scotland launched apublicprivate initiative that brings together theRoslin Institute, Scottish Enterprise, EdinburghUniversity and the Scottish National BloodTransfusion Service to develop human stem celllines that will be sold worldwide for drug testingand medicines development. Interestingly, theCenter is described as the first step in a supplychain to support the development of the widerstem cell sector in Scotland, providing cells thatcan be used by academics, NHS Scotland andcommercial companies [105]).

If state intervention is to be selective, thisthen raises the question of how the choices areto be made. One key factor is the resourcesimmediately to hand that can support stem celldevelopment. These can include intellectualresources (as in the Scottish case), a ready supplyof the raw materials required for early-stageresearch (e.g., human oocytes and embryos), thephysical resources of a large and diverse popula-tion to support the translational clinicalresearch, the political resources of sound regula-tory structures capable of maintaining scientificand public confidence and the financialresources of a viable venture capital or pharma-ceutical sector. If such resources are alreadywithin the jurisdiction of a state, then clearly itwould be unwise to neglect them.

If they are not, then a state can choose

whether to acquire them and, if so, how. Since apositive decision in favor of resource acquisitioninvolves a move into the international market,it is at this point that interaction with the forcesof globalization inevitably takes place. Forexample, Singapore has decisively entered theinternational scientific labor market with poli-cies expressly designed to attract stem cell scien-tists from the USA and the UK throughfinancial support and a liberal regulatory regime[106]. These policies exploit the relatively highglobal mobility among this group (according to

one survey, stem cell principal investigators[PIs] are 5.3-times more likely to receive at leastone international job offer than PIs in otherbiomedical fields [3]).

For emerging economies, the ability to attractpharmaceutical companies in support of biotechinnovation is much less problematic than it usedto be as what has been termed the second waveof globalization is now taking effect in the bio-medical as well as the IT industry [107]. Pro-pelled by the search for lower scientific andclinical labor costs in the context of a perceived

crisis in their profits, multinational pharmas areincreasingly outsourcing their R&D operationsto developing countries [4,5]. In April 2006,pharma companies were performing 838ongoing trials in the USA, 158 in the UK, 81 inRussia, 49 in India and 31 in China. The pre-diction is that pharma companies will doubletheir clinical research activities in developingnations over the next 3 years [108]. At the sametime, pharmas are attracted by the often lavishtax concessions accorded to foreign companiesmaking Foreign Direct Investment (FDI) inemerging economies, such as India and China,

Figure 1. Timescale for commercial opportunities.

Source [43].

Value

5 10 15 20

Time (years)

Cell banking

Clinical trials

Toxicity testing

Drug screeningManufacturing

Growth factors

Cell therapies

Research tools

Training

TherapeuticsResearch applicationsEnabling technologies


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Stem cell science in India: emerging economies and the politics of globalization SPECIAL REP ORT

77future science grouputure s ien e group www.futuremedicine.com

and, given the large populations of these coun-tries, by their value as potential markets for drugcompanies [6].

The interest of multinational pharmaceuti-cals in emerging economies is also stronglyinfluenced by the global loss of their quasimo-nopoly on leading-edge science and discovery.By 2002, small biotechs had become a criticalpart of pharmaceutical innovation and growth,

accounting for 70% of the drugs approved overthe previous 6 years. None of the top ten best-selling biotech products had been developed bya pharmaceutical company, although six aremarketed through big pharma [7]. With theirown drug pipelines drying up, pharma aredriven by a global search for the intellectualproperty (IP) of potential products that can beacquired from small biotechs during the variousphases of clinical trials through mergers andacquisitions or through joint ventures.

Amongst emerging economies, India has the

unique advantage of its recent successes in theglobal software and IT services market [8]. In thisrespect, India offers one of the very few examplesof an emerging economy that has managed bothto attract FDI in the area of high-tech softwaredevelopment, while successfully inserting itself asa competitive presence in the very heart of Sili-con Valley. It remains to be seen whether it willbe able to replicate this experience in the area ofpharmaceutical and new health technologies.

