Production Unit for Molecular Biology Enzymes & Applied Bio- Systems Product. Biotechnology. Government of Gujarat

Transcription

1 Production Unit for Molecular Biology Enzymes & Applied Bio- Systems Product Biotechnology Government of Gujarat

2 Contents Project Concept 3 Market Potential 5 Growth Drivers 6 Gujarat Competitive Advantage 8 Project Information 10 - Location/ Size - Infrastructure Availability/ Connectivity - Raw Material/ Manpower - Key Players/ Machinery Suppliers - Key Technologies - Intellectual Property Project Financials 16 Approvals & Incentives 17 Key Department Contacts 18 Page 2

3 Project Concept The concept The project envisages setting up a production unit catering Molecular Biology Enzymes & Applied Bio-Systems Product such as DNA sequencing kit, RNA sequencing, PCR Assays, etc. and technology transfer. Key DNA Sequencing methods Whole-Genome Sequencing Targeted Resequencing ChIP Sequencing Key RNA Sequencing methods mrna Sequencing Total RNA Sequencing Targeted RNA Sequencing RNA Exome Capture Sequencing Small RNA Sequencing Ribosome Profiling Ultra Low Input and Single Cell RNA Sequencing Widely used molecular and diagnostic biology enzymes TAQ Polymerase Restriction Enzymes Reverse Transcriptase Peroxidases Endonucleases Ligases Page 3

4 Project Concept Molecular biology enzymes Enzymes are macromolecular biological catalysts. They accelerate, or catalyze, chemical reactions. Nucleic acids used for molecular cloning can be of natural or synthetic origin, and their length ranges from a few to several thousands nucleotides. Nucleic acids can be extensively manipulated, in order to acquire specific characteristics and properties. Such manipulations include: propagation (catalysed by polymerases) ligation (catalysed by ligases) digestion (catalysed by ligases) addition of modifying groups such as phosphate or methyl groups (catalysed by methylases) Some of the key enzymes used in molecular cloning (also known as molecular biology enzymes) are: DNA polymerases are enzymes that catalyze the formation of polymers made by the assembly of multiple structural units or deoxyribo-nucleotides triphosphate (dntps). Key DNA polymerases used in molecular biology include Taq polymerase, Pol I, Pol II and Pol III. The DNA polymerases only add nucleotides to the 3 -OH end of a pre-existing primer containing a 5 -phosphate group. Primers are short stretches of RNA complementary to about 10 nucleotides of DNA at the 5 end of the molecule to replicate. Reverse transcriptases are enzymes that are used to generate complementary DNA (cdna) from an RNA template, a process termed reverse transcription. It is mainly associated with retroviruses. However, non-retroviruses also use RT (for example, the hepatitis B virus, a member of the Hepadnaviridae, which are dsdna-rt viruses, while retroviruses are ssrna viruses). Non-viral reverse transcriptases include transposons and telomerases. DNA-dependent RNA polymerases catalyze the 5 3 elongation of RNA copies from DNA templates, a process called transcription. Like DNA polymerases that lack proofreading exonuclease activity, RNA polymerases can add an extra base at the end of a transcript. The two main RNA polymerases used in molecular biology are SP6- and T7- RNA polymerases Restriction endonuclease are enzymes cut DNA at or near specific recognition nucleotide sequences known as restriction sites. Naturally occurring restriction endonucleases are categorized into four groups (Types I, II III, and IV) based on their composition and enzyme cofactor requirements, the nature of their target sequence, and the position of their DNA cleavage site relative to the target sequence Page 4

