Biotechnology

 

 

S. Visalakshi

 

Biotechnology is a frontier technology which has the potential to provide very substantial benefits to society in a wide range of sectors such as agriculture, medicine and health, forestry, animal husbandry, environment protection, and improving the quality of products and services. There is a lot of confusion about the definition of biotechnology. The definitions have been varying with the status and advancement of Biotechnology among countries and even within a country depending on the progress it has made in biotechnology. Now at least in Indian context people call “conventional” and “modern” biotechnology. Earlier this distinction was not made and a vague overarching definition including both the above categories was used.

Biotechnology can be defined in at least two ways. It can mean any technique which uses living organisms or parts thereof to make or modify products, improve plant or animal productivity or develop micro-organisms for specific uses. This definition encompasses new biological tools as well as ancient uses. A second and narrower definition refers to new “high-end” biotechnology, involving recombinant DNA, cell fusion and novel bio-process engineering techniques such as gene transfer, embryo-manipulation monoclonal anti-bodies and so on. In India earlier the first definition was prevalently used and it is being replaced gradually by the second one in the last few years (after 2000).

 

Special features of Biotechnology:

R&D intensiveness, long gestation periods, high investment, high value addition, heavy risk, stringent & evolving regulatory norms, uncertain levels of acceptance of BT products, ethical concerns etc. make BT very distinct from other technologies and especially from the point of view of investing in the field at research or commercialisation level. The cost of product development in the bio-industries is high. Taking a new diagnostic kit from the R&D lab to the market might cost anything from $2 to $30 million and may take upto 5 years. A new pharma product or crop variety might take 12-15 years and over $200 mn to reach the market (ABA 1999) (www.brisinst.org.au)

 

Investments in Biotechnology India:

A look at the allocations & expenditure by the department over the years (Tables 1 & 2) gives evidence of the importance assigned by the Government and commitment to make India one of advanced countries in BT in the developing world.

 

Table 1: Budgetary allocations of major funding agencies (Rs. Million)

Name of Agencies

1990/91

2000/01

Growth (%)

Department of Scientific and Industrial Research (DSIR)

131

584

446

Council of Scientific & Industrial Research (CSIR)

2351

9120

388

Department of Science and Technology (DST)

2589

7798

301

Department of Biotechnology (DBT)

655

1319

212

Indian Council of Agriculture Research  (ICAR)

3236

13990

432

Indian Council of Medical Research (ICMR)

396

1470

371

University Grant Commission (UGC)

3495

14070

403

NOTE: DST, DBT and DSIR are part of Ministry of Science and Technology while ICMR is with Ministry of Health, ICAR with Ministry of Agriculture and UGC with Ministry of Human Resource and Development (MHRD).

Source: Budgetary papers of relevant years, Min. of Finance (MoF) Government of India

 

The government initiatives involve establishment of infrastructure for research in Universities and public funded R&D institutions. The efforts also included generation of manpower for research and also absorption by industries in Biotechnology area. Department of Biotechnology which played the pivotal role in these efforts also created mechanisms for technology transfer and guidelines for regulation of GMOs and GMO based products. The efforts can be summarized by the following table (Table 2).

 

Table 2: Investments in Biotechnology by DBT (1990-2007)(Rupees in crores)

 

 

 

Manpower Development

infrastructure

Research Projects

TT / Dev.

Int. Coop

Total +

1990-91

7.39

7.86

15.78

10.57

0.74

59.65

1991-92

6

7.93

23.2

12.4

0.37

66.66

1992-93

4.22

10.19

28.63

5.26

0.67

49.01

1993-94

6.5

9.48

35.28

7.63

0.6

59.49

1994-95

7.8

9.1

36.77

9.2

0.44

63.31

1995-96

6.7

9.32

38.3

4.68

0.8

59.8

1996-97

6.43

7.94

37.9

7.06

0.83

60.16

1997-98

7.05

12.3

34.97

10.29

1.09

65.7

1998-99

9.46

10.23

43.22

9.19

1.66

73.76

1999-00

9.82

15

51.56

10.79

1.98

89.15

2000-01

10

35.47

43.35

11.18

2.5

102.5

2001-02

10.74

7.29

0

0

4.45

185.58

2002-03

10

28

104

9

6

235.6

2003-04

13

30

114

22

8

273.3

2004-05

 

 

 

 

 

 

2005-06

16.75

26.2

152.5

24.66

4.61

386.3

2006-07*

28

59

193

45

10

496

2007-08*

30.6

22.5

216

63

13.5

675

NOTE: * Estimates, + includes expenditure on other heads and R&D institutes under DBT

Source: DBT Annual Reports for various years.