Where emerging economies are much lessadvantageously placed, it is their access to theglobal financial markets that are essential to

enable early-stage biotech companies to take for-ward the results of basic stem cell research.Although private investors and individual venturecapital companies (VCs) can help biotech startupsit has been the long-term capital flowing from thelikes of the New York Stock Exchange (NYSE),the American Stock Exchange (AMEX) and, mostimportantly, the NASDAQ stock market that hasplayed the pivotal role in making the USA biotech

industry by far the largest in both market valuesand product sales [9]. Bearing in mind that 40%of all USA venture investing is in the life sciences,in 2005, private biotechs raised US$7 billion inUSA capital, up from US$5 billion in 2004, ofwhich US$3.5 billion was by venture capitalists[9]. In contrast to this, VC investment in Asia wasminiscule and barely registers when placed in theglobal context (Figure 2). Apart from Japan, Asianstock markets do not have the liquidity and vol-ume necessary to attract Western VCs or biotechfirms on any scale. Emerging economies in this

region therefore have to recognize that they face afunding gap in the life sciences innovation processand decide what policy options might address thisif their commercial model of stem cell science is tobe viable.

Indias global positionIf, as an emerging economy, India is to become asignificant player in the future stem cell market,it will need to be clear about its currentstrengths and weaknesses with regard to thoseareas of globalization likely to impact on thestem cell commercialization process.

Figure 2. Global biotech venture capital investment.

For more than a year, venture capital has held close to US$1.4 billion, with approximately three-quarters

going to North America.Source [109].

Amountraised($millions)

Financial quarter

1Q 2005 2Q 2005 3Q 2005 4Q 2005 1Q 2006 2Q 2006

$3

$355$802

$15$308

$1075

$26$351$802

$35$327$1176 $9

$370$931

$3$247

$1191

1800

1600

1400

1200

1000

800

600

400

200

0

AsiaPacificEuropeNorth America


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Science

Science is an international activity aggregatedfrom national components that remain fairly sta-ble over time. Here, we examine a selection ofthese components to assess Indias global posi-tion in the international scientific communityrelative both to developed countries and to other

emergent economies in the Asian region with aninterest in stem cell science.

A countrys proportion of the global output ofscience and technology publications measuredover time provides an indication of its control ofimportant intellectual resources necessary for thefirst stages of the commercialization process. Inthe Indian case, between 1988 and 2003, thisproportion has remained static at 2% (Figure 3).This compares unfavorably with China (a dra-matic rise from 1 to 4% more than a doublingof the articles published) and South Korea (a rise

from 0 to 2%). Thus, although the USAs sharein this period has declined from 38 to 30%, it isnot India that has benefited.

A similar relative weakness with regard toIndias Asian competitors is apparent in the dataon the number of doctoral degrees in the field ofphysical/biological science awarded between1983 and 2001 (Figure 4). Although India has ahigher absolute number (3727) than either SouthKorea or China, the rate of increase in PhD pro-duction is much higher in the case of the latterand, indeed, China may have now overtakenIndia. To an extent, this may be because the lack

of training opportunities in Indian universities inthe life science encourages postgraduate studentsto leave India to complete their PhDs abroad [11].At the Indian Institute of Science, 90% of thosewho finish PhDs choose to go abroad an indica-tor of Indias difficulty in sustaining the impor-tant middle tier of postdocs required for

successful scientific teams and laboratories [12].In assessing the significance of these figures, it

has to be remembered that scientific training, aswith other aspects of science, is an internationalas well as domestic activity. If we now examinethe ability of Indian students to access the larg-est sector of the international graduate educa-tion market, the USA, we find that Indiadominates other Asian countries in terms ofboth absolute numbers of graduate students andthe rate of increase in these numbers (Figure 5).Between 1987 and 2004, while the number of

Indian graduate students in the USA has quad-rupled from 15,600 to 63,000, Chinese studentshave increased at a much lower rate from 20,400to 50,800.

However, these figures do not necessarilytranslate into a global advantage for Indian sci-ence since most of these graduates choose toremain in the USA once they have gained theirdegrees. Between 1992 and 2003, the propor-tion of Indian graduates with science and engi-neering doctorates and biological/agriculturaldoctorates who had definite plans or plans tostay in the USA was consistently approximately

Figure 3. Share of global science and technology publications, 19882003.

Based on data from [10].

198

8

198

9

199

0

199

1

199

2

199

3

199

4

199

5

199

6

199

7

199

8

199

9

200

0

200

1

200

2

200

3

60

50

40

30

20

10

0

Percentage

Year

USAUKAustraliaJapan

South KoreaIndiaChina


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90% (Table 1). The net effect of this brain drain isthat in 2003, there were 448,700 Indian-bornresidents in the USA with degrees in science andengineering or related subjects, although only41,300 (9%) of these had doctoral degrees. Incomparison, the equivalent numbers of Chinese-born residents in the USA was 294,800, ofwhom 62,500 (21%) had doctoral degrees [15].