5 Market Potential Global trends Global molecular biology enzymes, kits & reagents market (US$b) Source: Markets and Markets Growth in molecular biology enzymes, kits & reagents market can be attributed to the technological advancements in the life science industry, increased research activities in the pharmaceutical and biotechnology sector, rising incidences of infectious diseases and genetic disorders as well as successful completion of human genome project. It can also be attributed to the significant growth expected in the global molecular diagnostics market (expected to reach USD 10.8 billion by 2020) North America is expected to account for the largest share of the molecular biology enzymes and kits & reagents market in Factors such as increasing research funding in applied markets; rising number of pharmaceutical & biotechnology companies; increasing prevalence of conditions involving molecular diagnostics, backed by reimbursement in the U.S.; and investments into research projects in Canada. The Asia-Pacific region is expected to grow at the highest CAGR during the forecast period. The high growth of this region can be attributed to increasing government interest in biomedical and biotechnology industries in China, presence of bioclusters in China, outsourcing of clinical research activities in China, conferences & meetings in Japan. Growing pharmaceutical industry backed by government initiatives in India, development of bioclusters in India, Korea-U.S. free trade agreement, and initiatives by non-profit organizations in Asia-Pacific. India,currently, has a marginal share in the global market for molecular biology enzymes. Hence, there is an opportunity in focused R&D and knowledge-based innovation in the field. Estimates of the market size for next generation diagnostics (including molecular diagnostics) in India in 2014 varied from INR crores. The market is expected to reach between INR crores by 2018.This is likely to significantly increase the demand for molecular biology enzymes in India. Page 5

6 Growth Drivers Increasing aging population Increased healthcare spending and demand for improved home care diagnostics It is estimated that the size of elderly population in India is set to rise from 98.9 million in 2015 to ~168million by With the rise in aging population, the incidence of infectious diseases, autoimmunity, and cancer also increases, resulting in demand of diagnostics. This, in turn, would increase the demand for molecular biology enzymes. The healthcare industry has observed a significant shift from hospital care to home healthcare. There is an urgent need to develop rapid and accurate home diagnostics as well as point-of-care tests for widely prevent communicable diseases (like tuberculosis, malaria, dengue and hepatitis B&C). There is a huge scope of enhancing healthcare services considering the low healthcare spending as a percentage of GDP of just 4.2% in India as compared to 10.6% globally in Rising demand of accurate diagnostic technology for chronic diseases Non-communicable diseases such as cardiovascular disease, diabetes, cancer and chronic obstructive pulmonary disease currently account for 53% of the total deaths in India and are expected to account for 67% of total deaths by For such diseases, recent advances in diagnostic microarrays would be helpful in genotyping and determination of diseaserelevant genes, mutation analysis, SNP (single nucleotide polymorphism) screening. This, in turn, would increase the demand for molecular biology enzymes utilized in genotyping. Increasing focus on genomics research Cost-effectiveness India already hosts several genomics research institutes, such as the Institute of Genomics and Integrative Biology (IGIB) and the National Institute of Plant Genome Research and the National Institute of Biomedical Genomics. Department of Biotechnology aims to create five more such centres, as well as several centres of excellence based on narrower, high-priority areas such as genetically modified organisms, vaccines and marine bioproducts India has the potential to evolve into an exporter for diagnostics testing. It is estimated that specialized tests like molecular diagnostics or hormone related tests cost 70-80% less in India than in US. This would have a positive impact on the molecular biology enzymes market. Innovation ecosystem The Indian Government has declared as the 'Decade of Innovation' recognizing the importance of innovation in driving economic growth, employment and competitiveness. The Government has created a public-private partnership (PPP) fund of US$ million to involve the private sector in R&D, especially in the fields of vaccines, drugs and pharmaceuticals. Page 6

7 Growth Drivers Government initiatives to promote molecular biology enzymes The Government of India has decided to increase health expenditure to 2.5 per cent of gross domestic product (GDP) by the end of the Twelfth Five Year Plan ( ), from the existing 1.4 per cent. FDI inflows into hospitals and diagnostic centres, and medical appliances stood at USD1.44 billion and USD0.6 billion respectively, during April September per cent foreign direct investment (FDI) is permitted for all health related services under the automatic route Custom duty on life-saving equipment has been reduced to 5 per cent from 25 per cent and exempted from countervailing duty Import duty on medical equipment has been reduced to 7.5 per cent Hospitals with at least 100 beds are eligible for 150 per cent deduction for capital expenditure; other measures include exemption of service tax There are several government institutes involved in genomics research, such as Institute of Genomics and Integrative Biology (IGIB),National Institute of Plant Genome Research and the National Institute of Biomedical Genomics. The Department of Biotechnology further aims to create five more such centres, as well as several centres of excellence. Indian geneticists have previously discovered mutations in breast-cancer genes that are unique to the Indian population and sequenced the genomes of several crops, including chickpea. The DBT s strategy aims to train researchers in the scanning and analysis of large numbers of genomes. The strategy also aims to create 150 technology-transfer organizations to help to commercialize discoveries made in publicly funded research laboratories, together with 40 technology and business incubators, which will provide equipment and guidance for new firms, and facilitate networking opportunities. Page 7

