The document discusses the evolution and growth of India's biotechnology sector. Some key points: - India has emerged as a dominant player in biotechnology, growing at 30-35% annually and becoming the 12th largest destination globally. - The sector has grown from a small beginning 25 years ago when the Department of Biotechnology was established, to over 400 companies today employing hundreds of thousands. - Indian biotech companies have developed drugs for diseases like cancer and diabetes and produce vaccines at significantly lower costs than international markets. - The government has strongly supported the sector through funding, institutions, and a supportive regulatory environment. However, the regulatory process remains complex. - India has strengths in human resources

2. Introduction
 India, which has earned a name worldwide as the most preferred
destination for global Information Technology outsourcing and
software services firms, is gradually making a mark in another
high-tech sector – biotechnology.
 Biotechnology, the application of science and technology to
modify biological systems for specific uses, encompasses many
fields from biopharma to agri-bio and biofuels, to cite a few.
Several Indian companies have started inventing and producing
biotechnology-based drugs for diseases such as cancer and
diabetes .
 In 2006, India also ranked first in terms of growth in the
transgenic crops sector where it registered over 200 per cent
compared to the global average of 13 per cent.

3.  The industry – currently expanding at 37 per cent per annum – is
growing phenomenally, and this can easily be sustained. It is
projected to burgeon into a $11.6 billion sector by 2017.
 From a small beginning 25 years ago, the sector has emerged as a
dominant one providing employment to hundreds of thousands of
skilled and qualified people.
 Third largest in Asia pacific and 12th
Biotech destination in world..
 The 30-plus percent growth rate is faster than the worldwide
industry average. Exports in the sector increased by a massive 47
per cent.

4. Evolution of The Biotech Sector in India
 The following is a chronology of key events that have shaped the Indian
Biotech Sector:
1942 NEW DELHI: India's largest research and development organization;
The Council of Scientific and Industrial Research (CSIR) is established.
1978 BANGALORE: The country’s first biotech company BIOCON is
established-for industrial enzymes and later biotherapeutics.
1981 HYDERABAD: Center for Cellular & Molecular Biology (CCMB)- for DNA & r-
DNA based research.
1984 CHANDIGARH: Institute for Microbial Technology,(IMTECH)- for R&D in
microbial bio-processing.
1986 NEW DELHI: Department of Biotechnology (DBT), set up by
Government of India-for promoting modern biology and biotechnology at
academic and industry levels.
1987 NEW DELHI: National Institute of Immunology (NII) set up by DBT- for
immunology research.
1989 BANGALORE: BANGALORE GENEI starts operations- to produce
restriction enzymes & other tools for DNA based R&D.

5. 1991 BANGALORE: National Center for Biological Sciences (NCBS)- to pursue R&D in
molecular biology.
1994 BANGALORE: Syngene International (Promoted by Biocon)- to offer R&D services in
drug discovery based modern biology.
1997 NEW DELHI: Center for Biochemical Technology (CBT)- to focus on
Bioinformatics and Genomics.
1997 HYDERABAD: Shantha Biotech launches India’s first recombinant
product, Hep B vaccine.
1998 BANGALORE: Monsanto research establishes an R&D center at IISc for plant
genomics.
1998 NEW DELHI: DBT approves Mahyco-Monsanto to conduct Bt cotton trials.
1999 BANGALORE: NCBS scientist sets up AVESTHAGEN a plant
genomics company.
2000 BANGALORE: Country’s first Bio informatics company Strand
Genomics formed by four IISc professors.
2000 NEW DELHI: GENOMED country’s first JV between Institute (CBT)
&Industry (Nicholas Piramal)- to pursue pharmaco-genomics.
2001 Reliance sets up Reliance Life Sciences to pursue stem cell based
research and product development.
2001 MUMBAI: GEAC approves Wockhardt’s EPO.