Given these data, it is to an extent surprisingthat if we employ a more interactive measure ofIndias global scientific position, the geographicscope of its international collaborations, a pic-

ture nonetheless emerges of India as marginallyahead of its Asian emerging economy rivals.Based on 2003 data, the USA had the broadest

network of international collaboration with US-based researchers co-authoring articles withresearchers from 172 other countries. The UKfollowed with co-authored articles with research-ers from 158 other countries. Amonge low- andmiddle-income countries, India ranked first,with 107 co-authoring countries, ahead of China(102) [17].

Intellectual property

Although the ability to train, recruit and retain ascientific workforce with international publica-tions and networks is an initial measure of anations capacity to compete in the global knowl-edge economy, the significance of this measurehas to be weighed alongside a countrys ability toexploit the knowledge produced through tradingin the national and international markets of IP. If

the IP issue is neglected, a state will find it diffi-cult to move from the knowledge base to the sub-sequent stages of commercialization. A crude butvaluable indicator of inventive activity is the useof the patent system in terms of patent filings byresidents and nonresidents (Figure 6).

Although India has increased the number ofits patent filings by 365% between 1995 and2004, its patenting activity is very small whencompared with South Korea and China (the lat-ter also has a larger rate of increase of 557%).Nor is it yet a significant global player in terms

of its filing of patents in the patent offices ofother countries a useful indicator of a countrysability to penetrate the knowledge economies ofother states. In 2004, India filed just 2400 pat-ents in other countries, compared with 30,900nonresident filings by South Korea and 137,800by Japan [19](China is also weak in this respectwith only 3100 nonresident filings.) This pat-tern is particularly evident in filings with theUSA Patent and Trademark Office (USPTO)and indicative of Indias inability to access what,at present, is the home to the engine of biotech-

nology innovation(Figure 7)

. When assessed interms of the efficiency of the translation of R&Dinvestment into patent filings, India also fallswell behind its Asian competitors. In 2004, itsresident patent filings per million dollars ofR&D expenditure was 0.23 (30th in the world),compared with 0.78 for China (12th) and 4.60for South Korea (1st) [20].

Biotechs

In order for the fruits of stem cell science to betranslated from proof of principle to a potentialtherapeutic product that is economically viable,

Figure 4. PhD degrees in physical/biological sciences.


Figure 5. Foreign graduate students in the USA.


20,000

10,000

0

1985

1987

1989

1991

1993

1995

1997

1999

2001

IndiaChinaJapan

South KoreaUKUSA

Year

Number

1987 1993 1999 2004

200,000

100,000

0

Year

Number

ElsewhereJapanSouth KoreaIndiaChina


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the early-stage involvement of the biotechnologysector is necessary. India has a rapidly developingbiotech sector currently estimated atUS$1.3 billion, which has been growing at a rateof 3537% per annum and is expected to

increase to US$3.5 billion by 2008. In terms ofnumbers of companies, within the AsiaPacificregion, India is placed third behind Australia andChina/Hong Kong [22].

Within the biotechnology sector, healthcareconstitutes an increasing proportion of the totalnumber of firms rising from 24 to 35% between2001 and 2003 (Table 2). It is also the sector inwhich the number of large firms has grown bythe largest amount (88%) in this period, signify-ing the rapid entry of transnational corporations.When assessed in terms of workforce, the growth

of the healthcare sector is even more marked,with healthcare employees constituting 53%(85,600) of the total biotech workforce in 2003compared with 20% for agriculture, the nextlargest sector [111]. In terms of the importantquestion of international links, it is the health-care sector that has formed the majority of alli-ances with foreign companies: 70 alliances(54%) out of a total of 129 [112].

Pharmaceuticals

Once proof of principle has been established,

experimental trials conducted and biotech com-panies involved to take the early-stage work for-ward, a strong pharmaceutical involvement is anessential component in the commercial develop-ment of the stem cell field. In this respect, Indiahas the advantage of an established pharmaindustry that, over the past two decades has,along with IT, become a major part of its hightech sector (Table 3).

Originally established as a vehicle for produc-ing generic drugs at low cost for a domestic mar-ket through the use of reverse-engineering skills,Indias pharma industry has expanded rapidly

and, with overall sales of US$8 billion andexports of $2.7 billion, is now establishing a glo-bal presence (Table 4). In the view of Ernst andYoung, Indian pharma companies are in transi-tion from international companies with success-

ful export strategies to multinational companies(MNCs) with a significant presence in multipleforeign markets [24].