8 Gujarat - Competitive Advantage Gujarat Biotechnology Overview Gujarat hosts more than 154 companies across pharmaceuticals and healthcare biotechnology, agriculture biotechnology, industrial biotechnology, bio-informatics and environmental biotechnology with turnover of over USD million Prominent biotech companies include ZydusCadila, Concord biotech, Cadila Pharmaceuticals, Maps India and Intas, Nanobiosym,Stemcyte Technology, Alexendria Real Estate Equities Inc., Asia Pacific Bioinformatics Network and Progeniq Pvt.Ltd. Biotech clusters-gujarat Biotech planned infrastructure-gujarat Zones Ahmedabad-Surendranagar (Biopharma) Jamnagar-Dwarka-Porbandar (Marine Biotech) Vadodara-Anand-Nadiad (Food processing) Vapi-Surat-Bharuch-Ankleshwar (Biochemical) Junagadh-Bhavnagar-Banaskantha-Mehsana (Agri) Industrial Parks Vadodara (Industrial Park) Anand (Food & Biotech Park) Jamnagar/ Bhavnagar (Marine Biotech Park) Gandhinagar/ Mehsana (Agri Biotech Park) Page 8

9 Gujarat - Competitive Advantage With the pioneering Gujarat Genomic initiative, Gujarat is at the forefront of genomics and molecular biology research The Gujarat State Biotechnology Mission (GSBTM) has established Gujarat Genomic initiative (GGI). GGI is a multi-unit, multi-disciplinary, multi-institutional initiative and an umbrella program of state government which involves participation of faculty, students, scientists and biotechnology industries. It has been developed based on multi-institutional efforts and would involve key state government organizations including Gujarat State Biotechnology Mission, DST, Government of Gujarat, Directorate of Forensic Science (DFS), Government of Gujarat(GOG) and Gujarat Forest Department. Overall, the Govt of Gujarat has undertaken more than 32 genomic initiatives, with significant investment. With rich biodiversity, Gujarat is one of the 34 biodiversity hotspots of the world. The state has over 2000 species of plants and more than 2700 species of animals. Other competitive advantages Page 9 Biotechnology has been identified as one of the key sectors for investment in Gujarat. 53 Biotech companies have committed to invest INR 1800 cr between in Gujarat More than 20 companies/institutes have collaborated with the Gujarat State Biotechnology Mission (GSTM) Ease of Doing Business Gujarat ranks 1 st in ease of doing business as per World Bank Report 2015; Also ranks fairly high in individual parameters such as setting up a business, allotment of land and obtaining a construction permit Flourishing Economy Gujarat s SDP (State Domestic Product) rose by 12% during ; Contributes 7.2% of the nation s GDP and shows leadership in many areas of manufacturing and infrastructure sectors Education (Skilled manpower) The unique combination of technical training institutions coupled with leading management institutions have been able to constantly churn out well trained professional workforce to meet industry demands. Over 30 different subjects heads in 25 different universities spread over about 30 towns all over the state of Gujarat. Nearly 11 universities, 70 colleges and 18 institutes are engaged in research in different areas of Biotechnology. Industries are mainly engaged in application based research, product development and contract research Strategic location and excellent infrastructure Located on the west coast of India, Gujarat is well connected to the major cities of the world by air and sea routes. It has 42 ports, 12 domestic airports and 1 international airport in addition to an extensive rail and road network.