 

Indian Biotechnology industry started after the research capabilities and infrastructure were developed. Most of BT commercialization basically happened in two phases. First in late 1980s, as low end biotech ventures in the form of tissue culture companies and ELISA or other formats of in vitro diagnostics. But most of the companies which were active in these areas slowly disappeared by mid 90s. The second phase had companies which are mostly diversified pharma companies which expanded their operations in the area of biotechnology. The new Biotech companies started as dedicated ones which were small and had narrow focus with a couple of products. The other breed of small companies mostly took service role at doing research at basic level or generating clinical data or bioinformatics.

There is a lot of confusion still persisting in the definition of biotechnology in Indian context. This led to various estimates of the companies operating in Biotechnology. Table 3 gives an idea of the confusion that is prevailing.

 

Table 3: Estimates of the number of companies in BT in India

 

ASSOCHAM

Frost & Sullivan Report

US Commercial Report

BCIL(200)

DBT

CII

Canada Govt. Report

BSS

Total no. of Companies

550

75

500

176

800

170

800

400

High-Tech Companies

 

 

 

 

25

60

 

163

Low-tech Companies

 

 

 

 

 

 

 

236

Agriculture- Based

140

 

75

49%

 

24%

10%

27%

Health- Related

110

 

300

25%

 

16%

60%

38%

Environmental- related

 

 

 

26%

 

 

 

 

Industrial, Genomics, Bioinformatics

300

 

 

 

 

 

30%

29%

 

 

Biotechnology Industry in India

At the industry level, the Indian biotechnology industry is still at a nascent stage. There are some success stories but still a lot needs to be done to make the industry move from being generic-focused to innovative research-oriented one. Traditionally, India has a strong presence in generic drugs market and this has helped many Indian companies enter the market for biogenerics – generic therapeutic products. Agro-biotech is another important area where a number of products have been introduced in the market/fields. India’s strong skills in the IT sector have played an important role for some Indian companies to diversify in bioinformatics. Many Indian companies are also offering attractive cost benefits to foreign companies through outsourcing, including contract R&D activities. However, there is still a lack of interest from the venture capitalists to pump in money in this sector (so far, some US$ 20 million have been invested by the venture capitalists). The main reasons cited for this lackadaisical attitude are: long gestation time in product commercialisation, present small size of the domestic market for biotech products, inadequate protection for IPRs, and prevailing controversies over consumption/use of GM products.

Biotech industry ideally is not a homogenous sector like pharma or agro-industry. It has medical, agricultural and industrial biotechnology. The variations in estimates of number of companies under BT give us an idea of the variety of products/activities included under it. The estimates range from 170 companies (C II, 2002) to 800 companies. Table 3 gives us an idea of this lack of clarity (Add from BSS-Table & summary of write up). While this confusion exists, the products based on BT have already reached market. Sales under various categories and projections for 2005 are expected to be sizable (Rs. 200 billions) and poised to grow at 20% annually. The increase in the number of companies in modern biotechnology is a post-1998 phenomenon. It is also observed that most of these new companies are involved in service sector namely either contract research clinical research or bio-information.

Like in any other country which has succeeded in commercializing biotechnology Indian biotech industry also could be observed to have three types of players:

Start-up companies with major focus on BT: This category is an outcome of public spending on R&D as happened in US. There are two models possible. One like the US, the academic scientists enter into business of their research results by their own efforts.
Some of the examples are:

  1. Avesthagengraine technologies
  2. Strand genomics
  3. Metabelix
  4. Biomakso
  5. Bhat Biotech
  6. Shantibiotec
  7. Preocentis
  8. Mascon
  9. Sudarshan Biotech
  10. Virchow biotech

 

The scientists have been able to garner sufficient funds from different sources. These companies have the following characteristics:

 

Established local companies: Companies under this category are those who have sufficient revenues from other business to try and enter BT area through investing in R&D initially. Some of the companies in this category are:

  1. Rallis
  2. Biocon
  3. Dr. Reddy’s Lab
  4. Dabur
  5. Bharat Serums

Characteristics:

  1. Have enough strength to take risk and wait during a long gestation period
  2. Links with national and international business
  3. Excellent production marketing competence and networks
  4. Have links with policy makers
  5. Can recruit new skilled manpower

Style:

 

MNC’s: Till now there are only a few products from these, that too in Agriculture area. R&D happens in parent countries and application related research is conducted in India. Monsanto, Syngenta Aventis and Astra Zeneca are examples under this category of firms who are involved in BT activities.

Characteristics:

  1. Have enough strength to take risk and wait during a long gestation period
  2. Links with national and international business
  3. Excellent production marketing competence and networks
  4. Have links with policy makers
  5. Can recruit new skilled manpower

Style:

 

MNC’s: Till now there are only a few products from these, that too in Agriculture area. R&D happens in parent countries and application related research is conducted in India. Monsanto, Syngenta Aventis and Astra Zeneca are examples under this category of firms who are involved in BT activities.

