Production of Specialised Nutraceutical Products. Biotechnology. Government of Gujarat

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1 Production of Specialised Nutraceutical Products Biotechnology Government of Gujarat

2 Contents Project Concept 3 Market Potential 4 Growth Drivers 5 Gujarat Competitive Advantage 6 Project Information 8 - Location/ size - Infrastructure availability/ connectivity - Raw material/ Manpower - Key players/ machinery suppliers - Potential collaboration opportunities - Key considerations Project Financials Approvals & Incentives 13 Key Department Contacts 14 Page 2

3 Project Concept The concept The project envisages setting up nutraceutical manufacturing unit to cater to the specialized niche segments such as lactose intolerance, hypercholesterolemia, parkinson s, alzheimer, prader willi syndrome, phenylketonuria, etc. Nutraceuticals intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, on the basis of recognized scientific principles. Plants, Animals and Micro-organisms are the source of Nutraceuticals ingredients. Various risk factors related to health result from an imbalance in nutrition. Such imbalances in India are widely prevalent leading to adverse outcomes. The impact of these outcomes is a productivity loss of around 1% point of India s GDP. Analysis of our dietary intake reveals nutritional imbalances across most segments of population: Majority of the undernourished population (380 million) faces a challenge to meet foundation needs to maintain normalcy of being. There is a huge population (5750 million) that is nourished in calorie intake but not in terms of nutrient intake. They face the challenge of meeting condition specific needs in addition to foundation needs and could be the largest contributor in making India the future cardiovascular and diabetes capital of the world. There is another population segment (80 million) which consumes nutrients and calories more than norm due to their enhanced physical requirements. Since many of the drivers underlying nutrition related concerns are irreversible and natural sources of nutrients are being consumed in sufficient quantities, the requirement of an external intervention has become a non-negotiable imperative that can supplement food diet to help prevent nutrition related disorders and promote wellness rather than treat illness. Such products have collectively been called as nutraceutical. Nutraceuticals Dietary Supplements Medical Food Functional F&B Vitamins & Minerals Herbal Protein Supplements Probiotic & Others Functional Foods Functional Beverages Ayurvedic Extracts Algae Extracts Plant Extracts Protein Powder Probiotic Fortified Omega Fatty Acid Fortified Protein Bars & Others Energy Drinks Sports Drinks Fortified Juices The use of medical foods has grown steadily to include various products for the treatment of illnesses and disorders that have a nutritional association. These include chronic conditions such as diabetes, cardiovascular disease, and osteoporosis; inborn errors of metabolism; mitochondrial disease; wound healing; pain management; gastrointestinal disorders; Huntington s disease and neurological and psychological disorders such as Alzheimer s disease and depression. Page 3

4 Market Potential Functional components Class Components Class Components Fatty acids Polyphenols Carotenoids CLA N-3 FA (DHA, EPA) Anthocyanidine, Catechins, Flavanones, Flavones, Proanthocyanidine Beta carotene, Luteine, Zeaxanthin, Lycopene Phytoestrogen Probiotics/ Prebiotics/ Synbiotics Dietary fiber Daidzein, Genistein, Lignans Lactobacillus Fructo-oligosaccharides Insoluble fiber, Beta glucan, Whole grain Other key nutraceutical entities Androstenedione Dehydroepiandrosterone Ipriflavone Prebiotics and probiotics sulfate Carnitine Fenugreek Karela Taurine Choline Ginkgo biloba γ-linolenic acid Vanadium Chondroitin sulfate Ginseng α-lipoic acid Vitamin E Chromium Glucosamine Melatonin Alpha lipoic acid Coenzyme Q10 Glutamine Omega-3 fatty acids Phosphatidlyserine (fish oils) Creatine Gymnema Phytosterols Saponin Aldurazyme (treats mucopolysaccharidosis) Key nutraceutical drugs available in market Animi-3 with Vitamin D Caprelsa (treats medullary thyroid cancer (amtc) Cerdelga (treats Gaucher disease type 1) Cerezyme (treats Gaucher disease type 1) Fabrazyme agalsidase beta (treats Fabry disease) Thyrogen (treats thyroid cancer) Cosamin DS Liquid Co-Q10 Coenzyme Q10 Melatonin Time Release MaxiTears Dry Eye Formula Page 4