10 Project Information Project location Following sites are proposed for the development of the glucose monitoring devices facility in Gujarat: Suggested locations Sanand Vadodara Ahmedabad Sanand Ahmedabad Vadodara Highlights of proposed plant for manufacturing of DNA sequencing kit Location Gujarat Land 10,000 square feet Laboratory space 6,000 square feet Office and miscellaneous space 4,000 square feet Total Investment INR 80 crore Employees The proposed facility will focus on manufacturing of reagents (enzyme fermentation and purification) and DNA sequencing kits. Page 10

11 Infrastructure Availability Infrastructure availability Gujarat has an extensive outlay of robust physical, social and industrial infrastructure, Logistics & connectivity which makes it an excellent investment destination. Rail Road Gujarat has a total railway length of 5,257 km (8.25% of India) Mumbai-Ahmedabad bullet train project planned with investment of US$16.58b Ahmedabad metro rail project construction to begin in with US$101.3m budget Govt of Gujarat further plans to invest US$1.65m in regional rail projects Gujarat has a wide road network of around 77,030 km. Of these, 95% roads are surfaced, all-weather roads. In budget, the state government further plans to invest US$8.3m in a four-lane road joining Vadodara- Ankleshwar,US$2.7m in construction of expressways and US$81.4m in resurfacing roads Air Port The state has 18 domestic airports (the highest in any state) and one international airport. During , the Ahmedabad airport handled 59,313 thousand tonnes of freight. Freight traffic at Vadodara and Rajkot measured 966 tonnes and 79 tonnes respectively during April-September, Utilities The state has one of the strongest port infrastructures in India, with 42 ports(21% of India s ports are in Gujarat), including one major port at Kandla and 41 minor ports, along a 1,600 km coastline. It is the first state in India to take up port privatisation. Gujarat Maritime Board, has developed port privatisation models such as private/joint sector ports, private/captive jetties Water Power Gujarat has a state-wide water supply grid spread across 1,20,769 km that aims to serve 75% of Gujarat s population. In the state budget for , US$83m was allocated for bulk water supply schemes and US$574m was allocated for improving the infrastructure of existing water supply systems Gujarat has 24-hour 3-phase uninterrupted power supply throughout the state, with installed power capacity of 29,293 MW(10.38% of India s overall power capacity) The state has surplus power to the tune of 2000 MW Page 11

12 Project Information Materials and reagents for TAQ polymerase Dialysis tubing cellulose membrane Dextrose NP40 Pre - lysis buffer E.coli strain Tris - HCl (ph 7.9) Lysozyme Storage buffer Ammonium sulfate M EDTA (ph 8.0) Glycerol TAQ buffer IPTG KCl Triton-X 100 MgCl 2 solution Ampicillin PMSF Lysis buffer Flasks (NH 4 ) 2 SO 4 Tween 20 Buffer A Materials and reagents for Restriction enzyme Centriguge and Oakbridge tubes B. badius strain and B. lentus strain puc18, pbr322 and Φ 174 DNAs Standard protein molecular weight markers Restriction buffers A, B, C, E and L DNA ladder Key players Sigma Aldrich Beckman Coulter Hoffmann-la Roche Illumina GE Lifesciences Agilent Technologies Thermo fisher scientific Merck KGaA Promega New England Biolabs, Inc. Bioline Promega Takara Bio Inc QIAGEN N.V Becton, Dickinson and Company Key raw material/ component suppliers Genemed Biotechnologies, Inc Minerva Biolabs Alpha Laboratories MBI Fermentas Ocimum Biosolutions Strand Life Bangalore Genei Molecular Connections Page 12