Characteristics:

  1. Limited interaction with other groups in the form of “contract research” that too in US or Europe for confidentially
  2. Project mode of scientific activity
  3. Often kept within organization in India

Style:

Strategy of these companies seems to be to develop exclusive products for American and European markets with strong IP protection and sell-ons for other markets through tie ups with Indian companies. They have good standing and marketing networks.

 

Structure of Biotech industry:

Some figures on the ownership pattern, size, nature of activity, products made etc. are given in the following tables.

 

Table 4: Ownership pattern of Biotechnology Companies in India

Ownership of Companies

No. of Companies

Percentage of Companies

Private

123

55.41

Public

77

34.68

Multinational companies

13

5.86

Other (JV + Proprietory)

8

3.60

Not Known

1

0.45

Total

222

 

 

 

Table 5: Size wise distribution of Biotechnology Companies

Size

No. of Companies

Percentage of Companies

Small

124

55.86

Medium

33

14.86

Large

63

28.38

Not Known

2

0.90

 

 

Table 6: Area of activities of Biotechnology Companies

Area

No. of Companies

Percentage of Companies

Agriculture

61+2

28.38

Healthcare

96+1

43.69

Industrial enzyme

10

4.50

Bioinformatics

10

4.50

Environment

3

1.35

Instrumentation

2

0.90

Research biological

2

0.90

BT education

3

1.35

Contract research organization

3

1.35

Clinical research org.

7

3.15

Others

21

9.46

Services

1

0.45

Probiotics

2

0.90

1. Agriculture
      a) Aquafeed

1

0.45
      b) Animalfeed

2

0.90
      c) Biofertilizer

7

3.15
      d) Biopesticide

10+2

5.40
      e) Seeds (Hybrid)

20

9.01
      f) Seeds (Transgenic)

9

4.05
      g) Plant nutrients                       and    others

12

5.40

 

61+2

28.38

2. Healthcare
      a) Biotherapeutics

20

9.01
      b) Diagnostics

17

7.66
      c) Drugs/ thera.

46+1

22.17
      d) Probiotics

3

1.35
      e) Vaccines

10

4.50

 

96+1

43.69

3. Industrial BT
      a) Enzymes

10

4.50 

 

10

4.50

4. Services

  a) Instruments

5

2.25
      b) Res. Biology & reagents

3

1.35
      c) CRO

5

2.25
      d) CLRO

7

3.l5
      e) Bioinformatics/genomics

10

4.50

 

30

13.51

5. Others

21

9.46

6. Not Known

3

1.35

 

 

Table 7: Nature of Activities of Biotechnology Companies

Nature

No. of Companies

Percentage of Companies

Research (R)

9

4.05

Production (P)

2

0.90

Marketing (M)

8

3.60

Services (S)

14

6.31

Research & Production (RP)

6

2.70

Research & Services (RS)

24

10.81

Production & Marketing (PM)

38

17.12

RPM (Research Prod. & Marketing)

119

53.60

RM

1

0.45

 

 

Table 8: Product Segment wise Distribution

No. of Companies

Percentage of Companies

1. Agriculture

 

 
     Aquafeed

1

0.45
     Animalfeed

2

0.90
     Biofertilizer

7

3.15
     Biopesticide

10+2

5.40
     Seeds (Hybrid)

20

9.01
     Seeds (Transgenic)

9

4.05
     Plant nutrients and others

12

5.40

 

61+2

28.38

2. Healthcare

 

 
     Biotherapeutics

20

9.01
     Diagnostics

17

7.66
     Drugs/ thera.

46+1

22.17
     Probiotics

3

1.35
     Vaccines

10

4.50

 

96+1

43.69

3. Industrial BT

 

 
     Enzymes

10

4.5 

 

10

4.50

4. Services

 

 

Instruments

5

2.25
     Res. Biology & reagents

3

1.35
     CRO

5

2.25
     CLRO

7

3.15
     Bioinformatics/genomics

10

4.50

 

30

13.51

5. Others

21

9.46

6. Not Known

3

1.35

 

 

Table 9: State wise Distribution of Biotechnology Companies

State

Visited

Secondary Sources

Total

Total Percentage

AP

48

6

54

24.32

Delhi

19

4

23

10.36

Gujarat

11

8

20

9.01

Karnataka

34

2

36

16.22

Maharashtra

51

19

70

31.53

MP

1

1

2

0.90

Tamil Nadu

8

6

14

6.31

West Bengal

0

1

1

0.45

Haryana

0

1

1

0.45

UP

0

1

1

0.45

Source: Visalakshi (2004)

 

 

Manpower involved in the biotech industry has increased over the years. But still there is a widespread dissatisfaction about the quality of manpower available to the industry in India (Ella 2005). The figure below gives an idea of the numbers engaged in Biotechnology R&D and production in India and their growth in the Years from 2001-05.