Here again, a number of regulatory andhuman resource problems must be addressed ifIndia is to successfully make the transitiontowards a global presence in the pharmaceuticalmarket. Although its large scientific labor forceis frequently cited in its favor, Ernst and Youngs2006 report nevertheless cites high staff turno-ver and a lack of adequately trained clinicalresearch staff as an abiding problem [24]. It is

likely that state investment in graduate clinicalresearch training, as well as some kind of incen-tive scheme for returnees, will be needed inorder for these market failures to be overcome.Moreover, it appears that India, much more sothan its competitor China, suffers from anumber of weaknesses in essential infrastructure India lacks specialized patent offices and IPcourts and, although it has a Drug ControllerGeneral responsible for clearing all clinical tri-als, it is widely thought to be understaffed,insufficiently standardized and too closely

aligned with the interests of the domestic phar-maceutical industry [25]. As yet, there is no cen-tralized database listing all the clinical trialstaking place in India. However, there is evi-dence that the Indian government has alreadyundertaken several initiatives to address theseproblems. Plans are underway to create an inde-pendent drug regulatory authority along thelines of the US FDA over the next 2 years, withthe long-term aim of securing reciprocalapproval rights. In this way, a drug approval inIndia will automatically grant approval in thelucrative North American market [114].

Table 1. Plans of Indian recipients of US science and engineering doctorates to stay inUSA, by field, 19922003.

Year All scince and engineering fields

Number (%)

Biological/agricultural sciences

Number (%)

Definite plans/plans No plans Definite plans/plans No plans

19921995 3708 (88) 506 (12) 714 (92) 58 (8)

19961999 4308 (90) 473 (12) 923 (91) 87 (9)

20002003 2889 (89) 350 (11) 762 (91) 76 (9)

Data include permanent and temporary residents. Recipients who plan to stay report plan to locate in the USA;

those with definite plans report postdoctoral research appointment or definite employment plans in the USA.



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At the same time, the establishment of a pat-

ent product regime in early 2005 looks to havereassured foreign-based MNCs that they cansafely re-enter the Indian market from whichthey had withdrawn because of the historicabsence of IP protection for their branded prod-ucts. Their interest in the Indian market is sharp-ened by the growth of the Indian middle class,which is fuelling an increase in Western stylechronic diseases and hence a demand for thedrugs that can treat them [26].

Foreign MNCs are also increasing their R&Dinvestment in India, which, between 1994 and2002, rose from US$5 to 80 million. However,

these data need to be seen in the context of a par-allel rise for China from US$5 to 646 millionand for South Korea from US$17 to 167 million(Figure 8).

As an emerging economy, India has a mix ofstrengths and weaknesses when assessed in termsof certain basic infrastructure requirements relat-ing to its global competitiveness in the stem cellfield. Its science base is developing but at aslower rate than that of its major Asia competi-tors, its scientific workforce suffers from a braindrain to the USA and its approach to, and use of,

its science IP is, in global terms, still relatively

unsophisticated. However, both Indias health-care biotech and pharmaceutical industries areestablished and rapidly expanding the latter ona global scale.

Policy interventionsGiven this global position and given that India isaware of the potential of stem cell science, whatsteps is it taking to improve its prospects in thispart of the global knowledge economy? To whatextent is India sensitive to the difficulties of com-mercialization in this field and to the novelforms of state support that may be needed?

Organization & funding of R&D

Indias commitment to biotechnology was firstformally recognized with the creation of theNational Biotechnology Board (NBTB) in1982, with the brief to create a research infra-structure and identify priority needs as a plat-form for long-term expansion of the healthcareand agricultural sectors [115]. This was suc-ceeded in 1986 by the DBT, part of the Minis-try of Science and Technology, that fundsresearch, manages and oversees projects

Figure 6. Patent filings by residents.

Source [18].

Japan

USA

South Korea

Germany

China

EuropeanPatent Office

Russia

UK

France

Australia

Italy

Ukraine

India

Sweden

Brazil

Other

0 100,000 200,000 300,000 400,000

Number of resident patent filings (top 15 offices)

+10%

+53%

+76%

+27%

+557%

+54%

+31%

+3%

+15%

+18%

-14%

-15%

+365%

-30%

+44%

-7%

Country


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through 16 task forces in specialized areas ofbiotechnology and acts as a link between thepublic sector and private industry [116]. Recog-nition of the significance accorded to biotech-nology policy is apparent in the DBTs rapidlyincreasing budget over the past 5 years(Figure 9). Decidedly ambitious, the DBTs lat-est plan announced its intention to create abiotechnology industry that would generateUS$5 billion in revenues per year and one mil-lion jobs by 2010 [28]. To date, the DBT hassupported more than 30 programs of stem cellresearch, including limbal, hematopoietic, neu-ral, liver, cardiac, human corneal and embry-onic stem cells and the establishment of stemcell lines [117].