6. 2002 BANGALORE: Institute of Bioinformatics & Applied Biotechnology, IBAB, a
jointly funded initiative between the Government of Karnataka & ICICI
commences academic program.
2002 GEAC approves Bt cotton for commercial planting.
2002 HYDERABAD: GEAC approves Shantha Biotech’s Interferon Alpha 2b.
2003 Gujarat government announces Biotech Venture Capital Fund
Wockhardt launched Wosulin (rDNA human insulin) and Biovac -B
(hepatitis B Vaccine) and Wepox (Erythropoitin) Strand Genomics
launched Avadis 2.0
2004 Biocon rollout with its public issue Ocimum Biosolution entered into
partnership with Genome Exploration of US.
2005 The introduction of the Product Patent regime in India mandated by the
WTO and TRIPS.

7. HUMAN RESOURCE
 India’s rich human capital is believed to be the
strongest asset for this knowledge-led industry. An English
speaking skill base comprising 3 million graduates, 700,000
postgraduates & 1500 PhDs qualify in biosciences and
engineering each year.
A large percentage opt for overseas opportunities. It is
estimated that 10% of researchers and 15% of scientists
engaged in Pharma/Biotech R&D in USA are of Indian origin.
 A services model ensures large levels of gainful
employment. The current employment statistics indicate
approximately 15,000 scientists in the Indian Biotech
sector of which 5000 are harnessed.

8. Institutions Identified as national Centres of Excellence

9. Biotech Focused Research Institutes

10. Bioinformatics
 Many companies have entered into contractual
arrangements for data management and development of
customized data mining software for several customers.
 These include-
Strand genomics, Kshema Technologies, Bigtec ,CDC Linux,
Jubilant Biosys and Molecular Connections.
 US companies like Affymax, Monsanto and others have also
established informatics divisions in India to take advantage
of low cost software development skills.

11. Riding the wave of Innovation
 According to a report by Ernst & Young titled “On the Threshold: The Asia Pacific
Perspective Global Biotechnology Report”, India now has the twelfth most successful
biotechnology sector in the world as measured by the number of companies. If the current
rapid pace of progress of the health biotechnology industry is any indicator, India holds
great promise at the national and international level in producing innovative drugs at a
cheaper price.
 Indian pharmaceutical and biotechnology companies are impacting the global health care
sector through affordable innovative drugs. While one dose of R-human insulin is priced in
the international market at $30 for 100 IU vials, the average Indian price per dose is $6.50,
an 80 per cent difference in price.
 Similarly, EGFR antibody costs $25,000 per treatment in the international market while the
same in India is $6,000 per treatment. Also, as against $150 per vial of Recombinant
Streptokinase in the global market, it is priced at $10 per vial in the Indian market, a 95 per
cent difference in price.

13. BIO-ENABLERS: THE POLICY FRONT
 The Indian Government had the foresight to identify Biotechnology
as a thrust sector for development in 1986 when it set up the
Department of Biotechnology (DBT) as a nodal agency for policy
making and development.
 Initially, the DBT focused on generating trained manpower &
infrastructure development. Over the years it has extended its reach
to other areas of focus such as genomics, proteomics, transgenics,
stem cell research and product development.

14. BUDGETRY ALLOCATION
 The budgetary allocation to Biotechnology has
increased from $ 150 million during the first phase,
1987-1988, to $300 million in the fiscal year 1997-
1998, $ 500 million in the fiscal year 2002-2003, $580
million in 2006-2007.
 The ministry of science & technology also plans to
introduce additional venture Capital funds in line with
its technology development fund (TDF) to promote
small and medium biotech enterprises.

15. Administrative organization of the main public agencies involved
in the funding of public research

16. IP Protection
 Since January 1st 2005 a new patent law came into effect, which
brings India in line with the World Trade Organization (WTO)
rules. Now, Indian companies have to honor international patents
and stop producing unlicensed generic drugs, which was a major
source of revenues over the past 30 years.
 Finally, there are concerns in India about the patenting of its
natural products. In 2004, for instance, Monsanto, an American
bio-agricultural company was granted a patent on “Chapati” from
the European Patent Office.
 “Chapati” bread has been used in the Indian society since
thousands of years and for many Indians it is unfortunate that
American and European patent authorities continue to grant
patents on indigenous products.