 

Source: Behera (2006)

 

Biotech market in India:

World market for biotech products is more than $100 billion and this is expected to grow to $170 billion by the year 2005.

India’s share in global biotech market is just 2%. The market for biotech products in India has increased five-fold from of its size in 1997 and is at present valued at $2.5 billion.

According to ‘The Biotechnology market in India’ report prepared by Market Research Centre of Agri-Food Tech services for the Govt. of Canada, the industry was valued at $3.7 billion and was expected to grow to $6.7 billion by 2000. The investment in biotech industry in India is about Rs.5500 crores. It is further estimated that in the first decade of the new millennium approximately Rs.20,000 crores would be invested mainly in the areas of healthcare, agriculture, environment and the food processing industries (All India Biotech Association Report).

 

Domestic market: Currently, there are some 220 companies engaged in biotechnology field and out of these some 50-60 companies are in modern biotechnology. According to a study made by the Confederation of Indian Industry (CII) of 52 Indian companies in the modern biotechnology segment, the total project investment by these companies was over US$ 100 million in the last decade. Out of these 52 companies, 32 alone were incorporated after 1998, showing the increased interest from the industry. Some foreign companies have presence in the Indian biotech sector, e.g. Monsanto, Pfizer, Astra Zeneca, Unilever, Dupont, Bayer, Eli Lilly, and Hoechst Roussel Vet, Millipore, and Novozymes.

As per the industry analysts, the domestic market for biotechnology products in India was about US$ 2 billion in 2001. An EU study estimated the Indian biotech market worth US$ 1.5 billion in 2000, with human health-biotechnology, agri-biotechnology and veterinary-biotechnology products dominating the market (85 per cent share) and industrial products, R&D, supplies, etc. accounting for the remaining share (15 per cent).

The biotechnology sector has still a minuscule share (< 1%) in country’s GDP. However, given the current growth potential (please see the following projections), this sector is certainly going to play a better role in India’s economy.

 

YEAR

Contribution of BT Industry to GDP (2002-03 to 200-07)

GDP  Current  Prices

Production Value

% of GDP

2002-03

2248614

2345

0.104

2003-04

2531168

3475

0.137

2004-05

2833558

4745

0.167

2005-06

3225963

8541

0.264

2006-07

Not Available

10272.9

Source: Ministry of Finance (MoF) accessed from Website

 

Presently, the foreign trade data for biotech products is not separately available (it is clubbed with the related areas, e.g. pharma products, seeds). The import and export data for pharmaceutical products (ITC/HS Chapter 30), and seeds - sowing (ITC/HS Code 1209) are briefly mentioned below:

 

Imports (Period: Fiscal year 2001-02)

Business sector

% of imports

change from pervious year

value in USD m

Main countries of origin

Pharmaceutical products

0.32

+10.61%

166.56

Germany, Switzerland, USA

Seeds

0.028

+  2.58%

14.28

South Korea, USA, Japan

Source: Department of Commerce, Indian Ministry of Commerce and Industry

 

 

Exports (Period: Fiscal year 2001-02)

Business sector

% of exports

change from pervious year

value in USD m

Main destination countries

Pharmaceutical products

2.40

+11.7%

1055.80

Russia, Brazil, South Asian

Seeds

0.03

-8.38%

13.54

USA, Japan, Netherlands

Source: Department of Commerce, Indian Ministry of Commerce and Industry

 

The industry analysts have projected the consumption of biotech products in India at a level of US$ 4.27 billion by 2010, with sub-sectoral forecast for human and animal healthcare products - US$1.7 billion; agriculture products including seeds - US$1.4 billion; industrial products - US$978 million; and other products - US$145 million approximately. India is expected to have a market share of about 8% in the world market for biotech products by 2010. Importantly, the market segment for modern biotechnology products and services, i.e. products involving recombinant processes, is rather small at the moment, but this segment is expected to grow at a comparatively higher average annual rate of 35-40 per cent. The Indian government has already granted marketing licences for about 25 recombinant protein therapeutics. The present market for diagnostic/vaccines is valued at US$ 200 to US$ 500 million (depending upon how a biotech product is defined). Currently, 50 per cent of diagnostic products in India are imported, and as the healthcare market is expanding, there is a big potential to be tapped by Swiss companies. In the agriculture segment, India, being the second largest food producer after China, offers a huge market for agri-biotechnology products. Indian scientists have traditionally been introducing hybrid seeds using tissue culture techniques.