5 Market Potential β Galactosidase Beta galactosidase is widely used in food industry to improve sweetness, solubility, flavor, and digestibility of dairy products. β-galactosidase, also called beta-gal or β-gal, is a glycoside hydrolase enzyme that catalyzes the hydrolysis of β-galactosides into monosaccharides through the breaking of a glycosidic bond. β-galactosides is extracted from microorganisms such as fungi, bacteria and yeasts; plants, animals cells, and from recombinant sources. The enzyme has two main applications; the removal of lactose from milk products for lactose intolerant people and the production of galactosylated products. These enzymes have been immobilized on both organic and inorganic support via techniques such as adsorption, covalent attachment, chemical aggregation, microencapsulation, and entrapment. Free and immobilized preparations of beta galactosidases have been experimented in various applications such as industrial, biotechnological, medical, analytical, and in different other applications. Sources of β Galactosidase Escherichia coli, Kluyveromyces lactis, Bovine liver, Pseudomonas fluorescens, Aspergillus oryzae, Saccharomyces cerevisiae, etc. The commercial sources of microbial beta-galactosidases (lactases) include the yeasts species Kluyveromyces marxianus, Kluyveromyces lactis and Candida kefyr which are used to hydrolyse lactose in milk due to their optimum ph. Nutraceuticals viz-a-viz Pharmaceuticals Prevention and Wellness Neutraceuticals Primary Focus Pharmaceuticals Secondary Focus Medical Supervision FDA Approval Prescription Results Slow, but effective Fast, may have side effects Page 5 8 of the Top 15 risk factors are related to nutrition and contribute to nearly forty percent of total deaths and thirty percent of total disease burden in developing countries like India

6 Market Potential Global Nutraceutical Market Global Nutraceuticals Market (US$b) e 2016f 2017f 2018f 2019f 2020f Source: RNCOS The global nutraceutical industry is likely to grow at a CAGR of 8% between US and Asia-Pacific (APAC) are the largest markets for nutraceuticals. Demand in APAC is led by Japan and China. Ageing population and increasing health consciousness, besides increasing penetration of large retail set-up (such as hypermarkets) are the primary drivers for growth of nutraceuticals market globally Indian Nutraceutical Market India Nutraceuticals Market (US$b) Global Nutraceuticals Market by Region (%), 2015 European Union 26% Rest of the World 8% US 36% 2015e 2016f 2017f 2018f 2019f 2020f Source: RNCOS Functional food and beverages market Dietary supplements market Source: RNCOS Asia Pacific 30% The Indian nutraceuticals market is expected to witness double digit growth in the next four years and is expected to reach US$6.1b by 2020 Currently, India has 2% market share in global nutraceuticals market. However, the region is emerging on the global nutraceutical market with rising demand, largely driven by dietary supplements market. The demand in dietary supplements in India is mainly focused on consumption of alternative herbal medicines and supplements Penetration of nutraceuticals currently stands at 22.5% in urban India and 6.3% in rural parts, representing a huge untapped potential Page 6

