Plot No. 2-D1, Obadenahalli, 3 rd Phase KIADB Industrial Area, Doddaballapur taluk, Bangalore Rural District , Karnataka State.

Transcription

1 ON Plot No. 2-D1, Obadenahalli, 3 rd Phase KIADB Industrial Area, Doddaballapur taluk, Bangalore Rural District , Karnataka State.

2 Table of Contents 1. EXECUTIVE SUMMARY 2. INTRODUCTION OF THE PROJECT/ BACKGROUND INFORMATION 3. PROJECT DESCRIPTION 4. SITE ANALYSIS 5. PLANNING 6. PROPOSED INFRASTRUCTURE 7. REHABILITATION AND RESETTLEMENT (R&R) PLAN 8. PROJECT SCHEDULE & COST ESTIMATION 9. ANALYSIS OF PROPOSAL (FINAL RECOMMENDATION)

3 1. Executive Summary M/s STELIS Biopharma Pvt. Ltd., is setting up a new biopharmaceutical facility to manufacture Monoclonal Antibodies and Therapeutic Proteins. This industry is promoted by director Shri Jeo Thomas. The plant is proposed to construct in about 10 acres of land. Products to be manufactured are 1. Monoclonal Antibodies 2. Therapeutic Proteins. The Company requires 3500 KVA power connections for the proposed project. The company also proposes to install 3 no s DG set for standby arrangement. The source of water is from KIADB, Internal Bore wells and outside purchase. The unit requires about 216 KLD during the operational phase. About 6.0 KLD of Biologically loaded effluent is generated per day from the process. Zero discharge Effluent treatment plant along with kill system is provided. The Company proposes to have an Effluent Treatment Plant (ETP) within the premises. The plant locational advantages regarding the infrastructural facilities like power, water, and roads are fully developed and connected to National Highways. This is well connected to National Highways and Airports for Domestic and International Market. The total estimated cost of the project is Rs Crores.

4 2. Introduction of the Project/ Background Information 2.1 Identification of project and project proponent M/s STELIS Biopharma Pvt. Ltd., is located at Plot No. 2-D1, Obadenahalli, 3 rd Phase KIADB Industrial Area, Doddaballapur taluk, Bangalore Rural District , Karnataka State. M/s STELIS Biopharma Pvt. Ltd. is proposing to construct biopharmaceutical facilities to manufacture Monoclonal Antibodies and Therapeutic Proteins. 2.2 Promoters The affairs of the company are being managed by the director Shri Jeo Thomas. Joe Thomas Joe has worked with Strides for over 6 years and has over 28 years experience in Business Development, Strategy formulation and Global Marketing Prior to joining Strides, has held many significant positions in The STC of India, Procter & Gamble Asia Pacific and Bio Serve Biotechnologies. He brings broad and in-depth domain knowledge in Life Sciences (Pharma Biotech and OTC Health) and Strategic and General Management expertise. He has held senior leadership level positions as Regional Director for P&G s Asia Export Operations in Singapore and MD/COO Global in Bio Serve India/US. Joe also serves on several Management & Advisory Boards of start-up firms to help guide their growth strategies. He is a Post Graduate in Chemistry with a diploma in Foreign Trade. At Strides, Joe leads initiatives for identifying future value streams and building the capability and capacity to execute strategic business initiatives. He is a member of the Global Leadership Council (GLC) of the Company. 2.3 Brief description and nature of the project. The proposed project will be manufacturing Monoclonal Antibodies and Therapeutic Proteins. The installed capacity of 10 kg per month. The proposed project aims to meet the local & global demand for contract manufacturing & for in house consumption of microbial and mammalian cell culture based drug substance. The facility is intended to produce bio-chemicals and therapeutic proteins on a campaign basis and is designed to meet both USFDA and EU regulations in addition to the regional requirements of schedule M as per Indian Standards. The process of manufacturing bio-chemicals and therapeutic proteins are produced from raw materials like Sodium chloride, Potassium chloride, Sodium phosphate and Potassium phosphate etc. The industry will mainly concentrate on zero discharge of effluents. 4

5 2.4 Need for the project and its importance to the country and or region. Products that are of Monoclonal Antibodies and Therapeutic Proteins will be utilized & manufactured based on the requirement of domestic & export markets. 2.5 Export possibility Products manufactured from this facility will be exported to cater to the requirements of international market. 2.6 Employment Generation Man power required for the construction of project building will be employed from nearby places. Directly around 125 numbers of qualified, skilled and semi-skilled man power will be recruited both on temporary and permanent basis from nearby places. Thus, the industry provides an employment opportunity for local people. 5

6 3. Project Description 3.1. Type of project including interlinked and interdependent project, if any. Not applicable 3.2. Location with coordinates. Figure: Areal view of the proposed project site 3.3. Details of alternative sites, considered and the basis of selecting the proposed site particularly the environmental considerations gone into should be highlighted. Not applicable 3.4. Size & magnitude of operation The proposed project envisages the production of following Products: Sl. No. Products Installed capacity 1 Monoclonal Antibodies 8 kg per month 2 Therapeutic Proteins 2 kg per month Total 10 kg per month 6