However, the genetically engineered seed market is very small at the moment, worth an estimated $2.5 million out of a total seed market worth US $ 450-500 million, but is expected to expand once controversies over GM products are settled down. Furthermore, there is a good market/R&D prospects for bio-pesticides and bio-fertilizers, bio-remediation products/processes, bio-fuels, bio-indicators, and bio-sensors.

 

Performance of Biotech Industry in India

The following tables and figures show some salient features of performance of this industry. The performance of the industry is gauged at economy level - contribution to GDP, Export, quantum of sales etc. It could also at the technology level – capability to innovate, nurture innovation and compete locally and globally through introduction of products.

 

 

Fig 1: Growth of revenue of indian Biotech industry 2002-2007

 

 

 

Fig 2: Forecast for 2015

 

 

 

Fig 3: Revenue Share of Biotech Sector 2007-08

 

 

 

Fig 4: R&D and Infrastructure Investment

 

 

 

Fig 5: Compound Annual Growth 2003

 

 

 

Fig 6: Biotech Industry (Domestic Vs Export)

 

 

 

Fig 7: Share of different segments in Export & Domestic Sales

 

 

Table 10: Biotech Industry Revenues (in crore rupees) from Exports and Domestic Sales

Sub Sectors

Exports

Domestic

Total

Value

% age

Value

% age

Value

BioPharma

3999.9

58

2900

42

6866.90

BioServices

1502

96

70

4

1572

BioAgri

51.78

4

1150

96

1201.78

BioIndustrial

30

7

380

93

410

Bio Informatics

150

79

40

21

190

 

 

Table 11: Sub Sector wise distribution of Exports and Domestic sales of Biotech products

 

BioPharma (in %)

BioServices (in %)

Bio-Agri (in %)

BioIndustrial (in %)

BioInformatics (in %)

Exports

70

26

1

1

3

Domestic Sales

64

2

25

8

1

Source: ABLE Survey - Biospectrum

 

 

Table 12: Past Sales of Biotech Products in India and Future Sales Estimates(Rs. In Million)

 

Particulars of Biotech Sub-sectors

Actual Sales 2005

Future Sales Estimate 2010

1

Human & Animal Health care Products

35320 (37.6)

93540 (38.5)

2

Agriculture (including traded varieties & hybrid seeds & other planting materials)

28880 (30.7)

78720 (32.4)

3

Industrial Products

28500 (30.3)

53590 (22.1)

4

Other Biotech Products

1300 (1.4)

17000 (7.0)

 

Total

94000 (100)

242850 (100)

 

Total (US Dollars)

2186

5782

Source: P K Ghosh

 

 

Table 13: Modern biotech products currently (2006-07) being produced in India

Sector

Major companies involved in production

Health Care Product

 

Hepatitis B surface antigen

Transgene Biotech, Hyderabad did the first experiments in the country to introduce the product based on a recombinant yeast strain by the name Hansenula polymorpha but subsequently sold the technology to Serum Institute Pune.

Shantha Biotechnics produced the recombinant strain in Pichia pastoris and started producing the pure antigen from the recombinant organism.

Wockhardt Ltd. Aurangabad produced the substance using recombinant yeast strain of Hansenula polymorpha. 

Bharat Biotech International Ltd. , Hyderabad produced the substance in Pichia pastoris.

Panacea Biotech Ltd., Delhi produced the substance in recombinant Pichia pastoris.

Serum Institute of India Ltd., Pune produced the substance using recombinant yeast strain of Hansenula polymorpha. 

Biological E Ltd., Hyderabad (BE) produced the substance using recombinant Pichia pastoris.

Efforts by several other newcomers as well as introduction of the product by direct importers.

Granulocyte Colony Stimulating Factor (GCSF)

Dr. Reddy’s Laboratory developed the recombinant E. coli strain and technology for the production of this lifesaving drug for leucopoiesis in various conditions especially in patients suffering from cancer after receiving chemotherapy.

Intas Ltd. Ahmedabad developed the clone and technology in E. coli and had introduced the product in the market.

Efforts by several other newcomers as well as introduction of the product by direct importers.

Recombinant Erythropoietin alpha

Wockhardt Ltd. Aurangabad started producing the product using genetically modified CHO cell lines.

Intas India Ltd. Ahmedabad developed its own clone in CHO cell line.

Efforts by several other newcomers as well as introduction of the product by direct importers.

Interferon alpha 2B & pegylated product

The product was developed by Shantha Biotechnics Ltd. Hyderabad in E. coli strain.

Efforts by several other newcomers as well as introduction of the product by direct importers.

Epidermal Growth Factor

Bharat Biotech Ltd. Hyderabad developed the product in E. coli.