The DBTs new strategy for the development ofIndias stem cell science has the following features:

The promotion of research for therapeuticapplications using adult and embryonic stemcells as well as other more readily availablesources, such as bone marrow, peripheralblood and umbilical cord blood;

A focus on basic research and the study of fac-tors that generate stem cells and how stem cellproliferation can be stopped;

The biology of stem cells; The expansion of hematopoietic stem cells

without differentiation and gene transduction,gene regulation and plasticity of stem cells;

The establishment of centers of excellence toincrease productivity in stem cell research.Interdisciplinary proposals are being developedwith the involvement of basic researchers,clinicians and industry;

The expansion of stem cell research in India [117].

City cluster stem cell programs are plannedfor Delhi, Vellore, Hyderabad, Pune and Banga-lore. At present, seven hESC lines are held at theReliance Life Sciences Laboratory in Mumbaiand three at the National Center for BiologicalSciences in Bangalore [118].

Two other government agencies with respon-sibilities that include the stem cell field are theICMR, part of the Ministry of Health, and theCouncil of Scientific and Industrial Research(CSIR). The ICMR is responsible for formulat-ing, coordinating and promoting biomedicalresearch in response to national health priorities.It has a supporting network of 21 nationalresearch institutes and centers as well as sixregional medical research centers. Meanwhile,the CSIR is a broadly based agency with aninfrastructure of laboratories, institutes andcenters for technology transfer.

Indias awareness of the need to expand itsR&D base is evident in the 25% increase in its2005 research budget allocation the highestrise in Asia and comparing favorably with that of

Figure 7. USA patent applications by origin of first-namedinventor, 19902003.


80,000

60,000

40,000

20,000

0

1990

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

China (inc. Hong Kong)South Korea

IndiaSingaporeJapanAustraliaUK

Year

Number

Table 2. Biotechnology firms in India by sector.

Sector 2001 2003

n % n %

Agriculture 85 48.3 132 32.9

Healthcare 43 24.4 142 35.4

Environment 4 2.3 16 4.0

Industrial biotech 42 10.5

Others 44 25.0 69 17.2

Total 176 100 401 100

Source [113].


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China (16%) and South Korea (10%). Further-more, India is moving towards creating its ownversion of the USA National Science Founda-tion, with a proposed annual budget of US$250million [29]. R&D allocations are generally made

within the countrys National Five-Year Plansand changes in the pattern of these allocationscan be taken to reflect shifts of national priori-ties. In this respect, it is interesting to note thatin the most recent Tenth Five-Year Plan therehas been a shift in focus from agricultural tomedical biotechnology. From only 13% of thetotal budget in the Ninth Five-Year Plan, theproportion allocated to medical biotechnologyhas increased to 36%. This priority changeincludes an emphasis on the clinical applicationof stem cells and the commercialization of thetissue culture program [119].

While public expenditure on medical R&D isincreasing, so also is that of the private sector.Stimulated by the change in the patentingregime (see below), Indias large pharmaceuticalcompanies, such as Dr Reddys Laboratory, Ran-baxy Laboratories and Wockhardt Ltd, areincreasing their R&D allocations in their searchfor innovative drugs. In 2003, average R&Dexpenditure as a percentage of sales stood at4.4% compared with 3.8% in 2002. It is esti-mated that this percentage may have surged to12% in 20052006 [120].

Stimulating the biotech market: IP & VC

As an emerging economy, India lacks a stockmarket with sufficient volume and liquidity toattract substantial international venture capitalinvestment in support of the early-stage andhigh-risk health biotechnology companies in thestem cell field. Nor is the protection of IP (anecessary condition of venture capitalist interest)as yet an established feature of biotechnologycommerce in India. However, recent legislationmakes it clear that the Indian government recog-nizes the important contribution of IP reform toits global competitiveness.