7 3.5. Project process details (a schematic diagram/flow chart showing the project layout, components of the project etc.) should be given. Process Flow Diagram:

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13 3.6. Raw material required along with estimated quantity, likely source, marketing area of final products, mode of transport of raw material and finished products. Raw materials required, for the production of Monoclonal Antibodies and Therapeutic Proteins are Sodium chloride, Potassium Chloride, Sodium phosphate, Potassium phosphate, Citric acid, Sodium Citrate, Tris Base, Sodium Acetate, Sodium Hydroxide, Glucose and Sodium bicarbonate etc., are procured from the local markets. A. Raw Materials Availability and Source of Market: Raw material availability and source of marketing will be from local market. B. Raw Materials Requirement S.No. Raw Materials Details Quantity per Annum, Kgs. 1 Sodium chloride Potassium Chloride 3 3 Sodium phosphate 80 4 Potassium phosphate 3 5 Citric acid Sodium Citrate Tris Base Sodium Acetate Sodium Hydroxide Glucose Sodium bicarbonate Pluronic F Protien Free Media L-Glutamine Sorbitol Ethanol Phosphoric Acid Acetic Acid Hydrochloric acid Resource optimization/recycling and reuse envisaged in the project, if any, should be briefly outlined. The resource that are recycled and reused are shown in the above process details i.e., in material balance.

14 3.8. Availability of water its source, Energy/power requirement and sources should be given. Water Requirement The main source of water is from KIADB, In house bore well supply & outside purchase. The unit requires about 216 KLD for its manufacturing and other activities. Power Requirement The Company requires 3500 KVA Electrical power and HSD is used in DG set. The company also proposes to install 3 no s DG set of capacity 1500 KVA. 3.9 Quantity of wastes to be generated (liquid and solid) and scheme for their Management/disposal. Quantity of water requirement and waste water generated from the proposed project activity is listed below Activity Water requirement Wastewater Quantity in KLD KLD Process Water Washings Boiler/ Cooling tower Domestic RO Reject Total ETP will be designed for 125KLD. Total solid waste generated from the ETP as sludge is about 75 Kgs /day will be reused as manure for greenbelt development. The Biologically loaded effluent generated per day is 6 KLD Schematic representations of the feasibility drawing which give information of EIA purpose Not Applicable 14

15 4. Site Analysis 4.1. Connectivity The project site is located at Plot no: 2-D1, 3 rd Phase Industrial area, Obadenahalli, Doddaballapur taluk, Bangalore rural district. It is 3.92 Km away from Doddaballapur towards NW direction. The excess road of the site is connected to Nagadenahalli road which is connected to NH- 207 in North direction and nearest highway is National Highway-207 at a distance of 1.06 Km towards North direction. Doddaballapur Railway Station is 3.09 Km towards West direction from the proposed project site. Obadenahalli is at a distance of 0.21 Km towards SW direction from the project site. Hence, no new routes or alterations are required in this regard Land form, land use and land ownership The proposed project is located in Obadenahalli village nearer to Doddaballapur taluk. M/s STELIS Biopharma Pvt. Ltd. has purchased the industrial area plot from KIADB Topography (along with map) The Doddaballapur taluk is bounded by Tumakuru district on NW direction, Bangalore district on South direction, Chikkaballapura district is at NE direction and Kolar district on SE direction. The Doddaballapur lies at a distance of 27.6 kms from the Bangalore rural district. The ground is mostly of rocky upland, plateau and flat- topped hills at an elevation of about 900m above MSL. 15

16 Figure: Location of the proposed project site with 10Km radius demarcation on topo sheet 4.4. Existing land use pattern (agriculture, non-agriculture, forest, water bodies (including area under CRZ), shortest distances from the periphery of the project to periphery of the forest, national parks, wild life sanctuary, eco sensitive areas, water bodies (distance from, the HFL of the river)). In case of notified industrial area a copy of the Gazette notification should be given. Salient features Obadenahalli Doddaballapur Railway Station National Highway- 207 Distance in Km 0.21 (SW) 3.09 (W) 1.06 (N) 16

17 4.5. Existing Infrastructure The proposed project is well connected by road. The approach road to the project site is National Highway Water supply to the proposed project is from KIADB, in house bore well, outside purchase. Electrical demand is from KPTCL and DG set will be used during the power cuts & plant requirements. M/s STELIS Biopharma Pvt. Ltd. has a land comprising of following blocks: 1. Production block - Drug Product Formulation (DP block). 2. Ware house. 3. Utility. 4. Reception & lobby. 5. Canteen. 6. Security & Gate office. 7. Others- ETP, Tank farm area, Electrical substation & Fuel storage etc Climatic data from secondary sources The climate in Doddaballapur district has max temperature is C and min. temperature is 15 0 C. The Doddaballapur district receives lowest rainfall is 754 mm Social Infrastructure available The approach road to the project site is NH- 207 which is in the North direction. KPTCL will provide electricity to the industrial area & water requirement in the area is utilized from KIADB, in house bore well & outside purchase. Government Hospital, Police Station, Fire Station, Schools and Colleges are available at Doddaballapur which is located at 3.92 Km towards NW direction from the proposed project site. 17