Streptokinase

Shantha Biotechnics, Hyderabad; Bharat Biotech Hyderabad, developed this technology in E. coli.

Recombinant Human Insulin

The product was developed in Hansenula polymorpha by Wockhardt India Ltd.

The product was developed in Pichia pastoris by Biocon India Ltd.

Efforts by several other newcomers as well as introduction of the product by direct importers.

Analogues CETUXIMAB

Biocon Ltd. Bangalore has launched a monoclonal antibody produced by genetic engineering method, which works to block certain receptors of epidermal growth factor that are responsible for proliferation of cancer cells. 

Excess of production of bio-molecules in the EGF pathway promotes growth and spread of several solid tumors. Epithelial cancers especially colorectal cancer responds well with the drug. The monoclonal antibody interrupting one or more of the intermediate molecules would disrupt signal transduction pathways and immune system will be activated to minimize their production. In the process the tumor growth shall slow down.

RITUXIMAB

Dr. Reddy’s Laboratory, Hyderabad is introducing the product based on local production and purification. The product is indicated for treating Non-Hodgkin’s Lymphoma and Rheumatoid Arthritis.

Several New Products & BioGenerics

Many companies are working on different compounds with/without collaborations to develop the technologies to market them. These have been dealt with in the descriptive part of the paper. It is anticipated that several new products would be introduced during the next one decade. Concurrently, imports of many such products would continue.

Agriculture

 

Bt Cotton

Private Sector

Mahyco – Monsanto Hybrid Seeds Pvt. Ltd. Mumbai, is a joint venture of Monsanto U.S.A. and Maharashtra Hybrid Seeds Company Ltd (Mahyco) Mumbai with 50 percent ownership each. Mahyco-Monsanto obtained approval for producing Bt cotton seeds containing Cry1Ac gene in March 2002 and started transferring the Bt Cry1Ac trait into Bt cotton hybrids held by Mahyco. These seeds are being sold to the cotton growers in the country. Later, they introduced Cry2Ab2 gene which is more tolerant to a wide spectra of insects with more sustainable insect resistant properties into Indian cotton cultivars and sold the transformed hybrids to the farmers.

Company also researching to generate plants resistance to herbicide glyphosate using  CP4 EPSPS gene.

Rasi Seeds Company Ltd., Tamilnadu purchased the transgenic seeds containing Cry1Ac as well as Cry2Ab2 genes from Monsanto-Mahyco and transformed their parental cotton lines to contain the above genes. The stable hybrids produced are being marketed.

Nath Seeds Ltd. Aurangabad obtained cotton seeds containing insect resistant genes GFM Cry1A and transformed their parental cotton cell lines with these. The stable hybrids produced therefrom are being sold to the cotton growers.

Syngenta India Ltd., Pune has introduced insect resistant cotton seeds containing Vip-3 gene. This gene codes for a toxic protein similar to Bt Cry1Ac. Syngenta India transferred the gene to its parental cotton lines and produced hybrids which are being sold in the market.

Ankur Seeds Ltd., Nagpur, purchased the transgenic seeds containing Cry1Ac as well as Cry2Ab2 genes from Monsanto-Mahyco and transformed their parental cotton lines to contain the above genes. The stable hybrids produced are being marketed.

Krishidhan Seeds Ltd., Jalna purchased the transgenic seeds containing Cry2Ab2 gene from Monsanto-Mahyco and transformed their parental cotton lines to contain the above gene. The stable hybrids produced are being marketed.

Ajeet Seeds Ltd., Aurangabad purchased the transgenic seeds containing Cry1Ac gene from Monsanto-Mahyco and transformed their parental cotton lines to contain the above genes. The stable hybrids produced are being marketed.

JK Seeds, Secunderabad, purchased the transgenic seeds containing Cry1Ac gene from BREF-Bioteck, IIT, Kharagpur & UDSC New Delhi and transformed their parental cotton lines to contain the above gene. The stable hybrids produced are being marketed.

Nuziveedu Seeds Co. Ltd., Hyderabad purchased the transgenic seeds containing Cry1Ac gene from Monsanto-Mahyco and transformed their parental cotton lines to contain the above genes. The stable hybrids produced are being marketed.

Rice

Private Sector Units

Mahyco, Mumbai is generating plants resistant to lepidopteran pests, bacterial blight and sucking pests using genes namely CrylAc, Xa21 and GNA genes

Mahyco Research Foundation, Hyderabad is generating  plants resistant to bacterial blight using Bacterial blight resistance conferring gene Xa-21

Hybrid Rice International, Guragaon is generating plants resistant to lepidopteran pests and herbicide tolerance using CrylA(b) and Cry9C for insect resistance and bar genes for herbicide tolerance.