In April 2005, the Patents (Amendments) Act2005 implemented Indias 1995 accession to theWorld Trade Organizations Trade RelatedAspects of Intellectual Property Rights (TRIPS)agreement. In amending Indias Patent Act of

1970, the new Act removes the previous encour-agement for process patenting, makes reverseengineering of copycat drugs illegal and encour-ages novel product development capable ofaccessing global markets. Its effects are likely tobe several. First, small biotechs will become moreaware of the ways in which patenting can be usedto realize the market value of their early-stagetranslational research. Second, the domesticpharmaceutical companies will be obliged toshift from process innovation and generic manu-facture to product innovation [30]. This, in turn,

will encourage both their search for alliances andmergers with the small biotechs with innovativeproduct potential and, as we have seen, pharma-ceutical investment in R&D. Finally, the intro-duction of exclusive marketing rights as a resultof the implementation of TRIPS means that for-eign pharmaceutical companies will once againbegin to view India as an attractive location forstrategic investment, particular in the current cli-mate of cost reductions and outsourcing [31] (a2005 survey of pharma senior executives foundthat 62% considered patent infringement a

problem in India, lower than China [70%], butstill too high for comfort [32]). Although it willtake time for India to build the appropriate pat-enting infrastructure, such as specialized IPcourts and more patent offices that are compu-terized and digitally linked, the broad patentingpolicy direction is now established.

With regard to stem cell science in particu-lar, Section 3 of the 2005 Patent Act lists bio-technological inventions that are notconsidered patentable. These include any livingentity of artificial origin, such as: transgenicanimals or plants; biological materials, such as

Table 3. The Indian pharma market in 2005.

Amount

Overall sales by India-based operations (foreign

and domestic)

US$8 billion

Domestic sales US$5 billion

Exports US$2.7 billion

Outsourcing services US$300 million

India market by 2010 (estimate) US$8 billion

Indian market by 2015 (estimate) US$12 billion

Source [26].

Table 4. Indian high-tech industry production, by industry(USA 1997 $ millions).

1980 2003

Pharmaceuticals 1217 6488

Medical, precision and optical

instruments

258 1620

Aircraft 68 322

Office and computing machinery 21 2963

Communication equipment 109 6199

Source [23].


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organs, tissues, cells, viruses, and the process ofpreparing them; and processes for cloninghuman beings or animals [121].

With a patenting policy being implemented, alogical policy partner is national support for thefacilitation of the VC function and the marketstimulation of new technologies, such as biotech-nology. In 1999, the Indian government estab-

lished the Technology Development Board tosupport and finance promising new ventures. By2003, it had promoted 103 projects valued at atotal of US$1.7 billion in biotechnology areas thatincluded health and medicine. At the same time,India has introduced guidelines to facilitate theemergence of venture capital funds (VCFs). In1996, the Securities and Exchange Board of India(SEBI) framed the SEBI (Venture Capital Funds)Regulations. While only eight domestic VCFswere registered with SEBI during 19961998, by20032004 more than 70 additional funds were

registered, the majority located in four major clus-ters Bangalore, Hyderabad, Pune and Mumbaiand Chennai where growth in the biotechindustry is very fast [33]. Overseas VCFs weregiven tax-exemption privileges in 1995. By 2000,figures from the Indian Venture Capital Associa-tion show that the combined total for domesticand overseas venture capital investment wasapproximately US$2.6 billion [122].

A parallel policy initiative in facilitating theearly-stage commercialization of biotechnologyis the Biotech Consortium India Limited

(BCIL). Established in 1990 by the ICMRsDepartment of Biotechnology, the BCIL isdesigned to act as a public limited company,with the objective of providing the linkagesamongst research institutions, industry, govern-ment and funding institutions, to facilitate accel-erated commercialization of biotechnology [123].Given the limited VCF presence in the early

1990s, the BCIL was to fulfill the same func-tions as the venture capital companies in theUSA i.e., promote the creation of firms by pro-viding venture capital and other forms of assist-ance for scientists to set up firms an interestingform of state intervention to counteract marketfailure [124].

State Governments in India also play animportant role in shaping the market environ-ment of stem cell science. Building on their con-siderable experience with IT innovation, mostStates have strategies to attract biotechnology

industry through policies such as tax conces-sions, cheap credit, subsidized industrial infra-structure and state support for technologyincubators [120].

In the private sector, a significant player inIndias emerging VC market and an indicator ofIndias growing domestic capacity in this field isIndustrial Credit and Investment Corporation ofIndia (ICICI) Venture. A subsidiary of ICICIBank, Indias second largest bank, ICICI Venturehas aggregate funds under management in excessof US$2 billion and focuses on sectors where it

Figure 8. R&D performed by foreign affiliates of USA multinational companies.