13 Project Information TAQ Polymerase isolation Cloning and isolation of TAQ Polymerase using pet expression Bacterial strains and 1 2 plasmids Amplification of TAQ DNA Polymerase gene E. coli XL1-Blue strain and pet 15b plasmid to be procured. Recombinant TaqpTZ57R plasmid to be purified using High Pure Plasmid Isolation Kit Recombinant Taq-pTZ57R plasmid to be utilized as the template for PCR amplification of Taq DNA polymerase gene. 1 3 Cloning of Taq DNA polymerase gene into expression vector 4 Ligation The amplified Taq polymerase gene to be digested with restriction enzymes. Vector to be digested using restriction enzymes. Electrophoresis and extraction from the agrose gel using QIA Quick Gel Extraction Kit Expression of Taq 5 polymerase gene 6 Ligation to be performed using DNA insert (30 ng), 14 ng vector, 1units of ligase enzyme, 1X ligase buffer. The reaction mixture to be incubated overnight at 16 C. The ligated mixture to be used for the transformation of E. coli XL1-Blue and BL21 (DE3) CaCl2 treated competent cells using heat shock method Purification and electophorsis of Taq polymerase enzyme Overnight cultures of the recombinant E. coli BL21 (DE3) / rpet-15b plasmids to be cultured overnight in LB medium containing ampicillin (100 μg/ml). Induction of Taq DNA polymerase to be performed using different concentrations of IPTG and samples to be shook, when the bacteria reach their semigrowth phase Enzyme purification to be accomplished by the Desai Method. A 12% polyacrylamide gel to be used for electrophoresis and Coomassie blue R- 250 (0.1 %) to be used for gel staining. 7 Western Blotting 8 Measurement of Taq DNA polymerase enzyme activity After electrophoresis, proteins to be transferred into nitrocellulose membrane. The cloned gene would be placed into pet15b vector with a poly His sequence attached to its 5 end, anti His antibody and ECL method to be used for the detection of the produced Taq DNA polymerase enzyme Notes Determination of the enzyme activity using PCR with reagents containing produced Taq DNA polymerase, genomic DNA of Bacillus subtilis, and primers for the amplification of the lipase gene. 1. PCR amplification to be performed using the following reagents: 1 X PCR reaction buffer (50 mm KCl, 20 mm Tris- HCl (PH 8.4), primers (each 2.5 μm), 3 mm MgCl2, 0.5 mm dntps, 0.4 μg template DNA, 1X Q solution, 5 Unit Taq polymeras (QIAGEN, Germany), with a final reaction volume was 50 μl. PCR cycles as follows: One cycle of 5 min at 94 C, 35 cycles of: l min at 94 C, 2 min at 55 C, 3 min 72 C, and one cycle of 20 min at 72 C. Page 13

14 Project Information Restriction enzymes isolation Isolation and purification of type II restriction enzymes Bacterial strains and 1 2 plasmids Restriction enzyme purification: Step 1 B. badius strain 1458 and B. lentus strain 1689 to be procured from MTCC culture collection from IMTECH, Chandigarh Bacterial cells to be suspended in 100 ml Buffer A (10 mm sodium phosphate buffer ph 7.4, 1 mm EDTA, 10% glycerol, 5 mm b- mercaptoethanol and 100 mm NaCl) and disrupted by sonication. 1 3 Restriction enzyme purification: Step 2 4 Restriction enzyme purification: Step 3 After sonication, the slurry was centrifuged at g for 2 h at 41C. The supernatant was collected and subjected to 70% ammonium sulphate precipitation and incubated for 1 h at 4 degrees C. The contents to be centrifuged at 8000g for 10 min. The pellet to be pooled and resuspended in Buffer A and applied to phoshocellulose column, preequilibrated with buffer A containing 0.1 M NaCl Restriction enzyme 5 purification: Step 4 6 SDS PAGE Analysis Active fractions to be pooled and dialyzed against buffer B 2 overnight at 4 degrees C. The supernatant to be applied to heparin-sepharose column. The endonuclease to be eluted at M NaCl. The active fractions to be pooled and dialyzed against buffer B containing 50% glycerol and stored at 20 degrees C. Purity of the fractions to be analyzed on 10% SDS-PAGE. Restriction endonuclease 7 assay 8 Biochemical assays for optimization of reaction conditions Chromatography fractions to be assayed for restriction endonucleases activity by incubation at 37 degrees C in restriction buffer using 0.5mg ml1 of puc18, pbr322 or F174 DNA as substrates and 1ml (12 16mg) of purified enzyme in total volume of 25ml for 90 min Notes In order to optimize reaction conditions, assays with different enzyme amounts to be tested in order to determine a range of experimental conditions resulting in a consistent pattern showing complete digestion 1. Sonication: 10 cycles of 2 min each with an interval of 5 min. 2. Buffer B: 10 mm Tris-HCl ph 7.5, 0.1 mm EDTA, 10% glycerol, 5 mm b-mercaptoethanol and 100 mm NaCl 3. Restriction buffer: 10 mm Tris HCl ph 8.0, 10 mm MgCl2, 1 mm dithiotheritol,0.1 mg ml1 bovine serum albumin, 0.1 M NaCl) Page 14