Tomato

Private Sector Units

Indo-American Hybrid Seeds, Bangalore is generating plants resistant to viral and fungal diseases using Alfalfa glucanase and Tomato leaf curl virus genes.

Proagro PGS (India) Ltd, Guragaon is generating plants resistant to lepidopteran pests using gene CrylA(b)

Corn/Maize

Private Sector Units

MAHYCO, Mumbai is generating plants resistant to lepidopteran pests using CrylA(b) gene.

Syngenta India Ltd., Pune is also generating plants resistant to lepidopteran pests using gene CrylA(b)

Brinjal/Eggplant

Private Sector Units

Proagro PGS (India) Ltd, Guragaon is generating plants resistant to lepidopteran pests using Cry1A(b) gene.

Mustard

Private Sector Units

MAHYCO, Mumbai is generating plants tolerant to herbicide using gene CP4 EPSPS.

Proagro PGS (India) Ltd, Guragaon is developing superior hybrid cultiovars using genes like Bar, barnase and barstar.

Pigeonpea

Private Sector Units

Mahyco, Mumbai has started transformation work using selectable marker GUS gene.

Cauliflower & Cabbage

Private Sector Units

Proagro PGS (India) Ltd, Guragaon was experimenting to generate cauliflower & cabbage plants resistant to lepidopteran pests using CrylH/cry9C. They were also developing superior hybrid cultivars of cauliflower using Bar, barnase and barstar genes.

Source: Modified from Ghosh (2008)

 

Apart from the products and processes for making products, the biotech companies also come out with public outputs in the form of publications and patents. The following tables give an indication of such activities by some of the biotech companies.

 

Table 14: Publications by some Companies with interest in Biotechnology

S. No.

Name of the Firm

No. of Publications

Year

1

Bangalore Genei Pvt Ltd (GENEI)

5

1998-2005

2

Bharat Biotech International Ltd

10

2000-2005

3

Gland Pharma Ltd (GLAND)

4

2000-2001

4

Lupin Ltd

8

2002-2007

5

Nicholas Pirmal India Ltd

30

2007-2008

6

Wockhardt Ltd

850

1987-2008

7

Wyeth Ltd

4

1993-1997

8

Ranbaxy

250

1990-2008

9

Cipla Ltd

21

1987-2007

10

Jubilant Organosys Ltd

3

2003-2005

11

lupin LTd

8

2002-2007

12

Rallis India Ltd

23

2004-1991

13

USV Ltd

5

2006-2002

Source: Web of Science.

 

 

NOTE: Data for 2008 is incomplete

Source: Indian Patent Office site & Ekaswa C

 

The number of patents by Indian companies with interest in Biotechnology has increased significantly since 2004. This is partially due to the fact that the companies realise the need to patent in the post-WTO era and also the data need to be looked into for patents which may not be in the area of Biotechnology(as some of the companies in the list also have products by chemical/synthetic methods).

In addition to producing products and patenting/publishing they are reaching out to research organisations in the country as well as outside India for improving their competition. This they do through alliances and also through patenting in other countries where they believe they have markets. Some of the major players in this respect are Dr. Reddy’s, Ranbaxy, Wockhardt and Panacea Biotech. The following tables give an indication of collaboration with organisations with in India and abroad by these companies.

 

Table 15: Research Collaborations by Indian Biotech Companies (Indicative List)

Product

Institution

Industrial Partner

Streptokinase

Institute of Microbial Technology (Imtech) Chandigarh

Cadila, Bharat Biotech

Follicle stimulating hormone

Indian Institute of science(IISc), Bangalore

Cadila

Human growth hormane

Indian Institute of science, Bangalore

Shantha Biotechnics

Hepatitis B vaccine

M.S. University of Baroda (MSU) ICGEB, New Delhi

Biologocal E. Ltd (BE)

Epidermal growth factor

Center for Biotechnology, N.Delhi,  M.S. University of Baroda

Bharat Biotech, Biological E. Ltd

Source: DBT reports

 

Table 16: Indian companies having collaboration with foreign partners

Company

Product

Indication

Status

Partner

Biocon Ltd (Banglore)

h-R3 amto EGfR Mab

Head and neck cancer, brain cancer, non-small cell lung cancer(NSCLC)

lab

Biocon Biopharmaceuticals a joint venture of biocon and CIMAB (Havana Cuba) has licensed South Asian rights from CIMAB

h-T1 humanized anti CD-6 Mab

T cell lymphoma,rheumatoid arthritis (RA)poriasis

Ph II

Biocon Biopharmaceuticals has ex-latin America rights from CIMAB

q-T3 Chimeric anti-CD-3 Mab

Organ,transplant

Ph ii

Biocon Biopharmaceuticals has ex-latin America rights from CIMAB

EGF cancer vaccine

cancer

Ph II

Biocon Biopharmaceuticals has South Asia rights from CIMAB

TGFalpha

cancer

Ph II

Biocon Biopharmaceuticals has South Asia rights from CIMAB

HER1 cancer Vaccine

cancer

Ph II

Biocon Biopharmaceuticals has South Asia rights from CIMAB

ZYH1

Dyslipidemia

Perclin

ZYH2

Type II diabetes

Perclin

ZYH3

Dyslipidemia, diabetes

Perclin

Dr. Reddy's lab Ltd (Hyd)