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views Indian companies as having a global com-petitive advantage: IT, life sciences and service sec-tors. It is currently forming a dedicated incubatorfund for supporting start-ups in the area of bio-technology and life sciences [125]. ICICI is alsohappy to work with State Governments. In collab-oration with Andhra Pradesh, the company isdesigning a joint initiative for a Knowledge Parknear Hyderabad for the promotion of life sciences.

Governance & trust

Emerging economies inevitably search for modes

of commercialization that can accelerate thembeyond the gravity of the developed worlds glo-balization dynamic. It is in their interest to movefast enough to establish their own counterdynamic that can act to redefine aspects of theglobalization process. However, as the case ofSouth Koreas Professor Hwang and stem cell sci-ence vividly illustrates, if this is at the expense ofscientific and ethical standards there may be ahigh price to pay. Scientific and public trust in acountrys science may be undermined at nationaland international level. And if trust goes, so does

market confidence.The maintenance of trust through the appro-

priate governance of a new field of biotechnol-ogy therefore constitutes an essential part of themodel of commercialization for an emerging, asmuch as a developed, economy. In stem cell sci-ence in India, there are three areas of govern-ance where political issues that can impact onpublic and scientific trust have already arisen:the supply of oocytes and embryos required forhESC research, the conduct of hESC researchand clinical experimentation with stem cells.

Indias in vitro fertilization clinics are anestablished source of embryos for research towhich foreign scientists come for supplies [126].However, in the wake of the setting up of theESC line research at Reliance Life Sciences Lab-oratory and the National Center of BiologicalSciences in 2001 and its associated publicity, thegovernment announced a crack-down on thetrade to counter the international view of Indiaas an embryo surplus nation [127]. Given themedical professions entrenched resistance to theregulation of in vitro fertilization, an area of

their work that, in India, is both sparsely moni-tored and highly lucrative, the governmentsproposals are unlikely to be implemented dili-gently [34]. If they are not, there is no reason tosuppose that there will be much public conflicton this issue. Where debate has occurred, bothsupporters and opponents have been able todraw on the same Hindu conceptual terrains ofVedic and Upanishadic philosophy suggesting aless-than-straightforward connection betweenreligious values and political position. In addi-tion, the cultural intricacies, stigmas and taboos

surrounding infertility in Indian culture seemmore likely to promote a self-protective silenceon the moral status of the human embryo ratherthan an open discussion [35].

Moreover, as stem cell therapies move intothe later stages of development, the field will beconfronted with many of the problems thatcurrently plague the conduct of pharmaceuticaltrials in general. As India becomes a globalcenter for clinical trials, both for its own indus-try and contract research organizations workingon behalf of foreign companies, the question of

Figure 9. Budgetary allocations to the DBT 19871988 to 20042005.

Source [120].

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ethical oversight becomes increasingly difficultto ignore. It is significant that the currentguidelines for human subject experimentationwere established after an incident in 1999,prompting the government to order a review ofsafety and ethical standards. The Ethical Guide-lines for Biomedical Research on Human Subjectswere published by the ICMR in 2000. How-ever, their recommendations are nonbindingand scandals continue to emerge [36]. At thesame time, the Drugs Controller General hasissued binding regulations on Good ClinicalPractices for Clinical Research in India (2001),based on the World Health Organizationsstandards, and it is reported that programs totrain clinicians in GCP are proliferating aroundthe country [128].

The formation and implementation of policy

on the regulation of stem cell research itself isheir to the problem of bureaucratic competition:resolvable but continuing. Of the two agenciesthat fund stem cell research and could thereforeassume responsibility for its licensing and moni-toring, DBT forms part of the Ministry of Sci-ence and Technology and ICMR part of theMinistry of Health. Significantly, the DBT andthe ICMR each issued guidelines the DBT in2001 and the ICMR in 2002 without consult-ing one another [37]. It was not until 2005 thatthey came together to draft a joint document

and, in 2006, produced their Guidelines for StemCell Research and Therapy[129].

The guidelines propose a system of reviewand monitoring of the field, based on aNational Apex Committee (NAC) for StemCell Research and Therapy and, at the institu-tional level, Institutional Committees for StemCell Research and Therapy. All research, includ-ing clinical trials, would require the priorapproval of, and be registered with, the NAC.Prohibited areas of research include reproduc-tive cloning, implantation of a human embryo

into the uterus after in vitromanipulation andtransfer of human blastocysts generated bysomatic cell nuclear transfer (SCNT) into ahuman or nonhuman uterus. Studies of chime-ras and the creation of a zygote by in vitroferti-lization or SCNT with the specific aim ofderiving a hESC line are restricted but not pro-hibited. At present, these guidelines have beensent for consultation to the USA National Insti-tute for Science and the USA Department ofHealth and Human Services. Precisely when,how and with what legislative backing they willbe implemented is not known.