7 Growth Drivers Growth in nutraceuticals market is likely to be driven by increasing focus on preventive healthcare and growing disposable income Focus on preventive healthcare due to chronic disease burden: Elderly population in India is expected to reach 143 million by 2021 from current 100 million. With ageing population, the chronic disease burden has also increased: Non-communicable diseases such as cardiovascular disease, diabetes, cancer and chronic obstructive pulmonary disease currently account for 53% of the total deaths and are expected to account for 67% of total deaths by With ageing of population and growing awareness about lifestyle-related disorders and risk factors, increase in life expectancy, rising cost of healthcare, and growing disposable income, there is a sharper focus on prevention of lifestyle related disorders using nutraceuticals Rapid retail growth: India s retail market is expected to double to US$ 1.3t by 2020 from US$600b in Increasing number of super markets, health and wellness chains, etc. would increase the consumers accessibility to nutraceutical products. Increasing co-prescription: In India, a multivitamin product is prescribed in In 16% of the prescriptions. Multivitamins are increasingly being co-prescribed in indications such as chronic alcohol liver cirrhosis, pregnancy, stroke, sepsis among others. Shift in consumption pattern and urbanization : With a rising urban population in India (33% in 2015, up from 27% in 1995), the consumption pattern has also changed in the nutraceuticals market. The traditional dietary supplements dominant market is now driven by functional foods. Emergence of new categories in health & wellness space: There is emergence of new niche categories such as anti-aging, energy boosting, skin care, digestive care, etc. are emerging as fast growing categories. Additionally, an increased product penetration in existing categories such as fortified water in health drink sub segment, fortified noodles, variety of flavours in sports and energy drinks, etc. is likely to drive the demand for nutraceuticals over the next five years Demand for specialized nutraceuticals is also driven by prevalent hereditary disorders such as the widespread lactose intolerance in India population. In a study conducted in 2015, 74% of Indians were found to be lactose- malabsorbers. Lucrative sector for pharma: Pharma companies are leveraging their existing brand equity in the nutraceutical sector, where they can bypass price regulations as nutraceutical products don't fall under the purview of the NPPA (National Pharmaceutical Pricing Authority). Even small and medium sized companies are now trying to de-risk their business by diversifying into the nutraceutical space Page 7

8 Gujarat - Competitive Advantage Gujarat Nutraceutical/ Pharmaceutical Overview Nutraceutical industry in Gujarat Upto domestic manufacturers including Anil Bioplus, West Coat Pharmaceuticals and Gujarat Research Allopathic Foundation (GRAF) have set up nutraceutical facilities in Gujarat. The state attracted investments of over INR 1000 crore in nutraceutical segment in Gujarat co-operative Milk Marketing Federation Ltd., (GCMMF Ltd) popularly known as AMUL is India's leader in probiotic yoghurt sales Gujarat Research Allopathic Foundation, Ahemdabad Investment: INR 150 crore Pharma clusters-gujarat Ahmedabad DSM, Vadodra Land: 5,000 meter square Investment: INR 60 crore Product Range: Fortitech premixes, micro-nutrition products ( tonnes per annum) Anil Bioplus, Halol,Vadodra Investment: INR 150 crore Product Range: Calcium and sodium gluconates via fermentation Ankleshwar Valsad Vapi Abbott, Jhagadia, Bharuch Land: 45 acres Investment: INR 450 crore Product Range: Global nutritional products (like Similac, PediaSure, Ensure, Mama s Best, Glucerna) Leading nutraceutical plants in Gujarat Pharma clusters in Gujarat Favourable climate, easy availability of raw material like dairy ingredients, proteins and vitamins are added advantages for the thriving nutraceutical industry in Gujarat Several international nutraceutical companies including Abbott and DSM have set up manufacturing base in Gujarat Besides nutraceutical manufacturing units, several cities in Gujarat including Ahmedabad, Vadodara, Valsad, Surat, Rajkot and Mehsana have a significant presence of natural extract based industry. Companies such as Unique Pharmaceuticals, JB Chemical, Cadila Pharmaceuticals, Paras Pharmaceuticals and Vasu Pharmaceuticals which are based in Gujarat, have international linkages in terms of import and export of natural extract products Government support 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 Page 8

9 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, Concordbiotech, 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 9

10 Gujarat - Competitive Advantage Other advantages Ease of doing business Only state which comply 100% with the environmental procedures. Gujarat fares highly when it comes to setting up a business, allotment of land and obtaining a construction permit. Flourishing economy Gujarat contributes 7.2% of the Nation s GDP and shows leadership in many areas of manufacturing and infrastructure sectors. Gujarat s SDP (State Domestic Product) at current price registered a growth of 11% during the year Strategic location and better infrastructure Located on the west coast of India, Gujarat is well connected to the major cities of the world by air and sea routes. The state has 45 ports, 12 domestic airports and 1 international airport in addition to an extensive rail and road network. Availability of skilled manpower The unique combination of technical training institutions (such as LM College of Pharmacy, Bombay College, B. V. Patel Pharmaceutical Education & Research Development Centre, Ahmedabad) coupled with leading management institutions such as IIM Ahmedabad, NIRMA, Mudra Institute of Communications etc., 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 Favourable labour policy The Gujarat government has recently passed the Labour Laws Bill (December 2015), to give an impetus to industrialization. The key reform includes a provision for out-ofcourt settlement to speed up the process labour related dispute resolutions. Better social infrastructure Gujarat has one of the lowest cost of living amongst the Indian states and is relatively less congested and less polluted, offering better standards of living to the inhabitants and providing a better environment to work. Page 10