DRF 2593(balaglitazone)PARAR Insulin sentisizer

Diabetes

Ph II

Licensed to novo Nordisk

DRF 1042 topoisomerase-I inhibitor

NSCLC,Colorectal cancer,ovarian cancer

Ph II

DRF-1644 topoisomerase-I inhibitor

cancer

Ph I

DRF 10945 PPAR alpha agonist

Dyslipidemia

Ph I

DRF10945 selective PPAR alpha agonist

Dyslipidemia

PhI

DRF 4158 selective PPAR alpha and gamma Agonist

Type II diabetes

perclin

Novartis discontinued development: Dr Reddy's evaluating

RUS 3108 perlevan inducer

Cardiovascular disorder

Preclin

DRF 11057 oxazolidinone molecule

Bacterial infections

perciln

DRL 11605

Metabolic disorders

Preclin

DRL13792 oxazolidionene molecule

Bacterial infections

Preclin

DRL5265

cancer

perclin

DRL13792

Bacterial infections

Perclin

Lupin Ltd (Mumbai)

Amigra

Migraine

Ph II

Desoris LLL-3348 Herbal compound

Psoriasis

IND field

Ranbaxy Laboratories Ltd (Delhi)

Parvosin RBx 2258 ala-adrenoceptor antagonist

Benign prostatic hyperplasis(BPH)

Ph II

Clafrinast RBX 7796 VLA 4 Antagonist

Allergic rhinitis,asthma

Ph II

Ranbezoild RBx 7644 oxazolidnone molecule

Bacterial infections

Ph I

RBx9001

BPH

IND field

RBx7643

Incontinence

Ind field

RBx4638

Respiratory

Perclin

RBx4467

Antifungal

Perclin

Source: Kumar A (2008)

 

Some of the public private partnerships that have been recently formed in the biotechnology area by companies in India gives an idea of the future direction in BT (See Table 16 for details).

 

Private Company Involved

Public Partners

Avesthagen

NCBS,  University of Agricultural Science, ICRISAT

Bangalore Genei

CCMB, IBA-ICAR

Bharat

DBT-AIIMS-NIH-CDC Atlanta-Stanford, ICGEB-AIIMS, IGIB

Bigtec

IMT

Biological E.(BE)

CCMB,IISC, ICGEB-AIIMS, CMC VELLORE.

CDC Linux

CRIS project team

Genotypic

IGIB, IISC, MADURAI KAMARAJ UNIVERSITY

IAHS

NRCPB

Ingenovis

IICT, CCMB

Monsanto

IISC, TERI

Nicholas Pirmal

IGIB

Rallis

ICGEB, IISC, MADURAI KAMARAJ UNIVERSITY

Shanta Biotechnics

Osamania University, CCMB,IISc, JNU, BARC, CCMB, AIIMS ,NII, IICB,

Anna University,  Tata Memorial Hospital, NDRI

SP Biotech Park

IICT, CCMB, CDFD

Strand Genomics

IISC

TCS

CSIR- NIMTLI project, CDFD

Themis

CDRI, IIT, IGIB

Wockhart

ICGEB

Xcyton

NIMHNS, IISC, ICGEB, AIIMS

Source: Various public sources, Annual reports of companies and different issues of Biospectrum

 

Apart from their activities in production, marketing and collaboration, the biotech industry in India also engages actively in participation in shaping policies for development of Biotechnology. They had been associated with resource allocation and prioritization by taking part in the committees and task forces for these purposes. Through the Association ABLE (Association of Biotech Led Enterprises) they have been able to communicate the problems faced by the industry and have helped in the formulation of the new Biotechnology policy. The industry’s influence has led to formation of new financing mechanisms like SBIRI and new single window regulatory body NBRA. Their active involvement has led to the coming up with a type of Bayh Dole Act for India. Their vocal expression of the quality of the manpower developed has been taken seriously and has been made one of the priority items in the new Biotechnology Policy.

 

 

 

Acknowledgement: Inputs by Ms. Himani Agarwal, Mr.Rohan Arora and Mr. Varun Satia in the form data collected from different sources are gratefully acknowledged.

 

 

 

 

 

References:

 

 

 

 

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