In this situation of uncertainty, Indian stemcell scientists feel free to consult their own con-sciences and make their own decisions. Even ifthe stem cell guidelines are still in draft form,medical scientists can, if they so wish, abide bythe principles of the ICMRs Ethical Research forBiomedical Research on Human Subjects pub-lished in 2000 [130]. Unfortunately, a 2005 sur-vey by the ICMR showed that in the absence ofany powers of enforcement, only a minoritychoose to do so: 40 (22%) of Indias 179 insti-tutional ethics committees followed the princi-ples laid down in this document [38]. As stemcell science moves from the laboratory to theclinic and the experimental treatment ofpatients, it does so in a governance vacuum [39].As a result, scientists such as Geeta Shroff canpublicize her treatment of 100 clinical cases of

spinal injuries, paralysis, tuberculosis, neu-romuscular dystrophy and multiples sclerosisconducted without ICMR approval and receivesimultaneous praise from the Indian HealthSecretary and condemnation from Westernstem cell scientists [40,131].

Although in the short term the absence ofeffective regulation may not limit (indeed insome respects it may facilitate) the clinicalexperimentation phase of stem cell sciencecommercialization, in the longer term it willprove a disadvantage. To be a global player in

the stem cell field, India must engage with theinternational scientific, financial and industrialcommunities and, sensitive to the need forpublic trust, these communities will increas-ingly require adherence to international ethicalstandards in the conduct of stem cell researchand development.

ConclusionsTo assume that there is but one model for thecommercialization of a new science is to ignorethe dynamic nature of globalization and the

possibilities it generates. In their review of theopportunities for biotech companies in Indiaand China, Goodall and colleagues remark onthe possibility that India and China are open-ing up a new model of biotech development:Call it the modular model, a kind of decen-tralized R&D system where different aspectsof R&D are distributed globally and con-ducted almost autonomously in different loca-tions [41]. As the emerging economies begin tomake their own distinctive contribution toglobalization in the health biotech field, so theWestern-centric assumptions regarding the


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components and sequence of commercializa-tion from basic science to therapeutic productmay need to be rethought.

In the India case, we can already see chal-lenges emerging to those assumptions as Indiabecomes aware of its strengths, its potentialpoints of global leverage and the means forcompensating (or finding a means for tradingagainst) its weaknesses. At present, Indias basicstem cell science is weak and reflects the coun-trys general difficulty of retaining and recruit-ing high-quality scientists (both overseas-basedIndian scientists and foreigners), despite thepriority shift towards a proportionally greaterinvestment by the state in medical biotechnol-ogy R&D. Yet, in terms of research materials,India has both a plentiful supply of the oocytesand embryos necessary for hESC research and

a large and diverse population to support theexpanding presence of a domestic and multi-national pharma industry. India may find itfeasible to provide Western scientists access toits research materials in exchange for access tosome of the scientific knowledge generated asa result.

Until recently, investment in early-stageresearch was inhibited by the porous patentingregime in India and the consequent inability ofinvestors to assure the gains that might bemade from IP. However, the 2005 reform of

the patenting system, coupled with the active

state encouragement of, and investment in, theVC function of the biotech market, has engi-neered a more promising state of affairs.Domestic Indian private VC is now being tar-geted at its life sciences market and its healthbiotech sector and associated international alli-ances are growing rapidly. This raises the ques-tion of whether USA VC and NASDAQmembership, the traditional engines of the glo-bal health biotech industry, are still necessaryconditions of global success in this field.

A more lasting constraint may be the limita-tions of Indias governance of its basic stem cellscience, clinical experimentation and drug tri-als. The not infrequent negative publicity onthese issues may not seriously dent public trustwithin India itself but is likely to be highly rel-evant to any potential international collabora-

tors be these scientists or industrialists whosee themselves as accountable to other constitu-encies [42,132]. The Western outsourcing ofR&D may have its cost attractions, but theHwang affair demonstrates the risks that mustbe borne if the protective mantle of appropriategovernance is not in place.

Acknowledgement

The research for this paper was conducted by the Global Pol-

itics of Human Embryonic Stem Cell Science Project funded

by the Stem Cell Programme of the Economic and Social

Research Council. Project number RES-340250001.

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Stem Cell Science in India