11 Project Information Suggested locations Manufacturing plant producing specialized nutraceutical products (targeting lactose deficiency) could be based in these locations: Ahmedabad Bharuch Ankleshwar Vapi Valsad Key highlights for proposed plant Location Gujarat Area 19,444 square meters Incubation area 12,944 square meters Lab space 4600 sq. m Office space 1900 sq. m Estimated project cost INR 120 crore Phase I INR 70 crore Phase II INR 50 crore Employees Upto 30 Page 11

12 Project Information Infrastructure availability Logistics & connectivity Gujarat has an extensive outlay of robust physical, social and industrial infrastructure, 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 Air 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 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, 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 Utilities 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 12

13 Project Information Patents and technologies Patent name Synergistic composition for treating gluten intolerance Methods of treating lactose intolerance Caenorhabditis elegans model for alzheimer's disease Hyperforin derivatives and their use in alzheimer s disease A vaccine to manage noninfectious disease, phenylketonuria (PKU) Methods and compositions for treating phenylketonuria Methods for treating hypercholesterolemia Classification C07K-14/00, A61K-38/00 A61K-31/195, A61K-31/44, A61K-31/440 C12Q-1/04 C07C-45/67, C07C-49/757, A61K- 31/122 A61K-39/00 A61K-31/195 C12N-15/11 Source: ipindiaonline.gov.in/patentsearch/search/index.aspx Patent name Classification Method for diagnosing alzheimer's disease G01N 33/68 Hypoestoxide, derivatives, related compounds, and agonists thereof for treatment or prevention of neurodegenerative diseases A61K 31/336 Fondazione telethon A61K 31/5415 Modified ß-Galactosidase Pyridinone compound, pharmaceutical composition containing the same and use C12N 15/09 C07D 401/14 Methods for treating proteinopathies A61K 31/00 Source: The list is non-exhaustive. For more details please refer to provided source. Page 13

14 Project Information Production of β-galactosidase by Aspergillus oryzae by solid state fermentation Isolation of A.oryzae Viable spore count Inoculum Preparation Isolate of A.Oryzae to be isolated and maintained on Potato Dextrose Agar (PDA) Solid substrate fermentation The viable spore number on PDA slant determined and petriplates further inoculated with spore suspension Extraction of crude enzyme After 6 days of incubation, inoculum prepared from slant under aseptic conditions Enzyme Assay Solid substrate such as wheat bran and rice husk inoculated with spore suspension and incubated Estimation of total soluble protein Mixture of fermented matter and distilled water agitated on rotary shaker, followed by filtration and centrifugation Manufacturing of finished product (tablet) The crude enzyme assayed using ONPG as substrate Packaging and Storage Total protein content in supernatant determined using Lowry protein assay The purified enzyme is then compressed into the finished product (tablet) Finished product packed in two steps inner packaging comprising aluminium foil or PVC, external packaging comprising wrapper and package insert. Potential collaboration opportunities BIRAC DBT GoI supported Savli, Vadodara Council for Scientific and Industrial Research International Union of Food Science and Technology (IUFoST) Key considerations Nutraceuticals and dietary supplements are sold in India under the name of Fast Moving Healthcare Goods (FMHG). India has passed Food Safety and Standards Act in year 2006 a modern integrated food law to serve as a single reference point in relation to regulations of food products including nutraceuticals, dietary supplements and functional foods. A revised guidelines is underway. FSSAI Regulations to be complied Page 14