17. Regulatory Issues
 The regulatory environment is still evolving and most
biotechnology companies consider the uncertain and costly
process of regulatory approval as the biggest obstacle for the
development of the industry in India.
 Currently, at least 3-4 regulatory bodies [Recombinant DNA
Appraisal Committee (RDAC), Regulatory Committee on Genetic
Manipulation (RCGM), Genetic Engineering Approval Committee
(GEAC)]are involved in the approval process which for instance
delayed Shanta Biotech’s introduction of its Streptokinase
product by 10 months.
 The government has recognized the problem and plans to create
a single national biotechnology authority in which it wants to
merge all relevant bodies. Moreover, the government aims to
conduct biosafety tests more efficiently. In future, if an event
has been tested (e.g. allergenic test) it does not have to be
retested in a different background.

18. Ethical Issues
 The Indian public is generally more opened minded towards technological advances
than other societies as the progress in the past decades is credited to the application
of new technologies. Nevertheless, India being the birthplace of several religions is
concerned with the impact of a technology that enables the physiological
manipulation of living organisms.
 Stem cell research is the most controversial biotechnology application. India is one of
the few countries in the world that is supportive of stem cell research and there are
already 15 laboratories working on stem cells. Thus, under certain conditions and with
the approval of the Department of Biotechnology stem cell research is generally
allowed.
 The Indian law allows stem cell research for therapeutic cloning, but prohibits
reproductive cloning. Moreover, research based on stem cells derived from adults,
bone marrow or fetal cord blood can only be undertaken after the donor has given
informed consent and within specific safety measures.
 Currently, the Indian Council of Medical Research and the Department of
Biotechnology are developing guidelines and rules for stem cell research. Those
guidelines will later be communicated to scientists in workshops.

19. Present Status
 A comprehensive survey conducted by the Confederation of Indian
Industry, CII, indicates that there are currently 160 registered
Biotechnology companies in the country.
 Of these60 are distinctly engaged in molecular and recombinant
biotechnology.
 More than 50% of these companies are located in Bangalore, and
Hyderabad.
 75% of these companies have been established in the last 5 years.

20. Segmentation of Indian Biotech Sector

21. Strengths & Opportunities of Indian Biotechnology
Strengths
 Human Resource: Trained manpower and
knowledge base.
 Academic Resource: Good network of
research laboratories.
 Industry Base: Well developed base
industries.
 International Experts: Access to intellectual
resources of NRIs in this area.
 Clinical Capability: Extensive clinical trials and
research-access to vast & diverse disease
populations.
 Bio-Diversity: India’s human gene pools and
unique plant, animal & microbial diversity
offer an exciting opportunity for genomic
research.
 Stem Cells Research: Several labs have
commenced research in stem cells and have
valuable stem cell lines.
Opportunities
 Large domestic market.
 Large export potential.
 Low cost research base for international
companies due to rising cost of R&D abroad.
 Vast and diverse disease based patient
populations provide unique opportunities for
clinical research and clinical trials.
 Supportive Government Policy on embryonic
stem cells research provides a useful
opportunity for international companies to
pursue such research in India.
 Human Biodiversity provides unique research
opportunities in Genomics.
 Plant & Microbial bio-diversity provides vast
prospecting opportunities for new drugs.
 Conducive Government policy on GM crops
provides useful opportunities for Agri-
Biotech .

22. Fellowships for higher studies in India:
 DST SC Bose fellowship
 CSIR Jawahar Lal Nehru Post Doctoral Fellowship
 UGC Dr. D.S. Kothari Post Doctoral fellowship
 DST young scientist Award (SERC Division)
 DST Woman Scientist fellowship
 DBT Post Doctoral Fellowship
 CSIR Research Associate scholarship
 K.S. Krishnan Research fellowship BARC
 UGC SAARC Fellowship
 Rajiv Gandhi Science Talent research fellowship
 JRF/SRF awarded by – UGC, CSIR, DBT, ICMR, ICAR
 Junior research scholarship for cancer biology TATA memorial centre
and TATA memorial hospital.
 Homi Bhaha centre for science education scholarship