18 5. Planning 5.1. Planning concept (type of industries, facilities, transportation, etc.,) Town and Country Planning Development authority classification. The proposed project is M/s STELIS Biopharma Pvt. Ltd. manufacturing industry. Qualified and Skilled man power is available in and around Doddaballapur & Bangalore both on permanent and temporary basis. The company is planning to have good team of employees in all areas. Looking in to long term planning, company will take all the necessary steps to develop a good team of work force. The company will provide basic amenities to staff & employees. The company will organize training classes for all the staff in the areas of Process up gradation, Quality Control, cost reduction techniques, Environment & Safety aspects etc Population Projection: Around 125 numbers of Qualified, Skilled and Semi-Skilled persons are employed in the operation of proposed project. Hence, the population inflation in the area is negligible Land use planning No. Type of Land Use Land Area in Sq. mtrs 1 Actual Plinth Coverage (DP & DS Block, Utilities, etc.) Actual Landscape Parking Area Internal Road Internal Pathways Total Area Assessment of infrastructure Demand (Physical & Social). There will not be any negative effect on the living conditions of people. Due to project activities, the surrounding areas are expected to improve by way of socio-economic development due to direct and indirect employment and the project will also lead to supporting utilities by improving job & business opportunities in the locality. 18

19 5.5. Amenities/facilities The company will provide all basic amenities to staff & employees such as Medical Health, Children education, transport, canteen facility, clothing, family welfare etc. as per policy of the company. 19

20 6.1. Industrial Area (Processing area) 6. Proposed Infrastructure No. Type of Land Use Land Area in Sq. mtrs. 1 DS Block (Ware House) DP Block Utility Block Reception & Lobby Canteen Security & Gate Office Others (ETP, Tank farm area, Electrical substation & Fuel storage) Actual Landscape Parking Area Internal Road Internal Pathways Total Area Residential Area (non-processing area) No housing is provided with in the proposed project site Green Belt Green belt with selected perennial plant species like Mango, Sapota, Custered, Coconut, Neem tree, Lawn etc., are grown in and around the site Social Infrastructure The proposed project is a located in KIADB industrial area, Obadenahalli village, Doddaballapur taluk having good infrastructure facility Connectivity Traffic and Transportation Road/Rail/Metro/Water ways etc. The project site is located in Obadenahalli Village, Doddaballapur taluk, Bangalore. It is 3.92 Km away from Doddaballapur. The approach road to the proposed site is Obadenahalli road at a 20

21 distance of 0.21 Km towards SW direction and National Highway- 207 is at 1.06 Km in North direction. Doddaballapur Railway Station is 3.09 Km towards West direction from the proposed project site. Obadenahalli is well connected to the major destinations by road. Hence, no new routes or alterations are required in this regard Drinking Water management (Source & Supply of water) The source of water is from KIADB, In house bore well, outside purchase. 10 KLD of water will be provided for domestic purpose Sewerage System About 9 KLD of waste water is generated from domestic purpose which is sent to the STP for further treatment Industrial waste management The industry shall adopt and follow an environmental management plan for abatement of pollution and overall enhancement of the quality of environment in and around the unit. It is mainly concentrating for zero discharge of effluents is concerned. About 6 KLD of domestic & biological effluent is generated from process and domestic effluent and it will be sent to Effluent Treatment Plant (ETP) for further treatment. Treated effluent will be reused for land scape & green belt development Solid waste management Solid waste shall collected & stored in HDPE drums and disposed to TSDF facility Power requirement & Supply/Source The company requires 3500 KVA Power connection for the proposed project and the same will be arranged by KPTCL. The company is also proposing to install 3 no s DG set of 1500 KVA as standby. 21

22 7. Rehabilitation and Resettlement (R&R) Plan 7.1. Policy to be adopted (Central/State) in respect of the project affected persons including home oustees, land oustees, and landless labourers (a brief outline to be given). Not applicable, since M/s STELIS Biopharma Pvt. Ltd. has purchased the property in KIADB industrial area from KIADB for manufacturing Monoclonal Antibodies and Therapeutic Proteins. 22

23 8.1. Project Schedule 8. Project Schedule & Cost Estimation The company is planning to procure ancillary machinery and have its trial production in June, The commercial production is planned to start from Aug Cost Estimates The estimated cost of the project is Rs. 248 Crores. Investment breakups of the proposed project are tabulated below: Description Amount ( In Rs. in Lakhs ) Land & Building Plant and Machinery Working capital margin & Contingencies Capital Investment

24 9. Analysis of proposal (Final recommendation) 9.1. Financial and social benefits with special emphasis on the benefit to the local people including tribal population, if any, in the area. Qualified and skilled man power is available in nearby places, both on temporary and permanent basis. The company is planning to have good team of employees in all areas. Looking in to long term planning, company will take all the necessary steps to develop a good team of work force. The company will provide all basic amenities to staff & employees such as Medical Health, Children education, transport, canteen facility, clothing, family welfare etc. as per policy of the company. The company will organize training classes for all the staff in the areas of process up gradation, quality control, cost reduction techniques, environmental safety, etc. 24