15 Project Information Intellectual Property There is a vast amount of intellectual property revolving around DNA TAQ polymerases and restriction endonucleases. Some of the pertinent patents/ patent applications have been listed below: SN Title ( Patent/ Application No) Applicant 1 Thermostable Taq polymerase fragment (US ) Roche Diagnostics Compositions for increasing polypeptide stability and activity, and related methods (IN5145DEN2012) Taq polymerase sequences useful for incorporating analogs of nucleoside triphosphates (US ) Polymerase compositions and methods of making and using same (US ) DNA polymerase mutants having enhanced template discrimination activity (AU ) Solis biodyne oü Gaucher Eric Life Technologies Corp Integrated DNA tech Inc 6 Restriction Endonucleases and Their Uses (US ) Thermo Fischer Scientific 7 High fidelity restriction endonucleases (JP ) New England Biolabs Inc 8 Method for manufacturing restriction enzymes from Bifidobacteria (US ) Kabushiki Kaisha Yakult Honsha 9 CspCI restriction endonuclease (US ) New England Biolabs Inc Method for cloning and producing the AatII restriction endonuclease and methylase (EP ) Methods for rapid production of double-stranded target DNA ( ) Methods for nucleic acid assembly and high throughput sequencing (US ) New England Biolabs Inc Sussman et al Gen9 Inc Potential collaboration opportunities The list is non-exhaustive. For more details please refer to provided source Source: Biotechnology Industry Research Assistance Council (BIRAC), New Delhi National Centre for Cell Science, Pune Centre for DNA Fingerprinting and Diagnostics, Hyderabad Institute of Life Sciences, Bhubaneshwar Indian Institute of Science, Bangalore - The centre has developed some software s for structural biology (such as CSSP, MIPS, FAIR and SSMBS). Others - University of Pune, IBAB Bangalore and Pondicherry University. Page 15

16 Project Financials Estimated project cost 1 2 Project components & specifications Land and building cost (Land: 10,000 square 4000 per square meter) Cost of other fixed assets (Technology, R&D, Software, Furniture & Fixture, Vehicles, Office Equipment, Computers, etc.) Cost (INR crore) Preliminary & pre-operative expenses 4 Contingency 4 5 Margin money for working 10 Total project cost 80 Means of finance INR crore 1 Promoters contribution 24 2 Debt 56 Estimated manpower requirement Manpower requirement : ~ Functional managers Administrative manager Technical personnel Non-technical personnel Persons Persons Persons Persons Other office staff 4-8 Persons Page 16

17 Approvals & Incentives Clearances/ approvals required Approvals/clearance required Incorporation of company Allotment of land Environmental clearance and No objection certificate (NOC) under air and water pollution control acts Approval of construction and country planning Department to be approached and consulted Registrar of companies State industrial development corporation Approval from Ministry of Environment and Forests, Government of India Rapid Environment Impact Assessment (REIA) studies Approval from Gujarat Pollution Control Board Town and country planning Municipal and local authorities Chief inspector of factories Pollution control board Electricity board Finance Eligible financing institutions under the NPOF scheme are i) Commercial Banks, Regional Rural Banks (RRBs), State Cooperative Banks (SCBs), State Co-operative Agricultural and Rural Development Bank (SCARDBs), Scheduled Primary Urban Cooperative Banks (PUCBs), North Eastern Development Finance Corporation (NEDFI), and such other institutions which will be eligible for refinance from NABARD. ii) Cooperatives where they seek loan from National Cooperative Development Cooperation (NCDC) Registration under state sales tax act and Central and State excise act Exiting business Other approvals Sales tax department Central and state excise department Ministry of corporate affairs Secretariat of Industrial Approvals (SIA), Ministry of Industries and Government Indian FDA authorities Lab-related clearances: Clearance from institutional animal ethics committee (IAEC) Clearance from Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) for animal labs Three tier approval mechanism for R&D activities on recombinant DNA products, and genetically modified crops: Institutional Biosafety Committee (IBSC) at the institute, the Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology and the Genetic Engineering Approval Committee (GEAC) in the Ministry of Environment and Forests Clearance from Foreign Investment Promotion Board (FIPB) in case of foreign direct investment Infrastructure related: Approval/NOC required from civic bodies like Gujarat Water Supply and Sewerage Board, Gujarat Electricity Board, etc. Page 17