23. Fellowships for higher studies in Foreign countries:
1. DAAD Fellowship: Indo German Fellowship for Ph.D. and Post
Doctorate students
2. JSPS Fellowship: Indo- Japanese fellowship for Post Doctorate
students
3. Jawahar Lal Nehru Full bright Fellowship: Indo- US fellowship for
PhD and Post Doctorate students.
4. Turkish Biotech/Agriculture research for pursuing Ph.D. in Turkey
5. DBT-TWAS Biotechnology fellowship for Post Doctorate Research
Overseas
6. Belgium Govt. Scholarship from External Division ministry of Human
Resource and Development

24. “Gene Meyers” Jr. V.P of Celera Genomics refers research in
informatics as a “TSUNAMI OF INFORMATION ”.The race and
competition will be who can mine it best. There will be such a wealth
of riches.
Future of Biotechnology is exciting with developments & advances in
(a) Stem cell research
(b) Gene Therapy
(c) Gene Cloning
(d) DNA Computing
in next few years.

25. Applications of Biotechnology in
Human Welfare
 Biotechnology is in news due to its sustaining and disrupting
innovations resulting in displacing existing technology.
 Biotech turnover in the country is 4 billion US dollars (2.2
billion US $ by exports), involving around 400 Biotech
companies.
 Applications of silk in drug delivery, wound healing, wound
dressing and cosmetics.
 Use of silk fibres as biomaterials in military as sutures for
wound ligations etc.
 Spider silk expressed in Bombyx mori-rubber like elasticity
and steel like strength

26. Applications of Biotechnology in
Human Welfare
 Silk fibre based biomaterials- Lifesaving constructs, in
1. Tissue engineering-silk scaffolds to develop ligament, bone,
cartilage tissue constructs and other innovative biomaterials.
2. As implantable flexible optical and electronic devices.
3. As silk based brain implant.
4. Silk implants for measuring electrical activity produced by
the heart and brain, and for monitoring nerve and skeletal
muscle activity.
5. For drug delivery or electrical stimulations, on-line imaging
and continuous monitoring of health.

27. Applications of Biotechnology in
Human Welfare
 Herbal drugs- Potent promise
 Combinations of different components in a herbal extract
interact with multiple sites and targets of a disease to
achieve synergistic therapeutic responses.
 DBT funded collaborative programs for use of herbal drugs
as anti-Dengue, anti-TB, anti-diabetic etc
 Need for Herbalnomic- as a system science that incorporate
mechanism of action and biomarker based research on
holistic herbal medicines.

28. Applications of Biotechnology in
Human Welfare
 Biotechnology in Food security and Society
 For ensuring nutritional adequacy for a population of more
than six billion.
 Nutrition security implies awareness and access at
affordable cost to-
1. Food security (Balanced diet
2. Safe drinking water
3. Disease-free environment
4. Healthcare outreach
5. Dietary diversification to enhance micronutrient security
6. Food fortification
7. Biofortification-seed based approach

29. Applications of Biotechnology in
Human Welfare
 Molecular breeding for crop improvement-
Harnessing the genes
 Use of MAS (Marker Assisted Selection) over conventional
plant breeding
 Pyramiding of genes using MAS- for more than one traits of
interest

30. Applications of Biotechnology in
Human Welfare
 Applications of nanoparticles- as nanotubes and
nanowires
1. Fluorescent biological labels
2. Drug and gene delivery
3. Biodetection of pathogens
4. Tissue engineering-Nanocrystalline silicon carbide-for heart
valve implants and Nanocyrstalline Zirconia as orthopedic
implant.
5. Tumour destruction via heating
6. Separation and purification of biological molecules and cells

31. Applications of Biotechnology in
Human Welfare
 New Technologies in Environmental Protection
 Replacement for petrochemicals (Hydrogen fuel)
 Reversal of global warming
 Biodegradable plastics-Alcaligenes eutrophus
 Biodesulphurisation-Thiobacillus ferroxidans

32. Conclusion
 The Indian Biotechnology industry has an interesting “
de-risked” model based on services and generic
products which has enabled the sector to earn early
revenues and even profits.
 The “Learn While you Earn” approach has helped to
develop globally competitive skills and good research
infrastructure.
 Emerging amendments in the IPR Regime, Clinical
Testing Legislation and the Biodiversity Bill all point to
an accelerated pace of growth and to a prosperous
future for this emerging sector of Biotechnology.

33. THANKS