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.

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.

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.

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.

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.

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.

Institutions Identified as national Centres of Excellence

Biotech Focused Research Institutes

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.

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.

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.

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.

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

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.

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.

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.

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.

Segmentation of Indian Biotech Sector

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 .

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

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

“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.

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

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.

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.

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

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

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

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

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.

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