18 Approvals & Incentives Incentives from Government of India (GoI) Type Government policies Details DBT (regulatory body, established in 1986,for biotechnology and bioinformatics) aims at fostering innovations and has the mandate to develop adequately skilled personnel in the bioinformatics industry Development of the Biotechnology Information System network (BTISnet) in 1987 to establish a strong infrastructure and human resource network for bioinformatics DBT formulated the Bioinformatics Policy of India (BPI) in 2004 Financial FDI Government has allocated INR18.2b in the budget to Department of Biotechnology for % FDI under automatic route in biotechnology sector Incentives from Government of Gujarat The Government has established Gujarat Council of Science City and developed Gujarat Science City laid over 107 hectares of land and further 300 hectares under acquisition for future expansion of science city and related projects. The Government provides project cost assistance of upto 60% of project cost (excluding land and building) to R&D institutes. For assistance to contract/sponsored research work, assistance of up to 50% of the project cost is provided (excluding cost of land and building) subject to a maximum of US$100,000. The Government has also proposed a world class innovation center (icreate) to be developed on a crawling campus aimed to foster innovation and support to start-ups engaged in research and developed. Gujarat Infrastructure Development Board (GIDB) has planned a Center of Excellence (COE) in nutraceuticals research with an investment of INR 35 crore as part of its vision BIG 2020 document As per the Gujarat Industrial Policy 2015, following are the key incentives provided to the manufacturing sector: Interest subsidy of 5% up to maximum amount of INR2.5m (~US$37,500 1 ) per annum for five years on the term loan of machinery and equipment anywhere in the state. Capital investment subsidy of 10% loan amount disbursed by Bank/Financial Institution up to a maximum amount of INR1.5m in municipal corporations areas. Assistance for technology acquisition from recognized institution for manufacturing products will be provided by way of 50% of the cost payable subject to a maximum of INR5m (~US$ 75,000 1 ), including royalty payment for first two year. Assistance for venture capital to raise promoter contribution in the form of equity or loan through Gujarat Venture Finance Limited (GVFL). Page 18

19 Approvals / Incentives Draft Biotech Policy Government of Gujarat Incentives for Biotechnology Parks Capital Subsidy Horizontal BT 25% of gross fixed capital investment (GFCI) in buildings and infrastructure facilities, excluding the cost of land, subject to a ceiling of Rs. 25 crores Vertical Biotech 300 per sqft for built up area subject to a ceiling of INR 25 crore Registration/ stamp duty concession 100% for developer of biotech park Incentive on power tariff and electricity duty Incentives for Biotechnology Units Capital Subsidy 10% of the Gross Fixed Capital Investment (GFCI) upto ceiling of INR 5 crore for units with GFCI up to INR 50 crore Units with GFCI above INR 50 crore shall be eligible for a capital subsidy of INR 5 crore per unit and additional 5% of the incremental GFCI over and above INR 50 crore subject to an overall ceiling of INR 50 crore. Interest subsidy, Lease rental subsidy, VAT/CST/GST Incentive Incentive on power tariff and electricity duty Employment generation incentive through EPF contribution Patent assistance Incentives for Biotechnology Incubators Capital assistance (50% of GFCI with ceiling of 1 crore), mentoring assistance (INR 5 lakh annually, operating assistance (25% of funds mobilized with ceiling of INR 1 crore), software procurement (50% of cost subject to ceiling of INR 1 crore) Stamp duty & registration exemption Incentive on power tariff and electricity duty Incentives for Biotechnology Startups Stamp duty & registration reimbursement Marketing & Product Development lakh for product development and 1 lakh for marketing Matching Equity Support Lease Rental Subsidy Capital Assistance Interest Subsidy Patent Assistance Special provision for Mega Projects or Centre of Excellence by Global Players In addition an empowered single window mechanism is being set for biotech investor facilitation in Gujarat. Page 19

20 Department of Biotechnology, Government of India Department of Science and Technology, Government of Gujarat Gujarat Industrial Development Corporation Industries Commissionerate This project profile is based on preliminary study to facilitate prospective entrepreneurs to assess a prima facie scope. It is, however, advisable to get a detailed feasibility study prepared before taking a final investment decision. Gujarat State Biotechnology Mission Department of Science & Technology Udyog Bhavan, 11th Block, 9th Floor, Sector - 11 Gandhinagar , Gujarat - INDIA Phone/ Fax : / mdbtm@gujarat.gov.in