15 Project Information Leading players* Company Sigma - Aldrich Novozymes Hester Bioscience Limited Sanofi-Genzyme Business Activity Leading supplier to the global Life Science industry: solutions and services for research, development and production of biotechnology and pharmaceutical drug therapies. Manufacturers of variety of Beta Galactosidase through E.Coli, Kluyveromyces lactis, bovine serum, etc. Novozymes is based on bioinnovation. We apply industrial biotechnology to challenge and complement traditional thinking in manufacturing processes and applications, in order to identify sustainable solutions for our custome. Hester Bioscience Ltd. is one of the largest privately held pharmaceutical companies in India. An integrated healthcare solutions provider catering to over 45 therapeutic areas that include cardiovascular, gastrointestinal, analgesics, haematinics, anti-infectives and antibiotics, respiratory agents, antidiabetics and immunological. Genzyme has long been known for our expertise in the class of rare genetic diseases known as lysosomal storage disorders (LSDs). Company Dabur Sami Labs Himalaya Herbal Healthcare Business Activity Manufactures and markets a wide selection of herbal products like health supplements, digestives and natural cures. Manufactures & supplies nutritional supplements, cosmeceuticals, fine chemicals, specialty chemicals, phytochemicals, phytonutrients & herbal extracts for health products companies. Provides variety of herbal products in pharmaceuticals, personal care, animal health, and well being like pure herbs. Parry Nutraceuticals Conducts research and development work in microalgal biotechnology which has resulted in many potent health supplements like Spirulina, Natural Beta carotene and Astaxanthin. Pharmed Medicare Bionova Manufactures specialty ingredients for nutritional, pharmaceutical, animal feed, and personal care industries. Manufacturing, research and development in areas of nutraceuticals, biotechnology, animal nutrition and biopharmaceuticals. Titan Biotech, Altar Lifesciences, Finecure Pharmaceuticals Ltd., Sydler, Salius, K D Chem-Pharma, Nilrise Pharmaceuticals Pvt Ltd., Zeon Lifesciences Ltd., Meteoric Lifesciences, etc. *Source: Gujarat State Biotechnology Mission Page 15

16 Project Financials Estimated project cost SN Cost parameters Cost (INR crore) 1 Land & site development 7 2 Building and civil works 17 3 Plant and machinery 80 4 Environmental protection measures 3 5 Misc. fixed assets 5 6 Preliminary & pre-operative expenses 4 7 Provision for contingencies 4 Total cost 120 Means of Finance INR Crore 1 Promoters contribution 36 2 Debt 84 Estimated manpower requirement Manpower requirement at the site R&D Operations Management Ancillary support Q&A Page 16

17 Approvals / Incentives Approvals required The manufacture, storage, distribution, sale and import of nutraceuticals in India are regulated under the Food Safety and Standards Act (FSSA). Industrial approval: Secretariat For Industrial Approval(SIA), New Delhi, Development Commissioner, KASEZ Land for project: Allotment of plot/shed in the Industrial Estate from GIDC Environment clearance: No Objection Certificate from the Gujarat Pollution Control Board, Environmental Clearance (EC) from Ministry of Environment and Forest (MOEF), Consent and Authorization from GPCB on meeting requirement for effluent disposal Construction of building: Local Authority and GIDC to provide plan approval for industrial estate Incentives from Government of India (GoI) Government promoted development of special economic zone (SEZ) for pharma sector with 19 dedicated SEZs at various stages of development. Government liberalized foreign direct investment (FDI) policies in the pharma sector with 100% FDI comprising 74% under automatic route for brownfield projects and 100% for green field projects under the automatic route No industrial license required for manufacture of majority of the drugs and pharmaceutical products. Manufacturers are free to produce any drug duly approved by the Drug Control Authority. Under the Budget 2016, a special patent regime proposed wherein global income by way of royalty from worldwide exploitation of patents developed and registered in India will be taxed at the rate of 10% on a gross basis plus surcharge/cess. The income will not be subject to MAT. The general tax rate is ~35%. Under the proposal for goods and services tax (GST), GST implementation will reduce taxes on manufactured goods thereby impacting pricing. The central GST will reduce transaction cost and provide additional benefit of credit for service tax paid by manufacturers. Type Government policies Financial 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 Government has allocated INR18.2b in the budget to Department of Biotechnology for FDI 100% FDI under automatic route in biotechnology sector Page 17

18 Approvals / Incentives 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). Draft Biotech Policy Government of Gujarat Incentives for Biotechnology Parks Capital Subsidy Page 18 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

19 Approvals / Incentives Draft Biotech Policy Government of Gujarat 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 Gujarat State Biotechnology Mission 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

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